Transcatheter Heart Valve Replacement Devices - Market Insights, Competitive Landscape, and Market Forecast - 2030

Transcatheter Heart Valve Replacement Market By Product (Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Replacement, And Transcatheter Pulmonary Valve Replacement), By Application (Aortic Valve Stenosis, Aortic Valve Regurgitation, Mitral Valve Stenosis, Mitral Valve Regurgitation, And Others), By End-User (Hospitals, Specialty Clinics, And Others) and by geography is expected to advance at a respectable CAGR forecast till 2027 owing to the growing number valvular disease, aortic stenosis disorder, among other cardiovascular disorders and the presence of robust number of devices in pipeline across the globe.

The global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2022 to 2027. The transcatheter heart valve replacement market is observing significant market growth primarily owing to the growing number of valvular heart diseases, and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2022-2027 growing at a substantial CAGR.

Transcatheter Heart Valve Replacement Market Dynamics:

One of the key aspects driving the transcatheter heart valve replacement market is the increasing demand for transcatheter heart valve replacement owing to the high prevalence of aortic stenosis disorder.

For instance, according to the World Health Organization 2020, the prevalence of calcific aortic valve stenosis was 9 million across the world. Also, as per the John Muir Health statistics, in the year 2020, about 1.5 million people in the United States suffered from aortic stenosis and about 500,000 people within this group of patients suffered from severe aortic stenosis. As per the same source in 2020, about 250,000 patients suffering from aortic stenosis were symptomatic in the United States.

Degenerative calcific aortic stenosis is found to be very common (with a prevalence of 12.4%) in high-income countries, according to the European Society of Cardiology, 2020. According to the same source, the prevalence of severe aortic stenosis in people over the age of 75 in Europe and the United States was around 3.4% in 2020. Furthermore, the disease is the second most common valvular lesion in the United States, affected approximately 5% of the population at the age of 65 in 2020. Because of the global increase in aortic stenosis cases, there will be a high demand for trans-catheter heart valves in the market.

Further, increasing technological advancements, rising product launches & approvals, and other strategic activities by the key players will propel the market of overall transcatheter heart valve replacement. For instance, in December 2022, Abbott, launched its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in India with severe aortic stenosis who are at high or extreme surgical risk.

Also, in January 2020, Jenavalve transcatheter aortic valve replacement system had been designated as a breakthrough device designation by US FDA for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.

Therefore, the factors stated above collectively will drive the overall transcatheter heart valve replacement market during the forecast period from 2022-2027.

However, the high cost of the devices and surgical procedure, the presence of alternative treatment options in the market, the risk associated with the replacement process, and others may prove to be challenging factors for the transcatheter heart valve replacement market growth.

The transcatheter heart valve replacement market was significantly impacted during the period of the COVID-19 pandemic. During the initial stage of the pandemic, the demand for transcatheter heart valve replacement devices suffered a downfall owing to the imposition of strict lockdown rules, and disruption in manufacturing, and supply. Moreover, owing to the diversion of the medical field towards dining COVID-19, the funding for R&D activities related to cardiac diseases was been diminished and many non-urgent surgeries were also postponed, thereby declining the demand for transcatheter heart valve replacement in the market. However, with the ease of lockdown restrictions, the upturn of resources and supply chain, the administration of a vaccine to the public, and the return of patients to hospitals for surgeries, the demand for transcatheter heart valve replacement increased and is anticipated to do the same during the forecast period from 2022 - 2027.

Transcatheter Heart Valve Replacement Market Segment Analysis:

Transcatheter Heart Valve Replacement Market by Product (Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Replacement, and Transcatheter Pulmonary Valve Replacement), Application (Aortic Valve Stenosis, Aortic Valve Regurgitation, Mitral Valve Stenosis, Mitral Valve Regurgitation, and Others), End-User (Hospitals, Specialty Clinics, And Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World).

In the product segment of the transcatheter heart valve replacement market, the transcatheter aortic valve replacement (TAVR) segment is expected to have a significant revenue share in the year 2021. This was primarily owing to the increasing cases of aortic stenosis disorder as TAVR is the first-line surgical procedure performed for aortic stenosis. Further, the availability of technologically advanced devices in the market, and rising device launches and approvals will also affect the market positively.

For instance, according to the American Heart Association, approximately 1.5 million people in the United States had aortic valve stenosis in020. The same source stated that approximately 100,000 patients had undergone TAVR procedures in the United States, compared to only 50,000 patients who have opted for open surgery for aortic valve replacement in the United States in 2020.

Also in 2019, TAVR procedures were initially indicated for patients with severe symptomatic aortic stenosis who were not fit for surgical treatment, as determined by the Heart Valve team, but newer guidelines have approved the treatment of TAVR in intermediate-risk aortic stenosis patients.

Additionally, the approval and launch of devices for transcatheter aortic valve replacement devices will lead to an increase in the demand for transcatheter heart valve replacement devices. In September 2021, the United States Food and Drug Administration approved Abbott's Portico with FlexNav transcatheter aortic valve replacement (TAVR) system for the treatment of individuals suffering from symptomatic, and severe aortic stenosis.

Therefore, owing to the above-mentioned advantages, the category is expected to witness considerable growth eventually contributing to the overall growth of the transcatheter heart valve replacement market.

North America is expected to dominate the overall Transcatheter Heart Valve Replacement Market:

Among all the regions, North America is expected to dominate global transcatheter heart valve replacement in the year 2021 and is expected to do the same during the forecast period from 2022-2027. This domination is attributed to the high prevalence of cardiovascular diseases such as aortic stenosis, aortic regurgitation, among others, rise in transcatheter heart valve replacement device approvals and launches, and others are the key factor contributing to the transcatheter heart valve replacement devices market in the region and are expected to aid in the growth of the North America transcatheter heart valve replacement devices market.

For instance, according to the American Heart Association, in the year 2020, 20% of older Americans suffered from aortic stenosis. It is common in people over the age of 65 years and if left untreated can cause heart failure and death. Owing to the increase in the prevalence of patients suffering from aortic stenosis, there will be an increase in the demand for transcatheter heart valve replacement devices.

Further, according to the Centers for Disease Control and Prevention (CDC) 2021, heart disease is the leading cause of death for men, women, and people in the United States. According to the same source, one person die every 36 seconds from cardiovascular diseases and about 6,59,000 people die due to heart diseases every year, in the region, which is about one in four deaths.

Lastly, the rising product approvals and launches in North America will also increase the demand for transcatheter heart valve replacement. For instance, in September 2019, Medtronic plc announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut™ PRO+ TAVR System - a new-generation Medtronic TAVR system that builds off the proven self-expanding, supra-annular Evolut TAVR platform.

Also, in July 2019, Abbott received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation.

Therefore, the interplay of the aforementioned factors above would provide a conducive growth environment for the North American region in the transcatheter heart valve replacement market.

Transcatheter Heart Valve Replacement Market Key Players:

Some of the key market players operating in the transcatheter heart valve replacement market include Medtronic, Boston Scientific Corporation, Bracco SpA, Edward 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, Livanova Plc, and others.

Recent Developmental Activities in the Transcatheter Heart Valve Replacement Market:

• In January 2022, Medtronic plc announced that the National Medical Products Administration (NMPA) approved the CoreValve Evolut PRO TAVR system for the treatment of severe aortic stenosis (AS) for symptomatic patients in China who are at high or extreme risk for open heart surgery.
• In September 2021, Abbott announced that Food and Drug Administration (FDA) has approved the company's Portico™ with FlexNav™ transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
• In April 2020, Abbott received CE Mark for its next-generation TriClip Transcatheter Tricuspid Valve Repair System, the first-of-its-kind minimally invasive tricuspid heart valve repair device available in Europe to treat tricuspid regurgitation (TR). The clip-based therapy, known as TriClip G4, is a non-surgical heart valve repair option specifically designed for the treatment of TR, or a leaky tricuspid valve, that allows physicians to tailor repair of the valve to each patient's unique anatomy.

Key Takeaways from the Transcatheter Heart Valve Replacement Market Report Study

• Market size analysis for current transcatheter heart valve replacement market size (2021), and market forecast for 5 years (2022-2027)
• The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the transcatheter heart valve replacement market.
• Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the global transcatheter heart valve replacement market.
• Various opportunities available for the other competitor in the transcatheter heart valve replacement market space.
• What are the top-performing segments in 2021? How these segments will perform in 2027.
• Which are the top-performing regions and countries in the current transcatheter heart valve replacement market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for transcatheter heart valve replacement market growth in the coming future?

Target Audience who can be benefited from this Transcatheter Heart Valve Replacement Market Report Study

• Transcatheter heart valve replacement products providers
• Research organizations and consulting companies
• Transcatheter heart valve replacement-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in transcatheter heart valve replacement
• Various end users who want to know more about the transcatheter heart valve replacement market and the latest technological developments in the transcatheter heart valve replacement market.

Frequently Asked Questions for the Transcatheter Heart Valve Replacement Market:

1. What is transcatheter heart valve replacement?

Transcatheter heart valve replacement is a procedure with a less invasive approach that helps replace the heart valve with a prosthetic valve to treat severe aortic stenosis and mitral regurgitation. It is an effective alternative to cumbersome open heart surgery, especially for high-risk patients.

2. What is the global market for transcatheter heart valve replacement?

The global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2022 to 2027.

3. What are the drivers for the global transcatheter heart valve replacement market?

The transcatheter heart valve replacement market is witnessing positive market growth owing to the factors such as the growing number of valvular diseases, aortic stenosis disorders across the globe, the rising focus on minimally invasive surgeries, and increasing technological advancements in device and surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, presence of a large number of devices in the pipeline, increasing product launches and approvals, and others will create an exigency for the transcatheter heart valve replacement market.

4. Who are the key players operating in the global transcatheter heart valve replacement market?

Some of the key market players operating in the transcatheter heart valve replacement market include Medtronic, Boston Scientific Corporation, Bracco SpA, Edward 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, Livanova Plc, and others.

5. Which region has the highest share of the transcatheter heart valve replacement market?

Among all the regions, North America is estimated to amass a significant revenue share in the global transcatheter heart valve replacement market. This can be ascribed to the transcatheter heart valve replacement manufacturers in the US, the growing number of valvular diseases, aortic stenosis disorder, surging burden of the geriatric population, increasing product launches and approvals, and others act as a supportive factor for the North America transcatheter heart valve replacement market growth.

This product will be updated with the latest data at the time of order. Consequently, dispatch time for this product will be 7-10 business days.