美國及全球單株抗體藥物市場

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.

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 MarketComment
  • 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