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"PCSK9 Inhibitors Market Analysis"PCSK9 Inhibitors Companies are 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

PCSK9 Inhibitors Market Analysis Summary

In 2023, the 7MM (seven major markets) PCSK9 inhibitors market was valued at approximately USD 2 billion, with the United States leading at around USD 900 million. That year, roughly 640,000 cases of diagnosed Familial Hypercholesterolemia were reported across the 7MM, with homozygous cases being uncommon. Among risk-specific populations, patients with peripheral artery disease formed the largest group for PCSK9 inhibitor use in preventive care. Currently approved therapies include PRALUENT (alirocumab), REPATHA (evolocumab), and LEQVIO (inclisiran). New entrants in development, such as Merck's oral PCSK9 inhibitor MK-0616 and LIB Therapeutics' LIB003, show promising potential. LIB003, offering once-monthly dosing and enhanced efficacy, is expected to capture a significant portion of future market share. Increasing awareness of the impact of LDL cholesterol on cardiovascular disease is anticipated to further fuel the growth of the PCSK9 inhibitor market in the coming years.

DelveInsight's “PCSK9 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast - 2034” report provides a comprehensive analysis of PCSK9 inhibitors, covering both historical and projected epidemiology, as well as market trends across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The PCSK9 inhibitors market is experiencing steady growth, fueled by evolving treatment approaches and ongoing research efforts. This latest 7MM report delivers detailed insights into key epidemiological patterns and the driving forces shaping market dynamics.

To know in detail about the PCSK9 Inhibitors market outlook, drug uptake, treatment scenario and epidemiology trends, click here; PCSK9 Inhibitors Market Forecast

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

• In 2024, the United States represented the largest PCSK9-targeted therapy market within the 7MM, valued at around USD 1,766 million, with projections indicating further growth by 2034.
• In October 2025, Amgen (NASDAQ:AMGN) today announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha® (evolocumab), a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke. The landmark Phase 3 VESALIUS-CV trial enrolled over 12,000 high-risk patients, approximately 85% of whom were maintained on a high-intensity or moderate low-density lipoprotein cholesterol (LDL-C) reducing therapy. Patients were followed for a median of approximately 4.5 years.
• In July 2025, Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (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® (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. 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. 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® (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® (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 novel class of lipid-lowering therapies designed to reduce low-density lipoprotein cholesterol (LDL-C), a major risk factor for cardiovascular diseases. They work by blocking the PCSK9 protein, which normally degrades LDL receptors in the liver, thereby increasing receptor availability to clear LDL-C from the bloodstream. Currently approved therapies include monoclonal antibodies such as PRALUENT (alirocumab) , REPATHA (evolocumab) , and the small interfering RNA-based therapy LEQVIO (inclisiran) . These drugs have shown significant efficacy in lowering LDL-C and reducing cardiovascular risk, making them essential for patients with familial hypercholesterolemia, atherosclerotic cardiovascular disease, or those intolerant to statins.

The PCSK9 Inhibitors market has witnessed steady growth, driven by increasing awareness of LDL-C management, improved treatment guidelines, and the unmet need in high-risk populations. Emerging candidates like Merck's MK-0616 (oral PCSK9 inhibitor) and LIB003 (LIB Therapeutics) promise greater convenience and efficacy, further shaping the future landscape of PCSK9 inhibitors.

Unlock key insights into the booming PCSK9 Inhibitors Market. Get the full report and stay ahead in the cardiovascular therapeutics race!: PCSK9 Inhibitors Treatment Market

PCSK9 inhibitors Market Outlook

PCSK9-targeted therapies represent a rapidly growing cardiovascular market, fueled by large patient populations, statin intolerance, and strong clinical efficacy. Despite pricing pressures, broader access and affordability are expected to sustain long-term adoption. Currently dominated by injectables like REPATHA , the market is shifting as Novartis's LEQVIO is projected to become a blockbuster in 2025. The upcoming launch of oral therapies and Verve's gene therapy will further transform treatment, addressing adherence challenges and expanding the market two- to threefold.

Leading oral candidates include Merck's enlicitide decanoate (with Phase III data) and AstraZeneca's laroprovstat. The PCSK9 market across the 7MM was valued at USD 2.4 billion in 2024 and is expected to grow significantly through 2034. The U.S. will remain the largest and fastest-growing market due to favorable access and early adoption, while growth in EU4 and the UK will rely on reimbursement structures. In Japan, oral therapies are expected to accelerate uptake.

Download the report to understand which factors are driving PCSK9 Inhibitors epidemiology trends @ PCSK9 Inhibitors Epidemiology Forecast

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

Explore breakthrough therapies like MK-0616, LIB003, and AQR-008 alongside key players driving innovation @ PCSK9 Inhibitors Drugs and Therapies

PCSK9 Inhibitors Market Dynamics and Trends

PCSK9 Inhibitors Market 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 Intolerance – Many patients fail to reach LDL-C targets on statins or ezetimibe, creating a strong case for PCSK9 inhibitors.

Proven 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.

PCSK9 Inhibitors Market 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.

To know more about PCSK9 Inhibitors companies working in the treatment market, visit @ PCSK9 Inhibitors Clinical Trials and Therapeutic Assessment

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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