DelveInsight’s “Congenital Hyperinsulinism (CHI) – Market Insights, Epidemiology, and Market Forecast-2032″ report delivers an in-depth understanding of the Congenital Hyperinsulinism, historical and forecasted epidemiology as well as the Congenital Hyperinsulinism market trends in the United States, the EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Congenital Hyperinsulinism market report provides current treatment practices, emerging drugs, Congenital Hyperinsulinism market share of the individual therapies, and current and forecasted Congenital Hyperinsulinism market size from 2019 to 2032 segmented by seven major markets. The report also covers current Congenital Hyperinsulinism treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Some of the key facts of the Congenital Hyperinsulinism Market:
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Delvelnsight has analyzed mutation-specific data of Congenital Hyperinsulinism, which suggests that mutations in the ABCC8 and KCNJ11 genes are the most common causes of Congenital Hyperinsulinism while mutations in several other genes (GLUD1, GCK, HADH, SLC16A1, HNF4A, and HNF1A) are also involved in the development of Congenital Hyperinsulinism . In the United States, in 2021, mutations in ABCC8 and KCNJ11 genes accounted for 4,917 cases, while other gene mutations accounted for 4,023 cases.
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In the EU5 countries, the diagnosed prevalence of Congenital Hyperinsulinism was maximum in the United Kingdom with 2,398 cases, followed by Germany with 2,066 cases in 2021. While, the least number of cases were in Spain, with 1,286 cases in 2021 respectively.
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In Japan, the diagnosed prevalence of Congenital Hyperinsulinism was 2,685 in 2021 growing at a CAGR of 1.0%.
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Congenital Hyperinsulinism Overview
Congenital hyperinsulinism is a condition that causes individuals to have abnormally high levels of insulin, which is a hormone that helps control blood sugar levels. People with this condition have frequent occurrences of low blood sugar (hypoglycemia). In infants and young children, these occurrences are characterized by a lack of energy (lethargy), irritability, or difficulty feeding. Repeated episodes of low blood sugar increase the risk for serious complications such as breathing difficulties, seizures, intellectual disability, vision loss, brain damage, and coma.
The severity of Congenital Hyperinsulinism varies widely among affected individuals, even among members of the same family. About 60% of infants with this condition experience a hypoglycemic episode within the first month of life. Other affected children develop hypoglycemia by early childhood. Unlike typical episodes of hypoglycemia, which occur most often after periods without food (fasting) or after exercising, episodes of hypoglycemia in people with Congenital Hyperinsulinism can also occur after eating.
Congenital Hyperinsulinism Epidemiology Insights:
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According to the National Institute of Health, Congenital Hyperinsulinism affects approximately 1 in 50,000 newborns. This condition is more common in certain populations, affecting up to 1 in 2,500 newborns.
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According to DelveInsight, the total diagnosed prevalent population of Congenital Hyperinsulinism in the seven major markets was estimated to be 20,948 in 2021, increasing at a CAGR of 1.2%.
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The diagnosed prevalent cases of Congenital Hyperinsulinism, in the United States, was 8,939 in 2021 and growing at a CAGR of 1.1%.
Congenital Hyperinsulinism Epidemiology Segmentation
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Total Congenital Hyperinsulinism diagnosed prevalent cases
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Total Congenital Hyperinsulinism type specific diagnosed prevelant cases
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Total Congenital Hyperinsulinism mutation specific diagnosed prevalent cases
Congenital Hyperinsulinism Market Outlook
There is only one approved therapy for CHI in the market, namely, PROGLYCEM (diazoxide) – a non-diuretic benzothiadiazole 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. A number of children with CHI are partially or completely unresponsive to diazoxide. Second-line treatment with other agents such as octreotide/lanreotide are required in such children. Somatostatin receptor analogs (SSRIs), typically octreotide/lanreotide, which inhibit insulin release, are preferred as second-line treatment in diazoxide-unresponsive patients. The use of SSRAs is off-label as only diazoxide is approved for CHI. Octreotide reduces insulin release by decreasing the insulin gene promoter activity, inhibiting voltage-dependent calcium channels and adenylyl cyclase activity. Long‐acting SSRAs are favored by families on account of the monthly injection regimen without recourse to daily injections as needed for octreotide therapy. One problem with using a long‐acting SSRA is the inability to reduce the dose, unlike with oral preparations such as diazoxide. Given that severity of CHI may naturally reduce over time, the use of fixed‐dose long‐acting SSRAs may be considered disproportionate.
According to DelveInsight, the Congenital Hyperinsulinism market in 7MM is expected to witness a major change in the study period 2019–2032.
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Congenital Hyperinsulinism Key Companies
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Zealand Pharma
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Rezolute
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Eiger BioPharma-ceuticals
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Crinetics
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AmideBio
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Hanmi Pharmaceutical
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And many others
Congenital Hyperinsulinism Therapies
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Dasiglucagon
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RZ358
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Avexitide
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CRN04777
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ABG-023
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HM15136
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And many others
Table of Contents
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Key Insights
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Report Introduction
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Executive Summary of Congenital Hyperinsulinism
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Disease Background and Overview
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Epidemiology and patient population
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The United States
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EU 5
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Congenital Hyperinsulinism Emerging Therapies
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Congenital Hyperinsulinism Market Outlook
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Market Access and Reimbursement of Therapies
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Market Drivers
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Market Barriers
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Appendix
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Congenital Hyperinsulinism Market Report Methodology
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DelveInsight Capabilities
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Disclaimer
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