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(Albany, US), November 5, 2026 – DelveInsight’s ‘Acute Coronary Syndrome (ACS) Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of Acute Coronary Syndrome, historical and forecasted epidemiology, as well as the Acute Coronary Syndrome 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 Acute Coronary Syndrome Market Report

• As per Idorsia Pharmaceuticals’ Annual Report 2025, late-stage programs for selatogrel continue to progress toward important readouts starting from the end of 2026.

• The 7MM ACS market was valued at ~USD 2,700 million in 2025 and is projected to reach ~USD 9,000 million by 2036, growing at a CAGR of 11.5% during 2026-2036.

• According to the estimates, the United States captured the largest share in the ACS market in 2025, at ~USD 2,200 million. The US Acute Coronary Syndrome market is also expected to remain a leading revenue contributor, supported by ~1.3 million incident cases of ACS in 2025 that are expected to increase further by 2036.

• According to DelveInsight’s estimates, the total incident cases of ACS in the 7MM were approximately 2.2 million in 2025.

• Acute Myocardial Infarction (AMI) accounted for a higher proportion of ACS cases, with ~835,000 cases in the United States in 2025, indicating a shift toward more severe clinical presentations.

• In 2025, among all therapies for ACS, the highest revenue is estimated to be generated by Antiplatelet Agents in the United States.

• Recent trial failures of leading SGLT2 inhibitors, JARDIANCE and FARXIGA/FORXIGA, in achieving the primary composite endpoint of reducing cardiovascular death and heart failure hospitalizations in myocardial infarction patients raise doubts about expanding the use of this class in this area.

• The leading Acute Coronary Syndrome Companies include AGEPHA Pharma, Amgen, Regeneron, Sanofi, Idorsia Pharmaceuticals, Viatris, Faraday Pharmaceuticals, Novo Nordisk, and others.

• Promising Acute Coronary Syndrome Therapies include Colchicine (LODOCO), Evolocumab (REPATHA), Alirocumab (PRALUENT), Selatogrel, FDY-5301, Ziltivekimab, and others.

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Acute Coronary Syndrome Overview

Acute Coronary Syndrome (ACS) is a group of conditions caused by a sudden reduction or blockage of blood flow to the heart, and it comprises acute myocardial infarction and Unstable Angina together. It includes unstable angina, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), and ST-Segment Elevation Myocardial Infarction (STEMI), representing varying degrees of severity. ACS is primarily triggered by plaque rupture and clot formation in the coronary arteries and commonly presents with chest pain or discomfort, though symptoms can differ across patients. Risk factors include hypertension, diabetes, smoking, obesity, and a sedentary lifestyle. The condition is more common in older adults and men, though the incidence in women is rising. Diagnosis is based on a combination of clinical evaluation, electrocardiogram (ECG), and cardiac biomarkers, particularly troponins, with serial testing often required to confirm a diagnosis. Additional tools such as echocardiography or coronary angiography may be used to assess heart function and identify the site of blockage.

Acute Coronary Syndrome Epidemiology Segmentation in the 7MM

• Total Incident Cases of ACS

• Type-specific Incident Cases of ACS

• Type-specific Incident Cases of AMI

• Gender-specific Incident Cases of ACS

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Acute Coronary Syndrome Epidemiology Key Findings

• The total incident cases of ACS in the 7MM were approximately 2.2 million in 2025, with the highest incidence in the United States.

• In 2025, AMI accounted for a higher proportion of ACS cases (~835,000 in the United States) compared to Unstable Angina.

• Approximately three-quarters of AMI cases were NSTEMI (~75%), while STEMI accounted for about one-quarter, indicating a clear predominance of NSTEMI presentations.

• ACS cases were predominantly observed in males (~75%), while females accounted for a smaller proportion.

• Secondary findings suggest that unstable angina accounts for roughly 10-30% of overall ACS cases.

Approved Therapies for Acute Coronary Syndrome

• Colchicine (LODOCO): AGEPHA Pharma

In June 2023, the US FDA approved LODOCO as the first targeted anti-inflammatory therapy for atherosclerotic cardiovascular disease. It demonstrated a ~31% reduction in cardiovascular events versus placebo and became available for prescription in the second half of 2023.

• Evolocumab (REPATHA): Amgen

A human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), marketed in the US since 2017.

• Alirocumab (PRALUENT): Regeneron and Sanofi

A PCSK9-inhibiting monoclonal antibody marketed in the US since 2019 and in the EU since 2025.

Acute Coronary Syndrome Pipeline Analysis

• Selatogrel (ACT-246475): Idorsia Pharmaceuticals and Viatris

A potent, fast-acting, reversible, and highly selective P2Y12 inhibitor being developed for AMI in patients with a history of AMI. It is intended to be self-administered subcutaneously via an autoinjector, with the potential to protect the heart muscle in the crucial time between symptom onset and first medical attention. The anticipated US launch is 2028.

• FDY-5301: Faraday Pharmaceuticals

A patented elemental reducing agent containing sodium iodide that catalytically destroys hydrogen peroxide generated in response to acute injury. A Phase II trial in reperfusion injury following STEMI showed the treatment was well-tolerated, with encouraging signals of potential efficacy in minimizing cardiac damage.

• Ziltivekimab: Novo Nordisk

A Phase III IL-6 inhibitor monoclonal antibody for AMI, administered subcutaneously.

Discover more about therapies set to grab Major Acute Coronary Syndrome Market Share @ Myocardial Infarction Therapeutics Market

Acute Coronary Syndrome Market Outlook

The treatment of ACS is a medical emergency focused on relieving symptoms, interrupting thrombosis, restoring myocardial perfusion, limiting infarct size, and preventing complications through rapid diagnosis and intervention. Management typically involves a combination of revascularization procedures (PCI, CABG, or fibrinolysis) and pharmacologic therapy. Core drug classes include antiplatelets, anticoagulants, beta-blockers, nitrates, statins, ACE inhibitors/ARBs, and calcium channel blockers. The ACS market is evolving as treatment focus shifts from traditional broad antithrombotic approaches to more targeted and mechanism-driven therapies, with agents like LODOCO highlighting the growing role of inflammation modulation alongside optimized P2Y12 inhibitors such as Ticagrelor. Increasing emphasis on personalized therapy and novel pathways (e.g., factor XI and platelet signaling) is creating opportunities for safer and more effective treatment, which positions the coronary artery disease therapeutic market for sustained expansion. The launch of first-in-class therapies, improved diagnostic approaches, and increasing disease awareness are expected to drive steady growth in the 7MM ACS market from 2022-2036. The United States leads in revenue, while Europe and Japan demonstrate steady growth, supported by increasing cardiovascular disease burden, improved diagnosis rates, and gradual adoption of novel adjunctive therapies.

Key Factors Driving the Acute Coronary Syndrome Market

• Rising ACS incidence driven by aging populations and rising lifestyle-related risk factors

• Opportunities in inflammation targeting and optimized antithrombotic strategies, with improved outcomes and controlled bleeding risk

• Growing innovation with agents such as Colchicine and advanced P2Y12 inhibitors such as Ticagrelor

• A robust pipeline of therapies including Selatogrel, FDY-5301, and Ziltivekimab

• Higher mortality and morbidity associated with AMI, creating demand for novel therapies in immediate intervention, long-term cardiovascular protection, and post-AMI care

Acute Coronary Syndrome Unmet Needs

• Delayed or missed diagnosis, especially in atypical presentations

• Need for better risk stratification and personalized treatment

• Poor control of modifiable risk factors (e.g., diabetes, hypertension)

• High risk of recurrence despite existing therapies

• Limited awareness and delays in accessing timely care

• Suboptimal long-term treatment adherence

Acute Coronary Syndrome Treatment Landscape

Treatment of ACS focuses on restoring blood flow, relieving symptoms, and preventing complications. Initial management includes antiplatelet agents, anticoagulants, nitrates, beta-blockers, and statins. Reperfusion therapy is critical, especially in severe cases, and may involve percutaneous coronary intervention (PCI) or thrombolytic therapy to reopen blocked arteries. Long-term management includes lifestyle modification, cardiac rehabilitation, and continued pharmacotherapy to reduce the risk of recurrence and improve survival. Most pharmaceutical efforts have been centered on AMI or the broader ACS category rather than unstable angina, which has shaped the myocardial infarction drugs market and the wider ACS Mart landscape.

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Scope of the Acute Coronary Syndrome Market Report

• Coverage: 7MM

• Study Period: 2022-2036

• Forecast Period: 2026-2036

• Acute Coronary Syndrome Companies: AGEPHA Pharma, Amgen, Regeneron, Sanofi, Idorsia Pharmaceuticals, Viatris, Faraday Pharmaceuticals, Novo Nordisk, and others.

• Acute Coronary Syndrome Therapies: Colchicine (LODOCO), Evolocumab (REPATHA), Alirocumab (PRALUENT), Selatogrel, FDY-5301, Ziltivekimab, and others.

• Acute Coronary Syndrome Market Dynamics: market drivers and unmet needs

• Acute Coronary Syndrome Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis

• Acute Coronary Syndrome Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Acute Coronary Syndrome Market Overview at a Glance

5. Epidemiology and Market Forecast Methodology of Acute Coronary Syndrome (ACS)

6. Key Events

7. Disease Background and Overview of Acute Coronary Syndrome (ACS)

8. Treatment and Management

9. Epidemiology and Patient Population of Acute Coronary Syndrome (ACS) in the 7MM

10. Patient Journey

11. Marketed Therapies

12. Emerging Therapies

13. Acute Coronary Syndrome (ACS): 7MM Analysis

14. Unmet Needs of Acute Coronary Syndrome (ACS)

15. SWOT Analysis of Acute Coronary Syndrome (ACS)

16. KOL Views of Acute Coronary Syndrome (ACS)

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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