Transcatheter Heart Valve Replacement Repair Market

Transcatheter Heart Valve Replacement Repair Market Outlook (2023 to 2033)

The global revenue from the Transcatheter Heart Valve Replacement Repair Market was approximately US$ 6.7 Billion in 2022, with the global market expected to grow at a CAGR of 13.0% to reach a valuation of approximately US$ 25.5 Billion by the end of 2033.

As assessed by Persistence Market Research, the transcatheter aortic valve replacement (TAVR) segment held a market share of around 83.3% in the global market, in 2022. Overall, transcatheter heart valve replacement repair market sales account for approximately 23.9% of revenue share in the global cardiac surgery devices market, which was valued at around US$ 28.3 Billion in 2022.

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Sales Analysis of Market from 2016 to 2022 Vs Market Outlook for 2023 to 2033

The global market recorded a historic CAGR of 9.4% in the last 6 years from 2016 to 2022.

The rising prevalence of various cardiovascular diseases like valvular heart diseases such as aortic stenosis is one of the main causes of the increased demand for TAVI procedures on a global level.

• As per the findings from the American College of Cardiology, 2021, the prevalence of valvular heart diseases is quite high in reference to the United States population. It reported that there were more than 5 million United States citizens who were diagnosed with such diseases in a year. This number includes 1.5 million individuals who were suffering from aortic stenosis in the United States and the ones who suffered from a severe aortic stenosis comprised of around 500,000 individuals, this was approximately 33% of the cases suffering from aortic stenosis.

Since the primary treatment for severe aortic stenosis is a valve replacement surgery, therefore this factor impacts the TAVR market in the most favorable manner.

There are various benefits offered by minimally invasive procedures due to which there is a surge in demand for minimally invasive procedures/surgeries. These procedures offer potential benefits in case of the heart surgeries, which includes less blood loss, reduced trauma, and pain, lower risk of infection, a faster recovery rate for the patients, shorter stay at the hospital and of course, less noticeable scars.

• Since the TAVI (transcatheter aortic valve implantation) is a minimally invasive procedure which involves the implantation of the new valve inside the patient’s heart in order to remove the old or damaged valve, therefore this is surging demand for the minimally invasive procedures, which can have a positive impact on the growth of the TAVR market.

TAVR is a very crucial procedure as it helps in rectifying the sensitive functioning of the heart in reference to valves. In the last decade there have been multiple FDA approvals when it comes to TAVI procedures, this paves the way for the growth of TAVR market.

• For its Next-Gen TAVR System, the Evolut FX TAVR system, which is very successful in the treatment of symptomatic severe aortic stenosis, Medtronic received the FDA approval in August 2021.
• In September 2021, Abbott's FlexNav TAVI system was given FDA approval for the treatment of patients with severe, symptomatic aortic stenosis.

Thus, the increasing approvals for TAVR systems and associated products from the regulatory bodies across the globe will result in availability and accessibility of efficient treatment options, ultimately resulting in improved patient compliance and greater adoption of the market.

The global market is likely to show high growth over the coming years at a CAGR of 13.0% and reach a global market size of US$ 25.5 Billion by 2033.

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How Can the Global Market Grow?

“Continuous Technological Advancements in TAVR Products Coupled with Increasing Prevalence of Cardiovascular Diseases”

The companies are coming up with second generation TAVR devices with better durability in order to avoid the immune rejections in the patients suffering from severe aortic stenosis.

Several published studies in the recent times, have concluded second generation TAVR devices have better safety related benefits. These studies also conclude that the transcatheter heart valve devices are linked with lower rate of paravalvular regurgitation, valve embolization and other bleeding events.

• Apart from this, advanced imaging technologies are becoming popular while taking decisions regarding the TAVR procedures. The advancement in the technologies is quite trendy in the dynamic field of the TAVI, which is expected to create lucrative opportunities for the market to flourish in the future with continuous technological developments in the TAVI and TAVR products.

Throughout the forecast period, the global market is anticipated to rise due to the rising number of people suffering from cardiovascular diseases such as coronary artery disease, heart failure, and hypertension. Aortic valve dysfunction is brought on by cardiovascular disorders, which increases the need for efficient valve replacement procedures.

• With an estimated 17.9 million deaths per year, cardiovascular diseases (CVDs) are the leading cause of death worldwide, as per WHO. Heart attacks and strokes account for more than four out of every five CVD deaths, the growing prevalence will demand more valve replacement surgeries such as TAVR, resulting in market expansion.

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Can the Market Growth Be Affected in Any Way?

“High Cost of Transcatheter Valves and Complications Associated with the TAVR Procedures”

The high costs associated with the transcatheter aortic valves is one of the key restraining factors for the TAVR market. Price is a very crucial factor which decides whether the device is feasible to be bought or not. Since the prices associated to such valves is quite high, therefore this is considered as a restraining factor for this market.

• According to an article published in the journal of Cardiovascular Intervention, 2020. the average cost of the transcatheter aortic valve is around US$ 64,395 for TAVR which is way too high. Hence, this factor is expected to negatively impacts the growth of the TAVR market.

Although TAVR is considered as an alternative to the open-heart aortic valve replacement procedure, there are some of the complications related to this kind of procedure. These potential risks include complications in the blood vessels, stroke, problem related to the rhythm of the heart, heart attack, infection, serious bleeding, problems related to the positioning of the valve like valve slipping out of place or regurgitation and others.

• One of the articles published by NCBI in February, 2021, stated that among the 106,749 patients who underwent transfemoral TAVR procedure, 2.2% died within the course of 30-days of the procedure due to several reasons related to their medical condition.

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Country-wise Insights

Why is the U.S. Market Booming?

“Growing Prevalence of Cardiovascular Diseases”

The U.S. accounted for around 48.7% market share in the global market in 2022.

The increasing prevalence of cardiovascular diseases such as aortic stenosis and availability of robust healthcare infrastructure are significant factors expected to drive the market throughout the forecast period in the U.S.

In the U.S., cardiovascular diseases are the leading cause of death for both men and women and for individuals of the majority of races and ethnicities.

• According to CDC data, cardiovascular disease kills one individual in the U.S. every 34 seconds. In the United States, cardiovascular disease accounted for the deaths over 697,000 individuals in 2020, accounting for 1 in 5 deaths.

Will the Germany Be a Lucrative Market for Transcatheter Heart Valve Replacement Repair?

“Presence of Vast Patient Pool”

The Germany market held around 12.9% market share of the global market in 2022.

The presence of well-established players operating in the German market, favorable reimbursement policies, and patients suffering from cardiovascular disease particularly the geriatric population are the key factors expected to propel the market in Germany.

• According to an article published in the journal of Secondary Prevention of Heart Attack and Strokes, Germany, the most severe consequence of coronary heart disease (CHD) is a heart attack. In Germany more than 1.3 million people have survived a stroke, while more than 3.6 million people have CHD. The patients suffering from CVDs are also increasing in numbers.

Thus, the presence of vast patient pool suffering from stokes will aid in the market growth in the coming times.

How is China Emerging as a Prominent Market?

“Increasing Obese Population”

China held a market share of about 4.6% of the global market in 2022.

The growing rates of obesity have resulted in the increasing number of patient suffering from cardiovascular disease, which is expected to create high demands for the TAVR surgeries in the future.

• Obesity directly influences the prevalence of cardiovascular risk factors such as dyslipidemia, type 2 diabetes, and hypertension. Independently from other cardiovascular risk factors, obesity increases the risk of cardiovascular disease development and mortality.
• Obesity has developed into a significant public health issue in China, according to data from the Global Health Journal, 2022. Most obese or overweight people are found in China, which has a huge population overall. In China, more than 50% of adults and 20% of children and adolescents are overweight or obese.

Category-wise Insights

Which Product Segment is Driving the Global Market?

“Better Patient Compliance and Broad Adoption of Balloon-Expandable TAVR Procedures”

The transcatheter aortic valve replacement (TAVR) segment held around 83.3% share of the total market in 2022.

In high-risk, elderly patients with severe calcific aortic stenosis, balloon-expandable transcatheter heart valve replacement repair has evolved as a life-saving and efficient alternative to surgical valve replacement. The TAVR procedures are now more widely employed as a result of the growing elderly population and the increasing number of patients with aortic stenosis. The better patient compliance provided by these, as well as patients' increased preference for TAVR surgeries, are other factors contributing to the segment's rise.

Which Indication Segment is Dominant Within the Global Market?

“Prevalence of Severe Aortic Stenosis”

The severe aortic valve stenosis segment held around 76.7% share of the total market in 2022.

Aortic stenosis is the second most prevalent valve lesion in the United States, according to the European Society of Cardiology. At 65 years old, it affects roughly 5% of the global population, the prevalence is increasing as the population ages. A population prevalence of 12.4% was found for aortic stenosis and a prevalence of 3.4% for severe aortic stenosis in people aged 75 and older in a meta-analysis studies, done in Europe, the USA, and Taiwan.

Which End User is Driving the Global Market?

“Expanding Patient Population Suffering from CVDs”

The hospital segment held around 53.6% share of the total market in 2022.

The market for this segment is being driven by an expanding patient population and an increase in demand for quick recovery times and short hospital stays, two trends that are anticipated to continue during the forecasted period as well.

Competition Landscape

By investing in mergers and acquisitions, the leading market players are aiming to strengthen their position. In addition, the players are making investments in strategic alliances with competitors in other markets.

Some key instances of development include:

• In September, 2022, Edwards Lifesciences launched the Sapien 3 Ultra Resilia Valve, after getting an FDA approval, which will be the first dry storage transcatheter heart valve available in the United States.
• In January, 2022, Medtronic announced approval for the Evolut PRO TAVR System in China for the treatment of severe aortic stenosis, a condition that is predicted to worsen due to China's ageing population.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the transcatheter heart valve replacement repair market, which are available in the full report.

Transcatheter Heart Valve Replacement Repair Industry Report Scope

Key Segments Covered in Transcatheter Heart Valve Replacement Repair Industry Research

Product:

• Transcatheter Aortic Valve Replacement (TAVR)
  • Self – Expandable Transcatheter Aortic Valves
  • Balloon-Expandable Transcatheter Aortic Valves
  • Mechanically Expanded Transcatheter Aortic Valves
• Transcatheter Mitral Valve Repair (TMVR)

Indication:

• Severe Aortic Valve Stenosis
• Valve-in-Valve Procedures (Failed Bioprosthesis)
• Aortic Regurgitation

End User:

• Hospitals
• Independent Cardiac Catheterization Labs
• Ambulatory Surgical Centres

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa