Congenital Hyperinsulinism Market Size, Share, Growth, Trends, and Global Industry Analysis: By Treatment (Drug Therapy (Diazoxide, Octreotide, Glucagon, Nifedipine, Others), Dietary Management, Surgery, and Others), By Disease Type (KATP-HI, GDH-HI, GK-HI, and Others), By Diagnosis Method (Blood Test, Genetic Test, and Plasma Sugar), By Route of Administration (Oral, Parenteral), By End Users (Hospitals, Clinics, Homecare, Others) and Region Forecast 2020-2031

Congenital Hyperinsulinism Market size was valued at US$ 203.8 billion in 2024 and is expected to reach US$ 283.0 billion by 2031, growing at a significant CAGR of 4.8% from 2025-2031. Congenital hyperinsulinism (CHI or HI), refers to a variety of congenital disorders which is characterized by inappropriate and unregulated insulin secretion from the beta-cells of the pancreas, causing Hyperinsulinaemic hypoglycaemia (HH), and the most common cause of severe CHI are mutations in ABCC8 and KCNJ11 genes. Based on the treatment type, the drug therapy segment’s Octreotide is anticipated to dominate the market share over the forecast period. According to the National Organization for Rare Disorders, the incidence of congenital hyperinsulinism is approximately 1/25,000 to 1/50,000 births. Growing awareness about congenital hyperinsulinism and the increased R&D activities for the development of novel therapies will act as the congenital hyperinsulinism market growth drivers. However, the high cost of treatment would be the restraining factor for the market. Advancements in diagnostic techniques and novel approaches to minimize side effects are opportunities for key players in the market for the expansion of the market.

Key Developments

• In April 2021, the US FDA granted Orphan Drug designation to AmideBio’s glucagon analog, ABG-023 for the treatment of congenital hyperinsulinism.
• In August 2021, Eiger BioPharmaceuticals received Breakthrough Therapy designation for Avexitide for the treatment of congenital hyperinsulinism by the US FDA.