Next-generation Transcatheter Aortic Valves Market Size, Share | 2031

Report Description

Global Next-generation Transcatheter Aortic Valves Market Outlook 2031

The global Next-generation transcatheter aortic valves market size was USD 2,212.7 Million in 2022 and is likely to reach USD 4,011.6 Million by 2031, expanding at a CAGR of 7.0% during 2023–2031. The market growth is attributed to the rising prevalence of aortic valve stenosis, increasing demand for minimally invasive procedures such as transcatheter aortic valve implantation (TAVI), and the growing geriatric population. New-generation transcatheter heart valves (THV) have significantly improved procedural safety, efficacy, and patient outcomes, making TAVR a viable option for patients at various risk groups.

Transcatheter aortic valve replacement (TAVR) is a procedure for replacing an aortic valve that has constricted and is unable to open fully. The aortic valve connects the left lower heart chamber to the main artery. The narrowing of the aortic valve is known as aortic valve stenosis. The valve dysfunction prevents or delays blood flow from the heart to the body. TAVR is a minimally invasive procedure that employs smaller incisions than open-heart valve surgery.

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It is a possibility for those who are unable to undergo cardiac surgery to replace their aortic valves. TAVR helps alleviate chest pain, shortness of breath, and other symptoms of aortic valve stenosis. Transcatheter aortic valve replacement is also known as transcatheter aortic valve implantation (TAVI).

The new-generation transcatheter aortic valves market is expected to expand in the coming years, due to a variety of factors. The rising prevalence of aortic valve stenosis (AS) and the growing need for minimally invasive procedures such as TAVR are boosting the Next-generation TAVR market. The growing elderly population is also helping to the TAVR market expand. Furthermore, developments in TAVI technology have resulted in a few procedural problems and improved clinical results for patients having TAVR, increasing the patient population and popularity of TAVR.

Artificial Intelligence (AI) Impact on the Global Next-generation Transcatheter Aortic Valves Market

Artificial intelligence (AI) is anticipated to have a substantial impact on the global Next-generation transcatheter aortic valves industry. AI is used to evaluate vast volumes of data and provide insights into how to enhance patient outcomes and reduce the risk of problems during TAVR treatments. AI also be used to create predictive models that aids in identifying patients at high risk of problems and guiding treatment decisions. Additionally, AI is utilized to optimize TAVR operations by giving operators real-time feedback and enhancing valve placement accuracy. The application of AI is projected to spread, driving the market innovation and growth.

The research report states that the COVID-19 Pandemic has significantly impacted the Next-generation transcatheter aortic valves market. According to an article published in the National Library of Medicine, there was a considerable decline in TAVR and surgical aortic valve replacement (SAVR) activity after the COVID-19 outbreak. The pandemic has affected over 1,200 clinical experiments, including the TELESTAR-TAVR research, which was postponed due to the outbreak.

Although postponed trials have resumed to recruit participants, there are delays in trial initiation and delayed recruitment persist. The pandemic has also caused delays and cancellations of deferrable treatments, such as TAVR, due to resource reorganization to address the demands of COVID-19 patients. Despite these hurdles, the TAVR industry has demonstrated resilience and continued to move forward, with the number of procedures increasing as COVID-19 case counts decreased.

Global Next-generation Transcatheter Aortic Valves Market Dynamics

Major Drivers - Increasing Prevalence of Valvular Heart Disease

The rising frequency of valvular heart disease is predicted to fuel the expansion of the Next-generation transcatheter aortic valve replacement (TAVR) industry. The prevalence of calcific aortic valve disease (CAVD) has increased sevenfold over the last 30 years, with age-standardized rates four times higher in developed countries.

According to the article The Global Burden of Valvular Heart Disease: From Clinical Epidemiology to Management, the disease burden of valvular heart disease (VHD) is expected to increase in the coming years, resulting in the rising morbidity and mortality rates. This is attributed to population aging, the availability of imaging techniques, diagnosis, & treatment; advances in valve surgery; and the introduction of transcatheter operations.

Furthermore, according to the Euro Heart Survey on valvular disease, aortic stenosis (AS) is the frequent VHD in developed countries, with the etiology being degenerative-calcific in the majority of patients (81.9%), rheumatic in 11.2%, congenital in 5.6%, and post-endocarditis in the remaining 1.3%. Aortic sclerosis affects around 40% of those over the age of 75, and only 2% develop each year to hemodynamically severe AS, due to the gradual degenerative process.

Major Drivers - Advancements in Technology

Technological advancements have had a tremendous impact on the Next-generation transcatheter aortic valve replacement (TAVR) market, resulting in the creation of enhanced procedural safety, efficacy, and patient outcomes. The advancement of TAVR technology has broadened its reach to young and low-risk patients, independent of surgical risk, resulting in few procedural problems and improved clinical outcomes. Ongoing clinical research in TAVR developments is creating a significant potential for market participants to enter the market, and the TAVR business is likely to expand during the forecasted period.

The market has been driven by technological advancements such as the development of new biocompatible and wear-resistant materials, the use of 3D printing to create customized heart valves, and the development of imaging & navigation technologies that allow for precise heart valve placement.

Existing Restraints - Increasing Competition

The high cost of Next-generation transcatheter aortic valve replacement (TAVR) has an impact on the industry, limiting patient access to surgery and influencing medical device pricing. According to studies, hospital expenditures for TAVR patients are higher than for surgical aortic valve replacement (SAVR) patients, despite the short ICU and hospital stay. However, the cost of TAVR is decreasing due to the adoption of improved procedures and technologies. The high cost of TAVR has an impact on the procedure cost-effectiveness, especially in low-risk populations where the cost-effectiveness is unknown.

Emerging Opportunities - Rising Demand for Minimally Invasive Procedures

The increasing demand for minimally invasive procedures, such as transcatheter aortic valve replacement (TAVR), is likely to boost the market. This trend is being driven by the increased use of minimally invasive operations, which provide advantages such as short recovery times, less surgical trauma, and enhanced patient outcomes. The global market for minimally invasive surgery is rising, and the demand for these procedures continues to drive the market.

Technological improvements in surgical robotics and the rising prevalence of osteoporosis are driving the growth of the minimally invasive devices market. Therefore, the increased demand for minimally invasive procedures is projected to benefit the TAVR industry, accelerating its expansion and adoption.

Scope of the Global Next-generation Transcatheter Aortic Valves Market Report

The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Product Segment Analysis

Based on product, the global Next-generation transcatheter aortic valves market is segregated into self-expandable valve, balloon-expandable valve, mechanically expandable valve, and non-metallic valve. The two predominant types of commercially available TAVR valves are balloon-expandable and self-expanding valves.

Sthe self-expandable valve segment had a high revenue share in 2022. Self-expanding valves, especially those with a supra-annular design, have a large effective orifice area and a low gradient. These benefit from low pacemaker rates and enhanced coronary access.

A rapid advancement in transcatheter aortic valve replacement (TAVR) technologies, including three generations of supra-annular self-expanding transcatheter systems, is expected to drive the market during the forecast period.

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Size Segment Analysis

Based on size, the global Next-generation transcatheter aortic valves market is segregated into small, medium, and large. The small segment had a high revenue share in 2022. Small size is used in aortic valve surgery. For example, ACURATE neo is implanted using a dedicated 14F expandable introducer sheath. The valve is available in three sizes (small, medium, and large) to accommodate native aortic annulus diameters ranging from 21 to 27 mm. The valve struts are positioned minimally in the left ventricular outflow tract (LVOT) to reduce the pressure on the conduction system. The three porcine pericardial leaflets are positioned supra-annularly in an attempt to reduce pressure gradients.

Indication Segment Analysis

Based on indication, the global Next-generation transcatheter aortic valves market is segmented into aortic stenosis and aortic valve regurgitation. The aortic stenosis segment is expected to have a significant market share in the coming years, due to the rising prevalence of aortic stenosis. For instance, aortic stenosis is one of the common and serious valve disease complications. More than 12% of the older US citizens have aortic stenosis. High-income countries have a high prevalence of degenerative calcific aortic valve stenosis (12.4%). Severe aortic stenosis affects 3.4% of people over 75 ages in Europe and the US.

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End-user Segment Analysis

Based on end-user, the global Next-generation transcatheter aortic valves market is segmented into hospitals, specialty clinics, and others. The hospitals segment had a high revenue share in 2022 and is expected to maintain its dominance throughout the forecast period. Hospitals provide a wide range of medical services to patients, including cardiac surgery using cardiac devices. Hospitals in the US and other countries utilize TAVR in various cardiovascular condition surgeries. These factors are anticipated to fuel the segment.

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Regional Outlook

In terms of region, the global Next-generation transcatheter aortic valves market is classified as Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa. North America dominated the global market in terms of sales, accounting for a notable share, due to its well-developed healthcare infrastructure. The increasing prevalence of aortic stenosis and aortic regurgitation in the population is likely drive the expansion of the market over the predicted period.

According to the article Aortic Regurgitation, published by StatPearls in April 2022, the prevalence of aortic regurgitation in the US ranged between 4.9% and 10.0%. Furthermore, according to the same source, men (13%) are more likely to suffer from aortic regurgitation than women (8.5%).

The Europe market is predicted to expand at the significant rate during the projection period. Increasing number of TAVR surgeries, economic growth, regulatory implications, and new product introductions in the EU drive the market.

In October 2021, JenaValve Technology, Inc., a TAVR system manufacturer, announced the Europe release of the Trilogy heart valve system. Furthermore, the Trilogy system is CE Mark approved for aortic stenosis, giving European clinicians dual-disease treatment options.

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