Infantile Spasm Treatment Market Industry Landscape And Acknowledgement with Top Players Catalyst Pharmaceuticals, GW Pharmaceuticals, Retrophin,Valerion Therapeutics, Orphelia Pharma SA, Insys Therapeutics

Infantile spasm treatment play a major role in modern healthcare, as they are used for the treatment of seizures of an epilepsy syndrome in infants usually below 1 year. The global infantile spasm treatment market size was valued at US$ 111.1 million in 2017 and is expected to exhibit a CAGR of 3.1% over the forecast period (2018 – 2026).

Infantile spasm, also called as west syndrome, is a rare disorder that affects children below 1 year age. Seizures in children often appear as normal hiccups or body movement, and parents are unaware about the presence of this disease in their kid. Therefore, to tackle this challenge, various governments and organizations are initiating programs to educate people about the disease. The government of China published a comprehensive list of rare diseases in 2018, in order to better identify the patients affected by rare disease and provide treatment for the same. Moreover, such initiatives will help to speed up the drug development process for rare diseases.Increasing birth rate could result in high prevalence of infantile spasm, which is expected to drive growth of the infantile spasms treatment market over the forecast period. However, high cost of treatment, lack of proper diagnosis of infantile spasm, and stringent regulations for drug approval are some of the factors hindering the market growth. For instance, Acthar, which is a corticotropin branded product from Mallinckrodt pharmaceutical, costs around US$ 125,000 per patient, i.e. US$ 28,000 per dose

North America holds dominant position in the global infantile spasm treatment market, owing to high adoption of infantile spasms treatment procedures and large scale research and development activities in this region. For instance, INSYS Therapeutics developed Cannabidiol in October 2012, Oral Solution for infantile spasm, which is under phase III clinical trial. The reoccurrence of infantile spasm is a major factor that boosts the market growth.

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Increasing prevalence of central nervous system (CNS) infection can develop infantile spasm which in turn is expected to boost the market growth. In July 2012, the National Center for Biotechnology Information (NCBI) report stated that around 50% of infantile spasm cases in the U.S. have a prenatal cause, including central nervous system infection, intrauterine insults, neurologic disorders such as tuberous sclerosis complex (TSC), and genetic syndrome. Moreover, approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) that helps in speedy approval by designating the orphan drug status to drugs targeted to benefit patients with rare disease is expected to boost the market growth.

Key Players

Major players operating in the global infantile spasm market include H. Lundbeck A/S, Mallinckrodt Pharmaceuticals, Catalyst Pharmaceuticals, GW Pharmaceuticals plc, Retrophin, Inc., Valerion Therapeutics, Orphelia Pharma SA, Insys Therapeutics, Inc., and Anavex Life Sciences Corp.

Increasing prevalence of central nervous system infection, may develop infantile spasm which in turn is expected to boost the infantile spasm treatment market. According to the National Center for Biotechnology Information (NCBI), in January 2018, the prevalence of infantile spasm was 2 to 3.5 infants per 10,000 live births. Government initiatives for rare disease treatment is expected to boost the market growth. For instance, The American Academy of Pediatrics also works with the Child Neurology Society, Child Neurology Foundation, American College of Emergency Physicians, and other partners to build advocacy, identify awareness gaps, and expand outreach opportunities. 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.

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.

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