Introduction
With several blockbuster biological products approaching patent expiry, the
biogenerics segment represents an attractive opportunity for companies looking
to escape intensifying competition in the commodity generics sector. The
generics industry is pushing for establishment of an approval pathway for
generic biologics, but even once this is in place, barriers to market entry will
be high.
Scope of this report
- Evaluation of developments in the regulatory environment for biogenerics
in the US and EU
- Analysis of market entry strategies of likely key biogenerics players
- Assessment of the market potential of biogenerics, and the barriers to
companies wishing to exploit this
Research and analysis highlights
While the US represents the major market for regular generics, in the case of
biogenerics, Europe is leading the development of the Western market, with the
issue having been addressed as part of a restructuring of pharmaceutical
legislation, making Europe the first market to establish a legal framework for
authorization of biogenerics.
Despite the high potential, relatively few companies are expected to enter
Western biogenerics markets due to high barriers to entry. Companies may try to
overcome these barriers by entering the superbiogenerics market, where higher
returns are achievable.
Players in the biogenerics market fall into two key categories: biotech
start-ups such as Cangene, Microbix and GeneMedix, and established generics
companies looking to expand their existing portfolios such as Stada, Teva, and
Sandoz.
Key reasons to read this report
- Evaluate the strategies of key biogenerics contenders, and assess their
threat to your business
- Understand the key regulatory issues surrounding approval of biogenerics
- Assess the barriers to entry in the biogenerics sector, as well as the
market potential
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