Blood clotting factors are proteins or enzymes that control bleeding. Blood clotting or blood coagulation is a process in which blood gets converted into solid clots at time of any wound or break down of blood vessels. Clotting can prevent death from bleeding and also restrict the entry of bacteria and viruses into the body. Haemostasis is the mechanism for blood clotting, which in controlled by a number of factors called blood clotting factors. Deficiency of these factors can cause blood clotting diseases such as haemophilia and von willebrand disease (VWD). According to Centre for disease control and prevention (CDC), 2017, around 20,000 males were suffering from Hemophilia in the U.S.
Blood Clotting Factors Market – Dynamics
Approval of novel drugs is expected to propel the market growth over the forecast period. For instance, in Janauary 2020, CSL Behring received Korea Ministry of Food and Drug Safety approval for Afstyla, a single-chain recombinant antihemophilic factor VIII therapy indicated for patients suffering from Hemophilia A. Also, in June 2019, Novo Nordisk received marketing authorization from European commission for Esperoct in the Europe. Esperoct is the brand name for turoctocog alfa pegol, N8-GP, indicated for surgical procedures in adolescents and adults with hemophilia A (congenital factor VIII deficiency). Further, in July 2019, Novo Nordisk received the Health Canada approved for Esperoct indicated for the treatment of patients with Hemophilia A.
High prevalence of Hemophilia is expected to drive the growth of the Blood Clotting Factor market. According to the data published by the Centers for Disease Control and Prevention (CDC) in September 2018, Hemophilia A affected 1 in 5,000 male births in the U.S. Similarly, according to the data published by Cleveland Clinic, in 2016, Hemophilia affected around 1 in 25,000 to 30,000 males. According to National Hemophilia Foundation 2018 report, one in 10,000 people are born with hemophilia A due to deficiency of clotting factor VIII and one in 50,000 people are born with hemophilia B due to lack of clotting factor IX
Rising initiatives and donation for supporting the patients diagnosed with Hemophilia is expected to propel the market growth over the forecast period. For instance, in April 2019, Grifols International SA a provider of plasma derived products, donated more than 100 million international units of blood clotting factor drugs under the long term initiative of providing support to the Hemophilia patients.
Blood Clotting Factors Market – Regional Insights
Hemophilia is a rare disorder affecting very small fraction of population across the globe. Pharmaceutical companies invest less amount on development of such drugs due to low return on investment. However, FDA has recognized this fact and has formulated favorable policy to motivate companies to invest in this area. Orphan Drug Act that applies to company operating in this area provides three special incentives i.e. 7 years exclusivity period, tax credit and waiver of prescription drug user fees. Due to such policy, the company has invested in rare disease research which has led to development of products such as Hemlibra (Emicizumab-kxwh), Adynovate and Others.
Furthermore, rising number of product approvals and increasing awareness regarding rare disease in developed economies such as U.S. and Canada has resulted in high number of patients receiving treatment. Owing to above mentioned factors, North America has dominated the market and it is also expected to retain position over the forecast period. For instance, in February, Novo Nordisk received the U.S. Food and Drug Administration (FDA) approval for Turoctocog alfa pegol also called as N8-GP (Esperoct), a long acting factor VIII replacement treatment for adults and children suffering from hemophilia A.
Asia Pacific is expected to witness robust growth in the market due to increasing number of patients suffering from disease, favorable reimbursement policy and rising product launch by the market players. For instance, in April 2019, Roche Products India Pvt. Ltd launched its hemophilia A drug, Emicizumab, branded as Hemlibra, in India. It is indicated as a prophylactic treatment for reducing frequency of bleeding episodes in patients with hemophilia A, through Factor VIII inhibitors. According to the Chinese Ministry of Health report 2012, in China, outpatient hemophilia treatment is covered by health insurance schemes in more than 80% of the cities in China, with reimbursement caps and patient co-pay requirements more than 50%.
Blood Clotting Factors Market Taxonomy:
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Key players in the blood clotting factors market:
Some of the key players operating in the blood clotting factors market includes Shire Plc, Baxter International Inc., Grifols International SA, Roche AG, Bayer AG, Pfizer Inc., Novo Nordisk A/S, Octapharma AG, Biogen Idec, and Kedrion S.P.A.