구조적 심질환용 기기 시장 : 제품 유형, 시술 유형, 재료 유형, 용도, 최종사용자별 - 세계 예측(2025-2030년)

The Structural Heart Devices Market was valued at USD 21.06 billion in 2024 and is projected to grow to USD 23.01 billion in 2025, with a CAGR of 9.60%, reaching USD 36.51 billion by 2030.

Structural heart device innovations are reshaping the landscape of cardiac care, offering new hope to patients with valve disorders, defect closures, and complex anatomical challenges. As demographic shifts drive greater demand for minimally invasive interventions, medical technology developers continue to refine delivery systems and materials that enhance procedural safety and patient outcomes. In parallel, regulatory bodies are evolving pathways to facilitate accelerated approvals for breakthrough solutions, underscoring the critical interplay between innovation and policy.

In recent years, advances in transcatheter techniques and the refinement of mechanical and tissue valve designs have led to substantial improvements in durability and hemodynamic performance. These technological breakthroughs have been complemented by enhanced imaging modalities and guidewire systems, which collectively support more precise device placement and reduced recovery times. As a result, hospitals and specialty cardiac centers are increasingly adopting integrated procedural protocols that leverage these tools to optimize the continuum of care.

Economic pressures and shifting reimbursement models have emphasized the importance of cost-effectiveness without compromising quality. Consequently, manufacturers are exploring novel materials ranging from advanced polymers to biocompatible alloys, while also investing in next-generation introducer sheaths and occluder configurations. These developments highlight the multifaceted drivers that are propelling the field forward.

This executive summary provides a cohesive exploration of transformative market shifts, tariff implications, segmentation insights, regional dynamics, and strategic recommendations to inform decision makers and guide future investments in structural heart device innovations.

Identifying Transformative Paradigm Shifts in Structural Heart Therapy Driven by Technological Advances, Patient-Centric Care Trends, and Regulatory Milestones Across the Ecosystem

The structural heart device sector is undergoing transformative paradigm shifts, driven by a confluence of technological breakthroughs, patient-centric care models, and evolving regulatory frameworks. As artificial intelligence and machine learning begin to intersect with device development, predictive analytics are enabling more accurate patient selection and personalized therapy protocols. This shift toward data-driven decision making is complemented by the expansion of 3D printing technologies that facilitate patient-specific implant design and rapid prototyping.

Meanwhile, there has been a pronounced movement toward minimally invasive procedures, reflecting growing patient preference for reduced hospitalization and expedited recovery. This trend has prompted developers to optimize delivery systems and guidewire flexibility, thereby enhancing procedural precision. Concurrently, remote monitoring platforms are maturing, allowing clinicians to track post-procedure hemodynamics and detect device-related complications at an early stage. Such capabilities promote proactive clinical management and foster continuous device improvement.

Regulatory milestones are also redefining market entry pathways. Accelerated approval programs, conditional on real-world evidence collection, are expediting access to groundbreaking therapies while maintaining rigorous safety standards. As a result, stakeholders across the ecosystem are recalibrating their strategies to align with both expedited approvals and long-term post-market surveillance commitments. Together, these transformative shifts underscore an era of rapid innovation, heightened collaboration, and patient-centered excellence within the structural heart device landscape.

Assessing the Far-Reaching Implications of United States Tariffs on Structural Heart Device Supply Chains, Cost Structures, Operational Resilience, and Strategic Manufacturing Decisions

United States tariff policies set to take effect in 2025 are poised to exert significant influence on structural heart device supply chains, thereby prompting strategic recalibrations across the industry. Manufacturers heavily reliant on imported components face rising input costs, particularly for specialized metallic alloys and polymer materials sourced from international suppliers. This escalation in procurement expenses necessitates either absorption of incremental costs or transfer of burdens downstream, which could challenge pricing structures and reimbursement negotiations.

In response, many organizations are exploring nearshoring initiatives to establish or expand domestic manufacturing capabilities. Such operational shifts enhance supply chain resilience, mitigate currency fluctuations, and reduce logistical complexities. Yet, these transitions demand substantial capital investment in facility expansion and workforce training. At the same time, partnerships with local contract manufacturers are gaining prominence, offering a more flexible approach to capacity scaling without requiring full vertical integration.

Moreover, tariff-induced cost pressures are catalyzing a renewed emphasis on material innovation. Research into alternative biocompatible substrates and hybrid composites is intensifying, with the goal of preserving performance while lowering dependence on tariff-affected imports. Stakeholders are also consolidating purchasing agreements and leveraging consortium models to negotiate more favorable terms with suppliers. These strategic responses collectively reflect an industry adapting to shifting trade landscapes and striving to protect both profitability and patient access.

Ultimately, the cumulative impact of these tariffs is not uniform but varies by device category and regional operational footprint. Forward-looking companies are engaging in scenario planning to anticipate potential policy adjustments, ensuring that their manufacturing and distribution networks remain robust in the face of evolving trade conditions.

Decoding Critical Segmentation Dimensions Revealing Product, Procedural, Material, Application, and End User Insights Propelling Structural Heart Device Strategies and Outcomes

Critical segmentation insights reveal nuanced opportunities across product, procedure, material, application, and end user dimensions, each informing targeted strategic initiatives. When examining product types, accessory devices such as delivery systems, guidewires, and introducer sheaths demonstrate the value of modular innovation, while heart valve devices encompassing mechanical, tissue, and transcatheter variants highlight evolving preferences toward less invasive implants. Occluders and closure devices, which include atrial septal defect occluders and left atrial appendage closure solutions, further underscore the expanding scope of percutaneous interventions.

Across procedural approaches, the dichotomy between minimally invasive surgery and open-heart surgery speaks to diverging clinical pathways. Minimally invasive techniques continue to gain traction due to shorter hospital stays and lower complication rates, yet open-heart procedures remain integral for complex cases requiring direct visualization. This procedural segmentation ties back to material considerations, where choices among metallic alloys, polymer materials, or tissue-based substrates influence device performance, biocompatibility, and long-term durability.

Application-based segmentation provides additional granularity, as therapies range from surgical aortic valve replacement to transcatheter aortic valve replacement and transcatheter mitral valve repair. Each application's unique anatomical and hemodynamic requirements drive distinct design parameters, procedural protocols, and post-implantation care regimens. Finally, segmentation by end user-including ambulatory surgical centers, hospitals, and specialty cardiac centers-illuminates varying adoption patterns, procurement cycles, and training needs. Together, these segmentation dimensions offer a comprehensive framework for aligning product development, marketing strategies, and clinical engagement initiatives with the dynamic demands of the structural heart device market.

Illuminating Regional Dynamics and Growth Drivers Shaping Structural Heart Device Adoption Patterns across the Americas, Europe Middle East Africa, and Asia-Pacific Markets

Regional dynamics within the structural heart device arena are characterized by distinct growth drivers and adoption patterns across the Americas, Europe Middle East Africa, and Asia-Pacific. In the Americas, advanced healthcare infrastructure and established reimbursement models support swift integration of next-generation transcatheter therapies. Leading hospitals and specialty centers invest heavily in multidisciplinary teams and high-fidelity imaging suites, thereby fostering an environment conducive to procedural innovation and clinical trials. Meanwhile, ambulatory surgical centers are increasingly participating in minimally invasive programs, expanding access to care and reducing overall treatment costs.

In Europe Middle East Africa, heterogeneous regulatory landscapes and variable healthcare funding models influence market penetration rates. Western European nations display robust uptake of percutaneous valves and occlusion devices, driven by concerted policy support and centralized purchasing agreements. At the same time, emerging markets in the Middle East and Africa are experiencing incremental growth, propelled by expanding cardiovascular disease awareness and incremental investments in interventional cardiology training.

The Asia-Pacific region represents a rapidly evolving frontier, fueled by an aging population, rising disposable incomes, and broadening hospital capacities. Countries such as Japan and Australia maintain sophisticated procedural ecosystems, while China and India are accelerating domestic manufacturing capabilities and forging strategic international partnerships. Collectively, these regional insights underscore the importance of tailoring market entry strategies, regulatory navigation plans, and distribution networks to the unique healthcare landscapes that define each geographic cluster.

Uncovering Strategic Movements and Competitive Differentiators among Leading Manufacturers Reshaping the Structural Heart Device Landscape through Innovation and Partnerships

Leading manufacturers are undertaking bold initiatives to maintain competitive differentiation through innovation, strategic collaborations, and targeted acquisitions. Corporations with legacy strength in valve technologies continue to invest in next-generation transcatheter solutions, leveraging decades of clinical data to support device enhancements. Simultaneously, emerging players are entering the market with disruptive materials and proprietary deployment mechanisms, forging partnerships with research institutions to accelerate preclinical validations.

Cross-industry alliances are becoming more prevalent, as technology firms contribute advanced analytics platforms and digital monitoring solutions to established device portfolios. Such collaborations enable remote patient surveillance and real-time procedural guidance, creating holistic ecosystems that extend beyond the cath lab. At the same time, established conglomerates are streamlining operational footprints by divesting non-core assets, redirecting capital toward structural heart programs with the highest strategic impact.

Mergers and acquisitions remain a pivotal strategy for scaling market reach and expanding therapeutic pipelines. By integrating complementary technologies-from polymer innovations to artificial intelligence-driven imaging-companies can offer turnkey solutions that address multiple points along the patient care continuum. This trend underscores the value of a diversified portfolio that blends mechanical, tissue, and transcatheter valve offerings with advanced occluder and closure devices.

Collectively, these competitive maneuvers illustrate an industry in flux, where success hinges on the ability to converge clinical excellence, digital integration, and agile operational models. Stakeholders that manage to balance these elements effectively will be best positioned to shape the next chapter of structural heart interventions.

Strategic Roadmap for Maximizing Market Position: Actionable Recommendations to Propel Growth, Enhance Collaboration, and Drive Innovation in Structural Heart Devices

To navigate the evolving structural heart device environment, industry leaders should prioritize the integration of digital health solutions, enabling remote monitoring platforms and predictive analytics to inform patient selection and post-procedure management. Such investments foster improved clinical outcomes and reinforce long-term device performance through continuous data feedback loops. Moreover, diversifying supply chains by establishing dual sourcing strategies and regional manufacturing hubs will bolster operational resilience in the face of tariff fluctuations and logistical disruptions.

Engagement with regulatory agencies remains critical; proactive collaboration on real-world evidence initiatives and conditional approval pathways can accelerate market access while ensuring robust safety monitoring. Concurrently, seeking strategic alliances and targeted acquisitions will enhance technology portfolios, allowing manufacturers to offer comprehensive procedural suites that span from delivery system innovation to advanced occlusion therapies. By embracing these collaborative models, organizations can achieve economies of scale and reduce time to market.

Finally, centering strategic planning around patient outcomes-through investment in biocompatible materials, minimally invasive delivery platforms, and clinician training programs-will drive differentiation and support favorable reimbursement conversations. Leaders that align business objectives with demonstrable clinical value and operational agility will be poised to capture emerging opportunities and sustain competitive advantage in the structural heart device landscape.

Elucidating Rigorous Research Methodology Underpinning the Comprehensive Structural Heart Device Analysis from Data Collection through Validation, Synthesis, and Expert Review

The research methodology underpinning this structural heart device analysis combines rigorous primary and secondary research phases to ensure comprehensive coverage and data integrity. Primary research involved detailed interviews with cardiologists, interventional specialists, and procurement executives across diverse healthcare settings, complemented by surveys of industry stakeholders to capture sentiment on technological trends, tariff impacts, and regional dynamics.

Secondary research encompassed an exhaustive review of peer-reviewed journals, regulatory filings, clinical trial registries, and company disclosures, providing a robust foundation of historical and contemporary insights. This process was further supported by extraction of device-specific information from patent databases and assessment of regulatory approvals to contextualize market entry timelines and post-market surveillance obligations.

Data validation was conducted through triangulation of multiple sources, including cross-referencing interview feedback with published literature and manufacturer reports. Analytical frameworks were applied to synthesize segmentation dimensions, tariff scenarios, and competitive strategies, ensuring logical coherence and actionable relevance. An expert panel comprising clinical advisors and industry analysts then reviewed draft findings, providing critical input to refine interpretations and validate strategic recommendations.

This multilayered approach guarantees that the insights presented are both empirically grounded and reflective of evolving market realities, equipping decision makers with the clarity needed to navigate the structural heart device space with confidence.

Synthesis of Key Takeaways Highlighting Structural Heart Device Trends, Strategic Imperatives, Innovative Drivers, and Future Directions for Stakeholders and Decision Makers

This executive summary has illuminated the critical trends shaping the structural heart device sector, from transformative technological shifts to the nuanced implications of upcoming tariff policies. Segmentation insights have underscored the importance of aligning product development with procedural preferences, material innovations, and varied end user requirements. Regional analyses have revealed distinct adoption dynamics, highlighting opportunities in established and emerging markets alike.

Key company strategies have demonstrated how innovation ecosystems are coalescing around digital integration, advanced materials research, and strategic partnerships. Actionable recommendations emphasize the need for diversified supply chains, proactive regulatory engagement, and a relentless focus on patient outcomes. By synthesizing these insights, industry leaders can better anticipate market demands, optimize operational resilience, and accelerate the delivery of life-saving therapies.

Looking forward, the structural heart device landscape will continue to evolve in response to demographic pressures, policy shifts, and technological breakthroughs. Stakeholders equipped with timely, evidence-based intelligence will be uniquely positioned to drive sustainable growth, foster clinical excellence, and ultimately improve the lives of patients with complex cardiac conditions. This summary serves as a roadmap for navigating the complexities of a dynamic market and seizing the strategic opportunities that lie ahead.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

• 4.1. Introduction
• 4.2. Market Sizing & Forecasting

5. Market Dynamics

• 5.1. Increasing focus on patient-specific customization in structural heart device design and delivery
• 5.2. Rising prevalence of cardiovascular diseases increasing demand for innovative heart devices
• 5.3. Expansion of remote patient monitoring systems linked to structural heart devices
• 5.4. Growing investments in biodegradable materials for safer structural heart implants
• 5.5. Advancements in minimally invasive structural heart device technologies enhancing patient outcomes
• 5.6. Collaborations among tech companies and medtech firms accelerating device innovation
• 5.7. Increasing shifts in regulatory frameworks influencing faster approvals of novel heart devices
• 5.8. Development of real-time imaging technologies aiding precise structural heart device placement
• 5.9. Expansion of structural heart device applications in treating congenital heart defects
• 5.10. Growth of transcatheter valve therapies fueling significant market expansion

6. Market Insights

• 6.1. Porter's Five Forces Analysis
• 6.2. PESTLE Analysis

7. Cumulative Impact of United States Tariffs 2025

8. Structural Heart Devices Market, by Product Type

• 8.1. Introduction
• 8.2. Accessory Devices
  • 8.2.1. Delivery Systems
  • 8.2.2. Guidewires
  • 8.2.3. Introducer Sheaths
• 8.3. Annuloplasty Rings
• 8.4. Heart Valve Devices
  • 8.4.1. Mechanical Heart Valves
  • 8.4.2. Tissue Heart Valves
  • 8.4.3. Transcatheter Heart Valves
• 8.5. Occluders & Closure Devices
  • 8.5.1. Atrial Septal Defect Occluders
  • 8.5.2. Left Atrial Appendage Closure Devices
  • 8.5.3. Patent Foramen Ovale Occluders
  • 8.5.4. Ventricular Septal Defect Occluders

9. Structural Heart Devices Market, by Procedure Type

• 9.1. Introduction
• 9.2. Minimally Invasive Surgery
• 9.3. Open-Heart Surgery

10. Structural Heart Devices Market, by Material Type

• 10.1. Introduction
• 10.2. Metallic Alloys
• 10.3. Polymer Materials
• 10.4. Tissue Materials

11. Structural Heart Devices Market, by Application

• 11.1. Introduction
• 11.2. Surgical Aortic Valve Replacement
• 11.3. Transcatheter Aortic Valve Replacement
• 11.4. Transcatheter Mitral Valve Repair

12. Structural Heart Devices Market, by End User

• 12.1. Introduction
• 12.2. Ambulatory Surgical Centers
• 12.3. Hospitals
• 12.4. Specialty Cardiac Centers

13. Americas Structural Heart Devices Market

• 13.1. Introduction
• 13.2. United States
• 13.3. Canada
• 13.4. Mexico
• 13.5. Brazil
• 13.6. Argentina

14. Europe, Middle East & Africa Structural Heart Devices Market

• 14.1. Introduction
• 14.2. United Kingdom
• 14.3. Germany
• 14.4. France
• 14.5. Russia
• 14.6. Italy
• 14.7. Spain
• 14.8. United Arab Emirates
• 14.9. Saudi Arabia
• 14.10. South Africa
• 14.11. Denmark
• 14.12. Netherlands
• 14.13. Qatar
• 14.14. Finland
• 14.15. Sweden
• 14.16. Nigeria
• 14.17. Egypt
• 14.18. Turkey
• 14.19. Israel
• 14.20. Norway
• 14.21. Poland
• 14.22. Switzerland

15. Asia-Pacific Structural Heart Devices Market

• 15.1. Introduction
• 15.2. China
• 15.3. India
• 15.4. Japan
• 15.5. Australia
• 15.6. South Korea
• 15.7. Indonesia
• 15.8. Thailand
• 15.9. Philippines
• 15.10. Malaysia
• 15.11. Singapore
• 15.12. Vietnam
• 15.13. Taiwan

16. Competitive Landscape

• 16.1. Market Share Analysis, 2024
• 16.2. FPNV Positioning Matrix, 2024
• 16.3. Competitive Analysis
  • 16.3.1. Abbott Laboratories
  • 16.3.2. AMETEK.Inc.
  • 16.3.3. Artivion, Inc.
  • 16.3.4. BIOTRONIK SE & Co. KG
  • 16.3.5. Boston Scientific Corporation
  • 16.3.6. Braile Biomedica Industria, Comercio e Representacoes Ltda.
  • 16.3.7. B. Braun Medical Inc.
  • 16.3.8. Cardinal Health, Inc.
  • 16.3.9. Direct Flow Medical, Inc.
  • 16.3.10. Edwards Lifesciences Corporation
  • 16.3.11. JenaValve Technology, Inc.
  • 16.3.12. Johnson & Johnson Services, Inc.
  • 16.3.13. Lepu Medical Technology (Beijing) Co., Ltd.
  • 16.3.14. Livanova PLC
  • 16.3.15. Medtronic plc
  • 16.3.16. Meril Life Sciences Pvt. Ltd.
  • 16.3.17. Micro Interventional Devices, Inc.
  • 16.3.18. MicroPort Scientific Corporation's
  • 16.3.19. Relisys Medical Devices Limited.
  • 16.3.20. TE Connectivity Corporation
  • 16.3.21. Teleflex Incorporated.
  • 16.3.22. Terumo Corporation
  • 16.3.23. TTK Healthcare Limited

17. ResearchAI

18. ResearchStatistics

19. ResearchContacts

20. ResearchArticles

21. Appendix