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PCSK9 Inhibitors (PCSK9i) disease - Epidemiology Forecast to 2034

Published Date : 2025

Pages : 115

Region : United States, Japan, EU4 & UK

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pcsk9 inhibitors pcsk9i disease epidemiology forecast insight

DelveInsight’s ‘PCSK9 Inhibitors (PCSK9i) disease - Epidemiology Forecast to 2034’ report delivers an in-depth understanding of PCSK9i, historical and forecasted epidemiology in the 7MM, i.e., the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Geographies Covered

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

Study Period: 2021-2034

PCSK9 Inhibitors Understanding

Proprotein convertase subtilisin/Kexin type 9 serine protease (PCSK9) plays a vital role in cholesterol metabolism by regulating low-density lipoprotein (LDL) receptor degradation, which reduces the clearance of circulating LDL particles. PCSK9 activity is inversely related to LDL cholesterol (LDL-C) level: Gain-of-function PCSK9 gene mutations are one cause of elevated LDL-C and cardiovascular risk in familial hypercholesterolemia (FH), whereas loss-of-function mutations cause low LDL-C and reduced risk of atherosclerotic cardiovascular disease (ASCVD).

PCSK9 inhibitors, in combination with other LDL lowering drugs, have been demonstrated to be highly effective for some people. Studies have shown that these drugs reduce LDL-C by 40–65% beyond the effect of other lipid-lowering drugs. The use of a PCSK9 inhibitor can reduce the chance of heart attack and stroke. New PCSK9 inhibitors are in development and are currently in clinical trials. The development of PCSK9 inhibitors, which are monoclonal antibodies directed against PCSK9, led to a significant enhancement of the lipid-lowering armamentarium, as PCSK9 inhibitors result in a consistent and robust reduction in LDL-C serum concentrations, substantially improving CV outcomes.

Statin therapy is without doubt the cornerstone of any LDL-C-lowering therapy. Therefore, any novel LDL-C-lowering medication would need to show efficacy on top of statin therapy or only be indicated in the minority of patients not tolerating statins. The metabolic changes induced by treatment with antibodies against PCSK9 and statin therapy are not identical. While both approaches lower LDL-C, triglycerides, apolipoprotein B, and increase HDL cholesterol, statins additionally reduce C-reactive protein (CRP), which PSCK9 antibodies do not.

PCSK9 binds to the LDL receptor. After internalizing the LDL receptor bound to PCSK9 (and an LDL particle), the LDL receptor is degraded. PCSK9 can be inhibited pharmacologically by using monoclonal antibodies that bind and neutralize PCSK9 or by RNA-targeting drugs which contain an RNA strand complementary to PCSK9 mRNA and lead to the assembly of an RNA-induced silencing complex (RISC) which degrades PCSK9 mRNA for a prolonged period of time and thereby inhibits the production of PCSK9. The consequence of both approaches is a lower concentration of PCSK9 that can bind the LDL receptor, which after internalization, more often cycles back to the cell surface and can take up further LDL particles, leading to lower LDL cholesterol serum concentrations.

Epidemiology Perspective by DelveInsight

The PCSK9 Inhibitors epidemiology division provides insights about historical and current PCSK9 Inhibitors patient pool and forecasted trends for every 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 DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

In the year 2020, the total prevalent cases of Familial Hypercholestrolemia was 3.1 million cases 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 PCSK9 inhibitors epidemiology [segmented as Total prevalent cases of Familial Hypercholesterolemia, Total diagnosed cases of Familial Hypercholesterolemia, Total type-specific cases of Familial Hypercholesterolemia, Total age group-specific cases of Familial Hypercholesterolemia, Total mutation-specific cases of Familial Hypercholesterolemia, Total risk factor-specific cases of PCSK9 Inhibitors in Prophylactic/Preventive setting, and Total Treated cases of PCSK9 Inhibitors] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2021 to 2034.

Country Wise- PCSK9 Inhibitors Epidemiology

Estimates show that the highest cases of Familial Hypercholesterolemia in the 7MM were in the United States, followed by Japan, France, the United Kingdom, Germany, Italy, and Spain in 2020.
In the United States, the total number of prevalent cases of Familial Hypercholesterolemia was 1.5 million cases in the year 2020 which are expected to grow during the study period, i.e., 2021-2034.
In the year 2020, the total prevalent cases of Familial Hypercholesterolemia were 1.3 million cases in EU-5 which are expected to grow during the study period, i.e., 2021-2034.
In Japan, the total number of prevalent cases of Familial Hypercholesterolemia was 0.4 million cases in the year 2020 which are expected to grow during the study period, i.e., 2021-2034.

Scope of the Report

The PCSK9 Inhibitors report covers a detailed overview explaining various construction approaches for PCSK9 Inhibitors, and treatment patterns.
The PCSK9 Inhibitors Report and Model provide an overview of the risk factors and global trends of PCSK9 Inhibitors in the seven major markets (7MM: The United States, Germany, France, Italy, Spain, the United Kingdom, and Japan).
The report provides insight about the historical and forecasted patient pool of PCSK9 Inhibitors in seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The report helps to recognize the growth opportunities in the 7MM concerning the patient population.
The report assesses the disease risk and burden and highlights the unmet needs of PCSK9 Inhibitors.
The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by total prevalent cases in the 7MM.
The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by total diagnosed cases in the 7MM.
The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by type-specific cases in the 7MM.
The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by age group-specific cases in the 7MM.
The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by mutation-specific cases in the 7MM.
The report provides the segmentation of the PCSK9 Inhibitors epidemiology by mutation-specific cases in the 7MM.
The report provides the segmentation of the PCSK9 Inhibitors epidemiology by risk factor-specific cases in prophylactic/preventive setting in the 7MM.
The report provides the segmentation of the PCSK9 Inhibitors epidemiology by total treated cases in the 7MM.

Report Highlights

10-Year Forecast of PCK9 Inhibitors epidemiology
7MM Coverage
Total Prevalent Cases of Familial Hypercholesterolemia
Total Diagnosed Cases of Familial Hypercholesterolemia
Type-specific Cases of Familial Hypercholesterolemia
Age group-specific Cases of Familial Hypercholesterolemia
Mutation-specific Cases of Familial Hypercholesterolemia
Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
Total Treated Cases of PCSK9 Inhibitors

KOL-Views

We interview KOL’s and SME's opinion through primary research to fill the data gaps and validate our secondary research. The opinion helps to understand the total patient population and current treatment pattern. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the indications.

Key Questions Answered

What will be the growth opportunities in the 7MM concerning the eligible patient population of PCSK9 Inhibitors?
What are the key findings of the PCSK9 Inhibitors epidemiology across the 7MM and which country will have the highest number of patients during the study period (2021-2034)?
What would be the total number of patients of PCSK9 Inhibitors related diseases across the 7MM during the study period (2021-2034)?
Among the EU5 countries, which country will have the highest number of patients during the study period (2021-2034)?
At what CAGR the patient population is expected to grow in the 7MM during the study period (2021-2034)?
What are the various recent and upcoming events which are expected to improve the prescription of PCSK9 Inhibitors?

Reasons to buy

The PCSK9 Inhibitors Epidemiology report will allow the user to -

Develop business strategies by understanding the trends shaping and driving the global PCSK9 Inhibitors market
Quantify patient populations in the global PCSK9 Inhibitors market to improve product design, pricing, and launch plans
Organize sales and marketing efforts by identifying the age-group in Familial Hypercholsterolemia that presents the best opportunities for PCSK9 Inhibitors in each of the markets covered
Understand the magnitude of PCSK9 Inhibitors population by its risk factor-specificity
The PCSK9 Inhibitors epidemiology report and model were written and developed by Masters and Ph.D. level epidemiologists
The PCSK9 Inhibitors 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 trends over an 10-year forecast period using reputable sources

Key Assessments

Patient Segmentation
Related Diseases Risk and Burden
Risk of related diseases by the segmentation
Factors driving growth in a specific patient population

List of Tables:

List of Table

Table 1: Summary of PCSK9 inhibitors, Market, Epidemiology, and Key Events (2021-2034)

Table 2: Molecular Genetic Testing Used in FH

Table 3: The Dutch Lipid Clinics Network Criteria Score (DLCNS)

Table 4: Recommendations for Pharmacological Low-density Lipoprotein Cholesterol-lowering

Table 5: Recommendations for the Detection and Treatment of Patients With Heterozygous Familial Hypercholesterolemia

Table 6: Recommendations for Lipid-lowering Drugs in Patients With Peripheral Arterial Disease (Including Carotid Artery Disease)

Table 7: Recommendations for Lipid-lowering Therapy in Very High-risk Patients With Acute Coronary Syndromes

Table 8: Recommendations for Statin Therapy Use in Patients With ASCVD

Table 9: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L])

Table 10: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L])

Table 11: Recommendations and Level of Evidence for the Prescription of a PCSK9 inhibitor Concerning the Patient’s Clinical Situation and LDL-C Levels

Table 12: LDL-C concentrations above which PCSK9s are recommended by NICE

Table 13: Comparison of Recommendations for PCSK9-mAb Use

Table 14: Total Prevalent Cases of Familial Hypercholestrolemia (2021-2034)

Table 15: Total Diagnosed Cases of Familial Hypercholesterolemia (2021-2034)

Table 16: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2021-2034)

Table 17: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2021-2034)

Table 18: Total Mutation-specific Cases of Familial Hypercholesterolemia (2021-2034)

Table 19: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (2021-2034)

Table 20: Total Treated Cases of PCSK9 Inhibitors (2021-2034)

List of Figures:

List of Figures

Figure 1: Epidemiology and Market Methodology

Figure 2: Intracellular and Extracellular Pathways of PCSK9

Figure 3: Mechanism and Role of PCK9 in Low-density Lipoprotein–Cholesterol Metabolism

Figure 4: Pharmacologic approaches to lower LDL cholesterol

Figure 5: Mechanism of Action for PCSK9-mAb and siRNA

Figure 6: Timeline of PCSK9 Inhibitors

Figure 7: Timeline of ICER’s Evaluation of PCSK9 Inhibitors

Figure 8: Difference Between HeFH and HoFH

Figure 9: Diagnostic Considerations by the American Heart Association

Figure 10: Algorithm for Consideration of PCSK9 Treatment in Severe FH Patients Without ASCVD

Figure 11: Secondary Prevention in Patients With Clinical ASCVD

Figure 12: Algorithm for Consideration of PCSK9 Inhibitor Treatment in Very High-risk Patients, i.e., With Atherosclerotic Cardiovascular Disease (ASCVD) or Diabetes Mellitus

Figure 13: Treatment Flow Chart for Adult (15 years or over) Heterozygous FH

Figure 14: Treatment Flow Chart for Adult (15 Years or Over) Homozygous FH

Figure 15: Total Prevalent Cases of Familial Hypercholestrolemia in the 7MM (2021-2034)

Figure 16: Total Diagnosed Cases of Familial Hypercholesterolemia in the 7MM (2021-2034)

Figure 17: Total Type-specific Cases of Familial Hypercholesterolemia in the 7MM (2021-2034)

Figure 18: Total Age-specific Cases of Familial Hypercholesterolemia in the 7MM (2021-2034)

Figure 19: Total Mutation-specific Cases of Familial Hypercholesterolemia in the 7MM (2021-2034)

Figure 20: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the 7MM (2021-2034)

Figure 21: Total Treated Cases of PCSK9 Inhibitors in the 7MM (2021-2034)

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