The global congenital hyperinsulinism treatment market size attained a value of USD 153.25 million in 2022. The market is expected to grow at a CAGR of 4.80% during the forecast period 2023-2031 to reach a value of about USD 223.70 million by 2031. 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 (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
Market Break Up by Treatment Method
Market Break Up by Treatment Channel
Market Break Up by Region
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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.
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.
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.
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.
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:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Diagnosis Method||
|Breakup by Treatment Method||
|Breakup by Treatment Channel||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
2 Research Methodology
3 Executive Summary
4 Congenital Hyperinsulinism Overview
4.1 Guidelines and Stages
4.3 Screening and Diagnosis
4.4 Treatment Pathway
5 Patient Profile
5.1 Patient Profile Model
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Current Scenario Evaluation
6.1 Emerging Therapies and Clinical Trials Synopsis
6.2 Patent Landscape
6.2.1 Patent Overview
220.127.116.11 Patent Status and Expiry
18.104.22.168 Timelines from Drug Development to Commercial Launch
22.214.171.124 New Drug Application
126.96.36.199.1 Documentation and Approval Process
6.3 Cost of Treatment
6.4 Regulatory Framework
6.4.1 Regulatory Overview
188.8.131.52 US FDA
184.108.40.206 EU EMA
220.127.116.11 INDIA CDSCO
18.104.22.168 JAPAN PMDA
7 Challenges and Unmet Needs
7.1 Treatment Pathway Challenges
7.2 Compliance and Drop- out Analysis
7.3 Awareness and Prevention Gaps
8 Global Congenital Hyperinsulinism Treatment Market
8.1 Global Congenital Hyperinsulinism Treatment Market Overview
8.2 Global Congenital Hyperinsulinism Treatment Market Analysis
8.2.1 Market Overview
22.214.171.124 Global Historical Congenital Hyperinsulinism Treatment Market Volume (2016-2022)
126.96.36.199 Global Forecast Congenital Hyperinsulinism Treatment Market Volume (2023-2031)
8.2.2 Global Congenital Hyperinsulinism Treatment Market by Diagnosis Method
188.8.131.52 Market Overview
184.108.40.206.1 Blood Test
220.127.116.11.1.1 Genetic Test
18.104.22.168.1.2 Plasma Sugar
8.2.3 Global Congenital Hyperinsulinism Treatment Market by Treatment Method
22.214.171.124 Market Overview
126.96.36.199.1 Drug Therapy
8.3 Global Congenital Hyperinsulinism Treatment Market by Treatment Channel
8.4 Global Congenital Hyperinsulinism Treatment Market by Region
8.4.1 Market Overview
188.8.131.52 North America
184.108.40.206 Asia Pacific
220.127.116.11 Middle East and Africa
18.104.22.168 Latin America
9 North America Congenital Hyperinsulinism Treatment Market
9.1 Market Share by Country
9.2 United States of America
9.2.1 Historical Trend (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
10 Europe Congenital Hyperinsulinism Treatment Market
10.1 Market Share by Country
10.2 United Kingdom
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
10.4.1 Historical Trend (2016-2022)
10.4.2 Forecast Trend (2023-2031)
10.5.1 Historical Trend (2016-2022)
10.5.2 Forecast Trend (2023-2031)
11 Asia Pacific Congenital Hyperinsulinism Treatment Market
11.1 Market Share by Country
11.2.1 Historical Trend (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
11.5.1 Historical Trend (2016-2022)
11.5.2 Forecast Trend (2023-2031)
11.6.1 Historical Trend (2016-2022)
11.6.2 Forecast Trend (2023-2031)
12 Latin America Congenital Hyperinsulinism Treatment Market
12.1 Market Share by Country
12.2.1 Historical Trend (2016-2022)
12.2.2 Forecast Trend (2023-2031)
12.3.1 Historical Trend (2016-2022)
12.3.2 Forecast Trend (2023-2031)
12.4.1 Historical Trend (2016-2022)
12.4.2 Forecast Trend (2023-2031)
13 Middle East and Africa Congenital Hyperinsulinism Treatment Market
13.1 Market Share by Country
13.2 Saudi Arabia
13.2.1 Historical Trend (2016-2022)
13.2.2 Forecast Trend (2023-2031)
13.3 United Arab Emirates
13.3.1 Historical Trend (2016-2022)
13.3.2 Forecast Trend (2023-2031)
13.4.1 Historical Trend (2016-2022)
13.4.2 Forecast Trend (2023-2031)
13.5 South Africa
13.5.1 Historical Trend (2016-2022)
13.5.2 Forecast Trend (2023-2031)
14 Congenital Hyperinsulinism Treatment Market Dynamics
14.1 Market Drivers and Constraints
14.2 SWOT Analysis
14.3 Porter’s Five Forces Model
14.4 Key Demand Indicators
14.5 Key Price Indicators
14.6 Market Events, Initiatives, and Trends
14.7 Value Chain Analysis
15 Supplier Landscape
15.1 Eli Lilly
15.1.1 Company Overview
15.1.2 Product Portfolio
15.1.3 Demographic Reach and Achievements
15.1.4 Mergers and Acquisitions
15.2 Novo Nordisk
15.2.1 Company Overview
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievements
15.2.4 Mergers and Acquisitions
15.3 Novartis AG
15.3.1 Company Overview
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievements
15.3.4 Mergers and Acquisitions
15.4 Rezolute, Inc.
15.4.1 Company Overview
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievements
15.4.4 Mergers and Acquisitions
15.5 Eiger BioPharmaceuticals.
15.5.1 Company Overview
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievements
15.5.4 Mergers and Acquisitions
15.6 Zealand Pharma A/S
15.6.1 Company Overview
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievements
15.6.4 Mergers and Acquisitions
15.7 Hanmi Pharmaceutical Co., Ltd.
15.7.1 Company Overview
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievements
15.7.4 Mergers and Acquisitions
15.8 Crinetics Pharmaceuticals, Inc.
15.8.1 Company Overview
15.8.2 Product Portfolio
15.8.3 Demographic Reach and Achievements
15.8.4 Mergers and Acquisitions
15.9 AmideBio LLC
15.9.1 Company Overview
15.9.2 Product Portfolio
15.9.3 Demographic Reach and Achievements
15.9.4 Mergers and Acquisitions
16 Global Congenital Hyperinsulinism Treatment Market- Distribution Model (Additional Insight)
16.2 Potential Distributors
16.3 Key Parameters for Distribution Partner Assessment
17 Payment Methods (Additional Insight)
17.1 Government Funded
17.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The key factors propelling the market growth are the increasing awareness about CHI and robust pipeline activity globally.
Based on the diagnosis, the market is categorised into prenatal testing consisting of blood tests which include genetic tests and plasma sugar, among others.
Based on the treatment, the market is segmented into drug therapies and surgery, among others.
The treatment channels in this market are public and private.
The different regions in the acute coronary syndrome treatment market are North America, Europe, Asia Pacific, Latin America, the Middle East and Africa.
CAH is a series of autosomal recessive illnesses characterised by a deficit of an enzyme involved in the manufacture of cortisol, aldosterone, or both. The most frequent form of CAH, accounting for more than 90% of cases, is 21-hydroxylase deficiency caused by CYP21A mutations or deletions.
The key companies involved in this market are Eli Lilly, Novo Nordisk, Novartis AG, Rezolute, Inc., Eiger BioPharmaceuticals., Zealand Pharma A/S, Hanmi Pharmaceutical Co., Ltd., Crinetics Pharmaceuticals, Inc., and AmideBio LL, among others.
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