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PUBLISHER: DelveInsight | PRODUCT CODE: 1126014

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PUBLISHER: DelveInsight | PRODUCT CODE: 1126014

PCSK9 Inhibitors (PCSK9i) disease - Epidemiology Forecast - 2032

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DelveInsight's 'PCSK9 Inhibitors (PCSK9i) disease - Epidemiology Forecast to 2032' 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.

Geography Covered:

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

Study Period: 2019-2032.

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.the immune response.

PCSK9 Inhibitors Epidemiology

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

The disease epidemiology covered in the report provides historical as well as forecasted PCSK9 Inhibitors epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2019 to 2032.

In the year 2021, the total prevalent cases of Familial Hypercholestrolemia was 3,129.5 K cases in the 7MM which are expected to grow during the study period, i.e., 2019-2032.

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 2019 to 2032.

Country Wise- PCSK9 Inhibitors Epidemiology

The epidemiology segment also provides the PCSK9 Inhibitors epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

KOL- Views

To keep up with the current PCSK9 Inhibitors patient pool and forecasted trend, we take KOLs and SMEs ' opinions working in the PCSK9 Inhibitors domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate the patient pool and forecasted trend.

Scope of the Report:

  • The report covers the descriptive overview of PCSK9 Inhibitors, explaining their causes, symptoms, pathophysiology, and genetic basis.
  • The report provides insight into the 7MM historical and forecasted patient pool covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
  • The report assesses the selected cancer types risk and burden and highlights the unmet needs of PCSK9 Inhibitors.
  • The report helps to recognize the growth opportunities in the 7MM concerning the patient population.
  • The report provides the segmentation of the PCSK9 Inhibitors epidemiology by 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.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence PCSK9 Inhibitors R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
  • A better understanding of tumor properties and various categories of PCSK9 Inhibitors will also contribute to the development of novel PCSK9 Inhibitors.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

PCSK9 Inhibitors Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • PCSK9 Inhibitors Epidemiology Segmentation

Key Questions

Epidemiology Insights:

  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical PCSK9 Inhibitors patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of PCSK9 Inhibitors in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM concerning the patient population about PCSK9 Inhibitors?
  • What are the key findings pertaining to the PCSK9 Inhibitors epidemiology across the 7MM and which country will have the highest number of incident cases of selected cancer types for PCSK9 Inhibitors the study period (2019-2032)?
  • At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?
  • What are the various recent and upcoming events which are expected to improve the uptake of PCSK9 Inhibitors?

Reasons to buy:

  • The report will help in developing business strategies by understanding trends shaping and driving the PCSK9 Inhibitors market
  • To understand the future market competition in the PCSK9 Inhibitors market and Insightful review of the key unmet needs
  • Organize sales and marketing efforts by identifying the best opportunities for PCSK9 Inhibitors in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for PCSK9 Inhibitors therapeutics in each of the markets covered
  • To understand the future market competition in the PCSK9 Inhibitors market
Product Code: DIEI1420

Table of Contents

1. Key Insights

2. Report Introduction

3. Table of Contents

4. PCSK9 Inhibitors Market Overview at a Glance

  • 4.1. Market Share (%) Distribution of PCSK9 Inhibitors in 2019
  • 4.2. Market Share (%) Distribution of PCSK9 Inhibitors in 2032

5. Executive Summary of PCSK9 Inhibitors (PCSK9i)

  • 5.1. Key Events

6. Epidemiology and Market Methodology

7. PCSK9 Inhibitors (PCSK9i) Background and Overview

  • 7.1. Introduction
  • 7.2. PCSK9 gene biology
  • 7.3. Functional mechanics of PCSK9
  • 7.4. PCSK9 Inhibitors
  • 7.5. PCSK9 Inhibition Strategies
  • 7.6. The Approval Status of PCSK9 Inhibitors
  • 7.7. Disease Areas of PCSK9 Inhibitors
    • 7.7.1. Primary Hyperlipidemia
    • 7.7.2. Prevention of Myocardial Infarction, Stroke, and Unstable Angina Requiring Hospitalization

8. Guidelines

  • 8.1. ESC/EAS Guidelines for the Management of Dyslipidemias
  • 8.2. American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
  • 8.3. Recommendations From an Expert Panel of the National Lipid Association
  • 8.4. Recommendations of the Spanish Society of Arteriosclerosis (SEA)
  • 8.5. NICE guidelines
  • 8.6. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
  • 8.7. Comparison of guidelines

9. Epidemiology and Patient Population

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale 7MM
  • 9.3. Epidemiology Scenario in the 7MM
    • 9.3.1. Total Prevalent Cases of FH
    • 9.3.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.3.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.3.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.3.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.3.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.3.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.4. Epidemiology Scenario in the US
    • 9.4.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.4.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.4.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.4.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.4.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.4.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.4.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.5. Epidemiology Scenario in EU5
    • 9.5.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.5.2. Total Diagnosed Cases of FH
    • 9.5.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.5.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.5.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.5.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.5.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.6. Epidemiology Scenario in Japan
    • 9.6.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.6.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.6.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.6.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.6.5. Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan
    • 9.6.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.6.7. Total Treated Cases of PCSK9 Inhibitors

10. Unmet Needs

11. Appendix

  • 11.1. Acronyms and Abbreviations
  • 11.2. Bibliography
  • 11.3. Report Methodology

12. DelveInsight Capabilities

13. Disclaimer

14. About DelveInsight

Product Code: DIEI1420

List of Tables

  • Table 1: Summary of PCSK9 inhibitors, Market, Epidemiology, and Key Events (2019-2032)
  • 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 (in Thousands) (2019-2032)
  • Table 15: Total Diagnosed Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 16: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 17: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 18: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 19: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 20: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 21: Total Prevalent Cases of Familial Hypercholestrolemia (in Thousands) (2019-2032)
  • Table 22: Total Diagnosed Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 23: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 24: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 25: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 26: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 27: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 28: Total Prevalent Cases of Familial Hypercholestrolemia (in Thousands) (2019-2032)
  • Table 29: Total Diagnosed Cases of Familial Hypercholesterolemia in EU5 (in Thousands) (2019-2032)
  • Table 30: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 31: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 32: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 33: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 34: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 35: Total Prevalent Cases of Familial Hypercholestrolemia in Japan (in Thousands) (2019-2032)
  • Table 36: Total Diagnosed Cases of Familial Hypercholesterolemia in Japan (In thousands) (2019-2032)
  • Table 37: Total Type-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 38: Total Age-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 39: Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 40: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in Japan (in Thousands) (2019-2032)
  • Table 41: Total Treated Cases of PCSK9 Inhibitors in Japan (in Thousands) (2019-2032)

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 (2019-2032)
  • Figure 16: Total Diagnosed Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 17: Total Type-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 18: Total Age-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 19: Total Mutation-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 20: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the 7MM (2019-2032)
  • Figure 21: Total Treated Cases of PCSK9 Inhibitors in the 7MM (2019-2032)
  • Figure 22: Total Prevalent Cases of Familial Hypercholestrolemia in the US (2019-2032)
  • Figure 23: Total Diagnosed Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 24: Total Type-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 25: Total Age-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 26: Total Mutation-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 27: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the US (2019-2032)
  • Figure 28: Total Treated Cases of PCSK9 Inhibitors in the US (2019-2032)
  • Figure 29: Total Prevalent Cases of Familial Hypercholestrolemia in EU5 (2019-2032)
  • Figure 30: Total Diagnosed Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 31: Total Type-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 32: Total Age-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 33: Total Mutation-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 34: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in EU5 (2019-2032)
  • Figure 35: Total Treated Cases of PCSK9 Inhibitors in EU5 (2019-2032)
  • Figure 36: Total Prevalent Cases of Familial Hypercholestrolemia in Japan (2019-2032)
  • Figure 37: Total Diagnosed Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 38: Total Type-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 39: Total Age-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 40: Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 41: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in Japan (2019-2032)
  • Figure 42: Total Treated Cases of PCSK9 Inhibitors in Japan (2019-2032)
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