TAVR Market

Transcatheter Aortic Valve Replacement Market Size (2023 to 2028)

The global TAVR market is projected to grow from USD 3.62 billion in 2023 to USD 8.47 billion by 2028, witnessing a CAGR of 18.50% during the forecast period.

Transcatheter Aortic Valve Replacement Market Share Insights

• An increase in the vulnerability of severe aortic stenosis is observed with age, increasing the demand for TAVI systems.
• Around 524 million people were above 65 in 2010, which is expected to reach 1.5 billion by 2050, constituting about 16% of the world population.
• Japan is the largest market in the Asia-Pacific region; it accounted for 76% of the regional market share in 2017 due to the increasing older population and the approval of new implants.
• By material, Cobalt-chromium had a significant share (65%) in the valve material segment, followed by Nitinol in 2019.
• Transfemoral implantation accounts for the largest share by the method, with a market share of nearly 90%
• Bovine heart tissues have a significant market share of 81% by valve leaflets materials, followed by porcine tissue.

MARKET DRIVERS:

The rising prevalence of CVDs and aortic stenosis, the growing adoption rate of minimally invasive therapies, and the rising geriatric population worldwide are significant factors driving the global TAVR market growth. The growing number of patients worldwide suffering from cardiovascular diseases such as heart failure, coronary artery disease, and hypertension is one of the significant trends fuelling the market's growth. For instance, cardiovascular disease causes the aortic valve to malfunction, which increases the demand for effective valve replacement procedures. According to World Health Organization (WHO), 17.9 million deaths happened because of cardiovascular diseases. Besides, increased funding for research and development activities, new product launches, and favorable reimbursement policies are expected to promote the transcatheter aortic valve replacement market growth during the forecast period. Furthermore, according to Frankel Cardiovascular Center (University of Michigan), an estimated 0.3 million people diagnosing with severe aortic stenosis every year.

The growing adoption of minimally invasive surgery (MIS) and technological advancements in transcatheter aortic valve replacement procedures further drive the TAVR market growth. It, in turn, aims to reduce healthcare spending. Besides, geographic expansion, financing, and adoption of advanced procedural devices and methods are expected to drive market growth during the forecast period.

Favorable reimbursement policies for TAVR procedures, growing demand for transcatheter procedures, improving patient outcomes and safety profiles, high success rates and shorter recovery times compared to traditional surgery and rising preference for TAVR among high-risk and intermediate-risk patients promote the TAVR market growth. The growing number of clinical trials and research studies on TAVR, rising awareness among physicians and patients about TAVR benefits, increasing healthcare expenditure, an increasing number of collaboration between device manufacturers and healthcare providers, rising prevalence of comorbidities such as diabetes and obesity, favorable regulatory environment and approvals for TAVR devices and growing demand for less invasive alternatives to surgical valve replacement further propel the TAVR market growth.

MARKET RESTRAINTS:

However, the risk associated with TAVR procedures, high costs of transcatheter aortic valves, lack of skilled professionals in some areas of developing markets, and device-related issues (such as device recalls, improper positioning of devices during implantation) are some of the factors restraining the growth of global TAVR market. In addition, strict regulations to restrict the approval of transcatheter devices to prevent surgical patient injury may hamper the market growth.

Impact of COVID-19 on the Global TAVR market:

The COVID-19 pandemic's impact on patients with aortic valve stenosis is undisclosed, and there is unpredictability about the suitable treatment procedure for these patients. The Asia-Pacific Society approves this study for Interventional Cardiology. Due to the incapacity to have face-to-face analysis during the pandemic, an online survey was organized inviting prominent opinion leaders (cardiac surgeons / interventional cardiologists/echocardiologists) in transcatheter aortic valve implantation (TAVI) in Asia to participate. Responses to a series of questions connected to the impact of COVID-19 on TAVI were assembled and analyzed. It then led to expert consensus guidance on the conduct of TAVI during the pandemic. Results The COVID-19 pandemic resulted in a 27% (15-85) reduction in case volume and 54% of operators required triage to treat their patients with severe aortic stenosis. The two most important parameters used for classification were symptoms and valve area. Peripheral changes included the introduction of teleconsultation, pre-procedural COVID-19 testing, optimization of protests, and the Cath lab setup. Besides, the length of stay was reduced from an average of 4.5 to 5 days. In conclusion, the COVID-19 pandemic has impacted the provision of TAVI services to patients in Asia. 

REPORT SCOPE:

This research report has segmented and sub-segmented the global TAVR market into the following categories.

TAVR Market - By Surgery Method:

• Transfemoral Implantation
• Transapical Implantation
• Transaortic Implantation
• Transcaval Implantation

Based on the surgery method, the transfemoral implantation segment is estimated to command the largest share of the global TAVR Market in 2022. Furthermore, it is expected to grow at the highest CAGR during the forecast period due to technological advancements such as vascular closure systems. Furthermore, the transfemoral implementation is a minimally invasive surgery, requires a short hospital stay, and provides quick recovery. Therefore, tutors and surgeons mostly suggest transfemoral implantation due to its better outcomes.

The transapical implantation segment is forecasted to witness a healthy CAGR during the forecast period due to the rising number of patients opting for efficient therapy with fast recovery. In addition, Braile Biomedical introduced a transapical aortic valve in Brazil in 2012, and the product introduction is to extend its product portfolio and boost market expansion in the Latin American region.

TAVR Market - By Valve Frame Material:

• Nitinol
• Stainless Steel
• Cobalt-Chromium

The nitinol segment is expected to account for the largest share of the global TAVR market during the forecast period by valve frame material. Since 2013, as the TAVR data registry, over 8000 procedures have been performed in Japan. Per Annals of Cardiothoracic Surgery, transcatheter aortic valve implementation (TAVI) devices are expected to be more efficient in treating high-risk patients. The shape memory properties of nitinol that allow better valve expansion and optimal fit within the aortic valve is one of the key factors propelling segmental growth. High flexibility, durability, biocompatibility, radial strength and conformability of nitinol material further drive the segmental growth. The rapid adoption of self-expandable valves that often utilize Nitinol frames due to their ease of deployment and retrievability and the growing number of R&D efforts to improve Nitinol-based TAVR devices to enhance performance and outcomes further contribute to the growth rate of the segment.

TAVR Market - By Valve Size:

• 14mm to 18 mm
• 18mm to 22 mm
• 22mm to 29mm

Based on the valve size, the 14mm to 18mm segment is likely to account for the highest share of the global market during the forecast period due to the increased number of minimally invasive surgeries and growth in the monitoring and detecting AAA. The presence of patients with smaller aortic valve anatomy requiring TAVR intervention, increasing recognition of the need for TAVR in patients with severe aortic stenosis and smaller valve sizes, advancements in technology and design to improve the feasibility and safety of TAVR procedures in smaller valve sizes and growing clinical evidence supporting the efficacy and safety of TAVR in the 14mm to 18mm range drive the segmental growth. The growing patient population, rising awareness among healthcare professionals about the benefits of TAVR in smaller valve sizes, favorable reimbursement policies and increasing coverage for TAVR procedures in this size range further contribute to the segment’s growth rate.

TAVR Market - By Valve Leaflets Material:

• Bovine Heart Tissue
• Cow Heart Tissue 
• Other Valve Leaflets Material 

By Valve Leaflets Material, the bovine heart tissue segment is predicted to hold the most considerable market share during the forecast period. The rise in the medical tourism industry and growing awareness regarding the advantages of minimally invasive techniques, such as less traumatic surgical experience, technological advancements, and innovative products, are expected to accelerate the segment's growth. 

TAVR Market - By End Users:

• Hospitals
• Ambulatory Surgical Centres 
• Cardiac Catheterization Laboratories 

Based on end-user, the hospital segment held the largest share of the global TAVR market in 2022 and the segmental domination is estimated to continue throughout the forecast period. The growing patient count primarily drives the segment's growth, sufficient availability of skilled and experienced medical surgeons, and highly advanced equipment. The availability of state-of-the-art cardiac care facilities, including catheterization labs and hybrid operating rooms in hospitals essential for performing TAVR procedures propels the segmental growth. The established referral networks with primary care physicians, clinics, and other healthcare providers further accelerate the growth rate of the segment.

The ambulatory surgical centers segment was the second-leading segment in 2022 and is predicted to register a healthy CAGR during the forecast period. The advantages of ASCs such as shorter hospital stays and faster recovery times compared to traditional hospitals majorly drive the segmental growth. Lower overhead costs of ambulatory surgical centers compared to hospitals further contribute to the growth rate of the segment.

TAVR Market -By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

The North America TAVR market had the largest share of 34% of the global market in 2022. In contrast, Asia-Pacific is estimated to grow at the highest CAGR of 21.20% during the forecast period. The United States dominated the market in 2019, accounting for over 45% of the transcatheter aortic valve implant market. It can be attributed to the high adoption of technologically advanced products, mergers and acquisitions, and favorable reimbursement policies. For example, reimbursement from government organizations such as the Centers for Medicare and Medicaid Services (CMS) helps patients opt for a transcatheter aortic valve replacement procedure. The primary payer for almost 92% of TAVR procedures was Medicare in 2019. It reinforced the economic advantage of TAVR over surgical aortic valve replacement (SAVR). The well-established healthcare industry can drive market growth in the region. The presence of several reputable market players who release continuous iterations of existing products can also play a critical role.

The European TAVR market accounted for a substantial share of the global market in 2022. Europe has similar growth factors to the Americas due to the increasing diagnosis of endovascular disease and a large senior population. In addition, the global transcatheter market will thrive in the region due to favorable regulations and many patients with sustainable income levels to pay for high-standard treatment. Recently, FEops received a USD 4.1 million fund to promote research and development of structural heart interventions. The Feops HEART Guide is a predictive planning guide that can provide information about the device's size and position during surgery to reduce injury risk.

APAC is predicted to witness the fastest CAGR in the global market during the forecast period. The presence of emerging economies, the growing prevalence of valvular heart diseases, particularly aortic stenosis, the increasing aging population in the Asia-Pacific region who are more prone to cardiovascular diseases, including aortic valve disorders, the growing number of investments to improve healthcare infrastructure including cardiac care facilities and specialized centers for cardiovascular interventions like TAVR primarily drive the market growth in the APAC region. The growing availability of advanced imaging systems and catheterization labs, the increasing number of well-trained interventional cardiologists and cardiac surgeons, the rising number of initiatives from the governments of APAC countries and favorable reimbursement programs further contribute to the regional market growth. China, Japan, India, South Korea, and Australia are predicted to control the major share of the APAC TAVR market during the forecast period.

The Latin America TAVR market is a noteworthy regional market for TAVR worldwide and is predicted to grow at a healthy CAGR during the forecast period. The MEA TAVR market accounted for a moderate share of the worldwide market in 2022 and is estimated to grow steadily during the forecast period.

KEY MARKET PLAYERS:

Notable companies leading the Global TAVR Market profiled in the report are Edwards Lifesciences Corporation (U.S.), Medtronic, Inc. (Ireland), Boston Scientific Corporation (U.S.), Abbott Laboratories (U.S.), St. Jude Medical Inc. (U.S.), JenaValve Technology, Inc. (Germany), Symetis SA (Switzerland), Direct Flow Medical, Inc. (U.S.), Sorin Group (Italy), Meril Life Sciences India Pvt Ltd (India) and Braile Biomedica (Brazil).

RECENT MARKET HAPPENINGS:

• In September 2020, Sahajanand Medical Technology Pvt. Ltd. launched TAVR Device Hydra in Central Europe.
• In December 2018, Marvel was introduced by Meril Life Sciences, the first company to manufacture transcatheter heart valves. It provides commercial availability globally wide.
• In April 2019, FDA approval was received by Boston Scientific Corp. for the LOTUS Edge Aortic valve system. It helps to provide physicians options to reposition and recapture the complete valve once full deployment.
• In August 2019, FDA approval was received by Medtronic Plc for an Evolut Transcatheter Aortic Valve replacement system.