Indian Generics, 2008-2012: The Growing Threat to Westernised Markets

Indian Generics, 2008-2012: The Growing Threat to Westernised Markets

Indian pharmaceutical companies are grabbing headlines on an almost daily basis and are increasingly carving out market shares for themselves in the US and many other markets around the world. Several leading Indian pharmaceutical companies have applied themselves to the challenge of entering Western markets with great success. These companies now present a very serious threat to the existing Western generic companies in their domestic markets as they take ever-larger market shares and increase the levels of competition.

Why has this challenge arisen - what advantages do Indian companies enjoy that enable them to compete so successfully with Western generic companies?

It is the purpose of this report to answer that question and to provide Western pharmaceutical companies and others that are interested by this phenomenon with some explanation of the background. It will also offer some guidance as to how companies might deal with what some see as a threat and others view as a welcome source of low-cost generics.

Report Highlights and Key Findings

• Provides a unique analysis of the leading Indian companies and their areas of expertise

• Examines the factors that have led to their success

• Overview of Indian R&D efforts directed towards developing new New Chemical Entities

• Investigates the local Indian market environment

• Provides a detailed legislative background and role of government agencies in the Indian generics industry

• Analysis of current and predicted future market sizes

• Identifies the drivers of future market growth

• Looks at current and past multinational companies present in India

• Comprehensively explains local healthcare insurance systems

• Explains why Indian generics companies have been so successful

• Identifies the market leaders in the domestic market

• Explores growth strategies companies use on their way up

• Identifies when the Indian growth spurt started

• Investigates the current status of intellectual property in India

• Elucidates the opportunities in the domestic market for foreign companies

• Provides a unique assessment of the Indian generics market both currently and prospectively

• Identifies which companies are likely to be the future generic giants

• Provides insight into what Indian companies themselves see as their main competitors

• Suggests the direction that the Indian pharmaceutical industry likely to follow in the future

Features of This Report:

• Research and analysis by an expert with inside knowledge of an Indian generic company

• Provides an crucial explanation of the key elements in the growing Indian success

• Tabulates and evaluates the leading players in the Indian domestic market

• Discusses the history and future prospects of the market leaders

• Analyses the current and projected market sizes

• Includes an examination of major trends in India and their probable impact

• Provides an overview of population and social trends that will affect growth

• Offers and in-depth analysis of the IP situation and how it has changed and is likely to change in the future

Reasons to Buy This Report:

• To establish if Indian generics businesses are taking a greater share in the European and US generic markets;

• Determines the impact of Indian generics on European and US generic competitors;

• Provides an analysis of the importance of Indian API manufacturers to US markets;

• Establishes the current situation of Indian manufacturing;

• Importantly surveys the trends in India that are likely to impact Western markets.

1. INTRODUCTION TO THE INDIAN PHARMACEUTICAL INDUSTRY

1.0 A Brief History

1.1 The First Companies

1.2 Government Measures to Encourage the Industry

1.2.1 Patents

1.2.2 Price Controls

1.2.3 Government Incentives

1.3 Leading Companies

1.3.1 The Top Ten Indian Pharmaceutical Companies in 2007

1.4 Changes in National Pharmaceutical Export-Import Ratios

1.4.1 The Shift from Active Pharmaceutical Ingredients to Formulations

1.5 The Medium-to-Small Players

1.6 Overseas Presence in the Indian Market

1.6.1 Multinational Branded Companies

1.6.2 Generic Companies

2. GROWTH OF THE INDIAN GENERICS INDUSTRY

2.0 History of the Indian Generics Industry

2.1 Origins - How did it all Start?

2.1.1 The Ladder to Success

2.2 Reverse Engineering

2.3 Speed to Market

2.4 Branded Generics - The Indian Way

2.5 Growth Strategies and Drivers

2.5.1 Active Pharmaceutical Ingredients

2.5.2 Contract Manufacture of Formulations

2.5.3 Own Registrations Abroad

2.5.4 Patent Challenges

2.5.5 Subsidiaries/Joint-Ventures

2.5.6 Acquisitions - The Rationale

2.5.6.1 Recent Acquisitions

3. INDIAN DRUG LEGISLATION

3.0 Legislative Background

3.1 The Drugs and Cosmetics Act, 1940

3.2 Drug Policy of 1986

3.3 Liberalisation Since 1991

3.4 Pharmaceutical Registration

3.5 Data Exclusivity

3.6 Barriers to Foreign Ownership

3.7 Price Controls

3.8 Patents and Intellectual Property

3.8.1 Indian Patents Third Amendment Bill, 2005

3.8.2 Trade-Related Intellectual Property Rights (TRIPS)

3.8.3 Doha Declaration

3.8.4 Impact on International Relations

3.9 Export Incentives

4. THE INDIAN DRUG MARKET

4.0 Domestic Market and Healthcare System

4.1 Market Size and Drivers of Growth

4.1.1 Market Size

4.1.2 Growth Drivers

4.1.2.1 Increased Prosperity and Life Expectancy

4.1.2.2 Improving Transport

4.1.2.3 Healthcare Expenditure

4.2 Leading Domestic Companies

4.3 Leading Foreign Players

4.4 The Indian Market in an International Context

4.5 Market Growth - Past and Future

4.6 The Healthcare System

4.6.1 Basic Healthcare

4.6.2 Hospitals

4.6.3 Health Insurance

4.6.3.1 Social Health Insurance

4.6.3.2 Private Health Insurance

4.6.4 The Poor

4.7 Traditional, Herbal and Ayurvedic Medicines

4.8 Factors Influencing Pricing

5. COMPANY PROFILES

5.1 [Company]

5.1.1 History

5.1.2 Sales Growth

5.1.3 Major Products

5.1.4 Overseas Presence

5.1.4.1 United States

5.1.4.2 Europe

5.2 [Company]

5.2.1 History

5.2.2 Sales Growth

5.2.3 Major Products

5.2.4 Overseas Presence

5.3 [Company]

5.3.1 History

5.3.2 Sales Growth

5.3.3 Major Products

5.3.4 Overseas Presence

5.4 [Company]

5.4.1 History

5.4.2 Sales Growth

5.4.3 Major Products

5.4.4 Overseas Presence

5.5 [Company]

5.5.1 History

5.5.2 Sales Growth

5.5.3 Major Products

5.5.4 Overseas Presence

5.6 [Company]

5.6.1 History

5.6.2 Sales Growth

5.6.3 Major Products

5.6.4 Overseas Presence

5.7 [Company]

5.7.1 History

5.7.2 Sales Growth

5.7.3 Major Products

5.7.4 Overseas Presence

5.8 [Company]

5.8.1 History

5.8.2 Sales Growth

5.8.3 Major Products

5.8.4 Overseas Presence

5.9 [Company]

5.9.1 History

5.9.2 Sales Growth

5.9.3 Major Products

5.9.4 Overseas Presence

5.10 [Company]

5.10.1 History

5.10.2 Sales Growth

5.10.3 Major Products

5.10.4 Overseas Presence

6. OUTLOOK FOR THE INDIAN GENERICS INDUSTRY

6.1 Growth Opportunities and Possible Threats for Indian Companies

6.1.1 Opportunities

6.1.3 Acquisitions

6.2 Threats

6.2.1 Market Saturation and Consolidation

6.2.2 Competition

6.3 Research and Development

6.3.1 New Developments

6.3.2 Alliances

7. CONCLUSIONS AND INSIGHTS FOR THE INDIAN GENERICS MARKET

7.1 Is India the Pharmaceutical Giant of the Future?

7.1.1 Domestic Market

7.1.2 International Growth

7.1.3 Environmental Concerns

7.1.4 Growth through Consolidation

7.1.5 Growth through New Products

7.1.5.1 Generics

7.1.5.2 New Chemical Entities

7.2 Are Indian Companies Allies or Opponents?

7.2.1 Alliances

7.2.2 Indian Companies as Competitors

7.3 Who will be Tomorrow’s Generic Champions?

7.3.1 The Future

List of Tables

Table 1 Presence of Asian Pharmaceutical Companies at Annual Global Exhibitions, 1997-2005

Table 1.1 Pricing Differentials of Ciprofloxacin (10 × 500mg tablets) in 2006

Table 1.2 Price Comparisons of Doxycycline in Europe, the US, and India

Table 1.3 Top Ten Indian Pharmaceutical Companies by Turnover, 2005

Table 1.4 Annual Revenues of the Leading Indian Drug Manufacturers, 2006-2007

Table 1.5 Value Growth Trends of Drug Exports and Imports in India, 1999-2005 (Crore Rupees)

Table 1.6 Domestic Sales of Medium-to-Small Sized Pharmaceutical Players (to March 2005)

Table 1.7 Members of the Organisation of Pharmaceutical Producers of India

Table 2.1 List of Brand Names for Cephalexin, the Manufacturers and Price Comparisons

Table 2.2 Sales Distributions (%) of Selected Indian Drug Manufacturers by Region, 2006

Table 2.3 Ranbaxy Cases and Outcomes with Pfizer in Europe, 2005-2007

Table 2.4 Selected Indian Drug Company Acquisitions in North America

Table 2.5 Selected Indian Drug Company Acquisitions in Western Europe

Table 2.6 Selected Indian Drug Company Acquisitions in Eastern Europe

Table 3.1 Indian Trade Balance, 2000-2007 (US$m)

Table 3.2 Comparison of Indian Data Exclusivity Proposals to Actual Practice in the West

Table 3.3 History of the Indian Patent System

Table 4.1 Analysis of Pharmaceutical Sales in India, Quarter ending March 2007

Table 4.2 Indices of Population and Economic Growth in India, 2004-2008

Table 4.3 Leading Indian Pharmaceutical Company Market Shares, 2004-2006

Table 4.4 Comparison of Indian Drug Sales by Value (US$m) with Key International Territories (2005-2006) and Population Statistics

Table 5.1 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.2 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.3 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.4 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.5 Major [Company] Brands and Sales (Rs and US$ million)

Table 5.6 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.7 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.8 [Company] Major Domestic Brands and Sales (Rps million), 2006-2007

Table 5.9 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.10 Annual Sales Figures (Rs and US$) for [Company], 2002-2007

Table 5.11 Annual Sales Figures (Rs and US$) for [Company], 2002-2006

Table 5.12 Annual Sales Figures (Rs and US$) for [Company], 2002-2007