Immune inhibitors are associated with haemophilia and inhibitors are antibodies developed in haemophilia patients. Haemophilia is a hereditary bleeding disorder, which occurs due to deficiency or absence of clotting factor VIII (haemophilia A) or clotting factor IX (haemophilia B). Although classification is not limited to the type of deficient clotting factor, it can be classified according to amount of clotting factor present as well. For instance, depending on factor VIII levels in patients with haemophilia A, it can be classified as mild haemophilia (5-25% of normal values), moderate haemophilia (1-5% of normal values), and severe haemophilia (<1% of normal values).
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Immune system of haemophilia patients’ produces antibodies called as inhibitors, which acts against the administered therapy. Haemophilia patients are administered either plasma-derived or recombinant replacement blood factor concentrates as medication therapy, which help in blood clotting. However, the inhibitors falsely target replacement factor concentrates as a foreign substance. These antibodies are developed after the patient has been administered with blood factor FVIII concentrate. Inhibitors act after 10 to 20 days of first exposure to factor replacement therapy. Most of these inhibitors remain in the blood for short time and disappear without treatment. However, more persistent inhibitors is a serious adverse event with respect to treatment of Haemophilia A. Commercially available anti-inhibitor coagulant complex includes FEIBA and FEIBA VH Immuno.
Immune Anti-Inhibitor Market Drivers
According to Centers for Disease Control and Prevention (CDC), 2016, an estimated 1 in 5 people with haemophilia A and about 3 in 100 people with haemophilia B develop inhibitors (antibodies). Moreover, patients suffering from Von Willebrand Disease (VWD) type 3 are also at a risk of developing inhibitors. According to National Haemophilia Foundation (NHF), haemophilia A occurs in 1 in 5,000 people and is four times as common as haemophilia B, which supports growth of the immune anti-inhibitors market. Ongoing research and development of different therapies for haemophilia with inhibitors are expected to boost growth of the global immune anti-inhibitor market. For instance, Roche is working on monoclonal antibodies for treatment of haemophilia with inhibitors. In June 2017, Roche’s emicizumab (Hemlibra) showed positive results in Phase III studies in haemophilia A with inhibitors. The U.S. Food & Drug Administration (FDA) approved Emicizumab (Hemlibra) once – weekly subcutaneous therapy for haemophilia A with inhibitors in September 2017. Emicizumab is a monoclonal antibody designed to facilitate blood clotting process by combining factors IXa and X. Moreover, the Center for Disease Control and Prevention (CDC) is examining the etiology of the haemophilia with inhibitors, which could help in development of novel therapies to boost growth of the immune anti-inhibitor market. Pipeline for haemophilia with inhibitors is also promising as few of the manufacturers are working on novel therapies for the condition. One such organization Catalyst Biosciences has a Factor VIIa marzeptacog alfa (activated) in the clinical trials for haemophilia A or B with inhibitors. Moreover, Bioverativ Inc., a Sanofi S. A.’s subsidiary has FVIIIa mimetic bispecific antibody under studies for haemophilia A with inhibitors. Multiple products are pipeline which are expected to receive approval over the forecast period, this in turn is projected to boost growth of the immune anti-inhibitor market over the forecast period.
Immune Anti-Inhibitor Market Insights
Government organizations and agencies are engaged in providing support to patients suffering from haemophilia with inhibitors by increasing the awareness of the disease. For instance, the National Haemophilia Foundation (NHF) Inhibitor Education Summits help in spreading awareness and information about the disease condition. Moreover, the Haemophilia Federation of America’s Helping Hands Program offers financial assistance to financially unstable population for attending national and state bleeding disorder educational meetings; travel for necessary medical procedures, surgeries and second opinions; and tutoring or education-related expenses.
Researchers are working on analyzing the risks associated with use of replacement factors, as in which replacement factors are more prone to facilitate development of antibodies. For instance, World Federation of Haemophilia (WFH) announced results from study published in journal ‘Blood’ in 2014, which demonstrated higher incidence of inhibitor development after treatment with Kogenate FS/Bayer/Helixate NexGen replacement factor. The World Federation of Haemophilia has requested the U.S. Food & Drug Administration and the European Medicine Agency (EMA) to examine the data. Such studies are expected to reduce the instances of haemophilia with antibodies. Furthermore, therapies such as Immune Tolerance Induction (ITI) which involve continuous treatment with replacement factors till they are no longer considered as foreign bodies by inhibitors are expected to restrain the growth of the market.
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Key players operating in global immune anti-inhibitor market include Shire Plc, Baxter International, Inc, F. Hoffmann La Roche Ltd., Novo Nordisk A/S, and CSL Behring.