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Global structural heart devices market Size, Share, Growth Drivers, Trends, Opportunities & Forecast 2025–2030

The global structural heart devices market, valued at USD 16 billion, is growing due to increasing prevalence of heart diseases and technological advancements.

Region:Global

Author(s):Geetanshi

Product Code:KRAC3802

Pages:87

Published On:October 2025

About the Report

Base Year 2024

Global Structural Heart Devices Market Overview

  • The Global Structural Heart Devices Market is valued at USD 16 billion, based on a five-year historical analysis. This growth is primarily driven by the increasing prevalence of heart diseases, advancements in minimally invasive surgical techniques, and rising healthcare expenditure. The demand for innovative heart devices, particularly in aging populations, has significantly contributed to the market's expansion.
  • Key players in this market include the United States, Germany, and Japan, which dominate due to their advanced healthcare infrastructure, high investment in research and development, and a strong presence of leading medical device manufacturers. The robust regulatory frameworks and high patient awareness in these regions further enhance their market leadership.
  • In 2023, the U.S. Food and Drug Administration (FDA) issued the “Breakthrough Devices Program Guidance,” streamlining the approval process for innovative heart devices. This regulation, published by the U.S. FDA, aims to expedite patient access to novel structural heart technologies by providing prioritized review and interactive communication for qualifying devices, thereby supporting faster market entry and improved health outcomes.
Global Structural Heart Devices Market Size

Global Structural Heart Devices Market Segmentation

By Type:The market is segmented into various types of devices, including Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement (TMVR), Mitral Valve Repair Devices, Left Atrial Appendage Closure Devices, Septal Occluders, Annuloplasty Rings, Heart Valve Repair Devices, and Accessories and Other Devices. Among these, TAVR has emerged as a leading sub-segment due to its minimally invasive nature, reduced hospital stays, and favorable patient outcomes, especially among elderly patients and those at high surgical risk.

Global Structural Heart Devices Market segmentation by Type.

By End-User:The market is categorized by end-users, including Hospitals, Cardiac Centers, Ambulatory Surgical Centers, and Research Institutions. Hospitals are the dominant end-user segment, driven by the increasing number of cardiac procedures performed in these facilities, their comprehensive infrastructure, and their capacity to invest in advanced medical technologies.

Global Structural Heart Devices Market segmentation by End-User.

Global Structural Heart Devices Market Competitive Landscape

The Global Structural Heart Devices Market is characterized by a dynamic mix of regional and international players. Leading participants such as Abbott Laboratories, Medtronic plc, Boston Scientific Corporation, Edwards Lifesciences Corporation, LivaNova PLC, JenaValve Technology, Inc., CardioKinetix, Biomerics, Comed BV, Braile Biomédica, JOTEC GmbH, Valcare Medical, W. L. Gore & Associates, Inc., Cardiovascular Systems, Inc., Neovasc Inc., CryoLife, Inc., Biotronik SE & Co. KG, AtriCure, Inc., Terumo Corporation, Cardiac Dimensions, Inc. contribute to innovation, geographic expansion, and service delivery in this space.

Abbott Laboratories

1888

Abbott Park, Illinois, USA

Medtronic plc

1949

Dublin, Ireland

Boston Scientific Corporation

1979

Marlborough, Massachusetts, USA

Edwards Lifesciences Corporation

1958

Irvine, California, USA

LivaNova PLC

2015

London, UK

Company

Establishment Year

Headquarters

Group Size (Large, Medium, or Small as per industry convention)

Revenue Growth Rate (YoY, 3-year CAGR)

Market Penetration Rate (Geographic coverage, hospital adoption)

Product Portfolio Breadth (Number of FDA/CE-approved devices)

Clinical Trial Pipeline (Number of ongoing/pending trials)

R&D Investment (% of revenue)

Global Structural Heart Devices Market Industry Analysis

Growth Drivers

  • Increasing Prevalence of Structural Heart Diseases:The prevalence of structural heart diseases is rising significantly, with an estimated 3 million new cases reported annually in the United States alone. According to the American Heart Association, heart valve disease affects approximately 6 million people, and this number is expected to increase as the population ages. This growing patient pool drives demand for innovative structural heart devices, creating a robust market environment for manufacturers and healthcare providers.
  • Advancements in Minimally Invasive Surgical Techniques:The shift towards minimally invasive surgical techniques has revolutionized the treatment of structural heart diseases. In future, it is projected that over 70% of heart procedures will be performed using these techniques, significantly reducing recovery times and hospital stays. This trend is supported by advancements in catheter-based technologies, which enhance procedural safety and efficacy, thereby increasing the adoption of structural heart devices in clinical practice.
  • Rising Geriatric Population:The global geriatric population is expected to reach approximately 1.7 billion in future, according to the World Health Organization. This demographic shift is critical as older adults are more susceptible to structural heart diseases, necessitating effective treatment options. The increasing number of elderly patients drives the demand for structural heart devices, prompting healthcare systems to invest in innovative solutions to manage age-related cardiovascular conditions effectively.

Market Challenges

  • High Cost of Structural Heart Devices:The high cost associated with structural heart devices poses a significant barrier to market growth. For instance, the average cost of a transcatheter aortic valve replacement (TAVR) procedure can exceed $60,000, limiting accessibility for many patients. This financial burden is compounded by varying reimbursement policies across regions, which can hinder the adoption of these life-saving technologies in healthcare systems, particularly in developing markets.
  • Stringent Regulatory Approvals:The regulatory landscape for medical devices is becoming increasingly stringent, particularly in regions like Europe and North America. In future, the average time for regulatory approval for new structural heart devices is projected to be around 12-18 months. This lengthy approval process can delay market entry for innovative products, impacting manufacturers' ability to capitalize on emerging opportunities and meet the growing demand for advanced treatment options.

Global Structural Heart Devices Market Future Outlook

The future of the structural heart devices market appears promising, driven by technological advancements and an increasing focus on patient-centric care. As healthcare systems continue to embrace personalized medicine, the integration of artificial intelligence and machine learning in diagnostics will enhance treatment outcomes. Additionally, the growth of outpatient procedures is expected to streamline patient care, making treatments more accessible and efficient, ultimately benefiting both patients and healthcare providers in the evolving landscape.

Market Opportunities

  • Emerging Markets with Increasing Healthcare Access:Emerging markets, particularly in Asia and Africa, are witnessing rapid improvements in healthcare infrastructure. In future, healthcare spending in these regions is projected to grow by 12% annually, creating significant opportunities for structural heart device manufacturers to expand their market presence and cater to the rising demand for advanced medical technologies.
  • Technological Innovations in Device Design:Continuous innovations in device design, such as bioresorbable materials and advanced imaging technologies, are opening new avenues for market growth. These innovations not only enhance the performance of structural heart devices but also improve patient outcomes. As R&D investments increase, the introduction of next-generation devices is expected to drive market expansion and attract new customers seeking effective treatment options.

Scope of the Report

SegmentSub-Segments
By Type

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Mitral Valve Replacement (TMVR)

Mitral Valve Repair Devices

Left Atrial Appendage Closure Devices

Septal Occluders

Annuloplasty Rings

Heart Valve Repair Devices

Accessories and Other Devices

By End-User

Hospitals

Cardiac Centers

Ambulatory Surgical Centers

Research Institutions

By Application

Aortic Valve Disorders

Mitral Valve Disorders

Congenital Heart Defects

Heart Failure

By Distribution Channel

Direct Sales

Distributors

Online Sales

By Region

North America

Europe

Asia-Pacific

Latin America

Middle East & Africa

By Price Range

Premium

Mid-range

Economy

By Patient Demographics

Pediatric Patients

Adult Patients

Geriatric Patients

Key Target Audience

Investors and Venture Capitalist Firms

Government and Regulatory Bodies (e.g., FDA, EMA)

Manufacturers and Producers

Distributors and Retailers

Healthcare Providers and Hospitals

Medical Device Regulatory Consultants

Health Insurance Companies

Clinical Research Organizations

Players Mentioned in the Report:

Abbott Laboratories

Medtronic plc

Boston Scientific Corporation

Edwards Lifesciences Corporation

LivaNova PLC

JenaValve Technology, Inc.

CardioKinetix

Biomerics

Comed BV

Braile Biomedica

JOTEC GmbH

Valcare Medical

W. L. Gore & Associates, Inc.

Cardiovascular Systems, Inc.

Neovasc Inc.

CryoLife, Inc.

Biotronik SE & Co. KG

AtriCure, Inc.

Terumo Corporation

Cardiac Dimensions, Inc.

Table of Contents

Market Assessment Phase

1. Executive Summary and Approach


2. Global Structural Heart Devices Market Overview

2.1 Key Insights and Strategic Recommendations

2.2 Global Structural Heart Devices Market Overview

2.3 Definition and Scope

2.4 Evolution of Market Ecosystem

2.5 Timeline of Key Regulatory Milestones

2.6 Value Chain & Stakeholder Mapping

2.7 Business Cycle Analysis

2.8 Policy & Incentive Landscape


3. Global Structural Heart Devices Market Analysis

3.1 Growth Drivers

3.1.1 Increasing prevalence of structural heart diseases
3.1.2 Advancements in minimally invasive surgical techniques
3.1.3 Rising geriatric population
3.1.4 Growing healthcare expenditure

3.2 Market Challenges

3.2.1 High cost of structural heart devices
3.2.2 Stringent regulatory approvals
3.2.3 Lack of skilled professionals
3.2.4 Complications associated with procedures

3.3 Market Opportunities

3.3.1 Emerging markets with increasing healthcare access
3.3.2 Technological innovations in device design
3.3.3 Collaborations and partnerships for R&D
3.3.4 Expansion of telemedicine and remote monitoring

3.4 Market Trends

3.4.1 Shift towards personalized medicine
3.4.2 Integration of AI and machine learning in diagnostics
3.4.3 Increased focus on patient-centric care
3.4.4 Growth of outpatient procedures

3.5 Government Regulation

3.5.1 FDA guidelines for device approval
3.5.2 CE marking requirements in Europe
3.5.3 Reimbursement policies for heart procedures
3.5.4 Safety standards for medical devices

4. SWOT Analysis


5. Stakeholder Analysis


6. Porter's Five Forces Analysis


7. Global Structural Heart Devices Market Market Size, 2019-2024

7.1 By Value

7.2 By Volume

7.3 By Average Selling Price


8. Global Structural Heart Devices Market Segmentation

8.1 By Type

8.1.1 Transcatheter Aortic Valve Replacement (TAVR)
8.1.2 Transcatheter Mitral Valve Replacement (TMVR)
8.1.3 Mitral Valve Repair Devices
8.1.4 Left Atrial Appendage Closure Devices
8.1.5 Septal Occluders
8.1.6 Annuloplasty Rings
8.1.7 Heart Valve Repair Devices
8.1.8 Accessories and Other Devices

8.2 By End-User

8.2.1 Hospitals
8.2.2 Cardiac Centers
8.2.3 Ambulatory Surgical Centers
8.2.4 Research Institutions

8.3 By Application

8.3.1 Aortic Valve Disorders
8.3.2 Mitral Valve Disorders
8.3.3 Congenital Heart Defects
8.3.4 Heart Failure

8.4 By Distribution Channel

8.4.1 Direct Sales
8.4.2 Distributors
8.4.3 Online Sales

8.5 By Region

8.5.1 North America
8.5.2 Europe
8.5.3 Asia-Pacific
8.5.4 Latin America
8.5.5 Middle East & Africa

8.6 By Price Range

8.6.1 Premium
8.6.2 Mid-range
8.6.3 Economy

8.7 By Patient Demographics

8.7.1 Pediatric Patients
8.7.2 Adult Patients
8.7.3 Geriatric Patients

9. Global Structural Heart Devices Market Competitive Analysis

9.1 Market Share of Key Players

9.2 Cross Comparison of Key Players

9.2.1 Company Name
9.2.2 Group Size (Large, Medium, or Small as per industry convention)
9.2.3 Revenue Growth Rate (YoY, 3-year CAGR)
9.2.4 Market Penetration Rate (Geographic coverage, hospital adoption)
9.2.5 Product Portfolio Breadth (Number of FDA/CE-approved devices)
9.2.6 Clinical Trial Pipeline (Number of ongoing/pending trials)
9.2.7 R&D Investment (% of revenue)
9.2.8 Gross Margin
9.2.9 Regulatory Approvals (Number of new approvals in last 3 years)
9.2.10 Brand Recognition (Market share, physician surveys)

9.3 SWOT Analysis of Top Players

9.4 Pricing Analysis

9.5 Detailed Profile of Major Companies

9.5.1 Abbott Laboratories
9.5.2 Medtronic plc
9.5.3 Boston Scientific Corporation
9.5.4 Edwards Lifesciences Corporation
9.5.5 LivaNova PLC
9.5.6 JenaValve Technology, Inc.
9.5.7 CardioKinetix
9.5.8 Biomerics
9.5.9 Comed BV
9.5.10 Braile Biomédica
9.5.11 JOTEC GmbH
9.5.12 Valcare Medical
9.5.13 W. L. Gore & Associates, Inc.
9.5.14 Cardiovascular Systems, Inc.
9.5.15 Neovasc Inc.
9.5.16 CryoLife, Inc.
9.5.17 Biotronik SE & Co. KG
9.5.18 AtriCure, Inc.
9.5.19 Terumo Corporation
9.5.20 Cardiac Dimensions, Inc.

10. Global Structural Heart Devices Market End-User Analysis

10.1 Procurement Behavior of Key Ministries

10.1.1 Budget Allocation for Cardiac Care
10.1.2 Preference for Local vs. International Suppliers
10.1.3 Evaluation Criteria for Device Selection

10.2 Corporate Spend on Infrastructure & Energy

10.2.1 Investment in Cardiac Care Facilities
10.2.2 Funding for Research and Development
10.2.3 Partnerships with Medical Device Manufacturers

10.3 Pain Point Analysis by End-User Category

10.3.1 Access to Advanced Treatment Options
10.3.2 Affordability of Procedures
10.3.3 Availability of Trained Healthcare Professionals

10.4 User Readiness for Adoption

10.4.1 Awareness of New Technologies
10.4.2 Training Programs for Healthcare Providers
10.4.3 Patient Education Initiatives

10.5 Post-Deployment ROI and Use Case Expansion

10.5.1 Measurement of Treatment Outcomes
10.5.2 Cost-Benefit Analysis of Devices
10.5.3 Expansion into New Patient Segments

11. Global Structural Heart Devices Market Future Size, 2025-2030

11.1 By Value

11.2 By Volume

11.3 By Average Selling Price


Go-To-Market Strategy Phase

1. Whitespace Analysis + Business Model Canvas

1.1 Market Gaps Identification

1.2 Value Proposition Development

1.3 Revenue Streams Analysis

1.4 Key Partnerships

1.5 Cost Structure Evaluation

1.6 Customer Segmentation

1.7 Channels of Distribution


2. Marketing and Positioning Recommendations

2.1 Branding Strategies

2.2 Product USPs

2.3 Target Audience Identification

2.4 Communication Strategy

2.5 Digital Marketing Approaches


3. Distribution Plan

3.1 Urban Retail Strategies

3.2 Rural NGO Tie-ups

3.3 Online Distribution Channels

3.4 Partnerships with Healthcare Providers


4. Channel & Pricing Gaps

4.1 Underserved Routes

4.2 Pricing Bands Analysis

4.3 Competitor Pricing Strategies


5. Unmet Demand & Latent Needs

5.1 Category Gaps

5.2 Consumer Segments Analysis

5.3 Emerging Trends in Patient Needs


6. Customer Relationship

6.1 Loyalty Programs

6.2 After-sales Service

6.3 Customer Feedback Mechanisms


7. Value Proposition

7.1 Sustainability Initiatives

7.2 Integrated Supply Chains

7.3 Competitive Advantages


8. Key Activities

8.1 Regulatory Compliance

8.2 Branding Efforts

8.3 Distribution Setup


9. Entry Strategy Evaluation

9.1 Domestic Market Entry Strategy

9.1.1 Product Mix Considerations
9.1.2 Pricing Band Strategy
9.1.3 Packaging Innovations

9.2 Export Entry Strategy

9.2.1 Target Countries Identification
9.2.2 Compliance Roadmap Development

10. Entry Mode Assessment

10.1 Joint Ventures

10.2 Greenfield Investments

10.3 Mergers & Acquisitions

10.4 Distributor Model Evaluation


11. Capital and Timeline Estimation

11.1 Capital Requirements

11.2 Timelines for Market Entry


12. Control vs Risk Trade-Off

12.1 Ownership vs Partnerships


13. Profitability Outlook

13.1 Breakeven Analysis

13.2 Long-term Sustainability Strategies


14. Potential Partner List

14.1 Distributors

14.2 Joint Ventures

14.3 Acquisition Targets


15. Execution Roadmap

15.1 Phased Plan for Market Entry

15.1.1 Market Setup
15.1.2 Market Entry
15.1.3 Growth Acceleration
15.1.4 Scale & Stabilize

15.2 Key Activities and Milestones

15.2.1 Milestone Planning
15.2.2 Activity Tracking

Research Methodology

ApproachModellingSample

Phase 1: Approach1

Desk Research

  • Analysis of market reports from industry associations such as the American College of Cardiology
  • Review of published articles in peer-reviewed journals focusing on structural heart interventions
  • Examination of regulatory filings and approvals from the FDA and EMA related to heart devices

Primary Research

  • Interviews with cardiologists specializing in structural heart disease treatments
  • Surveys conducted with hospital procurement departments regarding device purchasing trends
  • Field interviews with medical device sales representatives to gather insights on market dynamics

Validation & Triangulation

  • Cross-validation of findings through multiple data sources including clinical trial results and market surveys
  • Triangulation of data from healthcare providers, manufacturers, and regulatory bodies
  • Sanity checks through expert panel discussions with industry veterans and thought leaders

Phase 2: Market Size Estimation1

Top-down Assessment

  • Estimation of market size based on global healthcare expenditure on cardiovascular diseases
  • Segmentation of market data by device type, including transcatheter aortic valves and left atrial appendage closure devices
  • Incorporation of demographic trends and prevalence rates of heart diseases across regions

Bottom-up Modeling

  • Collection of sales data from leading manufacturers of structural heart devices
  • Estimation of market share based on unit sales and average selling prices of devices
  • Volume x price analysis to derive revenue projections for each device category

Forecasting & Scenario Analysis

  • Multi-factor regression analysis incorporating factors such as aging population and technological advancements
  • Scenario modeling based on potential changes in healthcare policies and reimbursement rates
  • Development of baseline, optimistic, and pessimistic forecasts through 2030

Phase 3: CATI Sample Composition1

Scope Item/SegmentSample SizeTarget Respondent Profiles
Cardiologists in Major Hospitals80Interventional Cardiologists, Electrophysiologists
Healthcare Procurement Managers60Hospital Procurement Officers, Supply Chain Managers
Medical Device Sales Representatives50Sales Managers, Territory Managers
Clinical Researchers in Cardiology40Clinical Trial Coordinators, Research Scientists
Regulatory Affairs Specialists40Regulatory Managers, Compliance Officers

Frequently Asked Questions

What is the current value of the Global Structural Heart Devices Market?

The Global Structural Heart Devices Market is valued at approximately USD 16 billion, driven by the increasing prevalence of heart diseases, advancements in minimally invasive surgical techniques, and rising healthcare expenditure, particularly among aging populations.

What are the key drivers of growth in the Structural Heart Devices Market?

Which regions dominate the Global Structural Heart Devices Market?

What types of devices are included in the Structural Heart Devices Market?

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