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心血管設備

市場調查報告書

商品編碼

1634197

全球心臟瓣膜設備市場 - 2025 - 2033

Global Heart Valve Devices Market - 2025 - 2033

出版日期: 2025年01月13日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2024年，全球心臟瓣膜器械市場規模達127.6億美元，預計到2033年將達到346億美元，2025-2033年預測期間複合年成長率為12.34%。

心臟瓣膜裝置是用於更換或修復受損或患病心臟瓣膜的醫療裝置，這對於確保血液單向流過心室至關重要。人的心臟有四個主要瓣膜，分別是二尖瓣、三尖瓣、肺動脈瓣和主動脈瓣。這些瓣膜根據心動週期中的壓力變化而打開和關閉，確保血液從心房平穩地流到心室並流出到身體，而不會回流。當這些瓣膜因狹窄（瓣膜收縮）或逆流（滲漏）等疾病而無法正常運作時，就會發生心臟瓣膜疾病，導致包括心臟衰竭在內的重大健康問題。

對心臟瓣膜設備的需求不斷成長是預測期內推動市場的促進因素。需求激增主要是由於心血管疾病發生頻率的增加，隨著生活方式的改變和人口老化，心血管疾病變得越來越常見。許多人需要進行心臟瓣膜手術來治療主動脈瓣狹窄等問題，從而對新型設備產生了更大的需求。隨著醫療保健技術的進步和更多微創手術的出現，心臟瓣膜設備的市場預計將顯著成長。

市場動態：

驅動程式和限制

對心臟瓣膜裝置的需求不斷增加

對心臟瓣膜裝置的需求不斷成長預計將成為全球心臟瓣膜裝置市場成長的重要因素。由於心血管疾病盛行率上升、技術進步、人們對心臟瓣膜裝置的認知不斷增強以及最近的推出和批准，對心臟瓣膜裝置的需求正在增加。

隨著個體年齡的成長以及肥胖和久坐行為等與生活方式相關的危險因素變得更加頻繁，心臟瓣膜問題的盛行率也會上升。心血管疾病盛行率的上升需要新穎的解決方案，從而刺激了對能夠恢復正常心臟功能並改善患者預後的心臟瓣膜裝置的需求。例如，根據美國疾病管制與預防中心的數據，心臟病是美國男性、女性以及大多數種族和族裔群體的主要死亡原因。在美國，每 33 秒就有一人死於心血管疾病。美國約有 695,000 人死於心臟病，即每 5 個人中就有 1 人死於心臟病。

此外，3D 列印技術的進步已經改變了基於特定患者解剖結構的客製化心臟瓣膜植入物的製造。這種程度的客製化提高了貼合度和功能性，從而帶來更好的臨床結果。此外，生物工程心臟瓣膜的研究正在進行中，重點是使用患者自身的細胞或捐贈組織複製天然瓣膜結構。該策略旨在減少與合成材料相關的排斥和長期困難。對心血管研究和開發的持續投資將這些技術進步推向更深層次。當組織致力於創新和改進現有心臟瓣膜裝置時，他們也在研究有望提高生物相容性和性能的創新材料和設計。

最近推出了採用最新技術製造的產品。例如，2024 年 6 月，全球醫療保健技術領導者美敦力公司 (Medtronic plc) 宣布推出其在心臟手術領域的最新創新產品 Avalus Ultra 瓣膜。這種下一代外科主動脈組織瓣膜旨在促進植入時的易用性和終生患者管理。對於從一開始就尋求適合未來的主動脈瓣解決方案的心臟外科醫生及其患者來說，這是一個絕佳的選擇。

程序和設備成本高

手術和設備的高成本等因素預計將阻礙全球心臟瓣膜設備市場。主要問題之一是心臟瓣膜手術所涉及的巨大價格負擔，特別是經導管主動脈瓣置換術 (TAVR) 等現代技術。這些治療通常不僅包括設備本身的費用，還包括術前影像、住院和術後護理等額外費用。這些高昂的費用可能使許多患者，特別是中低收入地區或沒有足夠保險的患者難以獲得所需的治療。因此，財務影響可能會阻礙患者獲得及時治療，從而減少市場總需求。

例如，根據美國國立衛生研究院的數據，使用機械和生物瓣膜進行瓣膜置換手術的自付費用中位數估計為 107,800 印度盧比（1684 美元）和 154,000 印度盧比（2406 美元），球囊瓣膜切開術的費用分別為14,456 印度盧比（367 美元）。每次機械和生物假體單瓣膜置換手術和球囊瓣膜切開術的總體成本估計分別為 127,919 印度盧比（1999 美元）、148,919 印度盧比（2372 美元）和 14,456 印度盧比（226 美元）。

Heart valve devices are medical devices used to replace or repair damaged or diseased heart valves, which are essential for ensuring unidirectional blood flow through the heart's chambers. The human heart has four primary valves, the mitral valve, tricuspid valve, pulmonary valve, and aortic valve. These valves open and close in response to pressure changes during the cardiac cycle, ensuring that blood flows smoothly from the atria to the ventricles and out to the body with no backflow. Heart valve disease occurs when these valves fail to function properly due to disorders such as stenosis (valve constriction) or regurgitation (leakage), leading to major health issues including heart failure.

The increasing demand for heart valve devices is the driving factor that drives the market over the forecast period. The surge in demand is due to this surge is primarily due to an increase in the frequency of cardiovascular diseases, which are becoming more common as lifestyles change and populations age. Many individuals require heart valve procedures to treat problems such as aortic stenosis, creating a greater demand for novel devices. As healthcare technology progresses and more minimally invasive procedures become available, the market for heart valve devices is expected to grow significantly.

Market Dynamics: Drivers & Restraints

Increasing demand for heart valve devices

The increasing demand for heart valve devices is expected to be a significant factor in the growth of the global heart valve devices market. The demand for heart valve devices is increasing owing to the rising prevalence of cardiovascular diseases, technological advancements, growing awareness regarding heart valve devices, and recent launches and approvals.

As individuals grow older and lifestyle-related risk factors such as obesity and sedentary behavior become more frequent, the prevalence of heart valve problems rises. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for heart valve devices that can restore normal heart function and improve patient outcomes. For instance, according to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. One person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease, that's 1 in every 5 deaths.

Furthermore, advances in 3D printing technology have transformed the manufacturing of custom-made heart valve implants based on specific patient anatomy. This amount of customization improves fit and functionality, leading to better clinical outcomes. Furthermore, research on bioengineered heart valves is underway, with an emphasis on reproducing natural valve structures using a patient's own cells or donor tissues. This strategy is intended to reduce rejection and long-term difficulties associated with synthetic materials. Continuous investment in cardiovascular research and development drives these technological advancements to greater depths. As organizations work to innovate and improve existing heart valve devices, they are also investigating innovative materials and designs that promise improved biocompatibility and performance.

There are recent product launches that are manufactured using the latest technologies. For instance, in June 2024, Medtronic plc, a global leader in healthcare technology, announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It's an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start.

High costs of procedures and devices

Factors such as high costs of procedures and devices are expected to hamper the global heart valve devices market. One of the primary issues is the significant price burden involved with cardiac valve procedures, particularly modern technology like transcatheter aortic valve replacement (TAVR). These treatments frequently include not only the cost of the devices themselves, but also additional costs such as preoperative imaging, hospital stays, and postoperative care. These high costs can make it difficult for many patients, particularly those in low- and middle-income areas or without adequate insurance coverage, to get the therapies they need. As a result, the financial implications may discourage patients from obtaining prompt treatment, reducing total market demand.

For instance, according to the National Institute of Health, The median out-of-pocket expenditure for valve replacement surgery using mechanical and bio-prosthetic valves was estimated to be INR107,800 (US$1684) and INR154,000 (US$2406), respectively, and for balloon valvotomy was estimated to be INR14,456 (US$367). Overall package cost per mechanical and bio-prosthetic single valve replacement surgery and balloon valvotomy procedure was estimated as INR127,919 (US$1999), INR148,919 (US$2372) and INR14,456 (US$226), respectively.

Segment Analysis

The global heart valve devices market is segmented based on heart valve replacement devices, position, heart valve repair devices, end-user, and region.

TMVR (Transcatheter Mitral Valve Replacement) segment is expected to dominate the global heart valve devices market share

The TMVR (Transcatheter Mitral Valve Replacement) segment is anticipated to dominate the global heart valve devices market owing to its growing importance in treating mitral valve disorders, technological advancements, recent launches and approvals, and increase in the number of mitral regurgitations. As people live longer, the prevalence of age-related heart diseases, including MR, increases, needing better treatment options. TMVR provides a less intrusive alternative to standard surgical techniques, making it especially appealing to patients who are at high risk of complications from open-heart surgery. This shift toward less intrusive procedures is consistent with general trends in healthcare, which show an increasing preference for interventions that shorten recovery time and hospital stays. For instance, with a global prevalence of over 2%, mitral regurgitation is a common valvular abnormality with various causes, including congenital conditions, rheumatic fever, and degenerative changes in the valve.

Technological advances in TMVR devices have also led to their projected market dominance. Recent advances have resulted in the creation of more complex and dependable equipment that improves procedural success rates and patient outcomes. These developments include improved valve designs that provide greater hemodynamic performance and biocompatibility, as well as upgraded delivery systems that make implantation easier. As these technologies advance, they are projected to gain broader acceptability among healthcare practitioners and patients, increasing demand for TMVR solutions.

For instance, in May 2024, 4C Medical Technologies, a Minnesota-based medical device company focused on structural heart disease, received the FDA's breakthrough device designation for its AltaValve System for transcatheter mitral valve replacement (TMVR). The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation (MR) patients. It is implanted via transseptal access and positioned above the native mitral valve when implanted.

Geographical Analysis

North America is expected to hold a significant position in the global heart valve devices market share

North America will likely account for a significant share of the global heart valve devices market, owing to its advanced healthcare infrastructure, a high prevalence of cardiovascular disorders, technological advancements, and recent launches and approvals. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for heart valve devices that can restore normal heart function and improve patient outcomes.

For instance, according to the National Institute of Health, approximately 82.6 million people in the United States currently have one or more forms of cardiovascular disease (CVD), making it a leading cause of death for both men and women. Common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent. The prevalence for men is 8.3 percent and for women is 6.1 percent. About 7 million Americans aged 20 or older have had a stroke. Each year approximately 610,000 experience their first stroke and another 185,000 experience a recurrence. Approximately 87 percent of all strokes are ischemic of which 10 percent result from intracerebral hemorrhage and 3 percent result from subarachnoid hemorrhage.

The region has established itself as a pioneer in the use of advanced medical technologies, particularly in cardiovascular care. One of the most significant developments is the invention and execution of transcatheter heart valve replacement (TAVR) operations, which have transformed the therapeutic landscape for patients with aortic stenosis and other valvular disorders. TAVR is a minimally invasive alternative to standard open-heart surgery that allows for faster recovery and shorter hospital stays, which is especially useful for older patients or those with complications.

For instance, in December 2024, Heart valve developer Anteris Technologies made its U.S. stock market debut one of the few initial public offerings by a MedTech company. The successful funding from this IPO is projected to considerably boost Anteris' capabilities in creating minimally invasive cardiac solutions, aligning with the increasing demand for cardiac surgery in aging populations.

Asia Pacific is growing at the fastest pace in the global heart valve devices market

The Asia Pacific region is emerging as the fastest-growing market for heart valve devices, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of cardiovascular disorders. Cardiovascular diseases (CVDs) continue to be a prominent cause of morbidity and mortality globally, and their prevalence is significantly increasing in the Asia Pacific area. Inactive lifestyles, poor dietary habits, smoking, and increased stress are all contributing factors to this growth.

For instance, according to the National Institute of Health, annual number of deaths from CVD in India is projected to rise from 2.26 million (1990) to 4.77 million (2020). Coronary heart disease prevalence rates in India have been estimated over the past several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations.

Competitive Landscape

The major global players in the global heart valve devices market include Abbott, Medtronic, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Edwards Lifesciences Corporation, Sorin Medical Group, TTK Heartvalve, JenaValve, Lepu Medical Technology (Beijing)Co., Ltd. among others.

Emerging Players

Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others

Key Developments

In November 2024, Meril Life Sciences Pvt Ltd. launched its next-generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve was launched in spite of the company's differences with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global heart valve devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Heart Valve Replacement Devices
3.2. Snippet by Position
3.3. Snippet by Heart Valve Repair Devices
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Increasing Demand for Heart Valve Devices
- 4.1.3. Restraints
- 4.1.4. High Costs of Procedures and Devices
- 4.1.5. Opportunity
- 4.1.6. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Heart Valve Replacement Devices

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 6.1.2. Market Attractiveness Index, By Heart Valve Replacement Devices
6.2. Mechanical Valve*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Bioprosthetic Valve
6.4. TAVR

7. By Position

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 7.1.2. Market Attractiveness Index, By Position
7.2. Mitral Valve*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Aortic Valve
7.4. Others

8. By Heart Valve Repair Devices

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 8.1.2. Market Attractiveness Index, By Heart Valve Repair Devices
8.2. Surgical Valve*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Balloon Valvuloplasty Devices
8.4. TMVR

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Ambulatory Surgical Centers
9.4. Others

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Replacement Devices
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Position
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Heart Valve Repair Devices
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Abbott*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Medtronic
12.3. Artivion, Inc
12.4. Boston Scientific Corporation
12.5. Micro Interventional Devices
12.6. Edwards Lifesciences Corporation
12.7. Sorin Medical Group
12.8. TTK Heartvalve
12.9. JenaValve
12.10. Lepu Medical Technology (Beijing)Co., Ltd.

LIST NOT EXHAUSTIVE