Market Trends of Transcatheter Aortic Valve Replacement Industry
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.