Global Congenital Hyperinsulinism Treatment Market Report and Forecast 2024-2032

Global Congenital Hyperinsulinism Treatment Market Outlook

The global congenital hyperinsulinism treatment market size attained a value of USD 160.61 million in 2023. The market is expected to grow at a CAGR of 4.80% during the forecast period 2024-2032 to reach a value of about USD 244.91 million by 2032. The market growth is driven by the increasing awareness of congenital hyperinsulinism and robust pipeline activity globally.

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Congenital Hyperinsulinism Treatment Market Insight

Congenital hyperinsulinism treatment market (HI) is a genetic condition in which the pancreatic insulin cells, known as beta cells, secrete an abnormally large amount of insulin. Excess insulin causes low blood sugar or low plasma sugar.

Low blood sugar is extremely harmful since the brain requires a steady supply of sugar. If the brain does not obtain enough sugar, it can cause seizures, brain damage, and even death.

Congenital hyperinsulinism is caused by genetic abnormalities that produce incorrect and excessive insulin release from pancreatic beta cells. 

The symptoms of hypoglycemia in infants are frequently difficult to distinguish since it can mimic normal infant behaviours. A few common symptoms include irritability, drowsiness, fatigue, increased food cravings, and rapid heart rate. Whereas moderate to severe symptoms include seizures and coma due to prolonged or extremely low plasma sugar.

Congenital hyperinsulinism is diagnosed using a combination of patient history, laboratory tests, and genetic tests. 

The child's history is a vital element of the diagnosis. This includes information such as when the low plasma sugars began, whether the baby was born big for gestational age (LGA), and any family history of low plasma sugars or unexplained newborn deaths, seizures. 

Blood tests are required to diagnose HI when the plasma sugar level is less than 50 mg/dL. With a plasma sugar of 50, it will find suppressed ketones and free fatty acids, an elevated insulin level (which may or may not be caught), and a glycemic response to glucagon, with the plasma sugar rising more than 30 mg/dL when glucagon is injected.

To screen for the mutations that cause the most prevalent kinds of HI, DNA from a blood sample from the infant with congenital HI and each parent can be studied. This should be considered for anyone suspected of having congenital HI. 

According to the global congenital hyperinsulinism treatment market research report, the market can be categorised into the following segments:  

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Market Break Up by Diagnosis Method

• Blood Test
  • Genetic Test
  • Plasma Sugar

Market Break Up by Treatment Method

• Drug Therapy
  • Diazoxide
  • Octreotide
  • Glucagon
  • Others
• Surgery

Market Break Up by Treatment Channel

• Public

• Private

Market Break Up by Region

• North America 
  • United States of America 
  • Canada 
• Europe 
  • United Kingdom 
  • Germany 
  • France 
  • Italy 
  • Others 
• Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
• Latin America 
  • Brazil 
  • Argentina 
  • Mexico 
  • Others 
• Middle East and Africa 
  • Saudi Arabia 
  • United Arab Emirates 
  • Nigeria 
  • South Africa 
  • Others 

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Global Congenital Hyperinsulinism Epidemiology

1 in every 50,000 neonates is born with congenital hyperinsulinism. This disorder is more prevalent in certain groups, affecting up to 1 in every 2,500 births. Approximately 60% of babies with HI are diagnosed within the first month of life. An additional 30% will be diagnosed later in the first year, with the remaining being diagnosed later.

Global Congenital Hyperinsulinism Treatment Market - Therapeutic Landscape

To avoid brain damage, hypoglycemia caused by HI must be treated as soon as possible. Unlike other hypoglycemia-causing situations in which alternate fuels, such as ketones or lactate, may be accessible for the brain during hypoglycemia, HI blocks the generation of these fuels, leaving the brain without an energy source.

Diazoxide, octreotide, and glucagon are among the common medications used to treat HI.

Diazoxide inhibits insulin secretion by acting on the KATP (ATP- Sensitive Potassium Channels) channel. It is often beneficial for newborns with stress-induced hyperinsulinism, GDH-HI (Glutamate dehydrogenase), or GK-HI (Glucokinase), and a subset of children whose underlying problem is unknown. Diazoxide is frequently ineffective in children with KATP-HI.

Octreotide is a medication that decreases insulin secretion as well. Octreotide is frequently quite successful at first, but it may lose effectiveness with time. In neonates, who are already at risk for NEC (necrotizing enterocolitis), octreotide is not currently indicated. Other medicines that are similar to octreotide include octreotide LAR and lanreotide, which have a longer duration of action and can be administered once a month. Longer-acting octreotide preparations are designated for patients who have responded to short-acting octreotide and are on a stable regimen.

Glucagon causes the liver to release glucose. When an infant with HI has low blood glucose levels and cannot be fed, glucagon can be given in an emergency. It works best as a holding therapy while the patient is being readied for surgery.

Children with diffuse KATP-HI frequently necessitate 95-99% pancreatectomies. These procedures are not curative, and KATP-HI children who have had them may still need regular meals and drugs to prevent hypoglycemia. Patient may also require additional procedures. The goal of such surgery is to reduce the intensive medical regimen that would otherwise be required to safeguard young patients from recurring, severe hypoglycemia.

Congenital Hyperinsulinism Investigational Therapies

NN414 appears to be a promising replacement for the currently utilised KATP channel opener diazoxide. Targeting KCa3.1 channels with channel openers or L-type Ca2+ channels with DXM or simvastatin may be useful for treating CHI caused by KATP channel mutations that are not susceptible to KATP channel openers.

Exendin-(9-39), an experimental glucagon-like peptide-1 (GLP-1) antagonist, protects fasting and protein-induced hypoglycemia in children with congenital hyperinsulinism. Could possibly be used in the treatment of CHI in children.

Congenital Hyperinsulinism Treatment Market Trends

The global congenital hyperinsulinism treatment market is expected to propel in the forecast period owing to the robust pipeline activities and increasing awareness of the disease. And the availability of effective therapies will also contribute to driving the market in the future. 

Global Congenital Hyperinsulinism Competitive Landscape

The report gives an in-depth analysis of the key players involved in the global congenital hyperinsulinism treatment market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows: 

• Eli Lilly

• Novo Nordisk

• Novartis AG

• Rezolute, Inc.

• Eiger BioPharmaceuticals.

• Zealand Pharma A/S

• Hanmi Pharmaceutical Co., Ltd.

• Crinetics Pharmaceuticals, Inc.

• AmideBio LLC

Key Highlights of the Report