Heart Valve Devices Market Size & Growth Analysis to 2030

Key Findings:

• The market size was valued at over US$ 10 Bn in 2023 and experiencing a significant growth rate of around 11.5% by 2030
• By product type, the mechanical heart valve segment dominated the market in the benchmark year 2023
• Geographically, North America is accounted to hold the largest revenue share of over 1/3 market share in the benchmark year 2023

The global heart valve devices market size was valued at over USD 10 billion in 2023 and experiencing a significant CAGR of around 11.5% during the forecast period from 2024 to 2030. The market is experiencing significant growth, driven by the rising prevalence of cardiovascular diseases, an aging population, and advancements in medical technologies. As the global population ages, the demand for heart valve replacements and repair procedures continues to increase, with heart valve diseases becoming more common.

Minimally invasive treatments, such as Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR), have revolutionized the market by offering quicker recovery times and reduced surgical risks compared to traditional open-heart surgery. This shift towards less invasive procedures is fueling the market’s expansion, as it allows for broader patient access and improves the overall success rates of heart valve surgeries.

The North American region currently dominates the market, with high adoption of advanced medical technologies and extensive healthcare infrastructure. However, the Asia-Pacific region is expected to witness the fastest growth due to increasing healthcare access, rising cardiovascular disease incidences, and growing awareness in countries like China and India. According to the NIH, the global burden of cardiovascular diseases is projected to increase, with an estimated 23.6 million people expected to die from cardiovascular diseases annually by 2030, making heart valve treatments increasingly critical.

Market Snapshot:

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Market Drivers:

The global heart valve devices market is driven by several key factors, including the rising prevalence of cardiovascular diseases, particularly among the aging population. As the global population continues to age, the incidence of heart valve diseases, such as aortic stenosis and mitral valve regurgitation, is rising, creating a higher demand for valve replacement and repair procedures. Additionally, the growing adoption of minimally invasive surgeries, such as Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR), is contributing to the market’s growth. These procedures offer several benefits over traditional open-heart surgeries, such as shorter recovery times, reduced risk of complications, and a lower need for general anesthesia, which makes them highly attractive to patients and healthcare providers.

Technological advancements are also a major driving force behind the expansion of the heart valve devices market. The development of biocompatible materials, such as tissue-engineered valves, has improved the durability and performance of heart valves, making them suitable for a broader range of patients, including the elderly. According to the World Health Organization (WHO), cardiovascular diseases remain the leading cause of death globally, accounting for nearly 18 million deaths annually. This underscores the critical need for advanced heart valve treatments, driving demand for innovative valve devices and solutions across the healthcare industry.

Market Trends:

Minimally Invasive Procedures: One of the most significant trends in the heart valve devices market is the increasing adoption of minimally invasive surgical procedures, such as Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR). These procedures, which involve inserting a replacement valve through a catheter, offer numerous advantages over traditional open-heart surgery. Patients experience shorter hospital stays, quicker recovery times, reduced post-operative complications, and a lower risk of infection and other adverse outcomes. As a result, these procedures have gained widespread acceptance, especially among older patients or those with comorbidities who may not be ideal candidates for open-heart surgery. This shift to minimally invasive techniques is driving the demand for advanced heart valve devices that are compatible with these procedures, significantly contributing to market growth.

Technological Advancements: Another driving factor in the heart valve devices market is the rapid pace of technological innovation. Recent advancements in heart valve design, materials, and manufacturing processes have led to the development of more durable, effective, and biocompatible valve solutions. Tissue-engineered valves, for instance, offer a more natural and long-lasting alternative to mechanical valves, reducing the risk of complications like blood clots and infections. Additionally, the development of biodegradable components has opened up new possibilities for the creation of temporary heart valves that can dissolve or be absorbed by the body, reducing the need for replacement surgeries. These innovations are improving patient outcomes, extending the lifespan of heart valves, and providing more options for patients with complex cardiovascular conditions, thus propelling the market forward.

Growth in Valve Replacements for Elderly Populations: The global aging population is contributing significantly to the growth of the heart valve devices market. As people live longer, the incidence of heart valve diseases, such as aortic stenosis and mitral valve regurgitation, is on the rise, especially among elderly individuals. This demographic is more prone to developing heart valve disorders due to the natural aging process of the heart and blood vessels. The increasing need for heart valve replacements or repairs in older adults is creating a substantial demand for these medical devices. Additionally, the elderly population often presents with other health conditions, making them more likely to be considered for minimally invasive treatments like TAVR, further boosting the market for heart valve devices.

Expansion in Emerging Markets: The heart valve devices market is also experiencing significant growth in emerging markets, particularly in the Asia-Pacific region. This growth is driven by improvements in healthcare infrastructure, greater access to advanced medical technologies, and rising awareness of heart valve diseases. Countries like China, India, and Brazil are seeing a growing number of patients seeking treatment for heart valve diseases, thanks to better healthcare policies, improved diagnostic tools, and increased investment in the medical sector. As these countries continue to modernize their healthcare systems and expand access to life-saving treatments, the demand for heart valve devices in these regions is expected to rise substantially, further contributing to global market growth.

Personalized Medicine and 3D Printing: A key trend that is revolutionizing the heart valve devices market is the increasing use of personalized medicine and 3D printing technologies. Personalized medicine allows for heart valve devices to be custom-designed to meet the specific needs of individual patients. This is especially important for patients with complex cardiovascular conditions or unique anatomical features that may make standard valve devices unsuitable. By using 3D printing technology, healthcare providers can create patient-specific valve models or even 3D-printed heart valves that offer a more precise fit and better functionality. This level of customization not only improves the effectiveness of heart valve treatments but also leads to better patient outcomes and satisfaction. As 3D printing technology continues to evolve and become more affordable, the application of personalized solutions in heart valve treatments is expected to increase, providing more tailored, effective treatment options for patients around the world.

Market Opportunities:

The global heart valve devices market presents several promising opportunities driven by technological advancements and increasing healthcare demands. One of the most significant opportunities lies in the development and adoption of minimally invasive procedures, such as Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR). As these procedures become more widely accepted, there is a growing need for advanced, high-quality heart valve devices that can meet the requirements of both patients and healthcare professionals. The market is also witnessing increased interest in biocompatible and tissue-engineered heart valves, which offer the potential for longer-lasting and more effective solutions. The shift toward these innovative devices, which reduce the need for repeated surgeries, presents a strong growth opportunity for manufacturers to develop cutting-edge products that can cater to an aging population and those with complex heart valve diseases.

Additionally, emerging markets such as Asia-Pacific, Latin America, and the Middle East present substantial growth opportunities for heart valve devices. As these regions invest in healthcare infrastructure and raise awareness of heart valve diseases, the demand for advanced medical treatments is on the rise. According to the World Health Organization (WHO), cardiovascular diseases are the leading cause of death globally, and they are increasingly affecting populations in developing regions. As a result, there is a significant opportunity for market players to expand their presence in these regions by offering affordable and accessible heart valve devices, especially as healthcare systems in these areas improve and populations continue to age. With the right investment in education, partnerships, and local healthcare systems, the heart valve devices market can experience rapid growth in these regions.

Market Restraints:

The global heart valve devices market faces several restraining factors that impact its growth. One of the primary challenges is the high cost associated with advanced heart valve treatments, especially minimally invasive procedures like Transcatheter Aortic Valve Replacement (TAVR). The high cost of both the devices and the associated medical procedures limits accessibility, particularly in low- and middle-income countries where healthcare budgets are constrained. Additionally, the complexity of heart valve surgeries, even when minimally invasive, requires skilled healthcare professionals and specialized equipment, which may not be readily available in some regions. Another concern is the risk of complications, such as valve failure or infection, which may lead to the need for additional procedures. These factors deter patients from seeking treatment and pose a barrier to market expansion, particularly in emerging markets with developing healthcare infrastructure.

Market Insights:

The global heart valve devices market is bifurcated into product type, procedure, application, end-user, and geography. On the basis of product type, the mechanical heart valves segment has historically dominated the global market in 2023, and continues to hold a significant share, particularly among younger patients and those who require a long-term solution. Mechanical valves are known for their durability and longevity, often lasting a lifetime, which makes them an attractive option for patients who are younger or otherwise in good health. The key advantage of mechanical valves is that they are made from strong, long-lasting materials such as titanium, carbon, or stainless steel, which contribute to their extended lifespan. This durability is especially important for younger patients who may require heart valve replacement due to conditions such as congenital heart defects or valve disease.

While the need for lifelong anticoagulant therapy is a trade-off, the mechanical valve segment remains dominant due to its proven track record in terms of durability and effectiveness. For younger patients, the benefits of a lifetime valve solution outweigh the risk of blood clots, making mechanical valves a preferred choice. Additionally, as healthcare systems globally continue to improve, particularly in developed regions, the availability of long-term treatments and specialized care to manage anticoagulant therapy enhances the appeal of mechanical heart valves. Despite the growing demand for minimally invasive options like transcatheter valves, the mechanical valve segment remains vital, driven by its reliability and the increasing need for long-lasting solutions in patients who are less likely to need valve replacements later in life.

Market Trends for Mechanical Heart Valves Sub-category:

• The mechanical heart valves segment continues to evolve with key trends focused on enhancing valve performance, durability, and biocompatibility. One significant trend is the advancement in valve materials. Manufacturers are increasingly focusing on developing mechanical valves made from innovative materials such as advanced carbon composites and pyrolytic carbon coatings. These materials improve valve durability, reduce wear, and enhance overall performance. Moreover, there is a growing emphasis on refining the design of mechanical heart valves to reduce the risk of complications, such as thrombosis, while still ensuring the longevity and mechanical integrity of the valve. This trend is expected to contribute to a higher adoption rate, particularly among younger patients who require long-lasting solutions.
• Another notable trend is the integration of digital technologies for better patient management. The use of wearable devices and remote monitoring tools is becoming more prevalent in the management of patients with mechanical valves, allowing for continuous monitoring of their anticoagulant therapy and overall cardiovascular health. This trend reflects the growing focus on personalized healthcare and improving patient outcomes post-surgery, which enhances the overall appeal of mechanical valves, especially in regions with more advanced healthcare infrastructure.

Market Opportunities for Mechanical Heart Valves Sub-category:

• The mechanical heart valves segment presents significant opportunities, particularly as the global population ages and the incidence of heart valve diseases rises. One of the biggest opportunities lies in expanding access to these devices in emerging markets. As healthcare infrastructure improves in regions such as Asia-Pacific, Latin America, and parts of Africa, there is an increasing demand for durable heart valve replacements. Mechanical valves, with their longer lifespan, are particularly well-suited for patients in these regions, where access to frequent surgeries and valve replacements might be limited.
• Another opportunity is in the growing trend of hybrid valve treatments, where mechanical valves are combined with minimally invasive procedures to reduce recovery times and improve patient outcomes. Mechanical valves are also gaining attention in complex cases where other treatment options may not be suitable, such as in patients with high surgical risk. As a result, there is a growing need for advanced mechanical valve designs that are easier to implant and reduce the overall risk of complications. With the continued advancements in materials and technology, the mechanical heart valve segment is poised to expand, addressing the needs of both high-risk and long-term patients globally.

The heart valve devices market research report presents the analysis of each segment from 2020 to 2030 considering 2023 as the base year for the research. The compounded annual growth rate (CAGR) for each respective segment is calculated for the forecast period from 2024 to 2030.

Historical & Forecast Period

• 2020-22 – Historical Year
• 2023 – Base Year
• 2024-2030 – Forecast Period

Market Segmentation:

By Product Type:

• Mechanical Heart Valves
• Biological Heart Valves
• Transcatheter Heart Valves

By Procedure:

• Surgical
• Transcatheter

By Application:

• Aortic Valve Diseases
• Mitral Valve Diseases
• Pulmonary & Tricuspid Valve Diseases

By End-User:

• Hospitals
• Ambulatory Surgical Centers
• Cardiac Centers

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Regional Analysis:

Geographically, the North America dominated the global heart valve devices market in the benchmark year 2023, primarily driven by advanced healthcare infrastructure, high patient awareness, and a growing aging population. The United States, in particular, is a leader in the adoption of cutting-edge heart valve technologies, including mechanical, biological, and transcatheter heart valves. The high prevalence of heart diseases, such as aortic stenosis and other valve-related conditions, has led to increased demand for heart valve replacement procedures. Additionally, the presence of major heart valve device manufacturers, extensive research and development activities, and well-established reimbursement policies further support North America’s dominance in the market. The region’s healthcare system is well-equipped to handle complex surgeries and treatments, which contributes to the steady growth in heart valve device adoption.

Moreover, North America benefits from favorable government policies and increasing investments in medical technology. The expansion of minimally invasive heart valve procedures like Transcatheter Aortic Valve Replacement (TAVR) has further boosted market growth, especially given the aging population in the region. With the growing trend of personalized healthcare and advancements in digital health technologies, North America continues to set the standard for heart valve device innovations. The well-established regulatory framework in the region also facilitates the introduction of new and improved heart valve devices, ensuring high standards of safety and effectiveness. As a result, North America remains the dominant region in the heart valve devices market, with continued growth expected due to ongoing medical innovations and the increasing number of patients requiring valve replacement.

Competitive Landscape:

Some of the notable market players operating in the global heart valve devices market are Edwards Lifesciences Corporation, Medtronic plc, Boston Scientific Corporation, Abbott Laboratories, LivaNova PLC, and JenaValve Technology, Inc. Companies are exploring markets by expansion, new investment, the introduction of new services, and collaboration as their preferred strategies. Players are exploring new geography through expansion and acquisition to gain a competitive advantage through joint synergy.

Recent Developments:

• In April 2024, Medtronic introduced its next-generation surgical aortic tissue valve, the Avalus Ultra Bioprosthesis. This new device is designed for easier implantation, enhanced visibility for future valve-in-valve procedures, and simplified sizing. It also features a polyetheretherketone (PEEK) base frame, ensuring consistent circularity and durability.
• In January 2023, Abbott received U.S. FDA approval for its Navitor transcatheter aortic valve implantation (TAVI) system. This system is intended for patients with severe aortic stenosis or those at high surgical risk due to various complications, offering a less invasive treatment option.
• In September 2020, Boston Scientific Corporation began a controlled launch of the ACURATE neo2 Aortic Valve System in Europe. This updated transcatheter aortic valve implantation (TAVI) technology includes several enhancements aimed at improving the clinical performance of the previous ACURATE neo platform, strengthening the company’s heart valve device portfolio in the European market.

Key Companies:

• Edwards Lifesciences Corporation
• Medtronic plc
• Boston Scientific Corporation
• Abbott Laboratories
• LivaNova PLC
• JenaValve Technology, Inc.
• Novostia SA
• Meril Life Sciences Pvt. Ltd.
• Corcym UK Limited
• Micro Interventional Devices, Inc.
• Auto Tissue Berlin GmbH
• Anteris Technologies Ltd.

Key Questions Answered by Heart Valve Devices Market Report

• Global heart valve devices market forecasts from 2024-2030
• Regional market forecasts from 2024-2030 covering Asia-Pacific, North America, Europe, Middle East & Africa, and Latin America
• Country-level forecasts from 2024-2030 covering 15 major countries from the regions as mentioned above
• Heart valve devices submarket forecasts from 2024-2030 covering the market by product type, procedure, application, end-user, and geography
• Various industry models such as SWOT analysis, Value Chain Analysis about the market
• Analysis of the key factors driving and restraining the growth of the global, regional, and country-level heart valve devices markets from 2024-2030
• Competitive Landscape and market positioning of top 10 players operating in the market