The relapse or reoccurrence of infantile spasm is a major factor driving growth of the infantile spasm treatment market. According to investigators from Okayama University Hospital, Japan, after the treatment of infantile spasm with ACTH therapy for 11 to 37 days, the disease reoccurred in 41% of the people under study.
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Moreover, the government of Brazil in year 2017 amended its regulatory rules for approving drugs for rare disease. In December 2017, Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA) published Resolution RDC 205/2017, regulating special procedures for clinical trials, registration, and certification of Good Manufacturing Practices (GMPs) of drugs intended to treat, prevent or diagnose rare diseases such as infantile spasm.
Key players in the market are focused on launching cost-effective generic drugs, in order to treat infantile spasm and address the critical unmet needs of patients. For instance, in May 2018, Amneal Pharmaceuticals launched vigabatrin for oral solution USP, which is a generic equivalent for Sabril. This is the second generic vigabatrin product available in the market. Aucta Pharmaceuticals and Upsher-Smith Laboratories, LLC launched vigabatrin for oral solution under the brand name Vigadrone in July 2018, which is another generic version of vigabatrin (Sabril).
As of 2018, there were around 5 novel drug candidates in development. 60% of these drugs are in phase III of development, which are expected to enter the market in the near future, thereby offering effective treatment among the fastest growing markets in the world.
Key players operating in the market are focused on adopting strategies such as mergers and acquisitions to enhance their product portfolio. For instance, in April 2014, Mallinckrodt Pharmaceuticals acquired Questcor, a company involved in contract manufacturing services. Questcor has FDA approved H.P. Acthar Gel, an injectable drug for 19 indications such as infantile spasm.
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The global infantile spasm market include H. Lundbeck A/S, Mallinckrodt Pharmaceuticals, Anavex Life Sciences Corp., Catalyst Pharmaceuticals, GW Pharmaceuticals plc, and Retrophin, Inc., Valerion Therapeutics, Orphelia Pharma SA, Insys Therapeutics Inc., Etrophin Inc., and Catalystpharma.