7개 주요 국가의 급성관상동맥증후군(ACS) 시장 규모는 2023년 약 26억 7,000만 달러에 달했습니다. 이 시장은 예측 기간 동안 상당한 연평균 성장률(CAGR)로 증가할 것으로 예상됩니다. 주요 7개국 중 ACS 시장 규모가 가장 큰 국가는 미국으로 2023년 전체 시장의 약 80%를 차지했습니다.
ACS는 무증상 환자부터 흉부 불편감/증상이 지속되는 환자, 심정지, 전기적/혈역학적 불안정성, 심인성 쇼크에 이르기까지 다양한 임상 증상을 동반하며, 2023년 주요 7개국에서 총 2,195,300건의 ACS가 발생했으며, 그 중 미국에서 가장 많은 사례가 발생하였습니다. 미국에서는 STEMI보다 NSTEMI 유형이 2023년 전체 ACS 환자 중 약 607,300명이 NSTEMI 유형에 속했습니다.
급성관상동맥증후군(ACS)은 심근으로 가는 혈액의 흐름이 갑자기 멈추거나 극도로 감소하는 질환의 총칭입니다. 심근에 혈액이 흐르지 않으면 심근이 손상될 수 있습니다. 심장 발작과 불안정 협심증은 모두 ACS입니다. 다른 ACS에는 ST상승형 심근경색증(STEMI)과 비ST상승형 심근경색증(NSTEMI)이 있습니다. 심근경색은 관상동맥성 심장병(CHD)의 일종으로 35세 이상 사망원인의 3분의 1을 차지하며, 일부 CHD는 무증상이지만 ACS는 항상 증상이 있습니다.
폐색은 보통 혈전으로 인해 발생하며 갑자기 완전히 발생할 수도 있습니다. 플라크가 파열되어 혈전이 형성되면 혈전의 일부가 파열되어 관상동맥을 막고 ACS를 유발할 수 있습니다. 흔하지는 않지만 관상동맥 경련도 혈류를 제한 할 수 있습니다. 막힘의 원인에 관계없이 심장에 대한 손상은 심각하며 의료 응급 상황입니다.
평가의 첫 번째 단계는 심전도 검사로 STEMI와 NSTEMI의 불안정 협심증을 감별하는 데 도움이 됩니다. 미국심장협회의 가이드라인에 따르면 ACS가 의심되는 환자는 도착 후 10분 이내에 심전도 검사를 받아야 한다고 명시되어 있습니다. 경피적 관상동맥 중재술(PCI) 센터에서는 STEMI가 확인되면 즉시 카테터 검사를 시작해야 합니다. 심장 효소, 특히 트로포닌, CK-MB/CK 비율은 NSTEMI와 조직 파괴가없는 심근 허혈을 평가하는 데 중요합니다. 흉부 엑스레이 검사는 폐렴이나 기흉과 같은 흉통의 원인이 심근경색 이외의 다른 원인을 진단하는 데 유용합니다.
이 보고서는 주요 7개국 급성관상동맥증후군(ACS) 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등을 조사하여 전해드립니다.
DelveInsight's "Acute Chronic Syndrome (ACS) - Market Insight, Epidemiology, and Market Forecast - 2034" 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.
Study Period: 2020-2034
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.
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.
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.
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.
Key Updates
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.
Delveinsight's 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.
In France, the proposed reimbursement rate of INSPRA was 65%. Moreover, the actual benefit of INSPRA remains substantial in the marketing authorization indications.
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:
Eligibility criteria for BRILINTA savings card
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.