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급성 관상동맥 증후군 : 시장 인사이트, 역학 및 시장 예측(2036년)

Acute Coronary Syndrome - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 237 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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급성 관상동맥 증후군(ACS)에 대한 인사이트와 동향

  • 급성 관상동맥 증후군(ACS)은 급성 심근경색과 불안정 협심증을 통칭하는 용어입니다. 2025년 주요 7개국에서 ACS의 총 발병 건수는 약 220만 건이었으며, 그중 이 질환의 발병 건수가 가장 많았던 나라는 미국이었습니다.
  • ACS는 관상동맥의 갑작스러운 폐색으로 인해 발생하며, 불안정 협심증, 비-ST 상승형 심근경색(NSTEMI) 및 ST 상승형 심근경색(STEMI)을 포함합니다. 불안정 협심증은 심전도나 혈액 검사에서 심근 손상 소견이 나타나지 않는 흉통을 보이며, NSTEMI는 ST 상승을 동반하지 않는 심장 바이오마커의 상승을 보이며, STEMI는 바이오마커의 상승과 심전도상 ST 상승을 모두 동반합니다.
  • 2차 조사 결과에 따르면, 불안정 협심증은 급성 관상동맥 증후군(ACS) 전체 사례의 약 10-30%를 차지하는 것으로 나타났습니다.
  • 급성 관상동맥 증후군(ACS)의 발병률은 남성이 더 높지만, 특정 위험 요인은 여성의 경우 ACS와의 연관성이 더 강한 경향을 보입니다. 이러한 성별 차이는 나이가 들면서 줄어들지만, 여성의 경우 여전히 비교적 높은 위험이 남아 있으며, 그 차이가 지속되는 경우가 많습니다. 고령화가 진행되고 생활습관과 관련된 위험 요인이 증가함에 따라, 여성의 급성 관상동맥 증후군(ACS) 발병률은 남성의 수준에 근접할 것으로 예상됩니다.
  • 현재의 치료제 시장은 항혈소판제, 항응고제, 혈관확장제, β-차단제, 지질강하제, 안지오텐신 전환 효소 억제제(ACE), 안지오텐신 II 수용체 길항제(ARB), 칼슘 채널 차단제 등의 치료제군으로 분류되어 있습니다.
  • 환자 관리의 현저한 발전과 여러 위험 요인에 대한 전체 인구의 생활 습관 변화에도 불구하고, 급성 심근경색(AMI)은 여전히 미국에서 발병률 및 사망률의 주요 원인으로 남아 있습니다.
  • 이러한 높은 유병률로 인해 급성 관상동맥 증후군(ACS)의 조기 발견과 관리가 매우 중요합니다. 연령, 성별, 인종에 따라 나타나는 비전형적인 증상은 진단을 놓치는 원인이 될 수 있으므로, 임상의의 각별한 주의가 필요합니다.
  • 제약 업계의 많은 노력은 불안정 협심증이 아닌, 급성 심근경색(AMI)이나 더 광범위한 급성 관상동맥 증후군(ACS) 범주에 중점을 두어 왔습니다. AMI로 인한 높은 발병률과 사망률로 인해, 즉각적인 개입, 장기적인 심혈관 보호, 그리고 AMI 후 관리라는 관점에서 미충족 의료 수요를 충족시킬 수 있는 새로운 치료법에 대한 수요가 높아지고 있습니다.
  • 주요 SGLT2 억제제인 '자르디안스(JARDIANCE)' 및 ' 파르시가가/포르시가가(FARXIGA/FORXIGA)'가 심근경색 환자에서 심혈관 사망 및 심부전으로 인한 입원 감소라는 주요 복합 평가 지표 달성에 실패했다는 최근 임상시험 결과에 따라, 이 분야에서 동종 계열 약물의 사용 확대에 대해서는 의문이 제기되고 있습니다.

G7 국가들의 급성 관상동맥 증후군(ACS) 시장 규모 및 전망

  • 2025년 ACS 시장 규모 : 약 27억 달러
  • 2036년 ACS 시장 규모 전망 : 약 90억 달러
  • ACS 성장률(2026-2036년) : 연평균 성장률(CAGR) 11.5%

급성 관상동맥 증후군(ACS) 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘을 포함하여 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 ACS 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 전 세계 각 지역의 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제공합니다. 본 보고서에서는 급성 관상동맥 증후군(ACS) 분야의 주요 미충족 요구 사항에 초점을 맞추어, 경쟁 구도와 임상 상황을 분석함으로써 고부가가치의 성장 기회를 도출하고, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

급성 관상동맥 증후군(ACS) 시장을 주도하는 주요 요인

ACS 발병률의 증가

고령화 및 생활 습관과 관련된 위험 요인의 증가에 힘입어 급성 관상동맥 증후군(ACS) 환자 수가 증가하고 있는 것이 시장 성장을 뒷받침하는 주요 요인으로 작용하고 있습니다. 미국에서는 2025년에 약 130만 건의 ACS 신규 사례가 보고될 것으로 예상되며, 2036년까지 그 수가 더욱 증가할 것으로 전망됩니다.

표적형 생물학적 제제 및 JAK 억제제 분야의 기회 확대

ACS의 새로운 치료법은 염증을 표적으로 하는 접근법과 최적화된 항혈전 전략으로 전환되고 있으며, 출혈 위험을 관리하면서 치료 성과를 향상시키고 있습니다. 콜히친이나 치카그레롤과 같은 첨단 P2Y12 억제제 같은 약물은 혁신의 진전을 여실히 보여주고 있습니다. 이에 따라 제약 기업들은 ACS 관리에 있어 염증 경로, 혈소판 억제, 그리고 보다 안전한 항응고 요법에 주력할 기회가 생기고 있습니다.

급성 관상동맥 증후군(ACS)의 이해와 치료 알고리즘

급성 관상동맥 증후군(ACS)의 개요와 진단

급성 관상동맥 증후군(ACS)은 심장으로 가는 혈류가 갑자기 감소하거나 차단됨으로써 발생하는 일련의 질환군입니다. 여기에는 불안정 협심증, 비-ST 상승형 심근경색(NSTEMI), 그리고 ST 상승형 심근경색(STEMI)이 포함되며, 중증도는 다양합니다. ACS에서는 일반적으로 흉통이나 불편감이 나타나지만, 증상은 환자마다 다를 수 있습니다. 가슴 통증이나 불편감은 ACS와 같은 심장 문제를 나타내는 바로 직전의 징후입니다. ACS로 인한 흉통은 심장마비 때처럼 갑자기 나타날 수 있습니다. 또한, 통증이 예측할 수 없거나, 안정을 취해도 악화되는 경우도 있는데, 이 모든 것이 불안정 협심증의 전형적인 증상입니다. 동맥 내에 장기간에 걸쳐 콜레스테롤이 축적되어 심장으로 가는 혈류가 감소한 결과, 만성적인 흉통을 겪고 있는 사람이라도, 플라크가 쌓인 부위에 혈전이 형성되면 급성 관상동맥 증후군(ACS)이 발생할 가능성이 있습니다. ACS는 주로 관상동맥 내 플라크의 파열과 혈전 형성에 의해 유발됩니다. 위험 요인으로는 고혈압, 당뇨병, 흡연, 비만, 운동 부족 등이 있습니다. 이 질환은 고령자나 남성에게서 흔히 나타나지만, 여성의 발병률도 증가하는 추세입니다.

급성 관상동맥 증후군(ACS)의 진단

ACS 진단은 임상 평가, 심전도(ECG) 및 심장 바이오마커를 종합하여 이루어집니다. 환자의 흉통, 호흡곤란, 방사통 등의 증상에 대한 평가가 이루어집니다. ST 부문의 상승이나 하강 등의 변화를 확인하기 위해 즉시 심전도 검사가 실시됩니다. 심근 손상을 확인하기 위해 심장 바이오마커, 특히 트로포닌을 측정합니다. 진단을 확정하기 위해서는 지속적인 검사가 필요한 경우가 많습니다. 심장 기능을 평가하고 폐색 부위를 파악하기 위해 심장초음파 검사나 관상동맥 조영술 등의 추가 검사가 시행되기도 합니다. 조기 및 정확한 진단은 적시 치료를 이끌어내고 예후를 개선하는 데 매우 중요합니다.

급성 관상동맥 증후군(ACS)의 치료

ACS 치료는 혈류 회복, 증상 완화 및 합병증 예방에 중점을 둡니다. 초기 치료에는 항혈소판제, 항응고제, 질산염, 베타 차단제, 스타틴 등이 포함됩니다. 특히 중증 환자의 경우, 재관류 요법이 매우 중요하며, 폐색된 동맥을 재개통시키기 위해 경피적 관상동맥 중재술(PCI)이나 혈전용해 요법이 시행되는 경우가 있습니다. 필요에 따라 산소 투여나 진통 처치도 이루어집니다. 장기적인 관리에는 재발 위험을 줄이고 생존율을 높이는 것을 목적으로 하는 생활 습관 개선, 심장 재활, 그리고 지속적인 약물 요법이 포함됩니다.

급성 관상동맥 증후군(ACS)의 역학

급성 관상동맥 증후군(ACS)의 역학적 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 2025년 주요 7개국에서 ACS 신규 발병자 총수는 약 220만 명이었습니다.
  • 2025년, 급성 심근경색(AMI)은 ACS 사례 중 더 높은 비율을 차지하고 있으며, 미국에서는 불안정 협심증에 비해 약 83만 5,000건으로, 더 심각한 임상 양상으로 진행되고 있음을 보여주고 있습니다.
  • AMI 사례의 약 4분의 3은 NSTEMI(약 75%)이며, STEMI는 약 4분의 1을 차지하고 있어 NSTEMI 사례가 명백히 우세함이 밝혀졌습니다.
  • ACS 사례는 주로 남성(약 75%)에서 나타나며, 여성은 더 적은 비율을 차지하고 있어 남성에게 편중되어 있는 것으로 나타났습니다.

급성 관상동맥 증후군(ACS) 시장의 전망

ACS 치료는 신속한 진단과 개입을 통해 증상 완화, 혈전 형성 방지, 심근 관류 회복, 심근경색 범위 억제 및 합병증 예방에 중점을 둔 응급 의료입니다. 치료에는 일반적으로 혈관 재건술(PCI, CABG 또는 섬유소 용해 요법)과 약물 요법을 병행합니다. 주요 약물군에는 항혈소판제, 항응고제, 베타 차단제, 질산염계 약물, 스타틴, ACE 억제제/ARB, 칼슘 채널 차단제가 포함되며, 이들이 복합적으로 작용하여 사망률, 재발성 허혈성 사건 및 심장에 가해지는 부하를 감소시킵니다. TIMI 점수나 GRACE 점수 등의 위험도 분류 도구는 항혈전 요법이나 고용량 스타틴을 포함한 치료 시작의 지침이 됩니다. 또한, 심부전이나 고혈압을 동반한 심근경색(MI) 후 환자에게는 에프레레논(INSPRA) 등의 약물이 보조적으로 사용됩니다. 특히, 사노피와 브리스톨-마이어스 스퀴브가 개발한 프라빅스는 2017년 미국 식품의약국(FDA)으로부터 ST 상승형 심근경색(STEMI) 환자의 사망률 및 심혈관 사건 재발을 감소시키는 적응증 확대 승인을 받아, 급성 관상동맥 증후군(ACS) 관리에서 그 핵심적인 역할이 한층 더 강화되었습니다.

새로운 관점에서 볼 때, ACS 관리는 기존의 항혈전제를 넘어, 표적을 좁힌 예방 전략으로 전환되고 있습니다. 치카그레롤이나 프라빅스와 같은 표준 치료제가 여전히 중심적인 위치를 차지하고 있지만, LODOCO와 같은 새로운 접근 방식은 잔존 심혈관 위험 감소에 있어 염증 조절의 역할을 부각시키고 있습니다. 맞춤형 치료와 새로운 신호 전달 경로(예 : 제11인자나 혈소판 신호 전달)에 대한 관심이 높아짐에 따라, 더 안전하고 효과적인 급성 관상동맥 증후군(ACS) 치료의 기회가 생겨나고 있습니다.

전반적으로, 동종 최초의 치료법 등장, 진단 기법의 발전, 그리고 질환에 대한 인식 제고에 힘입어 2022년부터 2036년까지 주요 7개국 규모의 ACS 시장은 꾸준한 성장을 이룰 것으로 예상되며, 이는 이미 출시된 제품과 개발 중인 파이프라인 모두에 큰 상업적 영향을 미칠 것으로 전망됩니다.

  • 추산에 따르면, ACS 시장에서 가장 큰 비중을 차지하는 곳은 미국이며, 2025년에는 약 22억 달러에 달할 것으로 전망됩니다.
  • ACS 시장은 치료의 초점이 기존의 광범위한 항혈전 요법에서 보다 표적화된 기전 주도형 치료법으로 전환됨에 따라 진화하고 있으며, LODOCO와 같은 약물은 유효성과 안전성의 균형 개선 및 잔존 위험 감소를 배경으로, 치카그레롤 등 최적화된 P2Y12 억제제와 함께 염증 조절의 역할이 확대되고 있음을 여실히 보여주고 있습니다.
  • 지역별 시장 동향을 살펴보면, 매출액 기준으로는 미국이 1위를 차지하고 있는 반면, 유럽과 일본은 심혈관질환 부담의 증가, 진단율 향상, 그리고 급성 관상동맥 증후군(ACS) 관리에 있어 새로운 보조 요법 및 맞춤형 치료 전략의 단계적 도입에 힘입어 꾸준한 성장세를 보이고 있습니다.
  • 2025년에는 미국 내 급성 관상동맥 증후군(ACS) 치료제 전체 중에서 항혈소판제가 가장 높은 매출을 올릴 것으로 추정됩니다.
  • PCSK9 억제제 : 에볼로쿠맙과 알릴로쿠맙은 PCSK9를 억제하는 단일클론 항체로, LDL-C 수치를 대폭 낮추어 급성 관상동맥 증후군(ACS) 후 심혈관 사건 재발 위험을 감소시킵니다. 이러한 약물은, 특히 스타틴 요법만으로는 충분히 조절할 수 없는 고위험 환자군에서, 2차 예방에 있어 표적형 지질 저하 생물학적 제제의 역할을 입증하고 있습니다.
  • 표적형 저분자 약물(항염증제) : LODOCO(콜히친)은 인플라마좀의 활성과 사이토카인 신호 전달을 조절하여 잔존하는 염증 위험 및 주요 심혈관 사건의 재발을 줄여주는 새로운 경구용 항염증제입니다. 이는 ACS에서 염증을 표적으로 하는 치료법의 중요성이 커지고 있음을 여실히 보여주고 있습니다.
  • 선진적인 항혈소판 요법 : 치카그레롤 및 플라그렐은 기존 약물에 비해 더 신속하고 일관된 혈소판 억제 작용을 나타내는 강력한 P2Y12 억제제로, 급성 관상동맥 증후군(ACS)에서 이중 항혈소판 요법(DAPT)의 핵심 역할을 강화하며 임상적 예후 개선에 기여하고 있습니다.

자주 묻는 질문

  • 급성 관상동맥 증후군(ACS)의 발병률은 어떻게 되나요?
  • 급성 관상동맥 증후군(ACS) 시장 규모는 어떻게 예측되나요?
  • 급성 관상동맥 증후군(ACS)의 주요 치료제는 무엇인가요?
  • 급성 관상동맥 증후군(ACS)의 성별 차이는 어떻게 나타나나요?
  • 급성 관상동맥 증후군(ACS)의 진단 방법은 무엇인가요?
  • 급성 관상동맥 증후군(ACS) 치료의 주요 목표는 무엇인가요?
  • 급성 관상동맥 증후군(ACS)에서의 새로운 치료법은 어떤 방향으로 발전하고 있나요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 급성 관상동맥 증후군 : 시장 개요

제5장 급성 관상동맥 증후군(ACS) 역학 및 시장 예측 조사 방법

제6장 주요 사건

제7장 급성 관상동맥 증후군(ACS) 배경과 개요

제8장 치료와 관리

제9장 주요 7개국의 급성 관상동맥 증후군(ACS) 역학 및 환자 인구

제10장 환자 경과

제11장 시판 치료제

제12장 새로운 치료법

제13장 급성 관상동맥 증후군(ACS) : 주요 7개국 분석

제14장 급성 관상동맥 증후군(ACS)의 미충족 수요

제15장 급성 관상동맥 증후군(ACS) SWOT 분석

제16장 급성 관상동맥 증후군(ACS)에 관한 KOL의 견해

제17장 시장 진입 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight 소개

KSM 26.07.20

Acute Coronary Syndrome (ACS) Insights and Trends

  • Acute Coronary Syndrome (ACS) comprises acute myocardial infarction and Unstable Angina together. The total incidence cases of ACS in the 7MM were ~2.2 million in 2025, of which the highest incidence cases of this disease were in the United States.
  • ACS arise from a sudden blockage in a coronary artery and include Unstable Angina, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), and ST-Segment Elevation Myocardial Infarction (STEMI). Unstable Angina presents with chest pain without ECG or blood test evidence of heart damage, NSTEMI shows elevated cardiac biomarkers without ST-segment elevation, while STEMI involves both biomarker elevation and ST-segment elevation on ECG.
  • Secondary findings suggest that unstable angina accounts for roughly 10-30% of overall ACS cases.
  • The incidence of ACS is higher in men, but certain risk factors have a stronger association with ACS in women. Although these sex-specific differences lessen with age, women often retain a relatively higher risk where differences persist. With aging populations and rising lifestyle-related risk factors, ACS incidence in women is expected to approach that of men.
  • The current treatment market has been segmented into the following therapeutic classes, include Antiplatelet agents, Anticoagulants, Vasodilators, Beta Blockers, Lipid-lowering drugs, Angiotensin-converting Enzyme Inhibitors (ACE), Angiotensin-II receptor Blockers (ARBs), and Calcium channel blockers.
  • Despite significant advances in patient management and population-wide lifestyle changes in several predisposing factors, AMI continues to be a major cause of morbidity and mortality in the US.
  • Due to its high prevalence, early detection and management of ACS are critical. Atypical presentations, influenced by age, sex, and ethnicity, can lead to missed diagnoses, requiring greater clinical awareness.
  • Most pharmaceutical efforts have been centered on AMI or the broader ACS category rather than unstable angina. The higher mortality and morbidity associated with AMI create a stronger demand for novel therapies that can address unmet needs in terms of immediate intervention, long-term cardiovascular protection, and post-AMI care.
  • 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.

Acute Coronary Syndrome (ACS) Market Size and Forecast in the 7MM

  • 2025 ACS Market Size: ~USD 2,700 million
  • 2036 Projected ACS Market Size: ~USD 9,000 million
  • ACS Growth Rate (2026-2036): 11.5% CAGR

DelveInsight's 'Acute Coronary Syndrome (ACS) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the ACS, historical and forecasted epidemiology, as well as the ACS market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Acute Coronary Syndrome (ACS) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates ACS patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in Acute Coronary Syndrome (ACS) and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Acute Coronary Syndrome (ACS) Market

Rising ACS incidence

The increasing incidence of ACS, driven by aging populations and rising lifestyle-related risk factors, is a key factor supporting market growth. In the US, there were ~1.3 million incident cases of ACS in 2025, which are expected to increase further by 2036.

Rising Opportunities in Targeted Biologics and JAK Inhibitors

Emerging therapies in ACS are shifting toward inflammation targeting and optimized antithrombotic strategies, offering improved outcomes with controlled bleeding risk. Agents like Colchicine and advanced P2Y12 inhibitors such as Ticagrelor highlight growing innovation. This creates opportunities for drug developers to focus on inflammatory pathways, platelet inhibition, and safer anticoagulation approaches in ACS management.

Emerging ACS Competitive Landscape

Some of the ACS drugs in clinical trials include Selatogrel, FDY-5301, Ziltivekimab, and others.

Acute Coronary Syndrome (ACS) Understanding and Treatment Algorithm

Acute Coronary Syndrome (ACS) Overview and Diagnosis

Acute Coronary Syndrome (ACS) is a group of conditions caused by a sudden reduction or blockage of blood flow to the heart. It includes unstable angina, NSTEMI, and STEMI, representing varying degrees of severity. ACS commonly presents with chest pain or discomfort, though symptoms can differ across patients. Chest pain or discomfort is the immediate signal for heart problems like ACS. Chest pain caused by ACS can come on suddenly, as is the case with a heart attack. Other times, the pain can be unpredictable or get worse even with rest-both hallmark symptoms of unstable angina. People who experience chronic chest pain resulting from decreased blood flow to the heart due to years of cholesterol buildup in their arteries can develop ACS if a blood clot forms on top of the plaque buildup. It is primarily triggered by plaque rupture and clot formation in the coronary arteries. 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.

Acute Coronary Syndrome (ACS) Diagnosis

Diagnosis of ACS is based on a combination of clinical evaluation, electrocardiogram (ECG), and cardiac biomarkers. Patients are assessed for symptoms such as chest pain, shortness of breath, and radiating discomfort. ECG is performed immediately to identify changes such as ST-segment elevation or depression. Cardiac biomarkers, particularly troponins, are measured to detect heart muscle damage. Serial testing is 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. Early and accurate diagnosis is critical to guide timely treatment and improve outcomes.

Acute Coronary Syndrome (ACS) Treatment

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. Oxygen and pain relief may also be provided as needed. Long-term management includes lifestyle modification, cardiac rehabilitation, and continued pharmacotherapy to reduce the risk of recurrence and improve survival.

Acute Coronary Syndrome (ACS) Unmet Needs

The section "unmet needs of Acute Coronary Syndrome (ACS)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Delayed or missed diagnosis, especially in atypical presentations

2. Need for better risk stratification and personalized treatment

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

4. High risk of recurrence despite existing therapies

5. Limited awareness and delays in accessing timely care

6. Suboptimal long-term treatment adherence, and others.....

Comprehensive unmet needs insights in Acute Coronary Syndrome (ACS) and their strategic implications are provided in the full report.

Acute Coronary Syndrome (ACS) Epidemiology

Key Findings from Acute Coronary Syndrome (ACS) Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the total incident cases of ACS in the 7MM were approximately 2.2 million in 2025.
  • In 2025, Acute Myocardial Infarction (AMI) accounted for a higher proportion of ACS cases; ~835,000 in the United States compared to Unstable Angina, indicating a shift toward more severe clinical presentations.
  • 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, indicating male predominance.

Acute Coronary Syndrome (ACS) Drug Chapters & Competitive Analysis

The ACS drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the ACS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the ACS therapeutics market.

Approved Therapies for Acute Coronary Syndrome (ACS)

Colchicine (LODOCO): AGEPHA Pharma

Colchicine has emerged as a key therapy in cardiovascular inflammation, transitioning from its traditional use in gout to reducing recurrent pericarditis and major adverse cardiovascular events (MACE). Its action involves inhibition of B-tubulin polymerization, thereby suppressing neutrophil activation and inflammasome signaling, leading to reduced inflammation markers such as hs-CRP. In June 2023, the US Food and Drug Administration approved LODOCO as the first targeted anti-inflammatory therapy for atherosclerotic cardiovascular disease. Developed by AGEPHA Pharma, it demonstrated a ~31% reduction in cardiovascular events versus placebo and became available for prescription in the second half of 2023.

Acute Coronary Syndrome (ACS) Pipeline Analysis

Selatogrel (ACT-246475): Idorsia Pharmaceuticals and Viatris

Selatogrel is a potent, fast-acting, reversible, and highly selective P2Y12 inhibitor being developed for the treatment of AMI in patients with a history of AMI. It is intended to be self-administered subcutaneously via a drug delivery system (autoinjector). This novel, self-administered emergency agent has the potential to protect the heart muscle in the very early phase of an AMI, in the crucial time between symptom onset and first medical attention to treat the ongoing AMI, and prevent early death.

Acute Coronary Syndrome (ACS) Key Players, Market Leaders, and Emerging Companies

  • AGEPHA Pharma
  • Amgen
  • Regeneron
  • Sanofi
  • Idorsia Pharmaceuticals
  • Viatris
  • Faraday Pharmaceuticals
  • Novo Nordisk, and others

Acute Coronary Syndrome (ACS) Drug Updates

  • As per Idorsia Pharmaceuticals' Annual Report 2025, late-stage programs for selatogrel continue to progress toward important readouts starting from the end of 2026.
  • As per Novo Nordisk's Annual Report 2025, the data readouts are expected between 2026 and 2027 across three clinical settings. Ziltivekimab could offer people with diabetes crucial protection against cardiovascular complications.
  • In April 2025, AGEPHA Pharma highlighted the clinical data that provides new information about how low-dose colchicine, 0.5 mg, reduces the risk of major adverse cardiovascular events (MACE) and supports its use in the treatment of cardiovascular disease.

Drug Class Insights

Acute Coronary Syndrome (ACS) 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, which together reduce mortality, recurrent ischemic events, and cardiac workload. Risk stratification tools such as TIMI and GRACE scores guide treatment initiation, including antithrombotic therapy and high-intensity statins. In addition, agents like Eplerenone (INSPRA) are used adjunctively in post-MI patients with heart failure or hypertension. Notably, Plavix, developed by Sanofi and Bristol Myers Squibb, received expanded approval from the US Food and Drug Administration in 2017 for reducing mortality and recurrent cardiovascular events in STEMI patients, reinforcing its central role in ACS management.

From an emerging perspective, ACS management is shifting toward targeted and preventive strategies beyond traditional antithrombotics. While standard agents like Ticagrelor and Plavix remain central, newer approaches such as LODOCO highlight the role of inflammation control in reducing residual cardiovascular risk. Increasing emphasis on personalized therapy and novel pathways (e.g., factor XI and platelet signaling) is creating opportunities for safer and more effective ACS treatment.

Overall, 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, with strong commercial implications for both marketed products and emerging pipelines.

  • According to the estimates, the largest market size of ACS was captured by the United States, i.e., ~USD 2,200 million in 2025.
  • 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, driven by improved efficacy-safety balance and residual risk reduction.
  • Regional market dynamics show the US leading 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 and personalized treatment strategies in ACS management.
  • In 2025, among all the therapies for ACS, the highest revenue is estimated to be generated by Antiplatelet Agents in the United States.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Acute Coronary Syndrome (ACS) (2022-2036 Forecast)

The ACS market is primarily driven by antithrombotic agents, lipid-lowering therapies, and emerging anti-inflammatory approaches, each targeting key pathways such as platelet activation, thrombin generation, lipid metabolism, and vascular inflammation underlying atherosclerotic events.

  • PCSK9 inhibitors: Evolocumab and Alirocumab are monoclonal antibodies that inhibit PCSK9, significantly lowering LDL-C levels and reducing the risk of recurrent cardiovascular events post-ACS. These agents validate the role of targeted lipid-lowering biologics in secondary prevention, particularly in high-risk patients inadequately controlled on statins.
  • Targeted small molecules (anti-inflammatory): LODOCO (colchicine) represents a novel oral anti-inflammatory approach that modulates inflammasome activity and cytokine signaling, reducing residual inflammatory risk and recurrent major adverse cardiovascular events, highlighting the growing importance of inflammation-targeted therapies in ACS.
  • Advanced antiplatelet therapies: Ticagrelor and Prasugrel are potent P2Y12 inhibitors that provide faster, more consistent platelet inhibition compared to older agents, reinforcing their role as cornerstones of dual antiplatelet therapy (DAPT) in ACS with improved clinical outcomes.

Acute Coronary Syndrome (ACS) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the ACS market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in ACS is expected to vary across anti-inflammatory agents, novel antiplatelet agents, metabolic therapies, and emerging regenerative approaches. Recently approved or emerging therapies such as LODOCO (colchicine) are expected to demonstrate moderate uptake, driven by their novel inflammation-targeting mechanism and proven reduction in cardiovascular events, while fast-acting agents like Selatogrel and Zalunfiban are anticipated to show rapid uptake, supported by their potential for early intervention and improved acute management outcomes.

In comparison, combination and regenerative approaches such as Dutogliptin + Filgrastim are expected to exhibit moderate but gradual uptake as clinical evidence evolves, while novel candidates like FDY-5301 may experience faster adoption, contingent on favorable efficacy and safety outcomes. Overall, adoption trends are likely to be driven by the need to address residual cardiovascular risk, improve early intervention, and complement existing standard-of-care therapies in ACS.

Acute Coronary Syndrome (ACS) Therapies Price Scenario & Trends

Pricing and analogue assessment of ACS therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of Acute Coronary Syndrome (ACS) Approved Drugs

Agepha Pharma announced FDA approval of LODOCO (colchicine) as an 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. LODOCO 0.5mg tablet cost per day is USD 495. This results in an annual cost of USD 5,940.

Further details are provided in the final report....

Industry Experts and Physician Views for Acute Coronary Syndrome (ACS)

To keep up with ACS market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the ACS emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in ACS, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University School of Medicine in Atlanta, the Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging ACS therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in ACS.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Acute Coronary Syndrome (ACS), 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.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising 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, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of ACS, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the ACS market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM ACS market.

Report Insights

  • Acute Coronary Syndrome (ACS) Patient Population Forecast
  • Acute Coronary Syndrome (ACS) Therapeutics Market Size
  • Acute Coronary Syndrome (ACS) Pipeline Analysis
  • Acute Coronary Syndrome (ACS) Market Size and Trends
  • Acute Coronary Syndrome (ACS) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • Acute Coronary Syndrome (ACS) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Acute Coronary Syndrome (ACS) Treatment Addressable Market (TAM)
  • Acute Coronary Syndrome (ACS) Competitive Landscape
  • Acute Coronary Syndrome (ACS) Major Companies Insights
  • Acute Coronary Syndrome (ACS) Price Trends and Analogue Assessment
  • Acute Coronary Syndrome (ACS) Therapies Drug Adoption/Uptake
  • Acute Coronary Syndrome (ACS) Therapies Peak Patient Share analysis

Report Assessment

  • Acute Coronary Syndrome (ACS) Current Treatment Practices
  • Acute Coronary Syndrome (ACS) Unmet Needs
  • Acute Coronary Syndrome (ACS) Clinical Development Analysis
  • Acute Coronary Syndrome (ACS) Emerging Drugs Product Profiles
  • Acute Coronary Syndrome (ACS) Market Attractiveness
  • Acute Coronary Syndrome (ACS) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Acute Coronary Syndrome (ACS) market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Acute Coronary Syndrome (ACS)?
  • What are the disease risks, burdens, and unmet needs of Acute Coronary Syndrome (ACS)? What will be the growth opportunities across the 7MM concerning the patient population with Acute Coronary Syndrome (ACS)?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Acute Coronary Syndrome (ACS)? What are the current guidelines for treating Acute Coronary Syndrome (ACS) in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Acute Coronary Syndrome (ACS) market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarizes and simplifies complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Acute Coronary Syndrome Market Overview at a Glance

  • 4.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 4.2. Market Share (%) Distribution of ACS by Therapies in the 7MM, in 2025
  • 4.3. Market Share (%) Distribution of ACS by Therapies in the 7MM, in 2036

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

6. Key Events

  • 6.1. Upcoming Key Catalysts
  • 6.2. Key Transactions And Collaborations
  • 6.3. News Flow
  • 6.4. Key Conference Highlights

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

  • 7.1. Introduction
  • 7.2. Sign and Symptoms
  • 7.3. Risk Factors
  • 7.4. Pathogenesis
  • 7.5. Classification of ACS
  • 7.6. Biomarkers
  • 7.7. Diagnosis
    • 7.7.1. Differential Diagnosis

8. Treatment and Management

  • 8.1. Treatment and Management Guidelines
    • 8.1.1. AHA/ACC/HFSA Guidelines for the Management of Heart Failure: Executive Summary
    • 8.1.2. NICE Guidelines for Acute Coronary Syndromes
    • 8.1.3. ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting With ST-Segment Elevation
    • 8.1.4. ESC Guidelines for the Management of Acute Coronary Syndromes (ACS)
    • 8.1.5. ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction
    • 8.1.6. Guideline Adherence and Long-term Clinical Outcomes in Patients with AMI in Japan

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

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Incident Cases of ACS in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Incident Cases of ACS in the United States
    • 9.4.2. Type-specific Incident Cases of ACS in the United States
    • 9.4.3. Type-specific Incident Cases of AMI in the United States
    • 9.4.4. Gender-specific Incident Cases of ACS in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Incident Cases of ACS in EU4 and the UK
    • 9.5.2. Type-specific Incident Cases of ACS in EU4 and the UK
    • 9.5.3. Type-specific Incident Cases of AMI in EU4 and the UK
    • 9.5.4. Gender-specific Incident Cases of ACS in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Incident Cases of ACS in Japan
    • 9.6.2. Type-specific Incident Cases of ACS in Japan
    • 9.6.3. Type-specific Incident Cases of AMI in Japan
    • 9.6.4. Gender-specific Incident Cases of ACS in Japan

10. Patient Journey

  • 10.1. Patient Descriptions

11. Marketed Therapies

  • 11.1. Marketed Competitive Landscape of Acute Coronary Syndrome (ACS)
  • 11.2. Colchicine (LODOCO): AGEPHA Pharma
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
    • 11.2.6. Clinical Trial Information
    • 11.2.7. Analyst's View
  • 11.3. Evolocumab (REPATHA): Amgen
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
    • 11.3.6. Clinical Trial Information
    • 11.3.7. Analyst's View
  • 11.4. Alirocumab (PRALUENT): Regeneron and Sanofi
    • 11.4.1. Drug Description
    • 11.4.2. Regulatory Milestones
    • 11.4.3. Other Developmental Activities
    • 11.4.4. Summary of Pivotal Trials
    • 11.4.5. Clinical Development
    • 11.4.6. Clinical Trial Information
    • 11.4.7. Analyst's View

12. Emerging Therapies

  • 12.1. Emerging Competitive Landscape of Acute Coronary Syndrome (ACS)
  • 12.2. Selatogrel (ACT-246475): Idorsia Pharmaceuticals and Viatris
    • 12.2.1. Product Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
    • 12.2.4. Safety and Efficacy
    • 12.2.5. Analyst's View
  • 12.3. Dutogliptin: Recardio
    • 12.3.1. Product Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
    • 12.3.4. Safety and Efficacy
    • 12.3.5. Analyst's View
  • 12.4. Ziltivekimab: Novo Nordisk
    • 12.4.1. Product Description
    • 12.4.2. Other Developmental Activities
    • 12.4.3. Clinical Development
    • 12.4.4. Safety and efficacy
    • 12.4.5. Analyst's View
  • 12.5. FDY-5301: Faraday Pharmaceuticals
    • 12.5.1. Product Description
    • 12.5.2. Other Developmental Activity
    • 12.5.3. Clinical Development
    • 12.5.4. Safety and Efficacy
    • 12.5.5. Analyst's View

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

  • 13.1. Key Findings
  • 13.2. Market Outlook of Acute Coronary Syndrome (ACS)
  • 13.3. Conjoint Analysis of Acute Coronary Syndrome (ACS)
  • 13.4. Key Market Forecast Assumptions of Acute Coronary Syndrome (ACS)
    • 13.4.1. Cost Assumptions
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of ACS in the 7MM
  • 13.6. The United States Market Size
    • 13.6.1. Total Market Size of ACS in the United States
    • 13.6.2. Market Size of ACS by Therapies in the United States
  • 13.7. EU4 and the UK Market Size
    • 13.7.1. Total Market Size of ACS in EU4 and the UK
    • 13.7.2. Market Size of ACS by Therapies in EU4 and the UK
  • 13.8. Japan Market Size
    • 13.8.1. Total Market Size of ACS in Japan
    • 13.8.2. Market Size of ACS by Therapies in Japan

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

  • 17.1. United States
    • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
    • 17.3.1. MHLW
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of ACS Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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