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시장보고서
상품코드
2024668
심혈관 디바이스 시장 보고서 : 디바이스 유형별, 용도별, 최종사용자별, 지역별(2026-2034년)Cardiovascular Devices Market Report by Device Type, Application (Coronary Artery Disease, Cardiac Arrhythmia, Heart Failure, and Others), End User, and Region 2026-2034 |
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세계의 심혈관 디바이스 시장 규모는 2025년에 658억 달러에 달했습니다. 향후에 대해 IMARC Group은 2034년까지 시장 규모가 1,064억 달러에 달하며, 2026-2034년에 CAGR 5.32%로 성장할 것으로 예측하고 있습니다. 중재적 심장학 시술의 도입과 더불어, 유리한 상환 정책이 결합되어 시장 성장을 촉진하고 있습니다.
최소침습 수술에 대한 수요
기존의 개흉수술에서 회복기간 단축, 수술 위험 감소, 환자 예후 개선 등을 초래하는 덜 침습적인 조사방법으로 사람들의 선호도가 변화하고 있는 것이 시장을 주도하고 있습니다. 예를 들어 2024년 4월 골웨이 대학 연구팀이 주도한 'FAST TRACK CABG' 연구는 환자의 심장 우회 수술 계획, 유도 및 수행에 대한 새로운 접근 방식을 처음으로 시험했습니다. 이번 연구를 통해 AI를 활용한 혈류 스캔 기능을 갖춘 비침습적 심장 CT가 실행 가능하고 안전하다는 것을 입증했습니다. 여기에 로봇 기술과 실시간 영상 진단 기술의 보급으로 큰 절개 없이도 판막, 스텐트, 기타 의료기기를 정확하게 배치할 수 있게 되면서 심혈관 기기 시장의 매출이 증가하고 있습니다. 예를 들어 2024년 2월 필립스는 방사선 피폭 없는 최소침습 수술을 실현하는 FORS(Fiber Optic RealShape) 기술을 탑재한 'LumiGuide'를 발표했습니다. 이와는 별도로, 최소침습수술은 특수 심혈관용 기구와 첨단 영상 진단 기술을 이용하여 작은 절개창을 통해 시행되며, 표적에 맞는 정밀한 치료를 가능하게 합니다. 일반적인 예로는 경카테터 승모판막치환술(TMVR), 경카테터 대동맥판막치환술(TAVR), 내시경하 정맥채취술 등이 있습니다. 그 결과, 이러한 기술은 전 세계에서 확산되고 있습니다. 예를 들어 2022년 12월, 세계적인 헬스케어 기업 중 하나인 Abbott는 중증 대동맥판막 협착증으로 수술 위험이 높거나 매우 높은 인도 환자들을 위한 새로운 경피적 대동맥판막 치환술(TAVI) 시스템인 Navitor의 출시를 발표했습니다. 기술의 발전과 함께 이러한 시술은 더욱 효과적이고 안전해졌으며, 그 결과 수많은 심혈관 질환의 치료에서 그 채택이 확대되고 있습니다. 예를 들어 2024년 5월 미국심장혈관조영술 및 중재시술학회(SCAI) 연례회의에서 발표된 새로운 1년 추적 데이터에 따르면 Anteris Technologies가 개발한 새로운 생체모방 경피적 대동맥판막치환술(TAVR) 시스템이 중증 대동맥판막협착증(AS) 치료에 새로운 대안을 제공할 수 있는 것으로 나타났습니다. (AS) 치료에 있으며, 심장 전문의에게 새로운 옵션을 제공할 수 있는 것으로 나타났습니다.
개량형 장치 도입
심혈관 기기는 만성 심장질환 및 뇌졸중의 치료, 진단, 관리에 있으며, 매우 중요한 역할을 하고 있습니다. 그 결과, 주요 기업은 의료진이 심혈관 질환의 심각성을 정확하게 평가하고, 환자의 심장 건강 상태를 모니터링하며, 효과적인 치료법을 개선할 수 있는 새로운 기기를 속속 출시하고 있습니다. 또한 심혈관 질환 치료를 위해 중재가 필요한 환자 수가 증가함에 따라 스마트 스텐트, 이식형 심박조율기, 제세동기 등에 대한 수요가 증가하고 있습니다. 이는 결과적으로 심혈관 기기 시장 전망에 긍정적인 영향을 미치고 있습니다. 예를 들어 2023년 12월 Terumo India는 관상동맥 질환 치료를 위한 약제용출형 스텐트 'Ultimaster Nagomi'의 출시를 발표했습니다. 이와 함께 심박조율기를 포함한 개량형 심혈관 기기 도입을 위한 연구개발(R&D) 활동에 대한 투자 확대도 중요한 성장 촉진요인으로 작용하고 있습니다. 예를 들어 2023년 5월, 심장 리듬 관리 분야의 글로벌 개발 기업 중 하나인 MicroPort는 자사의 광범위한 이식형 심박조율기 'Alizea'와 'Celea'에 대해 FDA의 승인을 획득했습니다. 또한 이들 제품에는 MicroPort가 개발한 알고리즘인 'AutoMRI 모드'가 탑재되어 있으며, MRI 검사를 받는 환자의 안전성을 높였습니다. 마찬가지로 2023년 7월, Abbott는 무연 공간 제조업체 시스템 'Aveir DR'의 FDA 승인을 발표했습니다. 또한 머신러닝과 AI는 방대한 양의 심혈관 데이터를 분석하여 치료 계획의 개인화, 환자 예후 예측, 진단 정확도 향상 등에 활용되고 있습니다. 예를 들어 2024년 1월 미국 메이요 클리닉의 심장 전문의 중 한 명인 데미라데 아데딘세워 박사가 주도한 연구에 따르면 AI가 탑재된 디지털 청진기가 임신 중 여성의 심근을 약화시키는 생명을 위협할 수 있는 질환인 주산기 심근병증의 진단 정확도를 향상시킬 수 있다고 제안했습니다. 제안되었습니다.
전략적 제휴
주요 기업, 의료기기 제조업체, 연구기관 및 의료기관은 정밀 영상 진단 툴을 포함한 순환기 의료기기를 도입하기 위해 제휴 및 인수합병(M&A) 활동을 하고 있습니다. 이는 심혈관계 의료기기 시장의 최근 기회 중 하나입니다. 예를 들어 2023년 9월 주요 심장 데이터 관리 플랫폼 중 하나인 페이스메이트(PaceMate)는 MedAxiom과의 제휴를 통해 단일 클라우드 네이티브 환경에서 심장 데이터 및 전자건강기록(EHR) 데이터에 대한 워크플로우 솔루션을 구축할 것이라고 발표했습니다. 구축한다고 밝혔습니다. 이에 따라 2023년 10월 GE헬스케어는 보스턴 사이언티픽(Boston Scientific)과 손잡고 첨단 심장 영상 진단 시스템 개발에 착수했습니다. 또한 이러한 제휴는 파트너의 현지 전문 지식과 유통망을 활용하여 기업이 복잡한 규제 상황을 극복하고 국제 시장에 접근하는 데 도움이 될 수 있습니다. 예를 들어 2023년 6월 필립스는 바이오트로닉(Biotronik)과 제휴하여 필립스 심포니 스위트(Philips SymphonySuite) 고객이 사용할 수 있는 심혈관 장치 라인업을 확장했습니다. 또한 2023년 5월 PaceMate는 FDA 승인을 받은 개인용 심전도 기술 및 원격 환자 관리 솔루션의 글로벌 리더인 AliveCor와 파트너십을 맺고 이식형 심장 장치 분야로 사업을 확장했습니다.
The global cardiovascular devices market size reached USD 65.8 Billion in 2025. Looking forward, IMARC Group expects the market to reach USD 106.4 Billion by 2034, exhibiting a growth rate (CAGR) of 5.32% during 2026-2034. The introduction of interventional cardiology procedures, coupled with favorable reimbursement policies, are stimulating the market growth.
Demand for Minimally Invasive Procedures
The shifting preferences of individuals from traditional open-heart surgeries toward less invasive methodologies that minimize recovery times, reduce surgical risks, improve patient outcomes, etc., are stimulating the market. For example, in April 2024, the FAST TRACK CABG study, overseen by a team of researchers at the University of Galway, tested a new approach to the planning, guidance, and conducting of heart bypass surgery on patients for the first time. It demonstrated that non-invasive cardiac CT with AI-powered blood flow scanning is feasible and safe. Besides this, the widespread adoption of robotics and real-time imaging techniques facilitates the accurate placement of valves, stents, and other devices without the need for large incisions, which is also elevating the cardiovascular devices market revenue. For instance, in February 2024, Philips introduced LumiGuide, which is powered by Fiber Optic RealShape (FORS) technology, for radiation-free, minimally invasive surgeries. Apart from this, minimally invasive procedures are performed via small incisions using specialized cardiovascular instruments and advanced imaging techniques, which allow for targeted and precise treatments. Some of the common examples include transcatheter mitral valve repair (TMVR), transcatheter aortic valve replacement (TAVR), endoscopic vein harvesting, etc. Consequently, they are gaining traction across the globe. For example, in December 2022, Abbott, one of the leading global healthcare companies, announced the launch of its novel transcatheter aortic valve implantation (TAVI) system, Navitor, for individuals in India with severe aortic stenosis who are at high or extreme surgical risk. As technology advances, these procedures are becoming more effective and safer, thereby leading to their increasing adoption in treating numerous cardiovascular conditions. For instance, in May 2024, according to new one-year data presented at the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI), a new biomimetic transcatheter aortic valve replacement (TAVR) system developed by Anteris Technologies can offer cardiologists with a new way to treat severe aortic stenosis (AS).
Introduction of Enhanced Variants
Cardiovascular devices play a crucial role in the treatment, diagnosis, and management of chronic heart conditions and stroke. Consequently, key players are launching novel devices that enable healthcare professionals to accurately assess the severity of cardiovascular diseases, monitor the heart health of patients, improve effective therapies, etc. Moreover, the increasing number of patients requiring intervention to address their cardiovascular conditions is escalating the popularity of smart stents, implantable pacemakers, defibrillators, etc. This, in turn, is positively influencing the cardiovascular devices market outlook. For example, in December 2023, Terumo India announced the launch of Ultimaster Nagomi, a drug-eluting stent intended for use in the treatment of coronary artery disease. Besides this, the growing investments in R&D activities to introduce improved cardiovascular devices, including pacemakers, are acting as significant growth-inducing factors. For instance, in May 2023, MicroPort, one of the global developers in the field of cardiac rhythm management, received FDA approval for its wide range of implantable pacemakers, Alizea and Celea. Additionally, they feature AutoMRI mode, an algorithm invented by MicroPort, that increases the safety of patients who are undergoing an MRI examination. Similarly, in July 2023, Abbott announced the FDA approval of its leadless pacemaker system, Aveir DR. Furthermore, machine learning and AI are employed for analyzing vast amounts of cardiovascular data to personalize treatment plans, predict patient outcomes, improve diagnostic accuracies, etc. For example, in January 2024, research led by Dr. Demilade Adedinsewo, one of the cardiologists at the Mayo Clinic in the U.S., suggested that the AI-enabled digital stethoscope could improve the diagnosis of peripartum cardiomyopathy, a potentially life-threatening condition that weakens the heart muscle of women during pregnancy.
Strategic Partnerships
Prominent companies, medical device manufacturers, research institutions, and healthcare organizations are collaborating and entering into mergers and acquisitions activities to introduce cardiovascular devices, including precise imaging tools. This represents one of the cardiovascular devices market recent opportunities. For instance, in September 2023, PaceMate, one of the leading cardiac data management platforms, announced the partnership with MedAxiom to create workflow solutions for cardiac and EHR data in a single, cloud-native environment. In line with this, in October 2023, GE HealthCare collaborated with Boston Scientific to develop enhanced cardiac imaging systems. Additionally, these partnerships aid companies in navigating complex regulatory landscapes and gaining access to international markets by leveraging the local expertise and established distribution networks of their partners. For example, in June 2023, Philips entered into a partnership with Biotronik to expand the range of cardiovascular devices available for Philips SymphonySuite customers. Besides this, in May 2023, PaceMate collaborated with AliveCor, one of the global leaders in FDA-cleared personal electrocardiogram technology and remote patient management solutions, to encompass implantable cardiac devices.
Therapeutic and surgical devices is the most popular device type
The increasing number of surgical procedures and therapeutic interventions aimed at treating cardiovascular diseases is propelling the segment's growth. Moreover, therapeutic and surgical devices include implantable cardioverter defibrillators (ICDs), stents, pacemakers, catheters, heart valves, ventricular assist devices (VADs), etc. They aid in regulating heart rhythm, restoring blood flow, providing mechanical circulatory support, etc. Consequently, they are gaining extensive traction as less invasive alternatives to traditional open-heart surgeries, which is elevating the cardiovascular devices market demand. For example, in December 2023, Medtronic plc, one of the global leaders in healthcare technologies, announced the FDA approval of the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). In line with this, in June 2023, Magenta Medical launched a feasibility study for the world's smallest heart pump that reduces vascular access complications during heart surgery.
Coronary artery disease (CAD) dominates the cardiovascular devices market share
CAD devices used for treatment, diagnosis, and management of coronary artery disease condition are gaining traction across countries. Moreover, the widespread adoption of diagnostic devices, such as intravascular ultrasound (IVUS) devices, angiography systems, and computed tomography angiography (CTA) machines, as they help in assessing the severity of coronary artery blockages, is propelling the market. For example, in August 2022, Medtronic announced the launch of its novel drug-eluting coronary stent, the Onyx Frontier drug-eluting stent (DES), following CE Mark approval. Besides this, in January 2024, Cleerly, one of the companies working to create a new standard of care for the diagnosis of heart disease, introduced Cleerly ISCHEMIA, which recently received U.S. Food and Drug Administration (FDA) 510(k) medical device clearance. Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool specifically designed for patients undergoing coronary computed tomography angiography (CCTA).
Hospitals account for the majority of the overall market share
Hospitals are the primary end users of cardiovascular devices. They provide a wide range of cardiac services, such as treatment, diagnosis, and surgical procedures for cardiovascular diseases. Hospitals have cardiac catheterization labs and specialized cardiology departments equipped with advanced imaging systems and surgical suites, which is increasing the cardiovascular devices market's recent price. For instance, in January 2024, Sylvia Jones, the health minister of Ontario, announced the development of a new cardiac lab at St. Mary's General Hospital in Kitchener, Canada, to help cardiac patients. They require a comprehensive range of devices, such as implantable devices, diagnostic equipment, surgical instruments, monitoring systems, etc., which is driving the growth in this segmentation.
North America exhibits a clear dominance in the market
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest market for cardiovascular devices.
The increasing prevalence of cardiovascular conditions, including stroke and peripheral artery disease, is propelling the regional market. For instance, as per the report published by the Heart and Stroke Foundation of Canada in February 2022, there were 750,000 patients diagnosed with heart failure. Moreover, favorable reimbursement policies and fast regulatory approvals are acting as significant growth-inducing factors. For example, in September 2023, CorVista Health announced the FDA approval of its non-invasive medical device system that is used for detecting the presence of cardiac disease. In line with this, in January 2024, Occlutech, a Swedish medical device company focused on structural heart disease, received the U.S. FDA approval for its ASD Occluder for the treatment of atrial septal defects (ASDs). Apart from this, as per the cardiovascular devices market statistics, the introduction of wireless ECG has allowed for real-time patient monitoring and diagnosis. This, in turn, will continue to stimulate the regional market in the coming years. For example, in February 2021, VivaLNK developed a wearable ECG monitoring solution designed to wirelessly capture ECG and heart rate during a six-minute walk test (6MWT).
The key players are investing significantly in R&D to develop innovative cardiovascular devices. They focus on improving device performance, durability, and patient outcomes. R&D efforts aim to introduce advanced technologies, such as minimally invasive procedures, remote monitoring systems, and personalized medicine approaches. Additionally, cardiovascular devices market companies are continuously launching new cardiovascular devices to expand their product portfolios. These launches often involve next-generation devices with improved features and enhanced capabilities. They are prioritizing addressing unmet clinical needs, such as novel therapies for specific cardiovascular conditions or devices that offer improved precision and ease of use. Besides this, collaborations and partnerships between key players, healthcare providers, and research institutions are common in the cardiovascular devices market. These collaborations foster innovation, facilitate knowledge exchange, and leverage collective expertise and resources to develop and commercialize new technologies and solutions.
The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include: