Heart Valve Repair & Replacement Devices Market to Grow by USD 3.73 Billion (2025-2029), Boosted by Innovations & Competition, AI's Impact on Trends - Technavio

NEW YORK, Jan. 21, 2025 /PRNewswire/ -- Report with market evolution powered by AI - The global heart valve repair and replacement devices market  size is estimated to grow by USD 3.73 billion from 2025-2029, according to Technavio. The market is estimated to grow at a CAGR of  9.1%  during the forecast period. Rising competition and innovations in the 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 solutions for treating damaged heart valves due to congenital, acquired, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases. Heart valves, including mitral and aortic, can be affected by regurgitation, stenosis, and damage leading to heart failure, stroke, blood clots, and even death. Treatment options range from medicines and lifestyle changes to surgical procedures. Key players in the market include Medtronic and Edwards Lifesciences, offering mechanical and biological prosthetic valves, transcatheter valves, and minimally invasive surgical procedures. FDA approval, acquisitions, and regulatory procedures add to the industry's stringency and growth. Trends include TAVR, TAVI, and TMVR technologies for repairing and replacing diseased valves. Diagnostic technologies are essential for identifying cardiovascular diseases early. High costs and regulatory procedures challenge market growth. SCA therapy and minimally invasive percutaneous balloon and transcatheter heart valve procedures are future industry drivers. 

In the healthcare industry, data plays a vital role in the design and development of heart valve repair and replacement devices. Manufacturers utilize data to create optimized valves for surgical applications. Data collection is essential, as it enables the creation of smart and intelligent heart valves using advanced 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 issues with heart valves, including those caused by congenital or acquired conditions, age-related changes, infections, heart attacks, calcific degeneration, and heart disease. Challenges include heart failure, stroke, blood clots, and death. Treatment options range from medicines and lifestyle changes to surgical procedures. Heart valve repair and replacement involve damaged mitral or aortic valves, with prosthetic valves (mechanical or biological) and transcatheter valves (TAVR, TAVI, percutaneous heart valves) being common solutions. Companies like Medtronic and Edwards Lifesciences are key players, with acquisitions driving industry growth. Regulatory procedures and their stringency impact market growth, with FDA approval required for new technologies. Minimally invasive procedures and diagnostic technologies for congenital heart defects and cardiovascular diseases are emerging trends. High cost remains a challenge.
• The heart valve repair and replacement market faces a significant challenge due to the shortage of skilled cardiologists. Early diagnosis and proper treatment of heart valve diseases are crucial for patient care, making the expertise of healthcare professionals an essential factor. However, the migration of trained specialists from developing countries to developed ones and high rates of burnout among professionals are contributing to this shortage. The lack of adequate skilled personnel can lead to misdiagnosis and improper treatment, potentially causing harm to patients. To address this issue, investing in training programs and creating a conducive work environment for healthcare professionals is necessary to retain their skills and commitment to the field.

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Segment Overview 

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

• 1.1 HV replacement devices
• 1.2 HV repair devices

• 2.1 Minimally invasive surgery
• 2.2 Transcatheter surgeries
• 2.3 Open surgeries

• 3.1 North America
• 3.2 Europe
• 3.3 Asia
• 3.4 Rest of World (ROW)

1.1 HV replacement devices-  In the Heart Valve Repair and Replacement Devices market, mechanical, tissue/bioprosthetic, and transcatheter valves continue to be crucial for treating damaged heart valves. Mechanical valves, made from synthetic materials, are durable and suitable for younger patients with a history of valve stenosis or regurgitation and atrial fibrillation, requiring lifelong anticoagulation. Notable mechanical valves include Medtronic's Open Pivot Mechanical Heart Valves and Edwards Lifesciences Corporation's INTUITY Elite Valve System. Tissue or bioprosthetic valves, derived from animal or human tissue or the patient's own cells, do not necessitate anticoagulation but typically need replacement every ten years. They are generally used in older patients and include Medtronic's Mosaic and Mosaic Ultra Bioprostheses and Abbott's EPIC Mitral Stented Tissue Valve with Linx Anticalcification Technology. Transcatheter or percutaneous heart valves enable minimal sedation and fewer incisions, resulting in shorter hospital stays for patients with aortic valve stenosis. However, they carry potential complications such as bleeding, stroke, arrhythmias, kidney disease, infections, and heart attacks. Notable transcatheter valves include Boston Scientific Corporation's LOTUS Edge Aortic Valve System, JenaValve Technology's JenaValve Pericardial TAVR System, and Medtronic's Evolut PRO System. The advancements in these heart valve technologies are expected to fuel the market's growth throughout the forecast period.

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Research Analysis

Heart valves are essential components of the cardiovascular system, allowing the efficient flow of blood through the heart. Heart valves can be affected by various conditions such as congenital defects, acquired diseases, age-related changes, infections, heart attacks, and calcific degeneration. These conditions can lead to regurgitation or stenosis, requiring treatment. Treatment options include medicines, lifestyle changes, and heart valve repair or replacement. 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 traditional open-heart surgery. The Heart Valve Repair and Replacement Devices market is subject to regulatory procedures and stringency of regulatory approval, with the FDA playing a key role. High costs and acquisitions by key companies like Medtronic have also impacted the market landscape. Diagnostic technologies are essential for accurate identification of heart valve diseases, including congenital heart defects and cardiovascular diseases.

Market Research Overview

Heart valves are essential components of the cardiovascular system that control the flow of blood through the heart. Damage to heart valves can result from congenital defects, age-related changes, infections, heart attacks, calcific degeneration, and other heart diseases. Damaged valves can lead to regurgitation or stenosis, which can cause heart failure, stroke, blood clots, and even death. Treatment options include medicines, lifestyle changes, and surgical procedures. Surgical procedures involve replacing the damaged valve with a prosthetic valve, either mechanical or biological. Transcatheter aortic valve replacement (TAVR) and transcatheter aortic valve implantation (TAVI) are minimally invasive percutaneous procedures that have gained popularity in recent years. The heart valve repair and replacement market is driven by the increasing prevalence of cardiovascular diseases and the aging population. However, the high cost and regulatory procedures, including the stringency of regulatory approval processes, are major challenges for market growth. Edwards Lifesciences is a key player in this market, offering a range of heart valve repair and replacement devices, including tissue bioprosthetic valves and transcatheter heart valves. Other industry growth drivers include acquisitions and technological advancements, such as transcatheter mitral valve replacement (TMVR) and diagnostic technologies for congenital heart defects.

Table of Contents:

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

• Product
• HV Replacement Devices
• HV Repair Devices
• Deployment
• Minimally Invasive Surgery
• Transcatheter Surgeries
• Open Surgeries
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)
• Indication
• End User

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

About Technavio

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SOURCE Technavio