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Global Biosimilars Market Report
2012 Edition

  • Publication Date:July 2012
  • Publisher:Koncept Analytics
  • Product Type: Report
  • Pages:40

Global Biosimilars Market Report 2012 Edition

The biosimilar market is presently a small segment of the pharmaceutical industry. However, in the years to come, the market for biosimilars has huge growth opportunity despite of the high entry barriers. The governments in the developed countries are desperately trying to control their national healthcare expenditure. Furthermore, the patents for several original bio drugs are expected to expire in the coming decade. These factors along with the new biosimilar guidelines by the US Food & Drug Administration are paving the path for the growth for the biosimilar market.

Biosimilars are generic version of bio drugs or off patent bio drugs, which are usually more cost effective compared to the original version of the drug. So far, Europe has been the most developed market for biosimilars. The biosimilar market in the Europe is strictly governed by European Medicines Agency (EMA).

The global biosimilar market is expected to become highly competitive in the coming years as original chemical drug makers, generic chemical drug makers, and original bio drug makers are entering into biosimilars business seeing the growth potential of the market. Within the biosimilar market, the pipeline for anti- TNF biosimilars is quite higher compared to other biosimilars.

It is expected that the market for Epoetin alpha and Insulin-glargine biosimilars will grow significantly during 2010-2015 in the developed countries, mainly driven by cost containment efforts from the US and European governments. Within the global first generation biosimilar market, the market for G-CSF biosimilar recorded huge growth in 2010 compared to the previous year.

The growth of the biosimilar market is mainly driven by rising aging population, growing healthcare expenditure, growing worldwide economy, and patent expiries of market leading bio drugs. New technologies like recombinant DNA technology, protein sequencing, protein electrophoresis, and western blotting are also expected to have a positive impact on the market. However, requirement of extensive clinical trials for obtaining approval, lower profit margins, and lower return on investments continues to challenge the attractiveness of the biosimilars market.

The report analyzes the global biosimilars market. The various drivers and challenges faced by the market are discussed in detail. The competitive landscape of the market is also highlighted and the key players are profiled with their key business strategies.

  • 1. Biosimilars: An Introduction
    • 1.1 Overview
    • 1.2 Differences between Biosimilars and Biobetters
    • 1.3 Manufacturing of Bio Drugs
    • 1.4 FDA's Guidance on Biosimilars in the US
    • 1.5 Present Market Conditions
  • 2. Biosimilars Market
    • 2.1 Worldwide Market
      • Market Value
      • Revenue Trend in Developed Countries
      • Product Pipeline
      • Market Statistics
    • 2.2 Biotech Product Market in the US
    • 2.3 Biosimilar Market in Europe
    • 2.4 Bio Drug Market in Korea
  • 3. Key Trends
    • 3.1 Global Drug Makers Rushing to Develop Biosimilars
    • 3.2 Urgent Requirement of Biosimilars in the US
    • 3.3 Policies of European Government to Control Healthcare Expenditure
  • 4. Growth Drivers
    • 4.1 Rising Healthcare Expenditure
    • 4.2 Rising Ageing Population
    • 4.3 Growing Worldwide Economy
    • 4.4 Upcoming Patent Expiries of Original Bio Drugs
  • 5. Significant developments
    • 5.1 Recombinant DNA Technology
    • 5.2 Protein Sequencing Method
    • 5.3 Protein Electrophoresis
    • 5.4 Western Blotting
    • 5.5 Monoclonal Antibodies (MAB) Technology
  • 6. Challenges
    • 6.1 Requirement of Extensive Clinical Trials for Obtaining Approval
    • 6.2 Strong Marketing Capabilities Required
    • 6.3 Lower Margins in Biosimilars
    • 6.4 Concern over Return on Investments of Biosimilars
  • 7. Biosimilars Market - Competitive Landscape
    • Competitive Overview
    • Market Share
  • 8. Company Profile
    • 8.1 Hospira Inc.
      • Business Description
      • Key Financials
      • Business Strategies
      • Product Development Strategy
      • Achieving Product Differentiation
    • 8.2 Teva Pharmaceutical Industries Limited
      • Business Description
      • Key Financials
      • Business Strategies
      • Increasing Generic Market Share
      • Expanding OTC Opportunities
    • 8.3 Merck & Co., Inc.
      • Business Description
      • Key Financials
      • Business Strategies
      • R&D Strategy
      • Merger Restructuring Program
    • 8.4 Novartis AG
      • Business Description
      • Key Financials
      • Business Strategies
      • Leadership in Innovation
      • Driving Productivity of the Organization
  • 9. Market Outlook
  • List of Charts
    • SWOT Analysis of Biosimilars Market
    • Biosimilar Development Process and Investment Costs
    • Competition in the Biosimilar Market
    • Global Bio Drugs Market, 2006-2011
    • Global Market Status of Off-Patent Bio Drugs, 2008-2011
    • Size of Biosimilar Pipeline, 2010
    • Revenue of Biosimilar & Biologics Products in Developed Countries, 2009-2015F
    • Worldwide Revenue of Biosimilars and Biologics Market, 2009-2015F
    • Global First Generation Biosimilar Market Status, 2009-2010
    • Expected Breakup of Global Drug Market, 2015E
    • Sales of Biologics Products in the US as a Percentage of Global Market, 2010
    • Global Healthcare Spending, 2005-2015E
    • Growth of Global Aging Population, 2005-2012E
    • World GDP per Capita, 2005-2010
    • Major Players in the Global Biosimilar Market, 2011
    • Market Share of Major Players in the European biosimilars market, 2010
    • Net Sales of Hospira by Reportable Segments, 2011
    • Net Sales & Net Income of Hospira, 2007-2011
    • Teva Share of Revenue by Reportable Segment, 2011
    • Net Revenues and Net Income of Teva, 2007-2011
    • Sales of Merck & Co. by Segments
    • Net Sales and Net Income of Merck & Co., 2007-2011
    • Novartis Share of Sales by reportable Segments, 2011
    • Net Sales and Net Income of Novartis, 2007-2011
  • List of Tables
    • Positives and Negatives of Biosimilar Industry
    • Global Market for Top Selling Bio Drugs, 2010-2016F
    • Major Biosimilar Product Revenues Trends in Developed Countries, 2009A-2015F
    • Clinical Development Cost of Monoclonal Antibodies, 2011E
    • Biosimilars Approvals in Europe, 2006-2009
    • Sales of Bio Drugs in Korea, 2007-2011
    • Expiry of Bio Drugs Patents in the Global Market, 2012-2019
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