PCSK9 Inhibitors Drugs Market 2034: EMA, PDMA, FDA Approvals, Clinical Trials, Medication, Statistics, Revenue, Pipeline, Therapies, and Companies by DelveInsight

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"PCSK9 Inhibitors Drugs Market"
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.
(Albany, USA) 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.
To Know in detail about the PCSK9 Inhibitors market outlook, drug uptake, treatment scenario and epidemiology trends, Click here;
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 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 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.
PCSK9 Inhibitors Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
PCSK9 Inhibitors Epidemiology Segmentation:
The PCSK9 Inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalence of PCSK9 Inhibitors
Prevalent Cases of PCSK9 Inhibitors by severity
Gender-specific Prevalence of PCSK9 Inhibitors
Diagnosed Cases of Episodic and Chronic PCSK9 Inhibitors
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
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the PCSK9 Inhibitors market or expected to get launched during the study period. The analysis covers PCSK9 Inhibitors market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the PCSK9 Inhibitors Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
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
Download the report to understand which factors are driving PCSK9 Inhibitors epidemiology trends @ PCSK9 Inhibitors Drugs and Therapies
PCSK9 Inhibitors Market Strengths
According to the World Heart Federation report, CVD alone, including heart disease and stroke, makes up nearly 50% of all non-communicable disease deaths. Prevention of CVD in high-risk patients by PCSK9 inhibition might help in relieving the high economic burden.
PCSK9 Inhibitors Market Opportunities Though monoclonal antibodies have, for the time being, established themselves as the most clinically useful inhibitors of PCSK9, other novel therapies are currently in various stages of development.
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
To know more about PCSK9 Inhibitors companies working in the treatment market, visit @ PCSK9 Inhibitors Clinical Trials and Therapeutic Assessment
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
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