1. Executive Summary
1.1 Generic Drugs: Industry and Market Review
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods
2. Introduction to the World Generics Market
2.1 Generic Drugs (Generics)
2.1.1 Authorised, Branded and True Generics
2.2 The 'Evergreening' of Pharmaceuticals
2.3 Restraints Facing 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 Market
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. The World Generic Drugs Market, 2013-2023
3.1 The World Generic Pharmaceuticals Market in 2011
3.2 Generic Products to Benefit from Patent Expiries
3.2.1 Sales Forecast for the World Generic Drugs Market, 2012-2016
3.2.2 Sales Forecast for the World Generic Drugs Market, 2017-2023
3.3 Global Market Breakdown, 2013-2023
4. Leading Companies in the World Generics Market
4.1 Teva Pharmaceutical Industries - Prospects from 2013
4.1.1 ANDAs and Approvals
4.1.2 M&A Activity
4.2 Sandoz (Novartis) - Prospects from 2013
4.3 Mylan - Prospects from 2013
4.3.1 Mylan's Acquisition of Bioniche Pharma Holdings
4.3.2 Mylan's Acquires Exclusive Worldwide Rights to GSK's Advair, Diskus and Seretide
4.4 Apotex - Prospects from 2013
4.5 Hospira - Prospects from 2013
4.5.1 Acquisition of Orchid's Generic Injectable Pharmaceutical Business
4.5.2 Hospira's Acquisition of Javelin Pharma
4.6 Watson Pharmaceuticals - Prospects from 2013
4.6.1 ANDAs and Approvals
4.6.2 M&A Activity
4.6.3 Eden Becomes Wholly-Owned Subsidiary of Watson
4.6.4 Watson Acquires Specifar Pharmaceuticals
4.6.5 Purchase of Ascent Pharmahealth Gives Watson Strong Footprint in Southeast Asia
5. The US Generics Market, 2013-2023
5.1 Analysis of the Current Market
5.2 The US Generics Market: Revenue Forecast 2013-2023
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, 2013-2023
6.1 Analysis of the Current Generics Market in Europe
6.2 Revenue Prospects for European Generics Markets 2013-2023
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 2013-2023
6.3.2 The Future of the German Generics Market
6.4 The French Generics Market
6.4.1 French Generics Market: Sales Forecast 2013-2023
6.4.2 The Future of the French Generics Market
6.5 The UK Generics Market
6.5.1 UK Generics Market: Sales Forecast 2013-2023
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 Italian Generics Market
6.6.1 Italian Generics Market: Sales Forecast 2013-2023
6.6.2 Promoting Generic Penetration
6.6.3 Prospects for the Italian Generics Market
6.7 The Spanish Generics Market
6.7.1 Spanish Generics Market: Sales Forecast 2013-2023
6.7.2 Challenges for the Spanish Market
6.7.3 Prospects for the Spanish Generics Market
6.8 Concluding Remarks
7. The Japanese Generics Market, 2013-2023
7.1 Analysis of the Current Market
7.2 Japanese Generics Market: Sales Forecast 2013-2023
7.3 Government Initiatives Have Driven Market Growth
7.3.1 Mergers and Acquisitions
7.4 Concluding Remarks
8. Emerging Generics Markets, 2013-2023
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 2013-2023
8.4 Brazilian Generics Market: Sales Forecast 2013-2023
8.5 Mexican Generics Market: Sales Forecast 2013-2023
8.6 South Korean Generics Market: Sales Forecast 2013-2023
8.7 Russian Federation Generics Market: Sales Forecast 2013-2023
8.7.1 Russian Federation Generics Market, 2013-2023
8.7.2 Analysis of the Russian Federation Market
8.8 India - Market Prospects from 2013
8.8.1 Indian Generics Market: Sales Forecast 2013-2023
8.8.2 International Success of India's Pharmaceutical Industry
8.9 China - Market Prospects from 2013
8.9.1 Chinese Generics Market: Sales Forecast 2013-2023
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. Opinions from Our Survey - Research Interviews
10.1 James Harris, CEO, Healthcare Economics LLC, Florida, USA
10.1.1 Main Challenges for the US Generics Market
10.1.2 Pricing Trends in Generic Products
10.1.3 On Authorised Generic Products
10.1.4 Current State of Biogeneric (Biosimilar) Legislation in the US
10.1.5 On Para 4 Challenges and Patent Cliff
10.1.6 On Generics Market in the Next Decade
10.2 Charlie Mayr, Generic Pharmaceutical Association (GPhA)
10.2.1 The Value of the Generics Market
10.2.2 Main Challenges for the US Generics Market
10.2.3 On Growth Trend in Generic Products
10.2.4 On US Pricing Trends in Generic Products
10.2.5 On Authorised Generic Products
10.2.6 On Biogeneric (Biosimilar) Products
10.3 Anjan Selz, CEO, Finox
10.3.1 Finox
10.3.2 Challenges in Biosimilar Development
10.3.3 Differences Between Europe and the US
10.3.4 Product Differentiation
10.3.5 Opportunities Existing in the Biosimilars Market
10.4 Dr Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC) [UK]
10.4.1 Immunogenicity in Biosimilars
10.4.2 Biosimilar Uptake in Europe
10.4.3 Biosimilar Monoclonal Antibodies
10.5 Cecil Nick, VP (Biotechnology), Parexel Consulting
10.5.1 Challenges in Biosimilar Development
10.5.2 Asian Biosimilar Development
10.5.3 Biosimilar Interferons
10.6 Dr Jason Kantor, Managing Director, RBC Capital Markets
10.6.1 Challenges in Developing Biosimilars
10.6.2 Biosimilar Pricing
10.6.3 Next-Generation Antibody Therapies
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
Appendices
Appendix A: Supplementary Information: Patent Expiries
Appendix B: About Visiongain
Appendix C: Visiongain Report Evaluation Form
List of Tables
Table 3.1 Generic Drugs Market: World Sales Forecast, 2011-2016
Table 3.2 Generic Drugs Market: World Sales Forecast, 2017-2023
Table 3.3 Generic Drugs Market: Developed Countries - Sales Forecasts, 2011-2023
Table 3.4 Generic Drugs Market: Emerging Countries - Sales Forecasts, 2011-2023
Table 4.1 Leading Companies in the World Generics Market: Sales and Market Shares, 2011
Table 4.2 The Top 10 Generics Market: M&A Deals, 2004-2010
Table 4.3 Sandoz Overview: Key Figures, 2009-2011
Table 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2010
Table 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2010
Table 5.3 US Generics Market: Sales Forecast, 2011-2016
Table 5.4 US Generics Market: Sales Forecast, 2017-2023
Table 6.1 German Generics Market: Sales Forecast, 2011-2016
Table 6.2 German Generics Market: Sales Forecast, 2017-2023
Table 6.3 French Generics Market: Sales Forecast, 2011-2016
Table 6.4 French Generics Market: Sales Forecast, 2017-2023
Table 6.5 UK Generics Market: Sales Forecast, 2011-2016
Table 6.6 UK Generics Market: Sales Forecast, 2017-2023
Table 6.7 Italian Generics Market: Sales Forecast, 2011-2016
Table 6.8 Italian Generics Market: Sales Forecast, 2017-2023
Table 6.9 Spanish Generics Market: Sales Forecast, 2011-2016
Table 6.10 Spanish Generics Market: Sales Forecast, 2017-2023
Table 7.1 Japanese Generics Market: Sales Forecast, 2011-2016
Table 7.2 Japanese Generics Market: Sales Forecast, 2017-2023
Table 8.1 Turkish Generics Market: Sales Forecast, 2011-2016
Table 8.2 Turkish Generics Market: Sales Forecast, 2017-2023
Table 8.3 Brazilian Generics Market: Sales Forecast, 2011-2016
Table 8.4 Brazilian Generics Market: Sales Forecast, 2017-2023
Table 8.5 Mexican Generics Market: Sales Forecast, 2011-2016
Table 8.6 Mexican Generics Market: Sales Forecast, 2017-2023
Table 8.7 South Korean Generics Market: Sales Forecast, 2011-2016
Table 8.8 South Korean Generics Market: Sales Forecast, 2017-2023
Table 8.9 Russian Federation Generics Market: Sales Forecast, 2011-2016
Table 8.10 Russian Federation Generics Market: Sales Forecast, 2017-2023
Table 8.11 Indian Generics Market: Sales Forecast, 2011-2016
Table 8.12 Indian Generics Market: Sales Forecast, 2017-2023
Table 8.13 Chinese Generics Market: Sales Forecast, 2011-2016
Table 8.14 Chinese Generics Market: Sales Forecast, 2017-2023
Table 9.1 SWOT Analysis of World Generic Drugs Market: Strengths and Weaknesses, 2013-2023
Table 9.2 SWOT Analysis of World Generic Drugs Market: Opportunities and Threats, 2013-2023
Table 11.1 Generic Drugs National Markets: Leading Developed Countries - Sales Forecasts, 2011, 2013, 2016, 2018, 2020 & 2023
Table 11.2 Generic Drugs National Markets: Leading Emerging Countries - Sales Forecasts, 2011, 2013, 2016, 2018, 2020 & 2023
Table A.1 Main Patent Expiries, 2011-2014
Table A.2 Main Patent Expiries by Number, 2011-2014
Table A.3 Main Patent Expiries, 2010
Table A.4 Main Patent Expiries, 2011
Table A.5 Main Patent Expiries, 2012
Table A.6 Main Patent Expiries, 2013
Table A.7 Main Patent Expiries, 2014
List of Figures
Figure 3.1 Generic Drugs Market: World Sales Forecast, 2011-2016
Figure 3.2 Generic Drugs Market: World Sales Forecast, 2017-2023
Figure 3.3 Generic Drugs Market: US and World Sales Forecasts, 2011-2023
Figure 3.4 Generic Drugs Market: Japan and Germany Sales Forecasts, 2011-2023
Figure 3.5 Generic Drugs Market: Top Five EU Countries Sales Forecasts, 2011-2023
Figure 3.6 Generic Drugs Market: Emerging Countries Sales Forecasts, 2011-2023
Figure 3.7 Generic Drugs Market: Sales Shares in Leading National Markets, 2011
Figure 3.8 Generic Drugs Market: Sales Shares in Leading National Markets, 2016
Figure 3.9 Generic Drugs Market: Sales Shares in Leading National Markets, 2019
Figure 3.10 Generic Drugs Market: Sales Shares in Leading National Markets, 2023
Figure 4.1 Leading Companies in the World Generics Market, 2011
Figure 4.2 Teva's Sales Shares by Product Line, 2011
Figure 4.3 Novartis' Business Segments Revenue Breakdown & Sandoz Share, 2011
Figure 4.4 Mylan's Sales by Therapeutic Category, 2011
Figure 4.5 Hospira's Sales by Geographical Region, 2011
Figure 4.6 Watson's Sales by Segment, 2011
Figure 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2010
Figure 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2010
Figure 5.3 US Generics Market: Sales Forecast, 2011-2023
Figure 5.4 ANDAs Received, Approved and Tentatively Approved, 2005-2009
Figure 5.5 US Generics Market: Leading Companies by Prescription Volume, 2011
Figure 6.1 German Generics Market: Sales Forecast, 2011-2023
Figure 6.2 French Generics Market: Sales Forecast, 2011-2023
Figure 6.3 UK Generics Market: Sales Forecast, 2011-2023
Figure 6.4 Italian Generics Market: Sales Forecast, 2011-2023
Figure 6.5 Spanish Generics Market: Sales Forecast, 2011-2023
Figure 7.1 Japanese Generics Market: Sales Forecast, 2011-2023
Figure 8.1 Turkish Generics Market: Sales Forecast, 2011-2023
Figure 8.2 Brazilian Generics Market: Sales Forecast, 2011-2023
Figure 8.3 Mexican Generics Market: Sales Forecast, 2011-2023
Figure 8.4 South Korean Generics Market: Sales Forecast, 2011-2023
Figure 8.5 Russian Federation Generics Market: Sales Forecast, 2011-2023
Figure 8.6 Indian Generics Market: Sales Forecast, 2011-2023
Figure 8.7 Chinese Generics Market: Sales Forecast, 2011-2023
Figure 11.1 Generic Drugs Market: US and World Sales Forecasts, 2011-2023
Figure 11.2 Generic Drugs Market: Leading Countries - Sales Forecasts, 2011-2023