World Generics Market, 2008-2013

World Generics Market, 2008-2013 published by Visiongain in November, 2008. This report consists of 126 pages and the price starts from US $ 2331.

Introduction

Abstract

The generics market remains a major growth area in the global healthcare market. That growth has been partly driven by cost-containment in several national healthcare sectors, with governments seeking to promote the use of generic products over higher-priced originator products. The global generic pharmaceuticals market was worth over $100bn in 2007, with market growth noticeably higher that that of the overall pharmaceutical market. Our new report - World Generics Market, 2008-2013 - will help you to understand the key developments in this sector and their significance, from the present looking forward. The report provides valuable commercial information on this exciting sector, one that no pharmaceutical company or related organisation can afford to ignore.

Over the period 2008 to 2013, visiongain foresees the generic market to sustain its strong current growth, with exciting new developments to be driven by the wave of blockbuster drugs approaching patent expiry. This report - World Generics Market, 2008-2013 - provides details of these drugs and potential generics revenues. The study also identifies the therapeutic areas that will face the highest levels of competition from generic substitutes from 2008 to 2013. Our report examines the global generics market and industry critically, with in-depth analysis, especially market forecasting and qualitative analysis of market drivers and restraints. The result is a comprehensive market-based report with detailed analysis and informed opinion.

Why you should buy this report

In particular, World Generics Market, 2008-2013 concentrates on the following essential aspects of the generics market and industry:

• Discussion of key issues affecting the global generics market and the wider pharmaceutical market/industry
• Why governments and healthcare organisations - including private insurers - are increasingly opting for generic medicines; we provide country-specific information there
• Discussion of drivers and opportunities in the generics sector
• Discussion of restraints and threats in the generics sector
• Sales forecasts from 2008-2013 for the global generics market and leading national generics markets - US, Japan, Germany, France, UK, Spain, Italy
• Discussion of developing generics markets, especially China, India and Russia, with major industrial developments covered.

Despite the potentially great opportunities to be harnessed by generics companies in both developed and developing countries, there remain marked obstacles to be overcome. While many generics companies are becoming larger and more innovative, originator drugs companies - especially top-10 pharma companies - are generally prepared for the threat from generics, having developed strategies to minimise the effects of sales erosion. Still, there are large potential losses in sales occurring currently - and likely to continue in the years ahead - as one blockbuster drug after another faces direct and indirect generic competition.

Certainly, the commercial opportunities for dynamic generics companies are great. Similarly, the cost-saving opportunities for both public and private healthcare providers worldwide are significant. By purchasing this report, you will be better able to appreciate those major developments in the global pharmaceutical market, with many stakeholders affected.

Table of Contents

1. Executive Summary

2. Overview of the World Generics Market

• 2.1 The World Pharmaceuticals Market Growth Stabilises to Generics' Advantage
• 2.2 What is a Generic Drug?
• 2.3 The Crumbling Branded Pharmaceutical Business Model
• 2.4 Regulatory Changes in Generics Approval Hasten Market Growth
  • 2.4.1 The US and European Regulation of Generic Drugs
  • 2.4.2 Generic Pharmaceuticals in the US Market
  • 2.4.3 The Hatch-Waxman Act, Patent Expiration and the Promotion of Generic Drugs: Title I of the Act
  • 2.4.4 The Hatch-Waxman Title I
  • 2.4.5 US Congress First-to-Market 180-Day Exclusivity Period Incentive
  • 2.4.6 The Hatch-Waxman Act Title II has Promoted Innovation in the Branded Pharmaceutical Industry
  • 2.4.7 The Hatch-Waxman Act Drives Influx of Generic Pharmaceuticals Significantly
• 2.5 European Generics Patent Legislation Differs from that of the US
  • 2.5.1 European Generic Drug Development: Variation between European Countries
  • 2.5.2 EU has Long Data Exclusivity Period
  • 2.5.3 Additional Protection Conferred by Supplementary Protection Certificates
• 2.6 Compulsory Licensing Allows Generic Manufacture before Patent Expiry
• 2.7 The Advantages of First-to-Market Generics
• 2.8 The Period of Market Exclusivity Varies from Country to Country
• 2.9 The 8+2+1 Rule - Moving Towards Standardisation
• 2.10 Generic Drugs are becoming Increasingly Important Globally

3. SWOT Analysis for the World Generics Market

• 3.1 SWOT Analysis for the Global Generics Sector, 2008-2013
• 3.2 The Ageing Population Constitutes One of the Strongest Drivers for the Pharmaceutical Industry
• 3.3 Rising Healthcare Costs are Leading to High Demand for Generics
• 3.4 FDA Approves More First-Time Generic Drugs
• 3.5 Generics Manufactures have Responded Vigorously to Market Opportunities
• 3.6 Low Price and High Volume are the Key Drivers of the Generics Market
  • 3.6.1 Generic Penetration Rate is High in UK, US and Germany
  • 3.6.2 Revenue Opportunities in Developing Markets are Attractive
• 3.7 The Lack of Competition from 3rd Generation Drugs also Drives the Market
• 3.8 Leading Generics Companies Now have the Capability to Provide Innovative Products
  • 3.8.1 Leading Generic Companies Transfer their Expertise to ' Supergenerics'
• 3.9 Leading Generics Companies are Highly Effective Organisations
• 3.10 Generic Company Merger and Acquisition Activity
• 3.11 The Generics Sector has Marked Weaknesses
  • 3.11.1 Concern Over Biogenerics is a Restraint
  • 3.11.2 Big Pharma has Instigated Generic Protection Strategies
  • 3.11.3 Restrictive Patent Processes as Perceived by Generics Companies
  • 3.11.4 Growth in Major Markets May Slow as Maximum Generic Penetration is Reached
  • 3.11.5 The US Branded Market Faces Significant Challenges from Generics and Parallel Trade
  • 3.11.6 Authorised Generics - The Most Aggressive PLM Strategy
• 3.12 Generics Market will Rise Up to the Challenges from Branded Pharmaceutical Companies

4. World Generics Market Forecast 2008-2013

• 4.1 The World Generics Market will Maintain High Growth in the Period 2008-2013
• 4.2 Generic Drugs for Chronic Diseases will Play a Significant Role in the Generics Market
• 4.3 Generics Market to Benefit from High Volume Sales of Blockbuster Drugs
  • 4.3.1 Patent Expirations in 2008
  • 4.3.2 Patent Expirations in 2009
  • 4.3.3 Patent Expirations in 2010
  • 4.3.4 Patent Expirations in 2011
  • 4.3.5 Patent Expirations in 2012

5. US Generics Market Forecast & Analysis 2008-2013

• 5.1 US Generics Market Sales Forecast 2008-2013
• 5.2 The US is the Most Established Generics Market
  • 5.2.1 Generic Penetration in the US Market is Still Increasing
  • 5.2.2 Generic Prescriptions Seeing Percentage Rises in the US
  • 5.2.3 Generic Pharmaceuticals Gain Strong Support from US-Managed Care Sector
  • 5.2.4 Blue Cross Blue Shield - An Example of Innovative Education
  • 5.2.5 Two-Tiered Formularies Cut Costs but Three-Tiered ones are Favoured
  • 5.2.6 Wal-Mart Prescription Programme helps the US Generics Market Expand
  • 5.2.7 FDA ANDA Backlog Grows

6. Japan: Generics Market Forecast & Analysis 2008-2013

• 6.1 Japanese Generics Market Sales Forecast 2008-2013
• 6.2 Impediments in Japan' s Generics Market
  • 6.2.1 The Key Reason for Low Generics Adoption is Financial
  • 6.2.2 Distribution Channels for Generics and Branded Drugs Differ in Japan
  • 6.2.3 Generics Manufacturing Capacity in Japan must Improve to Foster Growth
• 6.3 Japan' s Generics Market sees Slow Growth in 2007
• 6.4 Japan Can Reduce Rising Healthcare Costs through Generics
• 6.5 Prescribers' Attitude to Generics in Japan must Change to Drive Growth
• 6.6 Leading Generics Companies Merge - Further Mergers Predicted
  • 6.6.1 Japan' s Daiichi Sankyo Acquires Majority Stake in Ranbaxy

7. Overview of the EU Generics Market

• 7.1 Use of Generic Drugs Varies Greatly within the EU
• 7.2 A Coordinated Approach to Policy is Required in Europe

8. Germany: Generics Market Forecast & Analysis 2008-2013

• 8.1 German Generics Market Sales Forecast 2008-2013
  • 8.1.1 Germany has High Public Acceptance of Generics
  • 8.1.2 Generics Pricing in Germany
  • 8.1.3 Germany Introduces New Generic Substitution Rules
  • 8.1.4 "Aut Idem" Rules Drive Prices Down and Encourage Generic Substitution
  • 8.1.5 Regulations in Germany are in a State of Transformation

9. France: Generics Market Forecast & Analysis 2008-2013

• 9.1 French Generics Market Sales Forecast 2008-2013
  • 9.1.1 The French Generics Market is Expanding
  • 9.1.2 France has being Slow to Recognise Cost-Saving Value of Generics
• 9.2 New Measures Facilitate Generics Uptake in France
• 9.3 Integration of the New EU Pharmaceutical Reforms will Help Drive Generics Sector

10. UK: Generics Market Forecast & Analysis 2008-2013

• 10.1 UK Generics Market Sales Forecast 2008-2013
• 10.2 Favourable Regulations Drive the UK Generics Market
  • 10.2.1 A Change in Prescribing Protocols Increases Use of Generics
• 10.3 Generics Drug Tariff is Influential
  • 10.3.1 Department of Health Sets New Drug Tariff for Generics Manufacturers and Wholesalers
  • 10.3.2 Pharmacists are the Key for Higher Generic Substitution
• 10.4 PRODIGY Facilitates UK GP' s Generics Accessibility
• 10.5 The Future of the UK Generics Market

11. Spain: Generics Market Forecast & Analysis 2008-2013

• 11.1 Spanish Generics Market Forecast & Analysis 2008-2013
• 11.2 Generics Acceptance in Spain is Improving but Attitudes Still Limit Growth
• 11.3 The Reference Pricing System is Limiting Growth
• 11.4 Lack of Incentive Affects Prescribing Practices

12. Italy: Generics Market Forecast & Analysis 2008-2013

• 12.1 Italian Generics Market Sales Forecast 2008-2013
• 12.2 Italy' s Tight Price Controls will Reduce Generic Profit Margins
• 12.3 Changes in Pricing System in Italy May Help Drive Generic Sales
• 12.4 Changes in Cultural Attitudes Towards Generics will be Positive for Sales Growth

13. Emerging Generic Markets

• 13.1 Fast Emerging Economies such as China and India Hold Strong Generics Revenue Potential
• 13.2 India' s Market Abroad
  • 13.2.1 India' s Purchasing Power Parity
  • 13.2.2 The Indian Pharmaceutical Market will Provide Growth for Generics
  • 13.2.3 India' s Ranbaxy, Sun Pharma and Dr Reddy' s have Expanded into the World Generics Market
• 13.3 China' s Generics Market has Marked Revenue Potential
  • 13.3.1 Competitive Factors Influencing Sales of Domestic Generics in China
  • 13.3.2 Changes in Patent Regulations Required by the WTO may Affect the Supply of Generics
• 13.4 Russia' s Pharmaceutical Market is Largely Dominated by Generic Medicines
  • 13.4.1 Russia' s Generics Market Prospects are Bright

14. Conclusions

• 14.1 World Generics Market will Show Growth
• 14.2 Major Markets will Account for the Largest Generics Revenues
• 14.3 Healthcare Cost Reduction will Drive Demand for Generics in Leading Markets
• 14.4 Generic Drugs for Treating Chronic diseases will Play a Significant Role in this Market' s Expansion
• 14.5 Generics Market will Benefit from High Volume Sales of Blockbuster Drugs Losing Patent Protection
• 14.6 Generics Companies will Rise to the Challenges and Opportunities in the Global Pharmaceuticals Market from 2008-2013

List of Tables

• Table 2.1 World Pharmaceuticals Industry Revenues ($bn), 2000-2007
• Table 3.1 SWOT Analysis for the Generic Pharmaceuticals Market, 2008-2013
• Table 3.2 FDA First-Time Generic Drug Approvals, 2004-2008
• Table 3.3 Sales of Top-10 Generic Companies: Total Group Sales ($bn), Companies Share (%), 2006
• Table 4.1 World Generics Market Sales ($bn) Forecast, 2008-2013
• Table 4.2 World Pharmaceuticals Market Sales vs. World Generics Market Sales ($bn), 2008-2013
• Table 4.3 Major Markets Generics Sales Forecast ($bn), 2008-2013
• Table 4.4 Therapeutic Areas of Drugs Coming Off Patent, 2008-2012
• Table 4.5 Major Chronic diseases and Common Generic drugs
• Table 4.6 Total Patent Expirations by Sales ($bn), 2008-2012
• Table 4.7 Patent Expirations, 2008-2013
• Table 4.8 Key Patent Expirations, 2008
• Table 4.9 Key Patent Expirations, 2009
• Table 4.10 Key Patent Expirations, 2010
• Table 4.11 Key Patent Expirations, 2011
• Table 4.12 Key Patent Expirations, 2012
• Table 5.1 US Generics Market Sales ($bn) Forecast, 2008-2013
• Table 5.2 US Generic Drugs vs. Branded Drugs Revenue ($bn), Drugs Share (%), 2007
• Table 6.1 Japan Generics Market Sales ($bn) Forecast, 2008-2013
• Table 7.1 Generics Market Share by Volume (%) in Representative EU Countries, 2007
• Table 7.2 Generics Market Share by Value (%) in Representative EU Countries, 2007
• Table 7.3 Summary of Policies Affecting EU Generics Markets
• Table 8.1 Germany Generics Market Sales ($bn) Forecast, 2008-2013
• Table 9.1 France Generics Market Sales ($bn) Forecast, 2008-2013
• Table 10.1 UK Generics Market Sales ($bn) Forecast, 2008-2013
• Table 11.1 Spain Generics Market Sales ($bn) Forecast, 2008-2013
• Table 12.1 Italy Generics Market Sales ($bn) Forecast, 2008-2013
• Table 13.1 Leading Domestic Pharmaceutical Companies in India by Sales ($m), 2007
• Table 13.2 Leading Domestic Pharmaceutical Companies in China by Sales ($m), 2007
• Table 13.3 Leading Corporate Pharmaceutical Companies in China by Sales ($m), 2007
• Table 13.4 Leading Domestic Pharmaceutical Companies in Russia by Sales ($m), 2007
• Table 13.5 Leading Corporate Pharmaceutical Companies in Russia by Sales ($m), 2007
• Table 14.1Major Markets: Generics Sales Forecasts ($bn), 2008-2013

List of Figures

• Figure 2.1 World Pharmaceuticals Industry Revenues ($bn), 2000-2007
• Figure 3.1 FDA First-Time Generic Drug Approvals, 2004-2008
• Figure 4.1 World Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 4.2 Sales ($bn) of the World Generics Market vs. World Pharmaceuticals Market, 2008-2013
• Figure 4.3 Therapeutic Areas of Drugs Coming Off Patent, 2008-2012
• Figure 4.4 Total Patent Expirations by Sales ($bn), 2008-2012
• Figure 4.5 Number of Patent Expirations, 2008-2012
• Figure 5.1 US Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 5.2 US Generic Drugs vs. Branded Drugs Share (%), 2007
• Figure 6.1 Japan Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 7.1 Percentage (%) of Generic Drugs vs. Branded Medicines in the EU Market, 2007
• Figure 8.1 Germany Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 9.1 France Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 10.1 UK Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 11.1 Spain Generics Market Sales ($bn) Forecast, 2008-2013
• Figure 12.1 Italy Generics Market Sales ($bn) Forecast, 2008-2013

Companies Listed

• Abbott
• Actavis
• Alcon Labs
• Alkem
• Allergan
• Apotex
• Astellas
• AstraZeneca
• Aventis
• Barr
• Bayer
• Bayer Schering
• Berlin-CH/Menarini
• Boehringer Ingelheim
• Bristol-Myers Squibb
• Centre for Studying Health System Change
• Cipla
• Daiichi Sankyo
• Dr Reddy' s
• Eli Lilly
• European Free Trade Association (EFTA)
• European Generic Medicines Association (EGA)
• European Medicines Agency (EMEA)
• Forest Labs
• Fresenius
• Gedeon Richter
• GlaxoSmithKline
• Graceway
• HLJ Haerbin
• HN.Tongyongsanyang
• International Monetary Fund
• Johnson & Johnson
• Janssen
• Japanese Generic Pharmaceutical Manufacturers Association (JGPMA)
• Japanese Ministry of Health, Labour & Welfare (MLHW)
• Jiangsu YangZijiang
• JS LYG Hengrui
• JS Yangzijiang FTY
• Krka
• Lek
• Lupin Labs
• M.S.D.-Hangzhou
• Mallinckrodt
• Menarini
• Merck & Co
• Merck KGaA
• Mylan
• National Coalition on Health Care
• National Medical Expenditure (NME)
• NIchi-Iko
• Nicholas Piramal
• Novartis
• Nycomed
• Pfizer
• Pharmstandard
• Ranbaxy
• Ratiopharm
• Roche
• Sandoz
• Sanofi-Aventis
• Sanofi-Syn.M-Sheng
• Sanovil
• Sawia
• Servier
• SH.Asia Pioneer PH
• Shandong Qilu FTY
• Stada
• Sun Pharma
• Taiyo
• Takeda
• Tawo
• Teva
• The Medicines Company
• UCB
• UK National Health Service (NHS)
• US Food and Drug Administration (FDA)
• US Generic Pharmaceutical Association (GPhA)
• Wal-Mart
• Watson
• World Bank
• World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO TRIPS)
• Wyeth
• Zydus Cadila

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