Time-to-market is a key success factor for novel recombinant coagulation factors from new market entrants and established marketers

STUTTGART, Germany I July 1, 2013 I Last week the FDA approved Baxter’s novel recombinant factor IX (rFIX) product RIXUBIS as the first new rFIX for hemophilia B in more than 15 years. This approval marks the beginning of a fierce race for shares in the hemophilia market. The total hemophilia market for recombinant factor VIII, IX and VIIa products totaled US$ 7.2 bln in 2012 with steady growth rates during the last decade. There are 46 different molecules and R&D approaches for novel recombinant coagulation factors for hemophilia A and B in the pipeline of which 24 are in clinical development or under regulatory review. Given this tight competition, time-to-market will be an important success factor.

In addition, results of a recently published study about the risk of developing inhibitors with recombinant or plasma-derived factor VIII products left one recombinant factor VIII (rFVIII) rather vulnerable to market erosion because it was associated with a significantly higher rate of inhibitor formation than the main competitor products. This finding might be the starting point for a shift in market shares among the currently marketed recombinant factor VIII products and future ones.

The new report “Recombinant Coagulation Factors 2013 – The Race to Market and for Market Shares: A Technology & Pipeline Assessment and Corporate Benchmarking Analysis will explain the potential development and approval timelines of each of the advanced molecules. The report provides detailed profiles of active recombinant coagulation factors in clinical development. Preclinical projects are valued on the basis of the underlying technologies. Emerging alternative therapeutic approaches are described and assessed. The detailed target pipeline assessments put emphasis on the competitive situation regarding stage of development, inhibitor profile, half-life, administration frequency, clinical success and especially time to approval/market.

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SOURCE: La Merie Publishing