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Congenital Hyperinsulinism Treatment Market - By Drug Type (Diazoxide, Octreotide, Nifedipine, Glucagon), Route of Administration (Oral, Parenteral), Distribution Channel (Retail Pharmacies, Hospital Pharmacies), Global Forecast, 2023 - 2032

  • Report ID: GMI6333
  • Published Date: Jul 2023
  • Report Format: PDF

Congenital Hyperinsulinism Treatment Market Size

Congenital Hyperinsulinism Treatment Market size accounted for USD 146.4 million in 2022 and is estimated to grow at 5.5% to reach USD 251.1 million by 2032.

Congenital Hyperinsulinism Treatment Market

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 the market growth. Furthermore, increasing focus on precision medicine is driving the development of targeted therapies for congenital hyperinsulinism, thereby accelerating the market progress.

Congenital hyperinsulinism (CHI) is a rare genetic disorder characterized by excessive insulin production from the pancreas, leading to recurrent and severe hypoglycemia (low blood sugar levels). The goal of CHI treatments is to maintain stable blood sugar levels and prevent hypoglycemic episodes, which can cause significant neurological complications.

COVID-19 Impact

The COVID-19 pandemic had a negative impact on the congenital hyperinsulinism (CHI) treatment market. Healthcare systems faced resource constraints and restructured their services to prioritize COVID-19 care, leading to delays in non-emergency medical services, including CHI treatment. This had resulted in delayed diagnosis and treatment for some CHI patients, thus impacted disease management and patient outcomes. Such aforementioned factor negatively impacted the market growth. Additionally, supply chain disruptions had resulted in shortages and delays in accessing critical medications and medical supplies required for CHI management, thereby hindered the market growth during the pandemic.

Congenital Hyperinsulinism Treatment Market Trends

The increasing prevalence of congenital hyperinsulinism (CHI) worldwide is anticipated to boost the market growth. For instance, according to the Orphanet Journal of Rare Diseases report, congenital hyperinsulinism has an estimated global prevalence of 1/50,000. Similarly, as per National Institute of Health (NIH) report, congenital hyperinsulinism (HI) is the most frequent cause of severe, persistent hypoglycemia in new-born babies and children. In most countries, hyperinsulinism occurs in approximately 1/25,000 to 1/50,000 births. About 60% of babies with hyperinsulinism develop hypoglycemia during the first month of life. Thus, the increasing number of congenital hyperinsulinism cases globally has increased the demand for effective treatment options to manage this rare genetic disorder.

Congenital Hyperinsulinism Treatment Market Restraint

Limited approved treatment options for congenital hyperinsulinism may hamper the market growth. Due to the complexity and rarity of congenital hyperinsulinism (CHI), there is a lack of specific medications and therapies that have received regulatory approval for its management. Thus, the limited number of approved treatments poses challenges for healthcare providers and patients seeking treatment, thereby negatively impacting the market growth. Furthermore, the high cost associated with congenital hyperinsulinism treatment may hamper the market progress.

Congenital Hyperinsulinism Treatment Market Analysis

Congenital Hyperinsulinism Treatment Market, By Drug Type, (USD Million)

By drug type, the congenital hyperinsulinism treatment market is classified into diazoxide, octreotide, nifedipine, glucagon, and other drug types. The octreotide segment is projected to witness significant growth of 6.4% over the analysis timeframe. Octreotide is pivotal role in providing effective symptom management for individuals with congenital hyperinsulinism thereby, driving the segmental growth. Also, increasing number of drugs in the clinical trials will escalate the market growth. For instance, CRN04777 is an orally administered nonpeptide that is a potent and selective agonist of somatostatin 5 (SST5) receptors. It is currently under development for the treatment of congenital hyperinsulinism (HI), the most common cause of persistent hypoglycemia in new-borns and infants. Such development of novel drugs is anticipated to boost the market growth.

Congenital Hyperinsulinism Treatment Market, By Route of Administration,(2022)

Based on route of administration, the congenital hyperinsulinism treatment market is segmented into oral and parenteral. The oral segment accounted for 60.7% of the market share in 2022. Oral medications offer a non-invasive and easy-to-administer option for managing congenital hyperinsulinism (CHI). Such factor is beneficial for pediatric patients and their caregivers. Also, the oral route eliminates the need for injections, thereby reduce discomfort and improve treatment compliance. Such associated benefits with oral route of administration is expected to foster the market growth. Moreover, the oral route of administration facilitates self-administration, thereby augmenting the overall market trends.

Based on distribution channel, the congenital hyperinsulinism treatment market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies accounted for 45.3% of the market share in 2022. Hospital pharmacies play a crucial role in ensuring the timely availability of critical medications such as diazoxide and octreotide for treating congenital hyperinsulinism (CHI). Moreover, the close collaboration of hospital pharmacies with healthcare providers and specialists allows seamless coordination in delivering tailored treatment regimens to CHI patients, thus optimizing disease management and patient outcomes. Such aforementioned factors are expected to escalate the segmental expansion.

North America Congenital Hyperinsulinism Treatment Market, (USD Million)

North America congenital hyperinsulinism treatment market accounted for 61.3% business share in 2022 and is anticipated to grow at considerable growth rate during the forecast timeframe. 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 & research institutions will foster the development of new treatment options, thereby driving market growth. Further, the emphasis on patient-centric care and the availability of comprehensive medical services will contribute to the overall growth of the market in North America.

Congenital Hyperinsulinism Treatment Market Share

Major market players operating in the congenital hyperinsulinism treatment market include

  • Crinetics Pharmaceuticals, Inc.
  • Novartis AG
  • Zealand Pharma A/S
  • Rezolute, Inc.
  • Hanmi Pharm.Co.,Ltd
  • Teva Pharmaceutical Industries Ltd

These industry players majorly adopt various strategies including collaborations, acquisitions, mergers, and partnerships to create a global footprint and sustain market competition. Also, kindly note that the company profile section includes both companies that have commercial drug available in market as well as those that are into clinical phase development.

Congenital Hyperinsulinism Treatment Industry News:

  • 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 hyperinsulism (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 analog (ABG-023) for the treatment of congenital hyperinsulinism. This strategy helped the company to expand its product portfolio and customer base.

The congenital hyperinsulinism treatment market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By drug type

  • Diazoxide
  • Octreotide
  • Nifedipine
  • Glucagon
  • Other drug types

Route of administration

  • Oral
  • Parenteral

Distribution channel

  • Retail pharmacies
  • Hospital pharmacies
  • Online pharmacies

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • Rest of Middle East & Africa


Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

Congenital hyperinsulinism treatment industry size was worth USD 146.4 million in 2022 and is estimated to witness 5.5% CAGR from 2023 to 2032 attributed to the increasing government initiatives to support the development and accessibility of treatments of rare genetic disorders.

The octreotide drug type segment is estimated to record 6.4% CAGR from 2023 to 2032 driven by the increasing use for providing effective symptom management for individuals with congenital hyperinsulinism.

North America congenital hyperinsulinism treatment market accounted for 61.3% revenue share in 2022 and is projected to expand at notable CAGR from 2023-2032 owing to the presence of advanced healthcare infrastructure, the strong focus on R&D and favorable regulatory environment.

Some major companies engaged in the congenital hyperinsulinism treatment industry are Crinetics Pharmaceuticals, Inc., Novartis AG, Zealand Pharma A/S, Rezolute, Inc., Hanmi Pharm.Co., Ltd, and Teva Pharmaceutical Industries Ltd, among others.

Congenital Hyperinsulinism Treatment Market Scope

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Premium Report Details

  • Base Year: 2022
  • Companies covered: 10
  • Tables & Figures: 202
  • Countries covered: 19
  • Pages: 180
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