Congenital Hyperinsulinism Market: 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 Geography

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Congenital Hyperinsulinism Market was valued at USD 182 million in 2022 and is poised to grow at a CAGR of 5.5% over 2023-2029. 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.

Congenital Hyperinsulinism 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.

Congenital Hyperinsulinism Market Summary

Study Period


Base Year




Largest Market

North America

Fastest Growing Market

North America
Congenital Hyperinsulinism Market Dynamics

Initiatives by government and non-government organizations to create awareness of congenital hyperinsulinism treatment and increasing investments by pharmaceutical companies will impact the growth of the market. For example, Congenital Hyperinsulism International, focused on providing support such as disease diagnosis and disease management to the patient with CHI, held a family conference, in August 2022. For instance, in March 2022, Zealand Pharma completed a phase-III clinical trial for Dasiglucagon to control blood sugar in infants with congenital hyperinsulinism. Moreover, the other emerging therapies, such as RZ358, CSI-Glucagon, Pasireotide, and others will participate in the growth of the market. Thus, the increased awareness, research, and development for rare disorders will lead to the growth of the market within the forecast period. However, without the proper line of treatment for the disease, the growth of the market could get hampered.

Key Features of the Reports

  • The congenital hyperinsulinism market report provides granular level information about the market size, regional market share, historic market (2018-2022) and forecast (2023-2029)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Congenital Hyperinsulinism Market Segmentation

By Treatment Type
  • Drug Therapy
  • Dietary Management
  • Surgery
  • Others
By Disease Type
  • GDH-HI
  • GK-HI
  • Others
By Diagnosis Method
  • Blood Test
  • Genetic Test
  • Plasma Sugar
By Route of Administration
  • Oral
  • Parenteral
By End User
  • Hospitals
  • Clinics
  • Homecare
  • Others

Frequently Asked Questions

The Congenital Hyperinsulinism market was valued at USD 182 million in 2022 and is expected to grow at a 5.5% CAGR over the forecast period 2023 – 2029.

Advancements in diagnostic techniques and novel approaches to minimize side effects are the key opportunities for the Congenital Hyperinsulinism market.

Growing awareness about congenital hyperinsulinism and the increased R&D activities for the development of novel therapies are the growth drivers in the Congenital Hyperinsulinism market.

Eli Lilly, IVAX Pharmaceuticals, Teva Pharmaceuticals, Novo Nordisk, Novartis AG, Rezolute, Inc., Xeris Pharmaceuticals, Eiger BioPharmaceuticals., Zealand Pharma A/S, Hanmi Pharmaceutical Co., Ltd., Crinetics Pharmaceuticals, Inc., and AmideBio LLC are a few companies operating in the Congenital Hyperinsulinism market.

  • Eli Lilly
  • IVAX Pharmaceuticals
  • Teva Pharmaceuticals
  • Novo Nordisk
  • Novartis AG
  • Rezolute, Inc.
  • Xeris Pharmaceuticals
  • Eiger BioPharmaceuticals.
  • Zealand Pharma A/S
  • Hanmi Pharmaceutical Co., Ltd.
  • Crinetics Pharmaceuticals, Inc.
  • AmideBio LLC