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(Albany, US), October 16, 2026 – DelveInsight’s ‘Atherosclerotic Cardiovascular Disease Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of Atherosclerotic Cardiovascular Disease, historical and forecasted epidemiology, as well as the Atherosclerotic Cardiovascular Disease market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Atherosclerotic Cardiovascular Disease Market Report

• In August 2026, Insilico Medicine nominated ISM0900 as a Development Candidate (PCC) for cardiovascular risk management. Discovered via Insilico’s proprietary generative AI platform, ISM0900 is a potent, novel oral LPA inhibitor engineered to lower elevated Lipoprotein(a) levels and reduce long-term atherosclerotic cardiovascular disease risks.

• In June 2026, China’s NMPA officially accepted the New Drug Application (NDA) from Jiangsu Vcare PharmaTech for Sumecigrel capsule (formerly Vicagrel), a Class 1 innovative oral antiplatelet drug and new-generation P2Y12 receptor antagonist designed to treat and prevent atherosclerotic thrombotic events.

• In September 2025, Menarini Group announced that EMA has validated the Marketing Authorization Application (MAA) for obicetrapib and the obicetrapib/ezetimibe fixed dose combination, beginning the EMA’s centralized review procedure.

• In 2025, among the current Atherosclerotic Cardiovascular Disease Therapies, the largest revenue was generated by Evolocumab, i.e., ~USD 1,500 million in the United States.

• According to DelveInsight’s analysis, the Atherosclerotic Cardiovascular Disease Treatment Market Size was found to be ~USD 24,000 million in the 7MM in 2025 and is projected to reach ~USD 40,000 million by 2036, growing at a CAGR of 4.8% during 2026-2036.

• Among the 7MM, the United States accounted for the highest Atherosclerotic Cardiovascular Disease Treatment Market Size, with Germany being the second-highest contributor.

• As per DelveInsight’s estimates, the total diagnosed prevalent cases of Atherosclerotic Cardiovascular Disease in the 7MM were 65,415,000 in 2025.

• In 2025, approximately 55% of Atherosclerotic Cardiovascular Disease cases in the US occurred in males and 45% in females, accounting for around 17,300,000 male cases and 13,800,000 female cases.

• The leading Atherosclerotic Cardiovascular Disease Companies include Amgen, Novartis/Alnylam Pharmaceuticals, Sanofi/Regeneron Pharmaceuticals, Esperion Therapeutics/Daiichi Sankyo, Bayer/Johnson & Johnson, AGEPHA Pharma, Resverlogix, LIB Therapeutics, AstraZeneca, Merck, Novo Nordisk, and others.

• Promising Atherosclerotic Cardiovascular Disease Therapies include Evolocumab (REPATHA), Inclisiran (LEQVIO), Alirocumab (PRALUENT), Bempedoic acid (NEXLETOL/NILEMDO), Rivaroxaban (XARELTO), Olpasiran (AMG 890), Obicetrapib (TA-8995), Apabetalone (RVX000222), and others.

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Atherosclerotic Cardiovascular Disease Overview

Atherosclerotic Cardiovascular Disease (ASCVD) is a medical condition characterized by the buildup of fatty deposits (plaques) on the inner walls of arteries. These plaques consist of cholesterol, fatty substances, calcium, and other cellular waste products. Over time, the plaques can harden and narrow the arteries, which reduces blood flow to vital organs and tissues. It is a progressive and chronic condition that can affect various arteries throughout the body, including those supplying the heart (coronary arteries), brain (cerebral arteries), and legs (peripheral arteries). The most common manifestations of ASCVD include Coronary Artery Disease (CAD), cerebrovascular disease (stroke), and Peripheral Arterial Disease (PAD).

Diagnosis is based on a combination of clinical evaluation, laboratory tests, genetic analysis, and imaging techniques. Initial assessment typically includes lipid profile testing measuring total cholesterol, LDL-C, HDL-C, and triglycerides, along with additional biomarkers such as apolipoproteins, hsCRP, and lipoprotein (a) in selected patients to refine cardiovascular risk.

Atherosclerotic Cardiovascular Disease Epidemiology Segmentation in the 7MM

• Total Atherosclerotic Cardiovascular Disease Diagnosed Prevalent Cases

• Atherosclerotic Cardiovascular Disease Gender-specific Diagnosed Prevalent Cases

• Atherosclerotic Cardiovascular Disease Age-specific Diagnosed Prevalent Cases

• Atherosclerotic Cardiovascular Disease Comorbidity-specific Diagnosed Prevalent Cases

• Atherosclerotic Cardiovascular Disease Systemic Inflammation Cases

Download the report to understand which factors are driving Atherosclerotic Cardiovascular Disease Epidemiology trends @ Atherosclerotic Cardiovascular Disease Prevalence

Atherosclerotic Cardiovascular Disease Epidemiology Key Findings

• DelveInsight’s epidemiology model counts three age groups: 18-44 years, 45-64 years, and 65 years and above. Among these, the 65 and above age group was estimated to have the highest number of diagnosed Atherosclerotic Cardiovascular Disease cases in EU4 and the UK in 2025, at approximately 15,900,000, while the fewest cases were found in patients aged 18-44 years.

• In Japan in 2025, comorbidity-specific diagnosed prevalent cases of ASCVD were highest for Peripheral Artery Disease (PAD) at approximately 1,936,000 cases, while the lowest prevalence was observed in Acute Coronary Syndrome (ACS) with about 102,000 cases.

• Atherosclerotic Cardiovascular Disease prevalence continues to rise across the 7MM due to population aging, improved post-event survival, and sustained exposure to cardiometabolic risk factors, expanding the long-term secondary prevention pool.

Approved Therapies for Atherosclerotic Cardiovascular Disease

Pharmacologic management of Atherosclerotic Cardiovascular Disease continues to center on statins, ezetimibe, antiplatelets, and cardiometabolic therapies, with the PCSK9-targeted agents Evolocumab, Alirocumab, and Inclisiran providing established options for patients who require additional LDL-C reduction.

• Evolocumab (REPATHA): Amgen

REPATHA is a human immunoglobulin G2 (IgG2) monoclonal antibody directed against human PCSK9. It binds to PCSK9 and inhibits circulating PCSK9 from binding to the LDL receptor, preventing PCSK9-mediated LDL receptor degradation and permitting the LDL receptor to recycle back to the liver cell surface. By this inhibition, REPATHA increases the number of LDL receptors available to clear LDL from the blood, thereby lowering LDL-C levels. It was first approved in 2015 in the US and Europe for patients with hypercholesterolemia and ASCVD requiring additional LDL-C reduction, and in Japan in 2016, with later label expansions, including a 2025 US update for adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL-C.

• Inclisiran (LEQVIO): Novartis/Alnylam Pharmaceuticals

Inclisiran is a PCSK9-targeted siRNA therapy administered subcutaneously. It was approved in the US in 2021 for adults with clinical ASCVD or HeFH who require additional lowering of LDL-C, with further US approvals in 2023 and 2025, and has also been approved in the EU (2020) and Japan (2023).

• Alirocumab (PRALUENT): Sanofi/Regeneron Pharmaceuticals

Alirocumab is an immunoglobulin G1 (IgG1) monoclonal antibody PCSK9 inhibitor administered subcutaneously. It has been approved in the EU (2015), Japan (2016), and the US, with US approvals including adults with established cardiovascular disease (2019), adults with HeFH or clinical ASCVD requiring additional LDL-C lowering (2021), adult patients with HoFH (2021), and pediatric patients aged 8 and older with HeFH (2024).

Atherosclerotic Cardiovascular Disease Pipeline Analysis

• Olpasiran (AMG 890): Amgen/Arrowhead Pharmaceuticals

Olpasiran is an investigational siRNA therapy developed by Amgen to reduce elevated Lp (a) levels in adults with ASCVD. It functions by reducing Lp (a) production in liver cells through RNA interference, specifically inhibiting Lp(a) expression, and leverages siRNA technology originally advanced from Arrowhead Pharmaceuticals to achieve potent, dose-dependent Lp(a) lowering. The drug is currently being evaluated in two Phase III trials for the treatment of ASCVD in patients with elevated Lp (a), and a Phase III primary prevention study in patients with elevated Lp (a) who are at high risk for a first cardiovascular event was initiated in H2 2025. Its anticipated launch in the US is 2027.

• Obicetrapib (TA-8995): NewAmsterdam Pharma and Menarini Group

Obicetrapib is an oral small molecule CETP inhibitor in Phase III development for ASCVD and hypercholesterolemia.

• Apabetalone (RVX000222): Resverlogix

Apabetalone is an oral small molecule BET inhibitor in Phase III development for atherosclerosis and CAD.

Discover more about therapies set to grab Major Atherosclerotic Cardiovascular Disease Market Share @ Atherosclerotic Cardiovascular Disease Market Drivers and Barriers

Atherosclerotic Cardiovascular Disease Market Outlook

The Atherosclerotic Cardiovascular Disease Treatment Landscape is primarily driven by lipid-lowering therapies aimed at reducing LDL-C levels, supported by antiplatelet, anticoagulant, and anti-inflammatory agents for both primary and secondary prevention. Statins remain the cornerstone of therapy, while additional treatments such as ticagrelor, rivaroxaban, and LODOCO (low-dose colchicine) play key roles in reducing thrombotic and inflammatory cardiovascular risks. Among advanced lipid-lowering options, PCSK9-targeted therapies including evolocumab, alirocumab, and the siRNA therapy inclisiran have significantly improved LDL-C control in high-risk patients requiring additional lipid reduction beyond statins. Evolocumab currently leads the PCSK9 market, while inclisiran is gaining traction due to its twice-yearly dosing and potential adherence advantages. REPATHA’s growth continues to accelerate 10 years post-launch; however, LEQVIO and emerging oral PCSK9 therapies are projected to capture a larger share by 2036, particularly as inclisiran patents in the United States and Europe expire in 2034 and 2035, respectively.

Despite strong clinical efficacy, uptake of advanced lipid-lowering therapies remains limited due to cost and reimbursement barriers. However, increasing payer alignment and the development of next-generation therapies, including oral PCSK9 inhibitors, RNA-based agents targeting lipoprotein(a), and gene-editing approaches, are expected to expand treatment options and reshape the Atherosclerotic Cardiovascular Disease Therapeutics Market in the coming years. Among EU4 and the UK, Germany accounts for the maximum Atherosclerotic Cardiovascular Disease Treatment Market Size in 2025, while France occupies the bottom of the ladder.

Atherosclerotic Cardiovascular Disease Treatment Landscape

Management and prevention of Atherosclerotic Cardiovascular Disease primarily focus on lifestyle modification, pharmacotherapy, and interventional procedures. A healthy lifestyle, including a balanced diet rich in fruits, vegetables, whole grains, and fish, regular physical activity, and avoidance of tobacco, is the cornerstone of ASCVD prevention and risk reduction. Pharmacologic treatment is recommended for higher-risk individuals and commonly includes statins as first-line therapy, with additional agents such as ezetimibe, PCSK9 inhibitors, and omega-3 fatty acids when lipid control is inadequate. In patients with established disease or severe coronary artery blockage, revascularization procedures such as percutaneous coronary intervention (angioplasty with stent placement) or coronary artery bypass grafting may be used to restore blood flow and reduce cardiovascular complications. Despite guideline-directed care, residual inflammatory risk, incomplete LDL control, comorbidity load, and access gaps to advanced therapies remain major unmet needs limiting real-world secondary prevention impact.

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Scope of the Atherosclerotic Cardiovascular Disease Market Report

• Coverage- 7MM

• Study Period- 2022-2036

• Forecast Period- 2026-2036

• Atherosclerotic Cardiovascular Disease Companies- Amgen, Novartis/Alnylam Pharmaceuticals, Sanofi/Regeneron Pharmaceuticals, Esperion Therapeutics/Daiichi Sankyo, Bayer/Johnson & Johnson, AGEPHA Pharma, Resverlogix, LIB Therapeutics, AstraZeneca, Merck, Novo Nordisk, and others.

• Atherosclerotic Cardiovascular Disease Therapies- Evolocumab (REPATHA), Inclisiran (LEQVIO), Alirocumab (PRALUENT), Bempedoic acid (NEXLETOL/NILEMDO), Rivaroxaban (XARELTO), Olpasiran (AMG 890), Obicetrapib (TA-8995), Apabetalone (RVX000222), and others.

• Atherosclerotic Cardiovascular Disease Market Dynamics: Atherosclerotic Cardiovascular Disease market drivers and market barriers

• Atherosclerotic Cardiovascular Disease Competitive Intelligence Analysis: KOL Views, SWOT Analysis, Reimbursement, Conjoint Analysis, Unmet Need

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Atherosclerotic Cardiovascular Disease (ASCVD) Market Overview at a Glance

7. Disease Background and Overview

8. Treatment of ASCVD

9. Epidemiology and Patient Population of ASCVD

10. Patient Journey of ASCVD

11. Marketed Therapies

12. Emerging Therapies

13. ASCVD: 7MM Analysis

14. Unmet Needs of ASCVD

15. SWOT Analysis of ASCVD

16. KOL Views of ASCVD

17. Market Access and Reimbursement of ASCVD

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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