Familial Hypercholesterolemia Epidemiology Forecast Report

DelveInsight’s ‘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. 


Geographies Covered

• The United States

• EU5 (Germany, France, Italy, Spain, and the United Kingdom)

• Japan


Study Period: 2017–2030


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.


Familial Hypercholesterolemia (FH) Epidemiology Perspective by DelveInsight

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, Mutation-specific Diagnosed Prevalence of Familial hypercholesterolemia and Diagnosed Prevalence of Coronary Heart Disease due to 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 was found to be 2,367,466 in 2017. However, total diagnosed prevalent patient population of Familial Hypercholesterolemia (FH) was 965,405 in 2017, which is anticipated to increase by 2030 in the seven major markets.

• The diagnosed prevalence of FH was found to be 244,214 in the United States in 2017.

• In the EU5 Countries, France had the maximum diagnosed prevalent population of Familial Hypercholesterolemia (FH) in 2017, followed by Italy .

• Japan accounted for 221,519 cases of diagnosed prevalent population Familial Hypercholesterolemia (FH) in 2017.


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)

• 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).

• Deleveinsight has segregated prevalence of FH on the basis of genetic types, i.e., homozygous familial hypercholesterolemia (HoFH) and heterozygous hypercholesterolemia (HeFH).

• Expected Launch of potential therapies may increase market size in the coming years, assisted by an increase in diagnosed prevalent population of Familial Hypercholesterolemia (FH). Owing to the positive outcomes of the upcoming products during the developmental stage by key players such as Regeneron Pharmaceuticals, Novartis, LIB Therapeutics, NeuroBo Pharmaceuticals, Madrigal Pharmaceuticals and Arrowhead Pharmaceuticals have a potential to create a significant positive shift in the Familial Hypercholesterolemia (FH) Market Size.

• Delveinsight has also estimated the diagnosed prevalent population of Coronary Heart Disease (CHD) due to FH.


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 DelveInsight 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

1 Key Insights

2 Familial Hypercholesterolemia Market Overview at a Glance

2.1 Market Share (%) Distribution of Familial Hypercholesterolemia in 2017

2.2 Market Share (%) Distribution of Familial Hypercholesterolemia in 2030

3 Disease Background and Overview: Familial Hypercholesterolemia (FH)

3.1 Introduction

3.2 Types of Familial Hypercholesterolemia

3.2.1 Homozygous Familial Hypercholesterolemia (HoFH)

3.2.2 Heterozygous FH Familial Hypercholesterolemia (HeFH)

3.3 FH Causative Genes

3.3.1 LDL Receptor

3.3.2 Apo B-100

3.3.3 PCSK9

3.3.4 LDL Receptor Adapter Protein 1 (LDLRAP1)

3.4 Symptoms

3.5 Clinical Features of FH

3.5.1 Hyper-LDL-Cholesterolemia

3.5.2 Premature Coronary Artery Disease

3.5.3 Tendon and Skin Xanthomas

3.5.4 Corneal Arcus

3.5.5 Other Risk Factors in FH

3.6 Diagnosis

3.6.1 Detection of FH through Genetic Screening

3.6.2 Detection of FH through Cascade Screening

3.6.3 Achilles tendon radiography

3.6.4 Diagnosis of Pediatric FH

3.6.5 Establishing the Diagnosis

3.7 Differential diagnosis

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

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

6 Recognized Establishments

6.1 United States

6.2 Europe

6.3 Japan

7 Epidemiology and Patient Population: Key Findings

7.1 7MM Total Prevalent Population of Familial Hypercholesterolemia

7.2 7MM Total Diagnosed Prevalent Population of Familial Hypercholesterolemia

8 Country Wise-Epidemiology of Familial Hypercholesterolemia (FH)

8.1 United States

8.1.1 Assumptions and Rationale

8.1.2 Prevalent Population of Familial Hypercholesterolemia in the United States

8.1.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United States

8.1.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United States

8.1.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United States

8.2 EU5 Countries

8.3 Germany

8.3.1 Assumptions and Rationale

8.3.2 Prevalent Population of Familial Hypercholesterolemia in Germany

8.3.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in Germany

8.3.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Germany

8.3.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Germany

8.4 France

8.4.1 Assumptions and Rationale

8.4.2 Prevalent Population of Familial Hypercholesterolemia in France

8.4.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in France

8.4.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in France

8.4.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in France

8.5 Italy

8.5.1 Assumptions and Rationale

8.5.2 Prevalent Population of Familial Hypercholesterolemia in Italy

8.5.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in Italy

8.5.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Italy

8.5.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Italy

8.6 Spain

8.6.1 Assumptions and Rationale

8.6.2 Prevalent Population of Familial Hypercholesterolemia in Spain

8.6.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in Spain

8.6.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Spain

8.6.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Spain

8.7 United Kingdom

8.7.1 Assumptions and Rationale

8.7.2 Prevalent Population of Familial Hypercholesterolemia in the United Kingdom

8.7.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United Kingdom

8.7.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United Kingdom

8.7.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United Kingdom

8.8 Japan

8.8.1 Assumptions and Rationale

8.8.2 Prevalent Population of Familial Hypercholesterolemia in Japan

8.8.3 Diagnosed Prevalent Population of Familial Hypercholesterolemia in Japan

8.8.4 Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Japan

8.8.5 Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Japan

9 Appendix

9.1 Bibliography

9.2 Report Methodology

10 DelveInsight Capabilities

11 Disclaimer

12 About DelveInsight

Table 1: Diagnostic criteria for FH in Adults (15 years of age or older)

Table 2: Molecular Genetic Testing Used in Familial Hypercholesterolemia (FH)

Table 3: Pediatric FH diagnostic criteria

Table 4: Simon Broome Diagnostic Criteria for FH

Table 5: Make Early Diagnosis to Prevent Early Deaths (MEDPED) diagnostic criteria for Heterozygous Familial Hypercholesterolemia (FH)

Table 6: The Dutch Lipid Clinics Network Criteria Score (DLCNS)

Table 7: Total Prevalent Population of Familial Hypercholesterolemia in the 7MM (2017–2030)

Table 8: Total Diagnosed Prevalent Population of Familial Hypercholesterolemia in the 7MM (2017–2030)

Table 9: Prevalent Population of Homozygous Familial Hypercholesterolemia in the United States (2017–2030)

Table 10: Prevalent Population of Heterozygous Familial Hypercholesterolemia in the United States (2017–2030)

Table 11: Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United States (2017–2030)

Table 12: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United States (2017–2030)

Table 13: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United States (2017–2030)

Table 14: Prevalent Population of Homozygous Familial Hypercholesterolemia in Germany (2017–2030)

Table 15: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Germany (2017–2030)

Table 16: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Germany (2017–2030)

Table 17: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Germany (2017–2030)

Table 18: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Germany (2017–2030)

Table 19: Prevalent Population of Homozygous Familial Hypercholesterolemia in France (2017–2030)

Table 20: Prevalent Population of Heterozygous Familial Hypercholesterolemia in France (2017–2030)

Table 21: Diagnosed Prevalent Population of Familial Hypercholesterolemia in France (2017–2030)

Table 22: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in France (2017–2030)

Table 23: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in France (2017–2030)

Table 24: Prevalent Population of Homozygous Familial Hypercholesterolemia in Italy (2017–2030)

Table 25: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Italy (2017–2030)

Table 26: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Italy (2017–2030)

Table 27: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Italy (2017–2030)

Table 28: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Italy (2017–2030)

Table 29: Prevalent Population of Homozygous Familial Hypercholesterolemia in Spain (2017–2030)

Table 30: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Spain (2017–2030)

Table 31: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Spain (2017–2030)

Table 32: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Spain (2017–2030)

Table 33: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Spain (2017–2030)

Table 34: Prevalent Population of Homozygous Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Table 35: Prevalent Population of Heterozygous Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Table 36: Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Table 37: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Table 38: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Table 39: Prevalent Population of Homozygous Familial Hypercholesterolemia in Japan (2017–2030)

Table 40: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Japan (2017–2030)

Table 41: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Japan (2017–2030)

Table 42: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Japan (2017–2030)

Table 43: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Japan (2017–2030)

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: Total Prevalent Population of Familial Hypercholesterolemia in the 7MM (2017–2030)

Figure 6: Total Diagnosed Prevalent Population of Familial Hypercholesterolemia in the 7MM (2017–2030)

Figure 7: Prevalent Population of Homozygous Familial Hypercholesterolemia in the United States (2017–2030)

Figure 8: Prevalent Population of Heterozygous Familial Hypercholesterolemia in the United States (2017–2030)

Figure 9: Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United States (2017–2030)

Figure 10: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United States (2017–2030)

Figure 11: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United States (2017–2030)

Figure 12: Prevalent Population of Homozygous Familial Hypercholesterolemia in Germany (2017–2030)

Figure 13: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Germany (2017–2030)

Figure 14: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Germany (2017–2030)

Figure 15: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Germany (2017–2030)

Figure 16: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Germany (2017–2030)

Figure 17: Prevalent Population of Homozygous Familial Hypercholesterolemia in France (2017–2030)

Figure 18: Prevalent Population of Heterozygous Familial Hypercholesterolemia in France (2017–2030)

Figure 19: Diagnosed Prevalent Population of Familial Hypercholesterolemia in France (2017–2030)

Figure 20: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in France (2017–2030)

Figure 21: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in France (2017–2030)

Figure 22: Prevalent Population of Homozygous Familial Hypercholesterolemia in Italy (2017–2030)

Figure 23: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Italy (2017–2030)

Figure 24: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Italy (2017–2030)

Figure 25: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Italy (2017–2030)

Figure 26: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Italy (2017–2030)

Figure 27: Prevalent Population of Homozygous Familial Hypercholesterolemia in Spain (2017–2030)

Figure 28: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Spain (2017–2030)

Figure 29: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Spain (2017–2030)

Figure 30: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Spain (2017–2030)

Figure 31: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Spain (2017–2030)

Figure 32: Prevalent Population of Homozygous Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Figure 33: Prevalent Population of Heterozygous Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Figure 34: Diagnosed Prevalent Population of Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Figure 35: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Figure 36: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in the United Kingdom (2017–2030)

Figure 37: Prevalent Population of Homozygous Familial Hypercholesterolemia in Japan (2017–2030)

Figure 38: Prevalent Population of Heterozygous Familial Hypercholesterolemia in Japan (2017–2030)

Figure 39: Diagnosed Prevalent Population of Familial Hypercholesterolemia in Japan (2017–2030)

Figure 40: Mutation-specific Diagnosed Prevalence of Familial Hypercholesterolemia in Japan (2017–2030)

Figure 41: Diagnosed Prevalence of Coronary Heart Disease due to Familial Hypercholesterolemia in Japan (2017–2030)

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