The World Generics Market 2006-2011

Table of Contents

1. Executive Summary

• 1.1 Aims and Scope of the World Generics Market, 2006-2011

2. The World Pharmaceutical Market and the Rise of the Generic

• 2.1 Generic Drug Defined
• 2.2 The Generics Market is Price-driven
• 2.3 The Current Branded Pharmaceutical Business Model Is Not Working
• 2.4 R&D Spend Has Increased but the Number of NMEs Has Not
• 2.5 Leading Drugs are Facing Generic Competition
• 2.6 Increasing Government Preference for Generics
• 2.7 Bioequivalence Confirms Generic Status

3. Antidepressants - A Case Study in Generic Penetration

• 3.1 The World Antidepressant Market Will Crash by 2010
• 3.2 Generic Antidepressants Will Take Advantage of Increased Prevalence
• 3.3 Prozac - An Extreme Case of Patent Loss
  • 3.3.1 The Fate of Prozac
  • 3.3.2 The Generic Fluoxetine Market

4. The Hatch-Waxman Act and the US Generic Market

• 4.1 The Aims of the Hatch-Waxman Act
  • 4.1.1 Abbreviated New Drug Applications (ANDAs) Help Make Generics Cost-effective
  • 4.1.2 180-Day Exclusivity Period Encourages Aggressive Pharma Tactics
  • 4.1.3 First to Market Under 180-day Rule Guarantees High Revenues
  • 4.1.4 Manufacturers are Protected by Patent Extensions and the 30-month Stay
• 4.2 Changes to the Generic Application Process by the FDA
• 4.3 Out-of-court Settlements - Are they Anti-competitive?
• 4.4 The US Generics Legislation is Successful but Must Continue to Change

5. Regulations within the EU

• 5.1 Patents and SPCs
• 5.2 The Period of Market Exclusivity Varies from Country to Country
• 5.3 The 8+2+1 Rule - Moving Towards Standardisation
• 5.4 Is the EU 'Bolar' Provision Sufficient?

6. The WHO TRIPS Agreement and How Compulsory Licensing Affects the Generics Market

• 6.1 Changes to Patent Laws Provide Stability
• 6.2 Compulsory Licensing in the US and Other Countries
• 6.3 Regional Variations in Compulsory Licensing Practices
• 6.4 Compulsory Licensing and its Effect on the Generic Industry

7. The World Generics Market

• 7.1 The World Generics Market Will Maintain High Growth in the Period 2005-2011
• 7.2 Loss of Major Patents Will Drive the Generic Market Over The Next Five Years at the Expense of the Branded Market
• 7.3 Price is the Principal Competing Factor in the Generics Market
• 7.4 Countries with the Lowest Branded Drug Prices have the Highest Generic Growth
• 7.5 Governments are Increasingly Turning to Generics as a Way to Drive Down Healthcare Costs
• 7.6 The US Dominates the World Generics Market
• 7.7 The French Generics Market Will Increase its Global Market Share
• 7.8 Governments Can Influence Generic Markets Through their Influence on Branded Drug Prices
• 7.9 Competition Drives Down Prices and Restricts Growth
• 7.10 The Generic Pharmaceutical Market Varies Widely in Both Volume and Value
• 7.11 Generic Drugs Will Become Important in All Major Markets
  • 7.11.1 Generic CNS and Cholesterol Medicines Will Lead the Generic Market
  • 7.11.2 Other Key Therapeutic Areas Will Face Strong Generic Competition

8. Drivers and Restraints in the Generics Market

• 8.1 SWOT Analysis
• 8.2 Low Price and High Volume are the Key Drivers of the Generics Market
• 8.3 Soaring Healthcare Costs are Leading to High Demand for Generics
• 8.4 A High Volume of Blockbuster Drugs are Now Available
• 8.5 Generics Companies are Now Highly Efficient
• 8.6 Large Generics Companies Now Have the Capability to Provide Innovative Products
• 8.7 The Lack of Competition from 3rd Generation Drugs Drives the Market
• 8.8 Generic Company Merger and Acquisition Activity is a Symptom of Market Growth
• 8.9 Concern Over Biogenerics is a Restraint
• 8.10 Big Pharma Has Instigated Generic Protection Strategies
• 8.11 Restrictive Patent Processes are Failing to Help Generic Companies
• 8.12 Growth in Major Markets May Slow as Maximum Generic Penetration is Reached

9. World Generics Market by Country/Region

• 9.1 The US Generics Market is Strong
  • 9.1.1 The Increase of Generic Penetration in the US Has Slowed
  • 9.1.2 Increasing Acceptance of Generic Products Into Managed Care
  • 9.1.3 Blue Cross Blue Shield - An Example of Innovative Education
  • 9.1.4 Two-tiered Formularies Cut Costs but Three-tiered Ones are Favoured
  • 9.1.5 The Patent Reform Act 2005
  • 9.1.6 The ANDA Backlog at the FDA is Causing Concern
• 9.2 Generics in Japan Could Aid Healthcare Budgets
  • 9.2.1 Increasing Generic Use in Japan Will be Difficult
  • 9.2.2 The Japanese Generics Market Will Grow but Not Significantly
• 9.3 Use of Generic Drugs Varies Greatly Within the EU
  • 9.3.1 EGA - a Coordinated Approach to Policy is Required in Europe
• 9.4 Favourable Regulations Drive the UK Generics Market
  • 9.4.1 A Change in Prescribing Protocols Increases use of Generics
  • 9.4.2 Pharmacists are the Key for Higher Generic Substitution
  • 9.4.3 The Future of the UK Generics Market
• 9.5 The German Generics Market is the Largest in Europe
  • 9.5.1 "Aut Idem" Rules Drive Prices Down and Encourage Generic Substitution
  • 9.5.2 Regulations in Germany are in a State of Transformation
  • 9.5.3 Price Controls May Affect The German Generic Market
• 9.6 The French Generics Market is Growing Rapidly
• 9.7 Generic Acceptance in Spain is Improving but Attitudes Still Limit Growth
  • 9.7.1 The Reference Pricing System is Limiting Growth
• 9.8 Italy - Tight Price Controls Will Reduce Generic Profit Margins
• 9.9 The Indian Pharmaceutical Market Will Provide Growth for Generics
  • 9.9.1 Ranbaxy, Sun Pharma and Dr Reddy's Have Expanded into the World Generics Market
• 9.10 Generic Revenues Will Increase in China
• 9.11 Russia is Heavily Dependent on Imports

10. Biogenerics

• 10.1 Biogenerics Have Huge Potential but Face Significant Obstacles
• 10.2 Lucrative Biotech Patents are Lost but No Generics are Available
• 10.3 Scientific Barriers to Biogenerics
• 10.4 Regulatory Authorities and Biogenerics
  • 10.4.1 FDA Attitude to Biogenerics
  • 10.4.2 EU Legislation for Biosimilars Leads the Way
• 10.5 How the Branded Biopharmaceutical Market Approaches the Threat From Biogenerics
  • 10.5.1 The Branded Biotech Industry Defines Two Tiers of Biopharmaceuticals
  • 10.5.2 Innovative Improvements May Block Many Biogenerics
  • 10.5.3 Authorised Biogenerics or Cost Cuts Will Play a Major Role in the Future
• 10.6 How the Generic Sector is Preparing for the Expansion of Biogenerics
  • 10.6.1 The Generic Sector Wants Flexible Approval Processes for Biogenerics
  • 10.6.2 Are Transgenics the Answer to Cost Pressures?
• 10.7 Conclusion: Biogenerics Legislation is Vital for the Future of the Generics Market

11. Strategies and Trends for Generic Manufacturers

• 11.1 Hatch-Waxman Encourages Aggressive Legal Strategies
  • 11.1.1 Out-of-court Settlements - Nolvadex (Tamoxifen)
  • 11.1.2 Choosing the Right Patents - Paxil/Seroxat (paroxetine)
• 11.2 Early Identification of Viable Patents Pays Off for Generic Companies
• 11.3 Generic Pharmaceutical Companies are Investing in Novel Drugs
• 11.4 Generic Manufacturers are Growing in Size - Mergers and Acquisitions are Common

12. Strategies for Branded Manufacturers

• 12.1 Line Extension Strategies
• 12.1.1 New Indications and Formulations Require Careful Planning
• 12.1.2 OTC Switching is On the Rise
• 12.2 Authorised Generics are a Controversial Issue

13. Conclusion: Visiongain Predicts a Strong Future for Generics

• 13.1 The Generic Pharmaceutical Market is Thriving
• 13.2 Biogenerics are Vital for Future Expansion of the Generics Market
• 13.3 Generics Companies Will Grow by Consolidation and Innovation
• 13.4 Big Pharma Needs to Rethink its Approach to Generic Competition

List of Figures

• Figure 2.1 Comparison of R&D Costs and the Number of Approved NMEs, 1980-2004
• Figure 2.2 Plasma Concentration-time Curve for a Hypothetical Drug
• Figure 3.1 World Revenues ($m) for Antidepressants, 2003-2010
• Figure 3.2 Growth Rates and Patent Losses for Antidepressants, 2004-2010
• Figure 3.3 Prescription Trends for Antidepressants (US), 2002-2004
• Figure 3.4 Prescriptions for Generic Antidepressants (US), 2002-2004
• Figure 3.5 Percentage of Prescriptions for Generic and Branded Antidepressants (US), 2002
• Figure 3.6 Percentage of Prescriptions for Generic and Branded Antidepressants (US), 2004
• Figure 3.7 Global Revenues for Prozac 2000-2005
• Figure 3.8 US Retail Sales ($m) and Prescription Numbers of Generic Fluoxetine, 2001-2005
• Figure 3.9 Price of Generic Fluoxetine ($), 2001-2005
• Figure 7.1 World Generic Pharmaceuticals Revenues ($bn), 2004-2011
• Figure 7.2 Revenue Exposed to Generic Competition, 2004-2009
• Figure 7.3 Market Share for Generic Pharmaceutical Revenue by Region, 2005
• Figure 7.4 Market Share for Generic Pharmaceutical Revenue by Region, 2011
• Figure 7.5 Generic Prescription Numbers in the US, 2002-2005
• Figure 7.6 Therapeutic Areas of Drugs Coming Off Patent 2004-2009, by 2004 Revenue
• Figure 8.1 Growth Rates for Total Healthcare Spending (US), 2001-2004
• Figure 8.2 Growth Rates for US Prescription Drugs, 2002-2004
• Figure 9.1 Generic Market Share by Volume (US), 1995-2004
• Figure 9.2 Generic Penetration Levels in EU Countries, 2004
• Figure 9.3 Relative Drug Costs for EU Member States,2004
• Figure 9.4 Incidence of Generic Prescribing in EU countries, 2005
• Figure 10.1 Current EU Framework for Biologically Similar Products
• Figure 12.1 Growth of Nurofen Revenues (UK) 1994-1998
• Figure 13.1 Comparison of Growth Rates for the Total Pharmaceutical Market and the Generics Market, 2004-2007

List of Tables

• Table 2.1 Major Drugs Losing Patent Protection, 2004
• Table 2.2 Major Drugs Losing Patent Protection, 2005
• Table 2.3 Major Drugs Losing Patent Protection, 2006
• Table 2.4 Major Drugs Losing Patent Protection, 2007
• Table 2.5 Major Drugs Losing Patent Protection, 2008
• Table 2.6 Major Drugs Losing Patent Protection, 2009
• Table 3.1 Branded Drugs on the Antidepressant Market, 2004
• Table 7.1 World Generic Pharmaceuticals Revenues ($bn), 2004-2011
• Table 7.2 Number of Branded Drugs Facing US Patent Expiry, 2004-2009
• Table 7.3 Branded and Generics Price Differentials in Selected Leading European Countries, 2004
• Table 7.4 World Generic Market Growth Rate (%) by Country, 2004
• Table 7.5 Generic Pharmaceutical Revenue by Region ($m), 2004-2011
• Table 7.6 Change in Market Share by Region, 2005-2011
• Table 7.7 Speed of Generic Penetration in Leading European Pharmaceutical Markets, 2005
• Table 7.8 Leading Generic Drugs in the US by Pharmacy Retail Sales ($m), 2004
• Table 7.9 Leading Generic Drugs in the US by Volume ($m), 2004
• Table 7.10 Generic Market Share by Value and Volume in Leading Pharmaceutical Markets
• Table 7.11 Generic Market Share by Value and Volume in European Union Markets
• Table 7.12 Generic Market Share by Value and Volume in Developing European Markets
• Table 7.13 Main Therapeutic Areas for Major Drugs Coming Off-patent 2004-2009
• Table 8.1 Summary of Strengths, Weaknesses, Opportunities and Threats (SWOT) for the Generic Pharmaceutical Market
• Table 9.1 Healthcare Spending in EU Member States
• Table 9.2 Summary of Policies Affecting EU Generics Markets
• Table 9.3 Top 5 Indian Generic Pharmaceutical Companies, 2005
• Table 10.1 Biotech Drugs in the Top 50 Prescription Drugs, 2004
• Table 11.1 Leading Companies by Generics Sales Revenue ($m), 2004/2005
• Table 12.1 Examples of Different Reformulations
• Table 13.1 Recent Key Mergers and Acquisitions