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8th Annual Pricing and Reimbursement Conference Develop and leverage value enhancing pricing and reimbursement strategies

11th – 12th June 2009, Sheraton University City Hotel, Philadelphia, USA

Key Speakers:

• Samir K.Bhattacharyya, Senior Director Global Marketing Home Hemodialysis Therapy, Baxter Healthcare • Alina Ciobanu, Manager, Health Economics & Patient Access, Astrazeneca • Dr. Elyce A. Biddle, Senior Research Economist, National Institute for Occupational Safety and Health, U.S Govt. • Robert Humenick, Head Pricing and Reimbursement, Wyeth Pharmaceuticals • Dee Woodhull, CIH, CSP Senior Consultant, ORC Worldwide • Dr. Kevin W. Mayo, Vice President, Bridgehead International, Professor, University of the Sciences in Philadelphia • Dr. Nick Poulios, VP-Pricing & Reimbursement Strategy, Patient Access & Public Policy, Elan Pharmaceuticals • Todd Evans, Director, Pricewaterhouse Coopers • Dr. Eugene Mick Kolassa, Chairman, Medical Marketing Economics, LLC • W. Neil Palmer, Vice President, Pricing & Reimbursement, RTI Health Solutions • Christian Schuler, Partner, Simon-Kucher & Partners • Senior Principal, Pricing & Market Access, IMS Consulting • William Haddad, CEO, Biogenerics • George Wyatt, Managing Director, Wyatt Health Management • Sanjay Bajpai, President, Institute of Pharmaceutical Management • Cyrus Chowdhury, Management Consultant, Insight Strategy Advisors

Platinum Sponsor:

Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Sponsor:

PriceSpective is a management consulting firm specializing in innovative strategies to identify, capture, and communicate value for products, portfolios, and companies in the biopharmaceutical arena. We are uniquely positioned to deliver expert guidance in integrated global pricing and reimbursement (P&R) strategy due to our depth of experience with pricing and market access dynamics and the active engagement of our senior leadership. A flat operational model ensures that senior personnel are deeply involved in all aspects of project delivery to guide and ensure actionable insights. PriceSpective has experience in over 30 markets across North America, Europe, Asia, Latin America, and the Pacific region. Offices in London, Los Angeles, and Philadelphia provide the geographic scope tosupport our global capabilities. These locations are staffed by a team of experienced pricing professionalswith a mix of pharmaceutical industry, payer, medical, and consulting backgrounds. For further information, please visit www.pricespective.com.

Media Partners:

PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm BioSpectrum BusinessMonitor Applied Management Consultants Pharma and Healthcare Insight

“The global pharmaceutical pricing and reimbursement environment is notoriously complex and continuously changing. Pharma companies must implement strategic pricing assessments across global markets and product lifecycle phases in order to develop effective pricing policies.” (Source: Business Insights)

Pharmaceutical companies are facing challenges in the present economic climate. An effective pricing strategy is vital in implementation of assessments of cost effectiveness.

Visiongain’s 8th Annual Pricing and Reimbursement conference is aimed at providing you with the opportunity to gain an understanding of the healthcare market dynamics and P&R environment and create an effective price policy. This 2 day event will help you achieve competitive advantage in current pricing and reimbursement environment.

Why Attend? • Share and discuss the key global pricing and reimbursement approaches • Learn about the current global pharmaceutical market • Analyse the future pricing trends in US • Gain insight into the role of health economics in pricing • Design innovative P&R strategies for biopharmaceuticals • Stay up-to-date on the latest innovations in pricing and reimbursement • Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies • Make the most profitable decisions

-Pricing-

Standard Rate for 2 day conference- £1299 + VAT:£194.85 = Total:£1493.85

Academic & Health Care Organisations Rate for 2 day conference- £699 + VAT:£104.85 = Total:£803.85

If you would like to send more than 1 person then take advantage of the 3 for 2 offer. Send 3 people but only pay for 2. Excellent networking opportunities. Secure your delegate place today!!

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

Conference Agenda

Day 1, Thursday, 11th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Dr. Eugene Mick Kolassa Chairman Medical Marketing Economics, LLC

10:10 Identifying and overcoming the limitations of current approaches to pharmaceutical pricing • Why basic economic assumptions and models don’t apply to pharmaceutical markets • Why many pricing research approaches either ask the wrong questions or lead respondents to the wrong answers • Why failure to develop true pricing strategies always leaves money on the table • Why a lack of policies leads to bad pricing • Why failing to understand value is the number one pricing mistake • How to bring some pricing discipline and pricing power to your firms

Dr. Eugene Mick Kolassa Chairman Medical Marketing Economics, LLC

10:50 How to develop an effective pricing and reimbursement strategy? • What is an effective strategy? What should the goals be for any strategy? • The development process and how to maximise value from the outset: the lessons of strategic pricing assessments • How to stand out from the crowd and develop genuinely innovative P&R strategies

Sanjay Bajpai President Institute of Pharmaceutical Management

11:30 Morning refreshments

11:50 Latest innovations in pricing and reimbursement • Assessing approaches to innovation in the realm of P&R • The importance of price optimization and individually tailored pricing • Innovative pricing strategies

Robert Humenick Head Pricing and Reimbursement Wyeth Pharmaceuticals

12:30 The future of strategic pricing for pharma Changing business landscape, future of pricing and strategic opportunities for the pharmaceutical industry Exploring how the industry’s approach to sales and marketing will change as it moves towards providing a range of new products and services to the market Addressing the relationship of value based benefits, outcomes and comparative effectiveness to future pricing strategies

Todd Evans Director PricewaterhouseCoopers

13:10 Networking lunch

14:30 Assessment of EU market growth of private healthcare vs public • Where is the trend line heading? Are traditional levels of public healthcare provision sustainable? • What is the landscape for private healthcare provision in Europe? • Increasing private provision of healthcare will involve addressing traditional ideological concerns, making private healthcare more attractive and driving accountability of public healthcare providers

15:10 Comparing the European/US/Canada P&R and HE&OR systems • What are the similarities between the systems and is there a trend to harmonization? • What are the crucial differences and which system is most effective? • What are the implications of developing trends in different P&R systems?

W. Neil Palmer Vice President, Pricing & Reimbursement RTI Health Solutions

15:50 Afternoon refreshments

16:10 China: Portfolio, Pricing & Market Access • Portfolio optimization: Multinational Acclimation • Pricing: Draconian Dragons • Market Access: Guanxi Reimbursement

Cyrus Chowdhury Management Consultant Insight Strategy Advisors

16:50 Analyzing the future pricing trends in US • Obamamania, will it effect the development of the P&R system in the US • Cost-effectiveness in assessing pharma products, will the US adopt such a system in line with spiralling healthcare costs • Will the US continue to be a lucrative country for headline pricing trends, where next? Panel members will be drawn from the speakers who take part on day one or day two.

Panellists: Dr. Nick Poulios, VP-Pricing & Reimbursement Strategy, Patient Access & Public Policy, Elan Pharmaceuticals Dr. Kevin W. Mayo, Vice President, Bridgehead International, Professor, University of the Sciences in Philadelphia Senior Representative, IMS

17:30 Closing remarks from the chair

17:35 Networking drinks reception Take your discussions further and build new relationships in a relaxed and informal setting

Day 2, Friday, 12th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Dr. Elyce A. Biddle Senior Research Economist National Institute for Occupational Safety and Health, U.S Govt.

10:10 How to maximize return on investment? • All about ROI: – What metrics are appropriate? – How do you actually analyse your ROI? • How do you ensure that your P&R strategy is genuinely and consistently creating value? • How will broader market and policy changes affect the measurement of ROI?

George Wyatt Managing Director Wyatt Health Management

10:50 Presentation to be announced

Alina Ciobanu Manager, Health Economics & Patient Access Astrazeneca

11:30 Morning refreshments

11:50 Strategy to implementation: Patients receive treatment choice • Show how health economics was used to increase reimbursement for therapy access • Demonstrate the need for collaboration between and within organizations for achieving target results • Discuss importance of communication strategy and execution plays a significant role in healthcare policy changes

Samir K. Bhattacharyya Senior Director Global Marketing Home Hemodialysis Therapy Baxter Healthcare

12:30 Assessment of trends in generic pricing in US • Pricing methods for generic medicines, what is the state of the art? • Countering generic medicines pricing; tools and tactics • Trends in generic pricing specific to the US, in what direction is this going?

William Haddad CEO Biogenerics

13:10 Networking lunch

14:10 Key global pricing and reimbursement approaches • Making a global play: is there a P&R strategy that is effective everywhere? • Can the development of a globally-focused strategy actually contribute to P&R harmonisation? • The importance of the product and evolving product trends to the feasibility of a global strategy

Senior Principal Pricing & Market Access IMS Consulting

14:40 Measuring the value of reducing the risk of occupational injury or illness on the firm • Reducing or eliminating hazards to protect employees can reduce costs and increase production • Value is found by reducing costs and increasing production, as well as accomplishing other business objectives • The specific financial benefits of reducing risk may be found throughout a business process, and can be substantial • Risk reduction may enable the achievement of non-financial benefits that have an indirect relationship to cost and production

Dr. Elyce A. Biddle Senior Research Economist National Institute for Occupational Safety and Health, U.S Govt.

Dee Woodhull CIH, CSP Senior Consultant ORC Worldwide

15:20 Pricing & reimbursement and market access strategies for new oncology products • Current global pricing & reimbursement landscape for new oncologic agents • Future trends and challenges in P&R for oncology products • Lifecycle P&R issues associated with oncology drugs • Developing successful international P&R strategies for oncologic agents • Risk-sharing for pharmaceuticals in the US and EU

Christian Schuler Partner Simon-Kucher & Partners

16:00 Afternoon refreshments

16:20 The ultimate patient access: keeping the patient off the illness curve

Dr. Nick Poulios VP-Pricing & Reimbursement Strategy, Patient Access & Public Policy Elan Pharmaceuticals

17:00 Health Economics and its contribution to effective and sustainable P&R strategies • The ever more important contribution of Health economics and Outcomes research as a key component of P&R strategies • Taking the lead on health economics to get ahead of restrictive regulation and regional idiosyncrasies • Expected evolution or maybe the revolution offered by health economics and outcomes research, a critical assessment

Dr. Kevin W. Mayo Vice President Bridgehead International Professor for Mayes College of HealthCare Business and Policy (University of the Sciences in Philadelphia)

17:30 Chair’s closing remarks

17:40 End of conference

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In Vitro Diagnostics: Market Analysis 2009-2024

New innovative report discusses how the global IVD market will develop in light of commercial opportunities and high technological potential

In vitro diagnostics constitute an important, growing healthcare industry and market, one that is increasingly biotechnological and closely aligned with pharma. In vitro diagnostic (IVD) tests provide essential information about physiological states, aiding diagnoses and choice of treatments. IVD’s usefulness in drug development – especially via biomarkers – constitutes a major advance, and an expanding market opportunity. Our new report – In Vitro Diagnostics: Market Analysis 2009-2024 – analyses the global IVD market comprehensively. This new study provides sales forecasts and discussions of emerging technologies and commercial opportunities, along with other information that you require.

From 2009 onwards, visiongain believes that worldwide investment in IVD testing will increase, due to a variety of factors including: • Greater awareness of tests’ availability and usefulness • More-widely applicable, accurate and usable tests emerging • Increasing appreciation of early diagnosis, both for patient quality of life and cost efficiencies • Progressive harnessing of biotechnologies, especially in more-personalised medicine, including theranostics, as well as medical research.

The global IVD market generated sales of over $40bn in 2008. Visiongain predicts that the market will generate nearly $60bn in 2014. What will it be worth in 2019 and in 2024? Which tests will be most commercially successful? How will sales for genetic screening perform in coming years? In Vitro Diagnostics: Market Analysis 2009-2024 answers these and other crucial questions.

Highlights of In Vitro Diagnostics: Market Analysis 2009-2024

Highlights of this report include: • Market sizes and sales growth of major IVD test types from 2009 to 2024 • Individual market forecasts and discussion of the following diagnostic areas: • Cholesterol • HIV • Pregnancy/fertility • Diabetes/glucose • Genetics • Influenza • Cancer/oncology • Drugs of abuse • Regional market analyses for IVD tests • Analyses of commercial drivers and restraints, including SWOT analysis • Discussion of the value of over-the-counter/at-home products • Discussion of diagnostic test companies.

Comprehensive analysis of the IVD market area

In Vitro Diagnostics: Market Analysis 2009-2024 examines that sector critically, through a comprehensive review of information sources, both primary and secondary. This report provides detailed sales forecasts, discussions of pipeline developments and analysis of commercial drivers and restraints. There are detailed tables and figures included, as well as expert opinion from an original survey. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to benefit your work.

Why you should buy In Vitro Diagnostics: Market Analysis 2009-2024

Benefits from purchasing this report include your receiving: • Detailed sales forecasts for specific IVD markets, with market shares and growth data • Discussions why certain IVD test markets will grow more quickly than others, with future and pipeline developments covered • A review of leading IVD companies, and recent alliances/mergers • Insights into regional differences in IVD adoption • Analyses of which markets are most saturated • Analyses of which markets have the most scope and potential for expansion • A discussion of unmet medical needs and how these will affect certain markets, as well as assessment of commercial drivers and restraints.

Visiongain believes that there will be increasing adoption of diagnostic tests worldwide, especially in prevention of disease and in early diagnosis. The market for IVD tests will expand, but some fields and national markets will grow more quickly than others. Continuing advances in diagnostic tools, greater availability of over-the-counter tests and quicker response times will make IVD testing more valuable to patients, medical professionals, industry and healthcare systems. In which countries will IVD sales grow the most? How will pregnancy test sales perform in the future? Will at-home HIV tests reach the worldwide market? In which countries are drugs of abuse tests most commonly used? What is the market outlook for cholesterol tests? This report covers these and other crucial questions about the IVD market and industry from 2009 onwards.

You can order this report today

In Vitro Diagnostics: Market Analysis 2009-2024 will provide you with a greater understanding of the expanding IVD market worldwide. You can stay ahead by ordering this report today. You should read this report today. Contact me now to order your copy.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP 1999.

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP 3499. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP 4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP 6999. -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary 1.1 Focus of this Report 1.1.1 This Report Discusses IVD Tests According to Applications 1.1.2 How Companies are Discussed 1.1.3 Forecasts Include Laboratory-Only Companies 1.2 Crucial Points 1.2.1 Worldwide IVD Market Will Grow Well for the Next 15 Years 1.2.2 Short-Term Growth Led by Pregnancy, Influenza and Oncology Tests 1.2.3 SWOT Analysis 1.3 Aim, Scope and Format of this Report 1.3.1 Chapter Outlines 1.4 Research Methods

2 In Vitro Diagnostics (IVD) and Point of Care 2.1 What Are IVD Tests? 2.1.1 Biomarkers 2.2 How IVDs are Regulated by the FDA 2.3 Types of IVD Tests 2.4 Diagnostics Historically Separate from Pharmacological Treatment 2.5 Relative Costs of IVDs 2.6 Point of Care Tests (POCTs) 2.6.1 POCTs and Hospital Stays 2.6.2 What Home POCTs Say About the IVD Market 2.7 Laboratory IVD Tests versus Point of Care Testing 2.7.1 Diagnosis Turnover Rates 2.7.2 How Quickly Are Results Needed? 2.7.3 How Much do Shorter Turnaround Times Improve Treatment? 2.7.4 Economies of Scale

3 IVD Market Summary 3.1 Whole Market Analysis 3.2 Market Summary of Five IVD Tests with 2008 Sales of Over $5bn 3.3 Market Summary of Four IVD Tests with 2008 Sales Under $5bn

4 Genetic Tests 4.1 Genetic Tests: Medicine of the Future? 4.1.1 Genetic Tests and Tailored Medicine 4.2 Market Forecast, 2009-2024 4.3 2009 Call for Genetic Test Standards 4.4 Genetics and Oncology 4.4.1 BRCA1 and BRCA2 Genetic Tests 4.4.2 Genetics and HER2: Success Story 4.4.3 HER2 and Cancer: How IVDs and Therapy Interconnect 4.4.4 Genetics and Response to Gleevec for Gastrointestinal Cancer 4.5 Genetics and Statins 4.5.1 Celera’s Genetic Test for Statin Responsiveness: the KIF6 Allele 4.5.2 Interview with Thomas White, PhD, Chief Scientific Officer and VP of Research, Celera 4.6 Genetic Test Companies 4.6.1 Myriad Genetics 4.6.2 deCODE Genetics 4.6.3 23andMe 4.6.4 Navigenics 4.7 Market by Region: Forecast Discussion 4.7.1 US 4.7.2 Japan and China 4.7.3 Europe

5 Oncology Tests 5.1 How Cancer is Diagnosed: Currently and in the Future 5.2 Market Forecast: 2009-2024 5.3 Lung Cancer 5.3.1 Almac Diagnostics 5.3.2 Lung Cancer IVD: Worldwide Unmet Need 5.4 Prostate Cancer 5.4.1 Gen-Probe Incorporated 5.4.2 Gen-Probe and DiagnoCure Incorporated 5.4.3 Timeline for a PCA3 Point of Care Test 5.5 Colorectal Cancer 5.5.1 Quest Diagnostics 5.5.2 DiagnoCure Inc.: Molecular Diagnostics for Cancer 5.5.3 Aventir Biotech LLC: First FDA-Approved Faecal Occult Blood Test 5.5.4 Alpha Laboratories 5.6 Human Papillomavirus (HPV) and Cervical Cancer 5.6.1 Digene/Qiagen 5.6.2 Cytyc and Hologic

6 Diabetes/Glucose Tests and Monitoring 6.1 Brief Overview of Diabetes 6.2 Market Forecast, 2009-2024 6.3 Glucose IVD Market by Subdivision: Diagnostic Tests and Monitoring Devices 6.4 Types of Tests 6.4.1 Blood Tests 6.4.2 Urine Tests 6.5 Diabetes IVD Assessment Targets 6.5.1 Ketones 6.5.2 Microalbuminurea 6.5.3 Glucose 6.6 Top Diabetes IVD Companies 6.6.1 Lifescan/Johnson & Johnson 6.6.2 Roche 6.6.3 Abbott 6.6.4 Bayer Diagnostics 6.6.5 Home Diagnostics, Inc. 6.7 Immediate Results: Crucial for Glucose Monitoring and Point of Care Testing 6.8 Future Opportunities in the Diabetes/Glucose IVD Market 6.9 Market by Region: Forecast Discussion 6.9.1 India and China 6.9.2 United States 6.9.3 Europe

7 Cholesterol Tests 7.1 Market Forecast, 2009-2024 7.2 Cholesterol Testing Companies 7.2.1 Polymer Technology Systems (PTS) 7.2.2 Roche Diagnostics 7.2.3 Home Access Health Corporation 7.2.4 Atherotech, Inc. 7.3 Market by Region: Forecast Discussion 7.3.1 Europe 7.3.2 US 7.3.3 India 7.3.4 South America

8 HIV Tests 8.1 Market Forecast, 2009-2024 8.2 OTC HIV Tests: The Debate 8.2.1 Home Testing vs. Home Sampling 8.2.2 Home Tests and Home Results Not Approved 8.3 HIV Testing Companies 8.3.1 Home Access Health Corporation 8.3.2 OraSure Technologies 8.3.3 MedMira 8.3.4 Novartis/Chiron 8.4 Market by Region: Forecast Discussion 8.4.1 Europe 8.4.2 US 8.4.3 Asia 8.4.4 Africa: Where the HIV Problem is Worst

9 Influenza Tests 9.1 Market Forecast, 2009-2024 9.2 Test Targets 9.3 Typing: A and B Strains 9.3.1 Rapid Tests: 15 Minutes or Less 9.4 Rapid Test Companies 9.4.1 Becton, Dickinson and Company 9.4.2 Inverness Medical Innovations, Inc. 9.4.3 Quidel 9.4.4 SA Scientific, Ltd. 9.4.5 Meridian Bioscience, Inc. 9.5 2009 Swine Flu as Case Study 9.6 Avian Flu: H5N1 9.6.1 IVD Market Forecast and Avian Flu 9.6.2 Avian Flu Tests 9.6.3 Arbor Vita Corporation 9.7 Market by Region: Forecast Discussion 9.7.1 US 9.7.2 Japan: The Second-Largest Flu Market 9.7.3 Europe 9.7.4 Hong Kong: Site of Original Avian Flu Outbreak in Human Beings 9.7.5 Sites of Recent Avian Flu Outbreaks

10 Drugs of Abuse Tests 10.1 Market Forecast 10.2 Types of Tests: Individual and Multiple Assays 10.3 OTC Test Companies 10.3.1 Inverness Medical Innovations/First Check Diagnostics 10.3.2 BTNX Inc. 10.3.3 Phamatech 10.3.4 Alfa Scientific 10.3.5 ACON Laboratories/Inverness Medical Innovations 10.4 Market by Region: Forecast Discussion 10.4.1 US 10.4.2 Europe: The European Workplace Drug Testing Society

11 Fertility, Ovulation and Pregnancy Tests 11.1 Market Forecast 11.2 Male and Fertility Tests: Relative Sales 11.3 Over-the-Counter Tests: The Largest Market? 11.3.1 Pregnancy Tests 11.3.2 Ovulation Tests: As Contraceptive and Pro-Conception Tools 11.3.3 Female Fertility Tests 11.3.4 Male Fertility Tests: Improving Products 11.4 OTC Test Companies 11.4.1 Church & Dwight Co, Inc. 11.4.2 Swiss Precision Diagnostics: Inverness Medical Innovations and Procter & Gamble 11.4.3 Johnson & Johnson 11.4.4 Genosis PLC/The LifeStyle Company 11.5 Market by Region: Forecast Discussion 11.5.1 US 11.5.2 Europe 11.5.3 Japan 11.5.4 South America

12 Conclusions 12.1 Most IVD Test Markets are Growth Markets 12.2 Growth Drivers 12.2.1 The Greatest Unmet IVD Need 12.3 Growth-Limiting Factors 12.3.1 Growth-Limiting Factors for Specific Markets 12.3.2 Saturated Markets 12.4 Over the Counter Tests: The Added Value of Convenience 12.5 Diagnostic Innovation: Improving the Future of Medicine

List of Tables Table 1.1 Strengths and Weaknesses in the Current IVD Market Table 1.2 Opportunities and Threats in the Future IVD Market Table 3.1 IVD Tests Whole Market Forecast with Subdivisions, 2009-2024 ($bn) Table 3.2 IVD Tests Whole Market Forecast 2009-2024 ($bn) Table 4.1 Genetic Tests Forecast, 2009-2024 ($bn) Table 5.1 Oncology Market Forecast, 2009-2024 ($bn) Table 5.2 Top Five Cancers and Associated Deaths per Year Table 6.1 Diabetes / Glucose Tests Forecast, 2009-2024 ($bn) Table 6.2 Diabetes IVD Market Forecast by Subdivision, 2009-2024 ($bn) Table 6.3 Glucose Meter Companies and Products, 2009 Table 6.4 Glucose Meter Companies and Percentage of Paediatric Users, 2006 Table 7.1 Cholesterol Levels and Associated Risks Table 7.2 Cholesterol Tests Forecast, 2009-2024 ($bn) Table 8.1 HIV IVD Tests Market Forecast, 2009-2024 ($bn) Table 8.2 HIV Infection Numbers and Prevalence Rates in Asian Countries, 2007 Table 9.1 Influenza Market Forecast, 2009-2024 ($bn) Table 9.2 Types of Laboratory Influenza Tests (Non-rapid), 2009 Table 9.3 Rapid Influenza Tests Appropriate for Any Clinical Setting, 2009 Table 9.4 Rapid Influenza Tests Requiring Specific Laboratory Conditions, 2009 Table 9.5 Influenza Market Forecast, Including Avian Flu Test, 2009-2024 ($m) Table 9.6 Countries with Confirmed Human Avian Flu Cases, 2009 Table 9.7 Month, Year, and Country of Human Avian Flu Cases, January 08-March 09 Table 10.1 Drugs of Abuse IVD Forecast, 2009-2024 ($bn) Table 10.2 European Country WDT Regulations and Industries Table 11.1 Pregnancy and Fertility Tests Forecast, 2009-2024 ($m) Table 11.2 Sales Forecast for Male and Female Fertility Tests, 2009-2024 ($m)

List of Figures Figure 3.1 IVD Test Whole Market Forecast, 2009-2024 ($bn) Figure 3.2 Market Forecast 2009-2024: IVD Tests with Over $5bn in 2008 Sales ($bn) Figure 3.3 Market Forecast 2009-2024: IVD Tests with Less Than $5bn in 2008 Sales ($bn) Figure 4.1 Genetic Tests Forecast, 2009-2024 ($bn) Figure 5.1 Oncology Market Forecast, 2009-2024 ($bn) Figure 6.1 Diabetes / Glucose Tests Forecast, 2009-2024 ($bn) Figure 6.2 Diabetes IVD Market Forecast by Subdivision, 2009-2024 ($bn) Figure 6.3 Glucose Meter Companies and Percentage of Paediatric Users, 2006 Figure 7.1 Cholesterol Tests Forecast, 2009-2024 ($bn) Figure 8.1 HIV IVD Tests Market Forecast, 2009-2024 ($bn) Figure 9.1 Influenza Market Forecast, 2009-2024 ($bn) Figure 9.2 Influenza Market Forecast, Showing Avian Flu Test ($m), 2008-2024 Figure 10.1 Drugs of Abuse IVD Forecast, 2009-2024 ($bn) Figure 11.1 Pregnancy and Fertility Tests Forecast, 2009-2024 ($m) Figure 11.2 Sales Forecast for Male and Female Fertility Tests, 2009-2024 ($m) Figure 11.3 Fertility Test Market Breakdown, 2008

Companies Listed 23andMe Abaxis, Inc. Abbott ACON Laboratories Alfa Scientific Almac Diagnostics Alpha Laboratories American Diabetes Association American Liver Foundation Arbor Vita Corporation Arkray USA (Hypoguard) Armkel LLC Atherotech, Inc. Atria Genetics Aventir Biotech LLC AVERT Bayer Diagnostics Becton, Dickinson and Company Berkeley HeartLab Biomedix Inc. British In Vitro Diagnostics Association (BIVDA) BTNX Inc. Catalyst Oncology Celera Centers for Disease Control and Prevention (CDC) Chiron Church & Dwight Co, Inc. Coalition for 21st Century Medicine County of San Diego Health and Human Service Agency Child Welfare Services Cytyc deCODE Genetics Diabetic Supply of Suncoast DiagnoCure Incorporated Diagnostic Devices Digene drugstore.com Duke Medicine European Association of Urology European Workplace Drug Testing Society First Check Diagnostics Corp. Food and Drug Administration (FDA) Fox Chase Cancer Centre Genentech Genetics and Public Policy Center at Johns Hopkins University Genosis PLC Gen-Probe Incorporated GlaxoSmithKline Google Hologic Home Access Health Corporation Home Diagnostics, Inc. Inverness Medical Innovations, Inc Johnson & Johnson Liberty Medical LifeScan Lifestream Technologies Mayo Clinic McNEIL-PPC, Inc Medical Solutions MedMira Medscape Merck KGaA Meridian Bioscience, Inc. Myriad Genetics, Inc. Myriad Pharmaceuticals, Inc. National AIDS Trust (UK) National Cancer Institute (US) National Institutes of Health (NIH) Navigenics New Enterprise Associates (NEA) Novartis OraSure Technologies Phamatech Placer County (California) Health and Human Services and Probation and Parole Departments Polymer Technology Systems (PTS) Procter & Gamble Qiagen Quest Diagnostics Quidel Radboud University, Nijmegen (NL) Radiant Research Randox Roche Diagnostics SA Scientific, Ltd. Schering-Plough Scripps Genomic Medicine State of Oregon Department of Corrections Substance Abuse and Mental Health Services Administration (SAMSHA) Swiss Precision Diagnostics The LifeStyle Company Third Wave Technologies U.S. Diagnostics UNAIDS United States Department of Health and Human Services (HHS) University of Maryland WaveSense World Health Organization

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Dissolution Testing, Bioequivalence and Bioavailability Strategies

Assessing emerging applications, methodologies and techniques
24th-25th June 2009, London, UK

Key Speakers • Dr. Anita Klute, Senior Principal Scientist, Pfizer • Donal Murphy, Senior Scientist, AstraZeneca • Dr. Daniel Abran, Director, Scientific Development and Compliance, Sandoz • Dr. Nilufer Tampal Phd, Pharmacologist, CDER/FDA • Dr. Rajan K Verma, Group Leader, OCRS Department, Ranbaxy Research Laboratories • Dr. Rolf Hilfiker, Vice President, Head of Department Solid-State Development, Solvias • Kevin Ryan, Associate Director Analytical R&D, Pfizer • Dr Idris M.El Mahdi, Associate professor of pharmaceutics, Arab Medical Sciences University • Mr Cyrille Pertuy, Director Drug Product Development – Analytical Development, Ipsen • Dr. Christine Smith, Research Formulations, Pfizer • Michael Gamlen, Managing Director, Pharmaceutical Development Services • Dr Kevin Nott, Applications Scientist, Oxford Instruments Magnetic Resonance • Jon Howells, Consultant, PA Consulting • Dr Barbara Conway, School of Life and Health Sciences, Aston University • Dr Carlos R Camozzi, Medical Director, Orphan Europe • Hubert Pellikaan, Managing Director, Nextstep Pharma BV

Associate Sponsor :

For further information, please visit www.oxford-instruments.com

Media Partners: PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm

The importance of dissolution testing has increased and it has undergone lot of improvements in the last few years. Dissolution testing continues to be used as a critical tool for quality control to ensure performance of production lots and in selection of formulation development.

Following the success of our last conference Visiongain is pleased to invite you to its 2nd Annual Dissolution Testing, Bioequivalence and Bioavailability Strategies Conference. This 2 day event will bring together for you key industry players and academics from analytical research and development to share the latest innovations, formulations, developments in dissolution testing, bioequivalence and bioavailability.

Reasons to attend: • Explore advantages of different roles and applications of dissolution testing, bioequivalence and bioavailability • Be a part of the unique opportunity to hear special series of presentations from Pfizer • Gain a more in depth understanding of the IVIVC • Discuss the role of dissolution and disintegration in the early development of tablet formulations • Hear the latest strategies for development of dissolution methods for IR products • Understand recent European regulatory requirements for bioavailability and bioequivalence

-Pricing-

Standard Rate for 2 day Conference- £1299 + VAT:£194.85 = Total:£1493.85

Academic & Health Care Organisations Rate for 2 day conference- £699 + VAT:£104.85 = Total:£803.85

• If you would like to send more than 1 person then take advantage of the 3 for 2 offer. Send 3 people but only pay for 2.

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd

Conference Agenda

Day 1, Wednesday 24th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Dr. Anita Klute Senior Principal Scientist Pfizer

10:10 Impact of solid form on solubility and dissolution rate • Relationship between bioavailability, solubility and dissolution rate • Dependence of solubility and dissolution rate on solid form • Possible solid forms: polymorphs, hydrates, amorphous, salts, cocrystals • Stabilisation of the amorphous form • Characterisation of solid forms (XRD, Raman, DSC, DVS, TG-FTIR)

Dr. Rolf Hilfiker Vice President, Head of Department Solid-State Development Solvias

10:50 Applications of dissolution testing and similarity function in the evaluation of compressed microcapsules/microspheres • Significance of direct compression of of microspheres for industry • Selection of excipients for microspheres protection • The placebo pellets approach • Use of dissolution testing and similarity function for the estimation of degree of damage to drug pellets • Examples of directly compressed microspheres from the pharmaceutical industry

Dr. Idris M. El-Mahdi (Ph.D) Associate Professor of Pharmaceutics & Dean Arab Medical Sciences University

11:30 Morning refreshments

11:50 Developing dissolution methods for insoluble compounds – Highlighting how to overcome instability in aqueous media • Method development strategies for BCS Class II / IV drugs • Challenges in dissolution of compounds likely to hydrolyse in water • Benefits of anticipating automation early in the development

Cyrille Pertuy Director Drug Product Development – Analytical Development Ipsen

12:30 The role of dissolution and disintegration in the early development of tablet formulations containing poorly soluble substances • Justification for use of disintegration testing in QC testing of immediate release formulations, regardless of BCS classification • Application of dissolution in formulation selection • Applying ‘QbD’ philosophy to dissolution strategy for early clinical trials (up to PhIIa) – e.g. criticality of parameters such as particle size in ensuring consistent performance in immediate release products

Dr. Anita Klute Senior Principal Scientist Pfizer

13:10 Networking lunch

14:30 The role of dissolution testing in building the understanding and predicting bioperformance in solid oral dosage forms

Dr. Christine Smith Research Formulations Pfizer

15:10 Opportunities for the application of quality by design to dissolution strategy in commercial formulation development • Why we have a dissolution test • Elements of QbD • Application of QBD to the dissolution test and opportuinities for surrogacy • Key Quality Attributes for in vitro and in vivo performance tests • Development of QbD dissolution/ performance test strategies for IR and MR commercial formulations • QbD performance testing post commercialisation • Future of QbD

Kevin Ryan Analytical R&D Pfizer

15:50 Afternoon refreshments

16:10 Novel approach to combined dissolution and assay tests based on rapid extraction techniques • Principles behind rapid non invasive extraction • Systems with feedback • How assay and dissolution might be achieved

Jon Howells Consultant PA Consulting

16:50 Dissolution testing of non-conventional dosage forms • Value of dissolution testing for non-conventional dosage forms • Delivery of drugs to the oral cavity • Dissolution testing of chewing gum • Release of nicotine from medicated chewing gum formulations

Dr Barbara Conway School of Life and Health Sciences Aston University

17:30 Closing remarks from the chair

17:35 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting

Day 2, Thursday 25th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Strategy for development of discriminatory dissolution methods for IR products • Dissolution development with reference to the BCS framework • Method screening and optimisation • Assessing discrimination and biorelevance • Setting specifications

Donal Murphy Senior Scientist AstraZeneca

10:50 Case study: Use of dissolution testing to evaluate novel nanoparticles in suspension and tablets Nanosuspensions have been prepared using a new, scalable technology without the formation of amorphous material They can be isolated by spray drying to produce a readily compressible material A range of dissolution testing techniques have been used to compare the properties of the suspensions and spray dried material This has facilitated the development of rapidly dispersing tablets on a very small scale.

11:30 Morning refreshments

11:50 The role of low field MRI in tablet formulation • What information it provides • Integration of USP IV • Application to controlled and modified release dosage forms

Dr Kevin Nott Applications Scientist Oxford Instruments Magnetic Resonance

12:30 Dissolution testing of suspensions • Critical parameters in USP II and IV apparatus • Comparative analysis of dissolution vs Particle size • Case studies and IVIVC • Regulatory requirements

Dr. Daniel Abran Director, Scientific Development and Compliance Sandoz

13:10 Networking lunch

14:30 Dissolution testing for ANDA submissions

Dr. Nilufer Tampal Phd Pharmacologist CDER/FDA

15:10 Bioavailability studies of orphan drugs in paediatric population • The challenge of paediatric sample size • PK variability in children • Healthy volunteers vs. patients

Dr Carlos R Camozzi Medical Director Orphan Europe

15:50 Afternoon refreshments

16:10 IVIVC for generic drug products • Design of generic drug product • Role of IVIVC in generic drug product development and approval • Case histories

Dr. Rajan K Verma Group Leader, OCRS Department Ranbaxy Research Laboratories

16:50 Practical thermodynamics and solubility enhancing • Method of finding adequate combinations of excipients to boost API solubility • USP dissolution profiles from test formulations

Hubert Pellikaan Managing director Nextstep Pharma

17:30 Chair’s closing remarks

17:40 End of Conference

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Global Antivirals Market Analysis & Forecasts 2008-2023

Investors are turning their attention to antiviral drug discovery because there is a renewed recognition of the promising opportunities in this $20bn market. Twenty years from the inception of focused antiviral drug research, there are 8 blockbuster drugs currently on the market. Its double-digit growth makes it a standout segment within the general anti-infective therapeutic class. You should be maximizing your opportunities in this market. The opportunities for success are there now, you should capitalize on them immediately.

The key driver of the market is the rapid development of resistance to existing therapies by the evolving viruses. The constant need to update the pipeline fuels your investigative and commercial interest in this market – so you must act on this today. This report – Global Antivirals Market, 2008-2023 – analyses the global antiviral market comprehensively, outlining where you should aim your future developments to guarantee success. The analyses tackle different aspects of the market, including the leading therapeutic classes, leading antiviral products, key industrial players as partners and financial prospects and opportunities. The report also delivers in-depth predictions concerning how the market will develop from present until 2023.

Global Antivirals Market, 2008-2023 examines the market for antivirals critically, through comprehensive primary and secondary research. In addition to consultation with experts in the industry, this research involved a detailed study of policy documents, industrial reports and relevant news. Essentially, visiongain also applied unique in-house techniques such as our developed financial forecasting, SWOT analyses and qualitative projections which are unavailable elsewhere. The result is a comprehensive market-focused study with detailed financial analyses and uniquely informed opinion on the future of the antivirals market.

In particular, our new Global Antivirals Market 2008-2023 report concentrates on the following essential aspects of that market: • Antiviral drugs assessment and opportunities • Key industrial players in the global antivirals market • Forecasts of global antivirals market from 2008-2023, including in-house developed forecasts of the leading therapeutic agents • Forecasts for the antiviral therapies in the seven leading developed pharmaceutical country markets and two leading developing markets • Drivers and opportunities in the global antivirals market • Restraints and threats in the global antivirals market • Key opinion from relevant experts – full interview transcripts are included with the report (unavailable anywhere else) • Coverage of pipeline developments in the antivirals market, with discussion of trends from the present onwards

Why you should buy this report: • To receive a comprehensive analysis of the prospects for the antivirals industry from 2008-2023, including sales forecasts, major growth areas and most exciting pipeline developments • To discover predicted revenues, growth rates and other key metrics in the global antivirals market from 2008-2023, with leading brands and principal market segments covered • To determine the forces that influence the global antivirals market: • Drivers and restraints on that market • Competition • Strengths, weaknesses, opportunities and threats. • To find out where the global antivirals market is heading from 2008 onwards – both technologically and commercially

Further unique benefits to you when you order this report: • Full searchable report when you buy the company or corporate editions • Copies can be printed conveniently for offline reading • Expert opinion from industry sources – our independent viewpoint means industry experts talk openly and frankly to our analysts • Packed with analysis, figures, graphs and tables.

The information contained in this report is not available in any other source and is essential reading for you and your colleagues. By ordering and reading this report you can gain market advantage on your competitors today. When aligned with your in-house findings we are confident you will continue to succeed over the next 15 years.

I look forward to receiving your order today.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

Departmental copies (this entitles up to 5 individual users in your department) of this report are available for only GBP2999. This is not suitable for library usage.

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

Visiongain – Ltd.

        Table of  contents

      1 Executive Summary

1.1 Aims of This Report 1.2 A Brief Overview of the Chapters

2 Introduction 2.1 What is a Virus? 2.2 History of Virology 2.2.1 Origin of Viruses 2.2.2 Historical Developments in Virology 2.3 Classification of Viruses 2.3.1 DNA Viruses 2.3.2 RNA Viruses 2.3.3 Reverse Transcribing Viruses 2.4 Introduction to Viral Infections 2.4.1 Viral Life Cycle 2.4.2 Intrinsic Human Defences against Virus 2.5 How Do Antivirals Work? 2.5.1 Approach to Life Cycle Management 2.5.1.1 Before Cell Entry 2.5.1.2 During Viral Synthesis 2.5.1.3 Release Phase 2.5.2 Immune System Modulating 2.6 Antivirals Battle Highly Mutational Viral Genomes 2.7 The World Anti-Infective Market 2.7.1 Market Shares

3 The Global Market for Anti-Viral Drugs, 2008-2023 3.1 The Global Anti-Viral Market Generated High Revenues in 2007 3.1.1 Leading Segments in the Global Anti-Viral Market 3.1.2 Reverse Transcriptase Inhibitors, Immunoglobulin, Protease Inhibitors and Vaccine Segments 3.2 Global Anti-Viral Market Forecast, 2008-2023 3.3 Global Anti-Viral Market by Disease Area, 2008-2023 3.4 The Rise of the Hepatitis Segment from 2008 to 2013 3.5 The HIV Market Impeded by Patent Issues 3.5.1 Anti-HIV Agents Facing Looming Patent Expiries 3.5.2 Controversy Surrounding Patent Rights 3.6 The Influenza Segment Growth is Hampered by Conflicts 3.7 The Global Anti-Viral Market Will Undergo Shift 3.8 Leading Anti-Viral Brands and Forecast, 2008-2023 3.8.1 Will Tamiflu Retain its Leadership Position? 3.8.2 Combination Therapy Deemed Most Effective 3.8.3 Pegasys-Ribavirin Combination Therapy 3.8.4 Atripla – the Way Forward? 3.9 The Anti-Viral Market and Investment Activities

4 Factors Affecting the World Anti-Viral Market, 2008-2023 4.1 SWOT Analysis of the Anti-Viral Market 4.2 There is Much Reason for Optimism in the Anti-Viral Market 4.2.1 Drug Resistance is a Major Concern, but Stimulates Research Activity 4.2.2 Chronic Indications Ensure Long-Term Demand for Antivirals 4.2.3 Outbreaks of Viral Infections Give Rise to Major Global Public Health Crises 4.2.4 Low Diagnostic Rate Means that the Majority of Patients Are Unaware of Their Infections 4.3 Current Antiviral Treatments Marred by High Toxicity and Low Patient Compliance 4.4 The Threat of Bio-generic Penetration 4.4.1 Looming Patent Expiry Threatens Some Leading Brands 4.4.2 Does the Pipeline Have Enough Potential to Replace the Aging Brands? 4.5 Variability of Novel Targets and Mechanisms 4.6 Investment and Commercial Obstacles 4.6.1 Low Prevalence of Treatable Viral Diseases 4.6.2 Low Profitability from the Developing Countries 4.7 The Market Needs to Overcome Economic and Political Obstacles to Gain Access to Patients in Need 4.7.1 Will the Expanding Patient Population Drive Market Growth? A Case Study of the HIV Market 4.7.2 Expensiveness of Antiviral Treatments Forces Market Exclusivity and Limits Market Growth 4.7.3 Conjoint Effort from the Public and Private Domains to Achieve Greater Accessibility is a Positive Step Forward 4.8 How Will the Manufacturers Answer to Public Demands for Enhancing Treatment Availability? 4.8.1 Production Rate Unable to Meet Demands 4.8.2 The Controversy Towards Overriding Patent Rights 4.9 Are Vaccines Friends or Foes to the Antiviral Market?

5 Leading Companies in the Antiviral Market, 2008-2023 5.1 GSK, Roche, Merck, Gilead Sciences and Bristol-Myers Squibb 5.2 Is GSK’s Market Dominance in Jeopardy? 5.3 Roche’s Pipeline 5.4 What is Merck’s Competitive Edge in the Antiviral Market? 5.5 Gilead Sciences and Bristol-Myers Squibb Carve into the HIV Market

6 Leading Antiviral Brands, Forecasts and Analyses, 2008-2023 6.1 Top 15 Marketed Antivirals of 2007 6.2 Tamiflu 6.3 Gardasil 6.4 Valtrex 6.5 Pegasys 6.6 Truvada 6.7 Varivax 6.8 Synagis 6.9 Reyataz 6.10 Kaletra 6.11 Sustiva 6.12 Atripla 6.13 Combivir 6.14 Peg-Intron 6.15 Epzicom 6.16 Viread

7 Antivirals in the Leading Pharmaceutical Markets, Forecasts and Analysis, 2008-2023 7.1 Sales of Antivirals in the Leading Pharmaceutical Markets in 2007 7.2 Market Performance of Antivirals in the Leading Pharmaceutical Nations, 2008-2023 7.3 Will the US Retain Dominance? 7.4 Other Industrialised Countries to Undergo Steady Growth 7.5 How Will the Leading Developing Countries Fare in the Global Antivirals Market?

8 Promising Anti-Viral Technologies and Pipeline Developments 8.1 HIV Pipeline Development 8.1.1 Research Direction 8.1.2 Viral Enzymes as Targets 8.1.3 NNRTI 8.1.3.1 Intelence 8.1.3.2 Rilpivirine 8.1.4 NRTI 8.1.4.1 Apricitabine 8.1.5 Host Proteins as Targets 8.1.6 Viral-Entry Inhibitors: Attachment, Entry and Fusion Inhibitors 8.1.6.1 Selzentry/Celsentri 8.1.6.2 Vicriviroc 8.1.7 Integrase Inhibitors 8.1.7.1 Isentress 8.1.7.2 Elvitegravir 8.1.8 Maturation Inhibitors 8.1.8.1 Bevirimat 8.2 Hepatitis Pipeline Development 8.2.1 Research Direction 8.2.2 Interferons 8.2.2.1 Albuferon 8.2.3 NS3 Protease Inhibitors 8.2.3.1 Telaprevir 8.2.3.2 Boceprevir 8.2.4 Polymerase Inhibitors 8.2.4.1 R7128 8.3 Novel Technologies Head the Next Wave of Anti-Viral Drug Exploration 8.3.1 Could Monoclonal Antibodies Surpass the Dominant Small-Molecules? 8.3.2 RNA Interference Technology Raises Investment Interest

9 Interviews with Relevant Experts – Discussion of Current and Future Trends 9.1 Interview 1: Professor Erik De Clercq, Emeritus Professor, Rega Institute for Medical Research, K.U. Leuven, Belgium. 9.1.1 Promising Sub-Markets 9.1.2 Market Drivers and Restraints 9.1.3 Promising R&D Programmes 9.1.4 Market Direction 9.2 Interview 2: Dr. Michael Kinch, VP, Research and Development, Functional Genetics, Maryland, USA 9.2.1 Promising Sub-Markets 9.2.2 Market Drivers and Restraints 9.2.3 Arguments for Host-Oriented Therapeutic Approach 9.2.4 Biologicals Versus Small Molecules

10 Conclusions 10.1 Excitement Surrounds the Antivirals Market 10.2 The Next Market Leader 10.3 Hepatitis Segment Drives Innovative Antiviral Research 10.4 Pipeline Development 10.5 The Future of Antivirals

List of Tables Table 2.1, Historical Developments in Virology Table 2.2, Categorisation of Clinically Significant Viruses Table 2.3, The World Anti-Infective Market, Sales ($bn), 12 months to Q1 2008 Table 3.1, Antiviral Therapies Blockbusters, Sales ($m) and Market Share (%), 2007 Table 3.2, Global Anti-Viral Market, Sales ($bn) and Growth (%), 2006-2013, 2018, 2023 Table 3.3, Global Antiviral Market Breakdown by Disease Area, 2006 and 2007 Table 3.4, Global Anti-Viral Market by Disease Area, Sales ($bn) and Annual Growth (%), 2006-2013 Table 3.5, Market Performance of the Hepatitis Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.6, Marketed Antiviral Therapies for HIV/AIDS, Sales ($m), 2007 Table 3.7, Market Performance of the HIV Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.8, Market Performance of the Influenza Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.9, Global Anti-Viral Market by Disease Area, CAGR (%) and Market Share (%), 2007, 2013, 2018 and 2023 Table 3.10, Top 15 Anti-Viral Brands, Sales ($m) and Growth (%), 2007 Table 3.11, Top 15 Anti-Viral Brands, Sales ($m) and Growth (%), 2006-2013 Table 4.1, SWOT Analysis of the Antiviral Market, 2008 Table 4.2, Antivirals with Recent or Imminent Patent Expiration Table 4.3, Antiviral Patents Approved in the United States Table 5.1, Leading Companies in the Antiviral Market, Sales ($bn), 2007 Table 6.1, Sales of Tamiflu ($m), 2006-2013 Table 6.2, Sales of Gardasil ($m), 2006-2013 Table 6.3, Sales of Valtrex ($m), 2006-2013 Table 6.4, Sales of Pegasys ($m), 2006-2013 Table 6.5, Sales of Truvada ($m), 2006-2013 Table 6.6, Sales of Varivax ($m), 2006-2013 Table 6.7, Sales of Synagis ($m), 2006-2013 Table 6.8, Sales of Reyataz ($m), 2006-2013 Table 6.9, Sales of Kaletra ($m), 2006-2013 Table 6.10, Sales of Sustiva ($m), 2006-2013 Table 6.11, Sales of Atripla ($m), 2006-2013 Table 6.12, Sales of Combivir ($m), 2006-2013 Table 6.13, Sales of Peg-Intron ($m), 2006-2013 Table 6.14, Sales of Epzicom ($m), 2006-2013 Table 6.15, Sales of Viread ($m), 2006-2013 Table 7.1, Antivirals in the Leading Pharmaceutical Markets, Sales ($), Market Share (%) and Annual Growth (%), 2007 Table 7.2, Antivirals in the Leading Pharmaceutical Markets, Sales ($m), 2007-2013, 2018, 2023 Table 7.3, Antivirals in the Leading Pharmaceutical Markets, Market Share (%) and CAGR (%), 2007 and 2013 Table 8.1, HIV Life Cycle and Potential Targets for Antiretrovirals Table 8.2, Selected Viral Enzymes Inhibitors in Late Clinical Development Table 8.3, Selected Entry Inhibitors in Late Clinical Development Table 8.4, Selected Integrase Inhibitors in Late Clinical Development Table 8.5, Selected Interferons in Late Stage Development Table 8.6, Selected NS3 Protease Inhibitors in Late Clinical Development Table 8.7, Selected Polymerase Inhibitors in Late Clinical Development Table 8.8, Commercial Development of Antiviral mAbs Table 10.1, Global Anti-Viral Market, Sales ($bn) and Growth (%), 2006-2013, 2018, 2023 Table 10.2, Antiviral Therapies Blockbusters, Sales ($m) and Market Share (%), 2007

List of Figures Figure 2.1, Basic Structures of the Influenza Virus Figure 2.2, Life Cycle of a Typical RNA Virus Figure 2.3, The World Anti-Infective Market, Sales ($bn), 12 months to Q1 2008 Figure 2.4, The World Anti-Infective Market, Market Share (%), 12 months to Q1 2008 Figure 3.1, Leading Disease Areas in the Anti-Viral Market, Sales ($bn), 2007 Figure 3.2, Leading Drug Classes in the Anti-Viral Market, Sales 2007 ($bn) Figure 3.3, Global Anti-Viral Market Sales ($m), 2006-2013 Figure 3.4, Global Antiviral Market by Disease Area, Market Share (%), 2007 Figure 3.5, Global Anti-Viral Market by Disease Area, Sales ($m), 2006-2013 Figure 3.6, Global Hepatitis Market, Sales ($bn), 2006-2023 Figure 3.7, Global HIV Market, Sales ($bn), 2006-2023 Figure 3.8, Global Influenza Market, Sales ($bn), 2006-2023 Figure 3.9, Global Antiviral Market by Disease Area, Market Share (%), 2013 Figure 3.10, Market Share of the Leading Anti-Viral Drugs (%), 2007 Figure 5.1, Leading Companies in the Antiviral Market, Market Share (%), 2007 Figure 6.1, Top 15 Marketed Antiviral Therapies, Sales ($m), 2007 Figure 6.2, Top 15 Marketed Antiviral Therapies, Annual Growth (%), 2007 Figure 6.3, Sales of Tamiflu ($m), 2006-2023 Figure 6.4, Sales of Gardasil ($m), 2006-2023 Figure 6.5, Sales of Valtrex ($m), 2006-2023 Figure 6.6, Sales of Pegasys ($m), 2006-2023 Figure 6.7, Sales of Truvada ($m), 2006-2023 Figure 6.8, Sales of Varivax ($m), 2006-2023 Figure 6.9, Sales of Synagis ($m), 2006-2023 Figure 6.10, Sales of Reyataz ($m), 2006-2023 Figure 6.11, Sales of Kaletra ($m), 2006-2023 Figure 6.12, Sales of Sustiva ($m), 2006-2023 Figure 6.13, Sales of Atripla ($m), 2006-2023 Figure 6.14, Sales of Combivir ($m), 2006-2023 Figure 6.15, Sales of Peg-Intron ($m), 2006-2023 Figure 6.16, Sales of Epzicom ($m), 2006-2023 Figure 6.17, Sales of Viread ($m), 2006-2023 Figure 7.1, Antivirals in the Leading Pharmaceutical Markets, Sales ($m), 2007 Figure 7.2, Antivirals in the Leading Pharmaceutical Markets, Market Share (%), 2007 Figure 7.3, Antivirals in the US Market, Sales ($m), 2008-2013 Figure 7.4, Antivirals in Other Leading Industrialised Countries, Sales ($m), 2008-2013 Figure 7.5, Antivirals in China and India, Sales ($m), 2008-2013

Companies and Some Other Organisations Mentioned in the Report Abbott|AIDS Drug Assistance Programme|Alnylam Pharmaceutical|AnorMed|AstraZeneca Aurobindo|Avexa|Benitec|Bill and Melinda gates Foundation|Biolex Therapeutics|Boehringer Ingelheim|Bristol-Myers Squibb (BMS)|Cipla|Genentech|Genzyme|Gilead Sciences|Glaxo Wellcome|GlaxoSmithKline (GSK)|Hoffmann-La Roche|Human Genome Sciences|Incyte Intarcia|International AIDS Vaccine Initiative (NIAID)|Japan Tobacco|Johnson and Johnson Jointed United Nations Programme on HIV/AIDS (UNAIDS)|MedImmune|Medivir|Merck Mitsubishi|Monogram Biosciences|Novartis|OctoPlus|Panacos|Pfizer|Pharmaplaz|Pharmasset Inc|Progenics|Rega Institute for Medical Research|Samaritan|Schering-Plough|Tacere Therapeutics|Teijin Pharma|Tibotec|Tibotec-Virco|Trimeris|US Centers for Disease Control and Prevention (CDC)|US President’s Emergency Plan for AIDS Relief (PEPFAR) Vertex Pharmaceuticals|ViroChem Pharma|World Bank|World Health Organization (WHO)

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Inflammatory Bowel Diseases: World Market Report 2009-2024

This brand new in-depth market analysis examines the current and future prospects of the inflammatory bowel diseases (IBD) market. The world market for intestinal anti-inflammatories was worth over $2400 million in 2008, and had grown at 9% over the previous year.

The value of other types of drugs used to treat IBD, including immunosuppressants and monoclonal antibodies, approached $12000m. Visiongain predicts the market for intestinal anti-inflammatories and IBD drugs to continue expanding, based on rising disease rates and evolving diagnostic methods. Currently, IBD is under-diagnosed, especially in developing countries. As governments and health services address chronic illnesses like IBD, this market will expand into previously untreated regions. Continuing studies and surveys indicate that IBD is spreading globally, and has an especially high prevalence rate in India. In addition, the Latin American countries experienced 14% sales growth last year, and are set to account for an increasingly large share of the world market in years to come.

This report – Inflammatory Bowel Diseases: World Market 2009-2024 – discusses and analyses the major drug categories used in the treatment of IBD. This report forecasts the top brand-name and generic drugs used for IBD, including monoclonal antibody therapies. How much of an impact will monoclonal antibodies have on sales of other IBD-related therapies, for example? You should know and ths report will tell you. This report also analyses the major markets worldwide, discussing the principal national markets in detail, in addition to the world market. Through this report, you will discover how the leading markets will perform in the future, and how the relative values of each region will change over time. The US was the largest market in 2008, but will it retain its leading market share until 2024? How will the European market share compare with the Asian market share in 2014, 2019 and 2024?

Drug types analysed and forecasted in this report – Inflammatory Bowel Diseases: World Market 2009-2024 – include: • Aminosalicylate acid / 5-ASA • Corticosteroids • Immunomodulators • Antibiotics • Biologic therapies • Monoclonal antibodies. • Includes unique primary material unavailable elsewhere

This report covers disease and therapy distinctions between the two major types of IBD: Crohn’s disease and ulcerative colitis. It discusses these diseases and addresses aetiological theories that impact upon treatment. We provide the information you need to assess the future of those diseases and of the relevant markets. Sources consulted include industrial databases, commercial information, published economic research and market-specific interviews with experts in the IBD field. The result is a comprehensive market- and industry-based report with detailed analyses and informed opinion that you will not find anywhere else.

In particular, Inflammatory Bowel Diseases: The World Market 2009-2024 focuses on the following essential aspects of that market: • Forecast of the overall world IBD market from 2009 to 2024 • Forecasts of the current leading drugs’ sales from 2009 to 2024 • Assessments of pipeline developments • Analyses of short- and long-term drivers in the market • Analyses of how disease theories impact upon treatment procedures • Sales forecasts for the leading regional markets from 2009 to 2024, including discussions of specific country markets • Discussion of the importance of generics in the IBD market • Discussion of why the market contains so many types of drugs, and what that means for future developments • Assessments of opportunities and threats in the IBD market worldwide • Analyses of the impact monoclonal antibodies will have on the IBD market, present and future.

Why you should buy this report: • To receive a comprehensive assessment of the complex IBD market, including the various types of therapies • To receive a comprehensive analysis of the sales prospects for existing and new IBD drugs from 2009 to 2024 • To discover which types of therapies are most likely to succeed over the short- and long-term, and why each will succeed • For a thorough assessment of the current and future market at global and regional levels • To find out where the market is heading, both technologically and commercially • For a logical analysis of the multifaceted treatment options for IBD, including market drivers and restraints.

The global IBD market is highly complex, with multiple drugs being used simultaneously and/or sequentially for therapy. The market can therefore accept a large number of drugs, but the market is already fairly saturated, with several similar drugs on the market. What does such saturation mean for the futures of existing drugs? What does this mean for the pipeline? If, as visiongain’s interviewees say, IBD current drugs are less efficacious than they could be, what then are the promising future treatments that could fill therapeutic gaps? This report covers those important matters, amongst others.

As inflammatory bowel disease rates continue to rise, as too public awareness spreads and more-thorough diagnostic procedures expand the number of patients, the demand for IBD drugs will increase. What drugs and which companies will meet these therapeutic needs successfully in the future? Can new and future therapies compete successfully with established treatments? This report answers those and other important questions, to enable you to take advantage of this expanding market.

• PRICING –

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          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary 1.1 Inflammatory Bowel Diseases (IBD) Market Trajectory 1.1.1 Visiongain’s Prediction for the IBD Market 1.1.2 Prevalence Rates Rising Worldwide 1.2 Aims, Scope and Format of the Report 1.2.1 Chapter Outline 1.3 Complexities of the IBD Market: Assessing Multiple Drug Categories 1.4 Research Methods

2 What Is Inflammatory Bowel Disease? 2.1 Definition and Diagnosis 2.2 Signs, Symptoms and Secondary Conditions 2.2.1 Bleeding Ulcers, Fistulae, Bowel Perforations, Toxic Megacolon 2.2.2 Pyoderma Gangrenosum 2.2.3 Primary Sclerosing Cholangitis 2.2.4 Malnutrition, Poor Nutrient Absorption and Stunting 2.3 Ulcerative Colitis 2.4 Crohn’s Disease 2.5 Indeterminate Colitis: Distinguishing Crohn’s Disease from Ulcerative Colitis 2.6 Causes / Aetiology of Inflammatory Bowel Disease 2.7 Prevalence 2.8 Socioeconomic Costs 2.8.1 The Individual Cost of IBD

3 Autoimmune Disorders 3.1 Brief Overview of the Immune System 3.2 What are Autoimmune Diseases / Disorders? 3.3 What Causes Autoimmune Disorders? 3.4 Why are Autoimmune Diseases Spreading in Developed Countries, but Not in Developing Countries? 3.4.1 The Hygiene Hypothesis 3.5 What Inflammation is and Why Inflammation is Dangerous 3.5.1 What is Inflamed in Inflammatory Bowel Disease? 3.5.2 The Costs and Consequences of Non-Treatment

4 Treatments for Inflammatory Bowel Diseases 4.1 The Goals of IBD Treatment 4.1.1 Producing Remission 4.1.2 Maintaining Remission 4.2 Drug Categories and their Mechanisms of Action 4.2.1 Aminosalicylates / 5-ASA / Mesalazine / Mesalamine 4.2.2 Corticosteroids 4.2.3 Immunomodulators 4.2.4 Antibiotics 4.2.5 Biologic Therapies / Monoclonal Antibodies 4.3 Surgical Treatments 4.3.1 Surgery for Ulcerative Colitis 4.3.2 Surgery for Crohn’s Disease 4.4 The Leading Alternative Treatments: Hygiene Theory, Helminthic Therapy and Faecal Bacteriotherapy 4.4.1 Helminthic Therapy 4.4.2 Faecal / Fecal Bacteriotherapy / Human Probiotic Infusions (HPI) 4.4.3 Smoking

5 World IBD Market: Market Projection, Top Drug Projections 5.1 World Inflammatory Bowel Diseases Market, 2009-2024 5.1.1 The 5 Types of IBD Drugs 5.1.2 Other Drugs Cross-Indicated for IBD: Accounting for Monoclonal Antibodies 5.2 Lialda: Easier to Use, Growing in Significance 5.2.1 Unique Selling Point: Lialda is Lactose-Free 5.2.2 Lialda’s Downside 5.3 Asacol 5.4 Entocort 5.4.1 Steroid Side Effects and Entocort EC 5.5 Pentasa 5.5.1 Excellent Safety Profile Assisting Pentasa’s Sales 5.6 Salofalk 5.6.1 Salofalk Once-Daily 5.6.2 Salofalk and China Medical Sales Agreement 5.7 Budenofalk: 22% growth last year 5.7.1 Sales to be Boosted by New Sales Deal with Salix 5.8 Colazal: Losing Ground 5.9 Monoclonal Antibodies Forecasts 5.10 Remicade 5.10.1 Label Expansion Assisting Remicade’s Sales 5.11 Humira 5.11.1 Label Expansion Behind Humira’s Growth 5.11.2 Registered for Crohn’s in US and EU; In Phase III for Crohn’s in Japan 5.12 Cimzia 5.12.1 Challenged by the Committee for Medicinal Products for Human Use 5.13 Tysabri 5.13.1 Still Under Scrutiny for Liver Toxicity

6 Crucial Pipeline Developments: New Drug Targets, Innovative Delivery Technologies, and Cutting-Edge Treatments 6.1 Traficet-EN 6.2 Alicaforsen: Approved for Pouchitis, Cancelled for Crohn’s, Under Assessment for UC 6.3 Rifaxamin 6.4 Myoconda: Is this the Cure for IBD? 6.5 Bupropion (Wellbutrin) 6.6 Abatacept (Orencia) 6.7 Polyketals: Technology to Deliver Drugs to Internal Inflammation 6.8 Extracorporeal Photopheresis (Light Therapy Outside of the Body): Uvadex (Methoxsalen) 6.9 A New Monoclonal Antibody Indicated for Crohn’s Disease: Ustekinumab (Stelara) 6.10 Interleukins: Promising New Drug Targets (with a Table of Pipeline Interleukin Drugs) 6.11 Stem Cells: Prochymal by Osiris Therapeutics

7 Leading Companies 7.1 Procter & Gamble: 27% of the IBD Market 7.2 Ferring: Drug Originator and Innovator, but Limited Late-stage Pipeline 7.3 Shire 7.3.1 Lialda’s Success and its Potential 7.3.2 Shire’s Share of Pentasa 7.4 Dr. Falk 7.5 Prometheus Laboratories: Significance through IBD Drugs and Tests 7.5.1 Prometheus’s Diagnostic and Genetic Analysis Tests: Frontiers of IBD Treatment 7.5.2 Serology Retrospective Results 7.5.3 Prometheus and Monoclonal Antibodies 7.6 Salix: Losing Colazal, Gaining US License to Budenofalk 7.7 Cosmo Pharmaceuticals / Cosmo Technologies: Watch this Company! 7.7.1 MMX Revenues

8 World Markets by Region 8.1 Changing Regional Market Share 8.2 North America: Slower Growth, Market Share in 2024 Compared with 2009 8.3 Europe: Retaining Market Share in the Long Term? 8.3.1 United Kingdom 8.3.2 Germany 8.3.3 Poland: Increasing in Market Relevance 8.4 Africa, Asia, Australasia: Growing Markets 8.4.1 The Incidence and Prevalence of IBD in Asia 8.4.2 Japan 8.4.3 Australia 8.4.4 China 8.4.5 India 8.5 Latin America

9 Strengths, Weaknesses, Opportunities and Threats of the IBD Market 9.1 Strengths 9.1.1 Monoclonal Antibodies: a Threat to Intestinal Anti-Inflammatories? 9.2 Weaknesses 9.2.1 Genotyping: A Dead End? 9.3 Opportunities 9.4 Threats 9.4.1 Cures and/or Vaccines? 9.4.2 Market Saturation 9.4.3 The World Economic Climate – Will this Limit Uptake of New IBD Drugs in a Nearly-Saturated Market?

10 Visiongain Interviews with Relevant Key Opinion Leaders 10.1 Interview with Marco Greco, Chairman of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA). 10.1.1 Public Awareness 10.1.2 Differences Between European Countries 10.1.3 Drug Companies’ Involvement in Awareness Campaigns 10.1.4 Unmet Medical Needs 10.2 Interview with Dr. Alan Fraser, Associate Professor of Medicine, University of Auckland, Director for Clinical Examinations at Auckland Hospital. 10.2.1 Autoimmunity vs. Infection Theories 10.2.2 Monoclonal Antibodies 10.2.3 Genotyping 10.2.4 Remaining Therapeutic Gaps 10.2.5 Future Treatments 10.3 Interview with Professor Thomas Borody, MD, PhD, Director of the Centre for Digestive Diseases (Sydney), and Executive Director and Chief Medical Officer of Giaconda Limited 10.3.1 Mycobacterium avium paratuberculosis (MAP) Infection and IBD Aetiology 10.3.2 IBD and HIV/AIDS 10.3.3 Monoclonal Antibodies and Immunosuppressant Treatments 10.3.4 Potential Cure(s) 10.3.5 Remicade and MAP 10.3.6 Genotyping 10.3.7 Crohn’s vs. Colitis 10.3.8 Future Therapies 10.3.9 Potential and Future of Myconda

11 Conclusions 11.1 IBD Market Sales Forcasts 11.2 The Market will be Stimulated by New Delivery Technologies and New Drug Targets 11.3 Many Drugs and Generics on the Market, but Poor Disease Management Means High Potential Drug Uptake 11.4 The IBD Market – Will Sales Growth Continue Steadily from 2009 to 2024?

List of Tables Table 3.1 The Most Common Autoimmune Disorders, by Type Table 4.1 IBD Drugs by Type, Chemical Name and Brand Name Table 5.1 World Intestinal Anti-Inflammatories Sales Forecasts, 2009-2024 Table 5.2 Lialda Sales Forecast, 2009-2024 Table 5.3 Asacol Sales Forecast, 2009-2024 Table 5.4 Entocort Sales Forecast, 2009-2024 Table 5.5 Pentasa Sales Forecast, 2009-2024 Table 5.6 Salofalk Sales Forecast, 2009-2024 Table 5.7 Budenofalk Sales Forecast, 2009-2024 Table 5.8 Colazal Sales Forecast, 2009-2024 Table 5.9 Autoimmune-Indicated Monoclonal Antibodies Forecasts, 2009-2024 Table 5.10 Remicade Sales Forecast, 2009-2024 Table 5.11 Humira Sales Forecast, 2009-2024 Table 5.12 Cimzia Sales Forecast, 2009-2024 Table 5.13 Tysabri Sales Forecast, 2009-2024 Table 6.1 Interleukin-targeted Drugs Pipeline, by Phase and Company, 2008 Table 8.1 World Intestinal Anti-Inflammatories Sales Forecasts, 2009-2024 Table 8.2 World Market Sales Forecasts by Region, 2009-2024 Table 8.3 North America Sales Forecast, 2009-2024 Table 8.4 Europe Sales Forecast, 2009-2024 Table 8.5 Africa, Asia, Australasia Sales Forecast, 2009-2024 Table 8.6 Latin America Sales Forecast, 2009-2024 Table 9.1 Strengths and Weaknesses in the IBD Market Table 9.2 Opportunities and Threats in the IBD Market

List of Figures Figure 2.1 Direct and Indirect Medical Costs of IBD in 4 Countries Figure 5.1 World Intestinal Anti-Inflammatories Market Projection, 2009-2024 Figure 5.2 IBD Market Breakdown by Drug Type, 2008 Figure 5.3 Top-Selling IBD Drugs, 2008 Figure 5.4 Sales Forecasts of Top-Selling IBD Drugs, 2009-2024 Figure 5.5 Lialda Sales Forecast, 2009-2024 Figure 5.6 Asacol Sales Forecast, 2009-2024 Figure 5.7 Entocort Sales Forecast, 2009-2024 Figure 5.8 Pentasa Sales Forecast, 2009-2024 Figure 5.9 Salofalk Sales Forecast, 2009-2023 Figure 5.10 Budenofalk Sales Forecast, 2009-2024 Figure 5.11 Colazal Sales Forecast, 2009-2024 Figure 5.12 Autoimmune-indicated Monoclonal Antibodies Forecast Figure 5.13 Remicade Sales Forecast, 2009-2024 Figure 5.14 Humira Sales Forecast, 2009-2024 Figure 5.15 Cimzia Sales Forecast, 2009-2024 Figure 5.16 Tysabri Sales Forecast, 2009-2024 Figure 7.1 Top IBD Companies, 2008 Figure 8.1 World Intestinal Anti-Inflammatories Sales Forecast, 2009-2024 Figure 8.2 Regional Sales Forecasts, 2009-2024 Figure 8.3 Market Share by World Region, 2014 Projection Figure 8.4 Market Share by World Region, 2024 Projection Figure 8.5 North America Sales Forecast, 2009-2024 Figure 8.6 Europe Sales Forecast, 2009-2024 Figure 8.7 Africa, Asia, Australasia Sales Forecast, 2009-2024 Figure 8.8 Latin America Sales Forecast, 2009-2024

List of companies mentioned Abbott Alaven Pharm Amgen AstraZeneca Atlantic Healthcare Biogen Idec Biovail Biovitrum Bristol-Myers Squibb Center for Digestive Diseases (Sydney) Centocor ChemoCentryx Committee for Medicinal Products for Human Use (CHMP) Conaris Research Institute AG Cosmo Pharmaceuticals, S.p.A. Cosmo Technologies, Ltd. Crohn’s and Colitis Foundation of America (CCFA) Dong A Dr. Falk Pharma Elan (Ireland) European Federation of Crohn’s and Colitis Associations (EFCCA) European Medicines Agency (EMEA) Faes Farma Ferring Food and Drug Administration (FDA) Genmat Genzyme Giaconda Giuliani GlaxoSmithKline Isis Pharmaceuticals Johnson & Johnson Medarex Merck Novartis Osiris Therapeutics Pediatric Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center in Los Angeles Pfizer Probiotic Therapy Research Center, Sydney Procter & Gamble Prometheus Laboratories Salix Santarus Santen Schering-Plough Shire Stanford University Synergen Therakos University of Washington Wyeth ZymoGenetics

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The Global OTC Pharmaceutical Market 2009-2024

OTC pharma is influenced by changes in consumer spending – but significant commercial opportunities for OTC switching will drive market expansion worldwide – our new report explains General economic trends worldwide will affect the over-the-counter (OTC) pharma market from 2009 onwards, with both market restraints and opportunities present. In this new report – The Global OTC Pharmaceutical Market 2009-2024 – visiongain notes that Rx-to-OTC switching and the continuing importance of emerging pharma markets will drive OTC sales growth from 2009 onwards. Our forecasts reveal that the OTC pharma market will grow significantly next decade. This report explains where future OTC switching will occur, providing you with the information that you need to understand the current OTC market and its future prospects. The potential of this market remains significant, despite general economic uncertainty, visiongain asserts.

The Global OTC Pharmaceutical Market 2009-2024 examines all the major categories of OTC pharmaceuticals, including:

Analgesics – for internal and external uses Cough, cold and allergy preparations Dermatology – including antifungal agents and hair-loss treatments Gastrointestinal drugs – including those for acid-related disorders, laxatives and anti-diarrhoea preparations Anti-obesity treatments Smoking cessation aids Others – including contraceptives, statins and erectile dysfunction areas.

Demographic trends, lifestyles changes and clinical advances are transforming medicine and creating opportunities for therapeutic areas and drug types in OTC pharma. Consumers are increasingly willing to self-medicate, for convenience and cost savings in particular. New regulations are changing OTC retail channels and sales processes, including the range of products on offer. Importantly, governments and healthcare providers are promoting self-medication, viewing the process as a tool to help contain healthcare expenditure. Therefore the OTC pharma market holds high potential for continued growth in both mature and emerging geographical markets.

Taking advantage of such opportunities will take considerable skill in a crowded and competitive marketplace. Competing with private labels, gaining regulatory approval for further OTC switches and harnessing Web 2.0 in advertising are all challenges that are assessed in this report, along with other aspects of the market.

Comprehensive analysis of the OTC market area The Global OTC Pharmaceutical Market 2009-2024 examines that sector critically, through a comprehensive review of information sources, both primary and secondary. This report provides detailed sales forecasts, discussions of pipeline developments and analysis of commercial drivers and restraints, including a SWOT analysis. There are over 100 tables and figures included. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to aid your work.

Why you should buy The Global OTC Pharmaceutical Market 2009-2024 Benefits from purchasing this report include:

Your receiving a comprehensive appraisal of the OTC pharmaceutical market in 2008, including sales revenues and market shares for OTC categories, the top 10 companies and the leading OTC brands Your receiving sales forecasts and discussions covering the period 2009 to 2024, including the global OTC market, leading OTC brand forecasts, top OTC manufacturer forecasts and therapeutic category forecasts Your viewing sales forecasts for leading national OTC markets worldwide Your receiving coverage of OTC switching from 2009 onwards, with important developments that you cannot ignore Your viewing strengths, weaknesses, opportunities and threats facing the industry, with an emphasis on commercial drivers and restraints.

You can order this report today The Global OTC Pharmaceutical Market 2009-2024 will provide you with a greater understanding of the expanding OTC market worldwide. What effect will the current downturn in consumer spending have on the OTC market? What are the OTC product market shares in each of the top-10 OTC companies? Which will be the most-important Rx-to-OTC switches in future? If you want to understand this important market, you can stay ahead by ordering this report today.

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        Table of  contents

1 Executive Summary

2 Introduction to OTC Pharmaceuticals 2.1 OTC Pharmaceuticals 2.2 Key Features of OTC Pharmaceuticals 2.3 OTC Switching 2.4 Manufacture and Distribution of OTC Pharmaceuticals 2.5 Regulation of OTC Pharmaceuticals 2.5.1 United States 2.5.2 Japan 2.5.3 European Union 2.5.4 Other Countries 2.6 Major OTC Pharmaceutical Therapeutic Categories 2.7 Analgesics 2.7.1 Internal Analgesics 2.7.2 External Analgesics 2.8 Cough, Cold and Allergy Products 2.8.1 Cough and Cold Remedies 2.8.2 Anti-Allergy OTC Products 2.9 Dermatological Products 2.9.1 Minor Cuts and Wounds 2.9.2 Acne 2.9.3 Rashes, Itchy Skin, Dermatitis and Eczema 2.9.4 Cold Sores 2.9.5 Warts 2.9.6 Fungal Skin Infections 2.9.7 Haemorrhoids 2.9.8 Other Dermatological Products 2.10 Gastrointestinal Products 2.10.1 Indigestion and Heartburn 2.10.2 Anti-Diarrhoea OTC Pharmaceuticals 2.10.3 Laxatives 2.10.4 Anti-Emetic OTC Pharmaceuticals 2.10.5 Anti-Obesity OTC Pharmaceuticals 2.11 Smoking Cessation Aids 2.12 Other OTC Pharmaceuticals 2.13 Vitamins, Minerals and Supplements

3 The Global OTC Pharmaceutical Market 3.1 Global OTC Pharmaceutical Market 3.1.1 The Global OTC Market in 2008 3.1.2 Economic Downturn and OTC Switching: Global OTC Pharmaceutical Market Forecast, 2009-2024 3.1.3 World OTC Market to Increase 75% from 2008 Value by 2024 3.2 OTC Pharmaceutical Categories 3.2.1 OTC Category Revenues and Market Share, 2008 3.2.2 OTC Category Sales Forecasts, 2009-2024 3.3 Leading OTC Pharmaceutical Brands 3.4 Leading OTC Pharmaceutical Manufacturers 3.5 Johnson & Johnson 3.5.1 Johnson & Johnson’s OTC Pharmaceuticals and Nutritionals Franchise 3.5.2 The Global OTC Leader: Johnson & Johnson’s 2008 OTC Sales Revenues and Market Shares 3.5.3 Johnson & Johnson OTC Pharmaceutical Forecast, 2009-2014 3.5.4 Tylenol: The Only Billion Dollar OTC Brand 3.5.5 Tylenol Sales Forecast, 2009-2024 3.5.6 Johnson & Johnson’s Nicorette Nicotine Replacement Therapy 3.5.7 Nicorette Sales Forecast, 2009-2024 3.5.8 Zyrtec OTC/Reactine: Johnson’s & Johnson’s Fastest-Growing Brand of 2008 3.5.9 Other Leading Johnson & Johnson OTC Pharmaceuticals 3.6 GlaxoSmithKline 3.6.1 GSK Consumer Healthcare 3.6.2 GSK is Second-Largest Global OTC Pharmaceutical Company: 2008 OTC Sales and Market Shares 3.6.3 GSK OTC Pharmaceutical Forecast, 2009-2014 3.6.4 Panadol: GSK’s International Analgesic 3.6.5 Panadol Sales Forecast, 2009-2024 3.6.6 Nicabate/NicoDerm/Nicorette/NiQuitin Smoking Cessation Brands 3.6.7 Nicabate/NicoDerm/Nicorette/NiQuitin Sales Forecast, 2009-2024 3.6.8 alli: Pioneer OTC-Switch Diet Aid 3.6.9 alli Sales Forecast, 2009-2024 3.6.10 Other GSK Products with Revenues over $100m 3.7 Bayer 3.7.1 Bayer Consumer Care 3.7.2 Bayer’s OTC Pharmaceuticals: 2008 Sales and Market Shares 3.7.3 Bayer OTC Pharmaceutical Forecast, 2009-2014 3.7.4 Bayer Aspirin 3.7.5 Bayer Aspirin Sales Forecast, 2009-2024 3.7.6 Other Bayer OTC Pharmaceuticals 3.8 Novartis 3.8.1 Novartis OTC Pharmaceuticals 3.8.2 Sales and Market Share of Leading Novartis OTC Products in 2008 3.8.3 Novartis OTC Pharmaceutical Forecast, 2009-2014 3.8.4 Voltaren 3.8.5 Novartis’ Nicotine Replacement Business 3.8.6 Otriven, Theraflu, Excedrin and Lamisil: Other Leading Novartis OTC Brands 3.9 Proctor & Gamble 3.9.1 Proctor & Gamble OTC Pharmaceuticals 3.9.2 Prilosec OTC 3.9.3 Prilosec OTC Will Face Competition from Generics and Newer OTC Heartburn Drugs 3.9.4 Vicks 3.9.5 Vicks Market Forecast, 2009-2024 3.10 Wyeth/Pfizer 3.10.1 Wyeth Consumer Healthcare 3.10.2 Wyeth OTC Pharmaceuticals: 2008 Sales and Market Shares 3.10.3 Advil 3.10.4 Advil Market Forecast, 2009-2024 3.11 Sanofi-Aventis 3.11.1 Sanofi-Aventis OTC Division 3.11.2 Sales and Market Share of Sanofi-Aventis OTC Pharmaceuticals 3.12 Reckitt Benckiser 3.12.1 Reckitt Benckiser OTC Pharmaceuticals 3.12.2 Sales and Market Share of Reckitt Benckiser OTC Pharmaceuticals 3.13 Boehringer Ingelheim 3.13.1 Boehringer Ingelheim Consumer Health Care 3.13.2 Sales and Market Share of Leading Boehringer Ingelheim OTC Pharmaceuticals 3.13.3 The Dulcolax Franchise 3.13.4 Mucosolvan/Lasolvan and other Leading OTC Products 3.14 Perrigo 3.14.1 Perrigo Consumer Healthcare 3.14.2 Perrigo OTC Pharmaceuticals

4 OTC Switching 4.1 Motivations for OTC Switching 4.2 Recent OTC-Switching Activity 4.3 The Future Prospects for OTC Switching 4.4 Interview with Joshua P. Cohen, Ph.D., Senior Research Fellow at the Tufts Center for the Study of Drug Development 4.4.1 Prospects for OTC Statins in the US 4.4.2 Future OTC Switching Categories 4.4.3 Prospects for Behind-the Counter in the US 4.4.4 OTC Safety Issues 4.5 Gastrointestinal OTC Switching 4.5.1 H2-Blockers 4.5.2 PPIs Focus of Gastrointestinal OTC Switching 4.5.3 Omeprazole 4.5.4 Lansoprazole 4.5.5 Pantoprazole 4.5.6 Esomeprazole 4.5.7 Rabeprazole 4.5.8 Anti-Obesity OTC Switches 4.6 Cough, Cold and Allergy OTC Switching 4.6.1 First Generation Antihistamines 4.6.2 Second Generation Antihistamines 4.6.3 Third Generation Antihistamine 4.6.4 Fluticasone Propionate 4.7 Analgesic OTC Switching 4.7.1 Triptans 4.7.2 What are the Prospects for OTC Switching of Triptans in the US? 4.7.3 Arthritis Pain 4.8 Dermatological Drugs 4.9 Other OTC-Switching Categories 4.9.1 Oral Contraceptives 4.9.2 Cholesterol-Lowering Drugs 4.9.2.1 OTC Statins 4.9.2.2 The UK’s Zocor Heart-Pro 4.9.2.3 The Road to OTC Statins in the US 4.9.2.4 What are the Worldwide Prospects for Statin OTC Switching? 4.9.3 Erectile Dysfunction Drugs 4.10 OTC Switching: A Continuing Trend during 2009-2024

5 Issues Affecting the OTC Pharmaceutical Industry 5.1 SWOT Analysis of the OTC Pharmaceutical Industry 5.2 OTC Switching 5.3 Brand Identity and Private Labels 5.4 Developments in OTC Retail Channels 5.5 Will OTC Move Behind-the-Counter? 5.6 Web 2.0 Advertising Opportunities 5.7 Changing World Demographics 5.7.1 Population Increase and ‘Greying’ of the World Population 5.7.2 Emerging-Market Economies 5.8 The Worldwide Downturn in Consumer Spending, 2009-2010 5.9 Safety Concerns, Misuse and Abuse of OTC Pharmaceuticals 5.9.1 Safety Concerns 5.9.2 OTC Drug Misuse 5.9.3 OTC Drug Abuse 5.9.4 Impact on the OTC Industry

6 Leading OTC Pharmaceutical Country Markets 6.1 Leading OTC Country Markets in 2008 6.2 Leading OTC Country Markets Forecasts, 2009-2024 6.3 The US OTC Market 6.4 The Japanese OTC Market 6.5 European OTC Markets 6.6 Emerging OTC Markets

7 Conclusions 7.1 The Global OTC Market in 2008 7.1.1 Leading OTC Categories 7.1.2 Leading OTC Brands 7.1.3 Leading OTC Pharmaceutical Manufacturers 7.1.4 Leading OTC Country Markets 7.2 Global OTC Pharmaceutical Market Forecast, 2009-2024 7.2.1 OTC Growth Drivers 7.2.2 OTC Switching Activity 7.2.3 Emerging OTC Markets 7.3 Future OTC Market Dynamics

List of Tables Table 2.1 OTC Internal Analgesic Active Ingredients Table 2.2 OTC External Analgesic Active Ingredients Table 2.3 Cough, Cold and Allergy OTC Pharmaceutical Active Ingredients Table 2.4 Antifungal OTC Pharmaceutical Active Ingredients Table 2.5 Indigestion and Heartburn OTC Pharmaceutical Active Ingredients Table 2.6 Anti-Diarrhoea OTC Pharmaceutical Active Ingredients Table 2.7 OTC Laxative Active Ingredients Table 2.8 Nicotine Replacement Therapy OTC Formulations Table 3.1 OTC and Prescription-Only Pharmaceutical Markets, 2008 Table 3.2 World OTC Pharmaceuticals Sales Forecast, 2009-2014 Table 3.3 World OTC Pharmaceuticals Sales Forecast, 2015-2024 Table 3.4 OTC Category Revenues and Market Share, 2008 Table 3.5 OTC Category Sales Forecast, 2009-2024 Table 3.6 Top Eight OTC Brands, 2008 Table 3.7 Top Ten OTC Pharmaceutical Manufacturers, 2008 Table 3.8 Johnson & Johnson OTC Brands: 2008 Sales Revenues and Market Share Table 3.9 Johnson & Johnson Total OTC Pharmaceuticals Sales Forecast, 2009-2014 Table 3.10 Tylenol Products, 2009 Table 3.11 Tylenol Sales Forecast, 2009-2014 Table 3.12 Tylenol Sales Forecast, 2015-2024 Table 3.13 Nicorette Formulations (Johnson & Johnson), 2009 Table 3.14 Nicorette (Johnson & Johnson) Sales Forecast, 2009-2014 Table 3.15 Nicorette (Johnson & Johnson) Sales Forecast, 2015-2024 Table 3.16 GSK OTC Brands: 2008 Sales Revenues and Market Share Table 3.17 GSK Total OTC Pharmaceuticals Forecast, 2009-2014 Table 3.18 Panadol Formulations, 2009 Table 3.19 Panadol Sales Forecast, 2009-2014 Table 3.20 Panadol Sales Forecast, 2015-2024 Table 3.21 Nicabate/NicoDerm/Nicorette/NiQuitin NRT Brands (GSK), 2009 Table 3.22 Nicabate/NicoDerm/Nicorette/NiQuitin (GSK) Sales Forecast, 2009-2014 Table 3.23 Nicabate/NicoDerm/Nicorette/NiQuitin (GSK) Sales Forecast, 2015-2024 Table 3.24 alli Sales Forecast, 2009-2014 Table 3.25 alli Sales Forecast, 2015-2024 Table 3.26 Bayer OTC Brands: 2008 Sales Revenues and Market Share Table 3.27 Bayer Total OTC Pharmaceuticals Forecast, 2009-2014 Table 3.28 Bayer Aspirin Formulations, 2009 Table 3.29 Bayer Aspirin Sales Forecast, 2009-2014 Table 3.30 Bayer Aspirin Sales Forecast, 2015-2024 Table 3.31 Novartis OTC Brands: 2008 Sales Revenues and Market Share Table 3.32 Novartis Total OTC Pharmaceuticals Forecast, 2009-2014 Table 3.33 Novartis OTC Nicotine Replacement Therapy Products, 2009 Table 3.34 Proctor & Gamble OTC Brands: 2008 Sales Revenues and Market Share Table 3.35 Prilosec OTC Sales Forecast, 2009-2014 Table 3.36 Prilosec OTC Sales Forecast, 2015-2024 Table 3.37 Vicks US Formulations, 2009 Table 3.38 Vicks Sales Forecast, 2009-2014 Table 3.39 Vicks Sales Forecast, 2015-2024 Table 3.40 Wyeth OTC Brands: 2008 Sales Revenues and Market Share Table 3.41 Advil North American Formulations, 2009 Table 3.42 Advil Sales Forecast, 2009-2014 Table 3.43 Advil Sales Forecast, 2015-2024 Table 3.44 Sanofi-Aventis OTC Brands: 2008 Sales Revenues and Market Share Table 3.45 Reckitt Benckiser OTC Brands: 2008 Sales Revenues and Market Share Table 3.46 Boehringer Ingelheim OTC Brands: 2008 Sales Revenues and Market Share Table 4.1 Recent and Future Gastrointestinal OTC Switches Table 4.2 Recent and Future Cough, Cold & Allergy OTC Switches Table 4.3 Recent and Future Analgesic OTC Switches Table 4.4 Recent and Future Dermatological OTC Switches Table 4.5 Other Possible Future OTC Switches Table 5.1 SWOT Analysis of the OTC Pharmaceutical Sector, 2009 Table 5.2 World Population Forecast, 2008-2024 Table 5.3 Population Forecasts in Leading OTC Markets, 2008 & 2024 Table 5.4 GDP Forecast for Leading OTC Markets, 2008-2024 Table 6.1 OTC Revenues in Leading OTC Country Markets, 2008 Table 6.2 Leading OTC Country Markets Forecasts, 2009-2024

List of Figures Figure 2.1 The OTC Pharmaceutical Supply Chain Figure 3.1 OTC and Prescription-Only Pharmaceutical Markets, 2008 Figure 3.2 World OTC Pharmaceuticals Sales Forecast, 2009-2024 Figure 3.3 OTC Therapies (inc. Vitamins and Minerals) Revenues and Market Shares, 2008 Figure 3.4 OTC Category Revenues and Market Share, 2008 Figure 3.5 OTC Category Sales Forecast, 2009-2024 Figure 3.6 OTC Category Market Share Forecast, 2009-2024 Figure 3.7 Top Ten OTC Pharmaceutical Manufacturers, 2008 Figure 3.8 Top Ten OTC Manufacturers’ Market Shares, 2008 Figure 3.9 Johnson & Johnson OTC Brands: 2008 Market Share Figure 3.10 Johnson & Johnson Total OTC Pharmaceuticals Sales Forecast, 2009-2014 Figure 3.11 Tylenol Sales Forecast, 2009-2024 Figure 3.12 Nicorette (Johnson & Johnson) Sales Forecast, 2009-2024 Figure 3.13 GSK OTC Brands: 2008 Market Share Figure 3.14 GSK Total OTC Pharmaceuticals Sales Forecast, 2009-2014 Figure 3.15 Panadol Sales Forecast, 2009-2024 Figure 3.16 Nicabate/NicoDerm/Nicorette/NiQuitin (GSK) Sales Forecast, 2009-2024 Figure 3.17 alli Sales Forecast, 2009-2024 Figure 3.18 Bayer OTC Brands: 2008 Market Share Figure 3.19 Bayer Total OTC Pharmaceuticals Sales Forecast, 2009-2014 Figure 3.20 Bayer Aspirin Sales Forecast, 2009-2024 Figure 3.21 Novartis OTC Brands: 2008 Market Share Figure 3.22 Novartis Total OTC Pharmaceuticals Sales Forecast, 2009-2014 Figure 3.23 Proctor & Gamble OTC Brands: 2008 Market Share Figure 3.24 Prilosec OTC Sales Forecast, 2009-2024 Figure 3.25 Vicks Sales Forecast, 2009-2024 Figure 3.26 Wyeth OTC Brands: 2008 Market Share Figure 3.27 Advil Sales Forecast, 2009-2024 Figure 3.28 Sanofi-Aventis OTC Brands: 2008 Market Share Figure 3.29 Reckitt Benckiser OTC Brands: 2008 Market Share Figure 3.30 Boehringer Ingelheim OTC Brands: 2008 Market Share Figure 5.1 World Population Forecast, 2008-2024 Figure 5.2 Forecasted World Population Aged 65 or Over, 2008-2024 Figure 5.3 Population Forecasts in Leading OTC Markets, 2008 & 2024 Figure 5.4 GDP Forecast for Leading OTC Markets, 2008-2024 Figure 6.1 Market Share of Leading OTC Country Markets, 2008 Figure 6.2 Forecast Market Share of Leading OTC Country Markets, 2014 Figure 6.3 Forecast Market Share of Leading OTC Country Markets, 2019 Figure 6.4 Forecast Market Share of Leading OTC Country Markets, 2024 Figure 7.1 World OTC Pharmaceuticals Sales Forecast, 2009-2024

Organisations Mentioned in this Report Alliance Boots Abbott Adams Respiratory Therapeutics (Reckitt Benckiser) American Medical Association AmerisourceBergen AstraZeneca AZ Tika (AstraZeneca) Barr (Teva) Bayer Boehringer Ingelheim Bristol-Myers Squibb Cardinal Health Celesio Chattem CNS (GSK) Daiichi Sankyo Dexcel Dr. Reddy’s Laboratories Eisai European Medicines Agency (EMEA) Federal Trade Commission (US) Food and Drug Administration (FDA) (US) Galpharm (Perrigo) GlaxoSmithKline (GSK) Johnson & Johnson Kowa Lion McKesson Medicines and Healthcare products Regulatory Agency (MHRA) (UK) Menarini Merck & Co. Ministry of Health, Labour and Welfare (MHLW) (Japan) Mylan Novartis Nycomed Perrigo Pfizer Phoenix Proctor & Gamble Public Citizen (US) Ranbaxy Ratiopharm Reckitt Benckiser Roche Rohto Sagmel (Bayer) Sanofi-Aventis Santarus Sato Schering-Plough SSL International SSP Sun Symbion Consumer (Sanofi-Aventis) Taisho Takeda Target Teva Therapeutic Goods Administration (TGA) (Australia) Topsun (Bayer) Walmart Wyeth

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World Generics Market, 2008-2013

The generics market remains a major growth area in the global healthcare market. That growth has been partly driven by cost-containment in several national healthcare sectors, with governments seeking to promote the use of generic products over higher-priced originator products. The global generic pharmaceuticals market was worth over $100bn in 2007, with market growth noticeably higher that that of the overall pharmaceutical market. Our new report – World Generics Market, 2008-2013 – will help you to understand the key developments in this sector and their significance, from the present looking forward. The report provides valuable commercial information on this exciting sector, one that no pharmaceutical company or related organisation can afford to ignore.

Over the period 2008 to 2013, visiongain foresees the generic market to sustain its strong current growth, with exciting new developments to be driven by the wave of blockbuster drugs approaching patent expiry. This report – World Generics Market, 2008-2013 – provides details of these drugs and potential generics revenues. The study also identifies the therapeutic areas that will face the highest levels of competition from generic substitutes from 2008 to 2013. Our report examines the global generics market and industry critically, with in-depth analysis, especially market forecasting and qualitative analysis of market drivers and restraints. The result is a comprehensive market-based report with detailed analysis and informed opinion.

Why you should buy this report In particular, World Generics Market, 2008-2013, concentrates on the following essential aspects of the generics market and industry:

· Discussion of key issues affecting the global generics market and the wider pharmaceutical market/industry · Why governments and healthcare organisations – including private insurers – are increasingly opting for generic medicines; we provide country-specific information there · Discussion of drivers and opportunities in the generics sector · Discussion of restraints and threats in the generics sector · Sales forecasts from 2008-2013 for the global generics market and leading national generics markets – US, Japan, Germany, France, UK, Spain, Italy · Discussion of developing generics markets, especially China, India and Russia, with major industrial developments covered.

Despite the potentially great opportunities to be harnessed by generics companies in both developed and developing countries, there remain marked obstacles to be overcome. While many generics companies are becoming larger and more innovative, originator drugs companies – especially top-10 pharma companies – are generally prepared for the threat from generics, having developed strategies to minimise the effects of sales erosion. Still, there are large potential losses in sales occurring currently – and likely to continue in the years ahead – as one blockbuster drug after another faces direct and indirect generic competition.

Certainly, the commercial opportunities for dynamic generics companies are great. Similarly, the cost-saving opportunities for both public and private healthcare providers worldwide are significant. By purchasing this report, you will be better able to appreciate those major developments in the global pharmaceutical market, with many stakeholders affected.

• PRICING –

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Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1. Executive Summary

2. Overview of the World Generics Market 2.1 The World Pharmaceuticals Market Growth Stabilises to Generics’ Advantage 2.2 What is a Generic Drug? 2.3 The Crumbling Branded Pharmaceutical Business Model 2.4 Regulatory Changes in Generics Approval Hasten Market Growth 2.4.1 The US and European Regulation of Generic Drugs 2.4.2 Generic Pharmaceuticals in the US Market 2.4.3 The Hatch-Waxman Act, Patent Expiration and the Promotion of Generic Drugs: Title I of the Act 2.4.4 The Hatch-Waxman Title I 2.4.5 US Congress First-to-Market 180-Day Exclusivity Period Incentive 2.4.6 The Hatch-Waxman Act Title II has Promoted Innovation in the Branded Pharmaceutical Industry 2.4.7 The Hatch-Waxman Act Drives Influx of Generic Pharmaceuticals Significantly 2.5 European Generics Patent Legislation Differs from that of the US 2.5.1 European Generic Drug Development: Variation between European Countries 2.5.2 EU has Long Data Exclusivity Period 2.5.3 Additional Protection Conferred by Supplementary Protection Certificates 2.6 Compulsory Licensing Allows Generic Manufacture before Patent Expiry 2.7 The Advantages of First-to-Market Generics 2.8 The Period of Market Exclusivity Varies from Country to Country 2.9 The 8+2+1 Rule – Moving Towards Standardisation 2.10 Generic Drugs are becoming Increasingly Important Globally

3. SWOT Analysis for the World Generics Market 3.1 SWOT Analysis for the Global Generics Sector, 2008-2013 3.2 The Ageing Population Constitutes One of the Strongest Drivers for the Pharmaceutical Industry 3.3 Rising Healthcare Costs are Leading to High Demand for Generics 3.4 FDA Approves More First-Time Generic Drugs 3.5 Generics Manufactures have Responded Vigorously to Market Opportunities 3.6 Low Price and High Volume are the Key Drivers of the Generics Market 3.6.1 Generic Penetration Rate is High in UK, US and Germany 3.6.2 Revenue Opportunities in Developing Markets are Attractive 3.7 The Lack of Competition from 3rd Generation Drugs also Drives the Market
   3.8 Leading Generics Companies Now have the Capability to Provide Innovative Products 3.8.1 Leading Generic Companies Transfer their Expertise to ‘Supergenerics’ 3.9 Leading Generics Companies are Highly Effective Organisations 3.10 Generic Company Merger and Acquisition Activity 3.11 The Generics Sector has Marked Weaknesses 3.11.1 Concern Over Biogenerics is a Restraint 3.11.2 Big Pharma has Instigated Generic Protection Strategies 3.11.3 Restrictive Patent Processes as Perceived by Generics Companies 3.11.4 Growth in Major Markets May Slow as Maximum Generic Penetration is Reached 3.11.5 The US Branded Market Faces Significant Challenges from Generics and Parallel Trade 3.11.6 Authorised Generics – The Most Aggressive PLM Strategy 3.12 Generics Market will Rise Up to the Challenges from Branded Pharmaceutical Companies

4. World Generics Market Forecast 2008-2013 4.1 The World Generics Market will Maintain High Growth in the Period 2008-2013 4.2 Generic Drugs for Chronic Diseases will Play a Significant Role in the Generics Market 4.3 Generics Market to Benefit from High Volume Sales of Blockbuster Drugs 4.3.1 Patent Expirations in 2008 4.3.2 Patent Expirations in 2009 4.3.3 Patent Expirations in 2010 4.3.4 Patent Expirations in 2011 4.3.5 Patent Expirations in 2012

5. US Generics Market Forecast & Analysis 2008-2013 5.1 US Generics Market Sales Forecast 2008-2013 5.2 The US is the Most Established Generics Market 5.2.1 Generic Penetration in the US Market is Still Increasing 5.2.2 Generic Prescriptions Seeing Percentage Rises in the US 5.2.3 Generic Pharmaceuticals Gain Strong Support from US-Managed Care Sector 5.2.4 Blue Cross Blue Shield – An Example of Innovative Education 5.2.5 Two-Tiered Formularies Cut Costs but Three-Tiered ones are Favoured 5.2.6 Wal-Mart Prescription Programme helps the US Generics Market Expand 5.2.7 FDA ANDA Backlog Grows

6. Japan: Generics Market Forecast & Analysis 2008-2013 6.1 Japanese Generics Market Sales Forecast 2008-2013 6.2 Impediments in Japan’s Generics Market 6.2.1 The Key Reason for Low Generics Adoption is Financial 6.2.2 Distribution Channels for Generics and Branded Drugs Differ in Japan 6.2.3 Generics Manufacturing Capacity in Japan must Improve to Foster Growth 6.3 Japan’s Generics Market sees Slow Growth in 2007
   6.4 Japan Can Reduce Rising Healthcare Costs through Generics 6.5 Prescribers’ Attitude to Generics in Japan must Change to Drive Growth 6.6 Leading Generics Companies Merge – Further Mergers Predicted 6.6.1 Japan’s Daiichi Sankyo Acquires Majority Stake in Ranbaxy

7. Overview of the EU Generics Market 7.1 Use of Generic Drugs Varies Greatly within the EU 7.2 A Coordinated Approach to Policy is Required in Europe

8. Germany: Generics Market Forecast & Analysis 2008-2013 8.1 German Generics Market Sales Forecast 2008-2013 8.1.1 Germany has High Public Acceptance of Generics 8.1.2 Generics Pricing in Germany 8.1.3 Germany Introduces New Generic Substitution Rules 8.1.4 “Aut Idem” Rules Drive Prices Down and Encourage Generic Substitution 8.1.5 Regulations in Germany are in a State of Transformation

9. France: Generics Market Forecast & Analysis 2008-2013 9.1 French Generics Market Sales Forecast 2008-2013 9.1.1 The French Generics Market is Expanding 9.1.2 France has being Slow to Recognise Cost-Saving Value of Generics 9.2 New Measures Facilitate Generics Uptake in France 9.3 Integration of the New EU Pharmaceutical Reforms will Help Drive Generics Sector

10. UK: Generics Market Forecast & Analysis 2008-2013 10.1 UK Generics Market Sales Forecast 2008-2013 10.2 Favourable Regulations Drive the UK Generics Market
    10.2.1 A Change in Prescribing Protocols Increases Use of Generics 10.3 Generics Drug Tariff is Influential 10.3.1 Department of Health Sets New Drug Tariff for Generics Manufacturers and Wholesalers 10.3.2 Pharmacists are the Key for Higher Generic Substitution 10.4 PRODIGY Facilitates UK GP’s Generics Accessibility 10.5 The Future of the UK Generics Market

11. Spain: Generics Market Forecast & Analysis 2008-2013 11.1 Spanish Generics Market Forecast & Analysis 2008-2013 11.2 Generics Acceptance in Spain is Improving but Attitudes Still Limit Growth 11.3 The Reference Pricing System is Limiting Growth 11.4 Lack of Incentive Affects Prescribing Practices

12. Italy: Generics Market Forecast & Analysis 2008-2013 12.1 Italian Generics Market Sales Forecast 2008-2013 12.2 Italy’s Tight Price Controls will Reduce Generic Profit Margins 12.3 Changes in Pricing System in Italy May Help Drive Generic Sales 12.4 Changes in Cultural Attitudes Towards Generics will be Positive for Sales Growth

13. Emerging Generic Markets 13.1 Fast Emerging Economies such as China and India Hold Strong Generics Revenue Potential 13.2 India’s Market Abroad 13.2.1 India’s Purchasing Power Parity 13.2.2 The Indian Pharmaceutical Market will Provide Growth for Generics 13.2.3 India’s Ranbaxy, Sun Pharma and Dr Reddy’s have Expanded into the World Generics Market 13.3 China’s Generics Market has Marked Revenue Potential 13.3.1 Competitive Factors Influencing Sales of Domestic Generics in China 13.3.2 Changes in Patent Regulations Required by the WTO may Affect the Supply of Generics 13.4 Russia’s Pharmaceutical Market is Largely Dominated by Generic Medicines 13.4.1 Russia’s Generics Market Prospects are Bright

14. Conclusions 14.1 World Generics Market will Show Growth 14.2 Major Markets will Account for the Largest Generics Revenues 14.3 Healthcare Cost Reduction will Drive Demand for Generics in Leading Markets 14.4 Generic Drugs for Treating Chronic diseases will Play a Significant Role in this Market’s Expansion 14.5 Generics Market will Benefit from High Volume Sales of Blockbuster Drugs Losing Patent Protection 14.6 Generics Companies will Rise to the Challenges and Opportunities in the Global Pharmaceuticals Market from 2008-2013

List of Tables Table 2.1 World Pharmaceuticals Industry Revenues ($bn), 2000-2007 Table 3.1 SWOT Analysis for the Generic Pharmaceuticals Market, 2008-2013 Table 3.2 FDA First-Time Generic Drug Approvals, 2004-2008 Table 3.3 Sales of Top-10 Generic Companies: Total Group Sales ($bn), Companies Share (%), 2006 Table 4.1 World Generics Market Sales ($bn) Forecast, 2008-2013 Table 4.2 World Pharmaceuticals Market Sales vs. World Generics Market Sales ($bn), 2008-2013 Table 4.3 Major Markets Generics Sales Forecast ($bn), 2008-2013 Table 4.4 Therapeutic Areas of Drugs Coming Off Patent, 2008-2012 Table 4.5 Major Chronic diseases and Common Generic drugs Table 4.6 Total Patent Expirations by Sales ($bn), 2008-2012 Table 4.7 Patent Expirations, 2008-2013 Table 4.8 Key Patent Expirations, 2008 Table 4.9 Key Patent Expirations, 2009 Table 4.10 Key Patent Expirations, 2010 Table 4.11 Key Patent Expirations, 2011 Table 4.12 Key Patent Expirations, 2012 Table 5.1 US Generics Market Sales ($bn) Forecast, 2008-2013 Table 5.2 US Generic Drugs vs. Branded Drugs Revenue ($bn), Drugs Share (%), 2007 Table 6.1 Japan Generics Market Sales ($bn) Forecast, 2008-2013 Table 7.1 Generics Market Share by Volume (%) in Representative EU Countries, 2007 Table 7.2 Generics Market Share by Value (%) in Representative EU Countries, 2007 Table 7.3 Summary of Policies Affecting EU Generics Markets Table 8.1 Germany Generics Market Sales ($bn) Forecast, 2008-2013 Table 9.1 France Generics Market Sales ($bn) Forecast, 2008-2013 Table 10.1 UK Generics Market Sales ($bn) Forecast, 2008-2013 Table 11.1 Spain Generics Market Sales ($bn) Forecast, 2008-2013 Table 12.1 Italy Generics Market Sales ($bn) Forecast, 2008-2013 Table 13.1 Leading Domestic Pharmaceutical Companies in India by Sales ($m), 2007 Table 13.2 Leading Domestic Pharmaceutical Companies in China by Sales ($m), 2007 Table 13.3 Leading Corporate Pharmaceutical Companies in China by Sales ($m), 2007 Table 13.4 Leading Domestic Pharmaceutical Companies in Russia by Sales ($m), 2007 Table 13.5 Leading Corporate Pharmaceutical Companies in Russia by Sales ($m), 2007 Table 14.1Major Markets: Generics Sales Forecasts ($bn), 2008-2013

List of Figures Figure 2.1 World Pharmaceuticals Industry Revenues ($bn), 2000-2007 Figure 3.1 FDA First-Time Generic Drug Approvals, 2004-2008 Figure 4.1 World Generics Market Sales ($bn) Forecast, 2008-2013 Figure 4.2 Sales ($bn) of the World Generics Market vs. World Pharmaceuticals Market, 2008-2013 Figure 4.3 Therapeutic Areas of Drugs Coming Off Patent, 2008-2012 Figure 4.4 Total Patent Expirations by Sales ($bn), 2008-2012 Figure 4.5 Number of Patent Expirations, 2008-2012 Figure 5.1 US Generics Market Sales ($bn) Forecast, 2008-2013 Figure 5.2 US Generic Drugs vs. Branded Drugs Share (%), 2007 Figure 6.1 Japan Generics Market Sales ($bn) Forecast, 2008-2013 Figure 7.1 Percentage (%) of Generic Drugs vs. Branded Medicines in the EU Market, 2007 Figure 8.1 Germany Generics Market Sales ($bn) Forecast, 2008-2013 Figure 9.1 France Generics Market Sales ($bn) Forecast, 2008-2013 Figure 10.1 UK Generics Market Sales ($bn) Forecast, 2008-2013 Figure 11.1 Spain Generics Market Sales ($bn) Forecast, 2008-2013 Figure 12.1 Italy Generics Market Sales ($bn) Forecast, 2008-2013

Organisations Mentioned in this Report

Abbott|Actavis|Alcon Labs|Alkem|Allergan|Apotex|Astellas |AstraZeneca|Aventis|Barr|Bayer|Bayer Schering |Berlin-CH/Menarini|Boehringer Ingelheim|Bristol-Myers Squibb|Centre for Studying Health System Change|Cipla|Daiichi Sankyo|Dr Reddy’s|Eli Lilly|European Free Trade Association (EFTA)|European Generic Medicines Association (EGA)|European Medicines Agency (EMEA)|Forest Labs|Fresenius|Gedeon Richter|GlaxoSmithKline|Graceway|HLJ Haerbin |HN.Tongyongsanyang|International Monetary Fund|Johnson & Johnson|Janssen Japanese Generic Pharmaceutical Manufacturers Association (JGPMA)|Japanese Ministry of|Health, Labour & Welfare (MLHW)|Jiangsu YangZijiang|JS LYG Hengrui|JS Yangzijiang FTY|Krka|Lek|Lupin Labs|M.S.D.-Hangzhou|Mallinckrodt|Menarini|Merck & Co|Merck KGaA|Mylan|National Coalition on Health Care|National Medical Expenditure (NME)|NIchi-Iko|NicholasPiramal|Novartis|Nycomed|Pfizer|Pharmstandard|Ranbaxy|Ratiopharm|Roche|Sandoz|Sanofi-Aventis|Sanofi-Syn.M-Sheng |Sanovil|Sawia|Servier|SH.Asia Pioneer PH|Shandong Qilu FTY|Stada|Sun Pharma|Taiyo|Takeda|Tawo|Teva|The Medicines Company|UCB|UK National Health Service (NHS) |US Food and Drug Administration (FDA)|US Generic Pharmaceutical Association (GPhA)|Wal-Mart|Watson World Bank|World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO TRIPS)|Wyeth|Zydus Cadila

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Stem Cells – The Hype & Hope – World Analysis 2009-2024

Stem cell technologies – changes to US regulations to give exciting new hopes and potentially vast commercial opportunities – brand new indepth study analysis how.

Stem cells represent one of the most promising medical breakthroughs of all time, as our new market report explains. Currently, in 2009, the new US administration is lifting some major restrictions on stem cells technologies. This developmental obstacle now removed, all types of stem cells are available for expanding the therapeutic and commercial potentials, as our new report Stem Cells – The Hype & Hope – World Analysis 2009-2024 explains. Based upon the cells that create and renew all tissues potentially, stem cell therapies could revolutionise the treatment of disease, especially through tissue and organ replacement. Stem cells could provide revolutionary treatments for conditions from diabetes to multiple sclerosis, and from myocardial infarction to chronic obstructive pulmonary disease, amongst many others. Stem cell lines could also change the way pharmaceutical companies assess new chemical entities during R&D.

A conservative estimate places the potential market value of stem cells at over $150bn by late next decade. But will stem cell products be ready to meet regulatory hurdles and market requirements? Where is stem cell research heading today? What stem cell therapies are likely to hit the market from 2009 onwards? Where does the highest value lie in the short-term? What are the commercial threats there? This new visiongain report answers these and other crucial questions about this important developing field, one with vast commercial potential.

Comprehensive analysis of the global stem cells sector and market Stem Cells – The Hype & Hope – World Analysis 2009-2024 examines stem cells technology critically. We used a comprehensive review of information sources, including consultations with relevant experts. This report provides detailed sales forecasts, discussions of pipeline developments and analyses of important contemporary issues, especially relevant commercial drivers and restraints. This report also covers regulations and ethics. Sources used include commercial databases, industry news, published reports, policy documents and economic research. Importantly, visiongain applied rigorous financial forecasting, qualitative analyses and the assessment of unmet needs. The result is a comprehensive market- and industry-centred report with detailed analysis and informed opinion that you will not find elsewhere.

Why you should buy this report: Key information that you will find in Stem Cells – The Hype & Hope – World Analysis 2009-2024 includes:

Analyses of the existing market value for stem cells Analyses of the potential market value of stem cell therapies, including detailed revenue forecasts from 2009 to 2024 Forecasts for existing stem cell markets, including private cord blood banks and Osiris Therapeutics and NuVasive’s Osteocel Discussions of ethical complications and situations that influence the way stem cell medicine is perceived, researched and conducted Analyses of key organisations, suppliers and relevant national laws Expert opinions from original research interviews with key opinion leaders in stem cells research and technology Informed analyses of the strengths and weaknesses of the technologies from 2009 onwards Balanced assessments of commercial drivers and restraints in the stem cells field. Visiongain believes that stem cell technologies are progressing rapidly. We predict that more products will enter the market over the coming 5 years, changing the commercial landscape for stem cells.

You can order this report today Nobody with an interest in the stem cells field can afford to overlook this new market study from visiongain. The market environment in many countries will change, especially after favourable developments in the US in early 2009. Visiongain predicts that revenues for stem cell technologies will increase greatly from 2009 to 2024, with important events shaping trends. Will stem cells revolutionise medicine in the foreseeable future? What are the main obstacles to overcome there? What revenues can be achieved? This report covers those vital questions and many more. Do you want to know more about this important market? You can stay ahead in this exciting field by ordering this report today. You should read this report today. Contact me now to order your copy.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary 1.1 The Focus of This Report: “Stem Cells Therapy” versus “Regenerative Medicine” 1.2 Crucial Aspects of the Stem Cell Market 1.2.1 Summary Points 1.2.2 Potential Sales Values 1.3 Aims, Scope and Format of This Report 1.3.1 The Speculative Aspects of Assessing the Stem Cell Field 1.3.2 Chapter Outline 1.4 Research Methods

2 Stem Cells: Types and Sources 2.1 Defining Characteristics 2.1.1 Multipotency vs. Pluripotency 2.1.2 Germ Layers and Multipotent Cells 2.2 Embryonic Stem Cells 2.2.1 Abortion Debates, IVF, and Embryonic Stem Cells 2.2.2 Harvesting Human Eggs 2.3 Cybrids: Controversial Animal-Human Hybrids 2.3.1 “Disease in a Dish” Models Using Cybrids 2.3.2 Cybrids and Therapeutic Cloning 2.3.3 Animal or Human? 2.4 Adult Stem Cells 2.4.1 Tissue / Body Part Sources of Adult Stem Cells 2.5 Cord Blood: The “Natural” Source of Embryonic Stem Cells 2.5.1 “Cord-Blood-Derived Embryonic-Like Stem Cells” (CBE) 2.5.2 CBEs: Ethical and Available 2.5.3 Cord Blood Proven to Cure 2.5.4 The Odds of Needing a Blood Stem Cell Transplant 2.5.5 Cord Blood: Private Hope or Public Salvation? 2.5.5.1 Tissue Matching Can be Less Precise with Cord Blood 2.5.5.2 Extra-Familial Tissue Matching 2.5.5.3 Private Cord Blood Banking: Biological Insurance 2.5.5.3.1 Regional Rules on Private Cord Blood Banking 2.5.5.3.2 US Oversight of Cord Blood Stem Cells 2.6 Commercial Potential of Cord Blood Banks: Market Forecast 2.6.1 86% of Banks Established post-2000 2.6.2 Banks' Added Value 2.7 Do Stem Cells Cause Cancer? 2.7.1 Cancer Metastasisation Caused by Rogue Stem Cells? 2.7.2 Potency Re-programming Requires Insertion of Cancerous Gene 2.7.3 Will Stem Cell Treatments Cause Cancer?

3 Established Stem Cell Treatments 3.1 Bone Marrow Transplants: 40+ Years of Success 3.2 Peripheral Blood Stem Cells: Gaining Ground 3.3 Cord Blood Stem Cells 3.4 Graft-Versus-Tumour Effect: Donated Cells Kill Host’s Cancer Cells 3.4.1 Allogenic Transplants are Better for Killing Cancer 3.5 Graft-Versus-Host Disease: When Host and Transplant Do Not Mesh 3.5.1 Prochymal: Treatment for GvHD 3.6 Host-Versus-Graft: When Stem Cells are Rejected 3.7 “Saviour-Siblings”: Stem Cells from a Sibling, Created or Chosen to be a Saviour 3.7.1 UK Cases and Rules on Saviour Siblings 3.7.2 Regardless of the Ethics, Saviour Sibling Stem Cells Work

4 Emerging Stem Cell Treatments 4.1 Prochymal – Poised to be the First Revolutionary Stem Cell Treatment 4.1.1 Market Value of Prochymal Indications 4.1.2 Crohn’s Disease 4.1.3 Chronic Obstructive Pulmonary Disease 4.1.4 Diabetes and Prochymal 4.1.5 Cardiac Indications 4.1.6 Graft-Versus-Host Disease 4.1.7 Prochymal and Acute Radiation Syndrome 4.1.7.1 Proof-of-Concept for Prochymal for ARS 4.2 Osteocel Market Forecast: Osiris’s First Marketed Product, Now Sold by NuVasive 4.2.1 Osteocel: The Only Marketed Product with Viable Stem Cells 4.2.2 Osteocel XC 4.3 Other Wound Healing / Surgical Healing 4.4 Heart and Artery Repair 4.5 Autoimmune Diseases 4.5.1 Crohn’s Disease 4.5.2 Diabetes Types 1 and 2 4.5.3 Multiple Sclerosis 4.6 Reducing Rejection: Addressing Graft-Versus-Host Disease 4.7 Paralysis Treatments: Geron’s GRNOPC1. (The First Embryonic Stem Cell Clinical Trial) 4.7.1 How Much GRNOPC1 Can Geron Make? 4.8 Therapeutic Cloning / Somatic Cell Nuclear Transfer 4.8.1 Organ Transplants: Can Therapeutic Cloning Make Them Obsolete? 4.8.2 Growing Organs 4.8.3 Somatic Cell Nuclear Transfer for Disease Models

5 Leading Stem Cell Therapy Companies 5.1 Osiris: First to Market with Stem Cells 5.1.1 Prochymal and 2008 5.1.2 Osiris and NuVasive 5.1.3 Osteocel Sales Forecast 5.1.4 Osiris and Genzyme Marketing Agreement 5.1.5 Osiris and Boston Scientific: Partnership Ended 2008 5.2 Genzyme 5.3 Geron: First Embryonic Stem Cell Trial 5.4 Novocell: Looking to Follow Geron in Embryonic Stem Cell Trials 5.4.1 Johnson & Johnson and Novocell 5.4.2 Pfizer and Novocell 5.5 Pfizer and Induced Pluripotent Stem Cells (iPS) 5.6 Novartis: The Genomics Institute of the Novartis Research Foundation (GNF) 5.7 MediStem, Inc. (MediStem Laboratories, Inc.) 5.8 Regenetech 5.8.1 Biogenea-CellGenea 5.9 Neuralstem, Inc. 5.10 Advanced Cell Technology (ACT) 5.10.1 ACT and Transition Holdings, Inc. 5.10.2 ACT and CHA Biotech Co., Ltd. 5.10.3 ACT Acquired Mytogen, Inc. 5.11 Garnet BioTherapeutics / Neuronyx 5.12 Pluristem Therapeutics, Inc. 5.13 BrainStorm Cell Therapeutics 5.14 Cellerix: Ontari has EMA Orphan Drug Status 5.15 ReNeuron 5.16 CellCure Neurosciences, Ltd. 5.17 Athersys 5.18 Royan Institute (Tehran) 5.19 Reliance Life Sciences, India 5.20 Cytori Therapeutics

6 Major Stem Cell Suppliers 6.1 StemCell Technologies 6.1.1 Geron and StemCell Technologies 6.2 ES Cell International, Singapore: Aiming for the First Marketed Product Including Embryonic Stem Cells 6.3 Stemride International Limited (SIL) and Reproductive Genetics Institute, Chicago: Normal and Abnormal Cell Lines 6.4 Merck / Calibochem 6.4.1 Stem Cell Sciences and Merck 6.5 Cellular Dynamics International (CDI) 6.5.1 Roche and Cellular Dynamics: Pioneering Toxicity Assays 6.6 HyClone / Thermo Fisher Scientific 6.7 Stemgent 6.8 Stem Cell Innovations (SCI) 6.9 Axiogenesis (Germany) 6.9.1 Roche and Axiogenesis 6.10 StemLifeLine: Embryonic Stem Cells Without Embryo Destruction?

7 Overview of Regional Embryonic Stem Cell Regulations and Funding Bodies 7.1 Pan-Europe: Roche, GlaxoSmithKline and AstraZeneca 7.2 United States 7.2.1 California Stem Cell Research and Cures Initiative (Proposition 71) and The California Institute for Regenerative Medicines 7.2.1.1 Stanford University Received $75 Million for Stem Cell Research 7.2.1.2 UC Irvine Received $27 Million for Stem Cell Research Center 7.3 United Kingdom 7.3.1 The London Regenerative Medicine Network (LRMN) 7.4 Sweden 7.5 Switzerland 7.6 Belgium 7.7 France: Reassessing Embryonic Research in 2009 7.8 Less-Permissive European Countries for Stem Cells 7.8.1 Germany 7.8.2 Norway 7.8.3 Italy 7.9 Canada 7.10 Russia 7.11 Israel: At the Forefront of Research; Reproductive Cloning Ban Up for Reassessment in 2009 7.12 Gulf Countries: Funding Biotechnology, Funding Stem Cell Research 7.13 Singapore: Advanced and Prominent in Stem Cells 7.14 China: Open to the Potential of Stem Cell Technologies 7.15 India: First Stem Cells Facility Due to Open in 2009 7.16 Australia and the Australian Stem Cell Centre 7.17 Japan 7.18 South Korea 7.19 South Africa

8 Visiongain Interviews with Stem Cell Experts 8.1 Dr. Johan Luthman, PhD., Global Head of Exploratory Medicine (Neurology, Autoimmune & Inflammatory Diseases), Merck Serono (a division of Merck KGaA) 8.1.1 On the Difficulties of Translational Medicine 8.1.2 On the Differences Between Technology and Media Perceptions 8.1.3 On Confusion in the Media 8.1.4 On Stem Cells and Neurologic Disorders 8.1.4.1 On Which Neurological Disorders will be Treated First 8.1.4.2 On Multiple Sclerosis 8.1.5 On Why Stem Cell Results Take a Long Time 8.1.6 On When Stem Cell Therapies Will Reach the Market 8.1.7 On the Distinction between Regenerative Medicine and Stem Cell Therapies 8.2 Dr Stephen Minger, Senior Lecturer and Director of King’s College London’s Stem Cell Biology Laboratory (Wolfson Centre for Age-Related Diseases) 8.2.1 On Whether Adult or Embryonic Stem Cells Should Receive More Funding/Support 8.2.2 On Cord Blood and Embryonic Stem Cells 8.2.3 On the Need for More Immunological Assays 8.2.4 On How Long Until There are Human Stem Cell Therapies 8.2.5 On Cord Blood as a Source of Stem Cells 8.2.6 On Private Cord Blood Banking 8.2.7 On Therapeutic Cloning 8.2.7.1 On Therapeutic Cloning and Tissue Type Cell Lines 8.2.8 On the Promising and Unusual Immunological Properties of Embryonic Stem Cells 8.2.9 On Mesenchymal Stem Cells and Inflammation 8.2.10 On the Suggestive Use of Foreskin Fibroblasts 8.3 Gregory Bonfiglio, Proteus Venture Partners 8.3.1 On the Terms “Stem Cell Therapy” and “Regenerative Medicine” 8.3.2 On “Near Term” Applications 8.3.3 On the Value-Creation Curve for Venture Capital in Stem Cells 8.3.4 On There Being No Known Limits for Stem Cell Possibilities 8.3.5 On Stem Cells in 25 Years 8.3.6 On Funding as a Primary Limitation 8.3.7 On Stem Cells in Multiple Sclerosis and Diabetes Type 1 8.3.8 On Cord Blood 8.3.9 On Extracellular Matrixes 8.3.10 On Disease-Specific Cell Lines 8.3.11 On Adult vs. Embryonic Stem Cells 8.3.12 On Where There is Capital for Stem Cell and Regenerative Medicine Research 8.4 Josephine Quintavalle, Founder of Comment on Reproductive Ethics (CORE) 8.4.1 On Embryonic Stem Cells and Dehumanisation 8.4.2 On HFEA Regulation for Embryo Destruction 8.4.3 On Economics and Scientific Effectiveness 8.4.4 On Cord Blood 8.4.5 On Adult Stem Cell Therapies and the Economics of Therapy 8.4.6 On Public, Private and Private/Public Cord Blood Banks 8.4.7 On International Studies and International Communication

9 Market Value Potentials and Projections 9.1 Visiongain’s Stem Cells Market Projection 9.1.1 Complexities of Analysis 9.1.2 Bases for Visiongain’s Market Projection 9.2 Forecast by Market Subdivision 9.2.1 Laboratory Supplies 9.2.2 Bone Marrow Transplants 9.2.3 Organs and Tissues

10 SWOT Analysis 10.1 Strengths and Weaknesses 10.1.1 Strength in Numbers 10.1.2 Weakness in Fragmentation 10.1.3 Weakness in Funding Uncertainties 10.2 Opportunities and Threats 10.2.1 Opportunities Abound 10.2.2 The Constant Threat of Politics

11 Conclusions 11.1 The Hope 11.2 The Hype 11.3 The Short-Term Future 11.4 The Long-Term Future

Appendix: Religious Perspectives on (Embryonic) Stem Cells 1 Catholicism 2 Protestantism 3 Judaism 4 Islam 5 Hinduism

List of Tables Table 2.1 Types of Cellular Potency and Sources of Cells Table 2.2 Germ Layers and Associated Cells/Organs Table 2.3 Adult Stem Cell Sources Table 2.4 Private / Family Cord Blood Banks Sales Forecast, 2009-2024 Table 4.1 Market Value of Selected Prochymal Future Indications, Based Upon Sales Through Q3 2008 Table 4.2 Osteocel Sales Forecast, 2009-2024 (including Osteocel XC) Table 4.3 Clinical Trials of Stem Cell Studies for Surgical or Injury Healing, Phases I-III, 2009 Table 4.4 Stem Cell Heart Repair Clinical Trials, Phases III-IV, 2009 Table 4.5 Clinical Trials for Autoimmune Diseases (non-Prochymal), Phases I-III, 2009 Table 4.6 Clinical Trials for Graft-Versus-Host Disease, Phase II-III, 2009 Table 4.7 Countries' Donor Systems (Opt-in vs. Opt-out), 2009 Table 5.1 Osteocel Sales Forecast, 2009-2024 Table 9.1 Stem Cells Sales Forecasts, Total Market and by Sub-Market, 2009-2024 Table 10.1 Strengths and Weaknesses in the Stem Cells Market, 2009-2024 Table 10.2 Opportunities and Threats in the Stem Cells Market, 2009-2024

List of Figures Figure 2.1 Private / Family Cord Blood Banks Sales Forecast, 2009-2024 Figure 4.1 Market Value of Selected Prochymal Future Indications, Based Upon Sales Through Q3 2008 Figure 4.2 Osteocel Sales Forecast, 2009-2024 Figure 5.1 Osteocel Sales Forecast, 2009-2024 Figure 9.1 Stem Cells Total Market Sales Forecast, 2009-2024 Figure 9.2 Stem Cells Sales Forecasts by Sub-Market, 2009-2024

Companies and Organisations Mentioned in this Report Advanced Cell Technology Alliance Technology Ventures American Spinal Injury Association (ASIA) Anthony Nolan Trust Assisted Human Reproductions Agency, Canada AstraZeneca Athersys Australian Stem Cell Centre Axiogenesis AG Barts & The London NHS Trust Bayer Schering Pharma Biogenea-CellGenea Blutspendedienst Baden-Württemberg – Hessen Boston Scientific Corp. BrainStorm Cell Therapeutics Calibochem California Institute for Regenerative Medicines (CIRM) Cambridge University Hospitals Canadian Institute of Health Canadian Institutes of Health Research (CIHR) CellCure Neurosciences, Ltd. Cellerix Cellular Dynamics Cellular Engineering Technologies Centre for Cellular and Molecular Biology, India CHA Biotech Co., Ltd, Korea Children’s Hospital & Research Center, Oakland, California Christian Medical College, Vellore, India Clinical Research Facility for Stem Cells and Regenerative Medicine, India Comment on Reproductive Ethics (CORE) Cord Blood Registry, US Cordon Vital (CBR), Mexico Cryo-Cell International Cytori Therapeutics Department of Defense (US) Deutsches Herzzentrum Muenchen Duke University Eli Lilly and Company Else Kröner Fresenius Foundation ES Cell International, Singapore European Group for Blood and Marrow Transplantation European Medicines Agency (EMA) European Union Group on Ethics (EGE) Financiadora de Estudos e Projetos (FINEP) Food and Drug Administration (FDA) Franziskus-Krankenhaus Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul (FAPERGS) Garnet BioTherapeutics Genzyme German Heart Institute Geron Guidant Corporation Hadassah Medical Organization Haematology Service, University Hospital of Salamanca Harvard Biosciences, Inc. Harvard Stem Cell Institute Health Resources and Services Administration Human Fertilisation and Embryology Authority (HFEA) Imperial College London Institute for Medical Sciences, Nizam Instituto de Cardiologia do Rio Grande do Sul iPS Cells Israeli Health Ministry Johann Wolfgang Goethe University Hospitals Johns Hopkins University Johnson & Johnson Development Corporation King’s College London Kingston University, Surrey, UK Korea Stem Cell Bank Co., Ltd. (KSCB) Krankenhaus der Barmherzigen Brüder Trier Leids University Medical Centre LifeCell India London Development Agency London Regenerative Medicine Network (LRMN) M.D. Anderson Cancer Center Medical Research Council MediStem, Inc. Memorial Sloan-Kettering Cancer Center Merck KGaA Merck Serono Miltenyi Biotec Ministry of Health, Brazil Ministry of Health, Iran Ministry of Science and Higher Education, Poland Mytogen, Inc. National Cancer Institute (NCI) National Marrow Donor Program Nephros Neuralstem, Inc. Neuronyx NHS Foundation Trust Northwestern University Northwestern University Feinberg School of Medicine, Chicago Novartis Novocell NuVasive, Inc. OSI Pharmaceuticals Osiris Therapeutics Parent’s Guide to Cord Blood Foundation Pfizer Pluristem Therapeutics, Inc. Postgraduate Institute of Medical Education and Research, India Primogenix ProLife Alliance Proteus Venture Partners Queen Mary University of London Radius Medical, LLC Regenetech Reliance Life Sciences ReNeuron Reproductive Genetics Institute, Chicago Roche Royan Institute, Tehran Safeguard Scientifics, Inc. Schulz Foundation SCP Vitalife Partners Silesian School of Medicine Singapore Stem Cell Consortium SRH Klinikum Karlsbad-Langensteinbach Stem Cell & Regenerative Medicine International Stem Cell Authority, Ltd. Stem Cell Biology and Regenerative Medicines Institute, Stanford University Stem Cell Innovations Stem Cell Network, Canada Stem Cell Products Inc. Stem Cell Research Forum of India (SCRFI) Stem Cell Sciences Stem Cells for Safer Medicines (SC4SM) StemCell Technologies Stemgent StemLifeLine Stemride International Limited Stiftungsklinikum Boppard Swiss Stem Cells Network Texas A&M University The Broad Foundation The Genomics Institute of the Novartis Research Foundation Thermo Fisher Scientific (formerly HyClone) Transition Holdings, Inc., Ireland UC Irvine Universidad Autónoma de Madrid University College London University Hospital of Liege University Hospital, Basel, Switzerland University of Cambridge University of Louisville University of Minnesota University of Ottawa University of Oulu, Finland University of Salamanca University of Southern California University of Texas Medical Branch, Galveston University of Washington US Department of Health and Human Services ViaCell, Inc. Washington University School of Medicine Wilhelm Sander Foundation World Marrow Donor Association

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World Diabetes Market Analysis, 2009-2023

Incidence and prevalence of diabetes mellitus are increasing worldwide, in line with lifestyle changes and population aging. In particular, the rising prevalence of diabetes is closely linked with that of obesity, creating significant market opportunities. As discussed in this new visiongain report – World Diabetes Market Analysis, 2009-2023 – The World Health Organization estimates the number of diabetics to exceed 350 million by 2030. Governments and other healthcare providers around the world are investing in health education, diagnosis and treatments for this chronic, debilitating – but controllable – disorder.

In 2007, the diabetes treatment market worldwide was worth over $25 billion, and had double-digit growth from the year before. Consequently, it is one of the largest sectors in the global healthcare industry. All segments of the diabetes therapy market have been expanding, but which will grow fastest in years to come? What are the key therapeutic and commercial trends to watch? How will the principal national markets perform from 2009 to 2023? What will happen to the current leading products/therapies? How does diabetes overlap with obesity? This report will answer those and other crucial questions about this large, increasingly important pharmaceutical market.

This visiongain report – World Diabetes Market Analysis, 2009-2023 – provides in-depth analysis of the markets for insulins, insulin analogues and oral anti-diabetics. This report also covers the new GLP-1 analogues – such as Byetta and liraglutide – as well as potentially revolutionary insulin delivery technologies. Our study includes detailed sales forecasts for crucial products and market areas, providing the information you need to assess commercial aspects of the diabetes market fully. We cover both sales worldwide and for leading national markets, present and future. In addition to consultation with relevant experts – including interview transcripts – this original research involved a detailed study of policy documents, industrial reports and current developments, including R&D pipelines and line extensions. Importantly, visiongain applied techniques such as financial forecasting and analyses of market drivers and restraints. The result is a comprehensive market- and industry-based report with detailed analyses and informed opinion that you will not find anywhere else.

Highlights of World Diabetes Market Analysis, 2009-2023 include: • Analyses of the strengths, weaknesses, opportunities and threats that will affect the global diabetes market, particularly drivers and restraints • Sales forecasts for major drugs and discussion of prominent companies’ activities • Separate analyses and forecasts for the oral anti-diabetics and insulin analogues markets • Regional analyses for the United States, Europe, Japan, China and India, all divided into sales forecasts for oral anti-diabetics and insulin analogues • Expert opinion – derived from original research interviews – discussing diabetes research, promising drugs and the commercial and therapeutic significance of the obesity epidemic on diabetes incidence and treatment, present and future • Analyses of crucial future trends, including ultra-long-acting drugs and novel insulin-delivery technologies, as well as more-radical developments.

Why you should buy this report: • To receive forecasts of global revenue trends for diabetes treatments from 2009 to 2023 • To gain in-depth sales forecasts, from 2009 to 2023, covering strengths and weaknesses of key products and sub-markets • To gain an understanding of all sectors of the diabetes market, including commercial analyses of individual drugs, drug classes, pipelines and regional markets • To discover insight from original interviews with key opinion leaders (KOLs) • To find out how the diabetes market is set to change dramatically over the next fifteen years • To discover how the diabetes management sector is evolving worldwide in terms of diagnosis, assessment, treatment and patient compliance • To discover exactly why diabetes is a major concern for governments, and why this serious chronic illness is one of the most important global healthcare issues, with hundreds of millions of people suffering from diabetes and hundreds of million more currently at risk

Visiongain predicts continuing expansion of the market for the whole range of diabetes treatments, driven by increasing disease incidence as well as improvements to diagnoses and treatment access, especially in developing countries. Successful participating companies will benefit as a result, gaining market prominence from high-value products. The healthcare industry cannot afford to ignore current developments in diabetes treatment, as shown in this report. Diabetes is arguably the greatest healthcare threat in developed countries and a rising scourge in countries such as China, India and Brazil. Pharmaceutical, biotechnological and diagnostics companies cannot afford to overlook this developing field, especially for innovative therapies.

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        Table of  contents

1 Executive Summary 1.1 The Diabetes Market Trajectory 1.1.1 Visiongain’s Prediction for Total Diabetes Sales in 2023 1.1.2 Diabetes is Spreading at an Epidemic Rate: The Need for Pharmaceuticals is Growing 1.1.3 Diabetes Care Works: The Market Will Expand 1.1.4 Awareness, Advocacy and Government Spending Aimed at Diabetes are all Expanding 1.2 Aims, Scope and Format of the Report 1.3 Research Methodology

2 Introduction 2.1 What is Diabetes Mellitus? 2.1.1 Symptoms of Diabetes 2.1.2 Type 1 Diabetes 2.1.3 Type 2 Diabetes 2.1.4 Gestational Diabetes 2.1.5 Other types of Diabetes 2.1.6 “Pre-Diabetes”: Impaired Glucose Tolerance (IGT) and Metabolic Syndrome 2.2 Health Consequences: Diabetes Can Cause Heart, Kidney, Eye and Nerve Damage 2.3 Obesity: The Major Diabetes Risk Factor 2.4 Other Risk Factors: Age, Genetics, Race 2.5 Diagnosis: Guidelines are Subject to Change 2.6 Prevalence: By All Measures, Diabetes Rates are Rising Epidemically 2.7 The Economic Costs of Diabetes 2.8 Treatments 2.8.1 Insulin: A Therapeutic Mainstay 2.8.2 Other Medications 2.8.3 More Novel Therapies? A New Discovery about How Insulin Works May Lead to New Drugs 2.9 Diabetes Treatment Noncompliance Rates 25% to 90% Currently

3 World Diabetes Market, 2008-2023: Leading Drugs 3.1 Market Forecast, 2008-2023 3.2 Byetta Forecast 3.2.1 Byetta’s Strengths 3.2.2 Restraints on Byetta 3.3 Oral Antidiabetics Forecast 3.4 Actos Forecast 3.5 Avandia Forecast 3.6 Januvia Forecast 3.7 Avandamet Forecast 3.8 Human Insulin and Analogues Forecast 3.9 Lantus Forecast 3.10 Novorapid Forecast 3.11 Humalog Forecast 3.12 Novomix Forecast 3.13 Actraphane HM Forecast 3.14 Levemir Forecast 3.15 Other Diabetes-related Drugs: Symlin and Kinedak 3.16 Alternative Delivery Methods: The Possibilities to Watch 3.16.1 Exubera: Cautionary Case Study 3.16.2 Oral Delivery Technologies 3.16.3 Transdermal Technologies

4 Leading Companies in Diabetes Treatment 4.1 Novo Nordisk 4.1.1 Insulin Plant to be Built in China 4.1.2 FDA Delays Liraglutide Once-Daily 4.1.3 Teaming up with Merrion for Oral Delivery Technologies 4.2 Takeda 4.2.1 May Seek Atherosclerosis Application for Actos 4.3 sanofi-aventis 4.3.1 Patent Infringement Case with Novo Nordisk and Eli Lilly 4.4 Eli Lilly 4.4.1 Eli Lilly’s Fortunes Closely Linked to Amylin’s Performance 4.5 Amylin 4.5.1 Amylin’s Future Tied to Byetta LAR 4.6 Pipeline Developments 4.6.1 Liraglutide 4.6.2 Other GLP-1 Analogues 4.6.3 DPP-4 Inhibitors 4.6.4 Biguanides 4.6.5 New Therapy Class: Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors 4.6.6 Insulin Pipeline: Mostly Focused On Delivery Methods 4.6.7 Pipeline for Cures?

5 World Market Analysis by Region 5.1 United States Forecast 5.2 Europe Forecast 5.3 Japan Forecast 5.4 India Forecast 5.5 China Forecast 5.6 The Rest of the World

6 SWOT (Strengths, Weaknesses, Opportunities & Threats) Analysis 6.1 Strengths: Diabetes is Increasing, and Diabetes Drugs Are Effective 6.1.1 Diabetes is Chronic 6.1.2 Younger Patients, More Comprehensive Diagnoses 6.1.3 Prevention Inadequate 6.1.4 Drugs Often Used in Combination 6.2 Weaknesses 6.2.1 Diagnostic Inadequacies 6.2.2 Developing Countries Cannot Afford Many Newer Drugs 6.2.3 Noncompliance Rates up to 65% 6.3 Opportunities 6.3.1 Expanding Markets: India and China 6.3.2 Changing Guidelines for Diagnosing Diabetes 6.3.3 Techniques for Increasing Patient Compliance 6.3.4 Novel Drugs, Novel Delivery Methods 6.4 Threats 6.4.1 The Most-Significant Threat: Potential Changes in Drug Approval Guidelines 6.4.2 Changing FDA Guidelines for New Drug Approvals 6.4.3 Generic Erosion 6.4.4 Vaccine to Prevent Type 1 Diabetes? 6.4.5 Highly Publicised Diabetes Drugs Side Effects 6.5 Interview with Fred Levine, M.D., Ph.D., Professor, Burnham Institute for Medical Research; Director, Sanford Children’s Health Research Center 6.5.1 Alternative Delivery Methods 6.5.2 Cardiovascular Problems Associated with Oral Antidiabetics 6.5.3 Obesity and Diabetes 6.5.4 Byetta 6.5.5 Stem Cell Therapy/Cure 6.6 Interview with Björn Tyrberg, PhD., Associate Professor at Burnham Institute for Medical Research, Diabetes and Obesity Research Center 6.6.1 Diet and Diabetes 6.6.2 Link Between Obesity and Diabetes 6.6.3 Byetta and liraglutide

7 Conclusions: Diabetes is a High Growth Market 7.1 Diabetes Increasing Worldwide: High Prevalence and Incidence 7.2 World Market Value by 2023 7.3 How will Oral Antidiabetic and Insulin Sales Compare in the Future?

List of Tables Table 2.1 Diabetes Numbers in Millions, by WHO Region Table 2.2 Secondary Costs of Diabetes in the US Table 2.3 Total Costs of Diabetes to Africa Table 2.4 Diabetes World Market, 2007 Table 2.5 Insulin Types, by Onset Rate Table 2.6 Alternative Delivery Methods in the Pipeline, by Type and Development Stage, 2008 Table 2.7 Antidiabetic Drugs by Class, 2008 Table 3.1 Diabetes Sales Forecast, 2008-2023 Table 3.2 Sales Forecasts for Oral Antidiabetics and Insulins, 2008-2023 Table 3.3 Byetta Sales Forecast, 2008-2023. Table 3.4 Oral Antidiabetic Sales Forecast, 2008-2023 Table 3.5 Actos Sales Forecast, 2008-2023 Table 3.6 Avandia Sales Forecast, 2008-2023 Table 3.7 Januvia Sales Forecast, 2008-2023 Table 3.8 Avandamet Sales Forecast 2008-2023 Table 3.9 Insulin Sales Forecast 2008-2023 Table 3.10 Lantus Sales Forecast, 2008-2023 Table 3.11 Novorapid Sales Forecast, 2008-2023 Table 3.12 Humalog Sales Forecast, 2008-2023 Table 3.13 Novomix Sales Forecast, 2008-2023 Table 3.14 Actraphane HM Sales Forecast, 2008-2023 Table 3.15 Levemir Sales Forecast, 2008-2023 Table 3.16 Symlin Sales Forecast, 2008-2023 Table 3.17 Pipeline of Alternative Methods of Insulin Delivery, by Method and Development Stage, 2008 Table 4.1 Pipeline of Alternative Insulin Delivery Methods, 2008 Table 5.1 Sales and Market Share Forecasts, 2008-2023 Table 6.1 SWOT Table for Diabetes Therapies, 2008-2023

List of Figures Figure 2.1 Rise in Diabetes Cases, by WHO Region Figure 2.2 Secondary (Non-Medical) Costs of Diabetes in the US, 2007 Figure 2.3 Secondary Costs of Diabetes (minus direct medical costs), 2007 Figure 3.1 Total Diabetes Sales Forecast, 2008-2023 Figure 3.2 Diabetes Market, by Type and Market Share %, 2007 Figure 3.3 Sales Forecast for Oral Antidiabetics and Insulins, 2008-2023 Figure 3.4 Byetta Sales Forecast, 2008-2023 Figure 3.5 Oral Antidiabetic Sales Forecast, 2008-2023 Figure 3.6 Top Oral Antidiabetics, by Market Share, 2008 Figure 3.7 Actos Sales Forecast, 2008-2023 Figure 3.8 Avandia Sales Forecast 2008-2023 Figure 3.9 Januvia Sales Forecast, 2008-2023 Figure 3.10 Avandamet Sales Forecast, 2008-2023 Figure 3.11 Insulin Sales Forecast 2008-2023 Figure 3.12 Top-selling Insulins by Market Share Figure 3.13 Lantus Sales Forecast, 2008-2023 Figure 3.14 Novorapid Sales Forecast, 2008-2023 Figure 3.15 Humalog Sales Forecast, 2008-2023 Figure 3.16 Novomix Sales Forecast, 2008-2023 Figure 3.17 Actraphane HM Sales Forecast, 2008-2023 Figure 3.18 Levemir Sales Forecast, 2008-2023 Figure 3.19 Symlin Sales Forecast, 2008-2023 Figure 4.1 Leading Companies by Market Share, 2007 Figure 5.1 Regional Sales Forecasts, 2008-2023 Figure 5.2 Market Share by Region, 2013 Figure 5.3 Market Share by Region, 2018 Figure 5.4 United States Sales Forecast, 2008-2023 Figure 5.5 European Sales Forecasts, 2008-2023 Figure 5.6 Japanese Sales Forecast, 2008-2023 Figure 5.7 Indian Sales Forecast, 2008-2023 Figure 5.8 Chinese Sales Forecast, 2008-2023 Figure 5.9 Rest of the World Sales Forecast, 2008-2023

Companies mentioned in this report

Abbott Altea Therapeutics Amylin AstraZeneca Aventis Battelel Medical Device Solutions Baxter International Bayhill Therapeutics Boehringer Ingelheim Bristol-Myers Squibb Burnham Institute Chong Kun Dang CPEX/Bentley Diabetology Eli Lilly Emisphere Forest Galenix Generex Biotechnology GlaxoSmithKline Hoechst Human Genome Sciences Ipsen Lifescan MannKind Merck Merrion Novartis Novo Nordisk Ono Oramed Otsuka Pfizer Phenomix Phosphagenics Qdose Roche Sanofi-aventis Servier Takeda Ypsomed

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Statins: The World Market, 2009-2024

The world statins market is changing, with patent expires and maturity of the landmark product Lipitor (atorvastatin). Statins are at the forefront of strategies to combat dyslipidaemia, being pivotal in the prevention of coronary heart disease. Consequently, those drugs are one of the most widely-prescribed and most lucrative sectors of the pharmaceutical industry, with total revenues exceeding $26 billion in 2008. Importantly, the world statins market is poised to undergo a period of rapid and dynamic change, with the generic statin sector growing particularly strongly in the years ahead. When will annual sales of generic statins exceed those of branded statins? Which branded statin will continue to achieve year-on-year sales growth during the coming waves of generic competition? Statins: The World Market, 2009-2024 answers these vital questions – amongst others – and provides the essential information that you need to take advantage of opportunities in the changing statin drugs market from 2009 onwards.

Statins: The World Market, 2009-2024 provides a comprehensive analysis of the world statins market, compiled using a wealth of research tools – including interviews with key opinion-leaders, examination of commercial databases, company reports, policy documents, industry news and filings. This original study provides extensive sales forecasting, market shares present and future, informed opinion, as well as detailed analysis of unmet needs, pipeline developments and commercial opportunities for statin drugs.

Highlights of Statins: The World Market, 2009-2024 include: • Forecasts to 2024 for the overall world statin market, the generic statin market, the branded statin market and the dyslipidaemia market, including all statin types, the leading statin brands, leading manufacturers, country markets and combination statin drugs • Interviews with key-opinion leaders in the field • Examination of strengths, weakness, opportunities and threats facing major stakeholders in the sector – the market drivers and restraints • Analysis and forecasts for the leading statin markets in the US, Japan and Canada, together with leading European and emerging national markets • Analysis of the R&D pipeline for new statins, as well as other lipid-lowering drug types.

With full market forecasts for all the major generic statins, this new visiongain report reveals the significant commercial opportunities in new sectors of the statin market. However, significant opportunities exist for original branded products too. With relatively few single statins currently in development, new product developments in statins will mainly focus on statin combination drugs, visiongain predicts. In addition, strong growth in the statins sector will occur in emerging national markets – most notably in China and India – driving global sales. There are vast and expanding existing and potential patient populations for those drugs worldwide.

Importantly, there are opportunities for companies to raise sales by maximising patient compliance and accessing new patient groups. Statins: The World Market, 2009-2024 examines strategies for increasing patient compliance there. The report has detailed interviews with key-opinion leaders in this important field. Full interview transcripts are provided – you will not find this information anywhere else.

Why you should buy this report: • To receive a comprehensive analysis of the prospects for statins from 2009-2024, including predicted revenues, growth rates, market shares and other key metrics • To identify key pipeline developments and up-and-coming products, both in the field of statins, and for other lipid-lowering therapies • To discover the drivers, restraints, competition and opportunities influencing the global statins market –for leading brands, generics and statin combination drugs • To receive forecasts for leading statin country markets and major emerging markets for statin drugs, including China and India • To find out where that market sector is heading – both technologically and commercially – from the present onwards.

Statins: The World Market, 2009-2024 is essential reading for everybody involved in the statins market, revealing prospects for both existing competitors and potential market entrants from the present onwards.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary

2 Dyslipidaemia and Coronary Heart Disease 2.1 Cholesterol and Triglycerides 2.2 Lipoproteins Transport Cholesterol and Triglycerides 2.3 Dyslipidaemia and Atherosclerosis 2.4 Cholesterol Risk Levels 2.5 The Fredrickson/World Health Organization (WHO) Classification of Dyslipidaemia 2.6 Cardiovascular Disease 2.7 CHD Risk Factors 2.8 Cholesterol Testing 2.9 Primary and Secondary Prevention of Atherosclerosis

3 Statins and Other Lipid-Lowering Drugs 3.1 Statins: Mechanism of Action and Types 3.2 Lovastatin 3.2.1 Lovastatin Indications 3.2.2 Lovastatin Brands and Generic Manufacturers 3.3 Simvastatin 3.3.1 Simvastatin Indications 3.3.2 Simvastatin Brands and Generic Manufacturers 3.4 Pravastatin 3.4.1 Pravastatin Indications 3.4.2 Pravastatin Brands and Generic Manufacturers 3.5 Fluvastatin 3.5.1 Fluvastatin Indications 3.5.2 Fluvastatin Brands and Generic Manufacturers 3.6 Atorvastatin 3.6.1 Atorvastatin Indications 3.6.2 Atorvastatin Brands and Generic Manufacturers 3.7 Rosuvastatin 3.7.1 Rosuvastatin Indications 3.7.2 Rosuvastatin Brands and Generic Manufacturers 3.8 Pitavastatin 3.9 Statin/Other Lipid-Lowering Drug Combinations 3.9.1 Lovastatin/Nicotinic Acid 3.9.2 Simvastatin/Nicotinic Acid 3.9.3 Simvastatin/Ezetimibe 3.9.4 Atorvastatin/Fenofibrate 3.9.5 Atorvastatin/Ezetimibe 3.9.6 Atorvastatin/Ezetimibe/Fenofibrate 3.10 Statin/Other Cardiovascular Drug Combinations 3.10.1 Caduet (Atorvastatin/Amlodipine) 3.10.2 Pravadual (Pravastatin/Aspirin) 3.10.3 Generic Statin/Other Cardiovascular Drugs 3.11 Other Dyslipidaemia Drugs 3.11.1 Anion-Exchange Resins 3.11.2 Ezetimibe 3.11.3 Fibrates 3.11.4 Nicotinic Acid 3.11.5 Omega-3-Acid Ethyl Esters

4 The World Statin Market 4.1 Statins Dominate the Lipid-Lowering Drug Market 4.1.1 The World Lipid-Lowering Drug Market 4.1.2 World Lipid-Lowering Drug Market Forecast, 2009-2024 4.2 The World Statin Market, 2009-2024 4.2.1 The World Statin Market, 2008 4.2.2 Scope for Further Growth: World Statin Market Forecast, 2009-2011 4.2.3 The Impact of Atorvastatin Genericisation on the World Statin Market, 2011-2014 4.2.4 Further Generic Opportunities: World Statin Market Forecast, 2014-2019 4.2.5 What are the Prospects for the World Statin Market from 2019 to 2024? 4.2.6 Statin Type Market Forecast, 2009-2024 4.3 The Branded and Generic Statin Markets 4.3.1 The Branded and Generic Statin Markets, 2008 4.3.2 By 2018 Sales of Generic Statins Will Exceed Branded Revenues 4.4 Atorvastatin 4.4.1 The Atorvastatin Market in 2008 4.4.2 Atorvastatin Market Forecast, 2009-2024 4.4.3 Lipitor Market Forecast, 2009-2011 4.4.4 The Ultimate Patent Cliff: Lipitor Market Forecast, 2011-2014 4.4.5 The Fate of Lipitor: Market Forecast, 2014-2024 4.4.6 Generic Atorvastatin Market Forecast, 2009-2024 4.5 Rosuvastatin 4.5.1 The Rosuvastatin Market in 2008 4.5.2 Rosuvastatin Market Forecast, 2009-2024 4.5.3 Bucking the Trend of Other Branded Statins: Crestor Market Forecast, 2009-2014 4.5.4 What are Crestor’s Prospects During 2014-2024? 4.5.5 Generic Rosuvastatin Market Forecast, 2009-2024 4.6 Simvastatin 4.6.1 The Simvastatin Market in 2008 4.6.2 Simvastatin Market Forecast, 2009-2024 4.6.3 Zocor Market Forecast, 2009-2024 4.6.4 Generic Simvastatin Market Forecast, 2009-2024 4.7 Pravastatin 4.7.1 The Pravastatin Market in 2008 4.7.2 Pravastatin Market Forecast, 2009-2024 4.7.3 Mevalotin/Pravachol Market Forecast, 2009-2024 4.7.4 Generic Pravastatin Market Forecast, 2009-2024 4.8 Fluvastatin 4.8.1 The Fluvastatin Market in 2008 4.8.2 Fluvastatin Market Forecast, 2009-2024 4.8.3 Lescol/Lochol Market Forecast, 2009-2024 4.8.4 Generic Pravastatin Market Forecast, 2009-2024 4.9 Pitavastatin 4.9.1 The Pitavastatin Market in 2008 4.9.2 Pitavastatin Market Forecast, 2009-2024 4.10 Lovastatin 4.10.1 The Lovastatin Market in 2008 4.10.2 Lovastatin Market Forecast, 2009-2024 4.11 Statin/Non-Statin Combination Drugs 4.11.1 The Statin/Non-Statin Combination Drug Market in 2008 4.11.2 Launch of new Statin Combination Drugs Will Drive Growth During 2009-2014 4.11.3 Genericisation in the Statin/Non-Statin Combination Sector, 2014-2024 4.11.4 Vytorin/Inegy Market Forecast, 2009-2013 4.11.5 Vytorin/Inegy Market Forecast, 2014-2024 4.11.6 Caduet Market Forecast, 2009-2024 4.12 Leading Statin Manufacturers 4.12.1 Leading Statin Manufacturers, 2008: Seven Players Control 85% of the Market 4.12.2 Pfizer’s Statin Revenues Forecast, 2009-2014 4.12.3 A New Leading Statin Manufacturer by 2013 4.12.4 Merck & Co./Schering-Plough Statin Revenues Forecast, 2009-2014

5 Issues Affecting the Statin Industry 5.1 SWOT Analysis of the Statin Industry 5.2 Patient Compliance 5.2.1 Patients on Statins Exhibit Poor Patient Compliance 5.2.2 Effective Contact Between Patients and Healthcare Practitioners is the Key to Improving Patient Compliance 5.2.3 Developments in Cholesterol Testing 5.2.4 Diagnostic Testing for Genetic Markers May Increase Patient Compliance 5.2.5 Increasing Use of Web-Based Information Technology Will Improve Patient Compliance 5.3 Generic Statins 5.3.1 Expected Patent Expiries in the Statin Market 5.3.2 Governments and Insurers Will Favour Generic Statins 5.4 Statin Clinical Trials 5.5 Safety of Statins 5.6 Statin OTC Switching 5.6.1 The Rationale for OTC Switching 5.6.2 Statin OTC Switching in the UK 5.6.3 Statin OTC Switching in the US 5.6.4 What are the Worldwide Prospects for Statin OTC Switching? 5.7 Prevalence of Coronary Heart Disease 5.7.1 Coronary Heart Disease is the Leading Cause of Death Worldwide 5.7.2 Future Projections for Prevalence of Coronary Heart Disease 5.7.3 The Economic Cost of Coronary Heart Disease 5.8 Promising Non-Statin Lipid-Lowering Pipeline 5.8.1 Statins Cannot Treat All Forms of Dyslipidaemia 5.8.2 Developments in Existing Rivals for Statins 5.8.2.1 Novel Nicotinic Acid Formulations 5.8.2.2 New Formulation of Fibrates 5.8.2.3 Omega-3 Fatty Acids 5.8.2.4 Functional Foods and Nutritional Supplements 5.8.3 Novel Lipid-Lowering Agents 5.8.3.1 CETP Inhibitors 5.8.3.2 Cholesterol Absorption Inhibitors 5.8.3.3 Antisense Oligonucleotides 5.8.3.4 PPAR-Alpha Agonists 5.8.3.5 MTP Inhibitors 5.8.3.6 Phospholipase A2 Inhibitors 5.8.3.7 Nicotinic Acid Receptor Agonists 5.8.3.8 Human Antibodies

6 Expert Opinion on Methods to Improve Patient Compliance 6.1 Statin Patient Compliance: Humayun J. Chaudhry, D.O., M.S., FACP, Commissioner of Health Services, Suffolk County, New York 6.1.1 Improving Patient Compliance in Statin Therapy 6.1.2 The Future of Cholesterol Testing 6.1.3 Web-Based Information Technology in Statin Prescribing 6.2 Genetic Markers to Improve Patient Compliance: Thomas White, Ph.D., Chief Scientific Officer and Vice President of Research and David P. Speechly, PhD Vice President Corporate Affairs, Celera 6.2.1 Patient Compliance for Statins is Poor 6.2.2 Genetic Markers: The KIF6 Risk Allele 6.2.3 Genetic Markers Could Improve Patient Compliance 6.2.4 Diagnostic Tests for Genetic Markers 6.2.5 Evidence for Genetic Marker Tests Increasing Patient Compliance 6.2.6 Effect of Genetic Marker Diagnostic Effects on Future Statin Prescribing Patterns 6.2.7 The Future of Cholesterol Testing 6.2.8 Effect of Genetic Markers on Clinical Trials Involving Statins 6.2.9 Web-Based Technologies to Improve Patient Compliance

7 Statin Country Markets 7.1 Leading Country Markets in 2008 7.2 Leading Country-Market Forecasts, 2009-2024 7.3 The US Statin Market 7.3.1 The US Statin Market in 2008 7.3.2 US Statin Market Forecast, 2009-2014 7.3.3 US Statin Market Forecast, 2014-2024 7.4 The Japanese Statin Market 7.4.1 The Japanese Statin Market in 2008 7.4.2 Japanese Statin Market Forecast, 2009-2024 7.5 The Canadian Statin Market 7.6 European Statin Markets 7.7 Emerging Statin Markets: China and India

8 The Statin Pipeline 8.1 The Statin Pipeline Lacks New Products 8.2 New Statins and Statin Combination Drugs in Development 8.2.1 Crestor/TriLipix 8.2.2 Crestor for Patients with Elevated CRP 8.2.3 Simvastatin and Nicotinic Acid/Laropiprant 8.2.4 Pravastatin and Fenofibrate Combination Therapy 8.2.5 Simvastatin and Fenofibrate Combination Therapy 8.2.6 Vytorin for Kidney Disease and Acute Coronary Syndrome. 8.2.7 Simvastatin/Rosiglitazone 8.2.8 PPD Statin/RBx 10558 8.2.9 Simvastatin/Aspirin/Lisinopril/Hydrochlorothiazide 8.2.10 Simvastatin/Aspirin/Ramipril 8.2.11 NCX 6560 8.2.12 Atorvastatin/Ezetimibe

9 Conclusions 9.1 The Statin Market in 2008 9.2 Future Challenges for the Statin Industry 9.3 Rise of the Generics: World Statin Market Forecast, 2009-2024 9.4 Leading Statin Manufacturers and Country Markets

List of Tables Table 2.1 Risk Levels for Total Cholesterol Table 2.2 Risk Levels for LDL Cholesterol Table 2.3 Risk Levels for HDL Cholesterol Table 2.4 Risk Levels for Triglycerides Table 2.5 The Fredrickson/WHO Classification of Dyslipidaemia Table 3.1 Leading Generic Lovastatin Manufacturers Table 3.2 Leading Generic Simvastatin Manufacturers Table 3.3 Leading Generic Pravastatin Manufacturers Table 3.4 Branded Fibrates Table 3.5 Leading Prescription Omega-3 Acid Products Table 4.1 World Lipid-Lowering Drug Market, 2008 Table 4.2 Non-Statin Lipid-Lowering Drug Market, 2008 Table 4.3 World Lipid-Lowering Drug Market Forecasts, 2009-2014 Table 4.4 World Lipid-Lowering Drug Market Forecasts, 2015-2024 Table 4.5 Leading Statin Types and Brands, 2008 Table 4.6 Statin Type Market Forecasts, 2009-2014 Table 4.7 Statin Type Market Forecasts, 2015-2024 Table 4.8 The Branded and Generic Statin Markets, 2008 Table 4.9 Branded and Generic Statin Market Forecasts, 2009-2014 Table 4.10 Branded and Generic Statin Market Forecasts, 2015-2024 Table 4.11 Atorvastatin Market, 2008 Table 4.12 Atorvastatin Drugs Forecasts, 2009-2014 Table 4.13 Atorvastatin Drugs Forecasts, 2015-2024 Table 4.14 Rosuvastatin Market, 2008 Table 4.15 Rosuvastatin Drugs Forecasts, 2009-2014 Table 4.16 Rosuvastatin Drugs Forecasts, 2015-2024 Table 4.17 Simvastatin Market, 2008 Table 4.18 Simvastatin Drugs Forecasts, 2009-2014 Table 4.19 Simvastatin Drugs Forecasts, 2015-2024 Table 4.20 Pravastatin Market, 2008 Table 4.21 Pravastatin Drugs Forecasts, 2009-2014 Table 4.22 Pravastatin Drugs Forecasts, 2015-2024 Table 4.23 Fluvastatin Market, 2008 Table 4.24 Fluvastatin Drugs Forecasts, 2009-2014 Table 4.25 Fluvastatin Drugs Forecasts, 2015-2024 Table 4.26 Pitavastatin Drugs Forecasts, 2009-2014 Table 4.27 Pitavastatin Drugs Forecasts, 2015-2024 Table 4.28 Lovastatin Drugs Forecasts, 2009-2014 Table 4.29 Lovastatin Drugs Forecasts, 2015-2024 Table 4.30 Statin and Statin/Non-Statin Combination Drug Sales, 2008 Table 4.31 Statin/Non-Statin Combination Drug Market, 2008 Table 4.32 Statin/Non-Statin Combination Drugs Forecasts, 2009-2014 Table 4.33 Statin/Non-Statin Combination Drugs Forecasts, 2015-2024 Table 4.34 Leading Statin Manufacturers, 2008 Table 4.35 Leading Statin Manufacturers’ Revenue Forecasts, 2009-2014 Table 5.1 SWOT Chart for the Statins Industry, 2009-2024 Table 5.2 Expected Statin Patent Expiry Dates, 2009-2024 Table 5.3 Novel Lipid-Lowering Drugs in Development Table 7.1 Leading Statin Country Markets, 2008 Table 7.2 Leading Statin Country-Market Forecasts, 2009-2014 Table 7.3 Leading Statin Country Market Forecasts, 2015-2024 Table 8.1 The Statins Pipeline

List of Figures Figure 4.1 World Lipid-Lowering Drug Market, 2008 Figure 4.2 World Lipid-Lowering Drug Market Forecast, 2009-2024 Figure 4.3 Statin Type Market Share, 2008 Figure 4.4 Leading Statin Brand Market Share, 2008 Figure 4.5 World Statin Market Forecast, 2009-2024 Figure 4.6 Statin Type Market Forecast, 2009-2024 Figure 4.7 Statin Type Market Share, 2014 Figure 4.8 Statin Type Market Share, 2019 Figure 4.9 Statin Type Market Share, 2024 Figure 4.10 Branded and Generic Statin Market Forecasts, 2009-2024 Figure 4.11 Atorvastatin Drugs Forecasts, 2009-2024 Figure 4.12 Rosuvastatin Drugs Forecasts, 2009-2024 Figure 4.13 Simvastatin Drugs Forecasts, 2009-2024 Figure 4.14 Pravastatin Drugs Forecasts, 2009-2024 Figure 4.15 Fluvastatin Drugs Forecasts, 2009-2024 Figure 4.16 Pitavastatin Drugs Forecasts, 2009-2024 Figure 4.17 Lovastatin Drugs Forecasts, 2009-2024 Figure 4.18 Statin Combination Drugs Forecasts, 2009-2024 Figure 4.19 Leading Statin Manufacturers, 2008 Figure 4.20 Leading Statin Manufacturers’ Revenue Forecasts, 2009-2014 Figure 7.1 Statin Market Share by Country, 2008 Figure 7.2 Statin Market Share by Country, 2014 Figure 7.3 Statin Market Share by Country, 2019 Figure 7.4 Statin Market Share by Country, 2024 Figure 7.5 US Statin Market Forecast, 2009-2024 Figure 7.6 Japanese Statin Market Forecast, 2009-2024 Figure 7.7 Canadian Statin Market Forecast, 2009-2024 Figure 7.8 French, UK, Chinese and Indian Statin Market Forecasts, 2009-2024 Figure 9.1 World Statin Market Forecast,2009-2024

List of Companies Mentioned in this Report Abbott Actavis Aegerion Almirall Alter [Spain] Amarin American Heart Association American Medical Association [US] Apotex Arena Pharmaceuticals [US] Astellas AstraZeneca Atherotech Bagó [Argentina] Bayer Berkeley HeartLab (part of Celera) BioInvent [Sweden] Bristol-Myers Squibb Celera Center for Cardiovascular Disease in Women at Brigham and Women’s Hospital Centro Nacional de Investigaciones Cardiovasculares (National Centre for Cardiovascular Research, CNIC) [Spain] Chiesi Choongwae [South Korea] CINFA [Spain] Cobalt Laboratories Cobalt Pharmaceuticals Covidien Daiichi Sankyo Dr. Reddy’s Laboratories European Medicines Agency (EMEA) European Society of Cardiology Ferrer Food and Drug Administration (FDA) Galephar Pharmaceutical Research Gedeon Richter Genentech Genfit Genzyme GlaxoSmithKline (GSK) Human Genome Sciences (HGS) Intas Isis Japan Tobacco Johnson & Johnson Kissei Kowa Krka Kyorin LifeCycle Pharma Liposcience Lupin Medicines and Healthcare products Regulatory Agency (MHRA) [UK] Medley [Brazil] Menarini Merck & Co. Merck/Schering-Plough Pharmaceuticals [joint venture between Merck & Co. and Schering-Plough] Micro Labs Mitsubishi Tanabe Mochida Mylan Nichi-Iko [Japan] NicOx Nissan Chemical Novartis Par Pfizer Pharmaceutical Product Development (PPD) Pierre Fabre Polpharma Public Citizen [US] Ranbaxy Ratiopharm Recordati Roche Sanofi-Aventis Sawai [Japan] Schering-Plough Sciele [wholly owned subsidiary of Shionogi] Sepracor Servier Shionogi Sigma Pharmaceuticals [Australia] Sigma-Tau SkyePharma Solvay Stada Teva University of Auckland Watson World Health Organization (WHO) Zentiva Zydus Cadila

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The Global Vaccines Market 2008-2023

The period 2008-2023 will see a vaccine “boost”. There will be a new resurgence in the sales and utilisation of vaccines. Are you prepared for this? You should be.

During this period, vaccines will be one of the fastest growing segments of the pharmaceutical market. Vaccine revenues will increase in size by several hundred percent between 2007 and 2023. This brand new in-depth report The Global Vaccines Market, 2008-2023 describes trends in the market both quantitatively and qualitatively. In recent years, this global vaccines market has undergone a renaissance, as the importance of vaccines in both developed and developing nations becomes underlined by epidemiological patterns and healthcare needs.

The key growth driver for vaccines is their cost-effectiveness in combating disease. This situation will encourage greater use of vaccines by governments and private healthcare providers. New disease targets that could be mitigated through vaccination, including high profile (and potentially profitable) targets such as cancer. Visiongain notes that many healthcare providers are viewing preventative medicine enthusiastically, being aware of the significant increases in quality of life and reduction of healthcare expenditure that can result from prophylaxis. The vaccines industry is responding with innovative products, making full use of technological advances in biotechnology. This market has great developmental potential, both therapeutically and commercially. There are currently more than 1000 vaccines in research and development worldwide.

In particular, The Global Vaccines Market, 2008-2023 concentrates on the following essential aspects of the vaccine industry: • Sales forecasts for vaccines by disease area, brand and country, including novel therapeutic vaccines • Examination of strengths, weakness, opportunities and threats facing the vaccine industry • Expert opinion from key-opinion leaders in the field • In-depth analysis of the vaccine pipeline • Analysis of the prospects for therapeutic vaccines • Geographical breakdown of the vaccine market, including the leading emerging markets of China and India • Coverage of future trends in vaccine technology, formulation and manufacturing • Identification of key industrial players in the vaccines market.

The Global Vaccines Market, 2008-2023 examines the vaccines market comprehensively, using unique primary and secondary research. The report includes full transcripts of interview – you cannot get this information anywhere else.

Also included are company reports, filings and industry databases. Exclusively, visiongain have applied their in-house analytical techniques for financial forecasting and analysis of drivers and restraints. Now available to you this comprehensive market-based report with detailed analyses, forecasts and informed opinion is essential to your vaccine market development.

Therapeutic vaccines differ from currently-marketed vaccines. Instead of simply preventing infection from disease, therapeutic vaccines work with the body’s immune system to fight diseases and disorders, including cancer, addiction and allergies. Their therapeutic and commercial potential is vast. Visiongain predicts that therapeutic vaccines will significantly expand the market for vaccines, contributing to rapid revenue growth during the period 2008 to 2023.

Why you should buy this report: • To receive a comprehensive analysis of the prospects for vaccines, including key metrics and predicted revenues, by vaccine disease area and leading brand • To receive forecasts of vaccine sales in leading country markets from 2008-2023, including China and India • To discover the views of experts in the vaccines sector • To determine the forces that influence the market for vaccines: drivers, restraints, opportunities and threats • To find out where the vaccines market is heading – both technologically and commercially from 2008 to 2023.

Further unique benefits to you when you order this report: • Original primary research and analyses – you will not find this information anywhere else • Packed with charts, analysis, graphs and tables – with analytical forecasts and explanations • Full searchable report • Copies can be printed off for offline reading

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary

2 Vaccines and Vaccine-Preventable Diseases 2.1 Immunisation and Types of Vaccine 2.1.1 Vaccines: A Healthcare Triumph 2.1.2 The Immune System and Natural Immunity 2.1.3 Edward Jenner Laid the Foundation for Modern Vaccines 2.1.4 Vaccines Work by Creating Artificial Immunity 2.1.5 Vaccine Formulation 2.1.6 Types of Vaccine 2.1.6.1 Classification of Vaccines 2.1.6.2 Live, Attenuated Vaccines 2.1.6.3 Recombinant Live Vaccines 2.1.6.4 Inactivated Vaccines 2.1.6.5 Toxoid Vaccines 2.1.6.6 Subunit Vaccines 2.1.6.7 Conjugate Vaccines 2.1.6.8 Recombinant Subunit Vaccines 2.1.6.9 DNA Vaccines 2.1.6.10 Recombinant Vector Vaccines 2.2 Vaccine Preventable Diseases 2.2.1 Cervical Cancer/Human Papillomavirus (HPV) 2.2.2 Chickenpox and Shingles 2.2.3 Cholera 2.2.4 Diphtheria 2.2.5 Haemophilus influenzae Type b (Hib) Diseases 2.2.6 Hepatitis A 2.2.7 Hepatitis B 2.2.8 Influenza 2.2.8.1 Influenza Prevalence 2.2.8.2 The Influenza Virus 2.2.8.3 Influenza Pandemics and Avian Influenza 2.2.8.4 Influenza Vaccination 2.2.9 Japanese Encephalitis 2.2.10 Measles 2.2.11 Meningococcal Diseases 2.2.12 Mumps 2.2.13 Pertussis 2.2.14 Polio 2.2.15 Rotavirus Diseases 2.2.16 Rubella 2.2.17 Streptococcus Pneumoniae Infections 2.2.18 Tetanus 2.2.19 Tick-Borne Encephalitis 2.2.20 Tuberculosis 2.2.21 Typhoid 2.2.22 Yellow Fever 2.3 Top-Selling Vaccines in 2007 2.3.1 Paediatric Vaccines 2.3.1.1 Prevnar/Prevenar 2.3.1.2 Polio/Pertussis/Hib Vaccines (Sanofi-Aventis) 2.3.1.3 Infanrix/Pediarix 2.3.1.4 Varivax 2.3.1.5 M-M-R II 2.3.1.6 ProQuad 2.3.1.7 Menactra 2.3.1.8 RotaTeq 2.3.1.9 Rotarix 2.3.2 Other/Adult Vaccines 2.3.2.1 Adacel 2.3.2.2 Pneumovax 2.3.2.3 Zostavax 2.3.3 Influenza Vaccines 2.3.3.1 Fluzone/Vaxigrip/Mutagrip 2.3.3.2 Fluarix and FluLaval 2.3.3.3 Fluvirin 2.3.4 Prophylactic Cancer Vaccines 2.3.4.1 Gardasil 2.3.4.2 Cervarix 2.3.5 Hepatitis Vaccines 2.3.5.1 GSK Hepatitis Vaccines 2.3.5.2 Havrix 2.3.5.3 Engerix-B 2.3.5.4 Twinrix/Ambirix 2.3.5.5 Merck & Co./Sanofi Pasteur MSD Hepatitis Vaccines 2.3.5.6 Vaqta/Avaxim 2.3.5.7 Recombivax HB/HBvaxPRO 2.3.6 Therapeutic Vaccines 2.3.6.1 Grazax (ALK-Abelló/Menarini)

3 The World Vaccine Market 3.1 World Vaccine Market Forecast, 2008-2023 3.1.1 The World Vaccine Market Will Double by 2013 3.1.2 Therapeutic Vaccines Will Become Established 3.1.3 The World Vaccine Market, 2018-2023 3.2 Sales Forecast by Vaccine Class, 2008-2023 3.2.1 The Leading Vaccine Classes in 2007 3.2.2 Paediatric Vaccine Market Share 3.2.3 Other/Adult Vaccines Sales Forecast 3.2.4 Influenza Vaccines Market Growth 3.2.5 Prophylactic Cancer Vaccines Market 3.2.6 Hepatitis Vaccines Market 3.2.7 Rapid Growth for Therapeutic Vaccines 3.3 Leading Vaccine Manufacturers 3.3.1 A Few Major Players Dominate the Vaccine Market 3.3.2 High Entry Barriers to Market 3.4 Sales Forecast for Leading Vaccine Brands, 2008-2013 3.4.1 Leading Paediatric Vaccine Brand Forecasts, 2008-2023 3.4.1.1 Prevnar/Prevenar 3.4.1.2 Polio/Pertussis/Hib Vaccines 3.4.1.3 Infanrix/Pediarix 3.4.1.4 Varivax 3.4.1.5 M-M-R II 3.4.1.6 ProQuad 3.4.1.7 Menactra 3.4.1.8 RotaTeq 3.4.1.9 Rotarix 3.4.2 Leading Other/Adult Vaccine Brand Forecasts, 2008-2023 3.4.2.1 Adacel 3.4.2.2 Pneumovax 3.4.2.3 Zostavax 3.4.3 Leading Influenza Vaccine Brand Forecasts, 2008-2023 3.4.4 Leading Prophylactic Cancer Vaccine Brand Forecasts, 2008-2023 3.4.4.1 Gardasil 3.4.4.2 Cervarix 3.4.5 Leading Hepatitis Vaccine Brand Forecasts, 2008-2023

4 SWOT Analysis of the Vaccine Market 4.1 Analysis of the Market 4.2 Key Strengths of the Vaccine Industry 4.2.1 Vaccines Work 4.2.2 New Vaccine Technologies 4.2.2.1 Vaccine Manufacturers are Expanding the Scope of Vaccines 4.2.2.2 New Types of Vaccine 4.2.2.3 New Adjuvants for Vaccines 4.2.2.4 New Vaccine Delivery Mechanisms and Formulations 4.2.2.5 Other Developments in Vaccine Technology 4.2.3 New High-Margin Vaccines 4.2.4 Vaccines Will Not Face Significant Generic Competition 4.2.5 Personalised Vaccines 4.3 The Vaccines Industry: Weaknesses 4.3.1 Vaccine Research and Development is Lengthy and Expensive 4.3.1.1 The Vaccine Research and Development Process 4.3.1.2 Vaccine Research and Development and Outsourcing 4.3.2 Vaccine Manufacturing 4.3.2.1 Vaccine Manufacturing has High Costs 4.3.2.2 China, India and Brazil 4.3.3 Consolidation of the Industry 4.4 Opportunities for the Vaccine Industry 4.4.1 Vaccines for Diseases Currently Without a Vaccine 4.4.1.1 The Most Important Non-Vaccine Preventable Diseases 4.4.1.2 Cancer 4.4.1.3 Dengue Fever 4.4.1.4 Epstein-Barr Virus (EBV) 4.4.1.5 Helicobacter Pylori Infections. 4.4.1.6 Hepatitis C 4.4.1.7 Hepatitis E 4.4.1.8 HIV/AIDS 4.4.1.9 Malaria 4.4.1.10 Nosocomial Infections 4.4.1.11 Respiratory Infections 4.4.1.12 Roundworm and Hookworm Infections 4.4.1.13 Sexually-Transmitted Diseases 4.4.1.14 Tobacco 4.4.1.15 West Nile Virus Infections 4.4.2 Improved Vaccines for Partially Vaccine-Preventable Diseases 4.4.2.1 Vaccines Effective Against More Strains 4.4.2.2 Towards a Universal Influenza Vaccine 4.4.2.3 The Need for an Improved Tuberculosis Vaccine 4.4.3 Biodefence 4.4.3.1 The Future for Bioterrorism Vaccines 4.4.3.2 Pandemic-Preparedness 4.4.4 Changing World Demographics 4.5 Key Threats Facing the Vaccine Industry 4.5.1 The Anti-Vaccine Movement 4.5.1.1 Misinformation about Side-Effects of Vaccines 4.5.1.2 MMR Misinformation in the UK 4.5.1.3 Controversy Surrounding Mercury-Containing Vaccines 4.5.1.4 Campaigns Against Cervical Cancer Vaccines 4.5.1.5 Consequences of Anti-Vaccine Campaigns 4.5.2 Vaccines in the Developing World 4.5.2.1 Vaccine Distribution Networks 4.5.2.2 Vaccine Cost in Developing Countries 4.5.2.3 Improving Access to Vaccines in the Developing World

5 Vaccine Country Markets 5.1 The Vaccine Market in 2007: Geographical Analysis 5.1.1 The Commercial and Donor Vaccine Markets 5.1.2 Leading Vaccine Country Markets, 2007 5.1.3 Sales Forecast for Leading Vaccine Country Markets, 2008-2023 5.2 Leading Vaccine Country Markets 5.2.1 The US Vaccine Market 5.2.1.1 The US Vaccine Market, 2007 5.2.1.2 The US Vaccine Market, 2008-2023 5.2.2 The European Vaccine Market 5.2.2.1 The German Vaccine Market 5.2.2.2 The French Vaccine Market 5.2.2.3 The UK Vaccine Market 5.2.3 The Japanese Vaccine Market 5.2.4 The Chinese Vaccine Market 5.2.4.1 China is the Largest Vaccine Consumer in the World 5.2.4.2 Chinese Vaccine Manufacturing 5.2.4.3 Chinese Vaccine Research and Development 5.2.5 The Indian Vaccine Market 5.2.5.1 The Indian Vaccine Market is Rapidly Expanding 5.2.5.2 India is an Important Vaccine Exporter 5.2.5.3 Vaccine Research and Development in India 5.2.6 The Donor Vaccine Market

6 The Vaccine Pipeline 6.1 The Most Promising Sectors of the Vaccines Pipeline 6.2 Paediatric Vaccines Pipeline 6.2.1 Key Development in Paediatric Vaccines, 2008-2013 6.2.2 Hexaxim 6.2.3 Synflorix 6.2.4 Prevnar 13 6.2.5 Unifive 6.2.6 MenACWY-TT 6.2.7 Menveo/MenACWY-CRM 6.2.8 Hib-MenCY-TT 6.2.9 MenB 6.2.10 Meningitis B Vaccine 6.2.11 ORV 116E 6.3 Other/Adult Vaccines Pipeline 6.3.1 Key Developments in Other/Adult Vaccines, 2008-2013 6.3.2 Japanese Encephalitis Vaccines 6.3.2.1 Ixiaro/IC51 6.3.2.2 ChimeriVax-JE 6.3.3 Adenovirus Vaccines 6.3.4 Simplirix 6.3.5 Flavinum 6.3.6 HIV/AIDS Vaccines 6.3.6.1 ALVAC-HIV/AIDSVAX B/E 6.3.6.2 tgAAC09 6.3.6.3 VRC-HIVADV014-00VP 6.3.7 Biodefence Vaccines 6.3.7.1 Anthrax Vaccine 6.3.7.2 rF1V Plague Vaccine 6.3.7.3 Imvamune 6.3.8 CholeraGarde 6.3.9 Cytomegalovirus Vaccine 6.3.10 Dengue Fever Vaccines 6.3.10.1 ChimeriVax-Dengue 6.3.10.2 Dengue Virus Vaccine 6.3.11 Mosquirix 6.3.12 Nosocomial Infection Vaccines 6.3.12.1 Pseudomonas Aeruginosa Vaccine 6.3.12.2 V 710/Staphylococcus Aureus Vaccine 6.3.12.3 ACAM-CDIFF 6.3.12.4 StaphVAX 6.3.13 143717A/Varicella Zoster Virus Vaccine 6.3.14 Travellers’ Diarrhoea Vaccines 6.3.14.1 ACE393/Campylobacter Jejuni Vaccine 6.3.14.2 Travellers’ Diarrhoea Vaccine (Escherichia Coli) 6.3.15 GSK M72/Tuberculosis Vaccine 6.3.16 Typhoid Vaccine 6.3.17 ChimeriVax-West Nile 6.4 Influenza Vaccines Pipeline 6.4.1 Key Developments in Influenza Vaccines, 2008-2013 6.4.2 Cell-Based Influenza Vaccines 6.4.2.1 The Switch from Eggs 6.4.2.2 Optaflu 6.4.2.3 Influvac TC 6.4.2.4 FluBløk 6.4.2.5 Vero-Cell Technology 6.4.2.6 Per C6 6.4.3 H5N1 Influenza Vaccines 6.4.4 Novel Delivery Systems for Influenza Vaccines 6.4.5 New Adjuvants for Influenza Vaccines 6.4.6 ACAM-FLU-A 6.5 Hepatitis Vaccines Pipeline 6.5.1 Hepsilav/V270 6.5.2 Hepatitis B Vaccine 6.5.3 V 419/Hepatitis B Vaccine 6.5.4 Hepatitis E Vaccine 6.6 Prophylactic Cancer Vaccines Pipeline 6.6.1 V502/Human Papillomavirus Vaccine 6.6.2 Novel Prophylactic Cancer Vaccines 6.6.2.1 Epstein-Barr Virus Vaccine 6.6.2.2 Helicobacter Pylori Vaccine 6.7 Therapeutic Vaccines Pipeline 6.7.1 Therapeutic Cancer Vaccines 6.7.1.1 Sipuleucel–T/Provenge 6.7.1.2 TroVax 6.7.1.3 MAGE-A3 ASCI 6.7.1.4 Stimuvax 6.7.1.5 OncoVAX 6.7.1.6 MVax 6.7.1.7 CDX-110 6.7.1.8 Reniale 6.7.1.9 Biovaxid 6.7.1.10 Allovectin-7 6.7.1.11 GV1001 6.7.2 Therapeutic Vaccines for Hepatitis 6.7.2.1 Therapeutic Hepatitis B Vaccine 6.7.2.2 IC41/Hepatitis C Vaccine 6.7.2.3 GI-5005/Hepatits C Treatment Vaccine 6.7.2.4 ChronVac-C 6.7.3 Therapeutic Vaccines for HIV Infection 6.7.4 Therapeutic Vaccines for Other Viral Infections 6.7.4.1 TG 4001/R3484 (MVA-HPV-IL2/HPV Vaccine) 6.7.4.2 Cytomegalovirus Therapeutic Vaccine 6.7.5 Therapeutic Addiction Vaccines 6.7.5.1 Addiction Vaccines Will Target Nicotine and Drug Dependence 6.7.5.2 NicVAX 6.7.5.3 NIC002 6.7.5.4 TA-NIC 6.7.5.5 Niccine 6.7.5.6 TA-CD 6.7.6 Therapeutic Allergy Vaccines 6.7.6.1 Pollinex Quattro 6.7.6.2 House Dust Mite Allergy Vaccine 6.7.7 Therapeutic Vaccines for Chronic Disease

7 Expert Opinion from Key Opinion-Leaders in the Vaccine Industry 7.1 Dr Michael Watson, Executive Vice President Research and Development, Acambis 7.1.1 The Key Unmet Vaccine Needs in 2008 7.1.2 The Acambis Vaccine Pipeline and the ChimeriVax Platform 7.1.3 A Clostridium Difficile Vaccine 7.1.4 Progress Towards a Universal Influenza Vaccine 7.1.5 Improving Access to Vaccines in Developing Countries 7.1.6 The Future for Biodefence Vaccines 7.1.7 Highlights of the Acambis Pipeline 7.2 Gregory A. Poland, M.D., MACP, FIDSA, Mary Lowell Leary Endowed Professor of Medicine, Infectious Diseases, Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic (US) 7.2.1 Personalised Vaccines 7.2.2 Growth of Therapeutic Cancer Vaccines and Addiction Vaccines 7.2.3 Ignorance and Misconceptions about Vaccines 7.3 Dr Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals 7.3.1 Vaccines in the Pipeline for Nicotine Addiction 7.3.2 Vaccines in the Pipeline for Staphylococcus, Including MRSA, Infection 7.3.3 Nabi Biopharmaceuticals are Investigating the Anti-Viral RENS 7.4 Dr Ronald Ellis, Senior Vice President and Chief Technical Officer, NasVax, Israel 7.4.1 The Key Unmet Vaccine Needs in 2008 7.4.2 New Adjuvants for Influenza Vaccines 7.4.3 The Future for Intranasal Vaccines 7.4.4 The Vaccine Technology of the Future 7.4.5 The Future for Therapeutic Vaccines 7.5 Dr Steen S. Klysner, Chief Executive Officer, Nordic Vaccine 7.5.1 Nordic Vaccine’s Immune Enhancing Nano-Particle and Skin Patch Vaccine Technology 7.5.2 Vaccine Technology in 2023 7.5.3 Vaccines Will be Developed for New Diseases by 2023

8 Conclusions 8.1 The ‘Vaccine Boost’ 8.2 Vaccines Will Outperform the Overall Pharmaceutical Market During 2008-2023 8.3 Vaccine Growth Drivers 8.4 Emerging Markets for Vaccines

List of Tables Table 2.1 Vaccine Preventable Disease Statistics Table 2.2 Vaccine Classes Table 2.3 Example Brands for Polio/Pertussis/Hib Vaccines (Sanofi-Aventis*) Table 2.4 Brands in the Infanrix/Pediarix Range of Vaccines Table 3.1 Worldwide Vaccine Market ($bn), 2007-2013 Table 3.2 Worldwide Vaccine Market ($bn), 2014-2023 Table 3.3 Vaccines Sales ($bn) and Market Share by Vaccine Class, 2007 Table 3.4 Vaccines Sales ($bn) by Vaccine Class, 2007-2013 Table 3.5 Vaccines Sales ($bn) by Vaccine Class, 2014-2023 Table 3.6 Leading Vaccine Manufacturers, 2007 Table 3.7 Leading Paediatric Vaccine Sales ($bn), 2007-2013 Table 3.8 Leading Other/Adult Vaccine Sales ($bn), 2007-2013 Table 3.9 Leading Influenza Vaccine Sales ($bn), 2007-2013 Table 3.10 Gardasil Sales ($bn), 2007 Table 3.11 Leading Prophylactic Cancer Vaccine Sales ($bn), 2007-2013 Table 3.12 Leading Hepatitis Vaccine Sales ($bn), 2007-2013 Table 4.1 SWOT Chart for Vaccines Market Table 4.2 Selected Diseases Currently Without a Vaccine Table 4.3 Population Statistics 2007-2023 Table 4.4 GDP China, India, US and Japan, 2007-2023 Table 5.1 Commercial & Donor Vaccine Market, 2007 Table 5.2 Leading Vaccines Country Markets 2007 Table 5.3 Vaccines Sales Forecast ($bn) for Leading Country Markets, 2007-2013 Table 5.4 Vaccines Sales Forecast ($bn) for Leading Country Markets, 2014-2023 Table 6.1 Key Pipeline Paediatric Vaccines Table 6.2 Key Pipeline Other/Adult Vaccines Table 6.3 Key Cell-Culture Influenza Vaccines Table 6.4 Key Pipeline Hepatitis Vaccines Table 6.5 Key Pipeline Prophylactic Cancer Vaccines Table 6.6 Key Pipeline Therapeutic Cancer Vaccines Table 6.7 Key Pipeline Therapeutic Hepatitis Vaccines Table 6.8 Key Pipeline Therapeutic HIV/AIDS Vaccines Table 6.9 Key Pipeline Therapeutic Addiction Vaccines

List of Figures Figure 3.1 Worldwide Vaccine Market ($bn), 2007-2023 Figure 3.2 Market Share by Vaccine Class, 2007 Figure 3.3 Paediatric Vaccine Sales ($bn), 2007-2023 Figure 3.4 Sales ($bn) by Vaccine Class (Excluding Paediatric Vaccines), 2007-2023 Figure 3.5 Vaccine Sales ($bn) and Market Share by Vaccine Class, 2007-2023 Figure 3.6 Market Share by Vaccine Class, 2013 Figure 3.7 Market Share by Vaccine Class, 2018 Figure 3.8 Market Share by Vaccine Class, 2023 Figure 3.9 Leading Vaccine Manufacturers, 2007 Figure 3.10 Prevnar/Prevenar Sales ($bn), 2007-2013 Figure 3.11 Leading Paediatric Combination Vaccine Sales ($bn), 2007-2013 Figure 3.12 Varivax, M-M-R II and ProQuad Sales ($bn), 2007-2013 Figure 3.13 Menactra Sales ($bn), 2007-2013 Figure 3.14 RotaTeq and Rotarix Sales ($bn), 2007-2013 Figure 3.15 Adacel Sales ($bn), 2007-2013 Figure 3.16 Pneumovax Sales ($bn), 2007-2013 Figure 3.17 Zostavax Sales ($bn), 2007-2013 Figure 3.18 Leading Influenza Vaccine Sales ($bn), 2007-2013 Figure 3.19 Leading Prophylactic Cancer Vaccine Sales ($bn), 2007-2013 Figure 3.20 Leading Hepatitis Vaccine Sales ($bn), 2007-2013 Figure 4.1 Population of China, India, US and Germany, 2007-2023 Figure 4.2 Gross Domestic Product ($tr) for US, Japan, China and India, 2007-2023 Figure 5.1 Commercial and Donor Vaccine Market Share, 2007 Figure 5.2 Vaccine Market Share by Leading Country, 2007 Figure 5.3 Vaccines Sales for Leading Country Markets 2007-2023: Upper Group Figure 5.4 Vaccines Sales for Leading Country Markets 2007-2023: Lower Group Figure 5.5 Vaccine Market Share by Leading Country, 2013 Figure 5.6 Vaccine Market Share by Leading Country, 2018 Figure 5.7 Vaccine Market Share by Leading Country, 2023

Companies mentioned in this report

Acambis|Accentia Biopharmaceuticals|ACE BioSciences||Advisory Committee on Immunization Practices (ACIP) [US]|Aeras Global TB Vaccine Foundation|ALK-Abelló|Allergy Therapeutics AnGes MG|Antigenics|Astellas|AstraZeneca|AVANT Immunotherapeutics|Avax Technologies Barr|Bavarian Nordic|Baxter|Bharat Biotech|Bill & Melinda Gates Foundation|Biogen Idec Biological E.|Biotecnol|Celtic Pharma|Centers for Disease Control and Prevention (CDC) [US] China National Biotec Group|Chiron (acquired by Novartis in 2006)|Computer Sciences Corporation (CSC)|Crucell|CSL|Cytos Biotechnology|Daiichi Sankyo|Dendreon|Diamyd Medical Dynavax|DynPort Vaccine Company (DVC) [subsidiary of Computer Sciences Corporation (CSC)]|Emergent Biosolutions|European Medicines Agency (EMEA)|Food and Drug Administration (FDA)|GAVI Alliance|Genelabs|Genetic Immunity|GenVec GlaxoSmithKline (GSK)|GlobeImmune|Green Cross [Korea]|Independent Pharmaceutica Inovio Biomedical|Intercell|International AIDS Vaccine Initiative|Intracel|Kaketsuken Karolinska Institutet [Sweden]|LipoNova|Lonza|MedImmune (acquired by AstraZeneca in 2007)|Menarini|Merck & Co.|Merck KGaA|Mitsubishi Tanabe|Nabi Biopharmaceuticals NasVax [Israel]|National Institute of Allergy and Infectious Diseases (NIAID) [US] Novartis|Novavax|Oncothyreon|Oxford BioMedica|Pan American Health Organization (PAHO) Petrovax|Pfizer|PharmAthene|Pharmexa|Protein Sciences|Ranbaxy|Roche Sanofi Pasteur MSD [joint venture between Merck & Co. and Sanofi-Aventis] Sanofi-Aventis|Schering-Plough|Serum Institute of India|Sinovac|Solvay|Targeted Genetics Therapeutic Goods Administration [Australia]|Transgene|Tripep|UMN Pharma UNICEF (United Nations Children’s Fund)|University of Queensland [Australia] US Census Bureau|Vaccine Research Center (VRC) [part of NIAID, US]|Vaccinogen VaxGen|Vaxine [Australia]|Vical|Virax|Worldwide Health Organization (WHO) Wyeth|Wistar Institute [US]|Ludwig Institute of Cancer Research|Xenova (acquired by Celtic Pharma in 2005)

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Clinical Trials in Asia Summit 2009 Examining the latest developments in the field of antibody engineering

18th – 20th May 2009, The Park, New Delhi, India

Key Speakers include:

Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Mgmt Clinical Research, Pfizer, India Rajesh Karan, Regional Head of Translational Medicine & Scientific Operations, Novartis, India Anirban Roy Chowdhury, Clinical Research Manager, AstraZeneca, India
Subbaraju Sagi, Senior Sales Consultant,Oracle Health Sciences Cheryl Townsend, Director, Regional Operations, George Institute for International Health Celestine Juliet, Project Manager, Cipla
B. Priya, Clinical Operations Manager, Novotech Clinical Research India Krathish Bopanna, Senior Vice President, Acunova
Paula Mumby, Director, i3 Pharma Resourcing
Guljit Chaudhri, Sr. Advisor, i3 Research Milind Antani, Head-Pharma LifeSciences group, Nishith Desai
Arun Bhatt, President, Clininvent Research
Arani Chatterjee, Vice President, Clinical Research, Panacea Biotec

Platinum Sponsor:

IMS Health Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Silver Sponsor:

Oracle Oracle is a leading strategic software solutions provider to the health sciences industry. Oracle Health Sciences helps pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and services that deliver the most compelling customer and shareholder value. Addressing industry requirements, Oracle provides comprehensive solutions including clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance applications. Oracle partners with health sciences industry leaders – including the top 20 life sciences companies – to prevent and cure disease and enhance quality of life and accelerate insights for better health. For further information please visit: www.oracle.com

Associate Sponsor:

i3 Pharma Resourcing India i3 is a pharmaceutical services company, providing integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It is composed of i3 Pharma Resourcing, a world-class staffing partner; i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, engaged in pharmacovigilance and epidemiology; i3 Pharma Informatics, a data, science and technology provider of market analytics; i3 Statprobe, a leader in comprehensive data services; and i3 Innovus, delivering the science and solutions to achieve marketplace success. i3 helps companies gain sharper insights that lead to better patient care. For further information, please visit www.i3global.com

Media Partners: PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm Espicom

India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favored destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and parts of South Asia are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations.

Clinical Trials Summit 2009 will discuss the on-going pressing concerns faced in clinical trials operations, addressing the risks, timeline and budget constraint, whilst effectively tackling key challenges in overcoming trials agreement and site contract negotiation hurdles. This year, the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management will be discussed in order to improve and optimize the overall drug development effectiveness and ROI. Find out how to implement and benefit from electronic data management & monitoring cost effectively. This event will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Delegates will have the opportunity to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies (including IPR issues) and pharmacovigilance.

Reasons to register today: • How can you take advantage of the global market for clinical trials? • Improving and optimizing site management and overall productivity of clinical operations • Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets • Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and South Asia • Gaining insights on future forwards of clinical trials and valuing its potential • Discover how to improve your supplier-client relationships • Complete trials on schedule and budget by learning to overcome hurdles in investigator/patient recruitment • What are the issues with off-shoring trials to countries such as India & South Asia? What are the ways to overcome them? • Explore innovative strategies for outsourcing, what you should be looking for in a CRO? • Working with limited budget to ensure on time study completion • Escalating patient recruitment and improving patient retention to save cost and reduce lead-time • Maximizing trials results through overseas multinational/multi-centric trials • Avoiding potential pitfalls of trials agreement • Motivating and managing clinical project teams to improve timeline and progress

======================================================= Plus Unique Interactive Workshop, Monday 18th May 2009

This workshop will provide an in-depth review of the clinical trials market and discuss how businesses can take advantage of the current state of affairs in the markets worldwide. The interactive format will provide the opportunity for participants to explore ways to promote their products, brands and services in the medical industry.

Workshop led by –

Shoibal Mukherjee ,Sr Vice President ,Clinical Development ,GVKBio

Vivek Ahuja Director Clinical Operations ,Data Management & Pharmacovigilance GVKBio

Yash Rawat Associate Director Medical Affairs GVKBio

========================================================

-Pricing-

• 3 day pass – includes the 2-day conference and 1-day interactive workshop – available for only £400+ VAT:£60 = Total:£460

• 2 day Conference only ticket – available for only £300+ VAT:£45 = Total:£345

• Workshop only pass – available for only £175+ VAT:£26.25 = Total:£201.25

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd

Conference Agenda

Tuesday 19th May 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Arun Bhatt, President, Clininvent Research

09:40 – Evaluating Key Emerging Markets for Improved Strategy

Which emerging markets are hottest today? Which markets are next? What makes each market unique and how do markets compare? What are the challenges and risks of each market? Who is operating in each market?

Krathish Bopanna, Senior Vice President, Acunova

10:20 – Clinical Trial Management: Enabling Operational Efficiency

• New challenges call for new approaches • Technology as the Enabler of High Performance – The

  Place of Clinical Trial  Management Systems

• Implementation of a Clinical Trial Management

  System

• Clinical Trials Management of the Future • Clinical Trial Management Systems in the Wild

Subbaraju Sagi, Senior Sales Consultant Oracle Health Sciences

11:00 – Morning coffee & Discussion

11:20 – Enhancing Staff Performance in Multinational/Multi-Centered Trials

Structure of existing system for training and monitoring staff performance What are the common problems of staff monitoring and effective solutions Strategies to cope with high staff turnover rate to minimise cost for your trials

Paula Mumby, Director, i3 Pharma Resourcing

Cheryl Townsend, Director, Regional Operations, George Institute for International Health 12:00 – Networking luncheon

13:40 “Challenges of Project Management in India”.

Arun Bhatt, President, Clininvent Research

14:20 – Exploring collaborative opportunities and clinical trial partnership

• Identifying the anticipated advantages of a

collaborative clinical trial alliance for greater efficiency 
and cost reduction

• Developing programs for successful partnership • Utilising thought leader networking

Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer, India

15:00 – Afternoon tea

15:20 – Country and site selection for global clinical trials

When does patience recruitment get difficult and how can this issue be overcome? Determine the challenges in determining where, when and how to expand clinical operations How should you make your decision and implement your global expansion plans successfully?

Anirban Roy Chowdhury, Clinical Research Manager, AstraZeneca, India 16:00 – Panel Discussion: Overcoming regulatory challenges in Asian clinical trials

In this session, country representatives will gather to share various challenges experienced when conducting clinical trials in their respective countries. The audience will be given an opportunity to address pressing concerns they have with their existing and/or prospective trials in these countries.

Moderator –

Arun Bhatt, President, Clininvent Research

Panelists –

Milind Antani, Head-Pharma LifeSciences group,

                                            Nishith Desai

Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer, India

16:40 – Offshoring – Balancing the right opportunities and risks

Exploring potential operational challenges and strategies for managing offshore trials Outsourcing an entire project to Asia to extend your R&D capabilities? Risk-sharing deals versus higher value service deals

Celestine Juliet, Project Manager, Cipla 17:20 Chairperson’s closing remarks and end of conference

Wednesday 20th May 2009

09:00 – Coffee and registration

09:30 – Chair’s opening remarks

Arani Chatterjee, Vice President, Clinical Research Panacea Biotec

09:40 – Opportunity trials of Clinical Research in India: Focusing on Phase I and Phase II

A review the clinical research environment in India A focus on existing business models conduct clinical trials in India An evaluation the opportunities of potential collaborations

Rajesh Karan, Regional Head of Translational Medicine & Scientific Operations, Novartis, India 10:20 – Conducting Phase III and IV Trials: Practical Considerations

Discuss the common misconceptions and pitfalls • Regulatory and timing considerations • Selection and management of sites • Impact on future sale 11:00 – Morning coffee & discussion 11:20 – Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials What is the range of opportunities? Cut through the hype and learn how to evaluate service providers to avoid choosing the wrong one. How is India a host to reputable, reliable suppliers? What to look for in order to make the right decision and avoid major, costly mistakes? Will the current trend to outsource clinical trials to Asia be successful?

Mark Engel, Chairman, Excel PharmaStudies 12:00 – Rising Cost of Clinical Trials in Asia

Diverse socio-economic situation in Asia Drivers of cost competitiveness in Asia Challenges linked to the increase of clinical research activity in Asia and consequences on cost Effective Planning and Negotiating your Budgets with Partners

Guljit Chaudhri, Sr. Advisor, i3 Research 12:40 – Networking luncheon 14:00 – Conducting global clinical trial in government infrastructure B. Priya, Clinical Operations Manager, Novotech Clinical Research India

14:40 – Best practices for engaging regulatory authorities in Asia What are the recent regulatory changes and the changes in the pipeline? Reporting issues ( Adverse reactions/SUSARS etc) What are liabilities in clinical research? Reviewing the general regulatory issue (POA etc) An analysis on advertisement/marketing issues

Milind Antani, Head-Pharma LifeSciences group,

                                            Nishith Desai 

15:20 – Afternoon tea

15:40 – Clinical Trial Registry – India (CTRI)

Pandey, Arvind, Director, Institute of Research In Medical Statistics 16:20 –Panel Discussion – SWOT Analysis Strength, Weakness, Opportunities & Threats of the clinical trials in the India & South Asia. (An overall analysis of this three day event

Moderator –

Arani Chatterjee, Vice President, Clinical Research Panacea Biotec

Panelists –

Krathish Bopanna, Senior Vice President, Acunova
Subbaraju Sagi, Senior Sales Consultant, Oracle Health Sciences 17:00 – Chairperson’s closing remarks and End of Conference.

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Monoclonal Antibodies in Cancer Therapy 2009-2024

Monoclonal antibodies in cancer therapy – significant commercial opportunities with developing technologies and innovative products – our new report explains prospects

Monoclonal antibody-based therapies for cancer are a thriving part of the biotechnology sector, as our new market report explains. The oncology market continues to expand worldwide, with high demand for more-efficacious and better-tolerated cancer therapies. The monoclonal antibodies oncology market has been growing at a significant rate and holds high potential for continued growth in both developed and emerging geographical markets. Currently, new technologies are removing some of the drawbacks that monoclonal antibody therapies have experienced. Leading pharma companies are already investing heavily in monoclonal antibody technologies. Monoclonal antibodies with great commercial potential are in the oncology pipeline, as our new report – Monoclonal Antibodies in Cancer Therapy 2009-2024 – also explains.

The period 2009 to 2019 will reveal volatility in the monoclonal antibody therapies market as current-leading products reach peak sales and new-generation drugs emerge. Will technological advances further benefit monoclonal antibody-based therapies and their overall sales? Will better immunotoxicity profiles lead to higher revenues for products? What types of monoclonal antibody therapies will enter the market from 2009 onwards, and can they dominate this market? Where will the opportunities lie, and what are the market drivers and restraints? This report will provide you with the information that you need to understand current trends and future possibilities. In particular, we discuss prospects for the following products:

Rituxan Avastin Herceptin Erbitux Vectibix Campath. Comprehensive analysis of this important market area

Monoclonal Antibodies in Cancer Therapy 2009-2024 examines that market sector critically, through a comprehensive review of information sources, including consultations with relevant experts. This report provides detailed sales forecasts, discussions of pipeline developments and analysis of commercial drivers and restraints, including a SWOT analysis. There are over 55 tables and figures included. The result is a comprehensive market- and industry-centred report with detailed analyses and informed opinion.

Why you should buy this report

Benefits that you will gain from Monoclonal Antibodies in Cancer Therapy 2009-2024 include:

Appraisal of the existing market for monoclonal antibody cancer therapies Forecasting and discussion of market values for monoclonal antibody cancer therapies, including detailed sales forecasts for 2009 to 2024 Discussion of leading products, including sales forecasts, growth and market share analyses Analyses of 10 leading national markets for monoclonal antibody cancer therapies, including China and India, with forecasted sales and market shares Coverage of R&D pipeline developments, with trends to watch out for Exclusive interviews with a leading academic and mAbs journal chief editor and with a chief scientist in oncology within a leading pharma company Informed analyses of strengths and weaknesses of the technologies from 2009 onwards Balanced assessments of commercial drivers and restraints that the market area faces from 2009 to 2024. You can order this report today

Nobody with a commercial interest in biotechnology or in cancer therapies can afford to overlook this new study from visiongain. The market environment in many countries will change. There will also be further development of the Chinese and Indian biotechnology sectors – especially relevant from next decade onwards. Importantly, there will be increases in demand in both developed and developing national markets. With an impressive R&D pipeline, this area holds great potential for new products. Do you want to know more about this important market? You can stay ahead by ordering this report today.

Monoclonal Antibodies in Cancer Therapy 2009-2024 is essential reading for everybody involved with mAb development and strategy. The opportunities globaly are changing, especially in the next decade. Do you want to know more about important developments? You can stay ahead by ordering this report today.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1999

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP3499. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary

1.1 Aims of this Report 1.2 Brief Overview of the Chapters in this Report

2 Monoclonal Antibodies for Cancer Therapy 2.1 Oncology is the Fifth-Largest Therapeutic Class Worldwide by Total Sales 2.2 The Oncology Market is Expanding 2.3 Monoclonal Antibodies 2.3.1 What are Monoclonal Antibodies? 2.3.2 How do Monoclonal Antibody Therapies Work? 2.4 Categories of Monoclonal Antibodies for Therapeutic Use 2.4.1 Murine Antibodies 2.4.2 Chimeric and Humanised Antibodies 2.4.3 Human Antibodies 2.4.4 Immunogenicity 2.5 Current Monoclonal Antibody Cancer Therapies 2.5.1 Rituxan/MabThera 2.5.2 Avastin 2.5.3 Herceptin 2.5.4 Erbitux 2.5.5 Vectibix 2.5.6 Campath 2.5.7 Mylotarg 2.5.8 Zevalin and Bexxar 2.5.9 The Market Shares of Naked vs. Conjugated Monoclonal Antibodies 2.5.10 The Market for Monoclonal Antibody Therapies is Growing.

3 Total World Market 2009-2024 3.1 Summary of Key Findings 3.2 Biotech is a Rapidly-Expanding Market 3.3 Monoclonal Antibodies are a Central Part of the Biotech Market 3.4 Oncology – A Major Sales Driver in the Mab Sector 3.5 Total World Market in 2008 3.6 Predicted Sales from 2009-2024 3.7 The Big Three 3.8 Generic Competition 3.9 Chimeric Antibodies in Decline 3.10 The Shift Towards Human Antibodies

4 Key Products Analysis 4.1 Overview: Strong Pipeline Means Competition Will Increase 4.2 Roche/Genentech Dominated the Market in 2008 4.3 Rituxan/MabThera (Roche/Genentech) 4.3.1 Will Rituxan Continue Steady Growth over the Next Five Years? 4.4 Avastin (Roche/Genentech) 4.4.1 Broadened Profile and Patient Base 4.4.2 Continued Growth Despite Competition 4.5 Herceptin (Roche/Genentech) 4.5.1 Strong Competition in the R&D Pipeline 4.6 Erbitux (Merck/Imclone) 4.6.1 Aiming for the Top Three 4.7 Vectibix (Amgen) 4.7.1 The K-RAS Issue 4.8 Campath (Bayer Schering AG) 4.8.1 Future Increase in Revenue?

5 SWOT Analysis for the Monoclonal Antibody Oncology Therapies Market 5.1 Principal Drivers 5.1.1 Increasing Prevalence and High Economic Costs of Cancer 5.1.2 MAb Therapy Presents Lower Risk of Adverse Effects 5.1.3 Combining Existing Products 5.1.4 Biologicals vs. Chemically-Derived Pharmaceutical Products 5.1.5 Promising Pipelines 5.1.6 Improvements in Accessibility 5.1.7 New Production Methods will Reduce Costs 5.2 Principal Restraints 5.2.1 Development Costs – a High Barrier of Entry 5.2.2 Mode of Administration is a Limiting Factor 5.2.3 Insufficient Efficacy as a Single Agent 5.2.4 Immunogenicity – the Rise of Humanised and Human Monoclonal Antibodies 5.2.5 Financial Limitations in Research and Development 5.2.6 Adverse Events – Safety Concerns 5.2.7 Competition for Prime Drug Targets

6 MAbs in the Leading Pharmaceutical Markets 6.1 USA 6.2 Europe 6.3 Other Countries 6.3.1 India and China

7 The Monoclonal Antibody Cancer Therapies Pipeline 7.1 New Technology – Monoclonal Antibody Fragments 7.1.1 Bispecific T-Cell Engagers 7.1.2 Tandabs 7.2 Conjugated vs. Naked Antibodies 7.3 The Future of Human MAbs 7.4 Competition for Prime Drug Targets 7.4.1 Tailored Medicine 7.5 Solid Pipeline 7.6 Products to Watch 7.6.1 Roche’s Winning Pipeline 7.6.2 Genmab and GlaxoSmithKline’s Arzerra/HuMax-CD20 7.6.3 Amgen’s AMG 162

8 Visiongain Interviews with Relevant Experts 8.1 Dr Janice M. Reichert, Tufts University and Editor-in-Chief of the Journal mAbs 8.1.1 Major Challenges and Opportunities for Monoclonal Antibody Cancer Therapies 8.1.2 Future Developments and Pipelines 8.1.3 The Effect of Biosimilars 8.2 Dr David Blakey, AstraZeneca 8.2.1 The Future of Humanised and Fully-Human Antibodies 8.2.2 Therapeutic Antibody Fragments vs. Full-Length IgGs 8.2.3 Major Opportunities in Monoclonal Antibody Cancer Therapies

9 Conclusions 9.1 The MAb Market is Strong and Expected to Grow Stronger 9.2 Expansion into New Markets 9.3 Personalised Treatments Emerging 9.4 Growth Will Eventually Slow as Expansion of the Market Drives Prices Down 9.5 Outlook for the Future

List of Tables Table 2.1 Summary of Types of Monoclonal Antibodies for Cancer Therapy Table 2.2 Targets and Indications for Selected FDA-Approved Antibodies Table 3.1 Top Selling FDA Approved Antibodies, 2008 Table 3.2 Leading Monoclonal Antibodies for Oncology Therapies, Sales ($bn) and Market Shares (%), 2008 Table 3.3 Predicted Sales ($bn) for the World Market, 2009-2024 Table 3.4 Predicted Growth Rate (%) for the World Market, 2009-2024 Table 3.5 World Sales ($bn) and Market Shares (%) for the Different Types of Oncology Monoclonal Antibodies, 2008 Table 3.6 Market Shares (%) for Chimeric, Humanised and Human Monoclonal Antibodies, 2014-2024 Table 4.1 Predicted Sales ($bn) for the World Market, 2009-2016 Table 4.2 Predicted Sales ($bn) for the World Market, 2017-2024 Table 4.3 Market Shares (%) and CAGR (%) for Selected Products, 2008 and 2014 Table 5.1 SWOT Analysis, 2009-2024 Table 5.2 Side Effects of Monoclonal Antibody Therapy Table 6.1 Leading Regions of the Monoclonal Antibody Anticancer Therapies Market, Sales ($bn) and Market Shares (%), 2008 and 2014 Table 7.1 Selected Phase III and Pre-Registration Anticancer Monoclonal Antibodies, 2008 Table 9.1 Global Monoclonal Antibody Anticancer Therapies, Sales ($bn) and Growth (%), 2008-2014

List of Figures Figure 2.1 Sales ($bn) of Naked vs. Conjugated Monoclonal Antibodies, 2008 Figure 3.1 Market Shares (%) for the Main Categories of the Monoclonal Antibody Market for 12 Months up toQ3 2008 Figure 3.2 Sales ($bn) for the Top Three Monoclonal Antibody Oncology Therapies, 2005-2008 Figure 3.3 Sales ($bn) for Monoclonal Antibody Oncology Therapies for 12 Months up to Q3 2008 Figure 3.4 Market Shares (%) for Monoclonal Antibody Oncology Therapies for 12 Months up to Q3 2008 Figure 3.5 Predicted Sales ($bn) for the World Market, 2009-2024 Figure 3.6 Predicted Growth (%) of the World Market, 2009-2014 Figure 3.7 Predicted Sales ($bn) for the Big Three: Rituxan, Avastin and Herceptin, 2009-2014 Figure 3.8 Sales ($bn) for Different Types of Monoclonal Antibodies for Oncology, 2008 Figure 3.9 Market Shares (%) for Different Types of Monoclonal Antibodies for Oncology, 2008 Figure 3.10 Pipeline Drugs (Phase II and III) by Antibody Type, 2008 Figure 3.11 Predicted Market Shares (%) for Chimeric, Humanised and Human Monoclonal Antibodies, 2014-2024 Figure 4.1 Market Shares (%) for Companies in the Monoclonal Antibody Oncology Therapies Area, 2008 Figure 4.2 Sales ($bn) for Rituxan, 2005-2008 Figure 4.3 Sales ($bn) for Rituxan, 2009-2014 Figure 4.4 Market Share (%) for Rituxan, 2009-2014 Figure 4.5 Sales ($bn) for Rituxan/MabThera, 2009-2024 Figure 4.6 Sales ($bn) for Avastin and Rituxan, 2009-2024 Figure 4.7 Sales ($bn) for Avastin, 2005-2008 Figure 4.8 Market Share (%) for Avastin, 2009-2014 Figure 4.9 Sales ($bn) for Avastin, 2009-202 Figure 4.10 Sales ($bn) for Herceptin, 2005-2008 Figure 4.11 Sales ($bn) for Herceptin, 2009-2024 Figure 4.12 Market Share (%) for Herceptin, 2008-2014 Figure 4.13 Sales ($bn) for Erbitux, 2005-2008 Figure 4.14 Sales ($bn) for Erbitux, Herceptin and Rituxan, 2009-2024 Figure 4.15 Sales ($bn) for Erbitux, 2009-2024 Figure 4.16 Market Share (%) for Erbitux, 2009-2014 Figure 4.17 Sales ($bn) for Vectibix, 2009-2014 Figure 4.18 Market Share (%) for Vectibix, 2009-2014 Figure 4.19 Sales ($bn) for Vectibix, 2009-2024 Figure 4.20 Sales ($bn) for Campath, 2005-2008 Figure 4.21 Sales ($bn) for Campath, 2009-2024 Figure 4.22 Market Share (%) for Campath, 2009-2014 Figure 6.1 Leading Pharmaceutical Markets, Sales ($bn), 2008, 2014, 2019 and 2024 Figure 6.2 Leading Pharmaceutical Markets, Market Shares (%), 2008, 2014, 2019 and 2024 Figure 6.3 Leading Pharmaceutical Markets, CAGR (%), 2008-2014 Figure 6.4 Comparisons of the US, European, Chinese and Indian Markets, Market Shares (%), 2008-2024 Figure 7.1 Pipeline Drugs (Phase II) by Indication, 2008 Figure 7.2 Pipeline Drugs (Phase III) by Indication, 2008

Some Organisations Mentioned in this Report Abbott Laboratories Affimed Therapeutics AstraZeneca American Cancer Society Amgen Bayer Schering Pharma Biogen-Idec Bradmer Pharmaceuticals Bristol-Myers Squibb Dr. Reddy’s Laboratories Elan Pharmaceuticals Eli Lilly Esteve EMEA Fresenius SE Genentech Genmab Genzyme (ILEX Oncology) GlaxoSmithKline GlycArt Biotechnology ImClone Systems International Agency for Research on Cancer Johnson & Johnson Menarini Merck & Co. Micromet Millennium Pharmaceuticals Novartis Paladin Labs Pfizer Roche TeGenero Trion Pharma Tufts University US FDA Viventia Biotech World Health Organisation Wilex Wyeth Pharmaceuticals

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Dissolution Testing, Bioequivalence and Bioavailability Strategies

Assessing emerging applications, methodologies and techniques
24th-25th June 2009, London, UK

Key Speakers Dr. Anita Klute, Senior Principal Scientist, Pfizer Donal Murphy, Senior Scientist, AstraZeneca Dr. Daniel Abran, Director, Scientifi c Development and Compliance, Sandoz Dr. Nilufer Tampal Phd, CDER/FDA Dr. Rajan K Verma, Group Leader, OCRS Department, Ranbaxy Research Laboratories Dr. Rolf Hilfi ker, Vice President, Head of Department Solid-State Development, Solvias Kevin Ryan, Associate Director Analytical R&D, Pfizer Dr Idris M.El Mahdi, Associate professor of pharmaceutics, Arab Medical Sciences University Mr Cyrille Pertuy, Director Drug Product Development – Analytical Development, Ipsen Dr. Christine Smith, Research Formulations, Pfizer Dr Barbara Conway, School of Life and Health Sciences, Aston University Dr Carlos R Camozzi, Medical Director, Orphan Europe Hubert Pellikaan, Managing Director, Nextstep Pharma BV

Media Partners: PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm

The importance of dissolution testing has increased and it has undergone lot of improvements in the last few years. Dissolution testing continues to be used as a critical tool for quality control to ensure performance of production lots and in selection of formulation development.

Following the success of our last conference Visiongain is pleased to invite you to its 2nd Annual Dissolution Testing, Bioequivalence and Bioavailability Strategies Conference. This 2 day event will bring together for you key industry players and academics from analytical research and development to share the latest innovations, formulations, developments in dissolution testing, bioequivalence and bioavailability.

Reasons to attend: • Explore advantages of different roles and applications of dissolution testing, bioequivalence and bioavailability • Be a part of the unique opportunity to hear special series of presentations from Pfizer • Gain a more in depth understanding of the IVIVC • Discuss the role of dissolution and disintegration in the early development of tablet formulations • Hear the latest strategies for development of dissolution methods for IR products • Understand recent European regulatory requirements for bioavailability and bioequivalence

-Pricing-

Standard Rate for 2 day Conference- £1299 + VAT:£194.85 = Total:£1493.85

Academic & Health Care Organisations Rate for 2 day conference- £699 + VAT:£104.85 = Total:£803.85

• If you would like to send more than 1 person then take advantage of the 3 for 2 offer. Send 3 people but only pay for 2.

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd

Conference Agenda

Day 1, Wednesday 24th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

Dr. Anita Klute Senior Principal Scientist Pfizer

10:10 Impact of solid form on solubility and dissolution rate • Relationship between bioavailability, solubility and dissolution rate • Dependence of solubility and dissolution rate on solid form • Possible solid forms: polymorphs, hydrates, amorphous, salts, cocrystals • Stabilisation of the amorphous form • Characterisation of solid forms (XRD, Raman, DSC, DVS, TG-FTIR)

Dr. Rolf Hilfiker Vice President, Head of Department Solid-State Development Solvias

10:50 Applications of dissolution testing and similarity function in the evaluation of compressed microcapsules/microspheres • Significance of direct compression of of microspheres for industry • Selection of excipients for microspheres protection • The placebo pellets approach • Use of dissolution testing and similarity function for the estimation of degree of damage to drug pellets • Examples of directly compressed microspheres from the pharmaceutical industry Dr. Idris M. El-Mahdi (Ph.D)

Dr. Idris M. El-Mahdi (Ph.D)Associate Professor of Pharmaceutics & Dean Arab Medical Sciences University

11:30 Morning refreshments

11:50 Developing dissolution methods for insoluble compounds – Highlighting how to overcome instability in aqueous media • Method development strategies for BCS Class II / IV drugs • Challenges in dissolution of compounds likely to hydrolyse in water • Benefits of anticipating automation early in the development Cyrille Pertuy

Cyrille Pertuy Director Drug Product Development – Analytical Development Ipsen

12:30 The role of dissolution and disintegration in the early development of tablet formulations containing poorly soluble substances • Justification for use of disintegration testing in QC testing of immediate release formulations, regardless of BCS classification • Application of dissolution in formulation selection • Applying ‘QbD’ philosophy to dissolution strategy for early clinical trials (up to PhIIa) – e.g. criticality of parameters such as particle size in ensuring consistent performance in immediate release products

Dr. Anita Klute Senior Principal Scientist, Pfizer

13:10 Networking lunch

14:30 The role of dissolution testing in building the understanding and predicting bioperformance in solid oral dosage forms

Dr. Christine Smith Research Formulations Pfizer

15:10 Opportunities for the Application of Quality by Design to Dissolution Strategy in Commercial Formulation Development • Why we have a dissolution test • Elements of QbD • Application of QBD to the dissolution test and opportuinities for surrogacy • Key Quality Attributes for in vitro and in vivo performance tests • Development of QbD dissolution/ performance test strategies for IR and MR commercial formulations • QbD performance testing post commercialisation • Future of QbD

Kevin Ryan Analytical R&D, Pfizer

15:50 Afternoon refreshments

16:10 – Presentation to be announced

Jon Howells, Consultant, PA Consulting

16:50 Dissolution testing of non-conventional dosage forms • Value of dissolution testing for non-conventional dosage forms • Delivery of drugs to the oral cavity • Dissolution testing of chewing gum • Release of nicotine from medicated chewing gum formulations

Dr Barbara Conway, School of Life and Health Sciences, Aston University

17:30 Closing remarks from the chair

17:35 Networking drinksTake your discussions further and build new relationships in a relaxed and informal setting.

Day 2, Thursday 25th June 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Strategy for development of discriminatory dissolution methods for IR products • Dissolution development with reference to the BCS framework • Method screening and optimisation • Assessing discrimination and biorelevance • Setting specifications

Donal Murphy, Senior Scientist, AstraZeneca

10:50 – Use of dissolution testing to evaluate novel nanoparticles in suspension and tablets • Nanosuspensions have been prepared using a new, scalable technology without the formation of amorphous material • They can be isolated by spray drying to produce a readily compressible material • A range of dissolution testing techniques have been used to compare the properties of the suspensions and spray dried material • This has facilitated the development of rapidly dispersing tablets on a very small scale Michael Gamlen, Managing Director, Pharmaceutical Development Services

11:30 Morning refreshments

11:50 Practical thermodynamics and solubility enhancing • Method of finding adequate combinations of excipients to boost API solubility • USP dissolution profiles from test formulations

Hubert Pellikaan, Managing director, Nextstep Pharma

12:30 Dissolution testing of suspensions • Critical parameters in USP II and IV apparatus • Comparative analysis of dissolution vs Particle size • Case studies and IVIVC • Regulatory requirements

Dr. Daniel Abran, Director, Scientific Development and Compliance, Sandoz

13:10 Networking lunch

14:30 Dissolution testing for ANDA submissions

Dr. Nilufer Tampal Phd CDER/FDA

15:10 Bioavailability studies of orphan drugs in paediatric population • The challenge of paediatric sample size • PK variability in children • Healthy volunteers vs. patients

Dr Carlos R Camozzi, Medical Director, Orphan Europe

15:50 Afternoon refreshments

16:10 IVIVC for generic drug products • Design of generic drug product • Role of IVIVC in generic drug product development and approval • Case histories

Dr. Rajan K Verma, Group Leader, OCRS Department Ranbaxy Research Laboratories

16:50 Panel discussion: Bioavailability and Bioequivalence – Regulatory perspective

(Panelists will analyse the latest regulatory developments in the bioavailability and bioequivalence. Focus will be on the assessment of the bioequivalence and bioavailability studies from regulatory perspective. Panel members will be drawn from the speakers who take part on day one or day two.

17:30 Chair’s closing remarks

17:40 End of Conference

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Pharmacovigilance Report and Analysis 2009: Present Challenges and Future Goals

Pharmacovigilance gaining in importance after Vioxx problems – our new report analyses post-marketing assessment from the present onwards

Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch. Drug safety issues, such as those raised by Vioxx earlier this decade, have led to increased risk-averseness by regulators, with greater post-marketing assessment of drugs. Many regulatory agencies require detailed pharmacovigilance, with companies bearing extra costs, our new report also observes. Healthcare payers, prescribers and patients have high expectations from pharmacovigilance. They want thorough information – on adverse reactions and overall drug safety – upon which to make informed judgements. Pharmacovigilance is now being called upon to produce clear results, expressed openly. What will those trends mean for pharmacovigilance, from the perspectives of major stakeholders, including the pharma and biotech industries? Where is pharmacovigilance heading? What regulatory measures will continue, and which new processes will emerge? This new report – Pharmacovigilance 2009: Present Challenges and Future Goals – explains how that field will develop from the present onwards.

Clearly, pharmacovigilance is increasingly important worldwide, especially to avoid reoccurrences of serious, costly problems damaging to the industry. Pharmacovigilance is designed to provide crucial data on how drugs work in medical practice, from the short-term to the long-term. This information can aid drug development and marketing if harnessed properly, being a boon rather than a hindrance. In particular, visiongain believes that live licensing will form a significant part of pharma regulations and drug development in coming years. Pharmacovigilance will underpin processes and developments such as these, as this report further explains.

Comprehensive analyses and discussions

Using a wealth of research – including detailed quantitative and qualitative analyses, interviews with key opinion leaders and examination of policy documents, reports, industry news and commercial databases – our new study predicts how pharmacovigilance will develop from 2009 onwards.

Why you should buy Pharmacovigilance 2009: Present Challenges and Future Goals

By obtaining your copy of this report, you will benefit from:

unbiased assessments of the challenges and potential for pharmacovigilance detailed discussions of where pharmacovigilance is heading from 2009 onwards analyses and discussion of the relevant challenges facing the pharmaceutical industry analyses and discussion of how pharmacovigilance can influence the development, marketing and use of pharmaceuticals discussion of personalised medicine, and how pharmacovigilance can be utilised in better-targeted medicine discussion of how pharmacovigilance can contribute to live licensing views of experts in the field, with full texts of interviews from our survey forecasts of how pharmacovigilance costs will change over the next 15 years insight into public relations challenges faced by the industry, and how pharmacovigilance can help address those matters analyses of how actual risk and public perception interact. Visiongain believes that pharmacovigilance will contribute significantly to pharmaceutical development and marketing. Pharmacovigilance can also help to overcome public mistrust of the pharmaceutical industry. It can be a public relations system as well as a technological and pharmacological safeguard, as this report explains. This report examines public mistrust, discussing how pharmacovigilance can benefit rational communication and sound public understanding, taking emerging regulatory policies worldwide into account.

Includes exclusive interviews with organisations such as AstraZeneca, PharSafer Associates, ii4sm and more.

You can order this report today

Pharmacovigilance 2009: Present Challenges and Future Goals is essential reading for everybody involved with pharma regulatory affairs. The regulatory environment in many countries is changing, especially after events this decade. Do you want to know more about important regulatory developments? You can stay ahead by ordering this report today.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary

1.1 Aims, Scope and Format of the Report 1.1.1 The Problems Discussed in this Report 1.1.2 Terms in this Report 1.2 Chapter Breakdown 1.3 Future Costs 1.4 Research Methodology

2 History and Contexts of Pharmacovigilance

2.1 Pharmacovigilance: Watching the Drugs 2.1.1 Pharmacovigilance as Data Collection 2.1.2 The Future Trajectory of Pharmacovigilance 2.1.3 Pharmakon: Treatment and Poison 2.2 Adverse Drug Reactions (ADRs) are not “Side Effects” 2.2.1 ADRs are Informative 2.2.2 ADRs and Drug Development 2.3 Risk versus Harm 2.3.1 Monitoring Older Drugs vs. Newer Drugs 2.4 Pharmacovigilance History and Expansion 2.4.1 Established in 1971 by the WHO 2.4.2 Ever-Increasing Scope and Involvement 2.4.3 Sources of Pharmacovigilance Information 2.4.4 International Collaboration 2.4.5 The Uppsala Monitoring Centre (UMC) 2.5 “Phase IV” Clinical Trials: Filling the Gaps in Clinical Trials 2.5.1 Animal Models are Imperfect 2.5.2 Clinical Trials Look First for Efficacy, Second for Side Effects 2.5.3 Pharma Companies Not Presenting Full Clinical Trials Data 2.5.3.1 Ongoing Case: AstraZeneca and Seroquel 2.5.3.2 Pharmacovigilance and Clinical Trial Results 2.5.4 Pharmacovigilance and Under-Represented Groups 2.6 Reportage 2.6.1 Spontaneous Reporting: The Primary Source of Pharmacovigilance Information 2.6.1.1 Professional versus Patient Reporting Systems 2.6.1.2 Media Announcements and ADR Reports 2.6.2 Avoiding Human Error: “Never Events” 2.6.2.1 Prescribing and Dispensing Errors 2.6.2.2 Diminishing Punitive Reactions 2.6.3 Information from Hospitals: An Untapped Resource 2.6.4 Standardising Measurements and Definitions 2.6.5 mEDRA and the DOI System 2.7 Medical Pluralism: Patients Seek Advice and Treatment from a Variety of Sources 2.7.1 Tapping the Web: What Patients Say to Each Other 2.7.2 Tracking Advice: Internet Searches for Information 2.8 Effectiveness vs. Efficacy: In-Life Use vs. Clinical Use 2.8.1 Pharmacovigilance Assessments Must Consider How People ACTUALLY Use the Drug 2.8.2 Case Study: Viagra as Party Drug 2.8.2.1 Viagra and HIV: Is Viagra Helping Spread STDs? 2.8.3 Case Study: Pseudoephedrine and Methamphetamines 2.8.3.1 Pseudoephedrine Pharmacovigilance: Was the Public Helped or Harmed by Withdrawal? 2.8.4 The Viagra Case vs. The Pseudoephedrine Case 2.9 Patient Noncompliance 2.9.1 Noncompliance and Drug Effectiveness 2.9.2 Monetary Costs of Noncompliance 2.9.3 Can Pharmacovigilance Programs and Compliance Programs be Combined? 2.10 Risk Management 2.10.1 Making Choices For Patients 2.10.2 Relative Dangers 2.10.3 Stages of Risk Analysis and Management 2.10.4 Different Parties and Their Risk Management Assessments 2.11 Communicating Risk 2.12 Action Plan for Safety Issues

3 Pharmacovigilance Regulatory Bodies by Region

3.1 Increasing Mandatory Pharmacovigilance 3.2 WHO 3.3 European Union: EudraVigilance 3.3.1 Volume 9 3.3.2 United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA) and the Yellow Card Scheme 3.3.3 MHRA and Black Triangle Warnings 3.4 Bilateral Agreements: EMEA / FDA 3.5 FDA: Becoming Much More Conservative 3.5.1 Comparative Assessments 3.6 Japan has Rigorous Post-Marketing Drug Regulation 3.6.1 Standard Method for Drug Withdrawal 3.6.2 A System Worth Imitating 3.7 Companies Watching Each Other 3.7.1 Will Patients Access Pharmacovigilance Data? 3.7.2 Consumers of Data as well as Drugs?

4 Future Keywords: Transparency and Communication

4.1 Moving from Pharmacovigilance to Live Licensing 4.1.1 Meetings, Conversations, Communication 4.1.2 Successful Pharmacovigilance Does Not Make Headlines, but It Could 4.1.3 The Goal of Transparency: Redeeming the Public Trust 4.2 Hospitals Reduce Lawsuits by Apologising: Can Big Pharma Follow Suit? 4.2.1 Why Hospitals Traditionally Don’t Apologise 4.2.2 New Approach: Frank Admissions of Fault, and Apologies 4.2.3 Hospital Apology Success Rates 4.2.4 Can Pharma Duplicate This Success? 4.2.5 What if a Pharma Apology Made Headlines? 4.2.6 Does Pharma Have Much to Lose? 4.2.7 What Pharma Stands to Gain 4.3 T&C: Between Big Pharma and Regulatory Bodies 4.3.1 The WHO: Resolution Against Misleading Promotion 4.4 T&C: Between Big Pharma and Patients 4.4.1 Patient Compliance: Improved by Comprehension? 4.4.2 Individual Communication: Drug-Specific Forums on Company Websites? 4.4.3 Fostering Reportage: Company-Run Forums 4.4.4 Forums and Real-Time data: The Move to Live Licensing 4.4.5 Engaging Patients in Their Own Treatment 4.4.6 Communicating Ignorance: Crucial for the Transition to Live Licensing 4.5 Amongst Patients: Networking, Wikis, Blogs, Online Forums 4.5.1 Online Forums: The Power of Disinterest 4.5.2 Disease Blogs: Telling the Entire Story 4.5.3 Sales Personnel Forums: Not Good for Public Relations 4.6 T&C: Between Pharma and the Media 4.6.1 Communicating Effort: Stressing Pharmacovigilance 4.6.2 The Media and Individuals Distrust Pharma 4.6.3 Public Relations Case Study: Rezulin 4.7 T&C: Informing Doctors 4.7.1 What Doctors Know: Case Study: Zyprexa 4.7.2 Doctors Receiving Incorrect Information 4.8 Clinical Trials: Full and Impartial Reportage 4.8.1 Impartial Information: Assessing Risk 4.8.2 Informing Sales Representatives 4.8.3 Suspicious Approvals: Lexapro for Children 4.8.4 Case Study: AstraZeneca and Seroquel 4.8.5 Big Pharma Underwriting New Assessment Trials 4.8.6 Industry-Mediated or Media-Mediated Access to Information 4.9 Internal Communications: Company Departments Need to Share Information More Effectively 4.10 Exposing Links: Pharma and Academia 4.10.1 Pharma and Research Institutions 4.10.2 “Gifts” to Medical Schools, Medical Students, and Doctors 4.10.3 Good or Bad: Should Pharma Continue to Fund and be Allied with Medical Schools? 4.10.4 The 2008 and 2009 Harvard Medical School Protests and Inquiries 4.11 T&C: Between Countries – Centralised Databases and Standardised Reference Points 4.11.1 International Outsourcing of Clinical Trials 4.11.2 Involving Non-WHO Countries

5 Tailoring to Individuals and to Regions

5.1 Changing the One-Pill-Fits-All Paradigm 5.2 Looking for Case Clusters 5.3 Patient Registries 5.3.1 Registries By Disease 5.3.2 Registries By Drug Exposure and Diseases 5.3.3 The Case of Clozapine 5.3.4 Limiting Access to Registries: NOT for Prescriber Use 5.4 Designing Patient Registries 5.4.1 Size 5.4.2 Rationale / Purpose 5.4.3 Cost / Benefit 5.4.4 Preserving Privacy 5.5 Tailoring to Regions 5.5.1 The Developing World 5.5.2 The Developed World 5.6 Tailoring to Individuals 5.6.1 Best Care versus Ideal Care 5.6.2 Pharmacovigilance and Behaviour 5.6.3 Genomics / Pharmacogenomics 5.6.3.1 Expected Advantages of Pharmacogenomics 5.6.3.2 Slow Progress of Applicable Pharmacogenomics 5.6.4 Live Licensing

6 Pharmacovigilance and Live Licensing / Conditional Approval

6.1 Live Licensing and Increased Transparency 6.2 Supporting Drug Evolution 6.2.1 More Drugs Withdrawn under a Live Licensing Paradigm 6.2.2 Closely Tracking and Learning from ADRs 6.3 Live Licensing May Not be Cheaper Overall 6.4 Gaining Patient Trust: The First Major Obstacle 6.4.1 Old and New Paradigms Running Concurrently 6.5 Difficulties of Live Licensing: Monitoring Response, Tabulating Information 6.5.1 Responding Quickly 6.5.2 Assessing Response Without a Control Group 6.5.3 Self-Aware Patients 6.5.4 Distributing Information: Updating Data 6.6 Sensitive Pricing 6.6.1 Pricing for Regional Effectiveness 6.6.2 Pricing for Regional Affluence 6.6.3 Pricing for Performance: How Pharmacovigilance Will Facilitate This Inevitability

7 Unique Visiongain Interviews

7.1 Interview with Dr. Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca 7.1.1 On the Ideal Goal of Pharmacovigilance 7.1.2 On the Rarity of the Most Serious Events 7.1.3 On Discovering Rare Events: The Rule of Three 7.1.4 On Communicating Newly Discovered Side Effects 7.1.4.1 Drug Withdrawal as Extreme Measure 7.1.4.2 Communicating Risk 7.1.5 On Drug Withdrawal and the Media 7.1.6 On Good Pharmacovigilance NOT Making Headlines 7.1.7 On the Current Rising Costs of Pharmacovigilance 7.1.7.1 On the Cost Contribution of More Reporting 7.1.7.2 On the “Downstream Costs” of Pharmacovigilance 7.1.7.3 On the Future Costs of Pharmacovigilance 7.1.8 On Governments Redirecting Pharmacovigilance Costs 7.1.9 On Government Investment vs. Company Investment in Pharmacovigilance 7.1.9.1 On the Number of Industry vs. Government Pharmacovigilance Personnel 7.1.10 On the Number of Pharmacovigilance Personnel Per Portfolio 7.1.11 On Vioxx as Failure or Success 7.1.12 On the Future: More Risk-Averse or Towards Live Licensing / Conditional Approval? 7.2 Dr. Graeme Ladds, Founder of PharSafer Associates Ltd. 7.2.1 On Outsourcing Pharmacovigilance 7.2.1.1 On the Cost-Effectiveness of Outsourcing 7.2.1.2 On Transferring Pharmacovigilance from Outsourced to In-House Databases 7.2.2 On What Pharmacovigilance Is, and How Success is Measured 7.2.3 On Looking for Non-Drug Reasons for ADRs 7.2.4 On the Future Costs of Pharmacovigilance 7.2.5 On the Costs of Databases 7.2.6 On Countries Leading the Way in Pharmacovigilance Co-ordination 7.2.7 On Access to the WHO Database 7.2.8 On Vioxx as Success or Failure of Pharmacovigilance 7.2.9 On Stem Cells, Tissue Therapies, and New Complexities of Pharmacovigilance 7.3 Comments from Dr. Jan-Willem van der Velden, MD., Senior Vice President of Global Drug Safety, International Institute for the Safety of Medicines Ltd. (ii4sm). 7.3.1 On the Ideal Goal of Pharmacovigilance 7.3.2 On Future Costs of Pharmacovigilance 7.3.3 On Measurements of Success 7.3.4 On Vioxx as a Success or Failure of Pharmacovigilance

8 Scope and Costs of Pharmacovigilance

8.1 Costs of Pharmacovigilance for the Next 5 to 15 Years 8.2 The Costs of Reputation Loss 8.3 Current Scope and Limits of Pharmacovigilance 8.3.1 Actual Risk 8.3.2 Perceived Risk 8.4 Future Aspects 8.4.1 Cosmetics 8.4.2 Tissues / Stem Cells 8.5 Public Health and Pharmaceutical Growth

9 Conclusions

9.1 Pharmacovigilance Increasing and Expanding 9.1.1 Scope: More Products 9.1.2 Expansion: Doing More with Data 9.2 Regulatory Bodies and the Public Demand More from Pharmacovigilance 9.3 Pharmacovigilance: A Crucial Beginning in the Move to Live Licensing

List of Tables

Table 1.1 EU and US Pharmacovigilance Terminology Table 2.1 Risks of Death for Various Activities Table 2.2 Types and Progressive Stages of Risk Analysis / Management Table 2.3 Parties and Motivations Involved in Therapeutic Risk Management Table 2.4 Risk Communication Responsibilities of Companies, Doctors and Patients Table 2.5 Types of Responses to New Safety Information, from Least to Most Aggressive Table 5.1 Behavioural Tailoring Considerations Table 8.1 Hypothetical Costs of Pharmacovigilance, 2009-2024

List of Figures

Figure 6.1 Traditional Drug Development Progression Figure 6.2 Model of Development for Live Licensing Figure 8.1 Costs of Pharmacovigilance, 2009-2024

Organisations Mentioned in this Report AIDS Healthcare Foundation American Medical Student Association (AMSA) Amgen AstraZeneca Cambridge Antibody Technology Centers for Disease Control and Prevention (CDC) Commission on Human Medicines (CHM) Committee for Medicinal Products for Human Use (CHMP) Daiichi Sankyo Co Eli Lilly European Agency for the Evaluation of Medicinal Products European Assocation of Hospital Pharmacists European Commission European Hospital and Healthcare Federation (HOPE) European Medicines Agency (EMEA) European Network for Patient Safety (EuNetPas) European Society of Pharmacovigilance (later the International Society) Forest Laboratories Genentech GlaxoSmithKline Human Genome Sciences Institute for Health Improvement (IHI), USA International Society of Pharmacovigilance (ISoP) Medicines and Healthcare products Regulatory Agency (MHRA) Merck multilingual European Registration Agency (mEDRA) National Council on Patient Information and Education (US) National Institute for Health and Clinical Excellence (NICE) National Patient Safety Agency (NPSA) Pfizer Pharmaceutical Group of the European Union (PGEU) PricewaterhouseCoopers RBPGB Public Liasion Group Roche Royal Pharmaceutical Socity of Great Britain (RPSGB) STD Prevention and Control Services, San Francisco Department of Public Health The Pharmaceutical Research and Manufacturers of America (PhRMA) University of Illinois Hospital University of Michigan Health System Uppsala Monitoring Centre (UMC) US Department of Justice Warner-Lambert Company World Health Organization (WHO)

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Pharmacovigilance Report and Analysis 2009: Present Challenges and Future Goals

Pharmacovigilance gaining in importance after Vioxx problems – our new report analyses post-marketing assessment from the present onwards

Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch. Drug safety issues, such as those raised by Vioxx earlier this decade, have led to increased risk-averseness by regulators, with greater post-marketing assessment of drugs. Many regulatory agencies require detailed pharmacovigilance, with companies bearing extra costs, our new report also observes. Healthcare payers, prescribers and patients have high expectations from pharmacovigilance. They want thorough information – on adverse reactions and overall drug safety – upon which to make informed judgements. Pharmacovigilance is now being called upon to produce clear results, expressed openly. What will those trends mean for pharmacovigilance, from the perspectives of major stakeholders, including the pharma and biotech industries? Where is pharmacovigilance heading? What regulatory measures will continue, and which new processes will emerge? This new report – Pharmacovigilance 2009: Present Challenges and Future Goals – explains how that field will develop from the present onwards.

Clearly, pharmacovigilance is increasingly important worldwide, especially to avoid reoccurrences of serious, costly problems damaging to the industry. Pharmacovigilance is designed to provide crucial data on how drugs work in medical practice, from the short-term to the long-term. This information can aid drug development and marketing if harnessed properly, being a boon rather than a hindrance. In particular, visiongain believes that live licensing will form a significant part of pharma regulations and drug development in coming years. Pharmacovigilance will underpin processes and developments such as these, as this report further explains.

Comprehensive analyses and discussions

Using a wealth of research – including detailed quantitative and qualitative analyses, interviews with key opinion leaders and examination of policy documents, reports, industry news and commercial databases – our new study predicts how pharmacovigilance will develop from 2009 onwards.

Why you should buy Pharmacovigilance 2009: Present Challenges and Future Goals

By obtaining your copy of this report, you will benefit from:

unbiased assessments of the challenges and potential for pharmacovigilance detailed discussions of where pharmacovigilance is heading from 2009 onwards analyses and discussion of the relevant challenges facing the pharmaceutical industry analyses and discussion of how pharmacovigilance can influence the development, marketing and use of pharmaceuticals discussion of personalised medicine, and how pharmacovigilance can be utilised in better-targeted medicine discussion of how pharmacovigilance can contribute to live licensing views of experts in the field, with full texts of interviews from our survey forecasts of how pharmacovigilance costs will change over the next 15 years insight into public relations challenges faced by the industry, and how pharmacovigilance can help address those matters analyses of how actual risk and public perception interact. Visiongain believes that pharmacovigilance will contribute significantly to pharmaceutical development and marketing. Pharmacovigilance can also help to overcome public mistrust of the pharmaceutical industry. It can be a public relations system as well as a technological and pharmacological safeguard, as this report explains. This report examines public mistrust, discussing how pharmacovigilance can benefit rational communication and sound public understanding, taking emerging regulatory policies worldwide into account.

Includes exclusive interviews with organisations such as AstraZeneca, PharSafer Associates, ii4sm and more.

You can order this report today

Pharmacovigilance 2009: Present Challenges and Future Goals is essential reading for everybody involved with pharma regulatory affairs. The regulatory environment in many countries is changing, especially after events this decade. Do you want to know more about important regulatory developments? You can stay ahead by ordering this report today.

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        Table of  contents

1 Executive Summary

1.1 Aims, Scope and Format of the Report 1.1.1 The Problems Discussed in this Report 1.1.2 Terms in this Report 1.2 Chapter Breakdown 1.3 Future Costs 1.4 Research Methodology

2 History and Contexts of Pharmacovigilance

2.1 Pharmacovigilance: Watching the Drugs 2.1.1 Pharmacovigilance as Data Collection 2.1.2 The Future Trajectory of Pharmacovigilance 2.1.3 Pharmakon: Treatment and Poison 2.2 Adverse Drug Reactions (ADRs) are not “Side Effects” 2.2.1 ADRs are Informative 2.2.2 ADRs and Drug Development 2.3 Risk versus Harm 2.3.1 Monitoring Older Drugs vs. Newer Drugs 2.4 Pharmacovigilance History and Expansion 2.4.1 Established in 1971 by the WHO 2.4.2 Ever-Increasing Scope and Involvement 2.4.3 Sources of Pharmacovigilance Information 2.4.4 International Collaboration 2.4.5 The Uppsala Monitoring Centre (UMC) 2.5 “Phase IV” Clinical Trials: Filling the Gaps in Clinical Trials 2.5.1 Animal Models are Imperfect 2.5.2 Clinical Trials Look First for Efficacy, Second for Side Effects 2.5.3 Pharma Companies Not Presenting Full Clinical Trials Data 2.5.3.1 Ongoing Case: AstraZeneca and Seroquel 2.5.3.2 Pharmacovigilance and Clinical Trial Results 2.5.4 Pharmacovigilance and Under-Represented Groups 2.6 Reportage 2.6.1 Spontaneous Reporting: The Primary Source of Pharmacovigilance Information 2.6.1.1 Professional versus Patient Reporting Systems 2.6.1.2 Media Announcements and ADR Reports 2.6.2 Avoiding Human Error: “Never Events” 2.6.2.1 Prescribing and Dispensing Errors 2.6.2.2 Diminishing Punitive Reactions 2.6.3 Information from Hospitals: An Untapped Resource 2.6.4 Standardising Measurements and Definitions 2.6.5 mEDRA and the DOI System 2.7 Medical Pluralism: Patients Seek Advice and Treatment from a Variety of Sources 2.7.1 Tapping the Web: What Patients Say to Each Other 2.7.2 Tracking Advice: Internet Searches for Information 2.8 Effectiveness vs. Efficacy: In-Life Use vs. Clinical Use 2.8.1 Pharmacovigilance Assessments Must Consider How People ACTUALLY Use the Drug 2.8.2 Case Study: Viagra as Party Drug 2.8.2.1 Viagra and HIV: Is Viagra Helping Spread STDs? 2.8.3 Case Study: Pseudoephedrine and Methamphetamines 2.8.3.1 Pseudoephedrine Pharmacovigilance: Was the Public Helped or Harmed by Withdrawal? 2.8.4 The Viagra Case vs. The Pseudoephedrine Case 2.9 Patient Noncompliance 2.9.1 Noncompliance and Drug Effectiveness 2.9.2 Monetary Costs of Noncompliance 2.9.3 Can Pharmacovigilance Programs and Compliance Programs be Combined? 2.10 Risk Management 2.10.1 Making Choices For Patients 2.10.2 Relative Dangers 2.10.3 Stages of Risk Analysis and Management 2.10.4 Different Parties and Their Risk Management Assessments 2.11 Communicating Risk 2.12 Action Plan for Safety Issues

3 Pharmacovigilance Regulatory Bodies by Region

3.1 Increasing Mandatory Pharmacovigilance 3.2 WHO 3.3 European Union: EudraVigilance 3.3.1 Volume 9 3.3.2 United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA) and the Yellow Card Scheme 3.3.3 MHRA and Black Triangle Warnings 3.4 Bilateral Agreements: EMEA / FDA 3.5 FDA: Becoming Much More Conservative 3.5.1 Comparative Assessments 3.6 Japan has Rigorous Post-Marketing Drug Regulation 3.6.1 Standard Method for Drug Withdrawal 3.6.2 A System Worth Imitating 3.7 Companies Watching Each Other 3.7.1 Will Patients Access Pharmacovigilance Data? 3.7.2 Consumers of Data as well as Drugs?

4 Future Keywords: Transparency and Communication

4.1 Moving from Pharmacovigilance to Live Licensing 4.1.1 Meetings, Conversations, Communication 4.1.2 Successful Pharmacovigilance Does Not Make Headlines, but It Could 4.1.3 The Goal of Transparency: Redeeming the Public Trust 4.2 Hospitals Reduce Lawsuits by Apologising: Can Big Pharma Follow Suit? 4.2.1 Why Hospitals Traditionally Don’t Apologise 4.2.2 New Approach: Frank Admissions of Fault, and Apologies 4.2.3 Hospital Apology Success Rates 4.2.4 Can Pharma Duplicate This Success? 4.2.5 What if a Pharma Apology Made Headlines? 4.2.6 Does Pharma Have Much to Lose? 4.2.7 What Pharma Stands to Gain 4.3 T&C: Between Big Pharma and Regulatory Bodies 4.3.1 The WHO: Resolution Against Misleading Promotion 4.4 T&C: Between Big Pharma and Patients 4.4.1 Patient Compliance: Improved by Comprehension? 4.4.2 Individual Communication: Drug-Specific Forums on Company Websites? 4.4.3 Fostering Reportage: Company-Run Forums 4.4.4 Forums and Real-Time data: The Move to Live Licensing 4.4.5 Engaging Patients in Their Own Treatment 4.4.6 Communicating Ignorance: Crucial for the Transition to Live Licensing 4.5 Amongst Patients: Networking, Wikis, Blogs, Online Forums 4.5.1 Online Forums: The Power of Disinterest 4.5.2 Disease Blogs: Telling the Entire Story 4.5.3 Sales Personnel Forums: Not Good for Public Relations 4.6 T&C: Between Pharma and the Media 4.6.1 Communicating Effort: Stressing Pharmacovigilance 4.6.2 The Media and Individuals Distrust Pharma 4.6.3 Public Relations Case Study: Rezulin 4.7 T&C: Informing Doctors 4.7.1 What Doctors Know: Case Study: Zyprexa 4.7.2 Doctors Receiving Incorrect Information 4.8 Clinical Trials: Full and Impartial Reportage 4.8.1 Impartial Information: Assessing Risk 4.8.2 Informing Sales Representatives 4.8.3 Suspicious Approvals: Lexapro for Children 4.8.4 Case Study: AstraZeneca and Seroquel 4.8.5 Big Pharma Underwriting New Assessment Trials 4.8.6 Industry-Mediated or Media-Mediated Access to Information 4.9 Internal Communications: Company Departments Need to Share Information More Effectively 4.10 Exposing Links: Pharma and Academia 4.10.1 Pharma and Research Institutions 4.10.2 “Gifts” to Medical Schools, Medical Students, and Doctors 4.10.3 Good or Bad: Should Pharma Continue to Fund and be Allied with Medical Schools? 4.10.4 The 2008 and 2009 Harvard Medical School Protests and Inquiries 4.11 T&C: Between Countries – Centralised Databases and Standardised Reference Points 4.11.1 International Outsourcing of Clinical Trials 4.11.2 Involving Non-WHO Countries

5 Tailoring to Individuals and to Regions

5.1 Changing the One-Pill-Fits-All Paradigm 5.2 Looking for Case Clusters 5.3 Patient Registries 5.3.1 Registries By Disease 5.3.2 Registries By Drug Exposure and Diseases 5.3.3 The Case of Clozapine 5.3.4 Limiting Access to Registries: NOT for Prescriber Use 5.4 Designing Patient Registries 5.4.1 Size 5.4.2 Rationale / Purpose 5.4.3 Cost / Benefit 5.4.4 Preserving Privacy 5.5 Tailoring to Regions 5.5.1 The Developing World 5.5.2 The Developed World 5.6 Tailoring to Individuals 5.6.1 Best Care versus Ideal Care 5.6.2 Pharmacovigilance and Behaviour 5.6.3 Genomics / Pharmacogenomics 5.6.3.1 Expected Advantages of Pharmacogenomics 5.6.3.2 Slow Progress of Applicable Pharmacogenomics 5.6.4 Live Licensing

6 Pharmacovigilance and Live Licensing / Conditional Approval

6.1 Live Licensing and Increased Transparency 6.2 Supporting Drug Evolution 6.2.1 More Drugs Withdrawn under a Live Licensing Paradigm 6.2.2 Closely Tracking and Learning from ADRs 6.3 Live Licensing May Not be Cheaper Overall 6.4 Gaining Patient Trust: The First Major Obstacle 6.4.1 Old and New Paradigms Running Concurrently 6.5 Difficulties of Live Licensing: Monitoring Response, Tabulating Information 6.5.1 Responding Quickly 6.5.2 Assessing Response Without a Control Group 6.5.3 Self-Aware Patients 6.5.4 Distributing Information: Updating Data 6.6 Sensitive Pricing 6.6.1 Pricing for Regional Effectiveness 6.6.2 Pricing for Regional Affluence 6.6.3 Pricing for Performance: How Pharmacovigilance Will Facilitate This Inevitability

7 Unique Visiongain Interviews

7.1 Interview with Dr. Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca 7.1.1 On the Ideal Goal of Pharmacovigilance 7.1.2 On the Rarity of the Most Serious Events 7.1.3 On Discovering Rare Events: The Rule of Three 7.1.4 On Communicating Newly Discovered Side Effects 7.1.4.1 Drug Withdrawal as Extreme Measure 7.1.4.2 Communicating Risk 7.1.5 On Drug Withdrawal and the Media 7.1.6 On Good Pharmacovigilance NOT Making Headlines 7.1.7 On the Current Rising Costs of Pharmacovigilance 7.1.7.1 On the Cost Contribution of More Reporting 7.1.7.2 On the “Downstream Costs” of Pharmacovigilance 7.1.7.3 On the Future Costs of Pharmacovigilance 7.1.8 On Governments Redirecting Pharmacovigilance Costs 7.1.9 On Government Investment vs. Company Investment in Pharmacovigilance 7.1.9.1 On the Number of Industry vs. Government Pharmacovigilance Personnel 7.1.10 On the Number of Pharmacovigilance Personnel Per Portfolio 7.1.11 On Vioxx as Failure or Success 7.1.12 On the Future: More Risk-Averse or Towards Live Licensing / Conditional Approval? 7.2 Dr. Graeme Ladds, Founder of PharSafer Associates Ltd. 7.2.1 On Outsourcing Pharmacovigilance 7.2.1.1 On the Cost-Effectiveness of Outsourcing 7.2.1.2 On Transferring Pharmacovigilance from Outsourced to In-House Databases 7.2.2 On What Pharmacovigilance Is, and How Success is Measured 7.2.3 On Looking for Non-Drug Reasons for ADRs 7.2.4 On the Future Costs of Pharmacovigilance 7.2.5 On the Costs of Databases 7.2.6 On Countries Leading the Way in Pharmacovigilance Co-ordination 7.2.7 On Access to the WHO Database 7.2.8 On Vioxx as Success or Failure of Pharmacovigilance 7.2.9 On Stem Cells, Tissue Therapies, and New Complexities of Pharmacovigilance 7.3 Comments from Dr. Jan-Willem van der Velden, MD., Senior Vice President of Global Drug Safety, International Institute for the Safety of Medicines Ltd. (ii4sm). 7.3.1 On the Ideal Goal of Pharmacovigilance 7.3.2 On Future Costs of Pharmacovigilance 7.3.3 On Measurements of Success 7.3.4 On Vioxx as a Success or Failure of Pharmacovigilance

8 Scope and Costs of Pharmacovigilance

8.1 Costs of Pharmacovigilance for the Next 5 to 15 Years 8.2 The Costs of Reputation Loss 8.3 Current Scope and Limits of Pharmacovigilance 8.3.1 Actual Risk 8.3.2 Perceived Risk 8.4 Future Aspects 8.4.1 Cosmetics 8.4.2 Tissues / Stem Cells 8.5 Public Health and Pharmaceutical Growth

9 Conclusions

9.1 Pharmacovigilance Increasing and Expanding 9.1.1 Scope: More Products 9.1.2 Expansion: Doing More with Data 9.2 Regulatory Bodies and the Public Demand More from Pharmacovigilance 9.3 Pharmacovigilance: A Crucial Beginning in the Move to Live Licensing

List of Tables

Table 1.1 EU and US Pharmacovigilance Terminology Table 2.1 Risks of Death for Various Activities Table 2.2 Types and Progressive Stages of Risk Analysis / Management Table 2.3 Parties and Motivations Involved in Therapeutic Risk Management Table 2.4 Risk Communication Responsibilities of Companies, Doctors and Patients Table 2.5 Types of Responses to New Safety Information, from Least to Most Aggressive Table 5.1 Behavioural Tailoring Considerations Table 8.1 Hypothetical Costs of Pharmacovigilance, 2009-2024

List of Figures

Figure 6.1 Traditional Drug Development Progression Figure 6.2 Model of Development for Live Licensing Figure 8.1 Costs of Pharmacovigilance, 2009-2024

Organisations Mentioned in this Report AIDS Healthcare Foundation American Medical Student Association (AMSA) Amgen AstraZeneca Cambridge Antibody Technology Centers for Disease Control and Prevention (CDC) Commission on Human Medicines (CHM) Committee for Medicinal Products for Human Use (CHMP) Daiichi Sankyo Co Eli Lilly European Agency for the Evaluation of Medicinal Products European Assocation of Hospital Pharmacists European Commission European Hospital and Healthcare Federation (HOPE) European Medicines Agency (EMEA) European Network for Patient Safety (EuNetPas) European Society of Pharmacovigilance (later the International Society) Forest Laboratories Genentech GlaxoSmithKline Human Genome Sciences Institute for Health Improvement (IHI), USA International Society of Pharmacovigilance (ISoP) Medicines and Healthcare products Regulatory Agency (MHRA) Merck multilingual European Registration Agency (mEDRA) National Council on Patient Information and Education (US) National Institute for Health and Clinical Excellence (NICE) National Patient Safety Agency (NPSA) Pfizer Pharmaceutical Group of the European Union (PGEU) PricewaterhouseCoopers RBPGB Public Liasion Group Roche Royal Pharmaceutical Socity of Great Britain (RPSGB) STD Prevention and Control Services, San Francisco Department of Public Health The Pharmaceutical Research and Manufacturers of America (PhRMA) University of Illinois Hospital University of Michigan Health System Uppsala Monitoring Centre (UMC) US Department of Justice Warner-Lambert Company World Health Organization (WHO)

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Clinical Trials in Asia Summit 2009 Examining the latest developments in the field of antibody engineering

18th – 20th February 2009, New Delhi, India

Key Speakers include:

• Chandrashekhar Potkar, Director, Medical and Regulatory Affairs, Pfizer, India • Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Mgmt Clinical Research, Pfizer, India • Rajesh Karan, Regional Head of Translational Medicine & Scientifi c Operations, Novartis, India • Anirban Roy Chowdhury, Clinical Research Manager, AstraZeneca, India • Mark Engel, Chairman, Excel PharmaStudies • Celestine Juliet, Project Manager, Cipla • Krathish Bopanna, Senior Vice President, Acunova • Nermeen Varawalla, Vice President, Scientifi c & Medical Affairs, PRA International • Paula Mumby, Director, i3 Pharma Resourcing • Dan Zhang, CEO, Fountain Medical Development. • Dalvin Ni, VP, Fountain Medical Development. • Milind Antani, Head-Pharma LifeSciences group, Nishith Desai • Arani Chatterjee, Vice President, Clinical Research Panacea Biotec • Anil Jain, Assistant General Manager, Clinical Research, Panacea Biotec

Platinum Sponsor: IMS Health i3 Pharma Resourcing India

Media Partners: PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm Espicom

India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favored destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and parts of South Asia are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations.

Clinical Trials Summit 2009 will discuss the on-going pressing concerns faced in clinical trials operations, addressing the risks, timeline and budget constraint, whilst effectively tackling key challenges in overcoming trials agreement and site contract negotiation hurdles. This year, the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management will be discussed in order to improve and optimize the overall drug development effectiveness and ROI. Find out how to implement and benefit from electronic data management & monitoring cost effectively. This event will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Delegates will have the opportunity to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies (including IPR issues) and pharmacovigilance.

Reasons to register today: • How can you take advantage of the global market for clinical trials? • Improving and optimizing site management and overall productivity of clinical operations • Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets • Identify the data management, CMC supply chain, operational requirements and CRO infrastructure in India and South Asia • Gaining insights on future forwards of clinical trials and valuing its potential • Discover how to improve your supplier-client relationships • Complete trials on schedule and budget by learning to overcome hurdles in investigator/patient recruitment • What are the issues with off-shoring trials to countries such as India & South Asia? What are the ways to overcome them? • Explore innovative strategies for outsourcing, what you should be looking for in a CRO? • Working with limited budget to ensure on time study completion • Escalating patient recruitment and improving patient retention to save cost and reduce lead-time • Maximizing trials results through overseas multinational/multi-centric trials • Avoiding potential pitfalls of trials agreement • Motivating and managing clinical project teams to improve timeline and progress

======================================================= Plus Unique Interactive Workshop, Wednesday 18th February 2009

Conducting Clinical Trials in India: Achieving Evolving Sponsor Expectations

Led by: Dr. Dan Zhang, CEO, Fountain Medical Development Dr. Dalvin Ni, VP, Fountain Medical Development Dr Nermeen Y. Varawalla, Vice President, Scientific & Medical Affairs, PRA International

Timings: 09:30 – 10:00 Registration & refreshments 10:00 – 16:00 Workshop Timing includes lunch and refreshment breaks

Morning Session: Conducting Clinical Trials in China • Regulatory process in China • Conducting clinical studies in China: global studies vs. local registration trial • China and India: collaboration and competition

Afternoon Session: Conducting Clinical Trials in India: Achieving Evolving Sponsor Expectations • Protocol and study design customized for the Indian healthcare environment • Investigator and site selection • Smooth study start up • Site support • Delivering value beyond cost and time savings

========================================================

-Pricing- Standard Rates: – 3 day pass – includes the 2-day conference and 1-day interactive workshop – available for only GBP899+VAT

• 2 day Conference only ticket – available for only GBP699+VAT

• Workshop only pass – available for only GBP299+VAT

Non-profit and Academic Rates: – 3 day pass – includes the 2-day conference and 1-day interactive workshop – available for only GBP699+VAT

• 2 day Conference only ticket – available for only GBP499+VAT

• Workshop only pass – available for only GBP119+VAT

• If you would like to send more than 1 person then take advantage of the 3 for 2 offer. Send 3 people but only pay for 2. Excellent networking opportunities.

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd

Conference Agenda

Day 1, Thursday 19th February 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Chandrashekhar Potkar Director, Medical and Regulatory Affairs Pfizer, India

09:40 Examining the future market for clinical trials • How can you take advantage of the global market for clinical trials? • Identify the significance of the clinical trial in India and South Asia market • Emerging technologies that can be deployed to generate revenue • How to build a high-performing global medical team to achieve desired objectives and results. Nermeen Varawalla Vice President, Scientific & Medical Affairs PRA International

10:20 Evaluating key emerging markets for improved strategy • Which emerging markets are hottest today? • Which markets are next? • What makes each market unique and how do markets compare? • What are the challenges and risks of each market? • Who is operating in each market? Krathish Bopanna Senior Vice President Acunova

11:00 Morning refreshments & discussion

11:20 Optimising return on investment (ROI) of multinational and domestic clinical trials in China • How to choose the best strategies to ensure early involvement of China? • How to discover an innovative model to overcome regulatory hurdles? • How to build a high-performing global medical team to achieve desired objectives and results? • Can replicating a global protocol for a Chinese clinical trial be a best practice in a rapid growing market? Mark Engel Chairman Excel PharmaStudies

12:00 Enhancing staff performance in multinational/multi-centered trials • Structure of existing system for training and monitoring staff performance • What are the common problems of staff monitoring and effective solutions • Strategies to cope with high staff turnover rate to minimise cost for your trials Paula Mumby, Director, i3 Pharma Resourcing Cheryl Townsend, Director, Regional Operations, George Institute for International Health

12:40 Networking luncheon

14:00 Streamlining data reviews with integrated e-clinical systems • Defining data reviews as part of the electronic data validation plan • Efficient electronic data review in e-clinical systems • Enhancing compliance with electronic reviews • Integrating electronic data reviews in the EDC process

14:20 Clinical Trial Registry – India (CTRI)

14:40 Exploring collaborative opportunities and clinical trial partnership • Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction • Developing programs for successful partnership • Utilising thought leader networking Viraj Rajadhyaksha Senior Manager, Operations, Planning & Management Clinical Research Pfizer, India

15:20 Afternoon refreshments

15:40 Country and site selection for global clinical trials • When does patience recruitment get difficult and how can this issue be overcome? • Determine the challenges in determining where, when and how to expand clinical operations • How should you make your decision and implement your global expansion plans successfully? Anirban Roy Chowdhury Clinical Research Manager AstraZeneca, India

16:20 Panel Discussion: Overcoming regulatory challenges in Asian clinical trials In this session, country representatives will gather to share various challenges experienced when conducting clinical trials in their respective countries. The audience will be given an opportunity to address pressing concerns they have with their existing and/or prospective trials in these countries. Moderator: Chandrashekhar Potkar, Director, Medical and Regulatory Affairs, Pfizer, India Panellists: Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer, India

17:00 Offshoring – Balancing the right opportunities and risks • Exploring potential operational challenges and strategies for managing offshore trials • Outsourcing an entire project to Asia to extend your R&D capabilities? • Risk-sharing deals versus higher value service deals

17:40 Chairperson’s closing remarks

17:50 Networking drinks reception Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2, Friday 20th February 2009

09:00 Registration and refreshments

09:30 Chair’s opening remarks Arani Chatterjee Vice President Clinical Research Panacea Biotec

09:40 Opportunity trials of clinical research in India: focusing on phase I and phase II • A review of the clinical research environment in India • A focus on existing business models conduct clinical trials in India • An evaluation of the opportunities of potential collaborations Rajesh Karan Regional Head of Translational Medicine & Scientific Operations Novartis, India

10:20 Conducting phase III and IV trials in China: practical considerations • Discuss the common misconceptions and pitfalls • Regulatory and timing considerations • Selection and management of sites • Impact on future sales

11:00 Morning refreshments & discussion

11:20 Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials • What is the range of opportunities? • Cut through the hype and learn how to evaluate service providers to avoid choosing the wrong one. • How is India a host to reputable, reliable suppliers? • What to look for in order to make the right decision and avoid major, costly mistakes? • Will the current trend to outsource clinical trials to Asia be successful?

12:00 Rising cost of clinical trials in Asia • Diverse socio-economic situation in Asia • Drivers of cost competitiveness in Asia • Challenges linked to the increase of clinical research activity in Asia and consequences on cost • Effective Planning and Negotiating your Budgets with Partners

12:40 Networking luncheon

14:00 Accelerating patient recruitment and retention in clinical trials • What are the current challenges in the Asian market for patient recruitment & how to tackle them? • What are the recent applications of technology in clinical trial recruitment? • Develop new and innovative ways to reach patients • Understand key issues regarding patient recruitment in a global market • Incorporate an effective retention program as part of the overall recruitment strategy for clinical trials Anil Jain Assistant General Manager, Clinical Research Panacea Biotec

14:40 Compliance: Impact of e-clinical trials • Defining and articulating the clinical trials process • Conducting the clinical trial: document management, e-approval, distributed access-distributed resource • Tracking the clinical trial: productivity, milestones, responsibility

15:20 Afternoon refreshments

15:40 Best practices for engaging regulatory authorities in Asia • What are the recent regulatory changes and the changes in the pipeline? • Reporting issues ( Adverse reactions/SUSARS etc) • What are liabilities in clinical research? • Reviewing the general regulatory issue (POA etc) • An analysis on advertisement/marketing issues Milind Antani Head-Pharma LifeSciences group Nishith Desai

16:20 Minimise conflict and achieve a profitable sponsor-vendor partnership • What do CRO look for in a good sponsor? • What is the importance of billing terms in contracts? • Find out how trial site costs/RFPs are prepared • How to work with your sponsor for a profitable study

17:00 Panel Discussion – SWOT Analysis • Strength, Weakness, Opportunities & Threats of the clinical trials in the India & South Asia. (An overall analysis of this three day event) Moderator: Arani Chatterjee, Vice President, Clinical Research Panacea Biotec Panelists: Krathish Bopanna, Senior Vice President, Acunova

17:40 Chairperson’s closing remarks and end of conference

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Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024

There is great demand for lower-cost biological drugs: commercial and regulatory developments will make biosimilars and follow-on biologics a success – our new report explains how.

Revenues for biologic drugs reached approximately $125bn in 2008. Patents on most current biologics have expired or will expire during the period 2009 to 2024. In addition, there is mounting pressure from governments, insurers and patients’ groups to reduce costs of pharmaceuticals. Biologic drugs – noted as some of the most-expensive medicines – are major targets for cost savings. The developments facilitating follow-on biologics are gaining momentum, with significant commercial opportunities emerging – as our new report explains.

Recently Merck & Co. established a new biosimilar (follow-on biologic or biogeneric) development division; other major pharmaceutical companies plan to follow suit. In March 2009, three new bills on follow-on biologic legislation were introduced to the US Congress. Biosimilars are entering an important period of development. Is your company prepared for the opportunities and threats this will create? The new visiongain report – Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024 – provides you with essential information to understand this rapidly-emerging market.

This report predicts how the biosimilar market will evolve from 2009 to 2024. We indentify and discuss the biosimilar drugs and manufacturers that will achieve commercial success during the coming fifteen years. Biologic drug classes covered in this report include:

· Growth hormones · Insulin · Erythropoietin · Colony stimulating factors and interleukin-2 drugs · Interferons · Monoclonal antibodies · Fusion proteins.

The biosimilar prospects for each class are examined, biosimilar targets identified and market forecasts to 2024 provided, with extensive supporting information.

Comprehensive analysis of the global market Using a wealth of research – including detailed sales forecasting, interviews with key opinion leaders and examination of policy documents, reports, industry news, filings and commercial databases – our new study forecasts how the biosimilar market will progress from 2009 to 2024.

Why you should buy Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024 By obtaining your copy of this report, you will benefit from:

· Forecasts for the world biosimilar market, leading biosimilar drug types and leading national markets · Identification of biologic drugs with potential for commercial biosimilar development · Original interviews with biosimilar industry experts, who discuss the present and future of the sector · Examination of the driving forces, restraints, competition and opportunities facing commercial stakeholders in the biologic and biosimilar sectors · Analysis of biosimilar legislation and regulatory guidance in the US, Europe and Japan – with current and emerging trends discussed · Analysis of the biosimilar pipeline – find out what and who will be the leading biosimilar players over the next fifteen years · Prediction of where the market is heading – both technologically and commercially – from the present onwards.

The complexity of biologic drugs has retarded development of regulatory frameworks for approval of biosimilars in many countries. The EU was the first major regulatory authority to adopt a procedure allowing regulatory approval of biosimilar medicines. The US awaits a similar legal and regulatory framework. Currently, the FDA can only approve a restricted number of simpler ‘follow-on protein products’. Approval of more-complex biosimilars will necessitate a formal legal and regulatory pathway in the US. Visiongain believes that the US Congress will approve a biosimilar bill within a few years. In this report, we predict the emergence of biosimilar products in the US, in addition to developments in other major markets during the years ahead.

You can order this report today Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024 is essential reading for everybody involved with the biologics and biosimilar sectors. This report reveals prospects for both existing competitors and potential market entrants. Do you want to know more about this important market? You can stay ahead in this exciting field by ordering this report today.

• PRICING –

Individual report pricing – single user copies of this report are available for only GBP1499

          Departmental  copies (this entitles up to 5 individual users in your department) of this  report are available for only GBP2999. This is not suitable for library usage. 

Allow your whole company to have access to this information for only GBP4999. Company-wide License allows your whole company access and intranet use on CD Rom and .pdf. Suitable for library storage and use.

Does your company have over 2,500 employees? Have the whole company access this information for a special rate of only GBP6999 -ORDERING-

Ordering is simple! All you need to do to order this report is contact Suvitha.You can either call me on TEL: +44 (0)207 549 9946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

        Table of  contents

1 Executive Summary 2 Introduction to Biosimilars 2.1 Biotechnology and Biologic Drugs 2.2 Type of Biologic Drug 2.3 Biosimilars, Biogenerics and ‘Follow-On Protein Products’

3 The World Biosimilar Market, 2009-2024 3.1 World Biologic Drug Market 3.1.1 Leading Biologic Drug Types 3.1.2 Blockbuster Biologics 3.2 The Biosimilar Market in 2008 3.3 World Biosimilar Market Forecast, 2009-2024 3.3.1 Biologics Will Continue to Outperform ‘Small-Molecules’ 3.3.2 Biosimilar Market Takes Off: World Market Forecast, 2009-2014 3.3.3 World Biosimilar Market Forecast, 2014-2024 3.4 Growth Hormones 3.4.1 The Branded Growth Hormone Market, 2008 3.4.2 The Biosimilar Growth Hormone Market, 2008 3.4.3 Omnitrope (Sandoz) 3.4.4 Eutropin/Valtropin (LG Life Sciences/BioPartners) 3.4.5 Growth Hormone Market Outlook, 2009-2024 3.4.6 Branded Growth Hormone Market Forecast, 2009-2024 3.4.7 Biosimilar Growth Hormone Market Forecast, 2009-2014 3.4.8 What are the Prospects for Biosimilar Growth Hormones from 2014-2024? 3.5 Insulin 3.5.1 The Branded Insulin Market, 2008 3.5.2 The Biosimilar Insulin Market, 2008 3.5.3 Gensulin/SciLin (Bioton/SciGen) 3.5.4 Insugen (Biocon) 3.5.5 Rising Diabetes Prevalence Will Drive Insulin Market from 2009-2024 3.5.6 Branded Insulin Market Forecast, 2009-2024 3.5.7 Rapid Biosimilar Insulin Growth, 2009-2014 3.5.8 Biosimilar Insulin Market Forecast, 2014-2024 3.6 Erythropoietin 3.6.1 The Branded Erythropoietin Market, 2008 3.6.2 The Biosimilar Erythropoietin Market, 2008 3.6.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice) 3.6.4 Epiao (3SBio) 3.6.5 Silapo/Retacrit (Stada/Hospira) 3.6.6 The Erythropoietin Market 2009-2024: Branded Drugs Facing Increasing Biosimilar Competition 3.6.7 Biosimilar Erythropoietin Market Forecast, 2009-2014 3.6.8 A Favourable Outlook for Biosimilar Erythropoietin from 2014-2024 3.7 Colony Stimulating Factors (CSF) and Interleukin-2 (IL-2) 3.7.1 The Branded CSF and IL-2 Drug Market, 2008 3.7.2 The Biosimilar CSF and IL-2 Drug Market, 2008 3.7.3 The CSF and IL-2 Drug Market, 2009-2024: Prospects for Biosimilar Entry 3.7.4 Biosimilar CSF and IL-2 Drugs Market Forecast, 2009-2014 3.7.5 Biosimilar CSF and IL-2 Drugs Market Forecast, 2014-2024 3.8 Interferons 3.8.1 The Branded Interferon Market, 2008 3.8.2 The Biosimilar Interferon Market, 2008 3.8.3 Interferon Market Outlook, 2009-2024 3.8.4 Biosimilar Interferon Market Forecast, 2009-2014 3.8.5 Biosimilar Interferon Market Forecast, 2014-2024 3.9 Monoclonal Antibodies and Anti-Inflammatory Fusion Proteins (AIFPs) 3.9.1 The Monoclonal Antibodies + AIFP Market, 2008 3.9.2 Reditux (Dr. Reddy’s): The World’s First Biosimilar Monoclonal Antibody 3.9.3 Monoclonal Antibodies + AIFP Market: Further Growth during 2009-2024 3.9.4 Biosimilar Monoclonal Antibodies + AIFPs, 2009-2014 3.9.5 Biosimilar Monoclonal Antibodies Come into Play 3.9.6 Biosimilar Monoclonal Antibodies + AIFPs, 2019-2024

4 Issues Affecting the Biosimilars Industry 4.1 SWOT Analysis for the Biosimilar Industry 4.2 Biological Medicines Are Expensive 4.3 Many Biological Drugs have Expired or Soon-to-Expire Patents 4.4 Challenges in Developing Biosimilar Drugs 4.4.1 Biosimilars Not Developed with Ease of Traditional Generics 4.4.2 Biologics are Large Complex Molecules 4.4.3 Complex Manufacturing Process 4.4.4 Biologic Drugs are Heterogeneous 4.4.5 Biologic Drugs Difficult to Characterise & Slight Differences Have Important Clinical Consequences 4.4.6 Biologic Drugs Have Potential for Immunogenicity 4.5 Development of Regulations for the Approval of Biosimilars 4.5.1 Key Issues for Development of Biosimilar Regulations 4.5.2 Requirements for Clinical Trials 4.5.3 Debate over Clinical Trial Requirements in the US 4.5.4 Data Exclusivity Period 4.5.5 Biosimilar Substitution 4.5.6 International Non-Proprietary Names (INNs) 4.6 European Biosimilar Guidelines 4.6.1 EMEA Guidelines for Biosimilar Medicines 4.6.2 Testing Requirements 4.6.3 Clinical Testing For Multiple Indications 4.6.4 Data Exclusivity for Biologic Drugs in the EU 4.6.5 Naming of Biosimilars in the EU 4.6.6 Biosimilar Substitution Not Allowed in the EU 4.6.7 Future Development of EMEA Guidelines 4.7 Progress Towards Development of ‘Follow-On Protein Products’ Regulatory Pathway in the US 4.7.1 Lack of Biosimilar Regulatory Pathway in the US Restricts Market 4.7.2 Major Issues Affecting ‘Follow-on Protein Products’ Legislation in the US 4.7.3 When Will a Biosimilar Pathway be Created in the US? 4.8 Expert Opinion from Dr Suzanne Sensabaugh: Progress on Follow-On Protein Product Legislation in the US 4.8.1 Timescale of ‘Follow-On Protein Product’ Legislation 4.8.2 The Most Important Factor Delaying Follow-on Protein Product Legislation 4.8.3 Prospects for Asian Biosimilars Manufacturers 4.8.4 Prospects for Biosimilar Monoclonal Antibodies in the US 4.9 Economics of Biosimilar Development and Marketing 4.9.1 Development of Biosimilars More Expensive than Ordinary Generics 4.9.2 Biosimilars Will Face Competition from Newer Branded Biologic Drugs 4.9.3 Biosimilars Will Not Enjoy the Same Price Discounts as Traditional Generics 4.9.4 Opportunities for CROs and CMOs

5 Regional Biosimilar Markets 5.1 Leading Biologic Drug Country Markets, 2008 5.2 Asia Dominates the World Biosimilar Market 5.3 Regional Biosimilar Market Forecast, 2009-2024 5.4 The EU Biosimilar Market 5.4.1 Regulation of Generic Pharmaceuticals in the EU 5.4.2 Regulation of Biosimilars in the EU 5.4.3 Biosimilar Approvals by the EMEA, 2006-2009 5.4.4 European Biosimilar Market Forecast, 2009-2024 5.5 The US Biosimilar Market 5.5.1 Regulation of Biopharmaceuticals in the US 5.5.2 No Regulatory Pathway for Biosimilars in the US 5.5.3 FDA Has Already Approved a Number of ‘Follow-On Protein Products’ 5.5.4 More-Complex Follow-On Protein Products Must Bide Their Time 5.5.5 US Biosimilar Market Forecast, 2009-2024 5.6 The Japanese Biosimilar Market

6 The Biosimilars Pipeline 6.1 The Competitive Landscape of the Biosimilar Pipeline 6.1.1 Who Will Become Major Biosimilar Players? 6.1.2 Prospects for Biosimilar Monoclonal Antibodies 6.2 Biocon 6.3 Bioton/SciGen/BioPartners 6.3.1 Gensulin/SciLin (Bioton/SciGen) 6.3.2 Eutropin/Valtropin (LG Life Sciences/BioPartners) 6.3.3 Alpheon (BioPartners) 6.3.4 Biferonex (BioPartners) 6.4 CinnaGen 6.5 Cipla and Avesthagen 6.6 Dr. Reddy’s Laboratories 6.7 GTC Biotherapeutics and LFB Biotechnologies 6.8 Hospira 6.9 Intas and Apotex 6.10 Merck & Co. 6.10.1 Merck BioVentures 6.10.2 Merck & Co.’s Glyco-Engineering Technology 6.10.3 Insmed’s Biosimilars Acquired by Merck BioVentures 6.11 Ranbaxy/Zenotech 6.12 Sandoz 6.12.1 Sandoz Has Pioneered Biosimilars in Europe 6.12.2 Momenta and Sandoz Collaboration to Develop M-Enoxaparin and Other Biosimilars 6.13 Shantha Biotechnics 6.14 Stada 6.15 Teva 6.15.1 Teva is a Biosimilar Early-Adopter 6.15.2 Teva’s Joint Venture with Lonza 6.15.3 Teva’s Recent Acquisitions 6.16 Wockhardt 6.17 Interview with Dr. Rustom Mody, Director (Strategic Research & Quality), Intas Biopharmaceuticals: The Intas Biosimilars Pipeline and Prospects for Indian Companies in the Biosimilar Market 6.17.1 Intas’ Biosimilar Strategy 6.17.2 Intas’ Biosimilar Pipeline 6.17.3 Intas and Biosimilar Monoclonal Antibodies 6.17.4 Prospects for Indian CROs in Biosimilar R&D

7 Conclusions 7.1 Unmet Need for Cheaper Biologic Drugs 7.2 Biosimilars Are Not Generics 7.3 The World Biosimilar Market in 2008 7.4 Issues Slowing Down Adoption of Biosimilars 7.5 World Biosimilar Market Forecast, 2009-2024 7.6 Who Will Become Major Biosimilar Players?

List of Tables Table 2.1 Biologic Drug Types Table 3.1 Leading Biologic Drug Types, 2008 Table 3.2 Blockbuster Biologics Table 3.3 Leading Biosimilar Drug Types, 2008 Table 3.4 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024 Table 3.5 World Biosimilar Market Forecast, 2009-2014 Table 3.6 World Biosimilar Market Forecast, 2015-2024 Table 3.7 Biosimilar Drug Type Market Forecast, 2009-2024 Table 3.8 The Growth Hormone Market, 2008 Table 3.9 Biosimilar & Branded Growth Hormones: Market Shares & CAGR, 2009-2024 Table 3.10 Biosimilar Growth Hormones Forecast, 2009-2014 Table 3.11 Biosimilar Growth Hormones Forecast, 2015-2024 Table 3.12 Leading Insulin Brands, 2008 Table 3.13 The Insulin Market, 2008 Table 3.14 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024 Table 3.15 Biosimilar Insulin Forecast, 2009-2014 Table 3.16 Biosimilar Insulin Forecast, 2015-2024 Table 3.17 The Erythropoietin Market, 2008 Table 3.18 Biosimilar and Branded Erythropoietin: Market Shares and CAGR, 2009-2024 Table 3.19 Biosimilar Erythropoietin Forecast, 2009-2014 Table 3.20 Biosimilar Erythropoietin Forecast, 2015-2024 Table 3.21 The CSF and IL-2 Drug Market, 2008 Table 3.22 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024 Table 3.23 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2014 Table 3.24 Biosimilar CSF and IL-2 Drugs Forecast, 2015-2024 Table 3.25 The Interferon Market, 2008 Table 3.26 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024 Table 3.27 Biosimilar Interferons Forecast, 2009-2014 Table 3.28 Biosimilar Interferons Forecast, 2015-2024 Table 3.29 The Monoclonal Antibodies + AIFP Market, 2008 Table 3.30 Leading Monoclonal Antibody Brands Table 3.31 The Monoclonal Antibodies Market, 2008 Table 3.32 The Anti-Inflammatory Fusion Protein (AIFP) Market, 2008 Table 3.33 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024 Table 3.34 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2014 Table 3.35 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2015-2024 Table 4.1 SWOT Chart for the Biosimilar Market, 2009-2024 Table 4.2 Expected Key-Patent Expiry Dates for Leading Biologic Drugs, 2009-2019 Table 5.1 Leading Biologic Drug Country Markets, 2008 Table 5.2 Biosimilar Regional Markets, 2008 Table 5.3 Regional Biosimilar Market Forecasts, 2009-2014 Table 5.4 Regional Biosimilar Market Forecast, 2015-2024 Table 5.5 Biosimilar Approvals by the EMEA, 2006-2009 Table 6.1 Example Pipeline Biosimilar Drugs 1 Table 6.2 Example Pipeline Biosimilar Drugs 2

List of Figures Figure 3.1 Biologic Drug Type Market Share, 2008 Figure 3.2 Biosimilar Drug Type Market Share, 2008 Figure 3.3 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024 Figure 3.4 World Biosimilar Market Forecast, 2009-2024 Figure 3.5 Biosimilar Drug Type Market Share, 2014 Figure 3.6 Biosimilar Drug Type Market Share, 2019 Figure 3.7 Biosimilar Drug Type Market Share, 2024 Figure 3.8 Leading Growth Hormone Brands, 2008 Figure 3.9 Biosimilar and Branded Growth Hormones: Forecasts and Market Shares, 2009-2024 Figure 3.10 Biosimilar Growth Hormones Forecast, 2009-2024 Figure 3.11 Leading Insulin Brands, 2008 Figure 3.12 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024 Figure 3.13 Biosimilar Insulin Forecast, 2009-2024 Figure 3.14 Leading Erythropoietin Brands, 2008 Figure 3.15 Biosimilar and Branded Erythropoietin: Market Shares & CAGR, 2009-2024 Figure 3.16 Biosimilar Erythropoietin Forecast, 2009-2024 Figure 3.17 Leading CSF and IL-2 Brands, 2008 Figure 3.18 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024 Figure 3.19 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2024 Figure 3.20 Leading Interferon Brands, 2008 Figure 3.21 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024 Figure 3.22 Biosimilar Interferons Forecast, 2009-2024 Figure 3.23 Leading Monoclonal Antibodies + AIFP Brands, 2008 Figure 3.24 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024 Figure 3.25 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2024 Figure 5.1 Leading Biologic Drug Country Markets, 2008 Figure 5.2 Biosimilar Regional Markets, 2008 Figure 5.3 Regional Biosimilar Market Forecast, 2009-2024 Figure 5.4 European Biosimilar Market Forecast, 2009-2024 Figure 5.5 US Biosimilar Market Forecast, 2009-2024 Figure 7.1 World Biosimilar Market Forecast, 2009-2024

Organisations Mentioned in this Report 3SBio Abbott Abraxis BioScience Alexion Amgen Amphastar Apotex AstraZeneca Avesthagen AxiCorp Barr Bayer Beijing Shuanglu Biocon Biogen Idec BioPartners Biotechnology Industry Organization (BIO) Bioton Bristol-Myers Squibb CCL Pharmaceuticals CinnaGen Cipla CJ Corporation CoGenesys CSL CT Arzneimittel Daiichi Sankyo Dong-A Dr. Reddy’s Eden Biodesign Elan Eli Lilly European Medicines Agency (EMEA) Feron Food and Drug Administration (FDA) [US] Fraunhofer Institute Genentech Generic Pharmaceutical Association (GPhA) GeneScience Getz Pharma GlaxoSmithKline (GSK) GlycoFi GTC Biotherapeutics Halozyme Therapeutics Hexal Hospira Hualida Biotech Human Genome Sciences Insmed Intas Ipsen Johnson & Johnson Kissei Kyowa Hakko Kirin LFB Biotechnologies LG Life Sciences Lonza Medice Merck & Co. Merck KGaA Mérieux Alliance Ministry of Health, Labour and Welfare (MHLW) [Japan] Mitsubishi Tanabe Momenta National Institute for Health and Clinical Excellence (NICE) Novartis Novo Nordisk Pfizer PrimaPharm Qilu Ranbaxy Ratiopharm Roche Sandoz Sanofi-Aventis Schering-Plough SciGen Shantha Biotechnics Siegfried Biologics Stada Teva Therapeutic Goods Administration (TGA) [Australia] Tonghua Dongbao Upsher-Smith Wockhardt World Health Organization (WHO) Wyeth Zenotech

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World Gastrointestinal Disorders Market 2008-2023

The gastrointestinal (GI) disorders market has been one of the largest and most profitable therapeutic areas in the world pharmaceutical industry. With a reported $49.9bn in revenues in 2007, the GI disorders market competes consistently with cardiovascular diseases and oncology for the top 3 therapeutic areas in terms of market value. In 2007, this sector contributed seven blockbuster drugs, four of which ranked among the top 20 highest revenue generating prescription drugs in the world. However. the market is now mature, with well-established treatments now nearing the end of their patent life. So can you and your company continue to benefit from this market? Are you in a position to capture new profitable shares of the market?

There are new developments, with leading products achieving high blockbuster revenues. A number of these, including the third most lucrative drug label in the world, Nexium, are due to lose their patent protection within the next 5-8 years. The emergence of biologics for IBD treatments has slowed the decline of this market considerably, with high value products for this difficult-to-treat condition. Such products have facilitated a continuing rise in sales for the GI market. But how long can the biologics stabilise a market that is experiencing decline in sales of major products, especially due to generic competition? This informative, fully independent report will tell you. And tell you today!!

The purpose of this market report – World Gastrointestinal Disorders Market 2008-2023 – is to examine the prospects of the GI market. This report includes sales forecasts for leading products and submarkets, in addition to the overall GI market. The GI disorders market is one of the largest and most important in the pharmaceutical industry. Furthermore, the treatment of GI disorders has a high profile, both among the general population and in organised healthcare. Importantly, the GI market has recently entered a crucial phase, with mounting commercial pressures affecting revenue generation and causing market participants to reconsider strategies. This report outlines how leading companies are responding to the opportunities, threats and uncertainty.

World Gastrointestinal Disorders Market 2008-2023 examines the GI market critically through detailed analysis of market leaders and new developments, interviews and questionaires with industry players, plus commercial databases, company reports and business/industry news. Visiongain applied unique in-house techniques for financial forecasting, plus SWOT analysis and the assessment of unmet needs to provide a comprehensive market report with detailed analyses and informed opinion. In particular, this report concentrates on the following essential aspects of the GI market:

·The current state of the world market for drugs to treat gastrointestinal disorders ·Drivers and restraints ·Opportunities and threats ·Key industrial players in the GI market ·Revenue trends in the world gastrointestinal market between 2008-2023, including principal submarkets ·Prospects for leading GI drugs between 2008-2023 ·A comprehensive discussion of patent expiry and generic substitution and their commercial implications ·Analyses of the principal national markets for GI pharmaceuticals ·Discussion of leading pipeline products and line extensions.

Why you should buy this report:

-To receive a comprehensive analysis of the prospects for the world gastrointestinal disorders market from 2008-2023, including sales forecasts, major growth areas and most talked-about pipeline products -To discover predicted revenues, growth rates and other key metrics in the world gastrointestinal disorders market from 2008-2023, especially for leading brands -To determine the forces that influence the gastrointestinal disorders market -Drivers and restraints on market -Competition -Strengths, weaknesses, opportunities and threats. -To find out where the world gastrointestinal disorders market is heading from 2008 onwards, both technologically and commercially.

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        Table of  contents

1 Executive Summary

2 Introduction to Gastrointestinal Disorders 2.1 Gastrointestinal Disorders Constitute a Large Market for Pharmacological Treatments 2.1.1 Gastrointestinal Disorders have a Significant Economic Impact on Society 2.1.2 The Market for Gastrointestinal Drugs Generates Large Revenues and is Well Represented in the Top 20 Best Selling Prescription Drugs 2.2 Gastroesophageal Reflux Diseases 2.2.1 What is Gastroesophageal Reflux Disease (GERD)? 2.2.2 Aetiology of GERD 2.2.3 Symptoms of the Condition 2.2.4 Diagnosis of GERD 2.2.5 Prevalence of GERD 2.2.6 Economic Impact of GERD 2.2.7 Treatment of GERD 2.3 Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis) 2.3.1 What is Crohn’s Disease? 2.3.2 Aetiology of Crohn’s Disease 2.3.3 Symptoms of Crohn’s Disease 2.3.4 Diagnosis of the Condition 2.3.5 What is Ulcerative Colitis? 2.3.6 Aetiology of Ulcerative Colitis 2.3.7 Symptoms of Ulcerative Colitis 2.3.8 Diagnosis of Ulcerative Colitis 2.3.9 Worldwide Prevalence of Inflammatory Bowel Disease – Crohn’s Disease is Becoming Increasingly Prevalent Throughout the World 2.3.10 Economic Burden of Inflammatory Bowel Disease 2.3.11 Treatment of Inflammatory Bowel Disease 2.4 Irritable Bowel Syndrome 2.4.1 Overview of Irritable Bowel Syndrome 2.4.2 Aetiology of Irritable Bowel Syndrome 2.4.3 Symptoms of Irritable Bowel Syndrome 2.4.4 Diagnosis of Irritable Bowel Syndrome 2.4.5 Prevalence of Irritable Bowel Syndrome 2.4.6 The Cost of Irritable Bowel Syndrome 2.4.7 Treatment of Irritable Bowel Syndrome 2.5 Peptic Ulcer Disease 2.5.1 What is Peptic Ulcer Disease? 2.5.2 Aetiology of Peptic Ulcer Disease 2.5.3 Symptoms of the Condition 2.5.4 Diagnosis of Gastric Ulcers 2.5.5 Helicobacter Pylori: Often the Putative Causative Agent of Ulcers 2.5.6 Zollinger-Ellison Syndrome – A Rare Disorder that Can Be Treated by Acid Suppressing Drugs 2.5.7 Demographic Prevalence of Peptic Ulcers 2.5.8 Economic Impact of Peptic Ulcers 2.6 An Overview of the Gastrointestinal Drug Market 2.7 Proton Pump Inhibitors Currently Leading the Gastrointestinal Market

3 The World Gastrointestinal Market, 2008-2023 3.1 How Will Shifting Internal Dynamics Affect the World Gastrointestinal Market from 2008 to 2023? 3.2 Biologics Help Steady the Market – A Great Hope for the Future 3.3 Gastrointestinal Drugs among Some of the Most Lucrative in the Market in 2007 3.4 AstraZeneca 3.4.1 AstraZeneca and Prilosec’s Patent Expiry 3.4.2 AstraZeneca Faces Growing Biologics Market in GI Disorders 3.4.3 Collaborations in the Gastrointestinal Market 3.5 Will Biologics Overtake Proton Pump Inhibitors as the Leading Drug Class in the Gastrointestinal Market by 2013? 3.6 How Market for Biologics Therapies will Develop from 2008 to 2023 3.7 OTC Switching Creates Good Opportunities for Life Cycle Management – But at what Cost to Prescription Drug Revenues? 3.7.1 Effects of OTC Switching in GI Market 3.7.2 OTC Switching as a Strategy to Extend Brand Revenues and Profitability 3.8 The GI Market is Likely to Remain Strong in Terms of Prescription Numbers and Unit Sales – But Will Generics Continue to Threaten Significantly?

4 The World Market for Proton Pump Inhibitors, 2008-2023 4.1 The Proton Pump Inhibitors – A Strong Market under Increasing Threat from Patent Expiry and OTC Switching 4.2 Will PPIs Lose Dominance in the GI Market by 2013? 4.3 Loss of Patent Protection and Revenue Generation in the PPI Market 4.3.1 OTC Prilosec and Generics will Play Decisive Roles in the Dynamics of the GI Market 4.3.2 Reference-Based Pricing will Impose Additional Constraints on the PPI Market 4.4 Market Shares of the Leading GI Drugs – 2007 and 2013 Compared 4.5 Nexium will Face Declining Revenues and Loss of Predominance in the World Gastrointestinal Market 4.5.1 Brand Management is Succeeding for AstraZeneca – Will Competitors be able to Emulate this Winning Strategy? 4.5.2 Nexium Dropped from Reimbursement by Leading Health Insurer 4.5.3 AstraZeneca Reaches Deal with Ranbaxy Laboratories, but Continues to Battle Challenges to Nexium’s Patents 4.5.4 AstraZeneca Sets Aggressive Brand Extension for Nexium 4.6 Prevacid – Accelerated Decline Awaits this Major Brand 4.6.1 Prevacid is Attractive to Generic Companies 4.6.2 TAP Joint Venture Comes to an End 4.7 Protonix/Pantazol is Another Leading PPI in Decline – How Will it Fare? 4.7.1 Protonix Sales and Premature Generic Penetration 4.8 Pariet/Aciphex and Competition in the Market 4.8.1 Will Gains in the Asian GI Market be Enough to Offset Sales Maturation and Declines in Other Regions? 4.9 Prilosec/Losec – AstraZeneca Uses Product Lifecycle Management Decisively 4.9.1 Losec Maintains Blockbuster Status despite Expanding Generic Sales 4.9.2 Losec Shows Marked Growth in Japan and China

5 The World Market for Biologics Indicated for Gastrointestinal Disorders, 2008-2023 5.1 Biologics – A Thriving Market with Significant Prospects within the Maturing Gastrointestinal Space 5.2 Biologics’ Growth Will Outpace Other Classes in the Declining Overall Gastrointestinal Market 5.2.1 Biologics Enjoy Key Advantages over Other Drug Classes 5.3 Remicade and Humira Paving the Way for the High Profile of Biologics in the Gastrointestinal Market, With Significant Commercial Gains to be Made 5.4 Will Remicade Continue to Hold its Ground Despite Intense Competition from Second-Generation Therapies? 5.4.1 Remicade is the Current Leading Biologic, but how will it Fare in the Future?
5.5 Humira – High-Paced Growth? 5.5.1 Will Humira Supplant Nexium to Become the Leading Drug in the Gastrointestinal Market? 5.6 Biologics Do Not Face Biogeneric/Biosimilar Competition for the Time Being 5.7 Potential for Biologics is Enormous but Cost Containment Strategies will be an Underlying Restraint 5.7.1 Big and Expensive: Development Costs Limit Growth 5.8 High Profile Safety Cases Increase Regulatory Concerns

6 The World Market for Histamine H2 Receptor Antagonists and Mesalazines, 2008-2023 6.1 Histamine H2 Antagonists – This Older Class Will Suffer Declining Revenues from 2008-2023 6.2 The H2 Antagonists are Now a Mature Drug Class Characterised by the Loss of Patent and Availability of Generic Substitutes 6.2.1 Both Gaster and Zantac are Available in OTC Formulations 6.3 The Histamine H2-Antagonists Market will Remain Fragmented 6.4 Will Gaster Undergo the Least Decline in the H2-Antagnoists Group? 6.4.1 Further Decline Predicted for Gaster 6.5 Zantac Expected to Plunge Further 6.5.1 Zantac has Shown Market Sustainability, but will this Situation Last? 6.6 Mesalazines Have Dominated the Market for Inflammatory Bowel Disease Treatments, but for How Much Longer Can they Lead? 6.6.1 Can Mesalazines Seize Opportunity before Biologics Grow to Full Potential? 6.7 Mesalazine Products Struggling to Remain Competitive in the GI Market 6.8 Will Asacol Remain the Mesalazine of Choice? 6.9 Pentasa – Steady Growth Leads to Maturity

7 Factors that Influence the Prescription Gastrointestinal Market 7.1 SWOT Analysis of the Prescription GI Market 7.2 Shifting Dynamics in the GI Market Create Opportunities, Especially in Product Lifecycle Management and Generics 7.3 GERD Symptoms are Very Common – There are Opportunities for Expanding the Treatment Population 7.4 An Ageing Population will Drive the GI Market, Especially in Self Medication 7.5 Prilosec/Losec OTC has been Influential in the GI Market 7.6 What Unmet Needs Exist in the Gastrointestinal Market? What Potential Solutions? 7.6.1 How Effective are PPIs and H2 Antagonists? 7.6.2 Agents that may Improve Treatment of IBS, Crohn’s Disease and Ulcerative Colitis 7.7 Major Loss of Patent Protection will Constitute the Principal Restraint in the GI Market 7.8 Loss of Patent Protection will Lead to Increasing Generic Competition for Leading Drugs in the Market 7.9 Public and Private Health Insurers are Imposing Cost-Containment Strategies to Improve Cost-Effectiveness 7.9.1 Nexium Dropped from Reimbursement from Leading Health Insurer in the US – a Warning to Other Leading Brands 7.9.2 Reference-Based Pricing will Dissuade Uses of Highly-Priced Patented GI Drugs

8 Geographical Breakdown of the World Gastrointestinal Market 8.1 The Gastrointestinal Market in 2007: Geographical Analysis 8.2 Sales Forecast for the Leading Gastrointestinal Disorders Country Market, 2008-2023 8.3 The US Gastrointestinal Disorders Market, 2008-2023 8.4 The Gastrointestinal Disorders Market in Other Leading Developed Countries, 2008-2023 8.4.1 The Japanese Market 8.4.2 The French Market 8.4.3 The German Market 8.4.4 The Italian Market 8.4.5 The Canadian Market 8.4.6 The Spanish Market 8.4.7 The UK Market 8.5 The Gastrointestinal Disorders Market in Emerging Countries, 2008-2023 8.5.1 The Indian Market 8.5.2 The Chinese Market

9 Pipeline Drugs for Gastrointestinal Disorders 9.1 Overview of Emerging Drugs for Gastrointestinal Disorders 9.2 New Classes of Therapies are Being Investigated to Treat the Enigmatic Irritable Bowel Syndrome 9.2.1 Sucampo and Takeda’s Amitiza 9.2.2 AGI Therapeutics’ Rezular 9.2.3 Rottapharm’s Dexloxiglumide 9.2.4 Aryx Therapeutics’ ATI-7505 9.2.5 Dynogen Pharmaceuticals’ Pumosetrag 9.3 Pipeline Biologic Agents Aiming to Emulate and Extend the Initial Success of Existing Brands 9.3.1 UCB’s Cimzia 9.3.2 Elan’s Tysabri 9.3.3 Centocor/Schering-Plough’s Golimumab 9.3.4 Otsuka’s Tetomilast 9.3.5 Isis’ Alicaforsen 9.3.6 Bristol-Myers Squibb’s Orencia 9.3.7 Novartis’ Simulect 9.4 An Overall Assessment of Pipeline Developments in the Gastrointestinal Market

10 Conclusions: Gastrointestinal Disorders Constitute a Large Drugs Market that is Facing Decisive Commercial Pressures 10.1 Shifting Internal Dynamics Affecting the Prescription Gastrointestinal Market between 2008-2023 10.2 Biologics will Drive the Market 10.3 The World Gastrointestinal Market will be Affected by Cost-Containment Measures in Healthcare Budgets 10.4 Thinning Pipeline is a Major Cause of Concern 10.5 Continuing Public and Private Sector Investment is Required

List of Tables Table 2.1, Leading Gastrointestinal Drugs in 2007 Table 3.1, Leading Gastrointestinal Agents, Sales ($m) and Growth (%), 2007 Table 3.2, World Revenues ($m) for the Total Gastrointestinal Drugs Combined, 2007-2013, 2018, 2023 Table 3.3, Blockbuster Drugs in the World Gastrointestinal Market, 2007 Table 3.4, World Market Share (%) for Gastrointestinal Drugs by Company, 2007 Table 3.5, World Revenues ($m) for the Classes of Gastrointestinal Drugs, 2007-2013, 2018, 2023 Table 3.6, Blockbuster Drugs in the World Gastrointestinal Market, Revenues ($m), 2013 Table 3.7, Possible Future OTC Switching Table 4.1, World Leading Therapeutic Classes by Sales ($m), 2007 Table 4.2, World Revenues ($m) for Proton Pump Inhibitors, 2007-2013, 2018 and 2023 Table 4.3, Patent Expiry for Proton Pump Inhibitors, 2008 Table 4.4, World Revenues ($m) for Leading Proton Pump Inhibitors, 2007-2013, 2018, 2023 Table 4.5, World Market for Nexium, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 4.6, World Market for Prevacid, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 4.7, World Market for Prevacid, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 4.8, World Market for Pariet, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 4.9, World Market for Losec, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 5.1, World Market for Biologics Indicated for Gastrointestinal Disorders, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023 Table 5.2, World Revenues ($m) for Biologics Indicated for Gastrointestinal Disorders, 2008-2013, 2018, 2023 Table 5.3, World Market for Remicade, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023 Table 5.4, World Market for Humira, Sales ($m), Annual Growth Rate (%), CAGR (%), Market Share (%), 2008-2013, 2018, 2023 Table 6.1, World Revenue ($m) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023 Table 6.2, Patent Expiry for Histamine H2 Receptor Antagonists, 2008 Table 6.3, World Revenues ($m) for Leading Histamine H2-Antagonists, 2007-2013, 2018 and 2023 Table 6.4, World Market for Gaster, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 6.5, World Market for Zantac, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 6.6, World Revenue ($m) for Mesalazines, 2008-2013, 2018 and 2023 Table 6.7, World Revenues ($m) for Leading Mesalazines, 2007-2013, 2018 and 2023 Table 6.8, World Market for Asacol, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 6.9, World Market for Pentasa, Sales ($m), Annual Growth Rate (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 7.1, SWOT Chart for the Prescription Gastrointestinal Market, 2008-2023 Table 8.1, Leading Gastrointestinal Disorders Country Market, Sales ($m), 2007 Table 8.2, Gastrointestinal Disorders Sales for Leading Country Markets ($m), 2007-2013, 2018 and 2023 Table 9.1, Emerging Drugs for Gastrointestinal Disorders

List of Figures

Figure 3.1, World Revenues ($m) for the Total Gastrointestinal Drugs Combined, 2007-2013, 2018 and 2023 Figure 3.2, CAGRs (%) of the World Gastrointestinal Market Compared, 2007-2013, 2013-2018 and 2018-2023 Figure 3.3, CAGR (%) in World Revenues for the Classes of Gastrointestinal Drugs, 2007-2013 Figure 3.4, World Market Share (%) for Gastrointestinal Drugs by Company, 2008 Figure 3.5, World Revenues ($m) for the Classes of Gastrointestinal Drugs, 2007-2013, 2018 and 2023 Figure 3.6, World Market Share (%) for Gastrointestinal Drugs by Class, 2007 Figure 3.7, World Market Share (%) for Gastrointestinal Drugs by Class, 2013 Figure 3.8, World Market Share (%) for Gastrointestinal Drugs by Class, 2023 Figure 3.9, Sales of Blockbuster GI Drugs Compared, ($m), 2007-2013, 2018, 2023 Figure 4.1, World Revenues ($m) for Proton Pump Inhibitors, 2008-2023 Figure 4.2, CAGR (%) for the Proton Pump Inhibitors, 2007-2013, 2013-2018 and 2018-2023 Figure 4.3, Market Share (%) for Proton Pump Inhibitors in the World Gastrointestinal Market, 2007-2013, 2018 and 2023 Figure 4.4, World Revenues ($m) for Leading Proton Pump Inhibitors Drug, 2008-2023 Figure 4.5, World Revenues ($m) for the Proton Pump Inhibitors, 2007 and 2013 Compared Figure 4.6, World Market Share (%) for the Proton Pump Inhibitors, 2007 Figure 4.7, World Market Share (%) for the Proton Pump Inhibitors, 2013 Figure 4.8, World Nexium Revenues ($m), 2008-2023 Figure 4.9, World Prevacid Revenues ($m), 2008-2023 Figure 4.10, World Protonix Revenues ($m), 2008-2023 Figure 4.11, World Pariet Revenues ($m), 2008-2023 Figure 4.12, World Losec Revenues ($m), 2008-2023 Figure 5.1, World Market for Monoclonal Antibodies Indicated for Gastrointestinal Disorders, Sales ($m), 2008-2023 Figure 5.2, CAGRs (%) of the Gastrointestinal Market and the Biologics Drug Class – 2007-2013, 2013-2018, 2018-2023 Compared Figure 5.3, Market Share (%) of the Biologics Drug Class, 2007-2013, 2018 and 2023 Figure 5.4, World Revenue ($m) for the Classes of Gastrointestinal Drugs Compared, 2007, 2013, 2018 and 2023 Figure 5.5, Market Share of Leading Biologics – 2007, 2013, 2018 and 2013 Compared Figure 5.6, CAGRs of Leading Biologics – 2007-2013, 2013-2018, and 2018-2023 Compared Figure 5.7, World Revenues ($m) for Remicade, 2008-2023 Figure 5.8, World Revenues ($m) for Humira, 2008-2023 Figure 6.1, World Revenue ($m) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023 Figure 6.2, CAGR (%) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023 Figure 6.3, Market Share (%) of Histamine H2 Receptor Antagonists in the World Gastrointestinal Market, 2008-2013, 2018 and 2023 Figure 6.4, Market Revenues ($m) of Leading Histamine H2-Antagonists, 2007, 2013, 2018 and 2023 Figure 6.5, World Gaster Revenues ($m), 2008-2023 Figure 6.6, World Zantac Revenues ($m), 2008-2023 Figure 6.7, World Revenue ($m) for Mesalazines, 2008-2013, 2018 and 2023 Figure 6.8, CAGR (%) for Histamine H2 Receptor Antagonists, 2008-2013, 2018 and 2023 Figure 6.9, Market Share (%) of Mesalazines in the World Gastrointestinal Market, 2008-2013, 2018 and 2023 Figure 6.10, World Asacol Revenues ($m), 2008-2023 Figure 6.11, World Pentasa Revenues ($m), 2008-2023 Figure 8.1, Gastrointestinal Disorders Market Share by Leading Country (%), 2007 Figure 8.2, The US Gastrointestinal Disorders Market. Sales ($m), 2008-2023 Figure 8.3, The Gastrointestinal Disorders Market in Other Leading Developed Countries, Sales ($m), 2008-2023 Figure 8.4, The Gastrointestinal Disorders Market in India and China, Sales ($m), 2008-2023

Companies and Organisations Mentioned in this Report

Abbott Laboratories|Actavis|AGI Therapeutics|Alembic,Altana|American Gastroenterological Association (AGA),Apotex|Aryx Therapeutics|Astellas Pharma|AstraZeneca|Atlantic Healthcare|Barr Pharmaceuticals|Biogen Idec|Bristol-Myers Squibb|Centocor|Cerimon|Dr Reddy’s Laboratories|Dynogen Pharmaceuticals|Eisai|Elan Pharmaceuticals|Ferring|Genentech|GlaxoSmithKline|International Foundation for Bowel Dysfunction (IFBD)|Isis|Johnson & Johnson|Matrix|Merck & Co|Mylan|Novartis|Nycomed Pharma|Otsuka|Par Pharma|Proctor & Gamble|Ranbaxy Laboratories|Rottapharm|Sandoz|Sankyo|Schering-Plough|Sucampo|Sun|Takeda Pharmaceuticals|TAP Pharmaceuticals|Tegenero|Teva Pharmaceuticals|UCB|United Health|Wyeth|Zepharma

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Vaccine Manufacturing Global Innovation and opportunity for pharma and biotechs

11th – 12th May 2009, London, UK

Key Speakers: • Caterina Flyborg, Head, Vaccine Initiative, GE Healthcare Life Sciences • Crawford Brown, Chief Executive Offi cer, Eden Biodesign • Vito Maiorano, Director, Business Development, Baxter BioPharma Solutions • Steve Chatfi eld, Director for the Centre for Emergency Preparedness and Response, Health Protection Agency • David Venables, Site Director, Intercell Biomedical • Bo Kara, Director, Science and Technology, Avecia Biologics • Raf Lemmens, R&D Vaccine Program Leader, GE Healthcare Life Sciences • Daniel Galbraith, Head of Operations, BioOutsource • Bror Morein, Chairman of the Scientifi c Advisory Board, Iscanova • Raafat Fahim, President & Chief Executive Offi cer, Nabi Biopharmaceuticals • Catherine Mallalieu, Partner, D. Young & Co. • Sarah Gilbert, Reader in Vaccinology, Jenner Institute, University of Oxford • Stephen Taylor, Member of the Board, BioIndustry Association • Chris Davey, Senior Consultant, CEL International • Jan Hendriks, Account Manager International Support, Netherlands Vaccine Institute

Associate Sponsors: D Young & Co BIA Separations Isconova Marketing Sponsor: NanoSight Media Partners: PharmiWeb.com BIOTECHNOLOGY EUROPE Future Pharmaceuticals InPharm In-PharmaTechnologist.com Human Vaccines The Future Science Group

Vaccine development, supported by infusions of public and private venture capital, is re-entering a second golden age as one of the fastest growing sectors in the life-sciences industry. The global vaccines market, worth $25bn in 2009, is expected to sustain double-digit growth over the next 15 years, rising to over $100bn by 2024.

Over the past two centuries, immunisation programs have led to the control or elimination of several infectious diseases including smallpox, polio, measles, mumps and rubella. More recently, the past 30 years have seen significant changes both in the number of businesses involved in vaccine manufacture and the production systems used. These include fewer companies, higher costs, and a shift from egg-based to cell-based processes, to reduce allergenicity, optimise quality and increase output.

While more vaccines are now available than ever before, they have long presented special issues for producers, particularly regarding scale-up, affordability, and change of pace. Enduring challenges include ensuring good laboratory and manufacturing process, maintenance of product stability, and preparing a 100% safe and effective product. With time-to-market and flexibility increasingly important to improve cost-effectiveness, producers are becoming increasingly cognisant of the latest technologies to simplify development and manufacturing.

While the market remains dominated by a select group of key players, technology transfer is increasing between small biotech companies and big pharma. More significantly, with emerging markets set to dominate vaccine manufacturing by 2023, globalisation is being taken seriously as the quickest way to develop a product and increase market access. With current influenza vaccine production capacity vastly insufficient to meet the global demand in case of a pandemic, this threat has sparked a renewed interest at the global level in domestic or regional vaccine production in developing countries.

By attending this conference you will learn more about current and future trends in vaccine manufacture, namely: • Advances in cell-based manufacturing of influenza vaccines • Movement of production away from U.S. and Europe to Brazil, India and China, and the contract manufacturing of vaccines • Methods to speed up regulatory approval of new vaccine plants or new manufacturing processes and how to minimize delays • New vaccine technology, e.g. DNA vaccines. Are they easier to manufacture? • Planning for rapid manufacture of pandemic vaccines (‘bird-flu’, bio-emergency) • Development in process control, quality control and packaging in vaccines. • Case studies from international leaders in research and development.

-Pricing-

Standard Rate for 2 day conference- £1299 + VAT:£194.85 = Total:£1493.85

Academic & Health Care Organisations Rate for 2 day conference- £699 + VAT:£104.85 = Total:£803.85

If you would like to send more than 1 person then take advantage of the 3 for 2 offer. Send 3 people but only pay for 2. Excellent networking opportunities. Secure your delegate place today!!

• How to book –

Booking is simple! All you need to register is contact Suvitha. You can either call me on TEL:+44(0)2075499946 or email:suvitha.damodaran@visiongainglobal.com

Please feel free to contact me should you have any questions, I look forward to hearing from you.

Kind Regards,

Suvitha Damodaran Visiongain – Ltd.

Conference Agenda

Day 1, Monday, 11th May 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Vaccine manufacturing- strategies for the future • Vaccine market dynamics, a world in change • New approaches: development and deployment of innovative solutions in vaccine manufacturing • LEAN in manufacturing, maximizing the output of a facility • Vaccine manufacturing strategies, from a rigid approach to implementation of flexible technology • A vision for the future: distributed flexible manufacturing

Caterina Flyborg Head, Vaccine Initiative GE Healthcare Life Sciences

11:00 Practical Features of Monolith Chromatography for Flu Vaccine Manufacturing • Fast methods development to cGMP manufacturing scale • Process economic improvements with monolith technology • General application with virus and DNA based vaccine products

Aleš Štrancar Managing Director BIA Separations

11:30 Morning refreshments

11:50 Novel adjuvant and delivery system technologies • Third generation, low toxicity technologies • Increased safety and efficacy for demanding applications with long duration

Bror Morein Chairman of the Scientific Advisory Board, Iscanova Visiting Professor, Uppsala University

12:30 Bridging the gap in translational research • Upstream process development • Prospects for standard platform production processes • Case studies: adenoviral vaccine, suspension culture, whole cell microbial and recombinant protein methods

Crawford Brown Chief Executive Officer Eden Biodesign

13:10 Networking lunch

14:30 Fast track development of manufacturing processes for recombinant vaccine proteins produced using microbial systems • Rapid selection of an optimal expression system and early definition of the upstream production process • Exploiting pre-optimised platform approaches to purification to quickly define and establish the manufacturing process for bulk API • Reducing time-lines to move to clinical development

Bo Kara Director, Science and Technology Avecia Biologics

15:10 Batch testing for viral vaccine release in Europe and the USA • Critical issues with batch release of vaccines in development and licensed product • USA vs. Europe on the differences in vaccine safety • Risk assessments for the safety profiling of vaccines and testing

Daniel Galbraith Head of Operations BioOutsource

15:50 Afternoon refreshments

16:10 Collaborative vaccine partnering • Strategic alliances shaping the vaccine industry • Biotech and pharma approaches to strategic alliances • Case studies- what do partners want and need?

Rangappa Ramachandra Program Director and Lead Scientist, Immunology Covance

16:50 Outsourcing production and ensuring GMP and GLP

Vito Maiorano Director, Business Development Baxter BioPharma Solutions

17:30 Closing remarks from the chair

17:40 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting

Day 2, Tuesday, 12th May 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 The development of universal influenza vaccines • Current ‘flu vaccines target highly polymorphic antigens • Conserved antigens could be used to produce a universal ‘flu vaccine • Discussion of early clinical results

Sarah Gilbert Reader in Vaccinology Jenner Institute, University of Oxford

10:50 Developing MDCK cell-culture derived vaccines • Developing a cell-based platform for influenza vaccines • Drivers of immunogenicity and cross protection in animals • Clinical trial strategy and first data in humans- safety plus pre-clinical and manufacturing processes

Raafat Fahim President & Chief Executive Officer Nabi Biopharmaceuticals

11:30 Morning refreshments

11:50 The transition of a company and product from development to commercialisation • Defining the road-map from product development to market entry • Key business and process decisions to be made along the way • Identification and management of the transition in: – Process: from development to routine – People: changes in required experience and training – Systems: QA and QC oversight and control – Structure: Management responsibility

David Venables Site Director Intercell Biomedical

12:30 Site master planning and readiness – an integrated process for selecting the right option for capital investment and site development • Testing the business case for site development • Appraising non- financial and financial benefits • Practical examples of cost of goods modeling in assisting with investment decisions

Chris Davey Senior Consultant CEL International

Joanne Jacques Associate Director, Programme Management Medimmune

13:10 Networking lunch

14:30 Emergency preparedness and response: where the public sector can play a role in developing interventions such as vaccines

Steve Chatfield Director for the Centre for Emergency Preparedness and Response Health Protection Agency

15:10 Patentability and intellectual property ownership in a manufacturing context • Using intellectual property strategies to provide incentives for industry • IP & their impact on the cost and pricing of vaccines • Royalty fees and changes in international intellectual property laws

Catherine Mallalieu Partner D. Young & Co.

15:50 Afternoon refreshments

16:10 Influenza vaccine production capacity in developing countries • Growing importance of vaccine manufacturers in developing countries in ensuring access to vaccines • Initiatives to achieve a more equitable influenza vaccine manufacturing capacity at the global level • Supportive role of OECD-based vaccinology institutions in this process

Jan Hendriks Account Manager International Support Netherlands Vaccine Institute

16:50 BRICs- capabilities and advantages in a global market • The technological expansion and innovation of emerging suppliers in the international vaccine market • Movement of production away from U.S. and Europe to Brazil, India and China • How intellectual property protection affects access to vaccines in developing countries

17:30 Chair’s closing remarks

17:40 End of conference

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