Transcatheter Aortic Valve Replacement Market Size
Study Period | 2019 - 2029 |
Market Size (2024) | USD 6.03 Billion |
Market Size (2029) | USD 9.61 Billion |
CAGR (2024 - 2029) | 9.78 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Major Players*Disclaimer: Major Players sorted in no particular order |
Transcatheter Aortic Valve Replacement Market Analysis
The Transcatheter Aortic Valve Replacement Market size is estimated at USD 6.03 billion in 2024, and is expected to reach USD 9.61 billion by 2029, growing at a CAGR of 9.78% during the forecast period (2024-2029).
Factors such as the increasing burden of aortic stenosis coupled with a growing geriatric population, rising demand for minimally invasive procedures, and technological advancements are expected to boost the growth of the transcatheter aortic valve replacement market during the forecast period.
Transcatheter aortic valve replacement (TAVR) has become a crucial intervention for patients previously deemed inoperable, offering both symptom relief and a statistically significant reduction in mortality. Numerous studies have evaluated the progression of TAVR devices and their efficacy in treating aortic stenosis. For instance, a May 2023 article published in the Methodist DeBakey Cardiovascular Journal highlighted that, due to ongoing advancements in procedural techniques and device technology, TAVR has revolutionized the treatment approach for aortic stenosis patients over the last twenty years.
In addition to the above context, next-generation transcatheter heart valve devices, including the Acurate NEO2 THV and SAPIEN X4 THV, are demonstrating enhanced safety and efficacy compared to earlier models. With a heightened emphasis on the long-term management of aortic stenosis, these newer devices are particularly relevant as younger and lower-risk patients are anticipated to outlive their transcatheter heart valves (THV). Consequently, the superior safety and effectiveness of these advanced TAVR devices are poised to boost their adoption in TAVR procedures, driving the market's growth during the forecast period.
Furthermore, the rising adoption of TAVR systems for aortic stenosis treatment is set to boost market demand for these products, fueling the market's growth. For instance, in June 2023, Onecera Medical made strides by successfully implanting its Crea Aortic Valve, a transcatheter aortic valve replacement (TAVR) system, to treat aortic stenosis. Onecera Medical’s valve boasts a distinctive concave and convex design, ensuring a secure anchor in the aortic annulus. Additionally, the valve's differential radial force technology allows for varying radial forces based on its position within the annulus and aorta. As a result, these innovative systems are transforming TAVR procedures, positioning them as key drivers of the market's growth in the coming years.
Moreover, the introduction and approval of new products are set to boost the demand for next-generation offerings in the market, driving the market's expansion. For instance, in May 2024, Edwards Lifesciences unveiled the Sapien 3 Ultra Resilia valve in Europe. This valve is the sole transcatheter aortic valve replacement (TAVR) system featuring the company's innovative Resilia tissue technology. The newly introduced TAVR system caters to patients with heart valve disease, whether due to native calcific aortic stenosis across all surgical risk levels or due to the failure of a previous transcatheter or surgical bioprosthetic valve, especially those deemed at high risk for open surgical therapy. Thus, the launch of technologically advanced TAVR systems is expected to propel their adoption, especially for patients at high risk for open surgeries, bolstering the market's growth.
Therefore, the rising development of TAVR systems coupled with the growing number of research studies evaluating their effectiveness and safety in treating aortic stenosis, increasing adoption of TAVR systems across healthcare facilities, and new product launches by the key players, the studied market is expected to grow during the forecast period. However, the high cost of devices and procedures, severe risk associated with TAVR, and limited reimbursement are expected to impede the growth of the studied market during the forecast period.
Transcatheter Aortic Valve Replacement Market Trends
The Self-expanding Valves Segment is Expected to Witness Significant Growth Over the Forecast Period
The self-expanding valves segment is expected to witness significant growth during the forecast period due to rising demand for minimally invasive procedures, improvements in TAVR technology, better imaging and device design, and the growing number of research studies.
Several studies were conducted to assess the effectiveness of implanting intra-annular self-expandable valves (IA-SEV), Navitor, in Asian patients. For instance, a July 2024 article in Elsevier highlighted that IA-SEV showed excellent hemodynamic results and reduced paravalvular leakage, irrespective of valve size. This underscores the IA-SEV's value as a transcatheter heart valve, particularly for Asian patients who often have a smaller annulus. Consequently, such findings are anticipated to boost IA-SEV adoption as it facilitates less invasive procedures, leading to rapid recovery times and reduced hospital stays, making self-expandable TAVR devices more appealing to patients and providers, propelling the segment's growth in the coming years.
Similarly, in April 2024, a study that evaluated the efficacy of self-expanding versus balloon-expandable TAVR in patients with a small aortic annulus was published in the New England Journal of Medicine. The findings revealed that for patients with severe aortic stenosis and a small aortic annulus undergoing TAVR, the self-expanding supra-annular valve matched the clinical outcomes of the balloon-expandable valve and outperformed it in terms of bioprosthetic-valve dysfunction over 12 months. This equivalence and advantage of the self-expanding supra-annular valve grant healthcare providers greater flexibility in valve selection tailored to individual patient anatomy. Consequently, this is anticipated to broaden treatment options for patients with aortic stenosis, thereby fueling the segment's growth.
Moreover, as regulatory bodies increasingly approve new products, the demand for these advanced offerings is set to surge, driving the segment's growth. For instance, in March 2024, Medtronic secured approval from the United States Food and Drug Administration (FDA) for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system to treat symptomatic severe aortic stenosis. The Evolut FX+ TAVR system upholds the performance advantages of its predecessor, the legacy Evolut TAVR platform, and is engineered to enhance coronary access. This introduction underscores Medtronic's unwavering dedication to pioneering minimally invasive solutions for physicians addressing aortic stenosis in their patients.
With the rising number of studies evaluating the effectiveness and safety of self-expandable TAVR in aortic patients and new product approvals, the studied segment is expected to grow during the forecast period.
North America is Expected to Hold a Significant Share in the Market During the Forecast Period
North America is anticipated to have significant market growth over the forecast period owing to the rising prevalence of aortic stenosis, continuous improvement in valve design and delivery systems to enhance the safety and effectiveness of TAVR procedures, new product approvals, increasing preference for minimally invasive procedures, and favorable reimbursement policies in the region.
Various studies evaluated the use of the trilogy transcatheter heart valve for transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation. For instance, an April 2024 article in the Lancet journal underscored the safety and efficacy of employing a specialized transcatheter heart valve for treating native aortic regurgitation. It was observed that the initial clinical and hemodynamic outcomes are promising, alongside indications of left ventricular remodeling. These findings suggested that the trilogy transcatheter heart valve offers a viable treatment avenue for patients with significant aortic regurgitation, likely driving its increased adoption and subsequently fueling the market's growth during the forecast period.
As the treatment of choice for patients with aortic stenosis, the use of transcatheter aortic valve replacement (TAVR) systems is on the rise in the region. This trend is set to boost the demand for advanced TAVR systems, driving the market's growth. For instance, in May 2024, UPMC Harrisburg successfully conducted a pioneering TAVR procedure on a woman from Perry County, utilizing the Evolut FX+ TAVR system. The newly introduced Evolut FX+ TAVR system retains the performance advantages of its predecessor, the legacy Evolut TAVR platform. However, it boasts a modified diamond-shaped frame design, offering a coronary access window that's four times larger than earlier Evolut TAVR models. Additionally, the Evolut FX+ enhances catheter navigation, catering to the diverse anatomies of coronary arteries in patients. Such advancements underscore the growing adoption of TAVR systems in healthcare facilities, signaling a robust growth trajectory for the market in the coming years.
Moreover, the surge in new product launches and approvals is set to enhance the market presence of advanced TAVR systems, driving the market's growth during the forecast period. For instance, in January 2023, Abbott secured approval from the United States Food and Drug Administration for its innovative transcatheter aortic valve implantation (TAVI) system, Navitor. This self-expanding TAVI system is designed for individuals with severe aortic stenosis who face high or extreme risks for open-heart surgery. The newly introduced system provides physicians and patients with less invasive treatment options for prevalent and serious heart conditions and mitigates the common post-TAVI complication of blood backflow around the valve. Consequently, the emergence of these next-generation devices is poised to boost their adoption in TAVR procedures, further propelling the market's growth.
Therefore, owing to the rising number of research studies coupled with the increasing utilization of transcatheter aortic valve replacement systems and new product approvals, the studied market is expected to grow during the forecast period.
Transcatheter Aortic Valve Replacement Industry Overview
The transcatheter aortic valve replacement market is consolidated and dominated by a few key players. Key players hold significant market shares due to their technological advancements, new product approvals, and established presence in the aortic valve replacement field. Some of the key players in the market are Edwards Lifesciences Corporation, Medtronic, Boston Scientific Corporation, JenaValve Technology Inc., and Bracco SpA.
Transcatheter Aortic Valve Replacement Market Leaders
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Medtronic
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Abbott
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Edwards Lifesciences Corporation
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Boston Scientific Corporation
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Bracco SpA
*Disclaimer: Major Players sorted in no particular order
Transcatheter Aortic Valve Replacement Market News
- August 2024: Boston Scientific Corporation secured the CE mark for its latest transcatheter aortic valve replacement (TAVR) technology, the ACURATE Prime Aortic Valve System. The ACURATE Prime valve system is designed with several features to build upon the clinical performance of the ACURATE neo2 platform, including an additional valve size, which expands the treatment range to patients with a larger anatomy. This expansion broadens the treatment range, accommodating patients with larger anatomies. The system is specifically designed to restore function and normal blood flow through a narrowed aortic valve, catering to low, intermediate, and high-risk patients suffering from severe aortic stenosis.
- May 2024: Montefiore Einstein launched the Structural Heart Program at White Plains Hospital, specializing in Minimally Invasive Heart Valve Replacement Procedures using TAVR systems.
Transcatheter Aortic Valve Replacement Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definitions
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
-
4.2 Market Drivers
- 4.2.1 Increasing Burden of Aortic Stenosis Coupled with Growing Geriatric Population
- 4.2.2 Increasing Demand for Minimally Invasive Procedures
- 4.2.3 Technological Advancements
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4.3 Market Restraints
- 4.3.1 High Cost of Devices and Procedures
- 4.3.2 Severe Risk Associated with TAVR and Limited Reimbursement
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
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5.1 By Type of Device
- 5.1.1 Self-expanding Valves
- 5.1.2 Balloon-expandable Valves
- 5.1.3 Other Types of Devices (Mechanically Expandable Valves and Hybrid Valves)
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5.2 By Procedure
- 5.2.1 Transfemoral
- 5.2.2 Transapical
- 5.2.3 Transaortic
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5.3 By Material
- 5.3.1 Nitinol
- 5.3.2 Cobalt chromium
- 5.3.3 Stainless steel
- 5.3.4 Other Materials (Biological Tissues, Synthetic Materials, and Antithrombotic Coatings)
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5.4 By End User
- 5.4.1 Hospitals
- 5.4.2 Ambulatory Surgical Centers
- 5.4.3 Cardiovascular Centers
- 5.4.4 Other End Users (Research Institutions and Cath Laboratories)
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5.5 Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia-Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East and Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East and Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Medtronic
- 6.1.2 Abbott
- 6.1.3 Boston Scientific Corporation
- 6.1.4 Meril Life Sciences Pvt. Ltd Inc.
- 6.1.5 Edwards Lifesciences Corporation
- 6.1.6 St. Jude Medical Inc.
- 6.1.7 Bracco SpA
- 6.1.8 Transcatheter Technologies GmbH
- 6.1.9 JenaValve Technology Inc.
- 6.1.10 CryoLife Inc.
- 6.1.11 Lepu Medical Technology Co. Ltd
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityTranscatheter Aortic Valve Replacement Industry Segmentation
As per the scope of the report, transcatheter aortic valve replacement (TAVR) is a procedure that addresses the issue of a narrowed aortic valve. The aortic valve, located between the heart's left lower chamber and the body's primary artery, plays a crucial role. Unlike traditional open-heart valve surgery, TAVR is a minimally invasive procedure utilizing smaller incisions. This makes it a viable option for individuals who are not candidates for conventional heart surgery. By undergoing TAVR, patients can experience relief from symptoms associated with aortic valve stenosis, such as chest pain and shortness of breath.
The transcatheter aortic valve replacement market is segmented into types of devices, procedures, materials, end users, and geography. By type of devices, the market is segmented into self-expanding valves, balloon-expandable valves, and other types of devices. By procedure, the market is segmented into transfemoral, transapical, and transaortic. By material, the market is segmented into nitinol, cobalt chromium, and stainless steel. By end user, the market is segmented into hospitals, ambulatory surgical centers, cardiovascular centers, and other end users. By geography, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. For each segment, the market sizing and forecasts were made based on value (USD).
By Type of Device | Self-expanding Valves | |
Balloon-expandable Valves | ||
Other Types of Devices (Mechanically Expandable Valves and Hybrid Valves) | ||
By Procedure | Transfemoral | |
Transapical | ||
Transaortic | ||
By Material | Nitinol | |
Cobalt chromium | ||
Stainless steel | ||
Other Materials (Biological Tissues, Synthetic Materials, and Antithrombotic Coatings) | ||
By End User | Hospitals | |
Ambulatory Surgical Centers | ||
Cardiovascular Centers | ||
Other End Users (Research Institutions and Cath Laboratories) | ||
Geography | North America | United States |
Canada | ||
Mexico | ||
Geography | Europe | Germany |
United Kingdom | ||
France | ||
Italy | ||
Spain | ||
Rest of Europe | ||
Geography | Asia-Pacific | China |
Japan | ||
India | ||
Australia | ||
South Korea | ||
Rest of Asia-Pacific | ||
Geography | Middle East and Africa | GCC |
South Africa | ||
Rest of Middle East and Africa | ||
Geography | South America | Brazil |
Argentina | ||
Rest of South America |
Transcatheter Aortic Valve Replacement Market Research FAQs
How big is the Transcatheter Aortic Valve Replacement Market?
The Transcatheter Aortic Valve Replacement Market size is expected to reach USD 6.03 billion in 2024 and grow at a CAGR of 9.78% to reach USD 9.61 billion by 2029.
What is the current Transcatheter Aortic Valve Replacement Market size?
In 2024, the Transcatheter Aortic Valve Replacement Market size is expected to reach USD 6.03 billion.
Who are the key players in Transcatheter Aortic Valve Replacement Market?
Medtronic, Abbott, Edwards Lifesciences Corporation, Boston Scientific Corporation and Bracco SpA are the major companies operating in the Transcatheter Aortic Valve Replacement Market.
Which is the fastest growing region in Transcatheter Aortic Valve Replacement Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Transcatheter Aortic Valve Replacement Market?
In 2024, the North America accounts for the largest market share in Transcatheter Aortic Valve Replacement Market.
What years does this Transcatheter Aortic Valve Replacement Market cover, and what was the market size in 2023?
In 2023, the Transcatheter Aortic Valve Replacement Market size was estimated at USD 5.44 billion. The report covers the Transcatheter Aortic Valve Replacement Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Transcatheter Aortic Valve Replacement Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Transcatheter Aortic Valve Replacement Industry Report
Statistics for the 2024 Transcatheter Aortic Valve Replacement market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Transcatheter Aortic Valve Replacement analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.