World Generics Market 2009-2024

Table of Contents

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

• Abbott
• Actavis
• Apotex
• Arrow Group (Watson Pharmaceuticals)
• AstraZeneca
• Aurobindo (Pfizer)
• Barr Pharmaceuticals (Teva)
• Bayer
• Blue Cross Blue Shield Association
• Boehringer Ingelheim
• Bristol-Myers Squibb
• British Generics Manufacturers Association (BGMA)
• Centers for Medicare and Medicaid Services
• Daiichi-Sankyo
• Dr. Reddy' s Laboratories
• Eisai
• Eli Lilly
• European Generic Medicines Association (EGA)
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• Generic Pharmaceuticals Association (GPhA)
• German Pharmacy Association
• GlaxoSmithKline
• Greenstone (Pfizer)
• Hospira
• International Federation of Pharmaceutical Manufacturers Associations
• Italian Generics Association (Assogenerici)
• Johnson & Johnson
• Kowa Company Ltd
• Lundbeck
• Merck & Co
• Millennium Pharmaceuticals (Takeda)
• Mylan Inc
• National Health Service (NHS)
• Novartis
• Otsuka
• Pfizer
• Procter & Gamble
• Purdue/Mundipharma
• Ranbaxy
• Ratiopharm
• Roche
• Sandoz (Novartis)
• Sanofi-Aventis
• Schering-Plough
• Sciele Pharma (Shionogi)
• Shionogi
• Shire
• Spanish Association of Generic Medicines
• Stada Healthcare
• Sun Pharma
• Takeda
• Teva Pharmaceutical Industries
• UCB
• Watson Pharmaceuticals
• World Trade Organization (WTO)
• Wyeth