인공심장판막 : 시장 점유율 분석, 산업 동향과 통계, 성장 예측(2024-2029년)

The Global Prosthetic Heart Valve Market size is estimated at USD 11.94 billion in 2024, and is expected to reach USD 20.86 billion by 2029, growing at a CAGR of 11.80% during the forecast period (2024-2029).

The COVID-19 pandemic is expected to impact the prosthetic heart valve market significantly. COVID-19 disease poses a risk in managing patients with prosthetic heart valves; for instance, as per a February 2021 published article titled "Bioprosthetic Valve Thrombosis Associated With COVID-19 Infection", patients with prosthetic heart valves and endovascular devices may be at risk of thrombotic complications from the COVID-19 disease. Thus, such studies indicate that the demand for prosthetic heart valves was affected as the prosthetic heart valve patients were at risk of developing COVID-19 disease. However, with the introduction of vaccines and the upliftment of lockdown in various countries across the globe, there might be an increase in the number of patients undergoing heart valve placement, thereby expanding the scope of market growth shortly.

Further, the significant factors fueling the market's growth are the increasing prevalence of heart valve disease and rising regulatory approvals for new and advanced prosthetic heart valves. The growing prevalence of heart valve disease is a significant factor driving the market's growth. For instance, as per the World Heart Federation 2022, rheumatic heart disease is a condition that affects 39 million people worldwide. It is a condition in which the heart valves have been permanently damaged by rheumatic fever. Furthermore, as per a January 2022 published article titled "Uncovering the treatable burden of severe aortic stenosis in the UK," the results revealed that in the United Kingdom, in 2019, the prevalence of severe aortic stenosis was 1.48%, including 291,448 men and women aged more than or equal to 55 years. Thus, these statistics indicate that the demand for prosthetic heart valves is anticipated to increase over the coming years, thereby contributing to the market's growth.

However, the high cost of transcatheter aortic valve replacement (TAVR) procedures and the availability of alternative methods for treating heart valve diseases (HVD) are hindering the market's growth.

Prosthetic Heart Valve Market Trends

Transcatheter Heart Valve Segment is Expected to Register Robust Growth During the Forecast Period

The transcatheter heart valve segment is expected to hold a significant share by type of valve. This can be attributed to various factors such as the high burden of heart valve diseases, ease of implantation, a rise in the number of transcatheter heart valve surgery centers, and growth of the patient population, leading to an increase in the number of transcatheter aortic valve replacement procedures. For instance, according to a research study published in February 2020, titled "Epidemiology of aortic valve stenosis (AS) and aortic valve incompetence (AI): is the prevalence of AS/AI similar in different parts of the world?", the epidemiology of aortic valve disease varies enormously between high-income and low-income countries, and there is an exponential increase in the prevalence of aortic stenosis (AS) with age, with 0.2% in the 50-59-year group, 1.3% in the 60-69-year group, 3.9% in the 70-79-year group, and 9.8% in those aged 80-89 years. As transcatheter heart valves are used in patients suffering from aortic valve stenosis and incompetence, such studies indicate that the demand for transcatheter heart valves is anticipated to increase shortly.

Several market players implement strategic initiatives, thereby contributing to segment growth. For instance, in January 2022, SMT (Sahajanand Medical Technologies Limited) reported the publication of Hydra Transcatheter Aortic Heart Valve CE study data in the JACC (Journal of the American College of Cardiology) Cardiovascular Interventions journal. This study evaluated the 30-day and 1-year safety and performance of the Hydra transcatheter aortic heart valve in treating symptomatic severe aortic stenosis in cardiac patients at high or extremely high surgical risk. The Hydra CE study has demonstrated that transcatheter aortic valve replacement with the Hydra valve offers favorable efficacy at one year, providing a large effective orifice area and low transvalvular gradient as well as acceptable complication rates.

Thus, the segment is expected to witness significant growth over the forecast period due to the abovementioned factors.

North America is expected to Dominate the Prosthetic Heart Valve Market

Within North America, the United States has held a significant share of the market. The major factors boosting the market's growth are the high prevalence of heart valve disorders; product advancements; the number of heart valve replacement procedures; and the well-established healthcare infrastructure. For instance, as per the 2022 American College of Cardiology Foundation, the prevalence of valvular heart diseases (VHD) is rising in the United States, with more than 5 million Americans diagnosed each year, while up to 1.5 million people suffer from aortic stenosis (AS) in the United States. Approximately 500,000 of these patients suffer from severe AS.

Several market players are also implementing strategic initiatives, fueling the market's growth. For instance, in September 2021, Abbott reported that the United States Food and Drug Administration (USFDA) had approved the company's Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease.

Moreover, in January 2022, Artivion, Inc., a leading cardiac and vascular surgery company focused on aortic disease, reported the publication of PROACT clinical trial results in The Annals of Thoracic Surgery, the official journal of the Society of Thoracic Surgeons. The magazine, titled Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial, highlighted outcomes from the multicenter, non-inferiority, a two-arm study that assessed whether, after an On-X mechanical mitral valve replacement (MVR), patients could be safely managed with lower-intensity warfarin plus aspirin. The PROACT Mitral results add to the data from clinical trials that indicate that patients with On-X heart valves can be safely maintained with lower anticoagulation levels than required for competitors' mechanical valves. Such developments are expected to fuel the market's growth in the country's demand for prosthetic heart valves.

Thus, the market is expected to grow during the forecast period due to the abovementioned developments.

Prosthetic Heart Valve Industry Overview

The prosthetic heart valve market is moderately competitive. A majority of the leading players in this market are focusing on marketing and promotional activities, product launches and approvals, acquisitions, agreements, collaborations, and expansions to enhance their market presence and strengthen their distribution networks, cater to the needs of a growing customer base, widen their product portfolios, and boost their production capabilities. Some players operating in the market include Medtronic PLC, Edwards Lifesciences Corporation, Boston Scientific Corporation, St. Jude Medical Inc. (Abbott Laboratories), Symetis SA, Jenavalve Technology Inc., and Cryolife Inc., among others.

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TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Deliverables
• 1.2 Study Assumptions
• 1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Prevalence of Heart Valve Disease
  • 4.2.2 Rising Regulatory Approvals for New and Advanced Prosthetic Heart Valve
• 4.3 Market Restraints
  • 4.3.1 High Cost of Transcatheter Aortic Valve Replacement (TAVR) Procedures
  • 4.3.2 Availability of Alternative Methods for Treating Heart Valve Diseases (HVD)
• 4.4 Porter's Five Forces Analysis
  • 4.4.1 Threat of New Entrants
  • 4.4.2 Bargaining Power of Buyers/Consumers
  • 4.4.3 Bargaining Power of Suppliers
  • 4.4.4 Threat of Substitute Products
  • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD Million)

• 5.1 By Type of Valve
  • 5.1.1 Mechanical Heart Valve
  • 5.1.2 Bioprosthetic Heart Valve
  • 5.1.3 Transcatheter Heart Valve
• 5.2 By Position
  • 5.2.1 Mitral Valve
  • 5.2.2 Aortic Valve
  • 5.2.3 Other Positions
• 5.3 Geography
  • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
  • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
  • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
  • 5.3.4 Middle-East and Africa
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle-East and Africa
  • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Medtronic PLC
  • 6.1.2 Edwards Lifesciences Corporation
  • 6.1.3 Boston Scientific Corporation
  • 6.1.4 Abbott Laboratories (St. Jude Medical Inc.)
  • 6.1.5 Symetis SA
  • 6.1.6 Jenavalve Technology Inc.
  • 6.1.7 Cryolife Inc.
  • 6.1.8 TTK Healthcare Limited
  • 6.1.9 Colibri Heart Valve LLC
  • 6.1.10 Lepu Medical Technology Co. Ltd
  • 6.1.11 Foldax, Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS