Based on geography, the transcatheter aortic valve replacement market is primarily segmented into North America, Asia Pacific, Europe, the Middle East & Africa, and South & Central America. The market in Asia Pacific is anticipated to grow at the highest CAGR from 2023 to 2031. In terms of revenue, North America dominated the transcatheter aortic valve replacement market in 2023. The US is the major enabler of market growth in this region, which can be attributed to factors such as the increasing cases of cardiac diseases and the growing number of product launches by key players. In September 2022, Medtronic announced the expansion of its newest-generation, self-expanding TAVR system—the Evolut FX TAVR system—in the US. This system is offered with new features added to the existing Evolut platform to enhance the ease of use and predictability of valve deployment for physicians.
Rising Number of Aortic Valve Replacement Surgeries Fuels Transcatheter Aortic Valve Replacement Market Growth
According to data published by the Texas Heart Institute, ~106,000 heart valve procedures are performed annually in the US. The mitral or aortic valves are repaired or replaced in almost all of these procedures. This surge can be attributed to the rising incidences of chronic valve diseases such as aortic stenosis and left ventricular hypertrophy. Additionally, advancements in medical technology, population aging, and improved awareness of heart-related conditions contribute to the rising valve replacement surgeries. Aortic valve replacement is a critical procedure often used to treat aortic valve stenosis or regurgitation, conditions that can lead to serious complications if left untreated. As medical science continues to evolve, these surgeries are expected to become even safer and more accessible, contributing to better patient outcomes and improving the quality of life for those affected by aortic valve diseases. Healthcare systems are adapting to accommodate this growing demand for surgical interventions, emphasizing the importance of preventive measures and early detection in managing cardiovascular health.
Factors Limiting Market Growth:
Medical devices such as TAVR, used in invasive procedures, must meet safety requirements to avoid post-surgical complications in patients. The US regulatory authority including Food and Drug Administration/Center for Device and Radiological Health (FDA/CDRH) monitor these medical devices and designates TAVR products as Class III devices with a significant risk, requiring proof of safety and efficacy for their approval as part of the premarket approval (PMA) process. The US FDA is the first regulatory agency in the world to expand the indications for use of TAVR devices to include patients with severe aortic stenosis who are categorized as low-risk candidates for surgical aortic valve replacement (SAVR). These regulatory bodies work closely with the medical device industry to create clinical trial designs by using other sources of clinical evidence. Thus, stringent regulations associated with structural heart device manufacturing hinder the aortic valve replacement devices market growth.
Segmental Overview
The “transcatheter aortic valve replacement market analysis” was carried out by considering the following segments: procedure and end user. The market, by procedure, is segmented into transfemoral implantation, transapical implantation, and transaortic implantation. The transfemoral implantation segment held the largest transcatheter aortic valve replacement market share in 2023; it is anticipated to register the highest CAGR from 2023 to 2031. In terms of end user, the market is segmented into hospitals, ambulatory surgical centers, and others. The hospitals segment held the largest market share in 2023. This can be attributed to the availability of better facilities and employment of skilled physicians in hospitals. Further, the ambulatory surgical centers segment is anticipated to record the highest CAGR from 2023 to 2031. The scope of the transcatheter aortic valve replacement market report entails North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).
Transcatheter Aortic Valve Replacement Market: Competitive Landscape and Key Developments
Abbott Laboratories; Medtronic Plc.; Artivion Inc; Boston Scientific Corp; Edwards Lifesciences Corp; JenaValve Technology, Inc.; Blue Sail Medical Co Ltd; JC Medical, Inc; Venus Medtech HangZhou Inc; and Anteris Technologies Ltd are among the key companies profiled in the transcatheter aortic valve replacement market report. These companies focus on technological advancements to present new hi-tech products in their product portfolios. They also undertake geographic expansion initiatives to benefit from the growing consumer demand worldwide, which allows them to maintain their brand name in the global market.
As per company press releases, a few of the recent developments in the global transcatheter aortic valve replacement market are mentioned below:
In December 2022, Abbott launched the Navitor TAVI system to treat aortic stenosis cases in India. This latest-generation TAVI system offers best-in-class deliverability and access through small vessels. The system, with its advanced features, helps reduce or eliminate the risk of blood leakage around the valve implant, ultimately expanding treatment options for patients with severe aortic stenosis.
In September 2022, Medtronic the launch of Evolut FX next-generation TAVR system in the US for the treatment of symptomatic severe aortic stenosis. This self-expanding system significantly improved commissure alignment during TAVR procedures compared to earlier-generation Evolut systems.
In September 2022, Medtronic the launch of Evolut FX next-generation TAVR system in the US for the treatment of symptomatic severe aortic stenosis. This self-expanding system significantly improved commissure alignment during TAVR procedures compared to earlier-generation Evolut systems.