Abstract
Regulatory Affairs Hinder Development of the Biogenerics Market
While the development of an abbreviated regulatory pathway is crucial to the approval of new
biogenerics, growing concerns about the lack of a definition for bioequivalence and increasing
pressure from major biotechnology companies anxious to defend their ailing blockbuster patents are
preventing this from happening. This is currently the single largest restraint facing the
biogenerics market. Although the European Agency for the Evaluation of Medicinal Products (EMEA) is
now accepting applications for abbreviated market approval of new biogenerics, the United States is
yet to develop a shorter regulatory path to market. On the other hand, biogenerics are thriving in
less regulated countries such as India and China.
This Frost & Sullivan research service provides an in-depth strategic analysis of the global
biogenerics market along with an assessment of its immense potential. It discusses various critical
issues such as regulatory affairs that could hinder the development of the market. The detailed
pipeline analysis includes anticipated patent expiry dates for the most successful
biopharmaceuticals and analysis of forthcoming biogeneric products expected to be launched from 2005
to 2011.
Large Potential Market Size for Biogeneric Compounds
Several blockbuster drugs are expected to lose patent protection over the next ten years, paving
the way for competitors to legally manufacture biogeneric versions of these products and market
them. This represents tremendous potential for biogeneric manufacturers. Since there is no real need
to invest in drug discovery and clinical development, they gain from being able to sell the
biogeneric products at considerably lower prices than the patented original drugs.
This is expected to not only encourage consumers to purchase generic alternatives, it is also
receiving support from governments and healthcare providers seeking to reduce expenditure on
therapeutics. However, the high manufacturing costs for biologics compared to conventional small
molecule pharmaceuticals present a challenge to biogenerics manufacturers. "The most successful
participants are likely to be those that develop their own proprietary expression systems to
minimise costs, and above all, ensure that products are bioequivalent and produced to full current
good manufacturing practice (cGMP) standards," notes the analyst of this research service.
Biogenerics Market Anticipated to Expand Rapidly as Participants Overcome Regulatory Barriers
The large number of blockbuster biopharmaceuticals expected to lose patent protection in the
forecast period indicates that the biogenerics market will rapidly grow to billion-dollar levels
once regulatory barriers are overcome. Frost & Sullivan estimates that the biogenerics markets
in Europe and the United States alone have the potential to generate sales of $16.39 billion by 2011
at an average annual growth rate (AAGR) of 69.8 percent.
"Once regulations are clearly established, a flood of biogeneric alternatives is anticipated
to hit the market soon after the expiry of each blockbuster patent," remarks the analyst.
"As a result, biotechnology companies are likely to go to great lengths to reinforce their
patents, reformulate existing products and improve delivery systems in an effort to maintain the
customer base for their branded products." | 
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