PCSK9 Inhibitors (PCSK9i) Market Insights, Epidemiology, and Market Forecast-2030

November 16 20:15 2021
PCSK9 Inhibitors (PCSK9i) Market Insights, Epidemiology, and Market Forecast-2030
DelveInsight Business Research LLP
DelveInsight’s ‘PCSK9 Inhibitors (PCSK9i) Market’ report delivers an in-depth understanding of PCSK9i, historical and forecasted epidemiology as well as the PCSK9 Inhibitors market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Pcsk9 Inhibitors Market

The PCSK9 Inhibitors market report provides disease areas, emerging drugs, PCSK9 Inhibitors market share of the individual therapies, current and forecasted PCSK9 Inhibitors market size from 2018 to 2030 segmented by seven major markets. The Report also covers current PCSK9 Inhibitors prescription eligibility criteria, approved and emerging therapies, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

PCSK9 Inhibitors Market Outlook

Understanding the role of PCSK9 in cholesterol metabolism suggested that inhibiting its actions might lower LDL-C levels therapeutically. Monoclonal antibodies directed at PCSK9 are the first to be approved. Currently, there are two PCSK9 inhibitors available in the United States: alirocumab and evolocumab, approved by the FDA for adult patients to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia (including HeFH) to reduce LDL-cholesterol. Evolocumab is also approved as an adjunct to diet and other LDL-lowering therapies in patients with HoFH who require additional lowering of LDL-C.

The product was launched in the US at a list price of around USD 14,000 per patient per year—a considerable premium on the costs of primarily genericized statins. This disparity was highlighted in cost-benefit analyses by health-technology assessment bodies such as the Institute for Clinical and Economic Review (ICER) in the US, which concluded that the PCSK9 inhibitors were significantly overpriced even in the light of the FOURIER and ODYSSEY outcomes data. In October 2018, Amgen announced that it was cutting the US list price of Repatha by 60% to USD 5,850 per year. Sanofi and Regeneron struck an agreement with Express Scripts in May 2018 to lower the net price of Praluent within the range USD 4,460 to USD 7,975 per year. Later, in February 2019, Sanofi and Regeneron went further and cut the US list price of Praluent by 60% to USD 5,850 per year.


Price discounting has also proved an effective market-access tool for the PCSK9 inhibitors outside the US. In the UK, for example, NICE recommended both Repatha and Praluent for funding through the National Health Service in England. However, NICE’s final draft guidance restricted usage in patients with primary hypercholesterolemia or mixed dyslipidemia whose cholesterol remained too high despite lifestyle changes and treatment with other cholesterol-lowering drugs.


At present, a few companies have initiated clinical trials that are investigating new PCSK9 inhibitors. Key players such as AstraZeneca and Ionis Pharmaceuticals (AZD8233, ION449), LIB Therapeutics (LIB003, lerodalcibep), CiVi Biopharma (Cepadacursen sodium, CIVI-007), and a few others are investigating their candidates as novel PCSK9 inhibitors in the 7MM. In a nutshell, a few potential PCSK9 inhibitors are being investigated.


Key Findings

The PCSK9 Inhibitors market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of PCSK9 Inhibitors in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 16.5%. According to the estimates, the highest market size of PCSK9 Inhibitors is found in the United States followed by Japan.


The United States Market Outlook

The total market size of PCSK9 Inhibitors in the United States is expected to increase with a CAGR of 11.4% in the study period (2018–2030).

EU-5 Countries: Market Outlook

The total market size of PCSK9 Inhibitors in EU-5 countries is expected to increase with a CAGR of 24.3% in the study period (2018–2030).


Japan Market Outlook

The total market size of PCSK9 Inhibitors in Japan is expected to increase with a CAGR of 23.2% in the study period (2018–2030).

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Table of contents

1. Key Insights

2. Report Introduction

3. PCSK9 Inhibitors Market Overview at a Glance

3.1. Market Share (%) Distribution of PCSK9 Inhibitors in 2018

3.2. Market Share (%) Distribution of PCSK9 Inhibitors in 2030

4. Executive Summary of PCSK9 Inhibitors (PCSK9i)

5. Key Events

5.1. Epidemiology and Market Methodology

6. PCSK9 Inhibitors (PCSK9i) Background and Overview

7. Introduction

7.1. PCSK9 gene biology

7.2. Functional mechanics of PCSK9

7.3. PCSK9 Inhibitors

7.4. PCSK9 Inhibition Strategies

7.5. The Approval Status of PCSK9 Inhibitors

7.6. Disease Areas of PCSK9 Inhibitors

7.6.1. Primary Hyperlipidemia

7.6.2. 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. Epidemiology of PCSK9 Inhibitors

9.3. Epidemiology Scenario

9.3.1. Total Prevalent Cases of Familial Hypercholestrolemia

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

10. Patient Journey

11. Key Endpoints in PCSK9 inhibitor Clinical Trials

12. Marketed Drugs

12.1. Praluent (Alirocumab): Sanofi/Regeneron Pharmaceuticals

12.1.1. Drug Description

12.1.2. Regulatory Milestones

12.1.3. Other Developmental Activities

12.1.4. Pivotal Clinical Trial

12.1.5. Ongoing Current Pipeline Activity

12.2. Repatha (Evolocumab/AMG 145): Amgen

12.2.1. Drug Description

12.2.2. Regulatory Milestones

12.2.3. Other Developmental Activities

12.2.4. Pivotal Clinical Trial

12.2.5. Ongoing Current Pipeline Activity

12.3. Leqvio (Inclisiran): Novartis/Alnylam Pharmaceuticals

12.3.1. Drug Description

12.3.2. Regulatory Milestones

12.3.3. Other Developmental Activities

12.3.4. Pivotal Clinical Trial

12.3.5. Ongoing Current Pipeline Activity

13. Emerging Therapies

13.1. LIB003 (Lerodalcibep): LIB Therapeutics

13.1.1. Drug Description

13.1.2. Clinical Development

13.1.3. Safety and Efficacy

13.2. AZD8233 (ION449): AstraZeneca and Ionis Pharmaceuticals

13.2.1. Drug Description

13.2.2. Other Developmental Activities

13.2.3. Clinical Development

13.2.4. Safety and Efficacy

13.3. Cepadacursen sodium (CIVI-007): CiVi Biopharma

13.3.1. Product Description

13.3.2. Other Developmental Activities

13.3.3. Clinical Development

13.3.4. Safety and Efficacy

14. PCSK9 inhibitors: 7 Major Market Analysis

14.1. Key Findings

14.2. Market Outlook

14.3. Market of PCSK9 Inhibitors (PCSK9i)

14.4. Market Size of PCSK9 inhibitors

14.4.1. Total Market Size of PCSK9 inhibitors

14.4.2. Market Size of PCSK9 inhibitors by Therapies (Treatment and Secondary Prevention)

15. Market Access and Reimbursement

15.1. Key HTA decisions for PCSK9i

15.2. Reimbursement

15.3. Patient Access Programs

16. KOL Views

17. Market Drivers

18. Market Barriers

19. SWOT Analysis

20. Unmet Needs

21. Appendix

21.1. Bibliography

21.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

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