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시장보고서
Key Issues to Consider When Bringing Biologics to Market in Europe and Japan
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Abstract
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
- 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,
- 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
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