DUBLIN--(BUSINESS WIRE)--The "Congenital Hyperinsulinism - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
This 'Congenital Hyperinsulinism (CHI) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in-depth understanding of the Congenital Hyperinsulinism (CHI), historical and forecasted epidemiology as well as the Congenital Hyperinsulinism (CHI) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Congenital Hyperinsulinism (CHI) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Congenital Hyperinsulinism (CHI) market size from 2017 to 2030. The report also covers current Congenital Hyperinsulinism (CHI) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Congenital Hyperinsulinism (CHI) Market Outlook
As per the Congenital Hyperinsulinism International, congenital hyperinsulinism (HI) is the most frequent cause of severe, persistent hypoglycemia in newborn babies and children. In most of the countries, it is estimated to occur in approximately 1/25,000-1/50,000 births. Out of which, about 60% of babies with HI develop hypoglycemia during the first month of life, while 30% might be diagnosed in a later stage of their life. Thus, initiation of early treatment is essential for aggressive prevention of hypoglycemia and resulting brain damage.
There is only one approved therapy for CHI in the market, namely, Proglycem (diazoxide) - a non-diuretic benzothiadiazine derivative used for the management of symptomatic hypoglycemia. Proglycem capsules and suspension are manufactured by IVAX Pharmaceuticals and Teva Pharmaceuticals, respectively; the suspension was manufactured for Gate Pharmaceuticals, a division of Teva Pharmaceuticals. As per the FDA, the oral capsules have been discontinued; however, the oral suspension is clinically prescribed and currently underuse. Additionally, several generic versions of this drug is also available in the market now.
Parenteral glucose infusion is administered intravenously as a bolus as it is a potent trigger for insulin secretion. Glucagon administration is used as first-line therapy for managing CHI patients, particularly in emergencies where patients are unable to take oral feed and/or intravenous access is difficult to obtain.
Frequent feeding with high-calorie carbohydrates can reduce the frequency and severity of hypoglycemic episodes; hence, frequent feeding is another advised protocol. Long-term management or standard therapy is individualized, wherein the usual goal is to normalize plasma glucose levels, provide an age-adjusted fasting tolerance, and avoid neurological symptoms associated with hypoglycemia.
Surgery is performed to either remove a section or complete the pancreas in case of focal and diffuse congenital hyperinsulinism, respectively. The surgeries are not mandatorily curative, and the patients may continue to require frequent feeds and medications to prevent hypoglycemia post-surgery.
The first-line therapy is a potassium channel (KATP) channel opener for the treatment of the patients with CHI; Diazoxide and chlorothiazide belong to this class of drugs. Somatostatin analog such as octreotide is used as second-line therapy. Nifedipine or amlodipine belongs to calcium channel antagonists are merely used as a third-Line therapy, e.g., as an add-on treatment, in partial diazoxide/octreotide resistance, and/or following partial pancreatectomy.
The current emerging market of CHI possesses few potential drugs in late and mid-stage developments to be launched soon. Dasiglucagon is currently in the phase III stage of development followed by RZ358, CSI-Glucagon (Continuous Subcutaneous Glucagon Infusion), and Avexitide that are in phase II clinical developmental stage. Out of these therapies, RZ358 and CSI-Glucagon have already completed their phase II clinical developmental trial.
Key Topics Covered:
1 Key Insights
2 Congenital Hyperinsulinism (CHI) Market Overview at a Glance
2.1 Market Share (%) Distribution of CHI in 2017
2.2 Market Share (%) Distribution of CHI in 2030
3 Executive Summary of Congenital Hyperinsulinism (CHI)
4 Disease Background and Overview: Congenital Hyperinsulinism (CHI)
4.1 Introduction
4.2 Pancreatic β Cell Physiology, Glucose Metabolism and Insulin Secretion
4.3 Types of CHI based on histology
4.3.1 Focal CHI
4.3.2 Diffuse CHI
4.4 Causes of CHI
4.4.1 Transient Hyperinsulinism
4.4.2 Persistent Hyperinsulinism
4.5 Molecular Basis
4.5.1 Modes of Inheritance
4.6 Clinical Presentation and Symptoms
4.6.1 During the neonatal period
4.6.2 During infancy and childhood
4.6.3 Syndromic CHI are usually diazoxide-responsive
4.7 Pathophysiology
4.8 Genetics of hyperinsulinaemic hypoglycemia
4.8.1 Pancreatic β-cell KATP Channel Defects
4.8.2 Glutamate Dehydrogenase (GDH) and Hyperinsulinaemia-hyperammonaemia Syndrome (HI/HA)
4.8.3 Mutations in Mitochondrial L-3-Hydroxyacyl-CoA Dehydrogenase (HADH) and CHI
4.8.4 Activating Mutations in GCK and CHI
4.8.5 Mutations in Solute Carrier Family 16 Member 1 (SLC16A1) and Exercise-induced CHI
4.8.6 Hepatocyte Nuclear Factor (HNF) 1Aα&4α (HNF1α&4α) and CHI
4.8.7 Mutations in the Mitochondrial Uncoupling Protein 2 (UCP2) and CHI
4.8.8 Somatic overexpression of Hexokinase 1 (HK1) and CHI
4.8.9 Phosphoglucomutase 1 and 2 (PGM1 and 2) Gene Mutations and CHI
4.9 Diagnosis
4.1 Differential Diagnosis
5 Epidemiology and Patient Population
5.1 Key Findings
5.2 Total Diagnosed Prevalent Population of Congenital Hyperinsulinism in the 7MM
6 Country Wise-Epidemiology of Congenital Hyperinsulinism
7 Treatment
7.1 Emergency/Prompt Management
7.2 Standard Therapies (Long Term Management)
7.2.1 Surgery
7.2.2 Diazoxide
7.2.3 Octreotide
7.2.4 Calcium Channel Antagonists
7.2.5 Glucagon
7.3 Potential Novel Therapies
8 The United States Guidelines for CHI
8.1 Management of Neonates, Infants, and Children with a Persistent Hypoglycemia Disorder
8.1.1 Neonates, Infants, and Children with Hypoglycemia Disorders
9 European Guidelines for CHI
9.1 Management of hypoglycemia
9.1.1 Hypoglycemia Pathway I
9.1.2 Pathway II for Hypoglycemia
10 Japanese Guidelines for CHI
10.1 First-Line Treatment
10.2 Second-Line Treatment
10.3 Surgical Treatment
10.4 End of Treatment
11 Treatment Algorithm for CHI
12 Recognized Establishments
13 Unmet Needs
14 Marketed Drug
14.1 Proglycem: Teva Pharmaceuticals
14.1.1 Drug Description
14.1.2 Other Development Activities
14.1.3 Product Profile
15 Emerging Drugs
15.1 Key Cross Competition
15.2 Dasiglucagon: Zealand Pharma
15.3 XOMA 358/RZ358: XOMA/Rezolute
15.4 CSI-Glucagon (Continuous Subcutaneous Glucagon Infusion): Xeris Pharmaceuticals
15.5 Avexitide: Eiger BioPharmaceuticals
16 Attribute Analysis
16.1 Key Points
17 Congenital Hyperinsulinism (CHI): Seven Major Market Analysis
17.1 Key Findings
17.2 Market Size of Congenital Hyperinsulinism (CHI) in the 7MM
18 Market Outlook: 7MM
19 KOL Reviews
20 Case Reports
21 Market Drivers
22 Market Barriers
23 SWOT Analysis
24 Appendix
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