世界のジェネリック医薬品市場動向：2006年〜2011年

Abstract

In sharp contrast to the branded pharmaceutical market, which has stalled in recent year, the generics market is enjoying a period of unprecedented success. In 2005 the world generics market was worth $45bn, a growth of 14% on the previous year. Visiongain expects this level of growth to continue over the forecast period of this report.

The loss of patent protection by 2009 of almost $80bn worth of top selling drugs will be the major driving force for this generic market growth. Additionally, as healthcare costs in the developed world continue to increase, and the growth of pharmaceutical markets in developing countries continues to grow. More generic copies of successful drugs are being sold worldwide than ever before. This report describes how this burgeoning market will change over the forecast period and highlights the important issues for both originator companies and generic drugs manufacturers.

What is the therapeutic area with the most potential for generic companies? How are branded pharmaceutical companies preparing for the increasing threat of generic penetration? What challenges do generic companies face in the coming years? Read visiongain's The World Generics Market 2006-2011 report to find out.

The following issues are covered in detail:

• A summary of the relevant legislation affecting the generics industry
• A market forecast for the world generics market 2006-2011
• An assessment of the drivers and restraints of the market during this period
• A discussion of the attitudes to generics in different regions including the US, Europe and Asia
• The issue of Biogenerics and the changes in regulations required for their success
• A review of strategies for success for originator and generics companies

Why should you buy this report?

The progress of the generic pharmaceutical market is of great importance to anyone in the pharmaceutical industry. This report provides detailed financial data and invaluable opinion about how this market will change over the important period to come.

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