United States Congenital Hyperinsulinism Treatment Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market size and Growth

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

Key Development:

United States: Recent Industry Developments

✅ In July 2025, Rezolute presented baseline data from the fully enrolled Phase 3 study at the Endocrine Society's annual meeting. The data provides insights into the study's design and participant demographics.

✅ In May 2025, Rezolute announced the completion of enrollment in its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism. The study enrolled 62 participants, with topline data expected in December 2025.

✅ In January 2025, Rezolute received Breakthrough Therapy Designation from the FDA for ersodetug in the treatment of hypoglycemia due to congenital hyperinsulinism, based on positive Phase 2b study results.

Japan: Recent Industry Developments

✅ In May 2025, Hanmi Pharmaceutical highlighted the potential of efpegerglucagon (HM15136) to bring new hope to patients with congenital hyperinsulinism. The company emphasized the importance of continued research and development in this area.

✅ In May 2025, Hanmi Pharmaceutical announced steady progress in the development of efpegerglucagon (HM15136), a novel treatment for congenital hyperinsulinism. The company is advancing towards further clinical trials and regulatory approvals.

✅ In May 2025, Hanmi Pharmaceutical presented interim Phase 2 clinical trial results of efpegerglucagon (HM15136) at the Joint Congress of the European Society for Paediatric Endocrinology and the European Society of Endocrinology in Copenhagen. The results demonstrated notable improvements in reducing hypoglycemia events.

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Key Players:

=> 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.

Growth Forecast Projected:

The Global Congenital Hyperinsulinism Treatment Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Congenital Hyperinsulinism Treatment Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ 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

Regional Analysis for Congenital Hyperinsulinism Treatment Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Congenital Hyperinsulinism Treatment producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Congenital Hyperinsulinism Treatment revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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