U.S. and Worldwide Monoclonal Antibody Medicine

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