World Generics Market, 2008-2013

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

Companies Listed

• 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
• Nicholas Piramal
• 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