DelveInsight’s “Transcatheter Heart Valve Replacement Devices Market Insights, Competitive Landscape and Market Forecast-2030” report delivers an in-depth understanding of the transcatheter heart valve replacement devices market, historical and forecasted market trends across North America, Europe, Asia-Pacific, and the Rest of the World. The report comprehensively evaluates the current treatment landscape, emerging technologies, market share of individual products, and market forecasts through 2030, providing crucial insights for stakeholders in the cardiovascular device therapeutic area.
Market Outlook
According to DelveInsight’s analysis, the transcatheter heart valve replacement devices market is projected to grow substantially with an impressive 13.75% CAGR during the forecast period from 2024 to 2030, driven by the growing prevalence of cardiovascular disorders, increasing product developmental activities, rising sedentary lifestyle and lifestyle-associated disorders, and increasing preference for minimally invasive surgeries.
North America is expected to dominate the overall transcatheter heart valve replacement devices market, attributed to high instances of myocardial infarction, heart valve diseases, and associated risk factors, combined with significant advancements in product development and regulatory approvals, the presence of key market players, and the availability of well-established advanced healthcare infrastructure. DelveInsight’s analysis reveals that 2.5% of the Canadian population had heart valve diseases in 2022, increasing significantly after age 65 and reaching up to 13% after age 75, with projections indicating 1.5 million Canadians over 65 will have heart valve disease by 2040.
Download the Transcatheter Heart Valve Replacement Devices Market report to understand which factors are driving the market @ Transcatheter Heart Valve Replacement Devices Market Trends.
Transcatheter Heart Valve Replacement Devices Patient Pool
According to DelveInsight’s estimates, approximately 640 million people were living with heart and circulatory diseases worldwide in 2022, highlighting the substantial patient population requiring cardiovascular interventions. Furthermore, the World Health Organization reported a prevalence of 9 million cases of calcific aortic valve stenosis globally, representing a significant target market for transcatheter heart valve replacement technologies. The report also indicates that 805,000 people in the US experience myocardial infarction annually, with nearly 47% of Americans having at least one major heart disease risk factor, including high blood cholesterol, high blood pressure, and smoking.
Discover evolving trends in the Transcatheter Heart Valve Replacement Devices patient pool forecasts @ Transcatheter Heart Valve Replacement Devices Patient Pool Analysis.
Top Performing Market Segments
The DelveInsight report breaks down the transcatheter heart valve replacement devices market into key segments for easier understanding. It categorizes products into three types: Transcatheter Aortic Valve Replacement, Mitral Valve Replacement, and Pulmonary Valve Replacement. The market is also divided by application, including conditions like aortic and mitral valve stenosis or regurgitation. This clear segmentation helps in understanding treatment trends and how these devices are used in different healthcare settings.
Among all these segmentations, the transcatheter aortic valve replacement segment continues to demonstrate strong performance due to its transfemoral approach, which allows access to the aorta through the femoral artery in the groin, resulting in smaller incisions and less surgical trauma. This approach leads to significant benefits, including shorter recovery times, reduced post-operative pain, decreased hospital stays, fewer wound complications, and better prosthesis outcomes. Advanced imaging and device technology improvements have enhanced valve placement precision during procedures, leading to superior overall results.
Recent Developments
The transcatheter heart valve replacement landscape has experienced several important regulatory approvals and product launches in the first half of 2025. This reflects rapid innovation extending beyond aortic stenosis into mitral and tricuspid indications, as well as expanded patient populations and new device technologies.
In May 2025, the FDA approved a groundbreaking transcatheter mitral valve replacement system for patients with severe mitral annular calcification, based on the results of the SUMMIT trial. The FDA also expanded the SAPIEN 3 TAVR platform to include asymptomatic patients with severe aortic stenosis, following the EARLY TAVR trial, within the same month.
Additionally, Medtronic’s Evolut Pro+ and FX systems received CE Mark approval in Europe in May 2025, allowing for “redo” TAVR procedures within failed transcatheter valves. Abbott’s Tendyne™ TMVR system was also approved by the FDA in May 2025 for patients suffering from mitral valve disease and severe mitral annular calcification.
In June 2025, India’s CDSCO approved Foldax’s TRIA™ polymer mitral heart valve, making it the first commercially available polymer-based transcatheter valve. Earlier, in January 2025, Abbott launched its Navitor™ Vision next-generation TAVI system in India for patients with symptomatic severe aortic stenosis.
Discover recent advancements in the Transcatheter Heart Valve Replacement Devices landscape @ Transcatheter Heart Valve Replacement Devices Recent Developments.
Transcatheter Heart Valve Replacement Devices Competitive Landscape
The transcatheter heart valve replacement devices market is highly competitive, with major players including Medtronic, Boston Scientific Corporation, Bracco SpA, Edwards Lifesciences, Meril Lifesciences, JenaValve Technologies Inc., Venus Medtech (Hangzhou) Inc., Abbott, Bluesail Medical Co., Ltd., Braile Biomédica, CryoLife, Inc., SMT, Peijia Medical Limited, P+F Products + Features GmbH, and Livanova Plc, all advancing innovative technologies through robust research and development initiatives and strategic regulatory approvals.
Future Outlook
Looking ahead, the transcatheter heart valve replacement devices market is expected to witness continued innovation driven by enhanced device technology, improved patient outcomes, and expanding procedural adoption. While significant progress has been made in minimally invasive approaches, challenges remain in addressing complex anatomical variations, optimizing long-term durability, and improving accessibility across diverse patient populations. The market continues to evolve with technological advancements, focusing on enhanced delivery systems, improved valve designs, and expanded indications, positioning the industry for sustained growth through 2030.
Table of Contents
1. Transcatheter Heart Valve Replacement Market Report Introduction
2. Transcatheter Heart Valve Replacement Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Transcatheter Heart Valve Replacement Market Key Factors Analysis
6. Transcatheter Heart Valve Replacement Market Porter’s Five Forces Analysis
7. Transcatheter Heart Valve Replacement Market Assessment
8. Transcatheter Heart Valve Replacement Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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