World Generics Market, 2008-2013

Summary

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.

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