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시장보고서
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구조적 심장질환 치료 기기 : 시장 인사이트, 경쟁 구도 및 시장 예측(2034년)Structural Heart Devices - Market Insights, Competitive Landscape, and Market Forecast - 2034 |
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DelveInsight
개요:
- 구조적 심장 질환 치료 기기 시장은 2025년에 129억 4,000만 달러로 추산되며, 2034년까지 306억 2,000만 달러에 달할 것으로 예측됩니다. 이러한 성장의 배경에는 전 세계적으로 증가하는 판막 질환 및 구조적 심장 질환의 부담, 경카테터 수복·치환 기술의 급속한 보급, 그리고 최소 침습 심장 중재술 의료 인프라의 지속적인 확충이 있습니다.
- 전 세계 구조적 심장 질환용 기기 시장은 2026년부터 2034년까지의 예측 기간 동안 연평균 성장률(CAGR) 10.08%로 성장할 전망입니다.
- 제품 유형별로는 2025년에 교체용 기기 부문이 63%의 점유율을 차지하며 구조적 심장 질환용 기기 시장을 주도했습니다.
- 용도별로는 2025년에 심방중격결손증 부문이 29%의 점유율을 차지하며 구조적 심장 질환 치료 기기 시장을 주도했습니다.
- 최종 사용자별로는 2025년에 병원 부문이 45%의 점유율을 차지하며 구조적 심장 질환 치료 기기 시장을 주도했습니다.
- 북미는 2025년에 50%의 점유율로 전 세계 구조적 심장 질환 치료 기기 시장의 매출을 주도하며, 전 세계적으로 가장 높은 지역별 시장 점유율을 차지했습니다.
구조적 심장 질환 치료 기기는 심장 판막, 심실, 심벽 및 관련 혈관을 포함한 심장의 구조적 이상을 진단, 복구 또는 대체하기 위해 설계된 특수 의료 기술입니다. 구조적 심장 질환에는 심방중격결손증, 심실중격결손증, 난원공개존증 등의 선천성 이상과 대동맥판막협착증 및 승모판 역류증 등의 후천성 판막 질환이 모두 포함되므로, 치료에는 폐쇄기, 판막륜 성형 기기, 판막 성형 장치 등의 카테터를 이용한 수복 장치에 더해, 기계판막이나 생체판막을 포함한 외과적 및 경카테터 치환 장치가 점점 더 많이 활용되고 있습니다. 이러한 기술은 개흉 수술을 대체하는 저침습적 대안을 제공하여 수술로 인한 부담을 줄이고 입원 기간을 단축할 뿐만 아니라, 기존 수술로는 적응증이 되기 어려운 고령자나 고위험군 환자의 치료 접근성을 확대되고 있습니다. 본 시장은 제품 유형별로 오클루더, 고리상 연골 성형 기기, 판막 성형 기기 등을 포함한 수복 기기와, 기계판막 및 생체판막을 포함한 치환 기기로 분류됩니다. 또한, 적응증별로는 심방중격결손증, 대동맥판막협착증, 개존성 난원공, 심실중격결손증, 승모판 역류증 등으로 분류되며, 최종 사용자별로는 병원, 외래수술센터(ASC) 등으로 분류됩니다. 심혈관 질환 및 판막 질환의 유병률 증가, 경카테터 플랫폼의 지속적인 기술 발전, 그리고 전 세계적으로 저침습 심장 중재술로의 전환 가속화에 힘입어, 구조적 심장 질환용 기기는 현대 중재적 심장학의 초석이 되고 있습니다.
구조적 심장 질환용 기기 시장의 주요 시장 성장 촉진요인
- 대동맥판막 협착증, 승모판 역류, 선천성 심장 질환을 포함한 심혈관 질환 및 판막 질환의 전 세계 유병률 증가로 인해, 구조적 심장 중재술의 대상이 되는 환자층이 확대되고 있습니다.
- 대동맥판막 협착증은 전 세계적으로 가장 흔한 판막 질환으로 부상하고 있으며, 약 900만 명이 이 질환을 앓고 있는 반면, 승모판 역류증은 전 세계적으로 약 2,400만 명이 앓고 있어 지속적인 장기 수요를 뒷받침하고 있습니다.
- 차세대 경카테터 심장 판막, 최소 침습적 승모판 및 삼첨판 수복 시스템, 개선된 판막륜 성형술 플랫폼 등 지속적인 기술 발전으로 인해 적응증이 되는 환자의 해부학적 조건 범위가 넓어지고, 치료 성과도 향상되고 있습니다.
- 카테터를 이용한 시술은 개흉 수술에 비해 외과적 침습이 적고, 입원 기간이 짧으며, 회복도 빠르다는 장점이 있어, 저침습 심장 치료에 대한 수요 증가가 그 보급을 가속화하고 있습니다.
- 에드워즈 생명과학(Edwards Lifesciences)가 2025년 4월 ‘SAPIEN M3’ 경카테터 승모판막 치환 시스템에 대한 CE 마크를 획득하고, 애보트(Abbott)가 ‘TriClip’에 대한 지속적인 임상 증거를 축적하는 등, 규제 당국의 승인 및 적응증 확대로 인해 치료 대상이 되는 환자층이 확대되고 있습니다.
- 보스턴 사이언티픽(Boston Scientific)의 베일리스 메디컬(Baylis Medical) 인수나 아티비온(Artivion)의 2026년 엔도스팬(Endospan) 인수 등, 막대한 설비 투자와 활발한 M&A 활동을 통해 구조적 심장 질환 치료 기기 제품 포트폴리오와 제조 능력이 확대되고 있습니다.
- 전 세계 인구의 고령화와 고혈압, 비만, 당뇨병 유병률의 상승으로 인해 퇴행성 판막 질환의 발생률이 증가하고 있으며, 2034년까지 구조적 심장 질환 치료 기기 수요가 장기적으로 유지될 전망입니다.
구조적 심장 질환 치료 기기 시장 성장에 기여하는 요인
시장 성장 촉진요인
심혈관 질환 및 판막 질환 유병률 상승
구조적 심장 질환 치료 기기 시장의 가장 강력한 촉진요인은 판막 질환 및 구조적 심장 질환의 전 세계적 부담 증가입니다. 대동맥판막 협착증은 전 세계적으로 가장 흔한 판막 질환으로, 약 900만 명이 앓고 있는 것으로 추정됩니다. 한편, 승모판 역류증은 전 세계적으로 약 2,400만 명에게 영향을 미치고 있으며, 대동맥판 역류증은 이완기 고혈압과 함께 지속적으로 증가하고 있습니다. 심방중격결손증, 심실중격결손증, 난원공 개존증 등의 선천성 심장병은 여전히 전 세계에서 가장 흔히 진단되는 선천성 기형 중 하나이며, 미국에서는 전체 출생의 약 1%, 즉 연간 약 4만 명의 신생아가 선천성 심장병을 앓고 있으며, 그중 약 4명 중 1명의 영아가 즉각적인 치료가 필요합니다. 미국에서만 매년 500만 명 이상이 심장판막증으로 진단받고 있으며, 이와 관련된 사망자 수는 2만 5,000명을 초과합니다. 이러한 질환은 치료를 받지 않으면 심부전, 부정맥 또는 폐고혈압으로 진행되는 경우가 많기 때문에 수복 및 치환용 의료기기를 필요로 하는 대규모의 지속적인 환자층을 형성하며, 2034년까지 시장 성장 기반이 되고 있습니다.
경카테터 플랫폼의 기술적 진보
기기 설계와 중재술 기술 분야의 지속적인 혁신은 구조적 심장 질환 치료의 적용 범위와 안전성을 확대하는 데 있어 매우 중요한 역할을 해왔습니다. 차세대 경카테터 심장 판막, 저침습성 승모판 및 삼첨판 수복 시스템, 좌심방귀개 폐쇄 장치는 내구성, 정밀도 및 환자 예후 개선을 목표로 개발이 진행되고 있습니다. 실시간 영상 진단, 3D 심초음파 검사, AI를 활용한 시술 안내 분야의 상호 보완적인 발전으로 인해 정밀도와 의료진의 확신이 더욱 높아지고 있습니다. 최신 TAVR 시스템은 이첨판을 포함한 더 광범위한 환자의 해부학적 구조에 대응할 수 있도록 설계된 반면, Xeltis사가 개발을 진행 중인 수복형 및 생체 흡수성 폴리머 판막 플랫폼은 시간이 지남에 따라 생체 조직으로 변화하는 것을 목표로 하고 있습니다. 이러한 진보로 인해 치료의 적용 범위가 확대되고, 시장 성장이 촉진되고 있습니다.
시장 제약 요인
강력한 성장세를 보이고 있음에도 불구하고, 구조적 심장 질환용 기기 시장은 중대한 제약에 직면해 있습니다. 빈번한 제품 결함 및 리콜은 의료진의 신뢰를 훼손하고 치료의 보급을 저해하며, 제조업체에게 재정적·평판상의 문제를 야기하고 있습니다. 기기의 오작동이나 내구성 문제로 인해 제품 회수가 필요한 경우가 많으며, 이로 인해 시술이 지연되고 환자 안전에 대한 우려가 커지고 있습니다. 광범위한 임상시험, 장기간의 평가 기간, 엄격한 안전성 평가 등 제품 승인과 관련된 까다로운 규제 요건은 혁신을 지연시키고, 신규 시장 진출기업에게는 큰 진입 장벽이 되고 있습니다. 경카테터 플랫폼의 개발 및 제조에는 막대한 자본이 필요할 뿐만 아니라, 전용 하이브리드 수술실, 카테터 검사실, 고도로 훈련된 중재적 심장 전문의가 필요하기 때문에 신흥국이나 의료 자원이 부족한 의료 시스템에서의 도입이 제한되고 있습니다. 지역별 보험 급여 제도의 차이에 더해, 수입 의료기기 및 부품에 대한 관세로 인한 물류 및 비용 측면의 압박이 겹치면서, 질환 유병률 상승, 기술 혁신, 최소 침습 치료의 보급과 같은 근본적인 성장 요인이 여전히 견조하게 유지되고 있음에도 불구하고, 단기적인 성장은 더욱 억제되고 있습니다.
자주 묻는 질문
목차
제1장 구조적 심질환 치료용 의료기기 시장 : 서론
제2장 구조적 심질환 치료용 의료기기 시장 : 주요 요약
제3장 구조적 심질환 치료용 의료기기 시장 : 주요 요인 분석
제4장 AI, 지정학, 무역 및 경제 동향
제5장 규제 분석
제6장 Porter의 Five Forces 분석
제7장 구조적 심질환 치료용 의료기기 시장 : 평가
제8장 구조적 심질환 치료용 의료기기 시장 : 경쟁 구도
제9장 구조적 심질환 치료용 의료기기 시장 : 스타트업의 자금조달 및 투자 동향
제10장 구조적 심질환 치료용 의료기기 시장 : 기업 개요 및 제품 개요
제11장 KOL(Key Opinion Leader)의 견해
제12장 프로젝트 접근
제13장 DelveInsight에 대해
제14장 면책사항 및 문의
LSH 26.08.12Structural Heart Devices Market Summary
Overview:
- The Structural Heart Devices market is estimated at USD 12.94 billion in 2025 and is projected to reach USD 30.62 billion by 2034. Growth is anchored in the rising global burden of valvular and structural heart disease, rapid adoption of transcatheter repair and replacement technologies, and continued expansion of minimally invasive interventional cardiology infrastructure.
- The global Structural Heart Devices market is growing at a CAGR of 10.08% during the forecast period from 2026 to 2034.
- By product type, the replacement device segment dominated the Structural Heart Devices market with a 63% share in 2025.
- By application, the atrial septal defect segment dominated the Structural Heart Devices market with a 29% share in 2025.
- By end-user, the hospital segment dominated the Structural Heart Devices market with a 45% share in 2025.
- North America dominated the global Structural Heart Devices market revenue with a 50% share in 2025, representing the highest regional market share globally.
A structural heart device is a specialized medical technology designed to diagnose, repair, or replace abnormalities in the heart's structure, including its valves, chambers, walls, and associated vessels. Because structural heart disease encompasses both congenital defects, such as atrial septal defect, ventricular septal defect, and patent foramen ovale, and acquired valvular disorders, such as aortic valve stenosis and mitral regurgitation, treatment increasingly relies on catheter-based repair devices, including occluders, annuloplasty devices, and valvuloplasty devices, alongside surgical and transcatheter replacement devices, including mechanical and tissue heart valves. These technologies offer minimally invasive alternatives to open-heart surgery, reducing surgical trauma, shortening hospital stays, and expanding treatment access to elderly and high-risk patients who are often poor candidates for conventional surgery. The market is organized by product type across repair devices, including occluders, annuloplasty devices, valvuloplasty devices, and others, and replacement devices, including mechanical heart valves and tissue heart valves; by application across atrial septal defect, aortic valve stenosis, patent foramen ovale, ventricular septal defects, mitral regurgitation, and others; and by end-user across hospitals, ambulatory surgical centers, and others. Driven by the rising prevalence of cardiovascular and valvular disorders, continuous technological advancement in transcatheter platforms, and the accelerating global shift toward minimally invasive cardiac interventions, structural heart devices have become a cornerstone of modern interventional cardiology.
Structural Heart Devices Market Key Growth Drivers
- The rising global prevalence of cardiovascular and valvular disorders, including aortic stenosis, mitral regurgitation, and congenital heart defects, is expanding the patient pool eligible for structural heart interventions.
- Aortic valve stenosis has emerged as the most common valvular pathology worldwide, affecting an estimated 9 million people, while mitral regurgitation affects nearly 24 million people globally, sustaining durable long-term demand.
- Continuous technological advancement, including next-generation transcatheter heart valves, minimally invasive mitral and tricuspid repair systems, and improved annuloplasty platforms, is broadening eligible patient anatomies and improving procedural outcomes.
- Growing demand for minimally invasive cardiac interventions is accelerating adoption, as catheter-based procedures offer reduced surgical trauma, shorter hospital stays, and faster recovery relative to open-heart surgery.
- Regulatory approvals and label expansions, including Edwards Lifesciences' April 2025 CE Mark for the SAPIEN M3 transcatheter mitral valve replacement system and Abbott's continued TriClip clinical evidence generation, are widening the treatable patient population.
- Heavy capital investment and active M&A activity, including Boston Scientific's acquisition of Baylis Medical and Artivion's 2026 acquisition of Endospan, are expanding structural heart device portfolios and manufacturing capacity.
- An aging global population and rising rates of hypertension, obesity, and diabetes are increasing the incidence of degenerative valvular disease, sustaining long-term structural heart device demand through 2034.
Key Companies in Structural Heart Devices Market
The competitive landscape is led by the following active device manufacturers:
- Medtronic
- Boston Scientific Corporation
- Braile Biomedica
- JOTEC GmbH
- Edwards Life Sciences Corporation
- Valcare Medical
- W. L. Gore & Associates, Inc.
- Abbott Laboratories
- Cardiovascular Systems, Inc.
- XELTIS BV
Factors Contributing to the Growth of the Structural Heart Devices Market
Market Drivers
Rising Prevalence of Cardiovascular and Valvular Disorders
The most powerful driver of the Structural Heart Devices market is the rising global burden of valvular and structural heart disease. Aortic valve stenosis has become the most common valvular pathology worldwide, affecting an estimated 9 million people, while mitral regurgitation affects nearly 24 million people globally, and aortic regurgitation continues to rise alongside diastolic hypertension. Congenital heart defects, including atrial septal defect, ventricular septal defect, and patent foramen ovale, remain among the most common birth anomalies diagnosed worldwide, with congenital heart defects affecting nearly 1% of all births in the United States, or roughly 40,000 babies each year, and about one in four of these infants requiring immediate intervention. In the United States alone, more than 5 million people are diagnosed with heart valve disease annually, with over 25,000 associated deaths. Because these conditions frequently progress to heart failure, arrhythmias, or pulmonary hypertension if untreated, they create a large and durable population requiring repair or replacement devices, anchoring market growth through 2034.
Technological Advancements in Transcatheter Platforms
Continuous innovation in device design and interventional technique has been pivotal in expanding the scope and safety of structural heart procedures. Next-generation transcatheter heart valves, minimally invasive mitral and tricuspid repair systems, and left atrial appendage closure devices are being engineered for improved durability, precision, and patient outcomes. Complementary advances in real-time imaging, 3D echocardiography, and AI-enabled procedural guidance have further enhanced accuracy and physician confidence. Newer TAVR systems are now designed to treat a wider range of patient anatomies, including bicuspid valves, while restorative and bioresorbable polymer valve platforms, such as those in development by Xeltis, aim to evolve into living tissue over time. These advancements are broadening treatment applicability and reinforcing market growth.
Market Restraints
Despite strong momentum, the Structural Heart Devices market faces material constraints. Frequent product failures and recalls undermine physician confidence, disrupt treatment adoption, and create financial and reputational challenges for manufacturers, with device malfunctions or durability issues often necessitating product withdrawals that delay procedures and raise patient-safety concerns. Stringent regulatory requirements for product approval, including extensive clinical trials, long evaluation timelines, and rigorous safety assessments, slow innovation and create significant barriers to entry for new players. The high capital intensity of developing and manufacturing transcatheter platforms, combined with the need for specialized hybrid operating rooms, catheterization labs, and highly trained interventional cardiologists, constrains adoption in emerging economies and lower-resourced healthcare systems. Reimbursement variability across geographies, alongside the logistical and cost pressures introduced by tariffs on imported medical devices and components, further tempers near-term growth, even as the underlying drivers of rising disease prevalence, technological innovation, and minimally invasive adoption remain firmly intact.
Structural Heart Devices Market Segment Analysis
The Structural Heart Devices by Market by Product Type (Repair Device [Occluders, Annuloplasty Devices, Valvuloplasty Devices, and Others] and Replacement Device [Mechanical Heart Valves and Tissue Heart Valves]), Application (Atrial Septal Defect, Aortic Valve Stenosis, Patent Foramen Ovale, Ventricular Septal Defects, Mitral Regurgitation, and Others), End-User (Hospital, Ambulatory Surgical Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of World).
By Product Type
Dominant Subsegment: Replacement Device.
Dominant: Replacement Device ~ 63%
The replacement device segment accounted for approximately 63% of the Structural Heart Devices market in 2025. Replacement devices, spanning surgical and transcatheter mechanical and tissue heart valves, lead the market because transcatheter aortic valve replacement has become standard care across high-risk, intermediate-risk, and increasingly low-risk patients with severe aortic valve stenosis. Tissue heart valves dominate replacement volumes given their favorable hemodynamic profile and lower long-term anticoagulation burden relative to mechanical valves, while mechanical heart valves, championed by durable platforms such as On-X, remain the standard for younger patients requiring extended device longevity. The breadth of approved transcatheter valve platforms from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific, combined with continuous innovation extending TAVR to bicuspid and lower-risk anatomies, sustains great and dependable demand for replacement devices. While repair devices, particularly annuloplasty systems, are the fastest-growing product category, propelled by the expansion of transcatheter mitral and tricuspid repair, the sheer procedural volume and clinical maturity of valve replacement secure the segment's leadership across the forecast period.
By Application
Dominant: Atrial Septal Defect ~ 29%
The atrial septal defect segment accounted for approximately 29% of the Structural Heart Devices market in 2025. Atrial septal defect repair leads the application segment because ASDs are among the most common congenital heart defects diagnosed worldwide, and left untreated, they can progress to pulmonary hypertension, arrhythmias, and heart failure, creating consistent, recurring treatment demand. The rapid adoption of minimally invasive occluder devices has transformed ASD management, allowing physicians to close defects through catheter-based intervention rather than open-heart surgery, reducing procedural risk and recovery time while improving long-term outcomes. Ongoing innovation in occluder design, improved intraprocedural imaging, and expanding awareness and early detection are further driving adoption. While aortic valve stenosis represents the largest single valvular disease burden globally, with an estimated 9 million people affected, and mitral regurgitation is the fastest-growing application on the back of expanding transcatheter repair adoption, the high incidence and established treatment pathway for atrial septal defect secure its leadership across the forecast period.
Structural Heart Devices Market Region Analysis
Dominant Region: North America
North America accounted for approximately 50% of the global Structural Heart Devices market revenue in 2025, representing the highest regional market share globally. The region's dominance reflects a mature interventional cardiology ecosystem, a strong clinical-research base, and a favorable regulatory environment supported by frequent FDA product approvals and new device launches from leading manufacturers. Congenital heart defects affect nearly 1% of all births in the United States, impacting approximately 40,000 babies each year, while more than 5 million Americans are diagnosed with heart valve disease annually, with over 25,000 associated deaths, underscoring persistent clinical need. North America hosts the largest concentration of hybrid operating rooms, catheterization labs, and skilled structural heart programs, and sponsors benefit from proximity to leading manufacturers, including Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Strong reimbursement frameworks, regulatory clarity, and continued capacity investment anchor the region's continued leadership across the forecast period.
Fastest Growing Region: Asia-Pacific
Asia-Pacific is the fastest-growing region in the Structural Heart Devices market. The region's elevated CAGR is driven by rising cardiovascular and valvular disease prevalence, rapid expansion of interventional cardiology infrastructure, and growing healthcare investment across China, Japan, India, South Korea, and Australia. A growing elderly population, combined with lifestyle-related risk factors such as diabetes, hypertension, and obesity, is significantly increasing the incidence of structural heart conditions. Leading manufacturers are expanding their regional presence, partnering with local distributors, and pursuing regulatory approvals to accelerate market entry, while regional players such as Microport, Meril Life Sciences, and Venus Medtech scale local manufacturing capacity. The combination of high disease burden, infrastructure build-out, and improving physician training positions Asia-Pacific as the principal source of incremental growth over the forecast period.
Regional Commentary
North America
North America accounted for approximately 50% of the global Structural Heart Devices market revenue in 2025. The United States dominates on the strength of its interventional cardiology infrastructure, clinical-research base, FDA regulatory clarity, and the concentrated presence of leading device manufacturers, while continued investment in hybrid operating rooms and catheterization capacity reinforces its leadership.
Europe
Europe is a large and advanced regional market, supported by established CE Mark regulatory pathways, strong government-backed reimbursement in Germany, France, and the United Kingdom, and a leading role in clinical research and trial activity for next-generation mitral and tricuspid repair systems. Capacity investments by JOTEC GmbH, Braile Biomedica's European distribution partners, and continued transcatheter innovation reinforce the region's role in both diagnostic and therapeutic structural heart programs.
Asia-Pacific
Asia-Pacific is the fastest-growing region, propelled by rising cardiovascular and valvular disease incidence, rapid infrastructure build-out, and growing healthcare investment across China, Japan, India, South Korea, and Australia. Expanding TAVR and septal defect closure adoption, combined with growing local manufacturing capacity from regional players, is accelerating regional structural heart device growth.
Rest of World
The Rest of World region, spanning Latin America, the Middle East, and Africa, is an emerging growth frontier. Expanding cardiac care infrastructure, rising demand for minimally invasive valve therapy, and efforts to align regulatory frameworks with global standards are gradually broadening access, while international partnerships support the build-out of regional interventional cardiology capacity.
Structural Heart Devices Market Competitive Landscape
The Structural Heart Devices market is classified as Moderately Consolidated. A group of global leaders with broad product portfolios and deep clinical evidence, including Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific, anchors the top tier through robust transcatheter valve, repair, and occluder platforms, while specialized and fast-scaling providers such as Valcare Medical, XELTIS BV, JOTEC GmbH, Braile Biomedica, W. L. Gore & Associates, and Cardiovascular Systems compete through focused technologies, niche clinical indications, and regional manufacturing strength, increasing competition across the fastest-growing repair segments.
The competitive landscape can be evaluated across the following dimensions:
- Market concentration: Moderately consolidated, with a handful of global leaders dominating through robust product portfolios and a fast-growing field of specialized transcatheter repair providers.
- Leading players: Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific anchor the top tier through broad transcatheter valve and repair portfolios and continuous clinical evidence generation.
- Geographic reach: Leaders operate global, multi-country manufacturing and distribution networks essential for supplying hospitals and cardiac centers worldwide.
- Service portfolio strength: Top players offer end-to-end repair and replacement portfolios spanning occluders, annuloplasty and valvuloplasty devices, and mechanical and tissue heart valves.
- Clinical evidence: Ownership of long-term clinical trial data, including Abbott's TRILUMINATE Pivotal trial and Edwards Lifesciences' pivotal mitral and tricuspid programs, is a decisive competitive advantage.
- Strategic partnerships: Collaborations with hospital networks, research institutions, and investigator sites, such as Valcare Medical's work with Banner - University Medical Center, extend clinical reach.
- M&A activity: Active consolidation, including Boston Scientific's acquisition of Baylis Medical and Artivion's 2026 acquisition of Endospan, is expanding structural heart portfolios.
- Manufacturing capabilities: Advanced polymer, nitinol, and pericardial tissue engineering, alongside precision transcatheter delivery systems, are key competitive moats.
- Innovation focus: Transcatheter mitral and tricuspid repair and replacement, next-generation annuloplasty devices, restorative and bioresorbable valve platforms, and AI-enabled procedural guidance.
Structural Heart Devices Market Recent Developmental Activities
In May 2026, Artivion, Inc., the parent company of JOTEC GmbH, completed its acquisition of Endospan Ltd. for an upfront net purchase price of USD 135 million, adding the NEXUS Aortic Arch System to its structural and aortic repair portfolio.
In February 2026, Valcare Medical, Inc., announced the successful first U.S. transseptal implantation of its AMEND Transcatheter Mitral Valve Repair Annuloplasty System as part of its ongoing Early Feasibility Study.
Structural Heart Devices Market Segmentation
Structural Heart Devices Market by Product Type
- Repair Device
- Occluders
- Annuloplasty Devices
- Valvuloplasty Devices
- Others
- Replacement Device
- Mechanical Heart Valves
- Tissue Heart Valves
Structural Heart Devices Market by Application
- Atrial Septal Defect
- Aortic Valve Stenosis
- Patent Foramen Ovale
- Ventricular Septal Defects
- Mitral Regurgitation
- Others
Structural Heart Devices Market by End-User
- Hospital
- Ambulatory Surgical Centers
- Others
Structural Heart Devices Market by Geography
- North America Structural Heart Devices Market
- United States Structural Heart Devices Market Size in USD million (2023-2034)
- Canada Structural Heart Devices Market Size in USD million (2023-2034)
- Mexico Structural Heart Devices Market Size in USD million (2023-2034)
- Europe Structural Heart Devices Market
- Germany Structural Heart Devices Market Size in USD million (2023-2034)
- United Kingdom Structural Heart Devices Market Size in USD million (2023-2034)
- France Structural Heart Devices Market Size in USD million (2023-2034)
- Italy Structural Heart Devices Market Size in USD million (2023-2034)
- Spain Structural Heart Devices Market Size in USD million (2023-2034)
- Rest of Europe Structural Heart Devices Market Size in USD million (2023-2034)
- Asia-Pacific Structural Heart Devices Market
- China Structural Heart Devices Market Size in USD million (2023-2034)
- Japan Structural Heart Devices Market Size in USD million (2023-2034)
- India Structural Heart Devices Market Size in USD million (2023-2034)
- Australia Structural Heart Devices Market Size in USD million (2023-2034)
- South Korea Structural Heart Devices Market Size in USD million (2023-2034)
- Rest of Asia-Pacific Structural Heart Devices Market Size in USD million (2023-2034)
- Rest of the World (RoW) Structural Heart Devices Market
- Middle East Structural Heart Devices Market Size in USD million (2023-2034)
- Africa Structural Heart Devices Market Size in USD million (2023-2034)
- South America Structural Heart Devices Market Size in USD million (2023-2034)
Key Takeaways from the Structural Heart Devices Market Report Study
- Market size analysis for the current structural heart devices market size (2025), and market forecast for 9 years (2026 to 2034).
- Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures that happened over the last 3 years.
- Key companies dominating the global structural heart devices market.
- Various opportunities available for competitors in the structural heart devices market space.
- What are the top-performing segments in 2025? How will these segments perform in 2034?
- Which are the top-performing regions and countries in the current structural heart devices market scenario?
- Which are the regions and countries where companies should concentrate their opportunities for structural heart devices market growth in the future?
Target audience who can benefit from this structural heart devices market report study
- Structural heart devices product providers
- Research organizations and consulting companies
- Structural heart devices-related organizations, associations, forums, and other alliances.
- Government and corporate offices
- Start-up companies, venture capitalists, and private equity firms
- Distributors and traders dealing in structural heart devices
- Various end-users who want to know more about the structural heart devices market and the latest technological developments in the structural heart devices market.
Frequently Asked Questions:
Q1. What is the growth rate of the structural heart devices market?
The structural heart devices market is projected to expand at a CAGR of 10.08% during the forecast period from 2026-2034.
Q2. What is the market size of the structural heart devices market?
The structural heart devices market is estimated at USD 12.94 billion in 2025 and is projected to reach USD 30.62 billion by 2034.
Q3. Which region dominates the structural heart devices market?
North America dominated the Structural Heart Devices market with a 50% share of global revenue in 2025, supported by a mature interventional cardiology ecosystem, a strong clinical-research base, favorable reimbursement, and the concentrated presence of leading device manufacturers. Asia-Pacific is the fastest-growing region over the forecast period.
Q4. What are the key drivers of the structural heart devices market?
The principal drivers are the rising global prevalence of cardiovascular and valvular disorders, including aortic valve stenosis affecting an estimated 9 million people and mitral regurgitation affecting nearly 24 million people worldwide; continuous technological advancement in transcatheter repair and replacement platforms; growing demand for minimally invasive cardiac interventions; and accelerating regulatory approvals and label expansions.
Q5. Who are the major players in the structural heart devices market?
The major players include Medtronic, Boston Scientific Corporation, Braile Biomedica, JOTEC GmbH, Edwards Life Sciences Corporation, Valcare Medical, W. L. Gore & Associates, Inc., Abbott Laboratories, Cardiovascular Systems, Inc., and XELTIS BV, among other active providers profiled in the Competitive Landscape section. Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific lead through broad transcatheter portfolios and deep clinical evidence.
Table of Contents
1. Structural Heart Devices Market Report Introduction
- 1.1 Scope of the Study
- 1.2 Market Segmentation
- 1.3 Market Assumptions
2. Structural Heart Devices Market Executive Summary
- 2.1 Market at a Glance
3. Structural Heart Devices Market Key Factors Analysis
- 3.1 Structural Heart Devices Market Drivers
- 3.1.1 Rising Prevalence of Cardiovascular and Valvular Disorders
- 3.1.2 Technological Advancements in Transcatheter Platforms
- 3.1.3 Growing Demand for Minimally Invasive Cardiac Interventions
- 3.1.4 Regulatory Approvals and Expanding Clinical Indications
- 3.2 Structural Heart Devices Market Restraints and Challenges
- 3.2.1 Frequent Product Failures and Recalls
- 3.2.2 Stringent Regulatory Requirements for Product Approval
- 3.2.3 High Capital Intensity and Reimbursement Variability
- 3.3 Structural Heart Devices Market Opportunities
- 3.3.1 Transcatheter Mitral and Tricuspid Repair Expansion
- 3.3.2 Emerging-Market Infrastructure and Access Expansion
4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments
5. Regulatory Analysis
- 5.1 United States
- 5.2 Europe
- 5.3 Japan
- 5.4 China
6. Structural Heart Devices Market Porter's Five Forces Analysis
- 6.1 Bargaining Power of Suppliers
- 6.2 Bargaining Power of Buyers
- 6.3 Threat of New Entrants
- 6.4 Threat of Substitutes
- 6.5 Competitive Rivalry
7. Structural Heart Devices Market Assessment
- 7.1 By Product Type
- 7.1.1 Repair Device
- 7.1.1.1 Occluders
- 7.1.1.2 Annuloplasty Devices
- 7.1.1.3 Valvuloplasty Devices
- 7.1.1.4 Others
- 7.1.2 Replacement Device
- 7.1.2.1 Mechanical Heart Valves
- 7.1.2.2 Tissue Heart Valves
- 7.1.1 Repair Device
- 7.2 By Application
- 7.2.1 Atrial Septal Defect
- 7.2.2 Aortic Valve Stenosis
- 7.2.3 Patent Foramen Ovale
- 7.2.4 Ventricular Septal Defects
- 7.2.5 Mitral Regurgitation
- 7.2.6 Others
- 7.3 By End-User
- 7.3.1 Hospitals & Clinics
- 7.3.2 Ambulatory Surgical Centers
- 7.3.3 Others
- 7.4 By Geography
- 7.4.1 North America
- 7.4.1.1 United States Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.1.2 Canada Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.1.3 Mexico Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2 Europe
- 7.4.2.1 Germany Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2.2 United Kingdom Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2.3 France Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2.4 Italy Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2.5 Spain Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.2.6 Rest of Europe Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3 Asia-Pacific
- 7.4.3.1 China Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3.2 Japan Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3.3 India Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3.4 Australia Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3.5 South Korea Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.3.6 Rest of Asia-Pacific Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.4 Rest of World
- 7.4.4.1 Middle East Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.4.2 Africa Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.4.3 South America Structural Heart Devices Market Size in USD million (2023-2034)
- 7.4.1 North America
8. Structural Heart Devices Market Competitive Landscape
- 8.1 Market Concentration and Structure
- 8.2 Competitive Positioning and Market Share Analysis (Premium Offering)
9. Structural Heart Devices Market Startup Funding and Investment Trends
10. Structural Heart Devices Market Company and Product Profiles
- 10.1 Medtronic
- 10.1.1 Company Overview
- 10.1.2 Company Snapshot
- 10.1.3 Financial Overview
- 10.1.4 Service Portfolio
- 10.1.5 Strategic Initiatives / Entropy
- 10.2 Boston Scientific Corporation
- 10.2.1 Company Overview
- 10.2.2 Company Snapshot
- 10.2.3 Financial Overview
- 10.2.4 Product Portfolio
- 10.2.5 Strategic Initiatives / Entropy
- 10.3 Braile Biomedica
- 10.3.1 Company Overview
- 10.3.2 Company Snapshot
- 10.3.3 Financial Overview
- 10.3.4 Product Portfolio
- 10.3.5 Strategic Initiatives / Entropy
- 10.4 JOTEC GmbH
- 10.4.1 Company Overview
- 10.4.2 Company Snapshot
- 10.4.3 Financial Overview
- 10.4.4 Product Portfolio
- 10.4.5 Strategic Initiatives / Entropy
- 10.5 Edwards Life Sciences Corporation
- 10.5.1 Company Overview
- 10.5.2 Company Snapshot
- 10.5.3 Financial Overview
- 10.5.4 Product Portfolio
- 10.5.5 Strategic Initiatives / Entropy
- 10.6 Valcare Medical
- 10.6.1 Company Overview
- 10.6.2 Company Snapshot
- 10.6.3 Financial Overview
- 10.6.4 Product Portfolio
- 10.6.5 Strategic Initiatives / Entropy
- 10.7 W. L. Gore & Associates, Inc.
- 10.7.1 Company Overview
- 10.7.2 Company Snapshot
- 10.7.3 Financial Overview
- 10.7.4 Product Portfolio
- 10.7.5 Strategic Initiatives / Entropy
- 10.8 Abbott Laboratories
- 10.8.1 Company Overview
- 10.8.2 Company Snapshot
- 10.8.3 Financial Overview
- 10.8.4 Product Portfolio
- 10.8.5 Strategic Initiatives / Entropy
- 10.9 Cardiovascular Systems, Inc.
- 10.9.1 Company Overview
- 10.9.2 Company Snapshot
- 10.9.3 Financial Overview
- 10.9.4 Product Portfolio
- 10.9.5 Strategic Initiatives / Entropy
- 10.10 XELTIS BV
- 10.10.1 Company Overview
- 10.10.2 Company Snapshot
- 10.10.3 Financial Overview
- 10.10.4 Product Portfolio
- 10.10.5 Strategic Initiatives / Entropy
