World Generics Market

2009 - 2024

Publication Date	August 2009
Publisher	Visiongain
Product Type	Report
Pages	126
ISBN Number	not applicable
Product Code	VIS00095

Buy this product or for assistance call +44 20 7060 7474

PDF £1,499.00$2493 | €1678

FAX Order above formats by FAX

Summary

Impending patent expiries, increasing competition and changes in legislation: where will generics go from 2009 onwards? Our new report - World Generics Market 2009-2024 - explains the opportunities and challenges there

The generic pharmaceuticals sector has been expanding strongly in recent years as the need for cheaper medicines worldwide has increased. The next five years from 2009 will see more leading drugs going off patent, thus increasing opportunities for generics producers. Regulations favouring generic products give cause for optimism in the generics sector, while still leaving scope for novel branded drugs. We predict that total revenues in the generics market will continue to increase in the years ahead.

Major players have been moving into the generic drugs market - spearheaded by leading pharma companies and specialist pharma organisations. Established generics companies, such as Teva, are increasing in commercial prominence and international reach. There are many rising challengers in developed and developing countries, inspired by patent expiry on major drugs. What will be the main challenges and the main opportunities in this market from 2009 onwards? Our new report, World Generics Market 2009-2024, investigates such questions in depth, providing you with the information that you need.

This report reveals forecasted sales in the world generics market and in leading national markets, providing detailed quantitative and qualitative data. In particular, World Generics Market 2009-2024 includes generics market forecasts for:

The US
Europe (with special focus on Germany, France, the UK, Italy and Spain)
Japan
China
India
Russia.

Our report also gives in-depth profiles of the five leading generic manufacturers: Teva, Sandoz, Mylan, Watson and Ratiopharm.

Comprehensive analysis of the global generics sector

World Generics Market 2009-2024 examines that sector critically, through a comprehensive review of information sources. This report provides detailed sales forecasts, discussions of developments and analyses of commercial drivers and restraints, including a SWOT analysis. There are 61 tables and figures and a full interview with an expert in the sector. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to benefit your work.

Why you should buy World Generics Market 2009-2024
In this report you will receive the following benefits in particular:

`You will receive an appraisal of the current world generics market
You will receive analyses of the potential value of the world generics market, including detailed revenue forecasts from 2009 to 2024
You will receive analyses of the most-promising areas for generic drug development and marketing
You will receive forecasts for principal geographical markets, especially those with high growth potential
You will examine strengths and weaknesses of the worldwide generics sector from 2009 onwards, especially commercial drivers and restraints
You will discover expert opinion from our industry survey.

You can obtain this report today
Nobody with an interest in the generics sector can afford to overlook this new market study. The market environment in many countries will change, especially with the further rise in economic power of China and India. With an increasing focus on lowering healthcare costs, widening treatment access and patent expiries, this sector holds the potential for high, growing revenues from 2009 onwards. Do you want to know more about the rising generics market? You can stay ahead by ordering this report today.

Content

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

Companies Mentioned

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