Biogenerics: The World Market for Biosimilars

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Published Apr 1, 2008 | 153 Pages | Pub ID: KLI1399521

In one sense, the opportunity for follow-on proteins is as good as ever. Some of the biggest-selling biologics developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection or are set to lose patent protection in the US in 2007 and beyond. But there are also regulatory challenges to marketing follow-on biologics in the U.S. that companies will need to navigate to prosper.

In this report, Biogenerics: The World Market for Biosimilars Kalorama has identified key biologic products that are off patent and are either facing development of a generic competitor or are likely in Kalorama's estimate to face biogeneric competition in the future.

Since Kalorama Information last visited the market for synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies four years ago, there has been much more worldwide involvement in the development of the biogeneric arena.

Kalorama Information's survey includes as part of its market analysis a breakdown of generic replacements for:

  • Drugs with Active patents
  • Drugs with Expired patents
with this geographic breakdown:
  • World
  • US
  • non-US
As part of overall market coverage of biogenerics, this report includes:
  • Complete Overview
  • Market Size Projections for Biogenerics Products
  • Patent dates for Major Biopharmaceuticals
  • Issues and Trends in the Industry
  • Scientific Differences Between Biopharmaceuticals and Biogenerics
  • Key Regulations Affecting this Market
  • Company Profiles
The following critical trends occuring in biogenerics are discussed:
  • Worldwide Regulatory and Legislative Issues
  • Asia and Biogenerics
  • Scientific Issues
  • Patent Issues
  • Pricing Issues
  • Barriers to Entry
  • Innovator Strategies and Challenges
  • Bulk Suppliers and Contract Manufacturing
  • Bioequivalence Issues
  • International Issues
  • Low Cost Branded HGH
  • Biogenerics and Health-Care Spending
  • Intellectual Property
As part of Kalorama Information's trusted information gathering process, this report is the result of both primary and secondary research. In addition to exhaustive research, Key executives at biogeneric companies were consulted to uncover key trends and develop models.

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Introduction
  • 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 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 Generic Pharmaceuticals
  • Biopharmaceuticals
  • Areas of Treatment for Biopharmaceuticals
CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
  • Market Size and Growth
    • Non-U.S. Market
    CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
    • Market Size and Growth
      • World Market
      • Non-U.S. Market
    CHAPTER FIVE: ISSUES AND TRENDS
    • Overview
    • Worldwide Regulatory and Legislative Issues
      • Europe
      • United States
      • Rest of World
    • Asia and Biogenerics
    • Scientific Issues
    • Patent Issues
    • Pricing Issues
    • Barriers to Entry
    • Innovator Strategies and Challenges
    • Bulk Suppliers and Contract Manufacturing
    • Bioequivalence Issues
    • International Issues
    • Low Cost Branded HGH
    • Biogenerics and Health-Care Spending
    • Intellectual Property
    CHAPTER SIX: MARKET SUMMARY
    • Total Market Size and Forecast
    • Competitor Analysis
    CHAPTER SEVEN: CORPORATE PROFILES
    • Analiza, Inc
    • Apotex, Inc.
    • Barr Laboratories, Inc.
    • Biogenerix Ag
    • Biocon Ltd .
    • BioPartners GmbH
    • Cangene Corporation
    • Dr. Reddy’s Laboratories Limited
    • Dragon Pharmaceuticals, Inc.
    • GeneMedix PLC
    • Hospira, Inc.
    • Microbix Biosystems, Inc.
    • Momenta Pharmaceuticals Inc
    • Phage Biotechnology Corp
    • Sandoz
    • Sicor, Inc.
    • STADA Arzneimittel AG
    • TEVA Pharmaceutical Industries, Ltd.
    • Watson Pharmaceuticals, Inc.
    LIST OF EXHIBITS

    CHAPTER ONE: EXECUTIVE SUMMARY

    • Table 1-1: Total World Biogenerics Market Potential 2006-2012
    • Figure 1-1: The World Market Potential for BioGeneric Drugs by Revenues 2006-2012
    INTRODUCTION AND OVERVIEW
    • Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals
    CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
    • Table 3-2: Marketed Biopharmaceuticals with Expired Patents
    • Table 3-3: Total World Biogenerics Market Potential 2006-2012, Products with Expired Patents
    • Table 3-4: Total U.S. Biogenerics Market Potential 2006-2012, Products with Expired Patents Table 3-5: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products with Expired Patents
    CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
    • Table 4-1: Marketed Biopharmaceuticals with Active Patents
    • Table 4-2: Total World Biogenerics Market Potential 2006-2012, Products with Active Patents
    • Table 4-3: Total U.S. Biogenerics Market Potential 2006-2012, Products withActive Patents
    • Table 4-4: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products with Active Patents
    CHAPTER FIVE: ISSUES AND TRENDS
    • Table 5-1: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals
    CHAPTER SIX: MARKET ANALYSIS
    • Table 6-1: Total World Biogenerics Market Potential 2006-2012
    • Table 6-2: The World Market Potential for BioGeneric Drugs by Patent Segment 2006-2012
    • Figure 6-1 Total World Biogenerics Market Potential 2006-2012 (Active, Expired)
    • Figure 6-2 The World Market Potential for BioGeneric Drugs by Patent Segment (Active, Expired) 2006-2012
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