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.
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