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Global Congenital Hyperinsulinism Treatment Market Share, Size, Trends, Growth, Insights, Analysis, Forecast: By Diagnosis Method: Blood Test; By Treatment Method: Drug Therapy, Surgery; By Treatment Channel: Public, Private; Regional Analysis; Market Dynamics: Market Drivers and Constraints, SWOT Analysis; Supplier Landscape; 2023-2031
Global Congenital Hyperinsulinism Treatment Market Outlook
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.
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:
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
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
| REPORT FEATURES | DETAILS |
|---|---|
| Base Year | 2022 |
| Historical Period | 2016-2022 |
| Forecast Period | 2023-2031 |
| 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 |
|
| Market Dynamics |
|
| Supplier Landscape |
|
| Companies Covered |
|
*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 Preface
1.1 Objectives of the Study
1.1.1 Research Objectives
1.1.2 Key Findings of the Report
1.2 Limitations of the Study and Scope for Future Research
2 Research Methodology
3 Executive Summary
4 Global Congenital Hyperinsulinism Treatment Market Overview
4.1 Guidelines and Stages
4.2 Pathophysiology
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 Global Congenital Hyperinsulinism Treatment Market
6.1 Global Congenital Hyperinsulinism Treatment Market Overview
6.2 Global Congenital Hyperinsulinism Treatment Market Analysis
6.2.1 Market Overview
6.2.1.1 Global Historical Congenital Hyperinsulinism Treatment Market Volume (2016-2022)
6.2.1.2 Global Forecast Congenital Hyperinsulinism Treatment Market Volume (2023-2031)
6.2.2 Global Congenital Hyperinsulinism Treatment Market by Diagnosis Method
6.2.2.1 Market Overview
6.2.2.1.1 Blood Test
6.2.2.1.1.1 Genetic Test
6.2.2.1.1.2 Plasma Sugar
6.2.3 Global Congenital Hyperinsulinism Treatment Market by Treatment Method
6.2.3.1 Market Overview
6.2.3.1.1 Drug Therapy
6.2.3.1.1.1 Diazoxide
6.2.3.1.1.2 Octreotide
6.2.3.1.1.3 Glucagon
6.2.3.1.1.4 Others
6.2.3.1.2 Surgery
6.3 Global Congenital Hyperinsulinism Treatment Market by Treatment Channel
6.3.1 Public
6.3.2 Private
6.4 Global Congenital Hyperinsulinism Treatment Market by Region
6.4.1 Market Overview
6.4.1.1 North America
6.4.1.2 Europe
6.4.1.3 Asia Pacific
6.4.1.4 Middle East and Africa
6.4.1.5 Latin America
6.4.2 North America
6.4.2.1 Historical Market (2016-2022)
6.4.2.2 Forecast Market (2023-2031)
6.4.2.3 Break Up by Country
6.4.2.3.1 United States of America
6.4.2.3.2 Canada
6.4.3 Europe
6.4.3.1 Historical Market (2016-2022)
6.4.3.2 Forecast Market (2023-2031)
6.4.3.3 Break Up by Country
6.4.3.3.1 United Kingdom
6.4.3.3.2 Germany
6.4.3.3.3 France
6.4.3.3.4 Italy
6.4.3.3.5 Others
6.4.4 Asia Pacific
6.4.4.1 Historical Market (2016-2022)
6.4.4.2 Forecast Market (2023-2031)
6.4.4.3 Break Up by Country
6.4.4.3.1 China
6.4.4.3.2 Japan
6.4.4.3.3 India
6.4.4.3.4 ASEAN
6.4.4.3.5 Australia
6.4.4.3.6 Others
6.4.5 Latin America
6.4.5.1 Historical Market (2016-2022)
6.4.5.2 Forecast Market (2023-2031)
6.4.5.3 Break Up by Country
6.4.5.3.1 Brazil
6.4.5.3.2 Argentina
6.4.5.3.3 Mexico
6.4.5.3.4 Others
6.4.6 Middle East and Africa
6.4.6.1 Historical Market (2016-2022)
6.4.6.2 Forecast Market (2023-2031)
6.4.6.3 Break Up by Country
6.4.6.3.1 Saudi Arabia
6.4.6.3.2 United Arab Emirates
6.4.6.3.3 Nigeria
6.4.6.3.4 South Africa
6.4.6.3.5 Others
7 Current Scenario Evaluation
7.1 Emerging Therapies & Clinical Trials Synopsis
7.2 Patent Landscape
7.2.1 Patent Overview
7.2.1.1 Patent Status and Expiry
7.2.1.2 Timelines from Drug Development to Commercial Launch
7.2.1.3 New Drug Application
7.2.1.3.1 Documentation and Approval Process
7.3 Cost of Treatment
7.4 Regulatory Framework
7.4.1 Regulatory Overview
7.4.1.1 US FDA
7.4.1.2 EU EMA
7.4.1.3 INDIA CDSCO
7.4.1.4 JAPAN PMDA
7.4.1.5 Others
8 Challenges & Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop- out Analysis
8.3 Awareness and Prevention Gaps
9 Congenital Hyperinsulinism Treatment Market Dynamics
9.1 Market Drivers and Constraints
9.2 SWOT Analysis
9.3 Porter’s Five Forces Model
9.4 Key Demand Indicators
9.5 Key Price Indicators
9.6 Industry Events, Initiatives & Trends
9.7 Value Chain Analysis
10 Supplier Landscape
10.1 Eli Lilly
10.1.1 Company Overview
10.1.2 Product Portfolio
10.1.3 Demographic Reach and Achievements
10.1.4 Mergers and Acquisitions
10.1.5 Certifications
10.2 Novo Nordisk
10.2.1 Company Overview
10.2.2 Product Portfolio
10.2.3 Demographic Reach and Achievements
10.2.4 Mergers and Acquisitions
10.2.5 Certifications
10.3 Novartis AG
10.3.1 Company Overview
10.3.2 Product Portfolio
10.3.3 Demographic Reach and Achievements
10.3.4 Mergers and Acquisitions
10.3.5 Certifications
10.4 Rezolute, Inc.
10.4.1 Company Overview
10.4.2 Product Portfolio
10.4.3 Demographic Reach and Achievements
10.4.4 Mergers and Acquisitions
10.4.5 Certifications
10.5 Eiger BioPharmaceuticals
10.5.1 Company Overview
10.5.2 Product Portfolio
10.5.3 Demographic Reach and Achievements
10.5.4 Mergers and Acquisitions
10.5.5 Certifications
10.6 Zealand Pharma A/S
10.6.1 Company Overview
10.6.2 Product Portfolio
10.6.3 Demographic Reach and Achievements
10.6.4 Mergers and Acquisitions
10.6.5 Certifications
10.7 Hanmi Pharmaceutical Co., Ltd.
10.7.1 Company Overview
10.7.2 Product Portfolio
10.7.3 Demographic Reach and Achievements
10.7.4 Mergers and Acquisitions
10.7.5 Certifications
10.8 Crinetics Pharmaceuticals, Inc.
10.8.1 Company Overview
10.8.2 Product Portfolio
10.8.3 Demographic Reach and Achievements
10.8.4 Mergers and Acquisitions
10.8.5 Certifications
10.9 AmideBio LLC
10.9.1 Company Overview
10.9.2 Product Portfolio
10.9.3 Demographic Reach and Achievements
10.9.4 Mergers and Acquisitions
10.9.5 Certifications
11 Recommendations and Discussion
12 Global Congenital Hyperinsulinism Treatment Distribution Model (Additional Insight)
12.1 Overview
12.2 Potential Distributors
12.3 Key Parameters for Distribution Partner Assessment
13 Payment Methods (Additional Insight)
13.1 Government Funded
13.2 Private Insurance
13.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
Key Questions Answered in the Report
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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