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Coagulation Factors 2010 - The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins

La Merie Publishing, Sep 2010, Pages: 446


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The report “Coagulation Factors 2010 - The Portfolio Aspect as Decisive Force: A Competitive Landscape and R&D Pipeline Analysis of Hemostasis Proteins” provides a description, evaluation and assessment of the recombinant and plasma-derived coagulation factor pipelines as of September 2010. The authors analyze and assess the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation factor 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.

Global sales of the five major recombinant products of coagulation factors VIII, IX and VIIa in 2009 were US$ 5.5 bln (with $ conversion rate of September 2, 2010). As of 2009, substance patents have commenced to expire in the first territories and are continuing to expire over the next few years. As a consequence, established companies have intensified their efforts to defend or even expand their coagulation factor sales and new players have been entered this commercially attractive field.

Scope of the report:

- R&D pipeline overview;
- in depth profiles of most promising coagulation factors in the pipeline
- pipeline analysis for each coagulation factor ;
- evaluation and assessment of protein engineering and drug delivery technologies
- overview and analysis of marketed coagulation factors;
- profiles of more than 50 companies active in this business;
- corporate product portfolios and R&D pipelines;
- benchmark and SWOT analysis of corporate competitors within peer group

Highlights:

None of the established marketers of recombinant coagulation factors so far has achieved to get a next generation coagulation factor product approved 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.

Novo Nordisk extended its leading position in the competitive R&D landscape of next generation coagulation factor products with a highly differentiated portfolio approach.

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.

Benefits from the report:

- Understand your position in a highly competitive environment
- Avoid costly mistakes
- Learn from your competitors
- Challenge your strategy with a view from outside the organization
- Revise weaknesses of your molecule and development plan
- Identify threats to your business plan
- Realize new opportunities suggested by the report
- Reassure and build upon your strengths
- Find applications for your technology

Target audience:

- Project, product and portfolio managers
- Business development & licensing
- Research & development
- Technology evaluation
- Financial analysts
- Investment fund/venture capital managers
- Plasma fractionation companies with coagulation factor business
- Drug delivery companies
- Protein engineering companies
- Companies with surgery and wound healing business
- Companies interested in biosimilars/biogenerics


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