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The Market for Generic Biologics: Issues, Trends, and Market Potential

Biologics, or biopharmaceuticals, are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biogenerics are not generic biologics, because there can technically be no generic form of biologics. That is, the complex process of creating biologics, means that traditional definitions of bioequivalence used in the generic drug industry do not (or may not) apply. Industry participants are struggling with what to call these hybrid forms of biologics that will inevitably be created by the generic companies.

This report describes the complex regulatory and technical issues involved in the emerging biogeneric industry and forecasts the potential size and growth of the market for currently off-patent and soon-to-be off-patent biopharmaceuticals by analyzing likely candidates, their current market value, and any generic development underway.


Chapter One: Executive Summary

  • Scope and Methodology
  • Size and Growth of the Market
  • Trends Affecting the Market
  • Market Outlook

Chapter Two: Introduction and Overview

  • Biogenerics Overview
  • Biopharmaceutical Industry and the Approval Process
  • Genetic Engineering
  • The Traditional Approval Process
  • Regulations for Biopharmaceuticals
  • History of the Prescription Generic Pharmaceuticals Industry
  • The Generic Approval Process
  • Regulation of Prescription Generic Pharmaceuticals
  • Biopharmaceutical Therapeutic Areas

Chapter Three: BioGeneric Pharmaceuticals for Expired Biologic Patents

  • The Products
  • Market Size and Growth
    • World Market
    • U.S. Market
    • Non-U.S. Market

Chapter Four: BioGeneric Pharmaceuticals for Future Expired Biologic Patents

  • The Products
  • Market Size and Growth
    • World Market
    • U.S. Market
    • Non-U.S. Market

Chapter Five: Issues and Trends

  • Overview
  • Regulatory and Legislative Issues
  • Scientific Issues
  • Patent Issues
  • Pricing Issues
  • Barriers to Entry
  • Innovator Strategies and Challenges
  • Bulk Suppliers and Contract Manufacturing
  • Bioequivalence Issues
  • International Issues

Chapter Six: Market Summary

  • Total Market Size and Forecast
  • Competitor Outlook

Chapter Seven: Corporate Profiles

  • Analiza, Inc
  • Apotex, Inc.
  • Barr Laboratories, Inc.
  • BioGeneriX AG
  • Cangene Corporation
  • Dr. Reddy’s Laboratories Limited
  • Dragon Pharmaceuticals, Inc.
  • GeneMedix plc
  • IVAX Corporation
  • Microbix Biosystems, Inc.
  • Sandoz (Novartis)
  • Sicor, Inc.
  • STADA Arzneimittel AG
  • TEVA Pharmaceutical Industries, Ltd.
  • Watson Pharmaceuticals, Inc.
Appendix A: Company Directory
Appendix B: Generic Company Directory

List of Exhibits
Chapter One: Executive Summary

  • Table 1-1: Total World Biogenerics Market Potential 2004-2008
  • Figure 1-1: The World Market Potential for BioGeneric Drugs Revenues by Current Patent Status 2004-2008
  • Figure 1-2: The World Market Potential for BioGeneric Drugs Share by Current Patent Status 2008

Chapter Two: Introduction and Overview

  • Table 2-1: Major Areas of Biopharmaceuical Treatment

Chapter Three: BioGeneric Pharmaceuticals for Expired Biologic Patents

  • Table 3-1: Marketed Biopharmaceuticals with Expired Patents
  • Table 3-2: Total World Biogenerics Market Potential for Products with Currently Expired Patents 2004-2008
  • Table 3-3: Total U.S. Biogenerics Market Potential for Products with Currently Expired Patents 2004-2008
  • Table 3-4: Total Non-U.S. Biogenerics Market Potential for Products with Currently Expired Patents 2004-2008

Chapter Four: BioGeneric Pharmaceuticals for Future Expired Biologic Patents

  • Table 4-1: Currently Marketed Biopharmaceuticals with Active Patents—Product, Maufacturer, Approval Date
  • Table 4-2: Earliest Patent Expiry Dates for Selected Biopharmaceutical Products
  • Table 4-3: 2003 Revenues of Key Branded Biopharmaceutical Products
  • Table 4-4: Currently Marketed Biopharmaceuticals with Active Patents with Known Generic Development Underway (as of May 2004)
  • Table 4-5: Cost of Treatment for Selected Biopharmaceutical Products with Active Patents
  • Table 4-6: Total World Biogenerics Market Potential for Products with Active Patents 2004-2008
  • Table 4-7: Total U.S. Biogenerics Market Potential for Products with Active Patents 2004-2008
  • Table 4-8: Total Non-U.S. Biogenerics Market Potential for Products with Active Patents 2004-2008

Chapter Five: Issues and Trends

  • Table 5-1: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals

Chapter Six: Market Summary

  • Table 6-2: The World Market Potential for BioGeneric Drugs Revenues and
  • Growth by Current Patent Status 2004-2008
  • Figure 6-1: The World Market Potential for BioGeneric Drugs Revenues by Current Patent Status 2004-2008
  • Figure 6-2: The World Market Potential for BioGeneric Drugs Share by Current Patent Status 2008

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