Research Objectives

Antibody drugs were a $24 billion business in 2007. Although most pharmaceuticals are chemically synthesized small molecules, antibodies are large and complex proteins (immunoglobulins) that act as the human body's own weapons against infections, diseases and abnormal cancer cells. Monoclonal antibodies (MAbs) mimic the body's immune system with the antibody working as the drug molecule; only MAbs are engineered artificially outside the body, in the laboratory, rather than by a person's own immune system. Furthermore, MAbs are engineered to binding to one particular antigen only. MAbs are thus important tools for medicine as extremely targeted therapies for treating patients with severe diseases - especially autoimmune conditions and cancers.

This report analyzes the activities of the leading biopharmaceutical companies with antibody-based drug products currently on the market or scheduled for introduction soon. The focus is MAb therapeutics used for treating a disease or condition (as opposed to MAbs used as a diagnostic or for research). The report details the status of drug makers' antibody pipelines; their alliances, M&As and investments to develop and commercialize new MAb drugs; and their standing in the battle for market share and bringing a new best-selling drug to patients. Technological progression in the development of antibody and protein-based human therapies is overviewed. This report is part of Fuji-Keizai's ongoing efforts to track the U.S. and global biopharmaceuticals marketplace.



Table of Contents

Research Objectives
  Research Method and Sources
  Key Characteristics of Monoclonal Antibodies

1. Market Overview
  Timeline of FDA approval of therapeutic MAbs (drugs now on the U.S. market)
  MAbs in Clinical Trial (as of March 2008)
  Market Players
    Key Players & Business Model
      Large Pharmas
      Biotechnology Companies
      Technology/Platform Companies
      VC-funded Start-ups
      Contract Biopharma Manufacturers

2. Product Trends
  2.1 Current Products
    Company Name/Product Name/Introduction/Target Body/2007 Sales Amount ($M)
  2.2 Company Pipelines
    Company Name/Project Name/Current Stage/Target Body /Important Items

3. Technology Trends Overview: Current to Future
  3.1 Antibody and Immune System Overview
    3.1.1 Antibody Structure
      Immunoglobulin classes
    3.1.2 Antibody Targets
      Important targets for anti-cancer MAbs
        Target/Drug or Drug Candidate/Status
    3.1.3 Mechanisms of Action
      Variety of MAbs: different technologies, structures, targets, action mechanisms
        Brand Name/Technology/Structure/Target/Mechanism of Action
  3.2 Antibody Generation: Current and Emerging Technologies
      Evolution of MAb technology
    3.2.1 Hybridoma Technology
        Platform players:
    3.2.2 Genetically Engineered and Humanized MAbs
        Transgenic Animal Technologies
          Platform players:
        Library Technologies (phage display)
          Platform players:
        Optimization and Protein Engineering
          Platform players:
    3.2.3 Human MAb Platforms
      MabIgX
      HuCAL
    3.2.4 Alternatives to plain MAbs
      Antibody Conjugates
        Platform players:
      Antibody Fragments and Hybrids
        Platform players:
      Bifunctional MAbs
        Platform players:
      Recombinant polyclonal technology
        Platform players:
    3.2.5 Manufacturing
      Players:

4. Market Analysis
  4.1 Monoclonal Antibody Market Forecast (Total) 2006-2012
    Key Findings
      Late-stage MAb drugs: anticipated timeline for approval: 2009-2011
       Growth Drivers
      Market Impediments/Challenges
  4.2 Breakdown by Company
     Key Findings
  4.3 Breakdown by Therapy Segment
      MAb product revenues, by therapy areas: 2006-2012
      Monoclonal antibody share of total immunology drug market (by revenues): 2008 -2012
    Therapy Market Growth Drivers: Immunology and Cancer
      Monoclonal antibody share of total cancer drug market (by revenues): 2012
      Therapy areas, by market share ( %): 2007 revenues of all MAbs
  4.4 Breakdown by Therapies in the Pipeline (2012 Market Potential)
      Percentage of MAb drugs in pipeline, by therapy area (post-2008 potential)
      MAb drug candidates in development, by specific disease indication
    Growth Driver: Alzheimer's MAb pipeline
      Findings
      Infectious disease MAb pipeline
        Maker/Drug Name/Stage/Therapy Market Comment
      Osteoporosis MAb pipeline
        Maker/Drug/Stage/Therapy Market/Comment
      Finding
  4.5 Breakdown by Products
    Top 5 monoclonal antibody drugs, by sales
      DrugMaker /Product Revenues ($ Million): 2006-2012
      Market share (%) of top 5 MAb drugs, 2007
    Growth Drivers of the Top 5
    Multiple Indications as Growth Driver for Best-selling MAbs
      Revenue for dual-purpose cancer drug Avastin: 2008-2012
    Premium Pricing as Growth Driver and Inhibitor
      Drug/Unit Price/Monthly or Yearly Cost
      Finding
      MAb oncology products, by sales
      Drug Maker/Product Revenues ($Million): 2006-2012
    Growth Drivers for Cancer MAb Products
      Immunology MAb products, by sales
      Drug Maker/Product Revenues ($Million): 2006-2012
    Growth Drivers for Autoimmune Disease MAb Products
      Other MAb commercialized products, by sales
      Drug Maker /Product Revenues ($ Million): 2006-2012
    Growth Drivers and Impediments in Other Disease Markets
  4.6 Breakdown by Technology

5. M&A, Alliance Map
  5.1 MAb and related biologics M&A activity: 2005-2008 (YTD)
    Year/Buyer/Company Acquired /Asset Acquired/$ Value
    Key Findings
    Top 12 Pharmaceuticals (by 2007 sales) and MAb acquisitions or alliances

6. Major Company Analysis
  6.1Abbott Laboratories
    Profile of Monoclonal Antibody Business
      Currently marketed MAb drugs
        Drug Name/Target Therapy Area/Comment
    Market Superiority
    M&A Strategy
    Company Pipeline Analysis
      Technology pipeline analysis
      Therapy area pipeline analysis
      MAb and protein-based drugs in development
    Target pipeline analysis

  6.2 Amgen, Inc.
    Same as above-mentioned research items
  6.3 Biogen Idec, Inc.
    Same as above-mentioned research items
  6.4 Genentec/Roche
    Same as above-mentioned research items
  6.5 Johnson & Johnson/Centocor
    Same as above-mentioned research items
  6.6 Medimmune/Astrazeneca
    Same as above-mentioned research items
  6.7 Novartis Pharmaceuticals
    Same as above-mentioned research items
  6.8 UCB Biopharma
    Same as above-mentioned research items

7. Venture Company Activity (Total 20 companies)
  Common Research Item:
    Location/URL
    Profile
    Development

8. Key Findings
  Big Picture
  Pipeline
  Technology and Production




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