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Congenital Hyperinsulinism - Epidemiology Forecast - 2034

Published Date : 2025

Pages : 71

Region : United States, Japan, EU4 & UK

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congenital hyperinsulinism epidemiology forecast

DelveInsight's "Congenital Hyperinsulinism (CHI)- Epidemiology Forecast-2034" report delivers an in-depth understanding of the Congenital Hyperinsulinism, historical and forecasted epidemiology as well as the Congenital Hyperinsulinism trends in the United States, the EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

Geography Covered

The United States
The EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Japan

Study Period: 2021-2034

Congenital Hyperinsulinism (CHI) Understanding

The DelveInsight’s Congenital Hyperinsulinism epidemiology report gives a thorough understanding of Congenital Hyperinsulinism. Congenital Hyperinsulinism is characterized by inappropriate and unregulated insulin secretion from the β cells of the pancreas. In CHI, the β cells release insulin inappropriately, and insulin secretion is not regulated by the blood glucose level (as occurs normally). The action of insulin causes hyperinsulinemic hypoglycemia. High insulin levels prevent the formation of ketone bodies, which means that the brain is deprived of its most important fuel (glucose), and ketone bodies are used as alternative fuels.

As CHI is a congenital condition, a child show symptoms within the first few days of life, although very occasionally, symptoms may appear later in infancy. Symptoms of hypoglycemia can include floppiness, shakiness, poor feeding, and sleepiness, all of which are due to low blood glucose levels. Seizures (fits or convulsions) can also occur due to low blood glucose levels. If the child’s blood glucose level is not corrected, it can lead to loss of consciousness and potential brain injury.

Patients with CHI have dysregulated insulin secretion, resulting in hypoglycemia and hypoketonemia due to increased glucose utilization and lipolysis inhibition. In addition, hyperinsulinism typically results in shortened fasting time for age.

The diagnosis of CHI may be quite difficult if one relies on demonstrating a detectable blood insulin concentration at the time of hypoglycemia because insulin levels fluctuate widely over time in patients with CHI. Other signs and chemical markers must be used as clues to excess insulin action and are often easier to demonstrate.

There is very little evidence-based data regarding the management of CHI. Currently, no guidelines are available for the standard treatment and it is solely based on the experience of a small group of individuals.

The cornerstone of clinical management involves early diagnosis and appropriate therapy for patients. The aim is to keep plasma glucose levels above 3.5 mmol/L, given that the brain is deprived of alternative substrates. The treatment options include medical, surgical, or sometimes combination therapies.

Congenital Hyperinsulinism (CHI) Epidemiology

The epidemiology section provides insights about the historical and current Congenital Hyperinsulinism patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed prevalent patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides a historical as well as forecasted Congenital Hyperinsulinism epidemiology scenario in the 7MM covering the United States, the EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2021 to 2034.

In the year 2021, the total diagnosed prevalent cases of Congenital Hyperinsulinism were 15,487 in the 7MM which are expected to grow during the study period, i.e., 2021-2034.

The disease epidemiology covered in the report provides historical as well as forecasted Congenital Hyperinsulinism epidemiology (segmented as Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism, Type-specific cases of Congenital Hyperinsulinism (CHI) based on histological presentation, Mutation-specific Congenital Hyperinsulinism Cases, Total treated cases of Congenital Hyperinsulinism in the 7MM covering the United States, the EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2021 to 2034.

Country Wise Congenital Hyperinsulinism (CHI) Epidemiology

The epidemiology segment also provides the Congenital Hyperinsulinism epidemiology data and findings across the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

According to the DelveInsight, in the year 2021, the total diagnosed prevalent cases of Congenital Hyperinsulinism were 3,445 in the United States which are expected to grow during the study period, i.e., 2021-2034.
The highest number of total diagnosed prevalent cases of Congenital Hyperinsulinism was observed in Germany among the EU5 countries with 2,767 cases in 2021 which are expected to grow during the study period, i.e., 2021-2034.
In the year 2021, the total diagnosed prevalent cases of Congenital Hyperinsulinism were 1,282 cases in Japan which are expected to grow during the study period, i.e., 2021-2034.

KOL- Views

To keep up with the current Congenital Hyperinsulinism patient pool and forecasted trend, we take KOLs and SMEs ' opinions working in the Congenital Hyperinsulinism domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate the patient pool and forecasted trend.

Scope of the Report

The report covers the descriptive overview of Congenital Hyperinsulinism, explaining their causes, symptoms, pathophysiology, and genetic basis.
The report provides insight into the 7MM historical and forecasted patient pool covering the United States, the EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The report assesses the disease risk and burden and highlights the unmet needs of Congenital Hyperinsulinism.
The report helps to recognize the growth opportunities in the 7MM concerning the patient population.
The report provides the segmentation of the disease epidemiology segmented as Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism, Type-specific cases of Congenital Hyperinsulinism based on histological presentation, and Total Treated Cases of Congenital Hyperinsulinism in the 7MM covering the United States, the EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2021 to 2034.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Congenital Hyperinsulinism R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Congenital Hyperinsulinism.
Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Congenital Hyperinsulinism (CHI) Report Key Strengths

11 Years Forecast
7MM Coverage
Congenital Hyperinsulinism Epidemiology Segmentation

Key Questions

Epidemiology Insights:

What are the disease risk, burden, and regional/ethnic differences of Congenital Hyperinsulinism?
What are the key factors driving the epidemiology trend for seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
What is the historical Congenital Hyperinsulinism patient pool in seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
What would be the forecasted patient pool of Congenital Hyperinsulinism in seven major markets covering the United States, the EU5 (Germany, Spain, France, Italy, UK), and Japan?
Where will be the growth opportunities in the 7MM concerning the patient population about Congenital Hyperinsulinism?
Out of all 7MM countries, which country would have the highest diagnosed prevalent population of Congenital Hyperinsulinism during the forecast period (2025-2034)?
At what CAGR the patient population is expected to grow by 7MM during the forecast period (2025-2034)?

Reasons to buy

The report will help in developing business strategies by understanding trends shaping and driving the Congenital Hyperinsulinism disease market
To understand the future market competition in the Congenital Hyperinsulinism disease market
Organize sales and marketing efforts by identifying the best opportunities for Congenital Hyperinsulinism disease in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
Organize sales and marketing efforts by identifying the best opportunities for the Congenital Hyperinsulinism disease market
To understand the future market competition in the Congenital Hyperinsulinism disease market

1. Key Insights

2. Report Introduction

3. Congenital Hyperinsulinism (CHI) Market Overview at a Glance

3.1. Market Share (%) Distribution of CHI by drug class in 2021

3.2. Market Share (%) Distribution of CHI by drug class in 2034

4. Executive Summary of Congenital Hyperinsulinism (CHI)

5. Key Events

5.1. Future Prospectus

6. Epidemiology and Market Methodology

7. Disease Background and Overview

7.1. Introduction

7.2. Classification of CHI

7.2.1. Classification based on histology

7.3. Symptoms

7.4. Causes of CHI

7.4.1. CHI due to defects in channel and transporter proteins

7.4.2. CHI due to abnormalities in metabolic pathways

7.4.3. CHI due to defects in transcription factors

7.5. Pathophysiology

7.6. Genetics in CHI

7.7. Differential Diagnosis

7.8. Diagnostic Algorithm

7.9. Diagnosis of CHI

7.10. Diagnostic Guidelines for CHI

7.10.1. Pediatric Endocrine Society for Evaluation of Persistent Hypoglycemia in Neonates, Infants, and Children (2015)

7.10.2. The Japanese Society for Pediatric Endocrinology and the Japanese Society of Pediatric Surgeons (2017)

7.11. Treatment of CHI

7.12. Treatment Algorithm

7.13. Treatment Guidelines for CHI

7.13.1. Pediatric Endocrine Society for Management of Persistent Hypoglycemia in Neonates, Infants, and Children (2015)

7.13.2. Hywel DDA University Health Board (2021)

7.13.3. The Japanese Society for Pediatric Endocrinology and The Japanese Society of Pediatric Surgeons (2017)

8. Epidemiology and Patient Population

8.1. Key Findings

8.2. Assumptions and Rationale

8.3. Epidemiology Scenario in the 7MM

8.3.1. Total diagnosed prevalent Cases of Congenital Hyperinsulinism (CHI) in the 7MM

8.3.2. Type-specific diagnosed prevalence based on histological presentation in the 7MM

8.3.3. Mutation specific diagnosed prevalence of Congenital Hyperinsulinism in the 7MM

8.3.4. Total Treated Cases of Congenital Hyperinsulinism (CHI) in the 7MM

8.4. Epidemiology Scenario in the United States

8.4.1. Total diagnosed prevalent Cases of Congenital Hyperinsulinism (CHI) in the US

8.4.2. Type-specific diagnosed prevalence based on histological presentation in the US

8.4.3. Mutation specific diagnosed prevalence of Congenital Hyperinsulinism in the US

8.4.4. Total Treated Cases of Congenital Hyperinsulinism (CHI) in the US

8.5. Epidemiology Scenario in the EU5 Countries

8.5.1. Total diagnosed prevalent Cases of Congenital Hyperinsulinism (CHI) in the EU5

8.5.2. Type-specific diagnosed prevalence based on histological presentation in the EU5

8.5.3. Mutation specific diagnosed prevalence of Congenital Hyperinsulinism in the EU5

8.5.4. Total Treated Cases of Congenital Hyperinsulinism (CHI) in the EU5

8.6. Epidemiology Scenario in Japan

8.6.1. Total diagnosed prevalent Cases of Congenital Hyperinsulinism (CHI) in Japan

8.6.2. Type-specific diagnosed prevalence based on histological presentation in Japan

8.6.3. Mutation specific diagnosed prevalence of Congenital Hyperinsulinism in Japan

8.6.4. Total Treated Cases of Congenital Hyperinsulinism (CHI) in Japan

9. Unmet Needs

10. Appendix

10.1. Bibliography

10.2. Report Methodology

11. DelveInsight Capabilities

12. Disclaimer

13. About DelveInsight

List of Tables:

List of Tables

Table 1: Summary of Congenital Hyperinsulinism (CHI), Market, Epidemiology, and Key Events (2021-2034)

Table 2: Total Diagnosed-prevalent Cases of CHI in the 7MM (2021-2034)

Table 3: Type-specific diagnosed prevalence based on histological presentation in the 7MM (2021-2034)

Table 4: Mutation specific diagnosed prevalence of CHI in the 7MM (2021-2034)

Table 5: Total Treated Cases of CHI in the 7MM (2021-2034)

Table 6: Total Diagnosed-prevalent Cases of CHI in the US (2021-2034)

Table 7: Type-specific diagnosed prevalence based on histological presentation in the US (2021-2034)

Table 8: Mutation specific diagnosed prevalence of CHI in the US (2021-2034)

Table 9: Total Treated Cases of CHI in the US (2021-2034)

Table 10: Total Diagnosed-prevalent Cases of CHI in the EU5 (2021-2034)

Table 11: Type-specific diagnosed prevalence based on histological presentation in the EU5 (2021-2034)

Table 12: Mutation specific diagnosed prevalence of CHI in the EU5 (2021-2034)

Table 13: Total Treated Cases of CHI in the EU5 (2021-2034)

Table 14: Total Diagnosed-prevalent Cases of CHI in Japan (2021-2034)

Table 15: Type-specific diagnosed prevalence based on histological presentation in Japan (2021-2034)

Table 16: Mutation specific diagnosed prevalence of CHI in the 7MM (2021-2034)

Table 17: Total Treated Cases of CHI in Japan (2021-2034)

List of Figures:

List of Figures

Figure 1: Epidemiology and Market Methodology

Figure 2: Schematic Presentation of the Histological Subtypes of CHI

Figure 3: Histological Classification of CHI

Figure 4: Channel and Transporter Proteins Involved in the Process of Insulin Secretion From Pancreatic β cells

Figure 5: Metabolic Pathways and Transcription Factors Related to the Development of CHI

Figure 6: Regulation of Insulin Release From Pancreatic β-cell and Sites of Gene Mutations Involved

Figure 7: Genetics of CHI

Figure 8: Clinical Presentation of CRS

Figure 9: Metabolic Clues to Hypoglycemia Diagnosis

Figure 10: Treatment Algorithm of Congenital Hyperinsulinism (CHI)

Figure 11: HIGR Participants, by continent, distributed by HI types

Figure 12: Total Diagnosed-prevalent Cases of CHI in the 7MM (2021-2034)

Figure 13: Type-specific diagnosed prevalence based on histological presentation in the 7MM (2021-2034)

Figure 14: Mutation specific diagnosed prevalence of CHI in the 7MM (2021-2034)

Figure 15: Total Treated Cases of CHI in the 7MM (2021-2034)

Figure 16: Total Diagnosed-prevalent Cases of CHI in the US (2021-2034)

Figure 17: Type-specific diagnosed prevalence based on histological presentation in the US (2021-2034)

Figure 18: Mutation-specific diagnosed prevalence of Congenital Hyperinsulinism in the US (2021-2034)

Figure 19: Total Treated Cases of CHI in the US (2021-2034)

Figure 20: Total Diagnosed-prevalent Cases of CHI in the EU5 (2021-2034)

Figure 21: Type-specific diagnosed prevalence based on histological presentation in the EU5 (2021-2034)

Figure 22: Mutation specific diagnosed prevalence of CHI in the EU5 (2021-2034)

Figure 23: Total Treated Cases of CHI in the EU5 (2021-2034)

Figure 24: Total Diagnosed-prevalent Cases of CHI in Japan (2021-2034)

Figure 25: Type-specific diagnosed prevalence based on histological presentation in Japan (2021-2034)

Figure 26: Mutation specific diagnosed prevalence of Congenital Hyperinsulinism in Japan (2021-2034)

Figure 27: Total Treated Cases of CHI in Japan (2021-2034)

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