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The Future of Biosimilars: Key Opportunities & Emerging Therapies
Business Insights, Aug 2007, Pages: 120
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 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.
Key issues examined in this report...
-Regulatory hurdles. The future US biosimilars market is dependant
upon the provision of a regulatory framework, facilitated by the
Congressional enactment of legislation. It is speculated that the
earliest introduction of biosimilars is unlikely to occur before 2010.
-Competition from India and China. The strength of Indian and
Chinese product pipelines indicate that they are ready to exploit
market opportunities on a global scale.
-Key development opportunities. Original brand sales within the
$12bn market for Erythropoietin are likely to be drastically eroded
when biosimilar competition reaches the EU market in 2007.
-Pricing Strategies. With biosimilar prices expected to be 10% to
20% lower than the reference brand, pricing tactics are finely poised
between recouping investment and incentivizing brand switches.
-Marketing Strategies. The need for biosimilar marketing activities to
incorporate patient-oriented educational campaigns to overcome
negative perceptions, rather than mimic generic drugs’ marketing.
Some key findings from this report...
-Major brands of Eythropoietin products have become key
targets for biosimilars, after accounting for 18.7% ($12bn) of global
pharmaceutical sales in 2006. Amgen’s Aransep held 55% of the EPO
market in 2006, typifying the rapid growth of long-acting products.
Top five reasons to order your copy today
-Discover which strategies can overcome the barriers to
establishing biosimilars, and adopt the necessary measures to
compete effectively in the international marketplace.
-Compare the product portfolios of the early leaders in the
international market, including Teva, Sandoz, Barr (Pliva), Stada
(Bioceuticals), BioGeneriX (Ratiopharm) and Bitoton.
-Identify key product opportunities and potential competitive
threats across the major biotech product groups in the EU, India,
China and the US.
-Gain insights into key industrial trends that will shape the future
development of the biosimilars market landscape.
-Evaluate prospective business opportunities, including strategic
alliances and partnerships in research, manufacturing and
marketing.
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