Download Sample, Increasing Prevalence of Cardiovascular Diseases and Demand for Minimally Invasive Procedures Drives the Market
Cardiovascular disease burden has become a significant health concern worldwide, along with rising prevalence and an aging population, which significantly drives the market. Cardiac diseases such as aortic stenosis, which involves thickening and narrowing of the heart, and mitral regurgitation, along with the geriatric population and risk factors that worsen heart conditions such as obesity and hypertension, become prevalent, which drives the demand for heart valve devices. Aortic stenosis is the most frequently identified valvular heart condition, and its occurrence rises as the general population ages.
Nonetheless, AS is frequently identified in an advanced phase, requiring surgery, because of its extended period without symptoms. According to the National Institutes of Health (NIH), the prevalence of calcific aortic sclerosis is approximately 1% to 2% in individuals under 65 years old and 29% in those over 65 years old. Approximately 2–9% of individuals over 75 years old experience severe aortic stenosis. Aortic sclerosis affects 9–45% of patients aged 54–81, and its prevalence rises with age. The occurrence of aortic stenosis differs between patients with normal versus abnormal valves, depending on their age. The population is projected to double or triple in the next few decades as people get older.
Mitral regurgitation is another heart condition in which the mitral valve does not close properly, causing blood to flow back from the left ventricle to the left atrium during systole. This leads to a heart murmur heard at the heart's tip, sometimes spreading to the left armpit. Mitral regurgitation is a most common cardiac condition referred to as a valvular abnormality worldwide, affecting more than 2% of the population, according to the NIH, and resulting from a range of causes such as congenital conditions, rheumatic fever, and degenerative valve changes. Apart from this, there is growing demand for minimally invasive surgery as it offers faster recovery, less pain, is less scary, and a shorter hospital stay, which drives the heart valve device market expansion.
Nonetheless, AS is frequently identified in an advanced phase, requiring surgery, because of its extended period without symptoms. According to the National Institutes of Health (NIH), the prevalence of calcific aortic sclerosis is approximately 1% to 2% in individuals under 65 years old and 29% in those over 65 years old. Approximately 2–9% of individuals over 75 years old experience severe aortic stenosis. Aortic sclerosis affects 9–45% of patients aged 54–81, and its prevalence rises with age. The occurrence of aortic stenosis differs between patients with normal versus abnormal valves, depending on their age. The population is projected to double or triple in the next few decades as people get older.
Mitral regurgitation is another heart condition in which the mitral valve does not close properly, causing blood to flow back from the left ventricle to the left atrium during systole. This leads to a heart murmur heard at the heart's tip, sometimes spreading to the left armpit. Mitral regurgitation is a most common cardiac condition referred to as a valvular abnormality worldwide, affecting more than 2% of the population, according to the NIH, and resulting from a range of causes such as congenital conditions, rheumatic fever, and degenerative valve changes. Apart from this, there is growing demand for minimally invasive surgery as it offers faster recovery, less pain, is less scary, and a shorter hospital stay, which drives the heart valve device market expansion.
Expansion of Transcatheter Aortic Valve Therapies Drives the Market Expansion
There are two treatment options available for patients suffering from severe native calcific aortic valve stenosis (AS) who need a valve replacement. Cardiac valve therapies such as surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) are the two treatment options available for patients. The widespread use of TAVR as a mainstream treatment for aortic valve disease is owing to technological advancements and growing clinical evidence. TAVR is a rapidly developing method supported by numerous randomized control trials indicating similar or possibly better outcomes than SAVR in patients with extreme, high, intermediate, and low surgical risk. Recent advancements in transcatheter heart valves (THV) have greatly enhanced procedural safety, effectiveness, and patient results, making TAVR a desirable choice for various patient risk categories.
Additionally, transcatheter mitral valve replacement (TMVR) is a less intrusive procedure for treating structural heart disease by replacing a damaged mitral valve without the need for traditional open-heart surgery. Furthermore, there is another advancement in technology within the field of cardiology, such as the Mitra-Clip, which is an innovative tool that is inserted using a catheter to address issues with the mitral valve, as the mitral valve is crucial to the heart's intricate mechanisms. It is a revolutionary development for patients at high risk of open-heart surgery, providing a minimally invasive approach. Apart from this, the collaboration of surgical and transcatheter methods in hybrid operating rooms offers possibilities for advanced heart valve procedures. Hybrid methods such as valve-in-valve procedures and mixing mitral valve repair and replacement broaden treatment choices to meet the various clinical requirements of patients.
Additionally, transcatheter mitral valve replacement (TMVR) is a less intrusive procedure for treating structural heart disease by replacing a damaged mitral valve without the need for traditional open-heart surgery. Furthermore, there is another advancement in technology within the field of cardiology, such as the Mitra-Clip, which is an innovative tool that is inserted using a catheter to address issues with the mitral valve, as the mitral valve is crucial to the heart's intricate mechanisms. It is a revolutionary development for patients at high risk of open-heart surgery, providing a minimally invasive approach. Apart from this, the collaboration of surgical and transcatheter methods in hybrid operating rooms offers possibilities for advanced heart valve procedures. Hybrid methods such as valve-in-valve procedures and mixing mitral valve repair and replacement broaden treatment choices to meet the various clinical requirements of patients.
Recent Trends in Heart Valve Devices Market
- Rising demand for revolutionary treatment such as transcatheter aortic valve replacement (TAVR)
- Growing focus on transcatheter mitral valve repair (TMVR) and replacement (TMVR) techniques
- Ongoing developments in valve design, materials such as biocompatible polymers, and delivery systems are improving the performance and longevity of devices
- Increasing demand for Minimally invasive procedures for faster recovery and patient convenience
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Devices Specific Complications Hampers the Market Growth
Complications depending on the specific device used during heart valve replacement procedures may differ based on whether a mechanical or bioprosthetic valve is used, as well as the method of delivery, whether surgical or transcatheter. Individuals with the replacement of mechanical valves are very susceptible to blood clot formation owing to the foreign material and absence of endothelial lining. As blood clotting is the main problem with mechanical valve replacement, individuals may take blood thinners for the rest of their lives to address this problem.
However, mechanical valves have the ability to interfere with regular blood circulation, possibly resulting in hemolysis, which could lead to anemia and other blood-related issues. Apart from this, bioprosthetic valves are manufactured using animal materials such as porcine or bovine pericardium or human donor tissue. Over time, these valves may deteriorate or develop calcium build-up, causing valve dysfunction and requiring another surgery or replacement. Bioprosthetic valves may deteriorate sooner than anticipated in certain situations, necessitating early replacement. Though less frequent than mechanical valves, bioprosthetic valves also pose a risk of infective endocarditis, especially in patients with predisposing factors.
Furthermore, complications related to the implanted valve may cause leakage known as paravalvular leakage, which can impact valve performance and may necessitate further intervention for correction. Incorrect placement of the transcatheter valve during the procedure can result in insufficient sealing or blockage of blood flow. Complications with blood vessels, such as injury or bleeding at the site of access, can happen when large catheters are inserted into the arteries. Apart from this, the prosthetic valve malfunctions, leading to valve stenosis and regurgitation.
However, mechanical valves have the ability to interfere with regular blood circulation, possibly resulting in hemolysis, which could lead to anemia and other blood-related issues. Apart from this, bioprosthetic valves are manufactured using animal materials such as porcine or bovine pericardium or human donor tissue. Over time, these valves may deteriorate or develop calcium build-up, causing valve dysfunction and requiring another surgery or replacement. Bioprosthetic valves may deteriorate sooner than anticipated in certain situations, necessitating early replacement. Though less frequent than mechanical valves, bioprosthetic valves also pose a risk of infective endocarditis, especially in patients with predisposing factors.
Furthermore, complications related to the implanted valve may cause leakage known as paravalvular leakage, which can impact valve performance and may necessitate further intervention for correction. Incorrect placement of the transcatheter valve during the procedure can result in insufficient sealing or blockage of blood flow. Complications with blood vessels, such as injury or bleeding at the site of access, can happen when large catheters are inserted into the arteries. Apart from this, the prosthetic valve malfunctions, leading to valve stenosis and regurgitation.
New Product Development with Next Generation Features by Key Players Uplifts Market Expansion
Owing to the rising prevalence of cardiac diseases and continuous invention in heart valve technology, the heart valve device market is expanding. For instance, in April 2024, Medtronic announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It’s an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start.
Additionally, in April 2024, Abbott announced the U.S. Food and Drug Administration's (FDA) approval for the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with no abstention, that the benefits of TriClip outweighed the risks.
Additionally, in April 2024, Abbott announced the U.S. Food and Drug Administration's (FDA) approval for the company's first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with no abstention, that the benefits of TriClip outweighed the risks.
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Major Acceptance of Transcatheter Aortic Valve Replacement (TAVR) In North America Drive the Market Growth
The heart valve devices market is primarily driven by increasing reimbursement policies. The widespread acceptance of new heart valve technologies and advanced healthcare infrastructure in North America propels market growth. The etiology of aortic stenosis varies geographically, with calcific stenosis being more prevalent in North America and Europe, while rheumatic valve disease is more common in developing nations. The United States is at the forefront of implementing cutting-edge heart health devices because of its sophisticated healthcare infrastructure, which includes specialized cardiac centers.
For instance, there are around 800 heart hospitals, among which the top 50 are ranked for their treatment of challenging heart and vascular cases, including heart transplants, cardiac device implantation, major chest procedures, complex conditions such as endocarditis, heart failure, and circulatory issues, and the presence of well-integrated research institutions. As per the Centers for Disease Control (CDC), about 2.5% of the US population has valvular heart disease. Apart from this rising prevalence of heart valve diseases and geriatric population attributed to the market expansion in North America.
For the Asia-Pacific region, the heart valve device market Asia Pacific is projected to grow, attributed to the rising geriatric and obese population, rapid adoption of tissue valves, and active government support. The global market for heart valve devices is driven by factors such as favorable reimbursement scenarios, a rise in regulatory approvals, and the presence of a large target patient population. In addition, the surge in healthcare expenditure, implementation of government-funded insurance schemes, and growing medical tourism industry in several countries are attributable to market growth in the Asia Pacific.
For instance, there are around 800 heart hospitals, among which the top 50 are ranked for their treatment of challenging heart and vascular cases, including heart transplants, cardiac device implantation, major chest procedures, complex conditions such as endocarditis, heart failure, and circulatory issues, and the presence of well-integrated research institutions. As per the Centers for Disease Control (CDC), about 2.5% of the US population has valvular heart disease. Apart from this rising prevalence of heart valve diseases and geriatric population attributed to the market expansion in North America.
For the Asia-Pacific region, the heart valve device market Asia Pacific is projected to grow, attributed to the rising geriatric and obese population, rapid adoption of tissue valves, and active government support. The global market for heart valve devices is driven by factors such as favorable reimbursement scenarios, a rise in regulatory approvals, and the presence of a large target patient population. In addition, the surge in healthcare expenditure, implementation of government-funded insurance schemes, and growing medical tourism industry in several countries are attributable to market growth in the Asia Pacific.
The report provides a detailed overview of the heart valve devices market insights in regions including North America, Latin America, Europe, Asia-Pacific, Oceania, and the Middle East and Africa. The country-specific assessment for heart valve devices market has been offered for all regional market share, along with forecasts, market scope estimates, price point assessment, and impact analysis of prominent countries and regions. Throughout this market research report, Y-o-Y growth and CAGR estimates are also incorporated for every country and region, to provide a detailed view of the heart valve devices market. These Y-o-Y projections on regional and country-level markets brighten the political, economic and business environment outlook, which are anticipated to have a substantial impact on the growth of the heart valve devices market. Some key country and region included in the heart valve devices market report as follows:
| North America | United States, Canada |
| Latin America | Brazil, Mexico, Argentina, Colombia, Chile, Rest of Latin America |
| Europe | Germany, United Kingdom, France, Italy, Spain, Russia, Netherlands, Switzerland, Belgium, Sweden, Austria, Norway, Denmark, Finland, Ireland, Czech Republic, Rest of Europe |
| Asia Pacific | China, India, Japan, South Korea, Australia & New Zealand, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia Pacific |
| Middle East and Africa | GCC Countries, South Africa, Egypt, Turkey, Morocco, Israel, Iran, Kenya, Nigeria, Rest of MEA |
Heart Valve Devices Market Research Report Covers In-depth Analysis on:
- Heart valve devices market detailed segments and segment-wise market breakdown
- Heart valve devices market dynamics (Recent industry trends, drivers, restraints, growth potential, opportunities in Heart valve Devices industry)
- Current, historical and forthcoming 10 years market valuation in terms of heart valve devices market size (US$ Mn), volume (Units), share (%), Y-o-Y growth rate, CAGR (%) analysis
- Heart valve devices market demand analysis
- Heart valve devices market pricing analysis over forecast period (by key segment and by region)
- Heart valve devices market regional insights with region-wise market breakdown
- Competitive analysis – key companies profiling including their market share, product offerings, and competitive strategies.
- Latest developments and innovations in heart valve devices market
- Regulatory landscape by key regions and key countries
- Supply chain and value chain analysis in heart valve devices market
- Heart valve Devices market sales and distribution strategies
- A comprehensive overview of parent market
- A detailed viewpoint on heart valve devices market forecast by countries
- Mergers and acquisitions in heart valve devices market
- Essential information to enhance market position
- Robust research methodology
- Frequently Asked Questions -
What are the key drivers for the heart valve devices market growth?
The heart valve devices market is driven by advancements in medical technology, an aging population, increasing prevalence of cardiovascular diseases, and the growing demand for minimally invasive surgical procedures.
What are the future trends in the heart valve devices market?
Future trends include the adoption of next-generation devices, increased focus on personalized treatment options, advancements in AI-driven diagnostics, and the growth of minimally invasive procedures in emerging economies.
How is the competitive landscape analyzed in the report?
The report analyzes the competitive landscape by profiling key players, assessing their product portfolios, strategies, market shares, and geographical reach to provide actionable insights for stakeholders.
