Key Issues to Consider When Bringing Biologics to Market in Europe and Japan

SUMMARY

Introduction

In the past 25 years, more than 100 recombinant proteins and MAbs have reached the global market. Biologics have scored most of their successes in the United States, but they are a growing force in Europe and Japan, where they are well represented in companies' product pipelines. Issues that will make or break the successful integration of biologics in European and Japanese biopharmaceutical market include clinical trial design, patient recruitment, pricing methodology, reimbursement, treatment for orphan diseases and serious illnesses, and responding to a high unmet need.

Get the Answers You Need to Shape Your Strategy

As the biopharma market continues to grow in Europe and Japan, various region-specifi c factors will infl uence the performance of biologics in these markets. What factors will facilitate (or frustrate) market penetration of biologics in Europe? In Japan? What steps, if any, can companies take to enhance or mitigate these market conditions? As seen by GlaxoSmithKline's decision to set lower prices of its biologics in Europe, companies are adjusting their strategies to respond to a slow growth of biologics. Which strategies are sustainable and reproducible? How will changes at the individual company level affect the whole biologics industry? The performance of biologics depends not only on pricing and reimbursement but also on the impact of biosimilars. Is the outlook for biologics better as a result of biosimilars, or worse? Based on its recent experience with biosimilars, what impact does the European market anticipate from these agents? How will the Japanese experience mirror or differ from this example?

Scope

• Case studies: two examples of the commercialization and clinical development process of biologics, one in Europe and one in Japan.
• Companies: a review of leading European and Japanese companies that offer biologics.
• Deals: collaborations, M&As, and licensing deals in biologics.
• Strategic decisions: company- and country-level changes are causing waves in the biologics industry. Neil Grubert explores this specifi cally for reimbursement, using the EUnetHTA as an example.
• Outlook: our forecast for the biologics landscape in Europe and Japan.

TABLE OF CONTENTS

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
  • Biologics by the Numbers
  • Scope of This Report
• Key Elements to Consider in Commercializing Biologics in Europe and Japan
  • Regulatory Process
  • Price Setting
• European Perspective on the Biologics Environment
  • Review Times for Novel Therapies
    • Accelerated Assessment
    • Conditional Marketing Authorization
  • Orphan Drug Status
• Japanese Perspective on the Biologics Environment
  • Inadequate Infrastructure for Clinical Development
  • Regulatory Barriers
• How Are Biologics Makers Pursuing the European and Japanese Markets?
  • The European Landscape
  • The Japanese Landscape
• Pricing and Reimbursement of Biologics
  • Europe
  • Japan
    • Similar-Effi cacy Comparison Method
    • Cost-Calculation Method
• Impact of Biosimilars on the Biologics Market
  • Europe
  • Japan
• The Future of Biologics in Europe and Japan

Expert Commentary

• Health Technology Assessment: A Growing Challenge for the Biologics Industry in Europe
  • Neil Grubert, M.A

Sidebars

• Clinical Requirements Case Study: Why Amevive Failed and Raptiva Succeeded in Gaining Approval
• Pricing Methodology Case Study on Avastin: When Market Size Matters

Tables

• 1. Number of Drug Approvals via the Centralised Procedure, 2005-2008
• 2. Prices of Leading Biologics in Europe and Japan as a Percentage of U.S. Prices, 2006
• 3. Best-Selling Biologics in Japan, 2006-2007
• 4. Select Biologics Collaborations, January 2007-June 2008
• 5. Select Japanese Pharma Companies' Biologics Sales in Proportion to Total Sales, 2007
• 6. Japanese Company Pipelines: Late-Stage Biologics
• 7. Comparative Price and Sales of Key Biologics in Japan (vs. U.S. Prices), 2006
• A. Price of Chugai's Avastin (Bevacizumab) in Select Major Markets

Figures

• 1. Worldwide Sales of the Top 100 Pharmaceutical Drugs, by Type
• 2. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in Europe and Japan as a Percentage of U.S. Prices
• 3. Biologics as a Proportion of All Drugs Across the Major Markets, by Development Status
• 4. Number of Conventional-Technology Blockbusters vs. Biotechnology Blockbusters, 1997-2007
• 5. Market of First Launch of New Molecular Entities, 2005-2007
• 6. Number of Biologics Approved in Japan, 2005-2007