業界分析：企業は癌治療向けモノクローナル抗体の市場での成功を維持できるか

Abstract

Introduction:

From 2002 to 2005, global sales of monoclonal antibodies (MAbs) increased 179% to $14.1 billion. MAbs are revolutionizing cancer therapy, and promising new MAbs crowd the pipeline. But the industry landscape is changing-big pharma is moving in, competition is increasing, business strategies are proving inadequate, and pricing/reimbursement issues are increasingly vexing.

Get the Answers You Need to Shape Your Strategy:

• Small companies drive MAb technology development, but most survive precariously on license and royalty income from the big pharma/big biotech companies that dominate MAb commercialization. How can these technology leaders fend off acquisition by their big-and increasingly interested-licensees? What can they do to maximize income from their own technologies and ensure their continued independence?
• Three major acquisitions were announced in the first half of 2006. Three big pharma companies will acquire, among other assets, unique technologies that enable creation of fully human MAbs. Will competitors' access to these technologies be diminished? Will current license holders find they must renegotiate agreements on less favorable terms?
• Cancer-treating MAbs dominate the market, followed by MAbs for autoimmune and respiratory disease. Some 162 new MAbs are in pipelines worldwide, and more than 400 clinical trials are under way. Which companies lead the MAb market today? Why do some MAbs become blockbusters while others do not? Which MAbs now in the pipeline look like potential blockbusters?
• The MAb industry' s strong and evolving technology will continue to improve cancer treatment, but a more competitive market and escalating criticism of the extremely high cost of MAb therapy will present challenges. How can companies maintain their competitive advantage, deliver more efficacious therapies while controlling costs, and simultaneously respond to patients' and insurers' demands for reasonably priced MAb therapies?

Scope:

Monoclonal antibody technology: A review of technology methodologies.

Industry leaders: Companies, technology platforms, products, and pipelines.

Markets: Leading cancer-targeting MAbs, sales growth, and market share.

Industry dynamics: Important acquisitions, evolving business and deal strategies, and competition.

Pricing and reimbursement: Controversies and criticism from payers as well as the public.

Outlook: MAb industry strengths, weaknesses, opportunities, and threats.

Spectrum Expert Commentary: The view from an executive at an industry-leading company.

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Huge Success of Monoclonal Antibodies
• Technology in a Nutshell
• Major Monoclonal Technology Leaders
  • Spectrum Expert Commentary: Monoclonal Antibodies as Drug Delivery Agents
• Red Hot Monoclonal Products and Markets
  • Rituximab-Targeted B-Cell Therapy
  • Trastuzumab-Targeted HER2 Therapy
  • Bevacizumab-First Approved Antiangiogenesis Therapy
  • Cetuximab-First MAb to Treat Colorectal Cancer
  • Sales Growth and Market Share of Cancer-Targeting MAbs
• A Run on MAb Companies
  • Amgen Acquires Abgenix
    • Panitumumab
    • Denosumab
    • Combination Treatments
    • Manufacturing Facility
    • Antibody Patent Rights
  • AstraZeneca to Acquire Cambridge Antibody Technology
  • Merck & Co. Acquires Abmaxis
• Deal Strategies
• Making the Switch from Platform-Based to Product-Based Company
• Overflowing Clinical Pipelines for MAbs
• When Things Go Very Wrong
• Pricing and Reimbursement Controversies
  • Bevacizumab
  • Cetuximab and Trastuzumab
  • Cost-Containment Measures
  • Companion Diagnostics
• Outlook

Tables

• 1. Key Technology Leaders-Evolution of MAb Technologies
• 2. Financial Position of Key MAb Technology Leaders, 2005
• 3. Ranking of MAbs by Indication and Worldwide Sales
• 4. Select Codevelopment Alliances for MAbs in Cancer, 2004-2006
• 5. Late-Stage MAbs in Clinical Development for Cancer
• 6. Sales of Currently Marketed Cancer MAbs

Figures

• 1. Worldwide Sales of Select MAbs, 2005
• 2. MAbs: From Mouse to Human
• 3. Sales of MAbs by Therapeutic Indication, 2002 and 2005
• 4. Market Cap of Key MAb Companies .