Aortic Valve Replacement Market

Market Overview

The global aortic valve replacement market size was valued at USD 10722 million in 2021 and is expected to grow at USD 33516 million by 2030. The market is expected to grow at a CAGR of 14% during the forecast period (2022–2030).

The aortic valve replacement market is primarily being driven by the increasing prevalence of various valvular diseases such as aortic stenosis & aortic regurgitation and technological advancements in the heart valve market. Aortic stenosis is the most common valvular disease affecting the geriatric population. The aortic valve replacement market is primarily being driven by the increasing prevalence of various valvular diseases such as aortic stenosis & aortic regurgitation and technological advancements in the heart valve market. Aortic stenosis is the most common valvular disease affecting the geriatric population. 

So, the growing number of older people is a big reason why the said market segment is growing. Estimates from the United Nations say that the number of older people is expected to rise from 962 million in 2017 to 2.1 billion in 2050; that is how many people are expected to live on Earth. Over the next few years, the market is also expected to grow because of the rise of minimally invasive surgeries like TAVR and the development of sutureless valves. Several things are being done to make people aware of aortic valve replacement, which is expected to have a positive effect on the market in the coming years.

Market Dynamics

Global Aortic Valve Replacement Market Drivers 

Rising Prevalence of Valvular Diseases and Initiatives for Creating Awareness of Valve Replacement with Favorable Reimbursements to be the Key Drivers for the Market Growth

Most heart surgeries or heart valve replacements are done because of aortic stenosis or aortic regurgitation. With the rise in such aortic problems, more and more people are at risk for aortic stenosis. According to a report published, aortic stenosis affects about 2.5 million people in the U.S. who are over 75 years old. This means that almost 12.4% of the population has aortic stenosis. It is thought that by 2050, there will be 80 million older people, which is more than double what there are now.

Aortic regurgitation is another valve disease that needs surgery to fix (Aortic Valve Replacement, or AVR). This condition is more common as people age. So, the growing number of older people is a big reason why the market is growing. Most of the time, rheumatic heart disease is to blame for aortic regurgitation. Rheumatic heart disease is a type of chronic heart inflammation. WHO (World Health Organization) says that about 2% of people with cardiovascular diseases (CVDs) have rheumatic heart diseases. So, the growing number of rheumatic heart diseases is one of the key factors expected to affect the market in the coming years positively.

With the new techniques and treatment options available to cure or operate on a patient, more people are learning about them and getting referred and better care. On the basis of the numbers published by Medicare and Medicaid, the people of age above 65 years and having aortic stenosis is going up at a rapid pace, which was earlier recorded at 2500 in 1989 and raised to over 32000 in 2011. One of the main things that will drive the aortic valve replacement market over the next few years is the growing number of aortic valve surgeries done on older people.

Initiatives to Create Awareness about the Valve Replacement Technique Driving Market Growth

Most of the time, TAVR is better than surgery for replacing a heart valve than AVR. So, many different things are being done to spread the word about TAVR. Society of Thoracic Surgeons (STS) and the American College of Cardiology are working together on the STS/ACC TVT Registry to track how Transcatheter valve repair and replacement surgeries work in real life and how safe they are for patients. This registry has been approved by CMS and gives information about how patients do and guidelines for replacing and fixing things. The European Association of Percutaneous Cardiovascular Interventions started the Valve for Life project in 2015. The goal of this project was to make it easier for people in Europe to get Transcatheter valve procedures. This initiative aims to raise awareness about valvular diseases, help patients get more access to TAVR, raise educational standards for healthcare professionals, reduce gender and age discrimination in access to care, and remove barriers to therapy implementation. Key players in this market are doing a number of clinical studies to expand the scope of interventions, look at how safe devices are, and figure out what other treatment options are available and how long people live.

Along with this, one of the most important things that are expected to drive the market in the coming years is good insurance and reimbursement policies. For example, the Centers for Medicare & Medicaid Services (CMS) said that the Medicare National Coverage Determination policy would cover TAVR. Different insurance companies have different rates for how much they will pay for different procedures. The replacement of a heart valve is a major illness. How much you get back depends on how much you have insured. Such benefits and other things that create awareness about it are surely picking up the market. 

Global Aortic Valve Replacement Market Restraints

Product Recalls Due to the Safety Concern can be a Barrier to Market Growth

The fact that these valves have been recalled hurts this market. There are strict rules about how products can be approved. The safety of these products is very important because they are used to treat life-threatening conditions. The Lotus line of heart valves made by Boston Scientific Corporation is being taken off the market because of problems with the way they lock. Medtronic said it was recalling the Medtronic 3f Enable Aortic Bio-prosthesis because of problems with how to use its instructions. But if rules change, the approval process could become stricter in the near future, which could cut down on product recalls.

Global Aortic Valve Replacement Market Opportunities

Development of Sutureless Valves to Create Huge Opportunities in the Global Aortic Valve Replacement Market

Transcatheter aortic valves are widely used in the market because more people want minimal invasive surgeries. More research and development are being done on Transcatheter valves, and more people around the world are learning about TAVR. Key players in this market have done a number of clinical studies to test the safety, effectiveness, and range of interventions. Even though sutureless valves are not widely used, they offer a big opportunity for growth because they have so many benefits. Sutureless valves show good hemodynamic and post-surgery results and lower mortality. Only three valves without sutures have been put on the market: the Enable 3F, the Perceval, and the Edwards Intuity Valve System. But there are a number of sutureless valves in the works that could help the field of sutureless valves grow even more. Tissue valves and mechanical valves make up the rest of the valves. There are a lot of these valves on the market, but their growth is limited because new technologies like TAVR are coming out. Compared to developed economies, developing economies have more room to grow with mechanical and tissue heart valves, creating huge opportunities.

Regional Analysis

The global aortic valve replacement market is primarily segmented into three regions, namely North America, Europe, and Asia-Pacific, where Europe has the major market share among the other regions for the said market and leads the regional segmentation.

North America is the second leading region after the European region in terms of revenue generation from the aortic valve replacement market. Being known as the region having the most advanced healthcare facilities, North America has a substantial growth rate of 10% over the forecast period.

Europe is leading the global aortic valve replacement market with a market value of USD 3535 million in 2021 and is expected to grow to USD 9117 million by 2030 at a CAGR of 11%. Some of the main reasons the market is growing here are the high number of people with aortic stenosis, the development of effective treatments like TAVR, and more efforts to raise awareness about valve replacement surgeries.

The Asia-Pacific region is listed third in the list at a CAGR of 14% for the forecasted period of 2021 to 2030, which shows that the Asia-pacific region has the highest growth rate among all the other regions. With this growth rate, the Asia-Pacific region will soon lead the global aortic valve replacement market by dominating the revenue generation. 

Segmental Analysis

The global aortic valve replacement market is segmented by surgery type and by end-use. 

When segmented with respect to by surgery, the said market is further classified into minimal invasive surgery and open surgery, where minimal invasive surgery dominates the market with a major market share.

By Surgery Type

Minimal Invasive Surgery is the major dominant segment in the by surgery type segmentation which accounts for a market figure of USD 5838 million in 2021 and is expected to grow to USD 21860 million by 2030 with a CAGR of 16%. 

It is a possible replacement for SAVR. Some of the procedures that use these minimally invasive surgeries are mini-thoracotomy, mini sternotomy, and TAVR. Most people prefer these procedures because they cause less damage to the body and speed up the healing process. Minimally invasive surgeries are likely to rise as sutureless valves become more common. Using sutureless valves has cut the number of people who die during surgery for minimally invasive aortic valve replacement from 1.6% to 0.7%. For people who are at high risk, a sutureless prosthesis could be an alternative to TAVR.

Open surgery is one way to replace the aortic valve for aortic valve stenosis or aortic valve regurgitation. During this surgery, the damaged valve is taken out, and an artificial valve is put in its place; it can be a mechanical or a tissue valve. The open surgery type accounts for a significant market value with a strong CAGR of 8%, which is still an astonishing growth rate.

The end-user segmentation of the said market includes hospitals and ambulatory surgical centers, out of which the hospitals are the dominant segment. 

By End-User 

The hospital segment in the by end-use category contributes with a subsequent market value of USD 3953 million in 2021 and reaching at USD 11410 million by 2030 at a CAGR of 13%. Open surgery to replace the aortic valve is considered the gold standard for replacing heart valves. Open surgeries are more complicated than minimally invasive surgeries and take longer to heal from. Most hospitals in developing economies take care of primary health care. So, this segment is expected to have the largest share of market revenue over the next few years. 

The number of ambulatory surgery centers is going up in the developed regions, as the TAVR is a new surgery that is replacing open surgery. TAVR is a minimally invasive surgery that can be done in surgery centers because the surgery is less complicated and takes less time to do and recover from. So, the main thing driving the market for ambulatory surgical centers is the growing number of people, which cater to the growth of the said segment with a growth rate of 14%.

Recent Developments

• In February 2022, Boston Scientific Corporation closed its acquisition with the Baylis Medical Company, which offers advanced transseptal access solutions.
• In April 2022, Liva Nova PLC initiated a targeted commercial launch of the Essenz Patient Monitor for Cardiopulmonary Bypass Procedures.
• In May 2022, Medtronic and DaVita announced a new kidney health technology company by collaborating with their operations.