세계의 구조 심장 장치 시장 : 예측 - 제품별, 수기별, 연령층별, 적응증별, 최종 사용자별, 지역별 분석(-2032년)

According to Stratistics MRC, the Global Structural Heart Devices Market is accounted for $8.73 billion in 2025 and is expected to reach $18.47 billion by 2032 growing at a CAGR of 11.3% during the forecast period. Medical implants or instruments called structural heart devices are made to replace or fix broken or flawed cardiac components, such as walls, valves, or internal openings. When it comes to treating conditions like valve stenosis, regurgitation, atrial septal defects, and left atrial appendage closure, these devices are essential. Because structural heart devices offer patients a quicker recovery and fewer complications than open heart surgery, their use has increased dramatically due to advancements in minimally invasive procedures like transcatheter techniques. Moreover, the need for these devices is increasing in all global healthcare systems due to the aging population and the rising incidence of cardiovascular diseases.

According to the World Health Organization (WHO), cardiovascular diseases (CVDs) are the leading cause of death globally, claiming an estimated 17.9 million lives each year. These diseases encompass a range of heart and blood vessel disorders, including coronary heart disease, cerebrovascular disease, and rheumatic heart disease.

Market Dynamics:

Driver:

Increasing cardiovascular disease prevalence

Structural heart conditions like valvular heart disease, septal defects, and abnormalities of the left atrial appendage are major contributors to the growing global burden of cardiovascular diseases (CVDs). Almost 18 million deaths annually are attributed to CVDs, according to the World Health Organization. Demand for structural heart devices like transcatheter valves, occluders, and annuloplasty rings is fueled by the rising prevalence of conditions like aortic stenosis and mitral valve regurgitation, which call for surgical or catheter-based intervention. Timely device-based intervention is crucial in lowering morbidity and mortality because these conditions frequently worsen over time.

Restraint:

Expensive equipment and procedures

High procedural and device costs are linked to structural heart interventions, particularly those that use transcatheter techniques like TAVR or TMVR. When hospital expenses, imaging, and post-operative care are added to the high cost of a single transcatheter valve-which can reach $30,000-the overall burden on patients and healthcare systems is substantial. Access to these life-saving procedures is further limited in low- and middle-income countries (LMICs) by a lack of insurance coverage and inadequate healthcare funding. Additionally, health technology agencies' cost-effectiveness evaluations can impede or postpone broad adoption, even in developed countries, especially for patients who are asymptomatic or at intermediate risk.

Opportunity:

Creation of customized and up-and-coming equipment

The development of next-generation structural heart devices that provide enhanced safety, robustness, and usability has enormous potential. In order to reduce complications and increase procedural control, companies are concentrating on creating smaller, fully retrievable, and repositionable valves. owing to developments in digital imaging and 3D printing, customized and patient-specific devices can also maximize fit and function, particularly in cases that present anatomical challenges. Furthermore, these devices may offer real-time monitoring, enhance post-procedure care and lower hospital readmission rates by incorporating smart sensors and digital health technologies.

Threat:

High levels of price pressure and market competition

Major companies like Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific are constantly innovating and diversifying their portfolios in the fiercely competitive structural heart market. Although competition encourages creativity, it also increases pricing pressure, particularly as more businesses enter the market. Hospitals' tender-based procurement practices, consumers' increasing desire for economical solutions, and discussions with health systems and insurers frequently result in lower costs. Moreover, profit margins may be adversely affected by this price sensitivity, especially for startups or smaller businesses with constrained economies of scale.

Covid-19 Impact:

The COVID-19 pandemic had a significant short-term impact on the Structural Heart Devices Market, primarily due to the postponement of elective procedures and the reallocation of hospital resources toward critical care. Procedure volumes and device sales temporarily decreased as a result of the postponement of numerous structural heart interventions, such as transcatheter valve replacements and repairs, during the height of pandemic waves. Additionally, the production and distribution of medical devices were also impacted by disruptions in the global supply chain. On the other hand, the pandemic also hastened the adoption of digital health technologies and reaffirmed the significance of shorter hospital stays and minimally invasive procedures, which ultimately favor structural heart interventions.

The aortic valve stenosis segment is expected to be the largest during the forecast period

The aortic valve stenosis segment is expected to account for the largest market share during the forecast period, due to the widespread use of Transcatheter Aortic Valve Replacement (TAVR) procedures and their high prevalence in the elderly population. A less invasive option to surgical valve replacement, TAVR has gained popularity, especially for patients with high or intermediate surgical risk. Adoption rates have been greatly increased by improvements in procedure outcomes, expanded indications for lower-risk patients, and device design advancements. Furthermore, this segment is a major driver of growth in the structural heart intervention landscape due to rising awareness, reimbursement support, and clinical success rates.

The ambulatory surgical centers (ASCs) segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the ambulatory surgical centers (ASCs) segment is predicted to witness the highest growth rate. because of the increasing trend toward outpatient care and minimally invasive procedures. ASCs have several benefits, including lower procedure costs, shorter hospital stays, quicker patient turnover, and a lower chance of hospital-acquired infections. These centers can now perform many structural heart interventions, particularly transcatheter procedures, owing to improvements in procedural safety and device miniaturization. Growing investments, advantageous reimbursement reforms, and patient preference for convenient care settings are all contributing to ASCs' explosive growth and establishing them as a key growth engine in the field of structural heart treatment.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, driven by its growing geriatric population, high prevalence of cardiovascular diseases, and sophisticated healthcare infrastructure. In addition to the presence of major market players and established reimbursement policies, the region benefits from large investments in research and development. Additionally, strong market growth is also a result of growing awareness of minimally invasive procedures and the growing use of cutting-edge technologies like transcatheter aortic valve replacement (TAVR) and left atrial appendage closure.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. Numerous factors, such as an aging population, easier access to healthcare, and growing awareness of cardiovascular diseases, are responsible for this rapid expansion. India is leading the way in the market for structural heart devices. Furthermore, driving market expansion in the area is the use of minimally invasive procedures like Left Atrial Appendage Closure (LAAC) and Transcatheter Aortic Valve Replacement (TAVR).

Key players in the market

Some of the key players in Structural Heart Devices Market include Boston Scientific Corporation, Artivion, Inc., Medtronic Plc, Edwards Lifesciences Corporation, Abbott Laboratories, JenaValve Technology, Inc., LivaNova PLC, Meril Lifesciences Pvt. Ltd, LifeTech Scientific Corporation, Terumo Corporation, Numed Inc, Atricure, Inc, Cook Group Incorporated, Lepu Medical Inc and Braile Biomedica Inc.

Key Developments:

In May 2025, Artivion, Inc announced that it entered into separate, privately negotiated exchange agreements with certain holders of its 4.250% Convertible Senior Notes due 2025. Under the exchange agreements, the company will, subject to customary closing conditions, repurchase approximately $95 million principal amount of Existing Convertible Notes in exchange for a number of shares of the company's common stock to be determined based on the trading price of the common stock over a four trading day averaging period beginning.

In April 2025, Medtronic plc announced a strategic agreement to distribute the advanced Dragonfly(TM)* pancreaticobiliary system from Dragonfly Endoscopy, Inc. in the United States. This innovative platform introduces significant enhancements in pancreaticobiliary endoscopy - a field where procedural standards have remained largely unchanged for decades. Financial terms of the agreement were not disclosed.

In March 2025, Boston Scientific Corporation announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the TIVUS(TM) Intravascular Ultrasound System. An investigational technology, the TIVUS system is designed to denervate nerves surrounding blood vessels to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension.

Products Covered:

• Heart Valve Devices
• Annuloplasty Rings
• Occluders and Delivery Systems
• Accessories

Procedures Covered:

• Replacement Procedure
• Repair Procedure

Age Groups Covered:

• Pediatric
• Adults

Indications Covered:

• Atrial Septal Defect (ASD)
• Ventricular Septal Defect (VSD)
• Patent Foramen Ovale (PFO)
• Aortic Valve Stenosis
• Other Indications

End Users Covered:

• Hospitals
• Ambulatory Surgical Centers
• Cardiac Catheterization Labs
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Structural Heart Devices Market, By Product

• 5.1 Introduction
• 5.2 Heart Valve Devices
  • 5.2.1 Surgical Heart Valves
  • 5.2.2 Transcatheter Heart Valves
• 5.3 Annuloplasty Rings
• 5.4 Occluders and Delivery Systems
• 5.5 Accessories

6 Global Structural Heart Devices Market, By Procedure

• 6.1 Introduction
• 6.2 Replacement Procedure
  • 6.2.1 Surgical Aortic Valve Replacement (SAVR)
  • 6.2.2 Transcatheter Aortic Valve Replacement (TAVR)
  • 6.2.3 Transcatheter Mitral Valve Replacement (TMVR)
  • 6.2.4 Other Replacement Procedures
• 6.3 Repair Procedure
  • 6.3.1 Left Atrial Appendage Closure (LAAC)
  • 6.3.2 Transcatheter Mitral Valve Repair (TMVr)
  • 6.3.3 Transcatheter Tricuspid Valve Repair (TTVr)
  • 6.3.4 Valvuloplasty
  • 6.3.5 Other Repair Procedures

7 Global Structural Heart Devices Market, By Age Group

• 7.1 Introduction
• 7.2 Pediatric
• 7.3 Adults

8 Global Structural Heart Devices Market, By Indication

• 8.1 Introduction
• 8.2 Atrial Septal Defect (ASD)
• 8.3 Ventricular Septal Defect (VSD)
• 8.4 Patent Foramen Ovale (PFO)
• 8.5 Aortic Valve Stenosis
• 8.6 Other Indications

9 Global Structural Heart Devices Market, By End User

• 9.1 Introduction
• 9.2 Hospitals
• 9.3 Ambulatory Surgical Centers
• 9.4 Cardiac Catheterization Labs
• 9.5 Other End Users

10 Global Structural Heart Devices Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Boston Scientific Corporation
• 12.2 Artivion, Inc.
• 12.3 Medtronic Plc
• 12.4 Edwards Lifesciences Corporation
• 12.5 Abbott Laboratories
• 12.6 JenaValve Technology, Inc.
• 12.7 LivaNova PLC
• 12.8 Meril Lifesciences Pvt. Ltd
• 12.9 LifeTech Scientific Corporation
• 12.10 Terumo Corporation
• 12.11 Numed Inc
• 12.12 Atricure, Inc
• 12.13 Cook Group Incorporated
• 12.14 Lepu Medical Inc
• 12.15 Braile Biomedica Inc