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
