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The World Market for Biosimilars (EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other), 4th Edition


Attention: There is an updated edition available for this report.

The World Market for Biosimlars (EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other), 4th Edition

This study, The World Market for Biosimilars, 4th Edition (EPO, G-CSF, HGH, Insulin, Interferon alpha, mAbs, Others), is designed to provide a comprehensive look at the various strategies being used by select worldwide generic companies in exploring the emerging area of biosimilars, the issues and trends that are shaping the marketplace, and the potential feasibility of providing biosimilars within the United States regulatory environment.

Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process may facilitate bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years. As part of its coverage, the report provides the following:

  • Scientific Differences of Pharmaceuticals and Biopharmaceuticals
  • Market Share of Biosimilar Sales in Comparison to Brand Sales
  • Marketed Biologics with Expired Patents
  • Marketed Biologics with Active Patents
  • Cost Savings From Biosimilar Use
  • World Biosimilar Market Potential by Region 2010-2017
  • World Biosimilar Market Potential by Biological Class 2010-2017 ( EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other)
  • Biosimilars Pipeline by Company and Product Type
For the purposes of this study, Kalorama has focused on the market for products which have lost patent in key markets. Projections were made based on the progress that is occurring within the generic arena in terms of capabilities, capital, interest, and development of biopharmaceuticals. Kalorama has identified the biopharmaceuticals that have lost patent protection and are the first products produced by generic companies. As part of its coverage, the following companies were profiled:
  • 3SBio, Inc
  • Actavis, Inc.
  • Apotex, Inc.
  • Beijing Four Rings Biopharmaceutical Co Ltd
  • Biocad
  • Biocon Ltd .
  • Bio Sidus S.A.
  • BioXpress Therapeutics S.A.
  • Boehringer Ingelheim Gmbh
  • Celltrion, Inc.
  • Dong-A Pharmaceutical
  • Dr. Reddy’s Laboratories Limited
  • Epirus Biopharmaceuticals
  • Gedeon Richter
  • Harvest Moon Pharmaceuticals USA,
  • Hospira, Inc.
  • Kyowa Hakko Kirin Co., Ltd.
  • Merck & Company
  • Momenta Pharmaceuticals Inc
  • Phage Pharmaceuticals, Inc.
  • Ranbaxy Laboratories Limited
  • Reliance GeneMedix PLC
  • Reliance Life Sciences
  • Samsung Bioepis Co Ltd
  • Sandoz International GmbH
  • STADA Arzneimittel AG
  • TEVA Pharmaceutical Industries, Ltd.
  • Wockhardt Ltd.
  • Xiamen Amoytop Biotech Co Ltd.


  • Executive Summary
    • INTRODUCTION
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • The World Market for Biosimilars
        • Table Total World Biosimilar Market Potential 2010-2017
    • TRENDS AFFECTING THE MARKET
    • MARKET OUTLOOK
  • Introduction and Overview
    • BIOSIMILARS OVERVIEW
      • Table Scientific Differences of Pharmaceuticals and Biopharmaceuticals Entity Pharmaceutical Biopharmaceutical
    • BIOPHARMACEUTICAL INDUSTRY AND APPROVAL PROCESS
      • Genetic Engineering
      • Patent Approval
    • REGULATIONS FOR BIOPHARMACEUTICALS
    • HISTORY OF THE PRESCRIPTION GENERIC PHARMACEUTICALS INDUSTRY
    • HISTORY OF THE GENERIC APPROVAL PROCESS
    • REGULATION OF PRESCRIPTION GENERICPHARMACEUTICALS
    • BIOPHARMACEUTICALS
    • AREAS OF TREATMENT FOR BIOPHARMACEUTICALS
  • Biosimilar Pharmaceuticals for Expired Biologic Patents
    • Table Select Marketed Biologics with Expired Patents
  • Biosimilar Pharmaceuticals for Future Expired Biologic Patents
    • Table Select Marketed Biologics with Active Patents
    • Table Number of Select Biosimilar Products in Development 2012
  • Issues and Trends
    • OVERVIEW
    • WORLDWIDE REGULATORY AND LEGISLATIVE ISSUES
      • Europe
        • Table Biosimilars Approved in EU
      • United States
      • Japan
      • Rest of World
    • ASIA AND BIOSIMILARS
      • India
      • China
      • South Korea
    • SCIENTIFIC ISSUES
    • PATENT ISSUES
    • PRICING ISSUES
      • Table Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals
    • BARRIERS TO ENTRY
    • BIOSIMILAR DEVELOPMENT PARADIGM SHIFT
    • INNOVATOR STRATEGIES AND CHALLENGES
    • BULK SUPPLIERS AND CONTRACT MANUFACTURING
    • BIOEQUIVALENCE ISSUES
    • INTERNATIONAL ISSUES
    • LOW-COST BRANDED HGH
    • BIOSIMILARS AND HEALTH-CARE SPENDING
    • PATENT CHALLENGES
      • Table Patent Challenges by Company 2012
    • INTELLECTUAL PROPERTY
  • Market Summary
    • TOTAL MARKET SIZE AND FORECAST
      • Market Size and Growth
        • Table Total World Biosimilar Market Potential 2010-2017
      • Regional Market Analysis
        • Table World Biosimilar Market Potential by Region 2010-2017 (in millions)
      • Biologic Class Market Analysis
        • Table The World Market Potential for Biosimilars by Biological Class 2010-2017* (millions)
        • Table Market Share of Biosimilar Sales in Comparison to Brand Sales, 2012 Estimates
      • Market Potential
        • Table Biosimilars Pipeline by Product Type
    • COMPETITOR ANALYSIS
      • Table Market Share of Early Leaders in the World Biosimilar Market, 2012
  • Corporate Profiles
    • 3SBIO, INC
    • ACTAVIS, INC.
    • APOTEX, INC.
    • BEIJING FOUR RINGS BIOPHARMACEUTICAL CO LTD
    • BIOCAD
    • BIOCON LTD .
    • BIOPARTNERS GMBH
    • BIO SIDUS S.A.
    • BIOXPRESS THERAPEUTICS S.A.
    • BOEHRINGER INGELHEIM GMBH
    • CELLTRION, INC.
    • DONG-A PHARMACEUTICAL
    • DR. REDDY'S LABORATORIES LIMITED
    • EPIRUS BIOPHARMACEUTICALS
    • GEDEON RICHTER
    • HARVEST MOON PHARMACEUTICALS USA, INC
    • HOSPIRA, INC.
    • KYOWA HAKKO KIRIN CO., LTD.
    • MERCK & COMPANY
    • MOMENTA PHARMACEUTICALS INC
    • PHAGE PHARMACEUTICALS, INC.
    • RANBAXY LABORATORIES LIMITED
    • RELIANCE GENEMEDIX PLC
    • RELIANCE LIFE SCIENCES
    • SAMSUNG BIOEPIS CO LTD
    • SANDOZ INTERNATIONAL GMBH
    • STADA ARZNEIMITTEL AG
    • TEVA PHARMACEUTICAL INDUSTRIES, LTD.
    • WOCKHARDT LTD.
    • XIAMEN AMOYTOP BIOTECH CO LTD.
  • Company Directory

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