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心血管設備

市場調查報告書

商品編碼

1634190

全球結構心臟器材市場 - 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個工作天內

價格

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簡介目錄

2024年，全球結構心臟器材市場規模達到147.9億美元，預計2033年將達到288.4億美元，2025-2033年預測期間複合年成長率為8.0%。

結構性心臟裝置是一種專門的醫療裝置，用於治療影響心臟結構（例如瓣膜、心壁或心室）的各種問題。這些疾病可能是先天性的（出生時就存在），也可能是由於年齡、高血壓或其他心血管疾病等因素而隨著時間的推移而形成的。最常見的結構性心臟病是主動脈瓣疾病、二尖瓣疾病、心房中隔缺損 (ASD) 和心室中隔缺損 (VSD)。如果不及時治療，這些異常可能會導致嚴重的健康問題，通常需要進行手術干預或放置設備。

結構心臟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。許多人需要結構性心臟裝置來治療主動脈瓣狹窄等問題，對新型裝置產生了更大的需求。隨著醫療保健技術的進步和更多微創手術的出現，結構性心臟設備的市場預計將顯著成長。

市場動態：

驅動程式和限制

對結構性心臟設備的需求不斷增加

對結構性心臟器械的需求不斷成長預計將成為全球結構性心臟器械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、人們對結構性心臟裝置的認知不斷增強以及最近的推出和批准，對結構性心臟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結構性心臟裝置的需求。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，裝置設計和材料的進步導致了更堅固和生物相容性心臟瓣膜和封堵器的開發。這些增強功能不僅增加了設備的功能，還減少了與先前型號相關的問題。因此，由複雜材料製成的新型心臟瓣膜可以更好地模仿人體瓣膜的自然功能，從而增強血流並減少瓣膜逆流的情況。此外，擴展研究和臨床試驗繼續擴大這些設備的應用，使它們能夠用於更大範圍的患者場景。

最近推出了採用最新技術製造的產品。例如，2024年1月，Occlutech宣布美國食品藥物管理局（FDA）已批准Occlutech ASD封堵器和Occlutech Pistol Pusher用於治療心房中隔缺損（ASD）。此外，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結構性心臟設備市場。主要問題之一是結構性心臟裝置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。

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）。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。

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