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PharmaPoint: Hemophilia A and B Recombinant Factor Replacement Therapy - Global Drug

Press Release   •   Jan 16, 2017 14:46 IST

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Congenital hemophilia A and B are bleeding disorders that are caused by genetic X-linked deficiencies in the blood clotting Factors VIII and IX, respectively. Hemophilia manifests as mild, moderate, or severe inability to form clots, depending upon the endogenous levels of circulating factor in an individual patient. The mainstay of treatment for hemophilia is to replace the missing FVIII or FIX, produced using plasma-derived or recombinant methods. Some patients develop inhibitors to FVIII or FIX treatment and need a bypassing agent, such as FVIIa, to resolve bleeds. Patients of hemophilia A or B often require lifelong treatment to prevent and control bleeding episodes, and this therefore represents a lucrative sales opportunity.

GlobalData estimates the 2014 sales for recombinant hemophilia A and B markets at approximately $5.38 billion across the 7MM+A covered in this report. The market is expected to reach $6.25 billion in 2024 at a CAGR of 1.52%. This growth will be mainly driven by an increasing use of routine prophylaxis and a greater use of recombinant products in place of plasma-derived therapies.

The hemophilia recombinant treatment pipeline is strong, and crowded with multiple long-acting recombinant clotting factors; however, GlobalData expects a lack of initiative for hemophilia A patients to switch to long-acting rFVIII, and a limited scope for premium pricing for new agents, restraining the market growth. Overall, Baxalta is expected to remain as the market leader in the hemophilia space throughout the forecast period, dominating the market with its current gold standard therapy for hemophilia A, Advate, supported by the launch its of pegylated rFVIII, Adynovate.


Key Questions Answered

- What will be the impact of the new long-acting rFVIII and rFIX products in the hemophilia market sales? Led by Biogens Eloctate and Alprolix, moderate and high rates of adoption of the long-acting rFVIII and rFIX therapies, respectively, are expected.

- With the growing importance of long-acting Factors, what are the strategies of the companies that have short-acting assets to remain competitive? What are the other approaches that new entrants employ?

- Prevention of inhibitor formation remains as a major unmet need in the hemophilia space. What are the other unmet needs and opportunities in the hemophilia market?

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