Global Infantile Spasm Market - 2021-2028
発行: DataM Intelligence
ページ情報: 英文 180 Pages
The global infantile spasm market size was valued US$ XX billion in 2019 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Infantile spasm is also known as a West syndrome, is a rare seizure condition in an epilepsy syndrome of infancy and childhood. Infantile spasms are typically sudden, brief, bilateral and symmetric contractions of the muscles of the neck, trunk and extremities, occurring in clusters. Infantile spasms are often the presenting feature of a significant underlying neurological disorder.
The infantile spasm market growth is driven by the increasing number of births, rising prevalence of infantile spasms, product innovations, and growing scientific advancements in the treatment for infantile spasms.
The growing scientific advancements in the treatment of infantile spasms are driving the market growth. For example, due to recent advancements in the technology, a seizure alert device has been designed to detect seizures and warns the physician through phone calls, alarms, or text messages. This advancement aids in the early diagnosis by physicians, which increases the life expectancy of patients. The precise diagnosis of infantile spasms helps the physician make an accurate decision to refer an appropriate treatment procedure, thus improving the efficiency of the treatment. In addition, these advanced technologies also help reduce the undiagnosed population, thereby enhancing the penetration rate of infantile spasm drugs.
According to the National Organization for Rare Disorders, the incidence of infantile spasms is 2 to 3 per 10,000 live births, with a lifetime prevalence of 1.5 to 2 per 10,000 children. The condition is usually observed in 2% of childhood epilepsies and 25% of epilepsies in the first year of life. Almost 2,000-4,000 new cases are diagnosed in the U.S. annually. About 50%-70% of infantile spasms patients are affected by other types of seizures, whereas nearly 18%-50% develop either Lennox-Gastaut syndrome or other forms of symptomatic generalized epilepsy.
The high cost of infantile spasm drugs may restrict 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.
The coronavirus (COVID-19) pandemic and resulting lockdown in various countries across the globe have impacted major companies' financial status in the urea cycle disorders treatment market. The private healthcare sector is one of the sectors, which the COVID-19 pandemic has majorly impacted. The pandemic has negatively impacted the global infantile spasm market in various aspects such as research and development, production, and supply of medicines. The pandemic has also affected the growth of pharmaceutical businesses of various companies across the globe due to lockdowns implemented by governments of several countries.
Adrenocorticotropic hormone therapy is the most commonly used for infantile spasms in the United States owing to low side effects and greater efficacy than other medications. ACTH reduces neuronal excitability in IS by two mechanisms of action: (1) by inducing steroid release and (2) by a direct, steroid-independent action on melanocortin receptors. These combined effects may explain the robust, established clinical effects of ACTH in the therapy of IS.
Oral routes have advantages like ease in administration and low cost. For instance, according to the National Library of Medicine, the more cost-effective treatment was high-dose prednisolone, with an incremental cost-effectiveness ratio (ICER) of $333 per case of spasms resolved, followed by ACTH ICER of $1 432 200 per case of spasms.
For instance, Bio-Pharm Solutions Co., Ltd developing an orally administered JBPOS0101 for refractory infantile spasms patients, is currently under Phase 2 trials is expected to complete by 2022. Moreover, 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)
The hospital pharmacies held the largest share in the infantile spasm market. This is mainly owing to increasing number of patients suffering from conditions which are diagnosed, treated in hospitals equipped with advanced infrastructure and adequate facilities. Moreover, growing number of hospitals along with adequate reimbursement policies is also contributing to the growth of this segment.
North America region holds the largest market share of global infantile spasm market
The North American region holds a dominant position in the global infantile spasm market due to infantile spasms treatment procedures and large-scale research and development activities. For example, INSYS Therapeutics developed Cannabidiol in October 2012, Oral Solution for infantile spasm under phase III clinical trial. The increasing prevalence of central nervous system (CNS) infection can develop infantile spasms. For instance, 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, according to the Infantile Spasms Project, approximately 2000 to 4000 new cases of this disorder occur in the U.S. every year.
Furthermore, approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) that helps speedy approval by designating the orphan drug status to drugs targeted to benefit patients with a rare disease is expected to boost this region's market growth.
The global infantile spasm market is highly competitive with presence of global companies. Some of the key players which are contributing to the growth of the market include Valerion Therapeutics, Anavex Life Sciences Corp., GW Pharmaceuticals, plc., Mallinckrodt, H. Lundbeck A/S, ORPHELIA Pharma SA, INSYS Therapeutics, Inc., Retrophin, Inc., and Catalyst Pharmaceuticals, Amneal Pharmaceuticals, QUALITY CONTROL CHEMICALS INC, BOC Sciences, Chongqing Chemdad Co., Ltd, Shanghai Longyu Biotechnology Co., Ltd, Dayang Chemicals Co., Ltd. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, in May 2018, Amneal Pharmaceuticals launched vigabatrin for oral solution USP, which is a generic equivalent for Sabril.
Company Overview: Mallinckrodt Pharmaceuticals is an American-Irish domiciled manufacturer of specialty pharmaceuticals (namely, adrenocorticotropic hormone), generic drugs and imaging agents. It is founded in 1840. In 2017 it generated 90% of its sales from the U.S. healthcare system. While Mallinckrodt is headquartered in Ireland for tax purposes, its operational headquarters are in the U.S.
Product Portfolio: The Company's portfolio comprised of include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products.
Key developments: 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.
The global infantile spasm market report would provide an access to an approx. 61 market data table, 51 figures and 200 pages.
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