Market Challenges And Opportunities

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.

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.