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結構性心臟疾病器材－市場趨勢、競爭格局及至2032年預測

Structural Heart Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032
出版日期: | 出版商: DelveInsight | 英文 150 Pages | 商品交期: 2-10個工作天內

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結構性心臟疾病器材市場摘要

  • 全球結構性心臟疾病器材市場規模預計將從 2024 年的 117.5222 億美元成長到 2032 年的 252.6495 億美元，反映出強勁且持續的成長。
  • 全球結構性心臟疾病器材市場預計在 2025-2032 年預測期內將以 10.08% 的複合年成長率成長。
  • 市場成長的主要推動力是心血管疾病的增加和微創治療技術的進步。
  • 在結構性心臟疾病器材市場營運的主要企業包括：美敦力、波士頓科學公司、Braille Biomedica、JOTEC GmbH、愛德華生命科學公司、Valcare Medical、W.L. Gore & Associates, Inc.、雅培實驗室、心血管系統公司、XELTIS BV、JenaValve Technology, Inc.、Biomerics、Comtocoal、Comkk. AB、微創醫療科技股份有限公司、Meril Life Sciences Venus Medtech（杭州）有限公司等。
  • 預計北美將主導整個結構性心臟疾病器材市場。該地區市場成長的主要推動力是瓣膜性心臟疾病、先天性心臟病和其他心臟畸形等結構性心臟疾病病例數量的增加。
  • 在結構性心臟疾病器械類型區隔市場中，瓣環成形術器械類別預計將在 2025-2032 年預測期內保持強勁的複合年成長率。

結構性心臟疾病器材市場成長要素

  • 心血管疾病和瓣膜性心臟病盛行率上升推動結構性心臟疾病裝置的應用：心血管疾病，尤其是瓣膜性心臟病（如主動脈瓣狹窄、二尖瓣逆流和先天性心臟疾病）的盛行率上升，是推動結構性心臟疾病裝置應用的關鍵因素。這些疾病若不及時治療，往往會導致高發病率和高死亡率，因此迫切需要有效的治療方法。結構性心臟疾病裝置，例如經導管瓣膜置換術、瓣膜封堵器和瓣環成形系統，為患者提供了挽救生命的治療選擇，尤其適用於無法手術的患者或手術風險高的患者。例如，全球心血管危險因子（如肥胖、高血壓和糖尿病）的增加，以及人口老化，正在顯著擴大需要先進結構性心臟疾病治療的患者群體。
  • 結構性心臟疾病器械的技術進步正在推動市場成長：器械設計和介入技術的持續創新對於擴大結構性心臟疾病手術的範圍和安全性至關重要。新一代經導管心臟瓣膜、微創二尖瓣修復系統和左心耳封堵器旨在提高耐用性、精準度和患者療效。即時影像、3D心臟超音波圖和機器人輔助介入技術等配套技術的進步進一步提升了手術的精準度和醫生的信心。例如，最新的經導管主動脈瓣置換術術（TAVR）系統旨在適應更廣泛的患者解剖結構，包括二葉式主動脈瓣，使全球更多患者能夠受益於這項技術。這些進步正在拓寬治療範圍並推動市場成長。
  • 微創心臟介入治療需求的成長正在加速其普及：由於微創手術相較於傳統開胸手術具有諸多優勢，全球對微創治療方法的需求正在顯著成長。使用結構性心臟疾病裝置進行的導管介入手術可減少手術創傷、縮短住院時間、降低感染風險並加快康復速度，使其成為極具吸引力的選擇，尤其適用於老年患者和合併多種併發症的患者。越來越多的臨床證據支持這些手術的長期安全性和有效性，進一步增強了醫生和病人的信心。例如，經導管主動脈瓣置換術（TAVR）的迅速普及反映了人們對微創手術方式日益成長的偏好，目前已被視為許多高風險和中度風險患者群體的標準治療方案。這一趨勢正持續推動全球市場擴張。

本報告分析了全球結構性心臟疾病器材市場，重點介紹了關鍵趨勢、成長促進因素、課題和機會。

目錄

第1章 結構性心臟疾病器材市場報告概述

  • 調查範圍
  • 市場區隔
  • 市場假設

2. 結構性心臟疾病器材市場摘要整理

  • 市場概覽

第3章 結構性心臟疾病器材市場關鍵因素分析

  • 結構性心臟疾病器材市場促進因素
  • 結構性心臟疾病器材市場的限制因素與課題
  • 結構性心臟疾病器材市場的機遇

第4章 影響分析

  • 人工智慧驅動的創新和應用
  • 美國關稅影響分析

第5章 監理分析

  • 美國
  • 歐洲
  • 日本
  • 中國

6. 結構性心臟疾病器材市場：波特五力分析

7. 結構性心臟疾病器材市場評估

  • 依產品類型
    • 維修裝置
    • 替換裝置
  • 透過使用
    • 心房中膈缺損症
    • 主動脈瓣狹窄
    • 卵圓孔未閉合閉
    • 室間隔缺損
    • 二尖瓣逆流
    • 其他
  • 最終用戶
    • 醫院
    • 門診手術中心
  • 地區
    • 北美洲
    • 歐洲
    • 亞太地區
    • 其他地區

第8章 競爭情勢

第9章Start-Ups資金籌措與投資趨勢

10. 結構性心臟疾病器材市場公司及產品概況

  • Medtronic
  • Boston Scientific Corporation
  • Braile Biomedica
  • JOTEC GmbH
  • Edwards Life Sciences Corporation
  • Valcare Medical
  • WL Gore & Associates, Inc
  • Abbott Laboratories
  • Cardiovascular Systems, Inc.
  • XELTIS BV
  • JenaValve Technology, Inc.
  • Biomerics
  • Lepu Medical Technology（Beijing）Co., Ltd.
  • LivaNova Inc.
  • Comed BV
  • TORAY INDUSTRIES INC.
  • Occlutech International AB
  • Microport Scientific Corporation
  • Meril Life Sciences
  • Venus Medtech（Hangzhou）Inc.

第11章：KOL視角

第12章計劃方法

第13章：關於 DelveInsight

第14章 免責聲明和聯絡我們

Product Code: DIMDCL0037

Structural Heart Devices Market Summary

  • The global structural heart devices market is expected to increase from USD 11,752.22 million in 2024 to USD 25,264.95 million by 2032, reflecting strong and sustained growth.
  • The global structural heart devices market is growing at a CAGR of 10.08% during the forecast period from 2025 to 2032.
  • The market of structural heart device solutions is being primarily driven by the rising cardiovascular diseases and advancements in minimally invasive treatment technologies.
  • The leading companies operating in the structural heart devices market 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., XELTIS BV, JenaValve Technology, Inc., Biomerics, Lepu Medical Technology (Beijing) Co., Ltd., LivaNova Inc., Comed B.V., TORAY, INDUSTRIES INC., Occlutech International AB, Microport Scientific Corporation, Meril Life Sciences Venus Medtech (Hangzhou) Inc., and others.
  • North America is anticipated to dominate the overall structural heart devices market. The region's market growth is primarily driven by rising instances of structural heart conditions, including heart valve disease, congenital heart defects, and other cardiac abnormalities.
  • In the type segment of the structural heart devices, the annuloplasty devices category is expected to grow at a robust CAGR during the forecast period from 2025 to 2032.

Factors Contributing to the Growth of Structural Heart Devices

  • Rising Prevalence of Cardiovascular and Valvular Disorders Fueling Structural Heart Device Adoption: The increasing burden of cardiovascular diseases, particularly valvular disorders such as aortic stenosis, mitral regurgitation, and congenital heart defects, is a key factor driving the adoption of structural heart devices. These conditions are often associated with high morbidity and mortality if left untreated, creating an urgent demand for effective interventions. Structural heart devices such as transcatheter valves, occluders, and annuloplasty systems provide life-saving treatment options, especially for patients who are inoperable or at high surgical risk. For instance, the global rise in cardiovascular risk factors like obesity, hypertension, and diabetes, coupled with an aging population, has significantly expanded the patient pool in need of advanced structural heart interventions.
  • Technological Advancements in Structural Heart Devices Driving Market Growth: Continuous innovation in device design and interventional techniques has been pivotal in expanding the scope and safety of structural heart procedures. Next-generation transcatheter heart valves, minimally invasive mitral 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 robotic-assisted interventions have further enhanced procedural accuracy and physician confidence. For example, newer TAVR systems are now designed to treat a wider range of patient anatomies, including those with bicuspid valves, making the technology accessible to more patients worldwide. These advancements are broadening treatment applicability and reinforcing market growth.
  • Growing Demand for Minimally Invasive Cardiac Interventions Accelerating Adoption: There is a clear global shift toward minimally invasive treatment options due to their advantages over traditional open-heart surgery. Catheter-based procedures using structural heart devices offer reduced surgical trauma, shorter hospital stays, lower infection risks, and quicker recovery, making them particularly attractive for elderly patients and those with multiple comorbidities. Increasing clinical evidence supporting the long-term safety and efficacy of these procedures has further strengthened physician and patient confidence. For instance, the rapid adoption of transcatheter aortic valve replacement (TAVR) reflects the growing preference for minimally invasive alternatives, which are now considered standard care in many high-risk and intermediate-risk patient groups. This trend continues to accelerate market expansion worldwide.

Structural Heart Devices Market Report Segmentation

This Structural Heart Devices Market report offers a comprehensive overview of the global structural heart devices, highlighting key trends, growth drivers, challenges, and opportunities. It covers detailed market segmentation by Structural Heart Devices 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. The report provides valuable insights into the competitive landscape, regulatory environment, and market dynamics across major markets, including North America, Europe, and Asia-Pacific. Featuring in-depth profiles of leading industry players and recent product innovations, this report equips businesses with essential data to identify market potential, develop strategic plans, and capitalize on emerging opportunities in the rapidly growing Structural Heart Devices Market.

Structural heart devices are specialized medical technologies designed to diagnose, repair, or replace abnormalities in the heart's structure, including valves, chambers, walls, and associated vessels. These devices are primarily used to treat conditions such as valvular heart disease, septal defects, left atrial appendage closure, and other congenital or acquired structural disorders. Common examples include transcatheter heart valves, occluder devices, annuloplasty rings, and left atrial appendage closure systems. By offering minimally invasive alternatives to open-heart surgery, structural heart devices improve patient outcomes, reduce recovery times, and expand treatment options for high-risk or inoperable patients.

The growth of the global structural heart devices market is primarily driven by the rising prevalence of cardiovascular and valvular disorders, such as aortic stenosis, mitral regurgitation, and congenital defects, which are creating a substantial need for advanced treatment solutions. Alongside this, technological advancements in structural heart devices, including next-generation transcatheter valves, mitral repair systems, and left atrial appendage closure devices, are enhancing durability, precision, and procedural safety while expanding the pool of eligible patients. Furthermore, the growing demand for minimally invasive cardiac interventions is accelerating adoption, as catheter-based procedures offer reduced surgical risks, shorter hospital stays, and faster recovery compared to traditional open-heart surgeries. Collectively, these drivers are positioning structural heart devices as an essential component of modern cardiovascular care, supporting strong market growth during the forecast period from 2025 to 2032.

What are the latest Structural Heart Devices Market Dynamics and Trends?

The growing demand for structural heart devices is strongly driven by the rising incidence and prevalence of structural heart diseases, particularly heart valve disorders, congenital heart defects, and related conditions. According to DelveInsight analysis, in 2024, more than 500,001 individuals in Australia were diagnosed with heart valve disease, while an additional 250,002 cases remained undiagnosed, highlighting the scale of unmet clinical need. Similarly, in the UK, heart valve disease affected 11.29% of individuals aged 65 and older, underlining the impact of an aging population on disease burden. Globally, aortic valve stenosis has emerged as the most common valvular pathology, affecting an estimated 9 million people, with prevalence steadily rising due to increasing life expectancy and the growing incidence of atherosclerosis. In addition, aortic regurgitation, closely associated with diastolic hypertension, and mitral regurgitation, impacting nearly 24 million people worldwide, are further expanding the patient pool.

The increasing scale of these conditions is directly fueling demand for advanced treatment solutions, particularly minimally invasive options such as transcatheter heart valves, occluders, and mitral repair systems, which provide effective interventions for high-risk or elderly patients often unsuitable for open-heart surgery. As the global population continues to age and risk factors such as hypertension, obesity, and diabetes rise, the structural heart devices market is set to witness robust growth, with manufacturers innovating to meet the urgent clinical need for safe, durable, and patient-friendly therapies.

While the structural heart devices market holds strong growth potential, its expansion is restrained by frequent product failures and recalls, which undermine physician confidence, disrupt treatment adoption, and create financial and reputational challenges for manufacturers. Device malfunctions or durability issues often necessitate product withdrawals from the market, delaying procedures and raising concerns over patient safety. Adding to this challenge are stringent regulatory requirements for product approvals, as structural heart devices must undergo extensive clinical trials, long evaluation timelines, and strict safety assessments before commercialization. These complex and costly processes not only slow innovation but also create significant entry barriers for new players. Collectively, these restraints hinder the pace of market growth and limit the broader accessibility of structural heart devices despite their proven clinical importance.

Structural Heart Devices Market Segment Analysis

Structural Heart Devices 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 the World)

By Product Type: The Annuloplasty Devices Category Is Expected to Drive Market Growth

In the structural heart devices segment, annuloplasty devices are projected to register a robust CAGR of 11.13% between 2025 and 2032, reflecting strong market growth potential. This is due to the rising prevalence of mitral and tricuspid valve regurgitation, conditions that significantly impact cardiac function and quality of life if left untreated. Annuloplasty devices, which are used to reshape, reinforce, or tighten the valve annulus, play a critical role in restoring proper valve function and preventing disease progression. The increasing adoption of minimally invasive and transcatheter annuloplasty systems is further accelerating demand, as they offer safer alternatives for high-risk surgical patients, reduced recovery times, and improved long-term outcomes compared to traditional open-heart procedures.

Technological advancements have also been instrumental in boosting this segment, with companies introducing next-generation annuloplasty rings and bands that provide enhanced durability, flexible designs for better anatomical fit, and compatibility with catheter-based delivery systems. Among the various products, Carpentier-Edwards Physio and Physio II annuloplasty rings by Edwards Lifesciences dominate the market, recognized globally as the gold standard in mitral valve repair due to their proven clinical outcomes and long-term efficacy. Additionally, the emergence of transcatheter-based innovations such as Abbott's Cardioband system is expanding treatment options for patients ineligible for conventional surgery, further driving segment growth.

Collectively, the combination of a growing patient pool, increasing preference for minimally invasive solutions, and the dominance of clinically established products is positioning annuloplasty devices as one of the fastest-growing categories in the structural heart devices market.

By Application: Atrial Septal Defect Category Dominates the Market

In the application segment, atrial septal defect repair has firmly established itself as the dominant contributor to the structural heart devices market. This dominance is largely attributed to the high incidence of ASDs, which are among the most common congenital heart defects diagnosed worldwide. Left untreated, these defects can lead to serious complications such as pulmonary hypertension, arrhythmias, and heart failure, thereby creating a consistent demand for effective treatment options.

The introduction and rapid adoption of minimally invasive occluder devices have significantly transformed atrial septal defect management, allowing physicians to close defects through catheter-based interventions rather than open-heart surgery. These devices not only reduce procedural risks and recovery times but also improve long-term patient outcomes, making them the preferred choice for both patients and clinicians. In addition, ongoing technological innovations in occluder design, improved imaging support during procedures, and expanding awareness of early detection are further driving adoption.

Collectively, these factors have cemented atrial septal defect repair as the leading application within the structural heart devices market, highlighting its central role in fueling overall market growth.

By End-User: Hospitals Category Dominates the Market

The hospital segment dominates the end-user landscape of the structural heart devices market, accounting for approximately 45% of the market share in 2024. This is because hospitals remain the central hub for diagnosing, treating, and managing complex cardiovascular conditions. Structural heart procedures such as transcatheter aortic valve replacement (TAVR), mitral valve repair, annuloplasty, and septal defect closures require advanced infrastructure, specialized equipment, and highly skilled cardiologists and surgeons, resources that are most commonly concentrated in hospital settings. As the prevalence of structural heart diseases rises, hospitals are witnessing a steady influx of patients seeking both elective and emergency interventions, further boosting procedural volumes.

Additionally, hospitals are increasingly investing in state-of-the-art hybrid operating rooms, catheterization laboratories, and advanced imaging systems, enabling them to offer minimally invasive, image-guided therapies with higher precision and safety. The availability of comprehensive post-operative care, rehabilitation services, and multi-disciplinary teams within hospitals enhances patient outcomes and strengthens their role as the preferred treatment centers. Furthermore, favorable reimbursement frameworks for structural heart procedures in hospital-based settings are encouraging more patients to opt for advanced therapies.

Structural Heart Devices Market Regional Analysis

North America Structural Heart Devices Market Trends

In 2024, North America is projected to account for the largest share of the global structural heart devices market, representing approximately 50%, driven by the rising cases of structural heart conditions, including heart valve disease, congenital heart defects, and other cardiac abnormalities. Additionally, there is a shift toward minimally invasive procedures, supported by a highly advanced healthcare infrastructure and strong adoption of cutting-edge technologies. The region also benefits from a favorable regulatory environment, with frequent product approvals and new device launches by leading market players, further accelerating growth. These combined factors make North America a key region in the global structural heart devices market.

According to DelveInsight analysis, congenital heart defects affect nearly 1% of all births in the U.S., impacting approximately 40,000 babies each year. Among these, about 1 in 4 infants is born with a critical congenital heart defect that requires immediate intervention to ensure survival. Supporting this, the CDC's 2024 data highlights that around 1 in every 33 babies, or nearly 120,000 infants annually, are born with congenital anomalies, many of which include structural heart defects. Such a high incidence underscores the persistent clinical need for advanced treatment options. Structural heart devices, particularly occluders, septal defect closure systems, and valve repair technologies, play a vital role in addressing these conditions by providing life-saving interventions that restore normal cardiac function and prevent long-term complications.

Beyond congenital disorders, the burden of acquired structural heart conditions is equally significant. DelveInsight reports that more than 5 million people in the U.S. are diagnosed with heart valve disease each year, with over 25,000 annual deaths attributed to the condition. Many of these deaths could be prevented with timely treatment using structural heart devices such as transcatheter heart valves, annuloplasty rings, and minimally invasive repair systems, which provide effective alternatives to open-heart surgery. These devices are particularly beneficial for elderly or high-risk patients who may not be suitable candidates for traditional surgical procedures.

Collectively, the rising incidence of both congenital and acquired structural heart diseases is creating a substantial and expanding patient pool. This, in turn, is fueling demand for structural heart devices, as healthcare systems increasingly adopt these technologies to deliver safer, less invasive, and more effective interventions. As awareness grows, coupled with continuous innovation in device design and clinical success rates, the market for structural heart devices is experiencing robust growth across the U.S. and is expected to expand further in the coming years.

Europe Structural Heart Devices Market Trends

The Europe structural heart devices market is experiencing strong growth, driven by the rising prevalence of valvular heart diseases, particularly aortic stenosis and mitral regurgitation, which are increasing rapidly with the region's aging population. A key factor fueling this growth is the rapid adoption of transcatheter interventions, with transcatheter aortic valve replacement (TAVR) now firmly established across many countries and transcatheter mitral and tricuspid repair procedures gaining momentum, especially among elderly and high-risk patients. The market is further supported by favorable reimbursement policies and regulatory pathways, particularly in countries like Germany, France, and the UK, where government-backed healthcare systems ensure wider patient access to advanced therapies. Additionally, the growth of specialized cardiac centers equipped with hybrid operating rooms, catheterization labs, and skilled interventional cardiologists has accelerated the adoption of advanced devices and procedures. Europe also plays a leading role in technological innovation and clinical research, serving as a hub for trials and development of next-generation mitral and tricuspid valve repair systems. Coupled with a strong emphasis on minimally invasive and patient-centric care, these factors are positioning Europe as one of the fastest-growing and most influential regions in the global structural heart devices market.

Asia-Pacific Structural Heart Devices Market Trends

The Asia-Pacific structural heart devices market is witnessing rapid growth, largely driven by the rising prevalence of cardiovascular and valvular diseases across densely populated nations such as China, India, and Japan. A growing elderly population, coupled with lifestyle-related risk factors like diabetes, hypertension, and obesity, is contributing to a significant increase in structural heart conditions, thereby fueling demand for advanced interventions. One of the key trends in the region is the expanding adoption of minimally invasive procedures, particularly transcatheter aortic valve replacement (TAVR) and septal defect closure, which are increasingly being preferred over open-heart surgeries due to shorter recovery times and lower procedural risks.

Market growth is further supported by improvements in healthcare infrastructure, rising investments in specialized cardiac centers, and the growing availability of skilled interventional cardiologists across major urban centers. In addition, favorable government initiatives, increasing healthcare expenditure, and greater awareness of early diagnosis and treatment are helping accelerate patient access to advanced therapies. Leading manufacturers are also focusing on the Asia-Pacific region by expanding their presence, partnering with local distributors, and launching clinical studies to gain regulatory approvals. Collectively, these trends are positioning Asia-Pacific as one of the fastest-growing markets for structural heart devices, with significant untapped opportunities, particularly in emerging economies where structural heart disease remains underdiagnosed and undertreated.

Who are the major players in structural heart devices?

The following are the leading companies in structural heart devices. These companies collectively hold the largest market share and dictate industry trends.

  • 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
  • JenaValve Technology, Inc.
  • Biomerics
  • Lepu Medical Technology (Beijing) Co., Ltd.
  • LivaNova Inc.
  • Comed B.V.
  • TORAY INDUSTRIES INC.
  • Occlutech International AB
  • Microport Scientific Corporation
  • Meril Life Sciences
  • Venus Medtech (Hangzhou) Inc.

How is the competitive landscape shaping the structural heart devices market?

The competitive landscape of the structural heart devices market is moderately consolidated, with a handful of global leaders such as Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific dominating through robust product portfolios, strong clinical evidence, and continuous innovation, while regional players and emerging companies are contributing with niche solutions and cost-effective offerings. Leading manufacturers are heavily investing in R&D to develop next-generation transcatheter valves, annuloplasty systems, and occluder devices, with a strong focus on expanding the scope of minimally invasive and transcatheter interventions. Strategic collaborations with hospitals, research institutes, and healthcare providers remain central to their growth, enabling the integration of advanced devices into routine clinical practice and accelerating adoption across high-volume cardiac centers. Meanwhile, regional and mid-sized players are gaining traction in emerging markets by offering competitively priced products and building localized distribution networks, helping improve accessibility where structural heart disease remains underdiagnosed or undertreated. With rising disease prevalence, expanding clinical indications, and growing patient demand for minimally invasive therapies, competition in the market is intensifying as both established leaders and new entrants strive to enhance technological capabilities, widen geographic reach, and secure a larger share of this rapidly expanding sector.

Recent Developmental Activities in Structural Heart Devices

  • In April 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system received CE Mark approval. The device is approved for treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are not suitable for surgery or transcatheter edge-to-edge repair (TEER).
  • In March 2025, Abbott announced new results from its TRILUMINATE(TM) Pivotal trial, showing that the TriClip(TM) TEER system provides significant and lasting improvement in tricuspid regurgitation (TR) after two years.

Structural Heart Devices Market Segmentation

  • Structural Heart Devices Market Product Type Exposure
  • Repair Device
  • Occluders
  • Annuloplasty Devices
  • Valvuloplasty Devices
  • Others
  • Replacement Devices
  • Mechanical Heart Valves
  • Tissue Heart Valves
  • Structural Heart Devices Market Application Exposure
  • Atrial Septal Defect
  • Aortic Valve Stenosis
  • Patent Foramen Ovale
  • Ventricular Septal Defects
  • Mitral Regurgitation
  • Others
  • Structural Heart Devices Market End-Users Exposure
  • Hospitals
  • Ambulatory Surgical Centers
  • Others
  • Structural Heart Devices Market Geography Exposure
  • North America
  • United States
  • Canada
  • Mexico
  • Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific
  • Rest of the World
  • South America
  • Middle East
  • Africa

Impact Analysis

AI-Powered Innovations and Applications:

Artificial Intelligence (AI) is rapidly transforming the structural heart devices market by enhancing precision, efficiency, and patient outcomes in both diagnosis and intervention. AI-powered imaging and echocardiographic analysis enable more accurate assessment of valve anatomy, septal defects, and hemodynamic parameters, helping clinicians select the most suitable device and approach for each patient. Advanced algorithms assist in real-time intraoperative guidance during transcatheter procedures such as TAVR, mitral, and tricuspid valve repairs, improving accuracy, reducing procedural risks, and shortening operating times.

Beyond procedural support, AI-driven platforms are streamlining workflow optimization in cardiac catheterization labs by automating measurement, device sizing, and predictive case scheduling. Predictive analytics also enable early identification of patients at high risk of complications, supporting personalized treatment strategies and post-procedural monitoring. Additionally, the integration of AI in device development and clinical trials is accelerating innovation, providing insights into device durability, long-term outcomes, and patient-specific performance.

U.S. Tariff Impact Analysis on Structural Heart Devices:

The imposition of U.S. tariffs on imported medical devices, including structural heart technologies such as transcatheter valves, occluder devices, and annuloplasty systems, has created both cost pressures and strategic shifts across the market. Many of these devices, or their critical components, are manufactured in Europe and Asia, making them subject to additional import duties that increase overall procurement and distribution costs for U.S. healthcare providers. This has, in turn, placed upward pressure on treatment costs, potentially limiting accessibility for patients, particularly in smaller healthcare settings with constrained budgets.

From a manufacturer's perspective, tariffs have intensified the need for localized production and supply chain restructuring. Global leaders in structural heart devices are increasingly exploring U.S.-based manufacturing or assembly hubs to mitigate tariff-related costs, reduce dependency on imports, and ensure timely product availability. While this transition requires significant investment, it also fosters opportunities for local job creation and strengthens domestic production resilience.

On the flip side, higher tariffs may encourage regional players to innovate with cost-effective alternatives, thereby stimulating competition in the U.S. market. However, the short-term challenges of increased device prices and hospital budgetary strain could slow the adoption of advanced structural heart technologies, particularly among underfunded healthcare systems.

How This Analysis Helps Clients

  • Cost Management: By understanding the tariff landscape, clients can anticipate cost increases and adjust pricing strategies accordingly, ensuring profitability.
  • Supply Chain Optimization: Clients can identify alternative sourcing options and diversify their supply chains to reduce dependency on high-tariff regions, enhancing resilience.
  • Regulatory Navigation: Expert guidance on navigating the evolving regulatory environment helps clients maintain compliance and avoid potential legal challenges.
  • Strategic Planning: Insights into tariff impacts enable clients to make informed decisions about manufacturing locations, partnerships, and market entry strategies.

Key takeaways from the Structural Heart Devices Market report study

  • Market size analysis for the current structural heart devices market size (2024), and market forecast for 8 years (2025 to 2032)
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
  • Key companies dominating the structural heart devices.
  • Various opportunities available for the other competitors in the structural heart devices market space.
  • What are the top-performing segments in 2024? How these segments will perform in 2032?
  • 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 have concentrated on opportunities for the structural heart devices market growth in the future?

Frequently Asked Questions for the structural heart devices

1. What is the growth rate of the structural heart devices market?

  • The structural heart devices market is estimated to grow at a CAGR of 10.08% during the forecast period from 2025 to 2032.

2. What is the market for structural heart devices?

  • The structural heart devices market was valued at USD 11,752.22 million in 2024, and is expected to reach USD 25,264.95 million by 2032.

3. Which region has the highest share in structural heart devices?

  • North America is expected to dominate the structural heart devices market. This growth is primarily driven by the rising cases of structural heart conditions, including heart valve disease, congenital heart defects, and other cardiac abnormalities. Additionally, there is a shift toward minimally invasive procedures, supported by a highly advanced healthcare infrastructure and strong adoption of cutting-edge technologies. The region also benefits from a favorable regulatory environment, with frequent product approvals and new device launches by leading market players, further accelerating growth. These combined factors make North America a key region in the global structural heart devices market.

4. What are the drivers for structural heart devices?

  • The growth of the global structural heart devices market is primarily driven by the rising prevalence of cardiovascular and valvular disorders, such as aortic stenosis, mitral regurgitation, and congenital defects, which are creating a substantial need for advanced treatment solutions. Alongside this, technological advancements in structural heart devices, including next-generation transcatheter valves, mitral repair systems, and left atrial appendage closure devices, are enhancing durability, precision, and procedural safety while expanding the pool of eligible patients. Furthermore, the growing demand for minimally invasive cardiac interventions is accelerating adoption, as catheter-based procedures offer reduced surgical risks, shorter hospital stays, and faster recovery compared to traditional open-heart surgeries. Collectively, these drivers are positioning structural heart devices as an essential component of modern cardiovascular care, supporting strong market growth during the forecast period from 2025 to 2032.

5. Who are the key players operating in structural heart devices?

  • Some of the key market players operating in the Structural Heart Devices Market 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., XELTIS BV, JenaValve Technology, Inc., Biomerics, Lepu Medical Technology (Beijing) Co., Ltd., LivaNova Inc., Comed B.V., TORAY, INDUSTRIES INC., Occlutech International AB, Microport Scientific Corporation, Meril Life Sciences Venus Medtech (Hangzhou) Inc., and others.

Table of Contents

1. Structural Heart Devices Market Report Introduction

  • 1.1. Scope of the Study
  • 1.2. Market Segmentation
  • 1.3. Market Assumption

2. Structural Heart Devices Market Executive Summary

  • 2.1. Market at 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 Structural Heart Devices
    • 3.1.3. Growing Demand for Minimally Invasive Cardiac Interventions
  • 3.2. Structural Heart Devices Market Restraints and Challenges
    • 3.2.1. Frequent product failures and recalls
    • 3.2.2. Stringent regulatory concerns for product approval devices
  • 3.3. Structural Heart Devices Market Opportunity
    • 3.3.1. Integration of advanced technologies, such as digital twins and artificial intelligence, in the development of these devices

4. Impact Analysis

  • 4.1. AI-Powered Innovations and Applications
  • 4.2. U.S. Tariff Impact Analysis

5. Regulatory Analysis

  • 5.1. The 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 Consumers
  • 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 Devices
      • 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 Devices
      • 7.1.2.1. Mechanical Heart Valves
      • 7.1.2.2. Tissue Heart Valves
  • 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-Users
    • 7.3.1. Hospitals
    • 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 (2022-2032)
      • 7.4.1.2. Canada Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.1.3. Mexico Structural Heart Devices Market Size in USD million (2022-2032)
    • 7.4.2. Europe
      • 7.4.2.1. France Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.2.2. Germany Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.2.3. United Kingdom Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.2.4. Italy Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.2.5. Spain Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.2.6. Rest of Europe Structural Heart Devices Market Size in USD million (2022-2032)
    • 7.4.3. Asia-Pacific
      • 7.4.3.1. China Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.3.2. Japan Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.3.3. India Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.3.4. Australia Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.3.5. South Korea Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.3.6. Rest of Asia-Pacific Structural Heart Devices Market Size in USD million (2022-2032)
    • 7.4.4. Rest of the World (RoW)
      • 7.4.4.1. Middle East Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.4.2. Africa Structural Heart Devices Market Size in USD million (2022-2032)
      • 7.4.4.3. South America Structural Heart Devices Market Size In USD Million (2022-2032)

8. Competitive Landscape

9. Startup Funding & 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. Product Listing
    • 10.1.5. 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 Listing
    • 10.2.5. Entropy
  • 10.3. Braile Biomedica
    • 10.3.1. Company Overview
    • 10.3.2. Company Snapshot
    • 10.3.3. Financial Overview
    • 10.3.4. Product Listing
    • 10.3.5. Entropy
  • 10.4. JOTEC GmbH
    • 10.4.1. Company Overview
    • 10.4.2. Company Snapshot
    • 10.4.3. Financial Overview
    • 10.4.4. Product Listing
    • 10.4.5. 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 Listing
    • 10.5.5. Entropy
  • 10.6. Valcare Medical
    • 10.6.1. Company Overview
    • 10.6.2. Company Snapshot
    • 10.6.3. Financial Overview
    • 10.6.4. Product Listing
    • 10.6.5. 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 Listing
    • 10.7.5. Entropy
  • 10.8. Abbott Laboratories
    • 10.8.1. Company Overview
    • 10.8.2. Company Snapshot
    • 10.8.3. Financial Overview
    • 10.8.4. Product Listing
    • 10.8.5. 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 Listing
    • 10.9.5. Entropy
  • 10.10. XELTIS BV
    • 10.10.1. Company Overview
    • 10.10.2. Company Snapshot
    • 10.10.3. Financial Overview
    • 10.10.4. Product Listing
    • 10.10.5. Entropy
  • 10.11. JenaValve Technology, Inc.
    • 10.11.1. Compan Overview
    • 10.11.2. Company Snapshot
    • 10.11.3. Financial Overview
    • 10.11.4. Product Listing
    • 10.11.5. Entropy
  • 10.12. Biomerics
    • 10.12.1. Company Overview
    • 10.12.2. Company Snapshot
    • 10.12.3. Financial Overview
    • 10.12.4. Product Listing
    • 10.12.5. Entropy
  • 10.13. Lepu Medical Technology (Beijing) Co., Ltd.
    • 10.13.1. Company Overview
    • 10.13.2. Company Snapshot
    • 10.13.3. Financial Overview
    • 10.13.4. Product Listing
    • 10.13.5. Entropy
  • 10.14. LivaNova Inc.
    • 10.14.1. Company Overview
    • 10.14.2. Company Snapshot
    • 10.14.3. Financial Overview
    • 10.14.4. Product Listing
    • 10.14.5. Entropy
  • 10.15. Comed B.V.
    • 10.15.1. Company Overview
    • 10.15.2. Company Snapshot
    • 10.15.3. Financial Overview
    • 10.15.4. Product Listing
    • 10.15.5. Entropy
  • 10.16. TORAY INDUSTRIES INC.
    • 10.16.1. Company Overview
    • 10.16.2. Company Snapshot
    • 10.16.3. Financial Overview
    • 10.16.4. Product Listing
    • 10.16.5. Entropy
  • 10.17. Occlutech International AB
    • 10.17.1. Company Overview
    • 10.17.2. Company Snapshot
    • 10.17.3. Financial Overview
    • 10.17.4. Product Listing
    • 10.17.5. Entropy
  • 10.18. Microport Scientific Corporation
    • 10.18.1. Company Overview
    • 10.18.2. Company Snapshot
    • 10.18.3. Financial Overview
    • 10.18.4. Product Listing
    • 10.18.5. Entropy
  • 10.19. Meril Life Sciences
    • 10.19.1. Company Overview
    • 10.19.2. Company Snapshot
    • 10.19.3. Financial Overview
    • 10.19.4. Product Listing
    • 10.19.5. Entropy
  • 10.20. Venus Medtech (Hangzhou) Inc.
    • 10.20.1. Company Overview
    • 10.20.2. Company Snapshot
    • 10.20.3. Financial Overview
    • 10.20.4. Product Listing
    • 10.20.5. Entropy

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer & Contact Us

List of Tables

  • Table 1: Structural Heart Devices Market in Global (2022-2032)
  • Table 2: Structural Heart Devices Market in Global by Product Type (2022-2032)
  • Table 3: Structural Heart Devices Market in Global by Application (2022-2032)
  • Table 4: Structural Heart Devices Market in Global by End-User (2022-2032)
  • Table 5: Structural Heart Devices Market in Global by Geography (2022-2032)
  • Table 6: Structural Heart Devices Market in North America (2022-2032)
  • Table 7: Structural Heart Devices Market in the United States (2022-2032)
  • Table 8: Structural Heart Devices Market in Canada (2022-2032)
  • Table 9: Structural Heart Devices Market in Mexico (2022-2032)
  • Table 10: Structural Heart Devices Market in Europe (2022-2032)
  • Table 11: Structural Heart Devices Market in France (2022-2032)
  • Table 12: Structural Heart Devices Market in Germany (2022-2032)
  • Table 13: Structural Heart Devices Market in United Kingdom (2022-2032)
  • Table 14: Structural Heart Devices Market in Italy (2022-2032)
  • Table 15: Structural Heart Devices Market in Spain (2022-2032)
  • Table 16: Structural Heart Devices Market in the Rest of Europe (2022-2032)
  • Table 17: Structural Heart Devices Market in Asia-Pacific (2022-2032)
  • Table 18: Structural Heart Devices Market in China (2022-2032)
  • Table 19: Structural Heart Devices Market in Japan (2022-2032)
  • Table 20: Structural Heart Devices Market in India (2022-2032)
  • Table 21: Structural Heart Devices Market in Australia (2022-2032)
  • Table 22: Structural Heart Devices Market in South Korea (2022-2032)
  • Table 23: Structural Heart Devices Market in Rest of Asia-Pacific (2022-2032)
  • Table 24: Structural Heart Devices Market in the Rest of the World (2022-2032)
  • Table 25: Structural Heart Devices Market in the Middle East (2022-2032)
  • Table 26: Structural Heart Devices Market in Africa (2022-2032)
  • Table 27: Structural Heart Devices Market in South America (2022-2032)
  • Table 28: Competitive Landscape
  • Table 29: Startup Funding & Investment Trends

List of Figures

  • Figure 1: Structural Heart Devices Market Drivers
  • Figure 2: Structural Heart Devices Market Restraints
  • Figure 3: Structural Heart Devices Market Opportunities
  • Figure 4: AI-Powered Innovations in the Structural Heart Devices Market
  • Figure 5: US Tariff Impact on the Structural Heart Devices Market
  • Figure 6: Regulatory Analysis (US, EU, Japan, China)
  • Figure 7: Porter's Five Forces Analysis
  • Figure 8: Competitive Analysis
  • Figure 9: Structural Heart Devices Market in Global (2022-2032)
  • Figure 10: Structural Heart Devices Market in Global by Product Type (2022-2032)
  • Figure 11: Structural Heart Devices Market in Global by Application (2022-2032)
  • Figure 12: Structural Heart Devices Market in Global by End-User (2022-2032)
  • Figure 13: Structural Heart Devices Market in Global by Geography (2022-2032)
  • Figure 14: Structural Heart Devices Market in North America (2022-2032)
  • Figure 15: Structural Heart Devices Market in the United States (2022-2032)
  • Figure 16: Structural Heart Devices Market in Canada (2022-2032)
  • Figure 17: Structural Heart Devices Market in Mexico (2022-2032)
  • Figure 18: Structural Heart Devices Market in Europe (2022-2032)
  • Figure 19: Structural Heart Devices Market in France (2022-2032)
  • Figure 20: Structural Heart Devices Market in Germany (2022-2032)
  • Figure 21: Structural Heart Devices Market in United Kingdom (2022-2032)
  • Figure 22: Structural Heart Devices Market in Italy (2022-2032)
  • Figure 23: Structural Heart Devices Market in Spain (2022-2032)
  • Figure 24: Structural Heart Devices Market in the Rest of Europe (2022-2032)
  • Figure 25: Structural Heart Devices Market in Asia-Pacific (2022-2032)
  • Figure 26: Structural Heart Devices Market in China (2022-2032)
  • Figure 27: Structural Heart Devices Market in Japan (2022-2032)
  • Figure 28: Structural Heart Devices Market in India (2022-2032)
  • Figure 29: Structural Heart Devices Market in Australia (2022-2032)
  • Figure 30: Structural Heart Devices Market in South Korea (2022-2032)
  • Figure 31: Structural Heart Devices Market in Rest of Asia-Pacific (2022-2032)
  • Figure 32: Structural Heart Devices Market in the Rest of the World (2022-2032)
  • Figure 33: Structural Heart Devices Market in the Middle East (2022-2032)
  • Figure 34: Structural Heart Devices Market in Africa (2022-2032)
  • Figure 35: Structural Heart Devices Market in South America (2022-2032)
  • Figure 36: Competitive Landscape
  • Figure 37: Startup Funding & Investment Trends