抗腫瘍生物製剤：拡大する市場での成功戦略

Abstract

Introduction

Biological agents are essential tools in cancer treatment, particularly as antitumor drugs. Unsurprisingly, current R&D in this therapeutic area therefore focuses on antitumor agents, predominantly MAbs. While the market is robust-anticancer biologics garnered $9.5 billion in 2005-and expanding, the future for such high-cost drugs is fraught with competitive and fi nancial challenges.

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Monoclonal antibodies, generating $7.3 billion in sales in 2005, have been the most successful class of biological anticancer agents. What does the future hold for anticancer MAbs? Genentech' s Herceptin (trastuzumab) recently traversed a clinical path from approval in a small percentage of breast cancer patients to broader use as an early-stage treatment. How can MAbs and other biologics expand into new indications? How can agents leverage off-label use into new approvals and thus vastly expand sales potential? Third-party payers and patients have expressed concern over the high cost of anticancer biologics, denying off-label use or forgoing treatment altogether. What impact will reimbursement issues have on developing agents? Emerging agents may place pricing pressures on currently marketed antitumor therapies. How can companies protect the value of current agents? What approaches will manufacturers take to ensure that new drugs will be embraced in the clinic?

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Introduction
• Existing Biologic Antitumor Agents
• Monoclonal Antibodies
• Rituxan
• Herceptin
• Avastin
• Recombinant Cytokines
• Targeted Cytotoxins and Radiological Agents
• Emerging Antitumor Biologics
• Panitumumab
• Pertuzumab
• Galiximab
• Volociximab
• Mapatumumab
• CAT-3888
• CDP-791
• Herceptin: A Model for Expanding an Agent' s Reach
• Reimbursement Concerns with Anticancer Biologics
• Outlook

Tables

• 1. Select Antitumor Biologic Therapeutic Approaches
• 2. Current Antitumor Protein Drugs, 2006
• 3. Select Emerging Antitumor Biologic Agents, 2006
• 4. Early Stage Approaches to Biological Cancer Treatment
• 5. Critical Clinical Trial Results for Herceptin

Figures

• 1. Antibody Structure
• 2. Number of Anticancer Biologics on the Market, 1995-2006