1 Executive Summary
1.1 Aims of This Report
1.2 Chapter Overview
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: Is the Business Model Crumbling?
2.5 US Regulations
2.5.1 Obtaining FDA Approval: NDAs and ANDAs
2.5.2 The Hatch-Waxman Act: Promotion of Generic Drugs
2.5.3 The Hatch-Waxman Act: Incentives for the Branded Industry
2.5.4 Consequences of the Hatch-Waxman Act
2.5.5 Me First: Timing as a Key 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 Between 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: An Overview
3 Generic Products World Market Forecast 2009-2024
3.1 Generic Products Versus Branded Pharmaceuticals
3.2 Sales Forecast 2009-2024
3.3 Blockbuster Patent Expiries: The Fall of Giants
3.4 Implications of the Current Financial Climate
3.5 Key Patent Expiries: An Overview 2009-2014
3.5.1 Expected Key Patent Expiries in 2009
3.5.2 Expected Key Patent Expiries in 2010
3.5.3 Expected Key Patent Expiries in 2011
3.5.4 Expected Key Patent Expiries in 2012
3.5.5 Expected Key Patent Expiries in 2013
3.5.6 Expected Key Patent Expiries in 2014
3.5.7 Expected Key Patent Expiries 2009-2014: A Summary
3.6 Big Pharma Enters the Generics Market
3.7 Major Geographical Markets
3.7.1 A Shift in Market Share?
3.8 Key Therapeutic Areas
4 The US Generics Market 2009-2024
4.1 Analysis of the Current Market
4.2 Sales for the US Generics Market: Forecast 2009-2024
4.3 Is Market Penetration Reaching a Saturation Point?
4.4 Growing Consumer Acceptance of Generic Medicines
4.5 The ANDA Backlog
4.6 Declining Market Share
4.7 Regulatory Environment
4.8 Concluding Remarks
5 The European Generics Market 2009-2024
5.1 Analysis of the Current Generics Market in Europe
5.2 Sales for the European Generics Market: Forecast 2009-2024
5.2.1 The Generics Market Varies Within the EU
5.2.2 Pricing and Reimbursement
5.2.3 Key Challenges to Generic Medicines in Europe
5.3 The German Generics Market
5.3.1 Sales for the German Generics Market: Forecast 2009-2024
5.3.2 High Public Acceptance of Generic Products
5.3.3 "Aut Idem" Regulations Encourage Generics Substitution
5.3.4 The Future of the German Generics Market
5.4 The French Generics Market
5.4.1 Sales for the French Generics Market: Forecast 2009-2024
5.4.2 The Future of the French Generics Market
5.5 The UK Generics Market
5.5.1 Sales for the UK Generics Market: Forecast 2009-2024
5.5.2 Generics Prescribing Due to Increasing Cost Pressures
5.5.3 Reducing Generics Prices: the Drug Tariff System
5.5.4 The Increasing Role of Pharmacists
5.5.5 Easy Entry, Strong Price Competition
5.5.6 The Future of the UK Generics Market
5.6 The Spanish Generics Market
5.6.1 Sales for the Spanish Generics Market: Forecast 2009-2024
5.6.2 Low Price Differences Between Generic and Originator Drugs
5.6.3 Prescribing Practices are Limiting Growth
5.6.4 The Future of the Spanish Generics Market
5.7 The Italian Generics Market
5.7.1 Sales for the Italian Generics Market: Forecast 2009-2024
5.7.2 Steps Towards Higher Generics Penetration
5.7.3 Intellectual Property in Italy
5.8 Concluding Remarks
6 The Japanese Generics Market 2009-2024
6.1 Analysis of the Current Market
6.2 Sales for the Japanese Generics Market: Forecast 2009-2024
6.3 The Regulatory Environment
6.3.1 Boosting Generic Products
6.4 Prescribers' Attitude is a Major Obstacle
6.5 Mergers and Acquisitions
6.6 Concluding Remarks
7 Emerging Generics Markets 2009-2024
7.1 Increased Economic Power
7.2 India
7.2.1 Sales for the Indian Generics Market: Forecast 2009-2024
7.2.2 India's Patent Law
7.2.3 Section 3(d) of the Indian Patents Act
7.2.4 International Success of India's Pharmaceutical Industry
7.3 China
7.3.1 Sales for the Chinese Generics Market: Forecast 2009-2024
7.3.2 Pricing and Reimbursement
7.3.3 Patent Law
7.3.4 China or India?
7.4 Russian Federation
7.4.1 Sales for the Russian Federation Generics Market: Forecast 2009-2024
7.4.2 Imported Versus Domestic Pharmaceuticals
7.4.3 Pharmaceutical Distribution and Financial Strains
7.4.4 Per Capita Consumption Rates are Low
7.4.5 Prospects for the Russian Market
7.5 Concluding Remarks
8 Leading Generics Companies
8.1 Teva Pharmaceutical Industries
8.1.1 World Sales for Teva in 2008
8.1.2 Geographical Breakdown of Sales
8.2 Novartis' Sandoz
8.2.1 Sales and Presence in the Major Geographical Regions
8.3 Mylan Inc
8.3.1 Acquisitions
8.3.2 International Presence
8.4 Watson Pharmaceuticals
8.4.1 International Presence
8.5 Ratiopharm
8.5.1 International Presence
8.5.2 The Future for Ratiopharm
9 Market Drivers and Restraints
9.1 Primary Drivers
9.1.1 The Ageing Population: Opportunities for Growth
9.1.2 Healthcare on a Budget
9.1.3 Generics Penetration Rates in the Developed World
9.1.4 Opportunities in the Emerging Markets
9.1.5 Supergenerics
9.1.6 Generics Companies: Bulking Up
9.1.7 Mergers and Acquisitions
9.2 Primary Restraints
9.2.1 Dependency on Branded Pharmaceuticals
9.2.2 Branded Resistance
9.2.3 Biogenerics: Not as Easy as Small Molecules
9.2.4 Rigid Intellectual Property Laws
10 Expert Opinion
10.1 Charlie Mayr, GPhA
10.1.1 The Value of the Generics Market
10.1.2 Main Challenges for the US Generics Market
10.1.3 On Authorized Generic Products
10.1.4 On Biogeneric Products
11 Conclusions
11.1 Generics Penetration Reaching Maturity?
11.2 Patent Expiries: A Key Growth Driver
11.3 Dependence on the Brands: A Thinning Pipeline
11.4 Price Declines and Volume Increases
11.5 Summary of Forecasts
11.6 Concluding Remarks
List of Tables
Table 3.1 Generics World Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 3.2 Major Patent Expiries by World Sales ($bn), 2009-2014
Table 3.3 Patent Expiries by Number, 2009-2014
Table 3.4 Expected Key Patent Expiries, 2009
Table 3.5 Expected Key Patent Expiries, 2010
Table 3.6 Expected Key Patent Expiries, 2011
Table 3.7 Expected Key Patent Expiries, 2012
Table 3.8 Expected Key Patent Expiries, 2013
Table 3.9 Expected Key Patent Expiries, 2014
Table 3.10 Major Generics Markets, Market Share (%), 2008
Table 3.11 Major Therapeutic Areas in the Generics Market, Market Share (%), 2008
Table 4.1 US Generics Market, Sales ($bn) and Growth (%), 2008 -2014, 2019, 2024
Table 5.1 European Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.2 Key Challenges Affecting EU Generics Markets
Table 5.3 German Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.4 French Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.5 UK Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.6 UK Department of Health Classes of Generic Drugs
Table 5.7 Spanish Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.8 Italian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 6.1 Japanese Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.1 Indian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.2 Chinese Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.3 Russian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 8.1 Leading Companies in the Generics Market, World Sales ($bn) and Market Share (%), 2008
Table 8.2 Teva World Sales ($bn) by Therapeutic Class
Table 8.3 Teva Top Selling Products, World Sales ($bn), 2008
Table 8.4 Teva Sales ($bn) by Geographical Region, 2008
Table 8.5 Mylan World Sales ($bn) by Therapeutic Class, 2008
Table 8.6 Mylan Inc Sales Share (%) by Geographical Region, 2008
Table 8.7 Watson Pharmaceuticals World Sales ($bn) by Therapeutic Class, 2008
Table 8.8 Ratiopharm World Sales ($bn) by Therapeutic Class, 2008
Table 8.9 Ratiopharm Sales ($m) and Sales Share (%) by Geographical Region, 2008
Table 9.1 SWOT Analysis for The World Generics Market, 2009
List of Figures
Figure 3.1 Generic Products Versus Branded Pharmaceuticals, Market Share (%), 2008
Figure 3.2 Generics World Market Sales ($bn), 2008-2024
Figure 3.3 Expected Key Patent Expiries by Sales ($bn), 2009-2014
Figure 3.4 Major Generics Markets, Market Share (%), 2008
Figure 3.5 Key Generics Markets, Market Share (%), 2009
Figure 3.6 Key Generics Markets, Market Share (%), 2014
Figure 3.7 Key Generics Markets, Market Share (%), 2019
Figure 3.8 Key Generics Markets, Market Share (%), 2024
Figure 3.9 Major Therapeutic Areas in the Generics Market, Market Share (%), 2008
Figure 4.1 US Generics Market Sales ($bn), 2008-2024
Figure 5.1 European Generics Market Sales ($bn), 2008-2024
Figure 5.2 German Generics Market Sales ($bn), 2008-2024
Figure 5.3 French Generics Market Sales ($bn), 2008-2024
Figure 5.4 UK Generics Market Sales ($bn), 2008-2024
Figure 5.5 Spanish Generics Market Sales ($bn), 2008-2024
Figure 5.6 Italian Generics Market Sales ($bn), 2008-2024
Figure 6.1 Japanese Generics Market Sales ($bn), 2008-2024
Figure 7.1 Indian Generics Market, Sales ($bn), 2008-2024
Figure 7.2 Chinese Generics Market, Sales ($bn), 2008-2024
Figure 7.3 Russian Generics Market, Sales ($bn), 2008-2024
Figure 7.4 Chinese, Indian and Russian Generics Markets, Growth (%), 2009, 2014, 2019, 2024
Figure 7.5 Chinese, Indian and Russian Generics Markets, Market Share (%), 2009, 2014, 2019, 2024
Figure 8.1 Leading Companies in the Generics Market, Market Share (%), 2008
Figure 8.2 Teva Sales Share (%) by Geographical Region, 2008
Figure 8.3 Divisions of Novartis by Sales ($bn), 2008
Figure 8.4 Mylan Inc Sales Share (%) by Geographical Region, 2008
Figure 8.5 Ratiopharm Sales Share (%) by Geographical Region, 2008