세계의 구조 심장 장치 시장(2025-2033년)

The global structural heart devices market reached US$ 14.79 billion in 2024 and is expected to reach US$ 28.84 billion by 2033, growing at a CAGR of 8.0% during the forecast period 2025-2033.

Structural heart devices are specialized medical devices used to treat a variety of problems affecting the heart's structure, such as its valves, walls, or chambers. These disorders might be congenital (existing at birth) or develop over time as a result of factors such as age, high blood pressure, or other cardiovascular diseases. The most prevalent structural heart conditions are aortic valve disease, mitral valve disease, atrial septal defects (ASD), and ventricular septal defects (VSD). These anomalies can cause serious health problems if left untreated, typically demanding surgical intervention or device placement.

The increasing demand for structural heart devices is the driving factor that drives the market over the forecast period. The surge in the demand is due to this surge is primarily due to an increase in the frequency of cardiovascular diseases, which are becoming more common as lifestyles change and populations age. Many individuals require structural heart devices to treat problems such as aortic stenosis, creating a greater demand for novel devices. As healthcare technology progresses and more minimally invasive procedures become available, the market for structural heart devices is expected to grow significantly.

Market Dynamics: Drivers & Restraints

Increasing demand for structural heart devices

The increasing demand for structural heart devices is expected to be a significant factor in the growth of the global structural heart devices market. The demand for structural heart devices is increasing owing to the rising prevalence of cardiovascular diseases, technological advancements, growing awareness regarding structural heart devices, and recent launches and approvals.

As individuals grow older and lifestyle-related risk factors such as obesity and sedentary behavior become more frequent, the prevalence of heart valve problems rises. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for structural heart devices that can restore normal heart function and improve patient outcomes. For instance, according to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. One person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease, that's 1 in every 5 deaths.

Furthermore, advances in device design and materials have resulted in the development of more robust and biocompatible cardiac valves and occluders. These enhancements not only increase the devices' functionality but also reduce the problems associated with previous models. Thus, newer heart valves constructed of sophisticated materials can better imitate the natural function of human valves, resulting in enhanced blood flow and fewer cases of valve regurgitation. Furthermore, extending research and clinical trials continues to broaden the applications for these devices, allowing them to be used in a larger range of patient scenarios.

There are recent product launches that are manufactured using the latest technologies. For instance, in January 2024, Occlutech announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD). Moreover, in June 2024, Medtronic plc, a global leader in healthcare technology, announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It's an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start.

High costs of procedures and devices

Factors such as high costs of procedures and devices are expected to hamper the global structural heart devices market. One of the primary issues is the significant price burden involved with structural heart device procedures, particularly modern technology like transcatheter aortic valve replacement (TAVR). These treatments frequently include not only the cost of the devices themselves, but also additional costs such as preoperative imaging, hospital stays, and postoperative care.

For instance, according to the National Institute of Health, The median out-of-pocket expenditure for valve replacement surgery using mechanical and bio-prosthetic valves was estimated to be INR107,800 (US$1684) and INR154,000 (US$2406), respectively, and for balloon valvotomy was estimated to be INR14,456 (US$367). Overall package cost per mechanical and bio-prosthetic single valve replacement surgery and balloon valvotomy procedure was estimated as INR127,919 (US$1999), INR148,919 (US$2372) and INR14,456 (US$226), respectively. These high costs can make it difficult for many patients, particularly those in low- and middle-income areas or without adequate insurance coverage, to get the therapies they need. As a result, the financial implications may discourage patients from obtaining prompt treatment, reducing total market demand.

Segment Analysis

The global structural heart devices market is segmented based on repair devices, replacement devices, application, end-user, and region.

TMVR (Transcatheter Mitral Valve Replacement) segment is expected to dominate the global structural heart devices market share

The TMVR (Transcatheter Mitral Valve Replacement) segment is anticipated to dominate the global structural heart devices market owing to its growing importance in treating mitral valve disorders, technological advancements, recent launches and approvals, and increase in the number of mitral regurgitations. As people live longer, the prevalence of age-related heart diseases, including MR, increases, needing better treatment options. TMVR provides a less intrusive alternative to standard surgical techniques, making it especially appealing to patients who are at high risk of complications from open-heart surgery. This shift toward less intrusive procedures is consistent with general trends in healthcare, which show an increasing preference for interventions that shorten recovery time and hospital stays. For instance, with a global prevalence of over 2%, mitral regurgitation is a common valvular abnormality with various causes, including congenital conditions, rheumatic fever, and degenerative changes in the valve.

Technological advances in TMVR devices have also led to their projected market dominance. Recent advances have resulted in the creation of more complex and dependable equipment that improves procedural success rates and patient outcomes. These developments include improved valve designs that provide greater hemodynamic performance and biocompatibility, as well as upgraded delivery systems that make implantation easier. As these technologies advance, they are projected to gain broader acceptability among healthcare practitioners and patients, increasing demand for TMVR solutions.

For instance, in May 2024, 4C Medical Technologies, a Minnesota-based medical device company focused on structural heart disease, received the FDA's breakthrough device designation for its AltaValve System for transcatheter mitral valve replacement (TMVR). The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation (MR) patients. It is implanted via transseptal access and positioned above the native mitral valve when implanted.

Geographical Analysis

North America is expected to hold a significant position in the global structural heart devices market share

North America will likely account for a significant share of the global structural heart devices market, owing to its advanced healthcare infrastructure, a high prevalence of cardiovascular disorders, technological advancements, and recent launches and approvals. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for structural heart devices that can restore normal heart function and improve patient outcomes.

For instance, according to the National Institute of Health, approximately 82.6 million people in the United States currently have one or more forms of cardiovascular disease (CVD), making it a leading cause of death for both men and women. Common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent. The prevalence for men is 8.3 percent and for women is 6.1 percent. About 7 million Americans aged 20 or older have had a stroke. Each year approximately 610,000 experience their first stroke and another 185,000 experience a recurrence. Approximately 87 percent of all strokes are ischemic of which 10 percent result from intracerebral hemorrhage and 3 percent result from subarachnoid hemorrhage.

The region has established itself as a pioneer in the use of advanced medical technologies, particularly in cardiovascular care. One of the most significant developments is the invention and execution of transcatheter heart valve replacement (TAVR) operations, which have transformed the therapeutic landscape for patients with aortic stenosis and other valvular disorders. TAVR is a minimally invasive alternative to standard open-heart surgery that allows for faster recovery and shorter hospital stays, which is especially useful for older patients or those with complications.

For instance, in December 2024, Heart valve developer Anteris Technologies made its U.S. stock market debut one of the few initial public offerings by a MedTech company. The successful funding from this IPO is projected to considerably boost Anteris' capabilities in creating minimally invasive cardiac solutions, aligning with the increasing demand for cardiac surgery in aging populations.

Asia Pacific is growing at the fastest pace in the global structural heart devices market

The Asia Pacific region is emerging as the fastest-growing market for structural heart devices, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of cardiovascular disorders. Cardiovascular diseases (CVDs) continue to be a prominent cause of morbidity and mortality globally, and their prevalence is significantly increasing in the Asia Pacific area. Inactive lifestyles, poor dietary habits, smoking, and increased stress are all contributing factors to this growth.

For instance, according to the National Institute of Health, annual number of deaths from CVD in India is projected to rise from 2.26 million (1990) to 4.77 million (2020). Coronary heart disease prevalence rates in India have been estimated over the past several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations.

Competitive Landscape

The major global players in the global structural heart devices market include Medtronic, Abbott, JenaValve, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Biomerics, TORAY INDUSTRIES, INC., Occlutech LLC, Shanghai MicroPort Medical (Group) Co.Ltd. among others.

Emerging Players

Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others.

Key Developments

• In November 2024, Meril Life Sciences Pvt Ltd. launched its next-generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve was launched in spite of the company's differences with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global structural heart devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Repair Devices
• 3.2. Snippet by Replacement Devices
• 3.3. Snippet by Application
• 3.4. Snippet by End-User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
  • 4.1.2. Increasing Demand for Structural Heart Devices
  • 4.1.3. Restraints
  • 4.1.4. High Costs of Procedures and Devices
  • 4.1.5. Opportunity
  • 4.1.6. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Reimbursement Analysis
• 5.6. Patent Analysis
• 5.7. SWOT Analysis
• 5.8. DMI Opinion

6. By Repair Devices

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 6.1.2. Market Attractiveness Index, By Repair Devices
• 6.2. Occluders*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Annuloplasty Devices
• 6.4. Valvuloplasty Devices
• 6.5. Others

7. By Replacement Devices

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 7.1.2. Market Attractiveness Index, By Replacement Devices
• 7.2. Mechanical Valve*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Bioprosthetic Valve
• 7.4. TAVR

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Atrial Septal Defect*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Aortic Valve Stenosis
• 8.4. Ventricular Septal Defects
• 8.5. Mitral Regurgitation
• 8.6. Others

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Ambulatory Surgical Centers
• 9.4. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. U.K.
    • 10.3.7.3. France
    • 10.3.7.4. Spain
    • 10.3.7.5. Italy
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Medtronic*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Abbott
• 12.3. JenaValve
• 12.4. Artivion, Inc
• 12.5. Boston Scientific Corporation
• 12.6. Micro Interventional Devices
• 12.7. Biomerics
• 12.8. TORAY INDUSTRIES, INC.
• 12.9. Occlutech LLC
• 12.10. Shanghai MicroPort Medical (Group) Co.Ltd.

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us