Indian Generics, 2008-2012

A Growing Threat to Westernised Markets

Publication Date January 2008
ISBN n/a
Pages 138
Tables 40
Figures 5

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What advantages do Indian companies enjoy that enable them to compete so successfully with Western generic companies?

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.

The Challenge from Indian Generic Companies

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.

  • Executive Summary
  • 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
  • 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
    • 6.4 Opportunities in India for Overseas Companies
  • 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 x 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
    • Table 6.1 SWOT Analysis for the Indian Pharmaceutical Industry
    • Table 6.3 International Acquisition Targets by Indian Pharmaceutical Manufacturers,2006-2007
    • Table 6.2 Patent Expiries of Leading Branded Drugs, 2007-2011
    • Table 6.4 Indian Pharmaceutical Research and Development Expenditure, 2000-2006
    • Table 7.1 Promising Drug Candidates in Development from Indian Pharmaceutical Companies
    • Table 7.2 Indian Drug Company Revenues from the US Market (1998, 2003, and 2008)
    • Table 7.3 Indian Companies: Current and Potential Turnovers, 2006 & 2012 (US$m)
  • List of Figures
    • Figure 2.1 Drug Master Files Submitted by Indian Companies, 1996-2005
    • Figure 2.2 United States Food and Drug Administration Approved Manufacturing Sites, 2006
    • Figure 2.3 Indian Abbreviated New Drug Applications (ANDAs) Approved by the United
    • States Food and Drug Administration, 2001-2004
    • Figure 4.1 Indian Pharmaceutical Company Market Shares, 2004-2006
    • Figure 4.2 Value and Volume Growth Rates of the Indian Pharmaceutical Industry,1993-2006