The Global Prosthetic Heart Valve Market is expected to grow at a high CAGR of 10.8% during the forecasting period (2022-2029).
The prosthetic heart valve is surgically implanted in the heart to replace a heart valve that has been damaged due to a heart-related disorder. Heart valve replacement surgery is performed when repair of the valve is not an option, each valve has a tissue flap that opens and closes with every heartbeat.
The global prosthetic heart valve market growth is driven by the rise in prevalence of cardiac disorders, such as rheumatic heart diseases, increase in the geriatric population, changes in the lifestyle of people, and novel technological advancements in prosthetic heart valves, demand for minimally invasive cardiovascular surgeries.
The rising regulatory approvals for new and advanced prosthetic heart valves will drive the market growth
Regulatory approvals for new and advanced prosthetic heart valves are one of the key factors fueling the global prosthetic heart valve market. For instance, in March 2018, Abbott has received U.S. Food and Drug Administration (FDA) approval for Masters HP 15mm rotatable mechanical heart valve, which is the world’s smallest automatic heart valve, that will allow treating babies and toddlers in need of a mitral or aortic valve replacement. The European countries conduct a maximum number of clinical trials as a result of the high prevalence of heart diseases, such as aortic stenosis and mitral regurgitation. For instance, in Europe, more than 1.75 million people suffer from aortic stenosis. In addition, mechanical valve trials were highest in Europe (about 45.6%) followed by North America (38.1%).
The increasing prevalence of heart valve disease is a major factor driving the market's growth. For instance, as per the World Heart Federation 2022, rheumatic heart disease is a condition that affects 39 million people worldwide. It is a condition in which the heart valves have been permanently damaged by rheumatic fever. Furthermore, as per a January 2022 published article, titled "Uncovering the treatable burden of severe aortic stenosis in the UK", the results revealed that in the United Kingdom, in 2019, the prevalence of severe aortic stenosis was 1.48%, including 291,448 men and women aged more than or equal to 55 years. These factors are driving the growth of the market in the forecast period.
The high cost of transcatheter aortic valve replacement (TAVR) will hamper the growth of the market
However, the high cost of transcatheter aortic valve replacement (TAVR) procedures and the availability of alternative methods for treating heart valve diseases (HVD) are the factors hampering the market's growth.
The COVID-19 pandemic is expected to have a major impact on the prosthetic heart valve market. COVID-19 disease is posing a risk in the management of patients with prosthetic heart valves. For instance, as per a February 2021 published article titled "Bioprosthetic Valve Thrombosis Associated With COVID-19 Infection", patients with prosthetic heart valves and endovascular devices may be at risk of thrombotic complications from the COVID-19 disease. Thus, such studies indicate that the demand for prosthetic heart valves was affected as the prosthetic heart valve patients were at risk of developing COVID-19 disease. However, with the introduction of vaccines and the upliftment of lockdown in various countries across the globe, there might be an increase in the number of patients undergoing heart valve placement, thereby expanding the market growth in the forecast period.
The transcatheter heart valves segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)
The transcatheter heart valve segment is expected to hold a significant share. This can be attributed to various factors such as the high burden of heart valve diseases, ease of implantation, a rise in the number of transcatheter heart valve surgery centers, and growth of the patient population, leading to an increase in the number of transcatheter aortic valve replacement procedures. For instance, according to a research study published in February 2020, titled "Epidemiology of aortic valve stenosis (AS) and aortic valve incompetence (AI): is the prevalence of AS/AI similar in different parts of the world?", the epidemiology of aortic valve disease varies enormously between high-income and low-income countries, and there is an exponential increase in the prevalence of aortic stenosis (AS) with age, with 0.2% in the 50–59-year group, 1.3% in the 60–69-year group, 3.9% in the 70–79-year group, and 9.8% in those aged 80–89 years. As transcatheter heart valves are used in patients suffering from aortic valve stenosis and incompetence, such studies indicate that the demand for transcatheter heart valves is anticipated to increase in the near future.
Several market players are engaged in the implementation of strategic initiatives, thereby contributing to segment growth. For instance, in January 2022, SMT (Sahajanand Medical Technologies Limited) reported the publication of Hydra Transcatheter Aortic Heart Valve CE study data in the JACC (Journal of the American College of Cardiology) Cardiovascular Interventions journal. This study evaluated the 30-day and 1-year safety and performance of the Hydra transcatheter aortic heart valve in the treatment of symptomatic severe aortic stenosis in cardiac patients at high or extremely high surgical risk. The Hydra CE study has demonstrated that transcatheter aortic valve replacement with the Hydra valve offers favorable efficacy at 1 year, providing a large effective orifice area and low transvalvular gradient as well as acceptable complication rates.
North America region holds the largest market share of the global prosthetic heart valve market
North America dominates the market for Prosthetic Heart valves and is expected to show a similar trend over the forecast period, owing to the high prevalence of heart valve disorders, advancements in products, the number of heart valve replacement procedures, and well-established healthcare infrastructure. For instance, as per the 2022 American College of Cardiology Foundation, the prevalence of valvar heart diseases (VHD) is rising in the United States, with more than 5 million Americans diagnosed each year, while up to 1.5 million people suffer from aortic stenosis (AS) in the United States. Approximately 500,000 of these patients suffer from severe AS.
Several market players are also engaged in the implementation of strategic initiatives, thereby fueling the market's growth. For instance, in September 2021, Abbott reported that the United States Food and Drug Administration (USFDA) had approved the company's Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease. Thus, these factors are driving the growth of the market in the forecast period.
The prosthetic heart valve market is a moderately competitive presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Medtronic PLC, Edwards Lifesciences Corporation, Boston Scientific Corporation, Jude Medical Inc. (Abbott Laboratories), Symetis SA, Jenavalve Technology Inc., Cryolife Inc., TTK Healthcare Limited, Colibri Heart Valve LLC, Lepu Medical Technology Co. Ltd among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Prosthetic Heart Valve Market globally. For instance, in July 2021, CARMAT, the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, reported the first implant of its Aeson bioprosthetic artificial heart in a commercial setting.
Medtronic plc develops, manufactures, distributes, and sells device-based medical therapies to hospitals, physicians, clinicians, and patients worldwide. It operates through four segments: Cardiovascular Portfolio, Neuroscience Portfolio, Medical-Surgical Portfolio, and Diabetes Operating Unit.
Evolut PRO system: The Evolut PRO system goes has a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing.
The global prosthetic heart valve market report would provide access to approximately 40+ market data tables, 45+ figures, and in the range of 200 pages.
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