Abstract
Biotechnological products are continuing to exhibit substantial revenue gains,
with the top 12 biologics registering sales growth of 20%in 2006, amassing a
market share of $64 billion. However, the impending patent expiry of many
leading products has created a number of highly attractive market
opportunities for biosimilars. To exploit this significant potential, a
complex route to market must first be negotiated, including numerous barriers
to entry and regulatory hurdles. Prominent obstacles include the sizeable
investments in time and expertise associated with biosimilars development, in
addition to the fundamentally higher levels of cost and risk incurred by
manufacturers.
Legislative restraints in the US and a recently established regulatory
framework in the EU have also contributed to industrial obtrusiveness, but for
those developers who persevere, biosimilars are set to offer lucrative
returns. The Future of Biosimilars: Key opportunities and emerging therapies
is a new report published by Business Insights, examining the current market
and regulatory environment for biosimilars in Europe, India, China and the US,
whilst identifying the trends that will shape future market development.
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