Immune Anti-Inhibitor Market 2020 Exclusivity, Size, Share, Growth, Value, Trends, Segmentations, Top Mergers, and Forecast 2026
Immune Anti-Inhibitor Market – Insights
Immune inhibitors are antibodies developed in hemophilia patients. Hemophilia is a hereditary blood-related disorder that occurs due to deficiency or absence of clotting factor VIII (hemophilia A) or clotting factor IX (hemophilia B). The condition can be classified according to amount of clotting factor present although classification is not limited to the type of deficient clotting factor. For instance, hemophilia A can be classified as mild hemophilia (5-25% of normal values), moderate hemophilia, (1-5% of normal values), and severe hemophilia (<1% of normal values) depending on factor VIII levels in patients.
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The immune inhibitors in hemophilia patients act against the administered therapy. Hemophilia patients require either plasma-derived or recombinant replacement blood factor concentrates to aid blood clotting. However, the inhibitors falsely target replacement factor concentrates as a foreign substance. Administration of blood factor FVIII concentrate in the patient leads to development of Thee antibodies. The action of inhibitors begins after 10 to 20 days of first exposure to factor replacement therapy. Majority of the inhibitors reside in the bloodstream for a while and disappear without treatment. However, in case the inhibitors are still present in the blood, adverse effects can be evident in treatment of Hemophilia A. FEIBA and FEIBA VH Immuno are currently sold anti-inhibitor coagulant complex.
Increasing development of inhibitors in hemophilia patients to augment growth of the market
High cases of development of inhibitors in hemophilia patients is a major factor boosting growth of the global immune anti-inhibitor market. For instance, according to the Centers for Disease Control and Prevention (CDC), 2016, around 1 in every 5 people that suffer from hemophilia A and around 3 in every 100 people that suffer from hemophilia B develop inhibitors (antibodies). Moreover, patients suffering from Von Willebrand Disease (VWD) type 3 may also develop inhibitors. According to National Hemophilia Foundation (NHF), hemophilia A occurs in 1 in 5,000 people and is four times as common as hemophilia B.
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Increasing R&D in therapies for hemophilia with inhibitors is also expected to propel growth of the market. For instance, Roche is working on monoclonal antibodies for treatment of hemophilia with inhibitors. In June 2017, Roche’s emicizumab (Hemlibra) demonstrated positive results in Phase III studies in hemophilia A with inhibitors. In September 2017, the U.S. Food & Drug Administration (FDA) approved Emicizumab (Hemlibra) once – weekly subcutaneous therapy for hemophilia A with inhibitors. Emicizumab is a monoclonal antibody that combines factors IXa and X to aid blood clotting.
Moreover, R&D in assessing the risks linked with use of replacement factors is also expected to contribute to growth of the market. For instance, World Federation of Hemophilia (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 WFH requested the U.S. FDA and the European Medicine Agency (EMA) to assess the data. Such studies are expected to reduce the instances of hemophilia with antibodies.
Increasing initiatives of various organizations in R&D of therapies hemophilia with inhibitors is expected to fuel growth of the market. For instance, the Centers for Disease Control and Prevention (CDC) is assessing the etiology of the hemophilia with inhibitors in order to facilitate R&D of new therapies for the treatment of hemophilia with inhibitors. Moreover, increasing government support to patients suffering from hemophilia with inhibitors is also expected to fuel growth of the market. For instance, the National Hemophilia Foundation (NHF) Inhibitor Education Summits help in spreading awareness and information about the disease condition. Moreover, the Hemophilia 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.
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Immune Anti-Inhibitor Market – Restraints
In Immune Tolerance Induction (ITI), continuous treatment with replacement factors may lead to inhibitors not considering the replacement factors as foreign bodies. Adoption of such therapies is expected to hinder growth of the market.
Immune Anti-Inhibitor Market: Competitive Landscape
Key players in the market are focused on product development and conducting clinical trials to expand their product portfolio. For instance, Catalyst Biosciences has a Factor VIIa marzeptacog alfa (activated) in the clinical trials for hemophilia A or B with inhibitors. Moreover, Bioverativ Inc., a subsidiary of Sanofi S. A., has FVIIIa mimetic bispecific antibody under studies for hemophilia A with inhibitors.
Major players operating in global immune anti-inhibitor market include, F. Hoffmann La Roche Ltd., Shire Plc, Baxter International, Inc., Novo Nordisk A/S, and CSL Behring.
Immune Anti-Inhibitor Market Taxonomy-
The global immune anti-inhibitor market is segmented on the basis of product type, distribution channel, and geography.
By Product Type-
By Distribution Channel-
- Hospital Pharmacies
- Online Pharmacies
- Retail Pharmacies
- North America
- Asia Pacific
- Latin America
- Middle East
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