Immune Thrombocytopenia is an autoimmune disorder that results in an abnormally low level of platelets. Immune thrombocytopenia is asymptomatic bleeding disorders. Symptoms appear only after platelet count is extremely low. Those symptoms include petechiae, skin bruises, gum bleeding and others. According to the National Organization of Rare Diseases, the immune thrombocytopenia incidence in the U.S. is 3.3 per 100,000 adults/year. Estimated annual prevalence 9.5/100,000 in adults and 5.3/100,000 among children.
The male population is more significantly affected by immune thrombocytopenia when compared to the female population. Immune thrombocytopenia treatment includes corticosteroids and others symptomatic treatment drugs. FDA approved anti-D for immune thrombocytopenia and designated as an orphan drug. Along with these, anti CD20 antibody, rituximab, Sandimmune, Danocrine, Imuran, Cytoxan, vincristine and other drugs are used as immune thrombocytopenia treatment.
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Immune Thrombocytopenia Treatment Market: Drivers and Restraints
Orphan drugs may benefit multi-year regulatory exclusivity during which there is no submission of abbreviated NDA /505(b) applications by another manufacturer and it expected fuel immune thrombocytopenia treatment market. Along with these, orphan drugs receive exclusivity period of 7 Years. Exclusivity is meant to encourage investment in research and development by providing innovators with exclusive use for a limited time and expected to boost the immune thrombocytopenia treatment market.
This exclusivity operates independently of patent protection and protect the product from the generic competition, even if there is no patent covering the product and it is expected to fuel the growth of immune thrombocytopenia treatment market. In the US, the FDA will not grant final marketing approval to a generic competitor for a New Chemical Entity (NCE) until the expiration of the regulatory exclusivity period that commences upon the first marketing authorization of the reference product.
The FDA will accept the filing of an Abbreviated New Drug Application (ANDA) containing a patent challenge one year before the end of this regulatory exclusivity period and boosted the immune thrombocytopenia treatment market. Further, increasing government support in order to advance the research activities is expected to fuel the growth immune thrombocytopenia treatment market. European Union supports manufacturers which take part in the research for rare diseases through its multiannual framework programmes for research and technological development.
It offers financial grants to the research proposals and it boosts the immune thrombocytopenia treatment market. Under the FP7, EU granted over €620 million for 120 collaborative projects which are associated with rare diseases and it is expected to fuel immune thrombocytopenia treatment market. All these factors act as a potential driver for the burgeoning growth of immune thrombocytopenia treatment market.
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Immune Thrombocytopenia Treatment Market: Segmentation
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Immune Thrombocytopenia Treatment Market: Overview
The global Immune Thrombocytopenia Treatment market has witnessed robust growth due to increasing demand for devices. Immune thrombocytopenia treatment drugs are granted orphan designation by regulatory bodies has high flexibility over the pricing of drugs. This has given added advantage to developers along with regulatory exclusivity.
It is further supported by lack of alternative immune thrombocytopenia treatment options further boosted the growth of immune thrombocytopenia treatment market. Immune thrombocytopenia treatment market has witnessed monopolistic power due to limited players and limited to no competition. Monopolistic nature of the market is expected to offer high immune thrombocytopenia treatment market share to the manufacturers during the forecast period. Along with these, increasing focus of legislative bodies on developing reimbursement policies has fueled the immune thrombocytopenia treatment market.
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Immune Thrombocytopenia Treatment Market: Region-Wise Overview
The global Immune Thrombocytopenia Treatment market can be segmented into the following regions – North America, Latin America, Europe, the Asia Pacific Excluding China, China and the Middle East & Africa. North America immune thrombocytopenia treatment market is expected to remain dominant in the global immune thrombocytopenia treatment market. Europe immune thrombocytopenia treatment market is expected to remain the second dominant region in the global immune thrombocytopenia treatment market.
Asia Pacific Excluding China immune thrombocytopenia treatment market is expected to register fast CAGR during the forecast period in global immune thrombocytopenia treatment market. Latin America and Middle East & Africa accounts for a small market share in global immune thrombocytopenia treatment market
Immune Thrombocytopenia Treatment Market: Market Participants
Key participants operating in the Immune Thrombocytopenia Treatment market include GlaxoSmithKline, Novartis AG, Amgen Inc., Emergent BioSolutions, Octapharma USA., Pfizer Inc, Roche Holding AG, Merck & Company, Inc., and others. Players in immune thrombocytopenia treatment market are mainly focusing on collaborations and partnerships to keep pace with the competition and develop new products.
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