Summary

The 7 major heterozygous familial hypercholesterolemia markets reached a value of US$ 10.3 Billion in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 32.9 Billion by 2034, exhibiting a growth rate (CAGR) of 11.14% during 2024-2034.

The heterozygous familial hypercholesterolemia market has been comprehensively analyzed in IMARC’s new report titled “Heterozygous Familial Hypercholesterolemia Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034”. Heterozygous familial hypercholesterolemia (HeFH) is a genetic condition characterized by high levels of low-density lipoprotein (LDL) cholesterol in the blood. It is caused by a mutation in the LDL receptor gene, leading to increased LDL cholesterol production. HeFH is a type of familial hypercholesterolemia that is heterozygous, meaning it only exists in one copy of the gene. The symptoms can vary considerably, and some people may even have no signs at all. The most common symptom of HeFH is elevated levels of LDL cholesterol in the blood, which can increase the risk of developing heart disease and stroke. Other signs and symptoms of HeFH include chest pain, breathlessness, and cholesterol deposits in the skin or eyes. The diagnosis of HeFH is based on a combination of clinical evaluation, family history, and laboratory testing. Blood tests are used to assess the amounts of lipids and cholesterol in the blood, such as triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. The doctor may conduct additional tests, including a genetic test, to confirm the diagnosis of HeFH if the LDL cholesterol levels are high.

The rising incidences of genomic mutations coupled with the inflating demand for effective medications and therapies that can treat such conditions are primarily driving the global heterozygous familial hypercholesterolemia market. Additionally, the emerging popularity of statins owing to their various associated benefits, including enhanced endothelial function, higher atherosclerotic plaque stability, reduced oxidative stress-induced cell damage, etc., for treating HeFH is also creating a positive outlook for the market. Moreover, the increasing utilization of PCSK9 inhibitors for lowering LDL cholesterol levels from the bloodstream is further bolstering the market growth. Apart from this, several key players are introducing numerous drugs and therapies to achieve near-normal lipid profiles in hypercholesterolemia patients and reduce the risk of cardiovascular diseases. This, in turn, is acting as a significant growth-inducing factor. Furthermore, the widespread adoption of combination therapies, including multiple medications or a variation of drugs and lifestyle changes, for achieving optimal cholesterol control is expected to drive the heterozygous familial hypercholesterolemia market across the globe in the coming years.

IMARC Group’s new report provides an exhaustive analysis of the heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the heterozygous familial hypercholesterolemia market
Reimbursement scenario in the market
In-market and pipeline drugs
Competitive Landscape:
This report also provides a detailed analysis of the current heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia across the seven major markets?
What is the number of prevalent cases (2018-2034) of heterozygous familial hypercholesterolemia by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of heterozygous familial hypercholesterolemia by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with heterozygous familial hypercholesterolemia across the seven major markets?
What is the size of the heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia?
What will be the growth rate of patients across the seven major markets?

Heterozygous Familial Hypercholesterolemia: 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 heterozygous familial hypercholesterolemia 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 heterozygous familial hypercholesterolemia market?
What are the key regulatory events related to the heterozygous familial hypercholesterolemia market?
What is the structure of clinical trial landscape by status related to the heterozygous familial hypercholesterolemia market?
What is the structure of clinical trial landscape by phase related to the heterozygous familial hypercholesterolemia market?
What is the structure of clinical trial landscape by route of administration related to the heterozygous familial hypercholesterolemia market?

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Table of Contents

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 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Heterozygous Familial Hypercholesterolemia - Unmet Needs

10 Heterozygous Familial Hypercholesterolemia - Key Endpoints of Treatment

11 Heterozygous Familial Hypercholesterolemia - Marketed Products
11.1 List of Heterozygous Familial Hypercholesterolemia Marketed Drugs Across the Top 7 Markets
11.1.1 Bempedoic acid - Esperion Therapeutics
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
11.1.2 Alirocumab - Regeneron/Sanofi
11.1.2.1 Drug Overview
11.1.2.2 Mechanism of Action
11.1.2.3 Regulatory Status
11.1.2.4 Clinical Trial Results
11.1.2.5 Sales Across Major Markets
11.1.3 Evolocumab - Amgen
11.1.3.1 Drug Overview
11.1.3.2 Mechanism of Action
11.1.3.3 Regulatory Status
11.1.3.4 Clinical Trial Results
11.1.3.5 Sales Across Major Markets
11.1.4 Simvastatin - Merck & Co
11.1.4.1 Drug Overview
11.1.4.2 Mechanism of Action
11.1.4.3 Regulatory Status
11.1.4.4 Clinical Trial Results
11.1.4.5 Sales Across Major Markets
11.1.5 Pitavastatin – Kowa
11.1.5.1 Drug Overview
11.1.5.2 Mechanism of Action
11.1.5.3 Regulatory Status
11.1.5.4 Clinical Trial Results
11.1.5.5 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 Heterozygous Familial Hypercholesterolemia - Pipeline Drugs
12.1 List of Heterozygous Familial Hypercholesterolemia Pipeline Drugs Across the Top 7 Markets
12.1.1 Lerodalcibep - LIB Therapeutics
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 VERVE 101- Verve Therapeutics
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 Tafolecimab - Innovent Biologics
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. Heterozygous Familial Hypercholesterolemia - Attribute Analysis of Key Marketed and Pipeline Drugs

14. Heterozygous Familial Hypercholesterolemia – 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 Heterozygous Familial Hypercholesterolemia - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Heterozygous Familial Hypercholesterolemia - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Heterozygous Familial Hypercholesterolemia - 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 Heterozygous Familial Hypercholesterolemia - Access and Reimbursement Overview

16 Heterozygous Familial Hypercholesterolemia - Recent Events and Inputs From Key Opinion Leaders

17 Heterozygous Familial Hypercholesterolemia Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Heterozygous Familial Hypercholesterolemia Market – Strategic Recommendations

19 Appendix