Biogenerics 2005: A New Level of Complexity

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Publication Date: 2005-10-28

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Biogenerics (or biosimilars, or follow-on proteins) could now enter the EU market in a matter of months, and the US by 2009. The prize awaiting biogeneric manufacturers such as Sandoz, Teva, and BioPartners is a global market worth $20 billion. Market fragmentation, product-specific constraints and new challenges in biotechnology, drug delivery and marketing will present major barriers to entry.


Scope

  • In-depth analysis of product types and brands under threat, their suitability for biogenerics, and the forecast impact of biogenerics
  • Coverage of 25 biogenerics companies, their portfolios, partnerships and strategy, and analysis of improved, proprietary 'superbiogenerics'
  • Outline of regulatory progress, likely approval routes for biogenerics, and conflicting market pressures
  • Analysis of branded companies' franchises under threat, their strategies to deal with biogenerics, and their likely success


    • Report Highlights
    The EU regulatory pathway has progressed rapidly over the last two years, and Datamonitor expects the first biogeneric to be approved by 2006. In the US immediate progress depends on the FDA's use of the controversial 505(b)(2) pathway for insulin and growth hormone. Datamonitor nevertheless expects biogenerics to launch in the US by 2009.

    Biogenerics will require an entirely new development and marketing strategy: marketing and patient support will be much more important, and this will favour companies with strong financial resources and commercial experience. Further in the future, the development of 'superbiogenerics' (second-generation biogenerics), will be a vital opportunity.

    Different product types will differ greatly in their suitability as targets for biogenerics. Market size and patent expiry are not the only two considerations, as proven by the minimal interest in insulin. Epoetin, CSFs and human growth hormone are expected to account for the majority of the $2.2 billion in forecast biogeneric sales by 2010.


    Reasons to Purchase

  • Identify key potential partners and competitors in the emerging biogenerics industry and examine their products and strategies
  • Discover the advantages and drawbacks of key biogeneric product types, and learn the forecast levels of biogeneric competition within each class
  • Analyze and benchmark branded companies' strategies to maintain market share and their likely success

    • Table of Contents

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