The congenital hyperinsulinism market is poised for steady growth, driven by increasing disease awareness, improved neonatal screening, and advances in genetic and molecular diagnostics. Growth is further supported by the continued need for effective therapies, as existing treatment options such as diazoxide and somatostatin analogs remain inadequate for many patients. Meanwhile, emerging targeted therapies such as Dasiglucagon (Zealand Pharma), Ersodetug (RZ358; Rezolute), Avexitide (Amylyx Pharmaceuticals), Efpegerglucagon (HM15136; Hanmi Pharmaceutical), and others are expected to diversify the treatment landscape and create new commercial opportunities.
LAS VEGAS, Aug. 26, 2026 /PRNewswire/ -- Recently published Congenital Hyperinsulinism Market Insights report includes a comprehensive understanding of current treatment practices, congenital hyperinsulinism emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Congenital Hyperinsulinism Market Summary
- The market size for congenital hyperinsulinism was found to be USD 110 million in the 7MM in 2025.
- The United States accounted for the largest congenital hyperinsulinism treatment market size, approximately 41% of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The total diagnosed prevalent cases of congenital hyperinsulinism in the 7MM were 15,700 cases in 2025, which is expected to increase during the forecast period (2026-2036).
- Leading congenital hyperinsulinism companies, such as Zealand Pharma, Rezolute, Amylyx Pharmaceuticals, Hanmi Pharmaceutical, and others, are developing new congenital hyperinsulinism treatment drugs that can be available in the congenital hyperinsulinism market in the coming years.
- The promising congenital hyperinsulinism therapies in clinical trials include Dasiglucagon, Ersodetug (RZ358), Avexitide, Efpegerglucagon (HM15136), and others.
Discover new treatment for congenital hyperinsulinism @ https://www.delveinsight.com/report-store/congenital-hyperinsulinism-market
Key Factors Driving the Growth of the Congenital Hyperinsulinism Market
- Rising Disease Awareness and Improved Diagnosis: Growing awareness of congenital hyperinsulinism (CHI) among clinicians and caregivers is supporting earlier recognition and diagnosis. Advances in genetic testing and molecular diagnostics are also enabling more accurate identification of disease subtypes.
- Advancements in Genetic and Molecular Research: Improved understanding of the genetic mechanisms underlying CHI is facilitating the development of targeted therapeutic strategies. Growing knowledge of mutations affecting insulin secretion may also support more personalized approaches to treatment.
- Increasing Detection of Rare Genetic Disorders: Although congenital hyperinsulinism is a rare disorder, advancements in diagnostic techniques, patient registries, and disease reporting mechanisms are improving case identification worldwide. The growing number of diagnosed patients is, in turn, driving continued demand for effective treatment options.
- Growing Pipeline of Novel Therapies: Increasing clinical research into innovative pharmacological and molecular approaches is expected to expand treatment options for patients with congenital hyperinsulinism. The emergence of therapies such as Dasiglucagon (Zealand Pharma), Ersodetug (RZ358; Rezolute), Avexitide (Amylyx Pharmaceuticals), Efpegerglucagon (HM15136; Hanmi Pharmaceutical), and others targeting the underlying mechanisms of inappropriate insulin secretion could significantly reshape the market.
Download the report to understand the top emerging congenital hyperinsulinism drugs @ Congenital Hyperinsulinism Clinical Trials
As per Aparna Thakur, Project Manager of Forecasting at DelveInsight, novel strategies, including gene-based and other mechanism-driven interventions, are being explored to correct or modulate the underlying defects in insulin regulation. Although still in early stages, these therapies hold potential for disease-modifying outcomes but face challenges related to clinical validation, long-term efficacy, and safety.
DelveInsight's Congenital Hyperinsulinism Market Report delivers executive-level intelligence on the evolving market landscape, integrating epidemiology, treatment practices, competitive dynamics, emerging therapies, and market forecasts across the major markets through 2036. Built on a rigorous methodology combining comprehensive secondary research, primary interviews with key opinion leaders and industry experts, and proprietary patient-based forecasting models, the report provides a reliable foundation for strategic planning. Designed for pharmaceutical and biotech executives, it enables informed decisions on portfolio strategy, business development, market entry, investment prioritization, and commercial planning.
Congenital Hyperinsulinism Market Analysis
- The treatment landscape for congenital hyperinsulinism remains primarily centered on symptom control and the prevention of hypoglycemic episodes.
- Current management strategies include frequent feeding, continuous glucose administration, and pharmacological therapy.
- Diazoxide is generally considered the first-line treatment, while somatostatin analogs may be used in patients who do not respond adequately. In severe cases, particularly those involving focal disease, surgical approaches such as partial pancreatectomy may be necessary.
- However, treatment outcomes remain inconsistent, with many patients showing inadequate responses or resistance to established therapies.
- This persistent variability underscores the substantial unmet need for more effective and durable treatment options, particularly therapies capable of addressing the underlying pathophysiology rather than merely managing hypoglycemic symptoms.
- The therapeutic landscape is gradually shifting toward targeted, mechanism-based approaches. Among the notable investigational therapies is Ersodetug (RZ358), which is designed to modulate insulin receptor signaling and represents a novel therapeutic strategy for patients with severe or treatment-resistant congenital hyperinsulinism. Such approaches could mark a transition from conventional symptom management toward functional disease modification.
- Pharmaceutical companies and research organizations are increasingly investing in the development of novel therapies for this rare disorder.
- Ongoing research is aimed at deepening the understanding of congenital hyperinsulinism biology and identifying new therapeutic targets, with genetic and molecular insights playing an increasingly important role in guiding drug development.
- The emerging congenital hyperinsulinism pipeline remains relatively limited but is gaining momentum, with several investigational candidates potentially capable of reshaping the competitive landscape and addressing long-standing treatment gaps.
- As development programs advance and competition increases, the market is expected to see greater innovation and potentially improved outcomes for patients with this challenging condition.
Congenital Hyperinsulinism Competitive Landscape
Some of the congenital hyperinsulinism drugs under development include Dasiglucagon (Zealand Pharma), Ersodetug (RZ358; Rezolute), Avexitide (Amylyx Pharmaceuticals), Efpegerglucagon (HM15136; Hanmi Pharmaceutical), and others.
Zealand Pharma's ZEGALOGUE is a glucagon analog that elevates blood glucose by promoting glucose release from the liver. Although it is approved for the treatment of severe hypoglycemia in patients with diabetes, its mechanism may also offer therapeutic potential in congenital hyperinsulinism by counteracting hypoglycemia caused by excessive insulin secretion. The drug is currently in the registration stage, with the sponsor planning to resubmit a New Drug Application (NDA) in the second half of 2026.
Rezolute's Ersodetug is an investigational monoclonal antibody that targets the insulin receptor to modulate insulin activity and help maintain stable blood glucose levels in patients with congenital hyperinsulinism. The therapy is currently being evaluated in Phase III clinical development. It has received multiple regulatory designations, including Breakthrough Therapy Designation (BTD), the UK's Innovative Licensing and Access Pathway (ILAP) designation, and Orphan Drug Designations (ODD) from the US and European Union for congenital hyperinsulinism and insulinoma-associated hypoglycemia. However, in December 2025, Rezolute announced that the Phase III sunRIZE study of ersodetug in congenital hyperinsulinism did not achieve its primary endpoint of reducing weekly hypoglycemia events.
Hanmi Pharmaceutical's Efpegerglucagon is a long-acting glucagon analog currently being investigated in Phase II clinical development for congenital hyperinsulinism. The therapy is designed to increase blood glucose levels by stimulating hepatic glucose release. It has received Orphan Drug Designation from both the FDA and EMA, as well as the FDA's Rare Pediatric Disease Designation (RPDD). The global Phase II study is ongoing, with topline results anticipated in the second half of 2026. Earlier interim findings indicated a reduction in hypoglycemia events and demonstrated favorable tolerability. In November 2024, Hanmi presented interim Phase II data for efpegerglucagon in congenital hyperinsulinism at the European Society for Paediatric Endocrinology (ESPE) conference.
The anticipated launch of these emerging therapies are poised to transform the congenital hyperinsulinism market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the congenital hyperinsulinism market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about which pipeline drugs could transform congenital hyperinsulinism treatment market @ Congenital Hyperinsulinism Medications
Congenital Hyperinsulinism Epidemiology Segmentation
The congenital hyperinsulinism epidemiology section provides insights into the historical and current congenital hyperinsulinism patient pool and forecasted trends for the leading markets. In 2025, the estimated number of diagnosed prevalent cases of congenital hyperinsulinism in the US were around 3,500, and this figure is expected to rise by 2036.
The congenital hyperinsulinism treatment market report proffers epidemiological analysis for the study period 2022-2036 in the leading markets, segmented into:
- Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism
- Type-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism based on Histological Presentation
- Mutation-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism
- Total Treated Cases of Congenital Hyperinsulinism
Congenital Hyperinsulinism Market Report Metrics | Details |
Study Period | 2022-2036 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Congenital Hyperinsulinism Market CAGR | 12 % |
Congenital Hyperinsulinism Market Size in 2025 | USD 110 Million |
Key Congenital Hyperinsulinism Companies | Zealand Pharma, Rezolute, Amylyx Pharmaceuticals, Hanmi Pharmaceutical, and others |
Key Congenital Hyperinsulinism Therapies | Dasiglucagon, Ersodetug (RZ358), Avexitide, Efpegerglucagon (HM15136), and others |
Scope of the Congenital Hyperinsulinism Market Report
- Congenital Hyperinsulinism Patient Population Forecast
- Congenital Hyperinsulinism Therapeutics Market Size
- Congenital Hyperinsulinism Pipeline Analysis
- Congenital Hyperinsulinism Market Size and Trends
- Congenital Hyperinsulinism Market Opportunity
- Congenital Hyperinsulinism Market Unmet Needs
- KOL's Views on Congenital Hyperinsulinism
- Congenital Hyperinsulinism Market Access and Reimbursement
Table of Contents
1 | Congenital Hyperinsulinism Market Key Insights |
2 | Congenital Hyperinsulinism Market Report Introduction |
3 | Executive Summary of Congenital Hyperinsulinism |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology |
6 | Congenital Hyperinsulinism Market Overview at a Glance |
6.1 | Market Share (%) Distribution by Therapies in 2025 |
6.2 | Market Share (%) Distribution by Therapies in 2036 |
7 | Disease Background and Overview of Congenital Hyperinsulinism |
7.1 | Introduction |
7.2 | Causes of Congenital Hyperinsulinism |
7.3 | Signs and Symptoms of Congenital Hyperinsulinism |
7.4 | Pathogenesis of Congenital Hyperinsulinism |
7.5 | Pathophysiology of Itch in Congenital Hyperinsulinism Skin |
7.6 | Classification of Congenital Hyperinsulinism |
7.7 | Genetic Bases of Congenital Hyperinsulinism |
7.8 | Diagnosis of Congenital Hyperinsulinism |
8 | Treatment and Management of Congenital Hyperinsulinism |
9 | Treatment Guidelines |
10 | Epidemiology and Patient Population of Congenital Hyperinsulinism |
10.1 | Key Findings |
10.2 | Assumption and Rationale |
10.3 | Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the 7MM |
10.4 | The United States |
10.4.1 | Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the United States |
10.4.2 | Type-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism based on Histological Presentation in the United States |
10.4.3 | Mutation-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the United States |
10.4.4 | Total Treated Cases of Congenital Hyperinsulinism in the United States |
10.5 | EU4 and the UK |
10.6 | Japan |
11 | Patient Journey of Congenital Hyperinsulinism |
12 | Emerging Congenital Hyperinsulinism Drugs |
12.1 | Emerging Competitive Landscape of Congenital Hyperinsulinism |
12.2 | ZEGALOGUE (dasiglucagon): Zealand Pharma |
12.2.1 | Product Description |
12.2.2 | Other Developmental Activities |
12.2.3 | Clinical Developmental Activities |
12.2.3.1 | Clinical Trial Information |
12.2.4 | Safety and Efficacy |
12.2.5 | Analyst's View |
12.3 | Ersodetug (RZ358): Rezolute |
List to be continued in the report… | |
13 | Congenital Hyperinsulinism Market: 7MM Analysis |
13.1 | Key Findings |
13.2 | Congenital Hyperinsulinism Market Outlook |
13.3 | Key Congenital Hyperinsulinism Market Forecast Assumptions |
13.4 | Conjoint Analysis |
13.5 | Total Market Size of Congenital Hyperinsulinism in the 7MM |
13.6 | United States Congenital Hyperinsulinism Market Size |
13.6.1 | Total Market Size of Congenital Hyperinsulinism in the United States |
13.6.2 | Market Size of Congenital Hyperinsulinism by Therapies in the United States |
13.7 | EU4 and the UK Congenital Hyperinsulinism Market Size |
13.8 | Japan Congenital Hyperinsulinism Market Size |
14 | Unmet Needs of Congenital Hyperinsulinism |
15 | SWOT Analysis of Congenital Hyperinsulinism |
16 | KOL Views of Congenital Hyperinsulinism |
17 | Market Access and Reimbursement of Congenital Hyperinsulinism |
17.1 | United States |
17.2 | EU4 and the UK |
17.3 | Japan |
17.4 | Congenital Hyperinsulinism: Market Access and Reimbursement |
18 | Bibliography |
19 | Congenital Hyperinsulinism Market Report Methodology |
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