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.

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 Treatment Market Report Attributes
Report Attribute |
Details |
Base Year | 2022 |
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Congenital Hyperinsulinism Treatment Market Size in 2022 | USD 146.4 Million |
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Forecast Period | 2023 to 2032 |
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Forecast Period 2023 to 2032 CAGR | 5.5% |
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2032 Value Projection | USD 251.1 Million |
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Historical Data for | 2018 to 2022 |
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No. of Pages | 180 |
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Tables, Charts & Figures | 202 |
Segments covered | Drug Type, Route of Administration, Distribution Channel, and Region |
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Growth Drivers | - Rising prevalence of congenital hyperinsulinism (CHI)
- Increasing focus on personalized medicine
- Favourable government initiatives
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Pitfalls & Challenges | - Limited approved treatment options
- High treatment cost
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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
As congenital hyperinsulinism (CHI) becomes more common around the globe, the market for treatments is expected to grow rapidly. According to experts, about 1 out of every 50,000 people worldwide has CHI. This makes it one of the most common causes of severe low blood sugar in newborns and young children. In many countries, about 1 out of every 25,000 to 50,000 babies is born with CHI. About 6 out of 10 babies with CHI develop low blood sugar within their first month of life. This rising number of CHI cases is creating a greater need for effective treatments to help 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
When it comes to treating congenital hyperinsulinism, there are various types of drugs used, including diazoxide, octreotide, nifedipine, glucagon, and others. Among these, octreotide is expected to be a key player in the market, with a projected growth rate of 6.4% over the coming years. Octreotide is crucial in managing symptoms of congenital hyperinsulinism, which is the leading cause of low blood sugar in newborns and infants. As a result, the growth of the octreotide segment is driven by its effectiveness in treating this condition. Another factor that will likely contribute to market growth is the rise in the number of new drugs being tested in clinical trials. One promising drug in particular is CRN04777, an oral, nonpeptide that activates a specific receptor in the body. It is currently being developed to treat congenital hyperinsulinism and is expected to further boost market growth in the future.

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 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
Distribution channel
- Retail pharmacies
- Hospital pharmacies
- Online pharmacies
The above information is provided for the following regions and countries
- North America
- 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