Congenital Hyperinsulinism Treatment Market, by Disease Type (KATP-HI, GDH-HI, GK-HI, Other (SCHAD HI,HNF4A/HNF1A, etc.)), by Drug Type (Diazoxide, Octreotide, Glucagon, Nifedipine, Other (Sirolimus, Chlorothiazide, etc.), by Route of Administration (Oral, Parenteral), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030
Congenital hyperinsulinism(CHI) also called as hyperinsulinemic hypoglycemia, a rare endocrine condition that causes low blood glucose levels and occurs mainly in newborn babies, infants and children leading to permanent brain injury and is most frequent cause of severe hypoglycemia. Over secretion of insulin by beta cells in pancreas leads to gene mutation in KATP channel genes (ABCC8 and KCNJ11, HNF4A, HNF1A, HADH, and UCP2 or activating mutations of GLUD1, GCK, and SLC16A1) that cause congenital hyperinsulinism. There is significant risk of permanent brain damage in CHI, hence it is necessary to make a prompt diagnosis and obtain immediate management of the disease to prevent complications such as epilepsy, cerebral palsy and neurodevelopmental deficits. According to the National Organization for Rare Disorders database, approximately 1/25,000 to 1/50,000 HI births occurs in most of the countries including HI develop hypoglycemia during the first month of life. Irritability, sleepiness, excessive hunger, rapid heart rate are common symptoms that occurs while more severe symptoms, such as seizures and coma occur. There are many causes of congential hyperinsulinism based on different forms of the disease for example there are transient forms while some are due to genetic defects and persist for life. Prematurely born babies sometimes, develop hypoglycemia due to excessive insulin secretion. The cause of this inappropriate insulin secretion is still not clear, but it can last a few days to months.
Market Dynamics
Ongoing research for development of novel therapeutic options for the treatment of congenital hyperinsulinismby various key players such as Zealand Pharma A/S, Hanmi Pharm.Co., Ltd., Eli Lilly and Company is anticipated to drive the growth of global congenital hyperinsulinismtreatment market over the forecast period. For instance, in May 2019, Zealand Pharma A/S, a biotechnology company initiated Phase 3 clinical trial of Dasiglucagon. The study aims to assess the efficacy and safety of Dasiglucagon for the treatment of pediatric patients with congenital hyperinsulinism. The study is estimated to be completed by December 2022. Dasiglucagon is a peptide analogue of glucagon consisting 7 amino acid substitutions engineered to eliminate fibril formation as well as peptide aggregation.
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