Heart Valve Repair and Replacement Devices Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, UK, Japan, China, Canada - Size and Forecast 2024-2028

Heart Valve Repair And Replacement Devices Market Size 2024-2028 

The heart valve repair and replacement devices market size is estimated to grow by USD 2.58 billion at a CAGR of 7.08% between 2023 and 2028. The heart valve repair and replacement devices market is experiencing significant growth due to rising competition and innovations. This expansion is driven by the increasing incidence of valvular heart diseases, which necessitates the development of advanced solutions. One promising area of research is the use of tissue engineering approaches to create functional heart valves. These engineered valves offer several advantages over traditional mechanical and biological valves, including improved durability, reduced risk of thrombosis, and better biocompatibility. As the field of tissue engineering advances, we can expect to see more sophisticated and effective heart valve repair and replacement solutions, addressing the growing demand and improving patient outcomes.

What will be the Size of the Market During the Forecast Period?

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Market Dynamic and Customer Landscape

Heart valve repair and replacement devices refer to medical devices used to treat heart valve conditions such as regurgitation, stenosis, damage from infections, heart attacks, or age-related changes. These conditions can lead to heart disease and require intervention through either repairing the existing valve or replacing it entirely. Heart valve diseases can be congenital or acquired, and treatments include medicines and lifestyle changes, as well as more invasive procedures like Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI). FDA approval is required for these devices, and regulatory procedures can be stringent due to the high cost and potential risks involved. Key players in the market include Medtronic, with their Transcatheter Mitral Valve Replacement (TMVR) technology. Diagnostic technologies are also important in identifying heart valve conditions early, allowing for timely intervention. Other factors influencing the market include the prevalence of cardiovascular diseases and the increasing preference for minimally invasive procedures. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Key Market Driver

Rising competition and innovations overall heart valve repair and replacement devices market is notably driving market growth. The heart valve repair and replacement devices market is witnessing significant growth due to the development and regulatory clearance of innovative transcatheter heart valves. While Medtronic's CoreValve and Edwards Lifesciences' Sapien and Sapien XT are currently the globally recognized transcatheter heart valves, several other manufacturers have obtained regulatory clearance in Europe and are undergoing clinical trials for FDA approval. Notable examples include Boston Scientific's Lotus Valve System, which has already gained CE markings. The entry of these new devices into the market is anticipated to intensify competition and propel industry growth. Mechanical valves and tissue, bioprosthetic valves continue to dominate the market, but the adoption of transcatheter heart valves, including percutaneous and transcatheter aortic valve replacements, is increasing. The stringency of regulatory procedures for heart valve repair and replacement devices ensures the safety and efficacy of these devices, thereby instilling confidence in patients and healthcare providers. Thus, such factors are driving the growth of the market during the forecast period.

Significant Market Trends

Data-oriented technologies are the key trend in the market. The heart valve repair and replacement devices market is driven by the advancements in data collection and analysis technologies. Regulatory procedures for heart valve repair and replacement devices are stringent due to their critical role in surgical heart procedures. Manufacturers are developing intelligent heart valves using data-driven technologies such as IoT and artificial intelligence. These valves collect, store, and analyze data to provide actionable insights for optimal performance during surgeries. For instance, the FDA's recent approval of Siron's Solo Smart aortic pericardial heart valve is a significant development. Equipped with sensors and data collection and transmission technologies, this valve enables real-time data access for both patients and clinicians. Mechanical valves and bioprosthetic valves, including transcatheter heart valves and percutaneous heart valves, are the primary types of heart valve replacement devices. Industry growth is fueled by the increasing prevalence of heart valve diseases and the rising demand for minimally invasive procedures. Edwards Lifesciences is a notable player in the market, offering a range of heart valve repair and replacement devices. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge

Shortage of cardiologists is the major challenge that affects the growth of the market. The market encompasses mechanical valves, tissue bioprosthetic valves, transcatheter heart valves, and percutaneous heart valves. Regulatory procedures for these devices are stringent due to their impact on the surgical heart. Edwards Lifesciences is a notable industry player, offering advanced solutions. The market growth is driven by increasing rates of heart valve diseases and the availability of less invasive procedures like transcatheter aortic valve replacement. However, the shortage of skilled professionals for performing heart valve repair and replacement surgical interventions poses a challenge. Factors contributing to this shortage include the migration of specialists to developed countries and high rates of burnout among medical professionals. The use of percutaneous balloon valvuloplasty and transcatheter heart valves, such as transcatheter aortic valve implantation, is expanding the reach of these treatments to a larger patient population. Hence, the above factors will impede the growth of the market during the forecast period.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Abbott Laboratories - The company offers products such as Tendyne and TriClip.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Abbott Laboratories
• Artivion Inc.
• BioStable Science and Engineering Inc.
• Boston Scientific Corp.
• Colibri Heart Valve LLC
• Edwards Lifesciences Corp.
• JenaValve Technology Inc.
• LivaNova PLC
• Medtronic Plc
• Micro Interventional Devices Inc.
• Neovasc Inc.
• Valcare Medical
• Xeltis AG

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Segmentation

By Product 

The heart valve replacement devices segment is estimated to witness significant growth during the forecast period. Heart valve repair and replacement devices refer to medical technologies utilized for treating damaged heart valves, which can be congenital, acquired, or age-related. Damage to heart valves can lead to conditions such as regurgitation and stenosis, resulting in heart disease, heart failure, stroke, and even death. Treatment options include medicines, lifestyle changes, and surgical procedures. Heart valve replacement devices are essential for individuals with severely damaged or diseased valves. 

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The heart valve replacement devices segment accounted for USD 3.04 billion in 2018.  These devices are classified into mechanical, transcatheter, and tissue/bioprosthetic valves. Mechanical valves, manufactured from synthetic materials like plastic, carbon, or metal, are strong and long-lasting, with an average lifespan of about 25 years. They are suitable for patients below 65 years of age with valve stenosis or regurgitation and a history of atrial fibrillation. However, since blood cells adhere to mechanical valves and form blood clots, patients require lifelong anticoagulant therapy. Transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR) are minimally invasive alternatives to surgical valve replacement. TAVR and TAVI (transcatheter aortic valve implantation) are FDA-approved procedures for treating aortic valve stenosis in high-risk patients. Tissue/bioprosthetic valves, derived from animal or human tissue, have a shorter lifespan compared to mechanical valves but do not require anticoagulant therapy.

Regional Analysis

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North America is estimated to contribute 41% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. Heart valves are essential components of the cardiovascular system, responsible for regulating the flow of blood in and out of the heart. Damage to heart valves can occur due to congenital defects, acquired conditions such as infections, age-related changes, heart attacks, or calcific degeneration. These conditions can lead to regurgitation or stenosis, which may result in heart failure, stroke, blood clots, and even death. Heart valve repair and replacement devices are crucial for treating diseased valves, including the mitral and aortic valves.

Further, treatment options range from medicines and lifestyle changes to surgical procedures. Surgical procedures include transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR), which are minimally invasive alternatives to traditional open-heart surgery. The heart valve replacement market includes prosthetic valves, such as mechanical and biological valves, which are FDA-approved for use in patients. Acquisitions and collaborations among key players, including Medtronic, have expanded the market. Diagnostic technologies are also essential for accurately identifying congenital heart defects and cardiovascular diseases. High cost is a significant challenge in the heart valve repair and replacement market. However, advancements in technology continue to drive innovation and improve patient outcomes. For instance, TAVR and TAVI procedures have revolutionized the treatment of aortic valve disease, offering less invasive alternatives to open-heart surgery.

Segment Overview

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD Billion " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.

• Product Outlook
  • Heart valve replacement devices
  • Heart valve repair devices
• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • APAC
    • China
    • India
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of the Middle East & Africa

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Market Analyst Overview

Heart valves are essential components of the cardiovascular system, allowing the proper flow of blood through the heart. Damage to heart valves due to congenital defects, acquired conditions, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases can lead to regurgitation or stenosis, resulting in heart failure, stroke, blood clots, and even death. Treatment for damaged heart valves includes medicines and lifestyle changes, but when these methods are insufficient, surgical procedures such as valve repair or replacement become necessary. Heart valve repair and replacement devices include prosthetic valves, mechanical valves, and biological valves. Prosthetic valves are man-made, while mechanical valves have moving parts that open and close. Biological valves are derived from animal tissue. Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR) are minimally invasive procedures using catheters to replace or repair the valves without open-heart surgery. The FDA has approved several heart valve repair and replacement devices from companies like Medtronic. Acquisitions and technological advancements in diagnostic technologies and cardiovascular diseases continue to drive market growth, despite the high cost.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behavior
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies