Restraints
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.
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