Heart Valve Repair & Replacement Devices Market to Grow by USD 2.58 Billion (2024-2028), Innovation and Competition Boosting Revenue, AI Impact on Market Trends - Technavio

NEW YORK, Nov. 26, 2024 /PRNewswire/ -- Report on how AI is redefining market landscape - The global heart valve repair and replacement devices market  size is estimated to grow by USD 2.58 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of  7.08%  during the forecast period. Rising competition and innovations overall heart valve repair and replacement devices market is driving market growth, with a trend towards data-oriented technologies drive growth of market. However, shortage of cardiologists  poses a challenge.Key market players include 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, and Xeltis AG.

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Key Market Trends Fueling Growth

The Heart Valve Repair and Replacement Devices market encompasses the production and sale of devices used to treat damaged heart valves due to congenital, acquired, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases. Key heart valves include the mitral, aortic, and tricuspid valves. Damage can lead to regurgitation or stenosis, necessitating treatment through medicines, lifestyle changes, or surgical procedures. Heart failure, stroke, blood clots, and death can result from untreated diseased valves. Major players in the market include Medtronic, Edwards Lifesciences, and SCA. Trends include FDA approval of Transcatheter Aortic Valve Implantation (TAVI) and Transcatheter Mitral Valve Repair (TMVR), acquisitions, and the development of minimally invasive procedures. However, high costs and regulatory procedures, including stringency, hinder market growth. Heart valve repair and replacement devices include prosthetic valves (mechanical and biological), transcatheter heart valves, and percutaneous heart valves. Surgical procedures involve replacing the damaged valve with a prosthetic one or repairing the native valve. Diagnostic technologies aid in identifying congenital heart defects and cardiovascular diseases. Industry growth drivers include an aging population and increasing prevalence of heart disease. 

In the Heart Valve Repair and Replacement Devices market, data plays a significant role in the design and development of advanced valves. Manufacturers utilize data to create optimized valves that are beneficial during surgeries. Data collection is essential in the healthcare industry, enabling the production of smart and intelligent heart valves using technologies like IoT and artificial intelligence. These valves can gather, store, and analyze data, providing valuable insights to users in real-time. For instance, the FDA's recent approval of Siron's Solo Smart aortic pericardial heart valve showcases this innovation. Equipped with sensors and data transmission technologies, this valve offers real-time information to both patients and clinicians. 

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Market Challenges

• The Heart Valve Repair and Replacement Devices market encompasses solutions for addressing heart valve issues, including those caused by congenital or acquired conditions, age-related changes, infections, heart attacks, calcific degeneration, and heart disease. Challenges include treating damaged valves, mitral and aortic valve regurgitation and stenosis, heart failure, stroke, and blood clots leading to death. Treatment options range from medicines and lifestyle changes to surgical procedures. Surgical procedures involve repairing or replacing diseased valves with prosthetic valves, including mechanical and biological options. Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI) are minimally invasive alternatives to surgical procedures. Major players in the market include Medtronic, Edwards Lifesciences, and SCA. Regulatory procedures and their stringency impact market growth, with FDA approval and acquisitions driving industry expansion. Diagnostic technologies and minimally invasive procedures are key growth drivers for the market. High costs and regulatory procedures remain challenges. Heart valve repair and replacement devices address various heart valve conditions, including those caused by congenital heart defects and cardiovascular diseases. Mechanical valves, tissue bioprosthetic valves, transcatheter heart valves, and percutaneous heart valves are key product categories. Industry growth is driven by the increasing prevalence of heart valve diseases and the development of innovative, minimally invasive solutions.
• The heart valve repair and replacement market faces a significant challenge due to the shortage of skilled cardiologists. This shortage increases the risk of misdiagnosis and improper treatment, potentially harming patients. Factors contributing to this issue include the migration of trained specialists from developing countries to developed ones and the rising number of burnt-out professionals leaving the medical field. The importance of early and accurate diagnosis and treatment cannot be overstated, making it crucial to address this shortage and ensure a sufficient supply of competent professionals in the field.

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Segment Overview 

This heart valve repair and replacement devices market report extensively covers market segmentation by

1. Product 
• 1.1 Heart valve replacement devices
• 1.2 Heart valve repair devices
2. Geography 
• 2.1 North America
• 2.2 Europe
• 2.3 Asia
• 2.4 Rest of World (ROW)

1.1 Heart valve replacement devices-  Heart valve replacement devices are essential medical solutions for individuals with damaged heart valves. These devices are categorized into three types based on the valve material: mechanical, tissue/bioprosthetic, and transcatheter. Mechanical valves, manufactured from synthetic materials like plastic, carbon, or metal, offer durability and longevity, typically lasting about 25 years. They are suitable for patients below 65 years with valve stenosis or regurgitation and a history of atrial fibrillation. However, patients must take anticoagulants for life due to the risk of blood clots. Mechanical valves are ideal for patients with small-sized hearts and are represented by products like Medtronic Open Pivot Mechanical Heart Valves, Edwards INTUITY Elite valve system, and Carbomedics Aortic Family. Tissue/bioprosthetic valves, derived from animal tissues or human donor tissue, provide strength and a ten-year lifespan without anticoagulant consumption. They are recommended for older patients above 65 years. However, they may not be suitable for neonatal and pediatric patients due to their tendency to break down. Some popular bioprosthetic valves include Medtronic's Mosaic and Mosaic Ultra Bioprostheses and Abbott's The EPIC MITRAL STENDED TISSUE VALVE WITH LINX ANTICALCIFICATION technology. Transcatheter heart valves, designed to replace the aortic valve, are minimally invasive, requiring mild sedation and few incisions, with short hospital stays. They are beneficial for patients with aortic valve stenosis, improving their survival rate. Complications associated with transcatheter valves include bleeding, stroke, arrhythmias, kidney disease, infections, and heart attack. Boston Scientific Corporation's LOTUS Edge Aortic Valve System, JenaValve Technology's JenaValve Pericardial TAVR System, and Medtronic's Evolut PRO System are some transcatheter heart valves available in the market. The growth of the heart valve repair and replacement devices market is driven by the increasing prevalence of heart valve diseases, technological advancements, and an aging population. The demand for minimally invasive procedures and the rising awareness of heart valve replacement therapies are also contributing factors. These trends are expected to propel the growth of this market during the forecast period.

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Research Analysis

Heart valves are essential components of the cardiovascular system, allowing the efficient flow of blood between heart chambers and the rest of the body. Damage to heart valves due to congenital defects, acquired conditions such as infections, age-related changes, heart attacks, or calcific degeneration can lead to regurgitation or stenosis, requiring treatment. Heart disease patients may first attempt medicines or lifestyle changes, but when these methods fail, heart valve repair or replacement becomes necessary. Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Replacement (TMVR) are minimally invasive procedures that have gained popularity due to their lower risk compared to open-heart surgery. The FDA has approved several heart valve repair and replacement devices, leading to numerous acquisitions and innovations in the market. Cardiovascular diseases, including heart valve damage, affect millions worldwide, driving the demand for these devices. However, their high cost and stringent regulatory procedures can limit access to some patients. Diagnostic technologies, such as echocardiography, help identify heart valve issues early, allowing for timely intervention. Heart valve repair and replacement devices are crucial for treating various heart conditions, improving patients' quality of life and longevity. The market for these devices is constantly evolving, with ongoing research and development to address the unique needs of different patient populations.

Market Research Overview

Heart valves are essential components of the cardiovascular system, allowing the proper flow of blood through the heart. Damage to heart valves can occur due to congenital defects, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases. Damaged valves can lead to conditions such as regurgitation or stenosis, which can result in heart failure, stroke, blood clots, and even death. Treatment options include medicines, lifestyle changes, and surgical procedures. Heart valve repair and replacement devices are used to address damaged or diseased valves. These devices include prosthetic valves, such as mechanical and biological valves, as well as transcatheter valves like TAVR and TAVI. The industry has seen significant growth due to the increasing prevalence of cardiovascular diseases and the aging population. However, high costs and regulatory procedures, including FDA approval and stringency, can hinder market growth. Heart valve repair and replacement devices are used for both surgical procedures and minimally invasive percutaneous procedures. Mechanical valves and tissue bioprosthetic valves are common types of surgical heart valves, while transcatheter heart valves and percutaneous heart valves are used for minimally invasive procedures. Industry growth drivers include the increasing number of diagnostic technologies for congenital heart defects and the development of new technologies like TMVR.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Product
• Heart Valve Replacement Devices
• Heart Valve Repair Devices
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

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