The Product Portfolio Strategy as Decisive Force in Forming the Future Coagulation Factor Market

With over US$ 5.5 bln sales in 2009, the five recombinant products of coagulation factors VIII, IX and VIIa attracted more than 41 projects in the R&D pipeline, 12 of them already in the clinic, 7 within one year, and 22 filling the preclinical pipeline

Barcelona, Spain | September 8, 2010 | The Business Intelligence firm La Merie S.L. conducted its 2nd analysis of the coagulation factor R&D pipeline and benchmarked the over 50 companies. The study revealed that the total market of recombinant products of US$ 5.5 bln in 2009 motivated more than 50 companies to participate in race of next generation molecules to the market. None of the established marketers of recombinant coagulation factors so far has achieved to get a next generation coagulation factor product approved in order to convert sales from the first generation product to the next generation product.

The five marketed recombinant coagulation factors (VIII, IX and VIIa) are facing a total of more than 41 different projects among the three hemophilia coagulation factors in the R&D pipeline: 12 projects (equally distributed among the three factors) are in clinical stage and another 7 molecules are in IND enabling studies or at pre-IND stage ready to enter phase I during the next 12 months. Further 22 molecules are in preclinical R&D. The field is moving rapidly and the next two years will see important progress in the development of new molecules because the drug discovery phase has provided sufficient candidates for non-clinical and clinical development.

The target profiles of the upcoming new recombinant coagulation factors essentially  include the following aspects: manufacturing technology and process (safer and/or cheaper), way of administration (intravenous or subcutaneous); and half-life (regular, ultra-short, prolonged). In addition to differentiating the properties of a single coagulation factor, more than 10 companies are active with more than one of the three different coagulation factors emphasizing the importance of the portfolio aspect in the future marketing efforts. Not only the established companies with recombinant coagulation factors on the market are developing a differentiated portfolio, but also newcomers to the field are developing more than one factor. Portfolio not only means the addition of a second or even third coagulation factor, but even within the same coagulation factor molecules with different half-life properties or administration feature.

These results and more were found in the search conducted by La Merie. The report can be acquired at La Merie’s online store  (www.pipelinereview.com). 

The report “Coagulation Factors 2010 – The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins” analyzes and assesses the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies.

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