首页 > 市场调查报告书 > 医疗设备

心血管设备

市场调查报告书

商品编码

1634190

全球结构心臟器材市场 - 2025 - 2033

Global Structural Heart 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个工作天内

价格

※ 本网页内容可能与最新版本有所差异。详细情况请与我们联繫。

简介目录

2024年，全球结构心臟器材市场规模达到147.9亿美元，预计2033年将达到288.4亿美元，2025-2033年预测期间复合年增长率为8.0%。

结构性心臟装置是一种专门的医疗装置，用于治疗影响心臟结构（例如瓣膜、心壁或心室）的各种问题。这些疾病可能是先天性的（出生时就存在），也可能是由于年龄、高血压或其他心血管疾病等因素而随着时间的推移而形成的。最常见的结构性心臟病是主动脉瓣疾病、二尖瓣疾病、心房中隔缺损 (ASD) 和心室中隔缺损 (VSD)。如果不及时治疗，这些异常可能会导致严重的健康问题，通常需要进行手术干预或放置设备。

结构心臟设备的需求不断增长是预测期内推动市场的驱动因素。需求激增主要是由于心血管疾病发生频率的增加，随着生活方式的改变和人口老化，心血管疾病变得越来越常见。许多人需要结构性心臟装置来治疗主动脉瓣狭窄等问题，对新型装置产生了更大的需求。随着医疗保健技术的进步和更多微创手术的出现，结构性心臟设备的市场预计将显着成长。

市场动态：

驱动程式和限制

对结构性心臟设备的需求不断增加

对结构性心臟器械的需求不断增长预计将成为全球结构性心臟器械市场成长的重要因素。由于心血管疾病盛行率上升、技术进步、人们对结构性心臟装置的认识不断增强以及最近的推出和批准，对结构性心臟装置的需求正在增加。

随着个体年龄的增长以及肥胖和久坐行为等与生活方式相关的危险因素变得更加频繁，心臟瓣膜问题的盛行率也会上升。心血管疾病盛行率的上升需要新的解决方案，从而刺激了对能够恢復正常心臟功能并改善患者预后的结构性心臟装置的需求。例如，根据美国疾病管制与预防中心的数据，心臟病是美国男性、女性以及大多数种族和族裔群体的主要死亡原因。在美国，每 33 秒就有一人死于心血管疾病。美国约有 695,000 人死于心臟病，即每 5 个人中就有 1 人死于心臟病。

此外，装置设计和材料的进步导致了更坚固和生物相容性心臟瓣膜和封堵器的开发。这些增强功能不仅增加了设备的功能，还减少了与先前型号相关的问题。因此，由复杂材料製成的新型心臟瓣膜可以更好地模仿人体瓣膜的自然功能，从而增强血流并减少瓣膜逆流的情况。此外，扩展研究和临床试验继续扩大这些设备的应用，使它们能够用于更大范围的患者场景。

最近推出了采用最新技术製造的产品。例如，2024年1月，Occlutech宣布美国食品药物管理局（FDA）已批准Occlutech ASD封堵器和Occlutech Pistol Pusher用于治疗心房中隔缺损（ASD）。此外，2024 年 6 月，全球医疗保健技术领导者美敦力公司 (Medtronic plc) 宣布推出其在心臟手术领域的最新创新产品 Avalus Ultra 瓣膜。这种下一代外科主动脉组织瓣膜旨在促进植入时的易用性和终生患者管理。对于从一开始就寻求适合未来的主动脉瓣解决方案的心臟外科医生及其患者来说，这是一个绝佳的选择。

程序和设备成本高

手术和设备的高成本等因素预计将阻碍全球结构性心臟设备市场。主要问题之一是结构性心臟装置手术所涉及的巨大价格负担，特别是经导管主动脉瓣置换术 (TAVR) 等现代技术。这些治疗通常不仅包括设备本身的费用，还包括术前影像、住院和术后护理等额外费用。

例如，根据美国国立卫生研究院的数据，使用机械和生物瓣膜进行瓣膜置换手术的自付费用中位数估计为 107,800 印度卢比（1684 美元）和 154,000 印度卢比（2406 美元），球囊瓣膜切开术的费用分别为14,456 印度卢比（367 美元）。每次机械和生物假体单瓣膜置换手术和球囊瓣膜切开术的总体成本估计分别为 127,919 印度卢比（1999 美元）、148,919 印度卢比（2372 美元）和 14,456 印度卢比（226 美元）。这些高昂的费用可能使许多患者，特别是中低收入地区或没有足够保险的患者难以获得所需的治疗。因此，财务影响可能会阻碍患者获得及时治疗，从而减少市场总需求。

Structural heart devices are specialized medical devices used to treat a variety of problems affecting the heart's structure, such as its valves, walls, or chambers. These disorders might be congenital (existing at birth) or develop over time as a result of factors such as age, high blood pressure, or other cardiovascular diseases. The most prevalent structural heart conditions are aortic valve disease, mitral valve disease, atrial septal defects (ASD), and ventricular septal defects (VSD). These anomalies can cause serious health problems if left untreated, typically demanding surgical intervention or device placement.

The increasing demand for structural heart devices is the driving factor that drives the market over the forecast period. The surge in the 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 structural heart devices 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 structural heart devices is expected to grow significantly.

Market Dynamics: Drivers & Restraints

Increasing demand for structural heart devices

The increasing demand for structural heart devices is expected to be a significant factor in the growth of the global structural heart devices market. The demand for structural heart devices is increasing owing to the rising prevalence of cardiovascular diseases, technological advancements, growing awareness regarding structural heart 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 structural heart 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 device design and materials have resulted in the development of more robust and biocompatible cardiac valves and occluders. These enhancements not only increase the devices' functionality but also reduce the problems associated with previous models. Thus, newer heart valves constructed of sophisticated materials can better imitate the natural function of human valves, resulting in enhanced blood flow and fewer cases of valve regurgitation. Furthermore, extending research and clinical trials continues to broaden the applications for these devices, allowing them to be used in a larger range of patient scenarios.

There are recent product launches that are manufactured using the latest technologies. For instance, in January 2024, Occlutech announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD). Moreover, 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 structural heart devices market. One of the primary issues is the significant price burden involved with structural heart device 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.

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. 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.

Segment Analysis

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

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

The TMVR (Transcatheter Mitral Valve Replacement) segment is anticipated to dominate the global structural heart 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 structural heart devices market share

North America will likely account for a significant share of the global structural heart 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 structural heart 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 structural heart devices market

The Asia Pacific region is emerging as the fastest-growing market for structural heart 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 structural heart devices market include Medtronic, Abbott, JenaValve, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Biomerics, TORAY INDUSTRIES, INC., Occlutech LLC, Shanghai MicroPort Medical (Group) 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 structural heart 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 Repair Devices
3.2. Snippet by Replacement Devices
3.3. Snippet by Application
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 Structural Heart 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 Repair Devices

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Repair Devices
- 6.1.2. Market Attractiveness Index, By Repair Devices
6.2. Occluders*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Annuloplasty Devices
6.4. Valvuloplasty Devices
6.5. Others

7. By Replacement Devices

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 7.1.2. Market Attractiveness Index, By Replacement Devices
7.2. Mechanical Valve*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Bioprosthetic Valve
7.4. TAVR

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Atrial Septal Defect*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Aortic Valve Stenosis
8.4. Ventricular Septal Defects
8.5. Mitral Regurgitation
8.6. Others

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 Repair Devices
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 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 Repair Devices
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 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 Repair Devices
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 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 Repair Devices
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 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 Repair Devices
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Replacement Devices
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 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. Medtronic*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Abbott
12.3. JenaValve
12.4. Artivion, Inc
12.5. Boston Scientific Corporation
12.6. Micro Interventional Devices
12.7. Biomerics
12.8. TORAY INDUSTRIES, INC.
12.9. Occlutech LLC
12.10. Shanghai MicroPort Medical (Group) Co.Ltd.

LIST NOT EXHAUSTIVE