PCSK9 Inhibitors Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

The PCSK9 Inhibitors market size reached ~USD 2 billion in 2023 in 7MM and is expected to grow by 2034.
PCSK9 Inhibitors Market Summary

In 2023, The US PCSK9 Inhibitors market size was ~USD 900 million. Also, the 7MM reported around 640,000 diagnosed Familial Hypercholesterolemia cases, with homozygous forms being rare. Peripheral artery disease represented the largest risk factor-specific group for PCSK9 inhibitor use in preventive settings. Currently approved PCSK9 Inhibitor therapies include PRALUENT (alirocumab), REPATHA (evolocumab), and LEQVIO (inclisiran), while new candidates such as Merck's MK-0616 (oral PCSK9 inhibitor) and LIB003 (LIB Therapeutics) are in development. LIB003, with once-a-month dosing and higher efficacy, is projected to dominate future market share. Rising awareness of LDL cholesterol's role in cardiovascular disease is expected to further drive substantial growth of the PCSK9 inhibitor market in the coming years.

DelveInsight's "PCSK9 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast - 2034 report offers an in-depth understanding of the PCSK9 Inhibitors, historical and forecasted epidemiology as well as the PCSK9 Inhibitors market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. The PCSK9 Inhibitors market is steadily advancing, driven by evolving treatment strategies and ongoing research. DelveInsight's latest 7MM report offers in-depth insights into key epidemiology trends and market dynamics.

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Some of the key facts of the PCSK9 Inhibitors Market Report:

* The PCSK9 Inhibitors market size is anticipated to grow with a significant CAGR during the study period (2020-2034)
* In July 2025, Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio Registered (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia1. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies.
* In July 2025, Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha Registered (evolocumab) Pushtronex Trademark system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.1 Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.
* In June 2025, Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin. The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn). There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either trial.
* In April 2025, AstraZeneca announced that its experimental oral PCSK9 inhibitor, AZD0780, achieved a 50.7% reduction in LDL cholesterol over 12 weeks when added to statin therapy. This positions it as a strong competitor to existing injectable PCSK9 inhibitors, offering the advantage of oral administration without the need for fasting
* In April 2025, Verve Therapeutics' stock surged by 12.27% in pre-market trading, driven by the company's announcement of promising trial results for its cholesterol drug, VERVE-102
* In Febuary 2025, Despite previous approvals, inclisiran, a small interfering RNA therapy targeting PCSK9, was not included in the American Association of Clinical Endocrinology's 2025 guidelines for dyslipidemia management. The decision was based on limited evidence regarding its impact on cardiovascular outcomes
* In December 2024, LIB Therapeutics submitted a Biologics License Application (BLA) to the FDA for Lerodalcibep, seeking approval to lower LDL-C in patients with ASCVD, high ASCVD risk, and primary hyperlipidemia, including HeFH and HoFH.
* The PCSK9 Inhibitors Market in the 7MM was valued at approximately USD 2 billion in 2023, with the United States leading the market at around USD 900 million.
* In August 2023, The National Medical Products Administration (NMPA) of China has approved SINTBILO Registered (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia, according to Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a renowned biopharmaceutical company that develops, produces, and sells premium medications for the treatment of oncology, autoimmune, metabolic SINTBILO Registered (tafolecimab injection), the company's tenth product in its commercial portfolio, is Innovent's first medication to enter the cardiovascular market and the first domestic PCSK9 inhibitor licenced in China
* In the United States, there were approximately 1,490,000 prevalent instances of FH in 2021, and this figure is anticipated to rise from 2020 to 2034
* According to Hemphill et al. (2020), low-density lipoprotein (LDL) receptor gene mutations are the most frequent cause of homozygous familial hypercholesterolemia (HoFH), an inherited condition
* Around 1,275,000 instances of FH were widespread overall in EU-5 in 2021; this number is projected to rise from 2020 to 2034
* The overall number of prevalent FH cases in Japan was at 363,700 in 2021, and it is anticipated that this number will rise from 2020 to 2034
* Key PCSK9 Inhibitors Companies: Sirnaomics, Vaxxinity, Verve Therapeutics, Xinlitai Biotechnology, Novo Nordisk, AstraZeneca, Akeso Biopharma, Amgen, Jiangsu Hengrui Medicine Co., Innovent Biologics, LIB Therapeutics, AstraZeneca and Ionis Pharmaceuticals, CiVi Biopharma, and others
* Key PCSK9 Inhibitors Therapies: STP135G, PCSK9 inhibitor, VERVE 101, SAL-003, NNC 03850434, AZD 8233, AK102, Evolocumab, SHR-1209, Tafolecimab, LIB003 (Lerodalcibep), AZD8233 (ION449), Cepadacursen sodium (CIVI-007), CiVI-008, and others
* The PCSK9 Inhibitors market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage PCSK9 Inhibitors pipeline products will significantly revolutionize the PCSK9 Inhibitors market dynamics.

PCSK9 Inhibitors Overview

PCSK9 inhibitors are a class of cholesterol-lowering medications that target proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein involved in regulating low-density lipoprotein (LDL) cholesterol levels. These drugs are primarily used for patients with hypercholesterolemia or cardiovascular diseases who do not respond adequately to statins or cannot tolerate them.

PCSK9 binds to LDL receptors on liver cells, leading to their degradation and reducing the liver's ability to remove LDL cholesterol from the bloodstream. By inhibiting PCSK9, these drugs increase the number of LDL receptors, enhancing the clearance of LDL cholesterol and significantly lowering its levels. Two FDA-approved PCSK9 inhibitors, alirocumab and evolocumab, are monoclonal antibodies administered via subcutaneous injection. They have been shown to reduce LDL cholesterol by up to 60% and lower the risk of major cardiovascular events, such as heart attacks and strokes.

PCSK9 inhibitors are generally well-tolerated, with mild side effects like injection site reactions, flu-like symptoms, or upper respiratory tract infections. However, their high cost limits widespread use. These inhibitors represent a significant advancement in lipid management, particularly for patients with familial hypercholesterolemia or those at high cardiovascular risk. Ongoing research explores their potential broader applications and cost-effectiveness strategies.

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PCSK9 inhibitors Market Outlook

PCSK9 inhibitors, including alirocumab, evolocumab, and inclisiran, are FDA-approved therapies that reduce LDL cholesterol and lower the risk of cardiovascular events such as myocardial infarction, stroke, and unstable angina. They are prescribed as adjuncts to diet and other lipid-lowering therapies for adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) and established cardiovascular disease.

The PCSK9 inhibitors market is set for significant growth, fueled by the rising prevalence of cardiovascular diseases, increased awareness of LDL cholesterol management, and the strong clinical efficacy of PCSK9 inhibitors. Broader adoption in preventive healthcare, combined with ongoing R&D to expand therapeutic applications, is expected to further accelerate market expansion.

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PCSK9 Inhibitors Drugs Uptake and Pipeline Development Activities

MK-0616 (Merck Sharp & Dohme):

An investigational oral PCSK9 inhibitor in Phase II trials. It demonstrated significant LDL-C reduction compared to placebo, positioning it as a potential breakthrough despite competition from existing therapies.

LIB003 (Lerodalcibep, LIB Therapeutics):

A third-generation PCSK9 inhibitor under Phase III trials. Designed for once-monthly dosing with a small injection volume and long stability, it aims to overcome limitations of current LDL-C therapies.

AQR-008 (Aqur Biosciences):

A novel oral next-generation PCSK9 inhibitor targeting the EGF-A domain of LDL receptors. By preventing PCSK9 binding while preserving other functions, it enhances LDL receptor recycling and LDL-C clearance. Offers a convenient oral option for high-risk patients.

PCSK9 Inhibitors Therapies and Key Companies

* STP135G: Sirnaomics
* PCSK9 inhibitor: Vaxxinity
* VERVE 101: Verve Therapeutics
* SAL-003: Xinlitai Biotechnology
* NNC 03850434: Novo Nordisk
* AZD 8233: AstraZeneca
* AK102: Akeso Biopharma
* Evolocumab: Amgen
* SHR-1209: Jiangsu Hengrui Medicine Co.
* Tafolecimab: Innovent Biologics
* LIB003 (Lerodalcibep): LIB Therapeutics
* AZD8233 (ION449): AstraZeneca and Ionis Pharmaceuticals
* Cepadacursen sodium (CIVI-007): CiVi Biopharma
* CiVI-008: CiVi Biopharma

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PCSK9 InhibitorsMarket Drivers

* Rising Cardiovascular Disease Burden - Increasing prevalence of atherosclerotic cardiovascular diseases (ASCVD), myocardial infarction, and stroke drives demand for advanced lipid-lowering therapies.
* High Unmet Need in Statin-Resistant Patients - Many patients fail to reach LDL-C targets on statins or ezetimibe, creating a strong case for PCSK9 inhibitors.
* Strong Clinical Efficacy - Demonstrated ability to significantly lower LDL-C and reduce cardiovascular event risks enhances adoption.
* Advancements in Drug Development - Newer agents (e.g., oral MK-0616, monthly dosing LIB003) are improving convenience and patient compliance.
* Regulatory Approvals & Expanding Indications - FDA/EMA approvals (alirocumab, evolocumab, inclisiran) and ongoing pipeline expansion boost growth.
* Growing Awareness of Preventive Healthcare - Greater recognition of cholesterol management's role in preventing heart disease fuels market uptake.

PCSK9 InhibitorsMarket Barriers

* High Treatment Costs - PCSK9 inhibitors remain expensive compared to statins and generic alternatives, limiting accessibility.
* Insurance & Reimbursement Challenges - Strict payer restrictions and prior authorization hurdles slow down patient uptake.
* Injection-Based Therapy (for most approved drugs) - Fear of injections and preference for oral options affect adherence.
* Competition from Other Lipid-Lowering Therapies - Statins, ezetimibe, and newer therapies (e.g., bempedoic acid) compete with PCSK9 inhibitors.
* Limited Physician & Patient Awareness in Some Regions - Slows penetration in emerging markets.
* Long-Term Safety & Real-World Evidence Needs - While trials show efficacy, broader acceptance requires ongoing real-world data.

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Scope of the PCSK9 Inhibitors Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
* Key PCSK9 Inhibitors Companies: Sirnaomics, Vaxxinity, Verve Therapeutics, Xinlitai Biotechnology, Novo Nordisk, AstraZeneca, Akeso Biopharma, Amgen, Jiangsu Hengrui Medicine Co., Innovent Biologics, LIB Therapeutics, AstraZeneca and Ionis Pharmaceuticals, CiVi Biopharma, and others
* Key PCSK9 Inhibitors Therapies: STP135G, PCSK9 inhibitor, VERVE 101, SAL-003, NNC 03850434, AZD 8233, AK102, Evolocumab, SHR-1209, Tafolecimab, LIB003 (Lerodalcibep), AZD8233 (ION449), Cepadacursen sodium (CIVI-007), CiVI-008, and others
* PCSK9 Inhibitors Therapeutic Assessment: PCSK9 Inhibitors current marketed and PCSK9 Inhibitors emerging therapies
* PCSK9 Inhibitors Market Dynamics: PCSK9 Inhibitors market drivers and PCSK9 Inhibitors market barriers
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
* PCSK9 Inhibitors Unmet Needs, KOL's views, Analyst's views, PCSK9 Inhibitors Market Access and Reimbursement

Table of Contents

1. PCSK9 Inhibitors Market Report Introduction

2. Executive Summary for PCSK9 Inhibitors

3. SWOT analysis of PCSK9 Inhibitors

4. PCSK9 Inhibitors Patient Share (%) Overview at a Glance

5. PCSK9 Inhibitors Market Overview at a Glance

6. PCSK9 Inhibitors Disease Background and Overview

7. PCSK9 Inhibitors Epidemiology and Patient Population

8. Country-Specific Patient Population of PCSK9 Inhibitors

9. PCSK9 Inhibitors Current Treatment and Medical Practices

10. PCSK9 Inhibitors Unmet Needs

11. PCSK9 Inhibitors Emerging Therapies

12. PCSK9 Inhibitors Market Outlook

13. Country-Wise PCSK9 Inhibitors Market Analysis (2020-2034)

14. PCSK9 Inhibitors Market Access and Reimbursement of Therapies

15. PCSK9 Inhibitors Market Drivers

16. PCSK9 Inhibitors Market Barriers

17. PCSK9 Inhibitors Appendix

18. PCSK9 Inhibitors Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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