Acute Coronary Syndrome - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The market size of ACS in the 7MM was around USD 2.67 billion in 2023 and is expected to increase with a significant CAGR during the forecast period.
• Among the 7MM, the United States accounted for the largest market size of ACS, i.e., approximately 80% of the overall market in 2023.
• ACS are associated with a broad range of clinical presentations, from patients who are symptom free at presentation to patients with ongoing chest discomfort/symptoms and patients with cardiac arrest, electrical/haemodynamic instability, or cardiogenic shock.
• The total incident cases of ACS in the 7MM were ~2,195,300 in 2023, out of which the highest incident cases of this disease were in the United States.
• Among the total ACS incident cases, in the United States, majority of the cases were for NSTEMI than STEMI type, with NSTEMI accounting for approximately 607,300 cases in 2023.
• With the approval of AGEPHA Pharma's LODOCO, patients with residual inflammatory risk now have, for the first time, an FDA-approved treatment option specifically designed to reduce the risk of cardiovascular disease. LODOCO works by targeting inflammatory pathways that contribute to major cardiac events.
• Current treatment market has been segmented into the following therapeutic classes namely: Antiplatelet agents, Anticoagulants, Vasodilators, Beta Blockers, Lipid-lowering drugs, Angiotensin-converting Enzyme Inhibitors (ACE), Angiotensin-II receptor Blockers (ARBs), and Calcium channel blockers.
• Key players such as DalCor Pharmaceuticals and Roche (Dalcetrapib [RO4607381]), Jiangsu Vcare PharmaTech (Vicagrel), Abcentra (Orticumab), IMMEDIATE Therapeutics (IMT-358), Click Therapeutics (Clickheart [CT-111]), Idorsia Pharmaceuticals and Viatris (Selatogrel), Recardio (Dutogliptin), Amgen (Olpasiran), Faraday Pharmaceuticals (FDY-5301), Novo Nordisk (Ziltivekimab), Bristol Myers Squibb and Johnson & Johnson Innovative Medicine (Milvexian), CeleCor Therapeutics (Zalunfiban), Kancera (KAND567), CellProthera and BioCardia (ProtheraCytes), and others are evaluating their lead candidates in different stages of clinical development, respectively and will significantly impact the ACS market during the forecast period (2024-2034).
• Zalunfiban and selatogrel represent an exciting new generation of platelet antagonists that may be administered easily via subcutaneous injection at first medical contact in patients with STEMI.
• Despite significant advances in patient management and population-wide lifestyle changes in several predisposing factors, acute myocardial infarction (AMI) continues to be a major cause of morbidity and mortality in the US.
• The dynamics of the ACS market are anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, and incremental healthcare spending across the world.

This report delivers an in-depth understanding of ACS, historical and forecasted epidemiology as well as the ACS market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The ACS market report provides current treatment practices, emerging drugs, ACS market share of individual therapies, and current and forecasted ACS market size from 2020 to 2034, segmented by seven major markets. The report also covers current ACS treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

ACS Disease Understanding and Treatment Algorithm

ACS Overview

Acute Coronary Syndrome (ACS) is a term for a group of conditions that suddenly stop or severely reduce blood from flowing to the heart muscle. When blood cannot flow to the heart muscle, the heart muscle can be damaged. Heart attack and unstable angina are both ACS. Other ACS conditions include ST-elevation Myocardial Infarction (STEMI) and non-ST Elevation Myocardial Infarction (NSTEMI). It is a type of Coronary Heart Disease (CHD) which is responsible for one-third of total deaths in people older than 35. Some forms of CHD can be asymptomatic, but ACS is always symptomatic.

The blockage is usually due to a blood clot and can be sudden and complete. If a clot forms due to a plaque rupture, a part of the clot may break away and clog one of the coronary arteries, causing ACS. Though less common, spasms in the coronary artery may also limit blood flow. Regardless of the cause of the blockage, it is damaging to the heart and a medical emergency.

ACS Diagnosis

The first step of evaluation is an electrocardiogram, which helps differentiate between STEMI and NSTEMI unstable angina. American Heart Association guidelines maintain that any patient with complaints suspicious of ACS should get an electrocardiogram within 10 min of arrival. Cath lab should be activated as soon as STEMI is confirmed in a percutaneous coronary intervention (PCI) center. Cardiac enzymes, especially troponin, CK-MB/CK ratio are important in assessing the NSTEMI versus myocardial ischemia without tissue destruction. A chest x-ray is useful in diagnosing causes other than myocardial infarction presenting with chest pain like pneumonia and pneumothorax.

ACS Treatment

The initial treatment for all ACS includes aspirin (300 mg), heparin bolus, and intravenous heparin infusion if there are no contraindications to the same. Antiplatelet therapy with ticagrelor or clopidogrel is also recommended. The choice depends on the local cardiologist's preference. Ticagrelor is not given to the patients receiving thrombolysis. Supportive measures like pain control with morphine/ fentanyl and oxygen in case of hypoxia are provided as required. Nitroglycerin sublingual or infusion can be used for pain relief as well. In cases of inferior wall ischemia, nitroglycerine can cause severe hypotension and should be used with extreme caution, if at all. Continuous cardiac monitoring for arrhythmia is warranted.

Further treatment of ACS depends on whether it is a STEMI/NSTEMI or unstable angina. The American Heart Association recommends an emergent catheterization and percutaneous intervention for STEMI with door to procedure start time of fewer than 90 min. A thrombolytic (tenecteplase or other thrombolytic) is recommended if there is no percutaneous intervention available and the patient cannot be transferred to the catheterization lab in less than 120 min. American Heart Association guideline dictates the door-to-needle (TNK/other thrombolytic) time to be less than 30 min.

ACS Epidemiology

The ACS epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the Total Incident Cases of ACS, Type-specific Incidence of ACS, Type-specific Incidence of AMI and Gender-specific Incidence of ACS in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• The total incident cases of ACS in the United States is estimated to be ~1,306,700 in 2023. The cases are expected to increase by 2034.
• In EU4 and the UK, the incident cases of ACS were ~514,410 cases in males and ~269,750 cases in females in 2023.
• There were ~45,700 cases of STEMI and ~34,500 cases of NSTEMI in Japan in 2023.

ACS Drug Chapters

Marketed Drugs

LODOCO (colchicine): AGEPHA Pharma

Colchicine - an anti-inflammatory alkaloid - has assumed an important role in the management of cardiovascular inflammation after its first medicinal use in ancient Egypt. Primarily used in high doses for the treatment of acute gout flares during the 20th century, research in the early 21st century demonstrated that low-dose colchicine effectively treats acute gout attacks, lowers the risk of recurrent pericarditis, and can add to secondary prevention of major adverse cardiovascular events. As the first FDA-approved targeted anti-inflammatory cardiovascular therapy, colchicine currently has a unique role in the management of atherosclerotic cardiovascular disease.

In June 2023, the US FDA approved LODOCO as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

REPATHA (evolocumab): Amgen

REPATHA is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Over the last decade, inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged as a promising target to reduce residual cardiovascular disease risk. In December 2017, the US FDA approved REPATHA to prevent heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease. And later in May 2018, the European Commission also approved a new indication in the REPATHA label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke, or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

Emerging Drugs

Dalcetrapib (RO4607381): DalCor Pharmaceuticals and Roche

Dalcetrapib is an investigational therapy that would potentially be the first pharmacogenomic precision medicine in cardiovascular disease to reduce cardiovascular risk. Dalcetrapib, while under development by Roche, was evaluated in Phase III, a double-blind clinical trial, dal-OUTCOMES, that showed positive outcomes.

In September 2023, DalCor Pharmaceuticals announced the closing of a USD 80 million Series D financing round. This funding was utilized towards conducting the Dal-GenE-2 confirmatory trial in North America through a Special Protocol Assessment (SPA) agreement with the US FDA.

Dutogliptin: Recardio

Dutogliptin (REC-01), developed by Recardio, is a potent and selective DPP4 inhibitor. Dutogliptin is administered via SC injection; the protein belongs to the class of enzyme inhibitors called gliptins or DPP-IV inhibitors. The combination of G-CSF with dutogliptin significantly enhanced survival and reduced infarct size in the preclinical model. Once the diagnosis of AMI is confirmed and percutaneous intervention and stent implantation are completed, the patient receives or can self-administer daily SC injection of dutogliptin for 2 weeks in co-administration with G-CSF for 5 days.

In March 2024, Recardio completed the first partnering agreements, closing with regional partners outside of its key territories US and Europe. The selected regional partners will be involved in the global pivotal Phase III study for Recardio’s lead therapeutic candidate, dutogliptin, which is being developed for the treatment of AMI.

Drug Class Insight

P2Y12 inhibitor

The standard treatment for ACS involves DAPT, combining aspirin with a P2Y12 inhibitor. This combination significantly lowers the risk of major adverse cardiovascular events (MACE) following PCI. P2Y12 inhibitors block the P2Y12 receptor on platelets, which is activated by adenosine diphosphate (ADP). This inhibition prevents platelet activation and aggregation, thereby reducing thrombus formation.

DPP4 inhibitor

DPP-4 inhibitors have been shown to exert cardio protective effects, which may be beneficial in the context of ACS. They can improve endothelial function, reduce inflammation, and modulate atherosclerosis progression by lowering plasma lipid levels and suppressing pro-inflammatory cytokines. DPP-4 inhibitors may influence platelet reactivity. In patients with diabetes and acute myocardial infarction (AMI), DPP-4 inhibitors did not significantly change platelet activation when combined with standard antiplatelet therapy, indicating their potential role in maintaining effective platelet inhibition during ACS treatment.

ACS Market Outlook

Treatment of ACS is designed to relieve distress, interrupt thrombosis, reverse ischemia, limit infarct size, reduce cardiac workload, and prevent and treat complications. Treatment includes revascularization (with percutaneous coronary intervention, coronary artery bypass grafting, or fibrinolytic therapy) and pharmacologic therapy to treat ACS and underlying coronary artery disease.

Antiplatelet and antithrombotic drugs, which stop clots from forming, are used routinely. Anti-ischemic drugs (eg, beta-blockers, IV nitroglycerin) are frequently added, particularly when chest pain or hypertension is present. AMI carries a common manifestation of CVD in the elderly with an increased risk of mortality, morbidity, and excess costs. Currently, there are multiple effective management options following myocardial infarction, and guidelines recommend lifelong pharmaceutical prevention with beta-blockers, ACE inhibitors or angiotensin II receptor blockers, acetylsalicylic acid, and statins if not contraindicated.

The pharmacologic treatment of AMI can be broken down into several groups of medications that improve survival, decrease recurrent ischemic events, and provide symptomatic relief. The primary treatment is followed by multimodal regimen therapies. Unstable angina results from acute obstruction of a coronary artery without myocardial infarction. Symptoms include chest discomfort with or without dyspnea, nausea, and diaphoresis. Treatment is with antiplatelets, anticoagulants, nitrates, statins, and beta-blockers. Coronary angiography with percutaneous intervention or coronary artery bypass surgery is often necessary.

The current market has been segmented accordingly into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents itself with minor variations in the overall prescription pattern. Antiplatelet agents, Anticoagulants, Vasodilators, Beta Blockers, Lipid-lowering drugs, ACE, ARBs, and Calcium channel blockers are the major classes that have been covered in the forecast model.

• The market for ACS treatments is projected to grow significantly over the next few years with pharmaceutical companies like, and others actively developing and marketing ACS therapies.
• Among the 7MM, the US accounted for the largest market size of ACS. i.e., USD ~2150 million in 2023.
• Among EU4 and the UK, Germany accounted for the highest market size in 2023, while Spain occupied the lowest.
• The pipeline for ACS is diverse and consist of innovative therapies including Antiplatelet agents, Anticoagulants, Vasodilators, Beta Blockers, Lipid-lowering drugs, Angiotensin-converting Enzyme Inhibitors (ACE), Angiotensin-II receptor Blockers (ARBs), and Calcium channel blockers, and others.
• In 2034, among all the emerging therapies, the highest revenue is expected to be generated by Lipid-lowering drugs in the 7MM.

Key Updates

• As reported in April 2024, the EMPACT-MI trial found that JARDIANCE (empagliflozin) did not significantly reduce the composite risk of all-cause mortality and heart failure hospitalization in patients with AMI at increased risk of heart failure when compared to a placebo.
• In February 2024, CSL announced top-line results from the Phase III AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following AMI. The study did not meet its primary efficacy endpoint of MACE reduction at 90 days. As a result, there are no plans for a near-term regulatory filing. There were no major safety or tolerability concerns with CSL112.
• According to the news released in September 2023, DalCor Pharmaceuticals expects an interim efficacy analysis of Dal-GenE-2 in 2026 and aims to complete the trial by 2027.
• In September 2023, DalCor Pharmaceuticals announced the closing of a USD 80 million Series D financing round. This funding was utilized towards conducting the Dal-GenE-2 confirmatory trial in North America through a Special Protocol Assessment (SPA) agreement with the US FDA.

To be continued in the report….

ACS Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of ACS treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Given to the label expansion and better efficacy results lipid-lowering drugs are expected to capture the largest market share in the 7MM with a medium-fast uptake.

ACS Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase IIa, and Phase II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for ACS emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or ACS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

The analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Mount Sinai Fuster Heart Hospital, Stanford Medicine, University School of Medicine in Atlanta, University of Florida, Baylor Scott and White Research Institute in Dallas, Women’s Hospital Harvard Medical School, etc., were contacted. Their opinion helps understand and validate ACS epidemiology and market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Viatris patient assistance program (US)

This PAP program provides certain medicines free to patients with demonstrated financial need. Moreover, the company is committed to helping patients get the treatments they need, when and where they need them. For further procedures, the patient needs to follow the instructions below.

• Applicants qualify for the program’s financial requirements
• Applicants must be current United States residents (including US Territories)
• Applicants must be fully Uninsured
• The requested product must be prescribed by a licensed US healthcare professional for a Food and Drug Administration (FDA) approved indication
• Each applicant will be individually assessed for program eligibility based on the information provided within this application
• Applicants will only be evaluated for eligibility upon receipt of a completed and signed Viatris Patient Assistance Program (PAP) Application

In France, the proposed reimbursement rate of INSPRA was 65%. Moreover, the actual benefit of INSPRA remains substantial in the marketing authorization indications.

• BRILINTA (ticagrelor)

BRILINTA is an oral, reversible, direct-acting P2Y12 receptor antagonist that inhibits platelet activation. BRILINTA, together with aspirin, has been shown to significantly reduce the risk of MACE, defined as (MI, heart attack), stroke, or CV death, in patients with ACS or a history of MI.

BRILINTA savings card program

AstraZeneca is committed to assisting if the patient cannot afford BRILINTA:

• If the patient has private insurance, then the patient may be able to receive BRILINTA for as low as USD5 with the company’s BRILINTA savings card program
• If patients are uninsured or have Medicare Part D and still face affordability challenges, then the patient may be eligible for our patient assistance program

Eligibility criteria for BRILINTA savings card

• The patients must have commercial insurance, which is often referred to as “private insurance” and is typically provided by an employer
• The patient must be 18 years of age or older
• The patient must live in the United States or its territories

In Germany, Ticagrelor has been approved since February 2016 for adults who had a MI a year or more ago and are at a high risk of a new MI or stroke. However, an added benefit is not proven because positive effects are called into question by negative effects.

In France, the actual benefit of BRILIQUE 90 mg film-coated tablets remains substantial in the indication “prevention of atherothrombotic events in adult patients with the acute coronary syndrome (ACS)” at the dosage in the marketing authorization, i.e., for 12 months, post-SCA in combination with aspirin.

Scope of the Report

• The report covers a descriptive overview of ACS, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into ACS epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for ACS is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the ACS market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM ACS market.

ACS Report Insights

• Patient Population
• Therapeutic Approaches
• ACS Pipeline Analysis
• ACS Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

ACS Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• ACS Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

ACS Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the ACS market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the ACS total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
• Which country will have the largest ACS market size during the study period (2020-2034)?
• What are the disease risks, burdens, and unmet needs of ACS?
• What is the historical ACS patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of ACS?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of ACS?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to ACS therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for ACS and their status?
• What are the key designations that have been granted for the emerging therapies for ACS?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving ACS.
• To understand the future market competition in the ACS market and Insightful review of the SWOT analysis of ACS.
• Organize sales and marketing efforts by identifying the best opportunities for ACS in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the ACS market.
• To understand the future market competition in the ACS market.