August 19, 2008

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

Research and Markets ( has announced the addition of Decision Resources, Inc.'s new report "Key Issues to Consider When Bringing Biologics to Market in Europe and Japan" to their offering.

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-specific factors will influence 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?


- 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 specifically for reimbursement, using the EUnetHTA as an example.

- Outlook: our forecast for the biologics landscape in Europe and Japan.

Key Topics Covered:

- Overview

- Key Elements to Consider in Commercializing Biologics in Europe and Japan

- European Perspective on the Biologics Environment

- Japanese Perspective on the Biologics Environment

- How Are Biologics Makers Pursuing the European and Japanese Markets?

- Pricing and Reimbursement of Biologics

- Impact of Biosimilars on the Biologics Market

- Expert Commentary

- Sidebars

- List of Tables

- List of Figures

Companies Mentioned Include:



-Absynth Biologics

-Acorda Therapeutics

-Advanced Biologics

-Advanced Cell Technology

-Affi tech




-Bioceuticals Arzneimittel


-Biologics Delivery Systems





-Boehringer Ingelheim

-CMC ICOS Biologics


-CTM Biotech

-Cytovance Biologics

-Daiichi Sankyo

-DSM Biologics



-Eli Lilly





-Johnson & Johnson


-Kyowa Hakko

-MGI Pharma













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