Key Atherosclerotic Cardiovascular Disease Market Highlights
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Pacibekitug’s acquisition is expected to be a key ASCVD market driver, given its first-in-class status as an anti-interleukin-6 (IL-6) monoclonal antibody targeting cardiovascular inflammation.
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ASCVD affects approximately 26 million patients in the US alone, with the condition representing one of the leading causes of cardiovascular morbidity and mortality globally.
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ASCVD Companies: Novartis AG (NYSE: NVS), Amgen Inc. (NASDAQ: AMGN), Merck Sharp & Dohme Corp. (NYSE: MRK), NewAmsterdam Pharma, Novo Nordisk (NYSE: NVO), Pfizer Inc. (NYSE: PFE), Regeneron Pharmaceuticals (NASDAQ: REGN), Bristol Myers Squibb (NYSE: BMY), among others.
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The ASCVD market size was approximately USD 23 billion in the 7MM in 2023 and is projected to grow at a CAGR of 2.2% during the forecast period (2024–2034).
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Transaction premium: Novartis paid $48 per share, representing a significant 59% premium over Tourmaline’s closing price of $30.18.
Market Impact and ASCVD Patient Population
According to DelveInsight’s Atherosclerotic Cardiovascular Disease Market Insight, Epidemiology and Market Forecast report, there is a significant unmet ASCVD medical need with approximately 55.7 million diagnosed prevalent cases in the 7MM. In 2023, the US accounted for the highest market size at approximately USD 12 billion among the 7MM, representing about 52% of the total market, while EU4 countries and the UK accounted for significant portions collectively, and Japan represented a substantial market share.
The condition is a progressive and chronic disease 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). In the United States, approximately 14 million males and 11 million females were affected with ASCVD in 2023, with inflammation increasingly recognized as an independent and significant driver of cardiovascular risk.
Furthermore, DelveInsight’s analysis indicates that among comorbidity-specific cases in 2023, other coronary heart disease (CHD) had the highest number of cases at 28 million in the 7MM. The ASCVD treatment market is set for steady growth with the US market expected to rise at a CAGR of 2.8% by 2034, driven by emerging therapies targeting novel mechanisms including anti-inflammatory approaches.
Download the ASCVD Market report to understand how this and other factors will affect the ASCVD therapeutic market @ ASCVD Market Trends.
Pacibekitug Treatment Approach
Pacibekitug represents a first-in-class anti-interleukin-6 (IL-6) monoclonal antibody designed to target the underlying inflammatory pathophysiology driving cardiovascular risk in ASCVD patients. Unlike current standard-of-care approaches that primarily focus on lipid management, blood pressure control, and antiplatelet therapy, pacibekitug addresses inflammation as an independent cardiovascular risk factor by inhibiting IL-6, a key upstream cytokine that promotes systemic inflammation. The therapy is administered via quarterly dosing, offering ASCVD patients a convenient treatment option that targets disease progression through anti-inflammatory mechanisms rather than merely managing traditional risk factors.
“The pacibekitug acquisition addresses a critical unmet medical need in cardiovascular disease treatment,” said Shreeram Aradhye, Chief Medical Officer of Novartis. “With no widely adopted anti-inflammatory therapies currently available for cardiovascular risk reduction, pacibekitug represents a potential breakthrough in addressing the inflammatory component driving ASCVD progression.”
Pacibekitug Clinical Validation and Efficacy
The strategic value of pacibekitug was significantly enhanced following compelling clinical evidence from the pivotal TRANQUILITY Phase 2 trial in May 2025, which demonstrated remarkable anti-inflammatory efficacy in high-risk ASCVD patients. The study enrolled 143 patients with elevated C-reactive protein (CRP) levels and chronic kidney disease, representing a high cardiovascular risk population. Key clinical outcomes include dramatic reductions in inflammatory biomarkers: 86% reduction in CRP levels with the 50 mg dose, 75% reduction with the 25 mg dose, and 85% reduction with the 15 mg dose at Day 90, compared to only 15% reduction in the placebo group. The ASCVD therapy was well-tolerated with a favorable safety profile across the study population, representing the first successful quarterly dosing regimen for an IL-6 inhibitor in cardiovascular disease.
ASCVD Competitive Landscape and Market Positioning
Pacibekitug enters a treatment landscape dominated by established therapeutic classes including statins, PCSK9 inhibitors, and traditional cardiovascular medications, with anti-inflammatory approaches representing a largely untapped therapeutic avenue. The current ASCVD competitive landscape includes established treatments such as high-intensity statins, ezetimibe, PCSK9 inhibitors like Repatha and Praluent, antiplatelet agents, and ACE inhibitors for comprehensive cardiovascular risk management. Novo Nordisk is developing ziltivekimab, another IL-6 inhibitor in cardiovascular development with monthly subcutaneous dosing, while Amgen advances Olpasiran (AMG 890), a siRNA targeting lipoprotein(a), currently in Phase III development.
The broader ASCVD competitive ecosystem includes NewAmsterdam Pharma’s Obicetrapib (TA-8995), a CETP inhibitor in Phase III trials, and other emerging pipeline therapies targeting novel mechanisms. Pacibekitub’s first-in-class status as an anti-inflammatory cardiovascular therapy provides unprecedented competitive differentiation, supported by its Phase 3-ready development status and quarterly dosing convenience that could improve treatment adherence.
Explore the ASCVD Drug Battle: Pacibekitug vs. other atherosclerotic cardiovascular disease therapies. Discover how these breakthrough ASCVD therapies compare in efficacy, safety, cost, and market impact @ ASCVD Drugs Market.
Emerging ASCVD Pipeline Therapies
Several companies are actively developing next-generation ASCVD therapies, with Amgen’s Olpasiran targeting elevated lipoprotein(a) levels currently recruiting for Phase III trials to evaluate effects on coronary heart disease death, myocardial infarction, and urgent coronary revascularization. NewAmsterdam Pharma’s Obicetrapib is advancing through Phase III development as a CETP inhibitor designed to reduce LDL-C and increase HDL-C levels. Merck’s MK-0616 is expected to launch by 2027 with anticipated peak market share, representing another innovative approach in the evolving ASCVD treatment landscape.
Furthermore, the ASCVD pipeline includes companies developing advanced therapeutic approaches targeting various inflammatory pathways, novel lipid-modifying mechanisms, and precision medicine strategies. Despite this competitive environment, pacibekitug’s proven anti-inflammatory efficacy, convenient quarterly dosing, and Phase 3-ready status position Novartis to capture substantial market share in a therapeutic area with significant unmet medical needs and growing recognition of inflammation’s role in cardiovascular disease.
Discover more ASCVD pipeline therapies and the clinical development progress they are making @ ASCVD Clinical Pipeline.
Broader Novartis Cardiovascular Pipeline
Beyond pacibekitug, this acquisition represents Novartis’ fourth cardiovascular investment in 2025, following partnerships with ProFound Therapeutics and China’s Argo Biopharmaceutical, demonstrating the company’s strategic commitment to expanding its cardiovascular disease portfolio. The integration of pacibekitug strengthens Novartis’ position in cardiovascular inflammation and creates opportunities for combination therapy approaches with existing cardiovascular assets, potentially expanding the addressable patient population and market opportunity significantly.
Industry Expert Perspective
Clinical experts emphasize the significance of targeting inflammatory pathways in cardiovascular disease management. “The acquisition of pacibekitug represents a fundamental shift toward recognizing inflammation as a treatable cardiovascular risk factor,” commented leading cardiologists. “By targeting IL-6 and reducing systemic inflammation, this therapy addresses a critical component of ASCVD pathophysiology that has been largely untapped in current treatment paradigms, offering patients the potential for improved cardiovascular outcomes beyond traditional risk factor modification.”
Learn more about what other Industry experts are saying about the Novartis-Tourmaline Bio acquisition and how it will impact the ASCVD treatment market @ Key Opinion Leaders on ASCVD Market.
Looking Forward
The Novartis acquisition of Tourmaline Bio represents a paradigm shift in ASCVD treatment and demonstrates the growing recognition of inflammation as a therapeutic target in cardiovascular disease management. DelveInsight’s analysts emphasize that the absence of widely adopted anti-inflammatory therapies for cardiovascular risk reduction has highlighted a critical gap in current treatment approaches, with traditional paradigms focusing primarily on lipid management and blood pressure control without addressing inflammatory pathways. As the pharmaceutical industry continues to explore precision medicine and mechanism-based approaches in cardiovascular care, pacibekitug’s success may catalyze further investment in anti-inflammatory cardiovascular therapeutics and establish new standards of care for ASCVD patients at high inflammatory risk.
Table of Contents
1. Key Insights
2. Executive Summary of Atherosclerotic Cardiovascular Disease
3. Competitive Intelligence Analysis for Atherosclerotic Cardiovascular Disease
4. Atherosclerotic Cardiovascular Disease Market Overview at a Glance
5. Atherosclerotic Cardiovascular Disease: Disease Background and Overview
6. Atherosclerotic Cardiovascular Disease Patient Journey
7. Atherosclerotic Cardiovascular Disease Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. Atherosclerotic Cardiovascular Disease Unmet Needs
10. Key Endpoints of Atherosclerotic Cardiovascular Disease Treatment
11. Atherosclerotic Cardiovascular Disease Marketed Products
12. Atherosclerotic Cardiovascular Disease Emerging Therapies
13. Atherosclerotic Cardiovascular Disease: Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Market Outlook
16. Access and Reimbursement Overview of Atherosclerotic Cardiovascular Disease
17. KOL Views
18. Atherosclerotic Cardiovascular Disease Market Drivers
19. Atherosclerotic Cardiovascular Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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