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Congenital Hyperinsulinism Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034

May 2024 | 134 pages | ID: C4C2B171178CEN
IMARC Group

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The 7 major congenital hyperinsulinism markets reached a value of US$ 112.3 Million in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 180.9 Million by 2034, exhibiting a growth rate (CAGR) of 4.43% during 2024-2034.

The congenital hyperinsulinism market has been comprehensively analyzed in IMARC's new report titled "Congenital Hyperinsulinism Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Congenital hyperinsulinism (CHI) refers to a rare genetic disorder characterized by excessive insulin production in the pancreas, leading to low blood sugar levels (hypoglycemia). This condition primarily affects newborns and infants, posing significant health risks if not promptly diagnosed and managed. The symptoms of CHI can manifest as irritability, seizures, lethargy, and difficulty feeding, as the brain's energy supply is compromised due to low blood sugar. These indications can vary widely, ranging from mild to severe. Individuals suffering from the ailment may also experience developmental delays, brain damage, or life-threatening complications. The diagnosis of CHI involves various clinical and laboratory assessments. The healthcare professional will recommend blood workups to measure glucose and insulin levels in the body. Genetic testing is also performed to identify specific gene mutations responsible for the disorder. Imaging studies, like ultrasound or MRI, may help to visualize the pancreas and rule out numerous other causes of hypoglycemia.

The increasing cases of genetic anomalies affecting key genes like ABCC8 and KCNJ11 that disrupt the normal production of insulin and lead to severe hypoglycemia are primarily driving the congenital hyperinsulinism market. In addition to this, the inflating utilization of effective medical interventions, such as diazoxide, octreotide, glucagon, etc., aimed at managing the condition and averting potential complications, is also creating a positive outlook for the market. Moreover, the widespread adoption of dietary adjustments and continuous glucose monitoring systems for maintaining optimal blood sugar levels and preventing neurological damage is further propelling the market growth. These strategies enable precise glucose management and lessen the long-term impact on cognitive development. Apart from this, the rising usage of pancreatectomy, a surgical intervention that involves partial or complete removal of the pancreas to treat patients who became resistant to medical treatments, is acting as another significant growth-inducing factor. Additionally, the emerging popularity of genetic counseling and testing to help in evaluating risks and inheritance patterns associated with the condition is also augmenting the market growth. Furthermore, the escalating demand for gene therapy, since it involves introducing functional genetic material into cells, thereby rectifying or replacing malfunctioning genes linked to the disorder, is expected to drive the congenital hyperinsulinism market during the forecast period.

IMARC Group's new report provides an exhaustive analysis of the congenital hyperinsulinism market in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report the United States has the largest patient pool for congenital hyperinsulinism and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario and unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the congenital hyperinsulinism market in any manner.

Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the congenital hyperinsulinism market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the congenital hyperinsulinism market
Reimbursement scenario in the market
In-market and pipeline drugs
Competitive Landscape:
This report also provides a detailed analysis of the current congenital hyperinsulinism marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:
Market Insights

How has the congenital hyperinsulinism market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the congenital hyperinsulinism market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the congenital hyperinsulinism market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of congenital hyperinsulinism across the seven major markets?
What is the number of prevalent cases (2018-2034) of congenital hyperinsulinism by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of congenital hyperinsulinism by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with congenital hyperinsulinism across the seven major markets?
What is the size of the congenital hyperinsulinism patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of congenital hyperinsulinism?
What will be the growth rate of patients across the seven major markets?

Congenital Hyperinsulinism: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for congenital hyperinsulinism drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the congenital hyperinsulinism market?
What are the key regulatory events related to the congenital hyperinsulinism market?
What is the structure of clinical trial landscape by status related to the congenital hyperinsulinism market?
What is the structure of clinical trial landscape by phase related to the congenital hyperinsulinism market?
What is the structure of clinical trial landscape by route of administration related to the congenital hyperinsulinism market?
1 PREFACE

2 SCOPE AND METHODOLOGY

2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
  2.3.1 Primary Sources
  2.3.2 Secondary Sources
2.4 Market Estimation
  2.4.1 Bottom-Up Approach
  2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 EXECUTIVE SUMMARY

4 CONGENITAL HYPERINSULINISM - INTRODUCTION

4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 CONGENITAL HYPERINSULINISM - DISEASE OVERVIEW

5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 PATIENT JOURNEY

7 CONGENITAL HYPERINSULINISM - EPIDEMIOLOGY AND PATIENT POPULATION

7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
  7.2.1 Epidemiology Scenario (2018-2023)
  7.2.2 Epidemiology Forecast (2024-2034)
  7.2.3 Epidemiology by Age (?2018-2034?)
  7.2.4 Epidemiology by Gender (?2018-2034?)
  7.2.5 Diagnosed Cases (?2018-2034?)
  7.2.6 Patient Pool/Treated Cases (?2018-2034?)
7.3 Epidemiology Scenario - United States
  7.3.1 Epidemiology Scenario (2018-2023)
  7.3.2 Epidemiology Forecast (2024-2034)
  7.3.3 Epidemiology by Age (?2018-2034?)
  7.3.4 Epidemiology by Gender (?2018-2034?)
  7.3.5 Diagnosed Cases (?2018-2034?)
  7.3.6 Patient Pool/Treated Cases (?2018-2034?)
7.4 Epidemiology Scenario - Germany
  7.4.1 Epidemiology Scenario (2018-2023)
  7.4.2 Epidemiology Forecast (2024-2034)
  7.4.3 Epidemiology by Age (?2018-2034?)
  7.4.4 Epidemiology by Gender (?2018-2034?)
  7.4.5 Diagnosed Cases (?2018-2034?)
  7.4.6 Patient Pool/Treated Cases (?2018-2034?)
7.5 Epidemiology Scenario - France
  7.5.1 Epidemiology Scenario (2018-2023)
  7.5.2 Epidemiology Forecast (2024-2034)
  7.5.3 Epidemiology by Age (?2018-2034?)
  7.5.4 Epidemiology by Gender (?2018-2034?)
  7.5.5 Diagnosed Cases (?2018-2034?)
  7.5.6 Patient Pool/Treated Cases (?2018-2034?)
7.6 Epidemiology Scenario - United Kingdom
  7.6.1 Epidemiology Scenario (2018-2023)
  7.6.2 Epidemiology Forecast (2024-2034)
  7.6.3 Epidemiology by Age (?2018-2034?)
  7.6.4 Epidemiology by Gender (?2018-2034?)
  7.6.5 Diagnosed Cases (?2018-2034?)
  7.6.6 Patient Pool/Treated Cases (?2018-2034?)
7.7 Epidemiology Scenario - Italy
  7.7.1 Epidemiology Scenario (2018-2023)
  7.7.2 Epidemiology Forecast (2024-2034)
  7.7.3 Epidemiology by Age (?2018-2034?)
  7.7.4 Epidemiology by Gender (?2018-2034?)
  7.7.5 Diagnosed Cases (?2018-2034?)
  7.7.6 Patient Pool/Treated Cases (?2018-2034?)
7.8 Epidemiology Scenario - Spain
  7.8.1 Epidemiology Scenario (2018-2023)
  7.8.2 Epidemiology Forecast (2024-2034)
  7.8.3 Epidemiology by Age (?2018-2034?)
  7.8.4 Epidemiology by Gender (?2018-2034?)
  7.8.5 Diagnosed Cases (?2018-2034?)
  7.8.6 Patient Pool/Treated Cases (?2018-2034?)
7.9 Epidemiology Scenario - Japan
  7.9.1 Epidemiology Scenario (2018-2023)
  7.9.2 Epidemiology Forecast (2024-2034)
  7.9.3 Epidemiology by Age (?2018-2034?)
  7.9.4 Epidemiology by Gender (?2018-2034?)
  7.9.5 Diagnosed Cases (?2018-2034?)
  7.9.6 Patient Pool/Treated Cases (?2018-2034?)

8 CONGENITAL HYPERINSULINISM - TREATMENT ALGORITHM, GUIDELINES, AND MEDICAL PRACTICES

8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 CONGENITAL HYPERINSULINISM - UNMET NEEDS

10 CONGENITAL HYPERINSULINISM - KEY ENDPOINTS OF TREATMENT

11 CONGENITAL HYPERINSULINISM - MARKETED PRODUCTS

11.1 List of Congenital Hyperinsulinism Marketed Drugs Across the Top 7 Markets
  11.1.1 Proglycem (Oral Diazoxide) - Teva Pharmaceuticals
    11.1.1.1 Drug Overview
    11.1.1.2 Mechanism of Action
    11.1.1.3 Regulatory Status
    11.1.1.4 Clinical Trial Results
    11.1.1.5 Sales Across Major Markets
Kindly note that the above only represents a partial list of marketed drugs, and the complete list has been provided in the report.

12 CONGENITAL HYPERINSULINISM - PIPELINE DRUGS

12.1 List of Congenital Hyperinsulinism Pipeline Drugs Across the Top 7 Markets
  12.1.1 HM15136 - Hanmi Pharmaceutical
    12.1.1.1 Drug Overview
    12.1.1.2 Mechanism of Action
    12.1.1.3 Clinical Trial Results
    12.1.1.4 Safety and Efficacy
    12.1.1.5 Regulatory Status
  12.1.2 Dasiglucagon - Zealand Pharma/Novo Nordisk
    12.1.2.1 Drug Overview
    12.1.2.2 Mechanism of Action
    12.1.2.3 Clinical Trial Results
    12.1.2.4 Safety and Efficacy
    12.1.2.5 Regulatory Status
  12.1.3 Avexitide - Eiger BioPharmaceuticals
    12.1.3.1 Drug Overview
    12.1.3.2 Mechanism of Action
    12.1.3.3 Clinical Trial Results
    12.1.3.4 Safety and Efficacy
    12.1.3.5 Regulatory Status
Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. CONGENITAL HYPERINSULINISM - ATTRIBUTE ANALYSIS OF KEY MARKETED AND PIPELINE DRUGS

14. CONGENITAL HYPERINSULINISM – CLINICAL TRIAL LANDSCAPE

14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 CONGENITAL HYPERINSULINISM - MARKET SCENARIO

15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
  15.2.1 Congenital Hyperinsulinism - Market Size
    15.2.1.1 Market Size (2018-2023)
    15.2.1.2 Market Forecast (2024-2034)
  15.2.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.2.2.1 Market Size by Therapies (2018-2023)
    15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
  15.3.1 Congenital Hyperinsulinism - Market Size
    15.3.1.1 Market Size (2018-2023)
    15.3.1.2 Market Forecast (2024-2034)
  15.3.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.3.2.1 Market Size by Therapies (2018-2023)
    15.3.2.2 Market Forecast by Therapies (2024-2034)
  15.3.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.4 Market Scenario - Germany
  15.4.1 Congenital Hyperinsulinism - Market Size
    15.4.1.1 Market Size (2018-2023)
    15.4.1.2 Market Forecast (2024-2034)
  15.4.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.4.2.1 Market Size by Therapies (2018-2023)
    15.4.2.2 Market Forecast by Therapies (2024-2034)
  15.4.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.5 Market Scenario - France
  15.5.1 Congenital Hyperinsulinism - Market Size
    15.5.1.1 Market Size (2018-2023)
    15.5.1.2 Market Forecast (2024-2034)
  15.5.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.5.2.1 Market Size by Therapies (2018-2023)
    15.5.2.2 Market Forecast by Therapies (2024-2034)
  15.5.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
  15.6.1 Congenital Hyperinsulinism - Market Size
    15.6.1.1 Market Size (2018-2023)
    15.6.1.2 Market Forecast (2024-2034)
  15.6.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.6.2.1 Market Size by Therapies (2018-2023)
    15.6.2.2 Market Forecast by Therapies (2024-2034)
  15.6.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.7 Market Scenario - Italy
  15.7.1 Congenital Hyperinsulinism - Market Size
    15.7.1.1 Market Size (2018-2023)
    15.7.1.2 Market Forecast (2024-2034)
  15.7.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.7.2.1 Market Size by Therapies (2018-2023)
    15.7.2.2 Market Forecast by Therapies (2024-2034)
  15.7.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.8 Market Scenario - Spain
  15.8.1 Congenital Hyperinsulinism - Market Size
    15.8.1.1 Market Size (2018-2023)
    15.8.1.2 Market Forecast (2024-2034)
  15.8.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.8.2.1 Market Size by Therapies (2018-2023)
    15.8.2.2 Market Forecast by Therapies (2024-2034)
  15.8.3 Congenital Hyperinsulinism - Access and Reimbursement Overview
15.9 Market Scenario - Japan
  15.9.1 Congenital Hyperinsulinism - Market Size
    15.9.1.1 Market Size (2018-2023)
    15.9.1.2 Market Forecast (2024-2034)
  15.9.2 Congenital Hyperinsulinism - Market Size by Therapies
    15.9.2.1 Market Size by Therapies (2018-2023)
    15.9.2.2 Market Forecast by Therapies (2024-2034)
  15.9.3 Congenital Hyperinsulinism - Access and Reimbursement Overview

16 CONGENITAL HYPERINSULINISM - RECENT EVENTS AND INPUTS FROM KEY OPINION LEADERS

17 CONGENITAL HYPERINSULINISM MARKET - SWOT ANALYSIS

17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 CONGENITAL HYPERINSULINISM MARKET – STRATEGIC RECOMMENDATIONS

19 APPENDIX


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