 Spectrum --
July 2008
 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-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?
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
specifically for reimbursement, using the EUnetHTA as an example.
Outlook: our forecast for the biologics landscape in
Europe and Japan.
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