Congenital Hyperinsulinism Treatment Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Global Congenital Hyperinsulinism Treatment Market is Segmented By Type (K ATP-hyperinsulinism, GDH-hyperinsulinism, GK-hyperinsulinism, SCHAD-hyperinsulinism, UCP2-hyperinsulinism, HNF4A and HNF1A-hyperinsulinism, MCT1-Hyperinsulinism), By Drug Type (Diazoxide, Octreotide, Nifedipine, Other Drug Types), By Route of Administration (Oral, Intravenous, Subcutaneous), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

Congenital Hyperinsulinism Treatment Market Overview

Global Congenital Hyperinsulinism Treatment Market is expected to reach at a high CAGR during the forecast period 2023-2030.

The primary aim of this treatment is either case is blood glucose stabilisation and reduction of insulin levels to prevent neurological complications. Acute treatment may include parenteral glucose infusion, frequent feeding, and administration of glucagon. Congenital hyperinsulinism is characterized by dysregulated insulin secretion that results in persistent mild to severe hypoglycemia. 

The various forms of congenital hyperinsulinism represent a group of clinically, genetically, and morphologically heterogeneous disorders. Congenital hyperinsulinism is characterized by dysregulated insulin secretion that results in persistent mild to severe hypoglycemia. The various forms of congenital hyperinsulinism represent a group of clinically, genetically, and morphologically heterogeneous disorders.

Furthermore, the global congenital hyperinsulinism market is driven by various factors like advancements in treatment options, governments across various regions are increasingly recognizing the importance of addressing rare genetic disorders such as congenital hyperinsulinism(CHI) and are undertaking initiatives to support the development and accessibility of treatments. 

Through initiatives such as research grants, funding support, and regulatory incentives, governments are encouraging research and development in the field of rare diseases, thereby propelling market growth. 

Congenital Hyperinsulinism Treatment Market Scope

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Congenital Hyperinsulinism Treatment Market Dynamics

Rise in the Prevalence of Congenital Hyperinsulinism

The rise in the prevalence of congenital hyperinsulinism is one of the key factors that helps to drive the market during the forecast period. For instance, according article published in the National Library of Medicine titled Global Registries in Congenital Hyperinsulinism says that Congenital hyperinsulinism (HI) is the most frequent cause of severe, persistent hypoglycemia in newborn babies and congenital hyperinsulinism. 

In most countries, HI occurs in approximately 1/25,000 to 1/50,000 births. About 60% of babies with HI develop hypoglycemia during the first month of life. When HI is not recognized and diagnosed or if treatment is ineffective in preventing hypoglycemia, brain damage or death can occur.

Rising Awareness of Congenital hyperinsulinism among the Population 

The rise in awareness of congenital hyperinsulinism among the population creates to detection, and diagnosis of the disease in its early stages which indirectly helps the market to grow during the forecast period. Congenital Hyperinsulinism International is a non-profit organization providing support for congenital hyperinsulinism patients and raising awareness. 

For instance, in August 16, 2022, a family conference featured researchers, physicists, doctors, and patients to share experiences, increase awareness, and learn about treatment options.

Rise in Research & Development Activities for The Development of Congenital Hyperinsulinism

 The rise in research & and development activities for the development of congenital hyperinsulinism will help to find novel therapies which indeed help the market to grow during the forecast period.  For instance, in October 2021, Hanmi Pharm Co, Ltd., a pharmaceutical company initiated a Phase 2 Clinical trial for HM15136 to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HMI 5136, a Glucagon analogue chemically conjugated with the constant region of human immunoglobulin via non-peptidyl-flexible-linker, used as add-on therapy in subjects with congenital hyperinsulinism with persistent hypoglycemia and the trial is expected to be completed on March 2025.

Limited Approved Treatment Options Will Hamper the Market Growth

Limited approved treatment options for congenital hyperinsulinism hamper the market growth. Due to the complexity and rarity of congenital hyperinsulinism, there are no particular drugs or treatment approvals from the FDA. Thus, the limited number of approved treatments poses challenges for healthcare providers and patients seeking treatment, thereby negatively impacting the market growth. 

Also, some complications also hamper the market growth of them are like repeated episodes of low blood glucose increase the risk for serious complications such as breathing difficulties, seizures, intellectual disability, vision loss, brain damage, and coma.

Congenital Hyperinsulinism Treatment Market Segment Analysis

The global congenital hyperinsulinism treatment market is segmented based on type, drug type, route of administration, distribution channel and region.

The Diazoxide Segment From the Drug Type Segment Accounted For Approximately 41.7% of Congenital Hyperinsulinism Share

The diazoxide segment from the drug type segment accounted for 41.7% and it is expected to be dominated during the forecast period. Diazoxide, also known by the brand name Proglycem, is used to treat low blood sugar (hypoglycemia) caused by hyperinsulinism. This drug is the first-choice drug for the treatment of congenital hyperinsulinism which helps this segment to grow. It works by blocking the release of insulin from the pancreas. Diazoxide is the primary treatment for congenital hyperinsulinism, a nondiuretic benzothiadiazide used to reduce severe hypertension through smooth muscle relaxation. 

Originally formulated in the 1960s, it is the only drug approved for this indication in the US, Canada, the UK, the European Union, Congenital hyperinsulinism, Australasia, and Japan. Diazoxide binds to the sulfonylurea receptor-1 subunit in the ATP-sensitive K+ channel, increasing its permeability to potassium ions. This leads to excessive beta cell polarization and inhibition of Ca2+-dependent insulin secretion. Thus, advancements and approvals in this drug help the segment to grow during the forecast period.

Congenital Hyperinsulinism Treatment Market Geographical Share

North America Accounted for Approximately 38.4% of the Market Share

North America is estimated to hold about 38.4% of the total market share throughout the forecast period, owing to the region's advanced healthcare infrastructure and a strong focus on research and development is expected to supplement the market growth. Also, the favorable regulatory environment coupled with collaborations between pharmaceutical companies & and research institutions will foster the development of new treatment options, thereby driving market growth. 

For instance, in December 2022, the Congenital Hyperinsulinism (HI) Center at Congenital Hyperinsulinism Hospital of Philadelphia (CHOP), the nation's largest and most active centre of its kind, is celebrating the completion of 600 pancreatectomies, a surgical procedure that involves removing all or part of the pancreas. The procedure is used to treat some forms of congenital HI, a life-threatening genetic disorder in which the insulin cells of the pancreas, called beta cells, secrete too much insulin, leading to low blood sugar (hypoglycemia).

Congenital Hyperinsulinism Treatment Market Companies

The major global players in the market include Novartis AG, Par Pharmaceuticals, Ralington Pharma, Bayer AG, Novo Nordisk, Teva Pharmaceuticals USA, Merck, Sagent Pharma, Flagship Biotech International Pvt. Ltd, Uno Healthcare and among others.

COVID-19 Impact Analysis

Covid 19 had a substantial impact on the congenital hyperinsulinism market where the clinical trials of endocrinal disease therapies and treatments have a negative effect on COVID-19. For instance, in September 2020, an article published by the Nepal Journal of Epidemiology suggested that the COVID-19 pandemic had a negative impact on the clinical trial activities of endocrinal diseases such as congenital hyperinsulinism. There was a decrease in new patient/subject enrollment which was due to mitigation efforts such as self-isolation and inaccessibility of healthcare facilities during the pandemic with all aspects of clinical trials at various levels.

Key Developments

• In June 2023 Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for dasiglucagon for the prevention and treatment of low blood sugar (hypoglycemia) in pediatric patients 7 days of age or older with congenital hyperinsulinism.
• In August 2021, Eiger Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of congenital hyperinsulinism (HI). This strategy helped the company to expedite the development and review of drugs.
• In April 2021, AmideBio, LLC, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted an orphan drug designation to AmideBio's glucagon analogue (ABG-023) for the treatment of congenital hyperinsulinism. This strategy helped the company to expand its product portfolio and customer base.

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• To visualize the global congenital hyperinsulinism treatment market segmentation based on type, drug type, route of administration, distribution channel and region as well as understand key commercial assets and players.
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The global congenital hyperinsulinism treatment market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

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