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Familial Hypercholesterolemia (Type II Hyperlipoproteinemia) - Epidemiology Forecast to 2030

  • ID: 5017388
  • Report
  • January 2021
  • Region: Global
  • 80 pages
  • DelveInsight
This ‘Familial Hypercholesterolemia (FH) - Epidemiology Forecast-2030’ report delivers an in-depth understanding of the disease, historical and forecasted Familial Hypercholesterolemia (FH) epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

Familial Hypercholesterolemia (FH) Understanding

Familial Hypercholesterolemia (FH) is a genetic and hereditary disorder, which leads to a high level of LDL (bad) cholesterol. The condition begins at birth and can cause heart attacks at an early age.

FH is an autosomal-dominant disorder associated with mutations in the LDL receptor gene resulting in elevated plasma low-density lipoprotein cholesterol levels and premature atherosclerotic cardiovascular disease (ASCVD). FH is significantly under-recognized with as many as 1 in 300 having the heterozygous form and one in a million having the homozygous form of the disease. Patients with FH are characterized by a decreased clearance of LDL from the circulation and an increase in LDL synthesis, with changes in homozygotes being more marked than in heterozygotes, consistent with a gene dosage effect.

Heterozygous FH (HeFH) (mutation in one allele) is related with plasma LDL-C levels >190 mg/dL, whereas homozygous FH (HoFH) (mutation in both alleles) is associated with plasma LDL-C levels >500 mg/dL. As a result, there is a 20-fold increase in the risk of premature coronary heart disease (CHD) in untreated patients compared to control. HeFH patients usually develop CHD, without treatment, before age 55 and 60 for men and women, respectively. HoFH patients, however, develop CHD very early in life and can die before age 20 if untreated.

Epidemiology Perspective

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Prevalent Population of Familial hypercholesterolemia, Diagnosed Prevalent Population of Familial hypercholesterolemia, Age-specific Distribution of Familial Hypercholesterolemia and Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Familial Hypercholesterolemia (FH) Detailed Epidemiology Segmentation
  • The total prevalent population of Familial Hypercholesterolemia (FH) in the seven major markets is estimated to be 3,113,189 in 2020. However, total diagnosed prevalent patient population of Familial Hypercholesterolemia (FH) is estimated to be 598,635 in 2020, which is anticipated to increase by 2030 in the seven major markets.
  • The diagnosed prevalence of FH is estimated to be 323,808 in the United States in 2020.
  • The diagnosed prevalent cases of HoFH and HeFH in the United States were 652 and 289,693 in 2017.
  • In the US, in 2017, FH was most prevalent in the age group of 50-59 years, followed by 60-69 years, with 75,780 and 69,683 cases.
  • In the US, the estimated number of mutation-specific cases of FH caused by LDL receptor, APO B, PCSK9, and other rare mutations (SREBP2, STAP1, LDLRAP1 genes) were 251,148, 14,517, 13,065, and 11,613 cases in 2017.
  • In the EU5 Countries, France had the maximum diagnosed prevalent population of Familial Hypercholesterolemia (FH) in 2017, followed by the United Kingdom .
  • Japan accounts for 54,452 cases of diagnosed prevalent population Familial Hypercholesterolemia (FH) in 2020.
Scope of the Report
  • The report covers the descriptive overview of Familial Hypercholesterolemia (FH), explaining its causes, signs and symptoms, pathophysiology.
  • The report provides insight into the 7MM historical and forecasted patient pool covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan.
  • The report assesses the disease risk and burden and highlights the unmet needs of Familial Hypercholesterolemia (FH).
  • The report provides the segmentation of the disease epidemiology for 7MM by Total Prevalent Cases of Familial Hypercholesterolemia (FH), Total Diagnosed and Treated Cases of Familial Hypercholesterolemia (FH).
Report Highlights
  • Eleven Year Forecast of Familial Hypercholesterolemia (FH)
  • 7MM Coverage
  • Diagnosed Prevalent Population of Familial Hypercholesterolemia (FH)
  • Deleveinsight has segregated prevalence of FH on the basis of genetic types, i.e., homozygous familial hypercholesterolemia (HoFH) and heterozygous hypercholesterolemia (HeFH).
  • Report also covers Mutation-specific diagnosed prevalence of FH, including several mutations such as LDL receptor (LDLR) Mutations, Proprotein Convertase Subtilin/Kexin 9 (PCSK9), Apolipoprotein B (Apo B) and Other rare mutations (SREBP2, and STAP1 genes, LDLRAP1 gene).
  • The publisher has analysed age-specific epidemiology of FH and segregated the entire FH patient poplation into certain age groups, namely, < 18, 18-29, 30-39, 40-49, 50-59, 60-69, 70+. Among these age groups, FH was most prevalent in the age group of 50-59 years, followed by 60¬-69 years
Key Questions Answered
  • What is the disease risk, burden and unmet needs of Familial Hypercholesterolemia (FH)?
  • What is the historical Familial Hypercholesterolemia (FH) patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
  • What would be the forecasted patient pool of Familial Hypercholesterolemia (FH) at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Familial Hypercholesterolemia (FH)?
  • Out of the above-mentioned countries, which country would have the highest prevalent population of Familial Hypercholesterolemia (FH) during the forecast period (2020-2030)?
  • At what CAGR the population is expected to grow across the 7MM during the forecast period (2020-2030)?
Reasons to Buy

The Familial Hypercholesterolemia (FH) report will allow the user to -
  • Develop business strategies by understanding the trends shaping and driving the 7MM Familial Hypercholesterolemia (FH) market.
  • Quantify patient share distribution in the 7MM for Familial Hypercholesterolemia (FH).
  • The Familial Hypercholesterolemia (FH) epidemiology report and model were written and developed by Masters and Ph.D. level epidemiologists.
  • The Familial Hypercholesterolemia (FH) epidemiology model developed by the publisher is easy to navigate, interactive with dashboards, and epidemiology based on transparent and consistent methodologies. Moreover, the model supports data presented in the report and showcases disease trends over the eleven-year forecast period using reputable sources.
Key Assessments
  • Patient Segmentation
  • Disease Risk and Burden
  • Risk of disease by the segmentation
  • Factors driving growth in a specific patient population
Geographies Covered
  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period: 2017-2030
Note: Product cover images may vary from those shown
1 Key Insights

2 Familial Hypercholesterolemia Market Overview at a Glance

3 Executive Summary

4 Disease Background and Overview: Familial Hypercholesterolemia (FH)
4.1 Introduction
4.2 Types of Familial Hypercholesterolemia
4.2.1 Homozygous Familial Hypercholesterolemia (HoFH)
4.2.2 Heterozygous Familial Hypercholesterolemia (HeFH)
4.3 FH Causative Genes
4.3.1 LDL Receptor
4.3.2 Apo B-100
4.3.3 PCSK9
4.3.4 LDL Receptor Adapter Protein 1 (LDLRAP1)
4.4 Symptoms
4.5 Clinical Features of FH
4.5.1 Hyper-LDL-Cholesterolemia
4.5.2 Premature Coronary Artery Disease
4.5.3 Tendon and Skin Xanthomas
4.5.4 Corneal Arcus
4.5.5 Other Risk Factors in FH
4.6 Diagnosis
4.6.1 Detection of FH through Genetic Screening
4.6.2 Detection of FH through Cascade Screening
4.6.3 Achilles tendon radiography
4.6.4 Diagnosis of Pediatric FH
4.6.5 Establishing the Diagnosis
4.7 Differential diagnosis

5 Diagnostic guidelines for Familial Hypercholesterolemia by the American Heart Association (AHA)

6 Diagnostic guidelines for Familial Hypercholesterolemia by the National Institute for Health and Care Excellence (NICE)

7 Recognized Establishments
7.1 United States
7.2 Europe
7.3 Japan

8 Epidemiology and Patient Population
8.1 Key Findings
8.2 7MM Prevalent Population of Familial Hypercholesterolemia
8.3 7MM Diagnosed Prevalent Population of Familial Hypercholesterolemia

9 Country-wise Epidemiology of Familial Hypercholesterolemia (FH)
9.1 United States
9.1.1 Assumptions and Rationale
9.1.2 Prevalence of Familial Hypercholesterolemia in the United States
9.1.3 Diagnosed Prevalence of Familial Hypercholesterolemia in the United States
9.1.4 Age-specific Distribution of Familial Hypercholesterolemia in the United States
9.1.5 Mutation-specific Distribution of Familial Hypercholesterolemia in the United States
9.2 EU5 Countries
9.3 Germany
9.3.1 Assumptions and Rationale
9.3.2 Prevalence of Familial Hypercholesterolemia in Germany
9.3.3 Diagnosed Prevalence of Familial Hypercholesterolemia in Germany
9.3.4 Age-specific Distribution of Familial Hypercholesterolemia in Germany
9.3.5 Mutation-specific Distribution of Familial Hypercholesterolemia in Germany
9.4 France
9.4.1 Assumptions and Rationale
9.4.2 Prevalence of Familial Hypercholesterolemia in France
9.4.3 Diagnosed Prevalence of Familial Hypercholesterolemia in France
9.4.4 Age-specific Distribution of Familial Hypercholesterolemia in France
9.4.5 Mutation-specific Distribution of Familial Hypercholesterolemia in France
9.5 Italy
9.5.1 Assumptions and Rationale
9.5.2 Prevalence of Familial Hypercholesterolemia in Italy
9.5.3 Diagnosed Prevalence of Familial Hypercholesterolemia in Italy
9.5.4 Age-specific Distribution of Familial Hypercholesterolemia in Italy
9.5.5 Mutation-specific Distribution of Familial Hypercholesterolemia in Italy
9.6 Spain
9.6.1 Assumptions and Rationale
9.6.2 Prevalence of Familial Hypercholesterolemia in Spain
9.6.3 Diagnosed Prevalence of Familial Hypercholesterolemia in Spain
9.6.4 Age-specific Distribution of Familial Hypercholesterolemia in Spain
9.6.5 Mutation-specific Distribution of Familial Hypercholesterolemia in Spain
9.7 United Kingdom
9.7.1 Assumptions and Rationale
9.7.2 Prevalence of Familial Hypercholesterolemia in the United Kingdom
9.7.3 Diagnosed Prevalence of Familial Hypercholesterolemia in the United Kingdom
9.7.4 Age-specific Distribution of Familial Hypercholesterolemia in the United Kingdom
9.7.5 Mutation-specific Distribution of Familial Hypercholesterolemia in the United Kingdom
9.8 Japan
9.8.1 Assumptions and Rationale
9.8.2 Prevalence of Familial Hypercholesterolemia in Japan
9.8.3 Diagnosed Prevalence of Familial Hypercholesterolemia in Japan
9.8.4 Age-specific Distribution of Familial Hypercholesterolemia in Japan
9.8.5 Mutation-specific Distribution of Familial Hypercholesterolemia in Japan

10 Appendix
10.1 Bibliography

11 Report Methodology

12 Publisher Capabilities

13 Disclaimer

14 About the Publisher

List of Tables
Table 1: Summary of FH, Market, Epidemiology and Key Events (2017-2030)
Table 2: Diagnostic criteria for FH in Adults (15 years of age or older)
Table 3: Molecular Genetic Testing Used in Familial Hypercholesterolemia (FH)
Table 4: Pediatric FH diagnostic criteria
Table 5: Simon Broome Diagnostic Criteria for FH
Table 6: Make Early Diagnosis to Prevent Early Deaths (MEDPED) diagnostic criteria for HeFH
Table 7: The Dutch Lipid Clinics Network Criteria Score (DLCNS)
Table 8: Prevalent Population of FH in the 7MM (2017-2030)
Table 9: Diagnosed Prevalent Population of FH in the 7MM (2017-2030)
Table 10: Prevalence of FH in the US (2017-2030)
Table 11: Diagnosed Prevalence of FH in the US (2017-2030)
Table 12: Age-specific Distribution of FH in the US (2017-2030)
Table 13: Mutation-specific Distribution of FH in the US (2017-2030)
Table 14: Prevalence of FH in Germany (2017-2030)
Table 15: Diagnosed Prevalence of FH in Germany (2017-2030)
Table 16: Age-specific Distribution of FH in Germany (2017-2030)
Table 17: Mutation-specific Distribution of FH in Germany (2017-2030)
Table 18: Prevalence of FH in France (2017-2030)
Table 19: Diagnosed Prevalence of FH in France (2017-2030)
Table 20: Age-specific Distribution of FH in France (2017-2030)
Table 21: Mutation-specific Distribution of FH in France (2017-2030)
Table 22: Prevalence of FH in Italy (2017-2030)
Table 23: Diagnosed Prevalence of FH in Italy (2017-2030)
Table 24: Age-specific Distribution of FH in Italy (2017-2030)
Table 25: Mutation-specific Distribution of FH in Italy (2017-2030)
Table 26: Prevalence of FH in Spain (2017-2030)
Table 27: Diagnosed Prevalence of FH in Spain (2017-2030)
Table 28: Age-specific Distribution of FH in Spain (2017-2030)
Table 29: Mutation-specific Distribution of FH in Spain (2017-2030)
Table 30: Prevalence of FH in the UK (2017-2030)
Table 31: Diagnosed Prevalence of FH in the UK (2017-2030)
Table 32: Age-specific Distribution of FH in the UK (2017-2030)
Table 33: Mutation-specific Distribution of FH in the UK (2017-2030)
Table 34: Prevalence of FH in Japan (2017-2030)
Table 35: Diagnosed Prevalence of FH in Japan (2017-2030)
Table 36: Age-specific Distribution of FH in Japan (2017-2030)
Table 37: Mutation-specific Distribution of FH in Japan (2017-2030)

List of Figures
Figure 1: A typical diagram showing FH artery of FH patient
Figure 2: Combination of genetic mutation showing a clinical phenotype of FH homozygote.
Figure 3: Corneal arcus in FH patients
Figure 4: Diagnostic considerations by the American Heart Association
Figure 5: Prevalent Population of FH in the 7MM (2017-2030)
Figure 6: Diagnosed Prevalent Population of FH in the 7MM (2017-2030)
Figure 7: Prevalence of FH in the US (2017-2030)
Figure 8: Diagnosed Prevalence of FH in the US (2017-2030)
Figure 9: Age-specific Distribution of FH in the US (2017-2030)
Figure 10: Mutation-specific Distribution of FH in the US (2017-2030)
Figure 11: Prevalence of FH in Germany (2017-2030)
Figure 12: Diagnosed Prevalence of FH in Germany (2017-2030)
Figure 13: Age-specific Distribution of FH in Germany (2017-2030)
Figure 14: Mutation-specific Distribution of FH in Germany (2017-2030)
Figure 15: Prevalence of FH in France (2017-2030)
Figure 16: Diagnosed Prevalence of FH in France (2017-2030)
Figure 17: Age-specific Distribution of FH in France (2017-2030)
Figure 18: Mutation-specific Distribution of FH in France (2017-2030)
Figure 19: Prevalence of FH in Italy (2017-2030)
Figure 20: Diagnosed Prevalence of FH in Italy (2017-2030)
Figure 21: Age-specific Distribution of FH in Italy (2017-2030)
Figure 22: Mutation-specific Distribution of FH in Italy (2017-2030)
Figure 23: Prevalence of FH in Spain (2017-2030)
Figure 24: Diagnosed Prevalence of FH in Spain (2017-2030)
Figure 25: Age-specific Distribution of FH in Spain (2017-2030)
Figure 26: Mutation-specific Distribution of FH in Spain (2017-2030)
Figure 27: Prevalence of FH in the UK (2017-2030)
Figure 28: Diagnosed Prevalence of FH in the UK (2017-2030)
Figure 29: Age-specific Distribution of FH in the UK (2017-2030)
Figure 30: Mutation-specific Distribution of FH in the UK (2017-2030)
Figure 31: Prevalence of FH in Japan (2017-2030)
Figure 32: Diagnosed Prevalence of FH in Japan (2017-2030)
Figure 33: Age-specific Distribution of FH in Japan (2017-2030)
Figure 34: Mutation-specific Distribution of FH in Japan (2017-2030)
Note: Product cover images may vary from those shown
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