Global Heart Valve Devices Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Mechanical Heart Valves - [Aortic Valves, Mitral Valves], Biological Heart Valves - [Aortic Valves, Mitral Valves, Pulmonary Valves, Tricuspid Valves], Transcatheter Heart Valves - [Aortic Valves, Mitral Valves, and Pulmonary Valves]By Procedure;
Replacement Procedures- [Surgical Aortic Valve Replacement (SAVR), Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement, Other Replacement Procedures], Repair Procedures - [Transcatheter Mitral Valve Repair (TMVr), Transcatheter Tricuspid Valve Repair, Valvuloplasty, and Other]By Treatment;
Open Surgery and Minimally Invasive Surgery (MIS)By End Users;
Hospitals and Ambulatory Surgical CentersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global Heart Valve Devices Market (USD Million), 2021 - 2031
Heart Valve Devices Market was valued at USD 9,369.72 million in the year 2024. The size of this market is expected to increase to USD 21,717.62 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 12.8%.
Global Heart Valve Devices Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 12.8 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 12.8 % |
Market Size (2024) | USD 9,369.72 Million |
Market Size (2031) | USD 21,717.62 Million |
Market Concentration | Low |
Report Pages | 321 |
Major Players
- Abbott
- Boston Scientific Corporation
- CryoLife, Inc.
- Edward Lifesciences Corporation
- JenaValve Technology, Inc.
- Medtronic
- SYMETIS
- Neovasc, Inc.
- Sorin Group (LivaNova PLC)
- Micro Interventional Devices, Inc.
- XELTIS
- TTK HealthCare
- Lepu Medical Technology (Beijing) Co., Ltd. (Lepu Medical Group)
- Auto Tissue Berlin GmbH
- Novostia SA
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Heart Valve Devices Market
Fragmented - Highly competitive market without dominant players
The Heart Valve Devices Market is experiencing robust growth, driven by the rising incidence of cardiovascular diseases, which contribute to nearly 30% of all fatalities. An aging population and shifting lifestyle habits are significantly increasing the demand for heart valve repair and replacement devices, creating a dynamic market landscape. The development of transcatheter valve technologies has further accelerated this growth, catering to the demand for minimally invasive treatment options.
Technological Innovations Boosting Market Expansion
Cutting-edge advancements in heart valve technology are playing a pivotal role in market expansion. Nearly 40% of newly launched heart valve devices now feature advanced biomaterials and nanotechnology, enhancing durability and patient outcomes. Additionally, the integration of artificial intelligence (AI) in device design and preoperative planning is optimizing patient care, minimizing complications, and improving surgical precision.
Focus on Long-Term Device Performance
Long-term durability is a critical focus for manufacturers, as approximately 35% of innovations in this sector emphasize enhanced implant longevity and biocompatibility. This focus on long-lasting devices aims to reduce the need for repeat procedures and improve patient quality of life, reflecting a broader commitment to patient-centric solutions.
Regulatory Support and Favorable Reimbursement Policies
Supportive regulatory frameworks and streamlined reimbursement policies are further accelerating market growth. Nearly 45% of recent device approvals benefit from faster regulatory pathways and comprehensive reimbursement models, making advanced heart valve devices more accessible and financially feasible. This supportive environment is fostering innovation and encouraging higher adoption rates across healthcare systems.
Global Heart Valve Devices Market Recent Developments
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In May 2024, Edwards Lifesciences has launched its SAPIEN 3 Ultra RESILIA valve in Europe. This transcatheter aortic heart valve features the company's advanced RESILIA tissue technology, designed for enhanced durability. The device has also received CE mark approval for treating patients with heart valve disease caused by native calcific aortic stenosis
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In February 2024, Abbott Laboratories' heart valve replacement device has received approval from the U.S. Food and Drug Administration's advisory board. It is designed for patients who face a high risk of complications or death from traditional surgery
Segment Analysis
In this report, the Global Heart Valve Devices Market has been segmented by Product, Procedure, Teatment, End Users, and Geography.
Global Heart Valve Devices Market , Segmentation by Product
The Global Heart Valve Devices Market has been segmented by Product into Mechanical Heart Valves - Aortic Valves, Mitral Valves, Biological Heart Valves - Aortic Valves, Mitral Valves, Pulmonary Valves, Tricuspid Valves, Transcatheter Heart Valves - Aortic Valves, Mitral Valves, and Pulmonary Valves.
Mechanical Heart Valves – Aortic and Mitral Valves
Mechanical heart valves make up around 32% of the heart valve devices market. Known for their long-lasting performance, they are most commonly used in younger patients requiring valve replacement. Aortic valves lead this category due to high procedural volumes, while mitral valves are essential in managing complex left-heart conditions. The need for lifelong anticoagulation remains a key consideration.
Biological Heart Valves – Aortic, Mitral, Pulmonary, and Tricuspid Valves
Biological heart valves account for approximately 41% of the market and are increasingly used in patients over 65. These valves offer excellent biocompatibility and eliminate the need for continuous anticoagulation. Aortic and mitral valves dominate usage, while pulmonary and tricuspid valves are primarily used in congenital or right-sided heart valve disease.
Transcatheter Heart Valves – Aortic, Mitral, and Pulmonary Valves
Transcatheter valves, capturing around 27% of global demand, are transforming the valve replacement landscape. TAVR (Transcatheter Aortic Valve Replacement) procedures are now standard in many high-risk and intermediate-risk patients. Innovations in TMVR and TPVR are expanding this segment’s utility across diverse patient populations.
Global Heart Valve Devices Market , Segmentation by Procedure
The Global Heart Valve Devices Market has been segmented by Procedure into Replacement Procedures- Surgical Aortic Valve Replacement (SAVR), Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement, Other Replacement Procedures - Repair Procedures, Transcatheter Mitral Valve Repair (TMVr), Transcatheter Tricuspid Valve Repair, Valvuloplasty, and Other.
Replacement Procedures – SAVR, TAVR, TMVR, and Others
Replacement procedures represent the largest share of the heart valve devices market at 68%. Surgical Aortic Valve Replacement (SAVR) continues to be the gold standard for many younger and lower-risk patients. However, Transcatheter Aortic Valve Replacement (TAVR) has revolutionized care for high-risk populations and now accounts for a significant portion of procedures globally. Transcatheter Mitral Valve Replacement (TMVR) is an evolving technique, with growing interest due to its minimally invasive benefits.
Repair Procedures – TMVr, Tricuspid Valve Repair, Valvuloplasty, and Others
Repair procedures comprise about 32% of the market. TMVr (Transcatheter Mitral Valve Repair) is currently the leading repair method, offering a less invasive option for patients with mitral regurgitation. Advances in tricuspid valve repair and valvuloplasty are gaining momentum, particularly as interventional cardiology shifts toward treating previously inoperable patients with complex valve pathology.
Global Heart Valve Devices Market , Segmentation by Treatment
The Global Heart Valve Devices Market has been segmented by Treatment into Replacement procedures- Surgical aortic valve replacement (SAVR), Transcatheter aortic valve
Surgical Aortic Valve Replacement (SAVR)
SAVR remains a key treatment modality in the heart valve devices market, contributing around 42% of total procedures. It is widely used in younger patients or those with fewer comorbidities due to its superior long-term durability. While SAVR offers excellent outcomes, it involves open-heart surgery, making it less favorable for older or high-risk patients.
Transcatheter Aortic Valve Replacement (TAVR)
TAVR represents approximately 58% of the global market and continues to gain rapid adoption. This catheter-based approach allows valve replacement without open-heart surgery, significantly reducing recovery times and surgical complications. Its growing use across low-, intermediate-, and high-risk groups is fueling market expansion globally.
Global Heart Valve Devices Market , Segmentation by End Users
The Global Heart Valve Devices Market has been segmented by End Users into Hospitals, and Ambulatory Surgical Centers.
Surgical Aortic Valve Replacement (SAVR)
SAVR remains a key treatment modality in the heart valve devices market, contributing around 42% of total procedures. It is widely used in younger patients or those with fewer comorbidities due to its superior long-term durability. While SAVR offers excellent outcomes, it involves open-heart surgery, making it less favorable for older or high-risk patients.
Transcatheter Aortic Valve Replacement (TAVR)
TAVR represents approximately 58% of the global market and continues to gain rapid adoption. This catheter-based approach allows valve replacement without open-heart surgery, significantly reducing recovery times and surgical complications. Its growing use across low-, intermediate-, and high-risk groups is fueling market expansion globally.
Global Heart Valve Devices Market, Segmentation by Geography
In this report, the Global Heart Valve Devices Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
Regions and Countries Analyzed in this Report
Global Heart Valve Devices Market Share (%), by Geographical Region
North America
With a commanding 38% market share, North America dominates the heart valve devices market. The region is driven by early adoption of advanced transcatheter solutions, a strong presence of leading medical device manufacturers, and comprehensive reimbursement systems. The U.S., in particular, leads in clinical trials and procedural volume.
Europe
Europe holds a significant 27% share of the global market. Aging demographics, increased demand for minimally invasive heart valve procedures, and favorable regulatory environments are supporting sustained growth. Western Europe continues to lead in technology adoption and procedural innovation.
Asia Pacific
Asia Pacific captures about 23% of the market and is projected to expand rapidly. Rising awareness of heart valve disease, improving hospital infrastructure, and growing investment in healthcare technology are driving the regional surge. Countries like China and India are at the core of this momentum.
Middle East & Africa
Middle East & Africa account for approximately 6% of the market. The growing prevalence of cardiovascular conditions, expanding specialty hospitals, and supportive government initiatives are gradually improving access to heart valve procedures in key Gulf nations and parts of Africa.
Latin America
Latin America represents nearly 6% of global market value. With Brazil and Mexico at the forefront, the region is seeing increased procedural adoption in urban centers. However, economic constraints and limited reimbursement coverage present ongoing barriers to widespread market penetration.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Heart Valve Devices Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
---|---|---|---|---|---|
Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Rapid growth in cardiovascular disease cases
- Increasing prevalence of cardiovascular diseases
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Growing adoption of minimally invasive procedures - Growing adoption of minimally invasive procedures is significantly impacting the heart valve devices market by offering benefits such as faster recovery, reduced pain, and lower infection risk compared to traditional surgeries. These advantages have led to a rise in preference among patients and healthcare providers for less invasive treatment options, which is boosting demand for advanced heart valve devices.
This trend is especially important for elderly patients and high-risk individuals, expanding the potential patient base. Healthcare facilities are increasingly investing in modern technology and specialized training to support minimally invasive techniques, further driving market growth. The shorter hospital stays associated with these procedures also help reduce overall treatment costs, attracting more adoption globally.
Manufacturers are responding by developing innovative materials and designs optimized for minimally invasive use, enhancing device durability and patient compatibility. As focus continues on improving patient outcomes and reducing complications, the momentum behind minimally invasive heart valve interventions is expected to propel the market forward.
Restraints
- High cost of heart valve devices
- Limited access to advanced healthcare infrastructure
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Risk of complications associated with procedures - The risk of complications linked to heart valve procedures remains a major challenge for market expansion. Despite medical advances, surgeries including both open-heart and minimally invasive carry risks such as bleeding, infection, valve failure, and embolism, which can affect recovery and overall patient health.
These potential complications often discourage patients and providers from pursuing valve replacement or repair, particularly in regions lacking advanced medical infrastructure. Concerns about adverse effects and lengthy rehabilitation periods can lower adoption rates and limit market penetration. Additionally, insurance companies may impose stricter policies or higher costs due to these risks.
Device manufacturers must invest heavily in research and development to enhance safety and reduce procedural risks. Regulatory approval processes demand extensive clinical evidence of device efficacy and safety, potentially delaying new product launches and increasing expenses. Consequently, procedural risks continue to act as a significant restraint on market growth.
Opportunities
- Development of innovative products
- Focus on personalized medicine
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Integration of digital health solutions - The integration of digital health solutions offers substantial growth opportunities for the heart valve devices market. Technologies like remote monitoring, telemedicine, and AI-powered diagnostics improve pre-surgery evaluation, enhance surgical precision, and facilitate better post-operative care, all of which contribute to improved patient outcomes.
Continuous monitoring enabled by digital tools allows for early detection of complications, enabling timely medical interventions and reducing hospital readmissions. This proactive management not only enhances patient safety but also lowers long-term treatment costs and improves healthcare efficiency.
Digital integration also streamlines clinical workflows and supports personalized treatment plans tailored to individual patient needs. Collaborations between medical device companies and technology firms are driving innovation, aligning with healthcare trends toward value-based care and patient-centric approaches, thus broadening market reach and impact.
Competitive Landscape Analysis
Key players in Global Heart Valve Devices Market include:
- Abbott
- Boston Scientific Corporation
- CryoLife, Inc.
- Edward Lifesciences Corporation
- JenaValve Technology, Inc.
- Medtronic
- SYMETIS
- Neovasc, Inc.
- Sorin Group (LivaNova PLC)
- Micro Interventional Devices, Inc.
- XELTIS
- TTK HealthCare
- Lepu Medical Technology (Beijing) Co., Ltd. (Lepu Medical Group)
- Auto Tissue Berlin GmbH
- Novostia SA
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Procedure
- Market Snapshot, By Treatment
- Market Snapshot, By End Users
- Market Snapshot, By Region
- Global Heart Valve Devices Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Rapid growth in cardiovascular disease cases
- Increasing prevalence of cardiovascular diseases
- Growing adoption of minimally invasive procedures
- Restraints
- High cost of heart valve devices
- Limited access to advanced healthcare infrastructure
- Risk of complications associated with procedures
- Opportunities
- Development of innovative products
- Focus on personalized medicine
- Integration of digital health solutions
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Heart Valve Devices Market, By Product, 2021 - 2031 (USD Million)
- Mechanical Heart Valves
- Aortic Valves
- Mitral Valves
- Biological Heart Valves
- Aortic Valves
- Mitral Valves
- Pulmonary Valves
- Tricuspid Valves
- Transcatheter Heart Valves
- Aortic Valves
- Mitral Valves
- Pulmonary Valves
- Mechanical Heart Valves
- Global Heart Valve Devices Market, By Procedure, 2021 - 2031 (USD Million)
- Procedure
- Replacement procedures
- Surgical aortic valve replacement (SAVR)
- Transcatheter aortic valve replacement (TAVR)
- Transcatheter mitral valve replacement (TMVR)
- Other replacement procedures
- Repair procedures
- Transcatheter mitral valve repair (TMVr)
- Transcatheter tricuspid valve repair (TTVr)
- Valvuloplasty
- Other
- Procedure
- Global Heart Valve Devices Market, By Treatment, 2021 - 2031 (USD Million)
- Open Surgery
- Minimally Invasive Surgery (MIS)
- Global Heart Valve Devices Market, By End Users, 2021 - 2031 (USD Million)
- Hospitals
- Ambulatory Surgical Centers
- Global Heart Valve Devices Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Heart Valve Devices Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Abbott
- Boston Scientific Corporation
- CryoLife, Inc.
- Edward Lifesciences Corporation
- JenaValve Technology, Inc.
- Medtronic
- SYMETIS
- Neovasc, Inc.
- Sorin Group (LivaNova PLC)
- Micro Interventional Devices, Inc.
- XELTIS
- TTK HealthCare
- Lepu Medical Technology (Beijing) Co., Ltd. (Lepu Medical Group)
- Auto Tissue Berlin GmbH
- Novostia SA
- Company Profiles
- Analyst Views
- Future Outlook of the Market