1. Executive Summary
1.1 The Generic Drugs Sector: Industry and Market Review
1.2 Research & Analysis Methods
1.3 Chapter Breakdown for this Report
2. Overview of the World Generics Market
2.1 Generic Drugs: An Introduction
2.1.1 Authorised, Branded and True Generics
2.2 'Evergreening'
2.3 Limited Growth in the World Pharmaceutical Market
2.4 Branded Pharmaceuticals: End of a Business Model?
2.5 US Regulations
2.5.1 Obtaining FDA Approval: NDAs and ANDAs
2.5.2 The Hatch-Waxman Act Title 1: Promotion of Generic Drugs
2.5.3 The Hatch-Waxman Act Title 2: Incentives for the Branded Industry
2.5.4 Consequences of the Hatch-Waxman Act
2.5.5 Me First: Timing as a Crucial Factor
2.6 European Regulations
2.6.1 Generics' Entry into the European Markets
2.6.2 Further Protection of Branded Products in the European Markets
2.6.3 Variations Among European Countries
2.6.4 Moving Towards Standardisation
2.6.5 The 8+2+1 Rule
2.7 Japanese Regulations
2.8 Compulsory Licensing
2.9 Generic Drugs: Overview
3. Generic Pharmaceuticals: World Market Forecast 2010-2025
3.1 Generic Products versus Branded Pharmaceuticals
3.2 Overall Sales Forecast 2010-2025
3.3 Global Market Breakdown 2010-2025
4. Leading Companies in the World Generics Market
4.1 Teva Pharmaceutical Industries - Prospects from 2010
4.1.1 ANDAs and Approvals
4.1.2 M&A Activity
4.2 Sandoz - Prospects from 2010
4.3 Mylan - Prospects from 2010
4.4 Apotex - Prospects from 2010
4.5 Hospira - Prospects from 2010
4.6 Watson - Prospects from 2010
5. The US Generics Market 2010-2025
5.1 Analysis of the Current Market
5.2 The US Generics Market: Revenue Forecast 2010-2025
5.3 Regulatory Reform Can Keep the Market Growing
5.3.1 A New Pathway to the US Market for Biosimilars?
5.3.2 Reverse Payments
5.3.3 The ANDA Backlog
5.4 Growing Consumer Acceptance of Generic Medicines
5.5 Leading Companies in the US Generics Market
5.6 Concluding Remarks
6. Leading European Generics Markets 2010-2025
6.1 Analysis of the Current Generics Market in Europe
6.2 Revenue Prospects for European Generics Markets 2010-2025
6.2.1 The Two Categories of European Market
6.2.2 European Pricing Systems and their Effect on Generic Penetration
6.2.3 Patient Co-Payment
6.2.4 Challenges with the European Regulatory Environment
6.3 The German Generics Market
6.3.1 German Generics Market: Sales Forecast 2010-2025
6.3.2 The Future of the German Generics Market
6.4 The French Generics Market
6.4.1 French Generics Market: Sales Forecast 2010-2025
6.4.2 The Future of the French Generics Market
6.5 The UK Generics Market
6.5.1 UK Generics Market: Sales Forecast 2010-2025
6.5.2 Generics Prescribing Linked to Increasing Budgetary Constraints
6.5.3 Reducing Generic Drug Prices: the Drug Tariff System
6.5.4 The Increasing Role of Pharmacists
6.5.5 Easy Entry, Strong Price Competition
6.5.6 The Future of the UK Generics Market
6.6 The Spanish Generics Market
6.6.1 Spanish Generics Market: Sales Forecast 2010-2025
6.6.2 Challenges for the Spanish Market
6.6.3 Prospects for the Spanish Generics Market
6.7 The Italian Generics Market
6.7.1 Italian Generics Market: Sales Forecast 2010-2025
6.7.2 Promoting Generic Penetration
6.7.3 Prospects for the Italian Generics Market
6.8 Concluding Remarks
7. The Japanese Generics Market 2010-2025
7.1 Analysis of the Current Market
7.2 Japanese Generics Market: Sales Forecast 2010-2025
7.3 Government Initiatives Have Driven Market Growth
7.3.1 Mergers and Acquisitions
7.4 Concluding Remarks
8. Emerging Generics Markets 2010-2025
8.1 The EM-7: Pharma's Best Hope?
8.2 M&A as a Tactic for Entering the Generic Drugs Sector
8.3 Turkish Generics Market: Sales Forecast 2010-2025
8.4 Brazilian Generics Market: Sales Forecast 2010-2025
8.5 Mexican Generics Market: Sales Forecast 2010-2025
8.6 South Korean Generics Market: Sales Forecast 2010-2025
8.7 Russian Generics Market: Sales Forecast 2010-2025
8.7.1 Russian Generics Market, 2010-2025
8.7.2 Analysis of the Russian Market
8.8 India - Market Prospects from 2010
8.8.1 Indian Generics Market: Sales Forecast 2010-2025
8.8.2 International Success of India's Pharmaceutical Industry
8.9 China - Market Prospects from 2010
8.9.1 Chinese Generics Market: Sales Forecast 2010-2025
8.9.2 Chinese Generics Market: Discussion of Sector
9. World Generics Market: Strengths, Weaknesses, Opportunities and Threats
9.1 The Generics Sector Will Remain a High-Growth Area
9.2 Generics Offer Limited Profitability?
9.3 Emerging Markets and Generics: The Pharma Industry's Biggest Opportunity?
9.4 The Generic Drug Market's Growth is Assured, but Some Threats Remain
10. Expert Opinion
10.1 Charlie Mayr, Generic Pharmaceutical Association (GPhA)
10.1.1 The Value of the Generics Market
10.1.2 Main Challenges for the US Generics Market
10.1.3 On Authorised Generic Products
10.1.4 On Biogeneric (Biosimilar) Products
11. Conclusions
11.1 The World Generics Market Will Continue to Expand
11.2 The Emerging National Markets Hold Much Promise
11.3 Biosimilars Have Promise, but Difficulties and Uncertainties Remain
11.4 Concluding Remarks
Appendix A: Supplementary Information on the Sector
List of Tables
Table 3.1 Overall Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 3.2 Generics Market by Country: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 4.1 Leading Companies in the World Generics Market: Sales ($bn) and Market Shares (%), 2009
Table 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2009
Table 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2009
Table 5.3 US Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 6.1 German Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 6.2 French Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 6.3 UK Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 6.4 Spanish Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 6.5 Italian Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 7.1 Japanese Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.1 Turkish Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.2 Brazilian Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.3 Mexican Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.4 South Korean Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.5 Russian Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.6 Indian Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 8.7 Chinese Generics Market: Sales ($bn), Growth (%), CAGR (%), 2009-2025
Table 9.1 SWOT Analysis of the World Generic Drug Market, 2010
Table A.1 Main Patent Expiries, 2009-2014
Table A.2 Main Patent Expiries by Number, 2009-2014
Table A.3 Main Patent Expiries, 2009
Table A.4 Main Patent Expiries, 2010
Table A.5 Main Patent Expiries, 2011
Table A.6 Main Patent Expiries, 2012
Table A.7 Main Patent Expiries, 2013
Table A.8 Main Patent Expiries, 2014
List of Figures
Figure 3.1 Audited and Unaudited Generic Drug Sales ($bn), 2009
Figure 3.2 Overall Generics Market: Sales ($bn), 2009-2025
Figure 3.3 Overall Generics Market: Annual Growth (%), 2009-2025
Figure 4.1 Leading Companies in the World Generics Market ($bn), 2009
Figure 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2009
Figure 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2009
Figure 5.3 US Generics Market: Sales ($bn), 2009-2025
Figure 5.4 ANDAs Received, Approved and Tentatively Approved, 2005-2009
Figure 5.5 Leading Companies in the US Generics Market by Prescription Volume, 2009
Figure 6.1 German Generics Market: Sales ($bn), 2009-2025
Figure 6.2 French Generics Market: Sales ($bn), 2009-2025
Figure 6.3 UK Generics Market: Sales ($bn), 2009-2025
Figure 6.4 Spanish Generics Market: Sales ($bn), 2009-2025
Figure 6.5 Italian Generics Market: Sales ($bn), 2009-2025
Figure 7.1 Japanese Generics Market: Sales ($bn), 2009-2025
Figure 8.1 Turkish Generics Market: Sales ($bn), 2009-2025
Figure 8.2 Brazilian Generics Market: Sales ($bn), 2009-202
Figure 8.3 Mexican Generics Market: Sales ($bn), 2009-2025
Figure 8.4 South Korean Generics Market: Sales ($bn), 2009-2025
Figure 8.5 Russian Generics Market: Sales ($bn), 2009-2025
Figure 8.6 Indian Generics Market: Sales ($bn), 2009-2025
Figure 8.7 Chinese Generics Market: Sales ($bn), 2009-2025
Figure 11.1 Generics Market: Overall Sales Prospects ($bn), 2009-2025