Atherosclerotic Cardiovascular Disease (ASCVD) Market Size in the 7MM was approximately USD 23,000 million in 2024

Atherosclerotic Cardiovascular Disease Market Size was highest in the US among the 7MM in the 2023, accounting for approximately USD 12 billion which is further expected to rise at a CAGR of 2.8% by 2034.

In 2023, the Atherosclerotic Cardiovascular Disease (ASCVD) market size was the largest in the United States among the 7MM, reaching around USD 12 billion, and is projected to grow at a CAGR of 2.8% through 2034. The US also recorded the highest diagnosed prevalence, with nearly 26 million cases approximately 14 million males and 11 million females, expected to rise further by 2034.

The ASCVD market is fueled by increasing disease prevalence, therapeutic innovations, and supportive government initiatives, though it continues to face challenges such as high treatment costs, stringent regulations, and adherence issues. Reimbursement frameworks emphasize preventive care and drug pricing negotiations. Key unmet needs include long-term disease management, improved access to advanced therapies, and personalized treatment options.

Current market therapies include statins, ezetimibe/bempedoic acid combinations, and PCSK9 inhibitors, contributing to a total 7MM market size of USD 23 billion in 2023. With the anticipated introduction of novel agents like Olpasiran, MK-0616, and Obicetrapib, the market is expected to expand at a CAGR of 2.2% over 2024–2034. In Japan, the ASCVD market was valued at USD 3 billion in 2023 and is projected to grow steadily through 2034.

DelveInsight’s latest report, “Atherosclerotic Cardiovascular Disease (ASCVD) – Market Insights, Epidemiology, and Market Forecast – 2034,” delivers an in-depth, data-driven analysis of one of the most critical and complex cardiovascular conditions impacting global health systems today. ASCVD remains the leading global driver of morbidity and mortality, fueled by the rising prevalence of hypertension, diabetes, dyslipidemia, obesity, and chronic kidney disease (CKD), which together accelerate plaque progression and create highly complex, multi-morbid patient profiles across coronary, cerebrovascular, peripheral, and aortic disease.

Recent Developments in the Atherosclerotic Cardiovascular Disease Market

• In January 2025, the US Food and Drug Administration (FDA) granted 510(k) clearance for Roche’s Tina-quant® Lipoprotein (a) Gen.2 Molarity assay - the first FDA-cleared blood test in the US to measure lipoprotein (a) [Lp(a)] levels in molar units. This assay supports the evaluation of lipid metabolism disorders and helps assess the risk of atherosclerotic cardiovascular disease (ASCVD) when used alongside clinical evaluations and other lipid tests.
• Earlier, on August 28, 2024, Novartis announced that its Phase III V-MONO trial of Leqvio® (inclisiran) achieved its primary endpoints. The study showed that twice-yearly administration of Leqvio led to significant reductions in low-density lipoprotein cholesterol (LDL-C) compared with placebo and ezetimibe in patients with low to moderate ASCVD risk.

Escalating Clinical and Economic Burden of Atherosclerotic Cardiovascular Disease (ASCVD)

ASCVD represents a progressive and chronic condition characterized by the accumulation of lipid-rich plaques within arterial walls, ultimately restricting blood flow and leading to life-threatening events such as myocardial infarction, ischemic stroke, and peripheral artery disease (PAD). The condition increasingly presents earlier in life due to the rapid global growth of cardiometabolic disorders, including diabetes and obesity, significantly raising long-term treatment complexity and healthcare costs.

According to DelveInsight’s analysis, in 2024, the total diagnosed prevalent cases of ASCVD across the 7MM (United States, EU4, the United Kingdom, and Japan) were approximately 65 million, with the burden projected to rise steadily throughout the forecast period (2025–2034). The United States alone accounted for nearly 30 million ASCVD cases in 2024, underscoring its dominant contribution to the global disease burden.

From an economic perspective, the total ASCVD market size in the United States was estimated at approximately USD 23 billion in 2024, with sustained growth anticipated over the next decade. Across the 7MM, ASCVD continues to exert immense pressure on healthcare systems due to high rates of hospitalizations, recurrent cardiovascular events, and long-term pharmacologic management.

 

Shifting Patterns in Atherosclerotic Cardiovascular Disease (ASCVD) Subtypes and Patient Profiles

DelveInsight’s report highlights that Peripheral Artery Disease (PAD) constitutes the largest share of ASCVD cases across all payer and demographic groups, reflecting the widespread systemic impact of atherosclerosis. Stroke, particularly ischemic stroke, represents the second most common subtype, followed by coronary revascularization and recent acute coronary syndrome (ACS). These patterns emphasize that ASCVD is not confined to a single vascular territory but is a multi-system disease requiring integrated, long-term management strategies.

Demographic analysis reveals that aging populations contribute significantly to disease prevalence. In the EU4 and the UK, individuals aged 65 years and above accounted for approximately 16 million diagnosed ASCVD cases in 2024, while in the United States, males represented around 55% of total ASCVD cases. In Japan, comorbidity-specific analysis shows that other coronary heart disease (CHD) remains the largest ASCVD segment, followed by PAD.

Advances in Diagnosis and Risk Stratification

Diagnosis of ASCVD is increasingly shifting toward integrated risk assessment models that combine traditional lipid profiles with advanced biomarkers and imaging technologies. Beyond standard measures such as LDL-C and triglycerides, clinicians are now incorporating inflammation markers (hs-CRP), lipoprotein(a) [Lp(a)], apolipoprotein B (apoB), and genetic variants including LDLR, APOB, and PCSK9 to enable more precise stratification of high-risk patients.

Vascular imaging modalities such as ultrasound, CT, MRI/MRA, and catheter-based angiography—play a growing role in detecting plaque burden, calcification, and arterial stenosis. This multidimensional diagnostic approach is essential in identifying patients with residual cardiovascular risk who may benefit from advanced or combination therapies.

Atherosclerotic Cardiovascular Disease (ASCVD) Treatment Landscape and Standard of Care

Pharmacologic management of ASCVD centers on statins, ezetimibe, antiplatelet agents, antihypertensives, and cardiometabolic therapies, forming the backbone of both primary and secondary prevention. Over the past decade, PCSK9-targeted agents, including evolocumab (REPATHA), alirocumab (PRALUENT), and inclisiran (LEQVIO), have emerged as established ASCVD-approved options for patients with persistent LDL-C elevation despite maximally tolerated statin therapy.

Anti-inflammatory and antithrombotic therapies are also gaining traction. Low-dose colchicine (LODOCO) and factor Xa inhibitors such as rivaroxaban (XARELTO) are increasingly incorporated into treatment algorithms for select high-risk populations, reflecting a broader therapeutic focus beyond lipid lowering alone.

Robust Pipeline Signals Continued Innovation

Despite the availability of effective therapies, a substantial proportion of high-risk ASCVD patients fail to achieve guideline-recommended lipid targets, leaving significant unmet needs. This gap is driving robust pipeline activity across multiple therapeutic classes, including siRNA, antisense oligonucleotides (ASOs), CETP inhibitors, and next-generation oral lipid-lowering agents.

Key emerging therapies profiled in the report include olpasiran (AMG 890) targeting elevated Lp(a), obicetrapib (TA-8995) as a highly selective CETP inhibitor, pelacarsen (TQJ230), and apabetalone (RVX000222), among others. Several of these candidates are currently in Phase III development and are expected to reshape the competitive landscape by offering differentiated mechanisms of action, dosing convenience, and broader risk reduction.

Atherosclerotic Cardiovascular Disease (ASCVD) Market Outlook Across the 7MM

DelveInsight projects that the ASCVD market across the 7MM will continue to expand steadily through 2034, driven by rising prevalence, earlier diagnosis, longer treatment duration, and uptake of premium-priced innovative therapies. The United States captured the largest market share in 2024, with approximately USD 17.2 billion, while among EU4 and the UK, Germany is expected to lead market growth, followed by Italy and the UK.

While statins are expected to continue generating the highest overall revenue due to widespread use, advanced lipid-lowering agents and cardiometabolic therapies are anticipated to contribute an increasing share of market growth over the forecast period.

Strategic Insights and Expert Perspectives

The ASCVD report integrates Key Opinion Leader (KOL) insights, real-world prescription pattern analysis, SWOT and conjoint analyses, and reimbursement assessments to provide a holistic market view. Expert interviews reveal persistent challenges related to therapy adherence, underutilization of nonstatin lipid-lowering therapies, and limited patient and physician awareness of residual cardiovascular risk.

DelveInsight’s qualitative analyses further explore barriers to access, cost-effectiveness considerations, and regional reimbursement dynamics, offering actionable intelligence for pharmaceutical companies, investors, and policymakers.

Comprehensive Coverage and Decision-Support Value

The report provides a detailed examination of ASCVD epidemiology segmented by total diagnosed prevalent cases, gender, age, comorbidities, and systemic inflammation, alongside a thorough review of current and emerging therapies, pipeline development activities, and market access considerations. Covering the study period from 2020 to 2034, it equips stakeholders with forward-looking insights to inform clinical development, commercialization strategies, and investment decisions.

About DelveInsight

DelveInsight is a leading life sciences consulting and market research firm, providing end-to-end solutions across healthcare consulting, competitive intelligence, market assessment, pipeline analysis, and epidemiology forecasting. DelveInsight’s proprietary analytical frameworks, real-world data integration, and expert-driven insights empower stakeholders to make informed, strategic decisions in an increasingly complex healthcare landscape.