구조적 심장 폐색 기기 시장 규모, 점유율, 동향 분석 : 유형별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Structural Heart Occlusion Devices Market Size, Share & Trends Analysis Report By Type (Left Atrial Appendage Occlusion Devices, Atrial Septal Defect Occluders), By End-use, By Region, And Segment Forecasts, 2025 - 2030

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한글목차

시장 규모와 동향 :

세계의 구조적 심장 폐색 기기 시장 규모는 2024년에 40억 달러로 추정되며, 2025-2030년에 CAGR 7.0%로 성장할 것으로 예측됩니다.

구조적 심장폐쇄장비 시장은 구조적 심장질환의 부담 증가, 최소침습적 치료의 수용 증가, 유리한 규제 및 상환 변경으로 인해 발전하고 있습니다. 임상적 인식 증가와 시술의 혁신으로 대상 환자가 확대되고 있으며, 강력한 플러스 성장 전망이 강화되고 있습니다.

구조적 심장질환의 유병률 증가는 구조적 심장 폐색 기기 시장의 주요 촉진요인입니다. 심방중격결손증, 난원공개존증, 좌심방 부속기 이상과 같은 질환은 진단 기술이 계속 발전함에 따라 임상적 관심이 높아지고 있습니다. 미국심장협회의 2024년 통계 업데이트에 따르면 미국내 심방세동(AF) 유병률은 2010년 약 520만 명에서 2030년 1,210만 명으로 증가할 것으로 예상되어 효과적인 중재에 대한 임상적 요구가 증가하고 있음을 강조하고 있습니다. 인식이 개선되고 진단 경로가 표준화됨에 따라 폐색요법을 받을 수 있는 환자층이 크게 확대되어 시장 성장의 강력한 기반이 될 것입니다.

세계에서 심방세동(AF) 유병률이 지속적으로 증가하고 있는 가운데, 좌심방 부속기 폐쇄술(LAAO)이 구조적 심장폐쇄장비 시장을 주도하고 있으며, LAAO는 비판막성 심방세동 환자, 특히 출혈 위험이 높은 환자의 뇌졸중 예방에 경구용 항응고제 대신 비약물 요법을 제공합니다. 2025년 2월 European Heart Journal Supplements에 게재된 논문은 장기 경구용 항응고제(OAT)가 금기인 환자에서 LAAO의 채택이 증가하고 있는 것에 초점을 맞추었습니다. 이 논문은 뇌졸중 예방에 있으며, OAT의 역할에도 불구하고 특정 환자, 특히 출혈성 사건의 병력이 있는 환자는 허혈성 뇌졸중 위험이 여전히 높다는 점을 강조하고 있습니다.

규제 및 상환 구상은 구조적 심장 폐색 기기 시장 형성에 있으며, 점점 더 중요한 역할을 하고 있습니다. 임상 도입을 촉진하고, 혁신에 대한 투자를 촉진하고, 첨단 치료에 대한 환자 접근성을 확대하기 위해서는 우호적인 정책 환경이 필수적이며, 2025년 3월 미국 메디케어 및 메디케이드 서비스 센터(CMS)는 LAmbre Plus 좌심방 부속기 폐쇄 시스템을 평가하는 REDUCE-AF CED(Coverage with Evidence Development)에 따라 임상시험을 승인했습니다. 이번 결정은 비판막성 심방세동 환자에서 기기 사용을 지원할 수 있는 강력한 임상적 증거를 구축하는 데 규제 당국이 지속적으로 중점을 두고 있다는 점을 반영합니다.

목차

제1장 분석 방법·범위

제2장 개요

제3장 구조적 심장 폐색 기기 시장 : 변동 요인·경향·범위

• 시장 연관 전망
  • 모시장 전망
  • 관련/부수 시장 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 구조적 심장 폐색 기기 시장 : 분석 툴
  • 업계 분석 : Porter의 산업 분석
  • PESTEL 분석

제4장 구조적 심장 폐색 기기 시장 : 유형별 추정·동향 분석

• 구조적 심장 폐색 기기 시장 : 유형별 대시보드
• 구조적 심장 폐색 기기 시장 : 유형별 변동 분석
• 구조적 심장 폐색 기기 시장 : 시장 규모 예측과 동향 분석, 유형별(2018-2030년)
• 좌심이(LAA) 폐색 기기
• 심방중격결손(ASD) 폐색 기기
• 동맥관개존증(PDA) 폐색 기기
• 기타

제5장 구조적 심장 폐색 기기 시장 : 최종 용도별 추정·동향 분석

• 구조적 심장 폐색 기기 시장 : 최종 용도별 대시보드
• 구조적 심장 폐색 기기 시장 : 최종 용도별 변동 분석
• 구조적 심장 폐색 기기 시장 : 시장 규모 예측과 동향 분석, 최종 용도별(2018-2030년)
• 병원
• 전문 클리닉
• 학술연구기관

제6장 구조적 심장 폐색 기기 시장 : 지역별 추정·동향 분석(국가별, 유형별, 적응증별, 최종 용도별)

• 세계의 구조적 심장 폐색 기기 시장 : 지역별 대시보드
• 시장 규모 예측과 동향 분석(2018-2030년)
• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 영국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 스웨덴
  • 노르웨이
  • 덴마크
• 아시아태평양
  • 중국
  • 일본
  • 인도
  • 호주
  • 태국
  • 한국
• 라틴아메리카
  • 브라질
  • 아르헨티나
• 중동 및 아프리카
  • 사우디아라비아
  • 남아프리카공화국
  • 아랍에미리트
  • 쿠웨이트

제7장 경쟁 구도

• 최근 동향과 영향 분석 : 주요 제조업체별
• 기업/경쟁 분류
• 주요 기업의 시장 점유율 분석(2024년)
  • Abbott
  • Boston Scientific Corporation
  • Occlutech
  • Lifetech Scientific
  • Medtronic
  • W. L. Gore & Associates
  • Lepu Medical Technology (Beijing)Co.,Ltd
  • Emtree Medical (Cardia Inc.)
  • Biosense Webster (Johnson & Johnson)
  • PFM Medical GMBH

KSA

영문 목차

영문목차

Market Size & Trends:

The global structural heart occlusion devices market size was estimated at USD 4.0 billion in 2024 and is projected to grow at a CAGR of 7.0% from 2025 to 2030. The structural heart occlusion devices market is advancing due to the rising burden of structural heart diseases, increasing acceptance of minimally invasive therapies, and favorable regulatory and reimbursement changes. Growing clinical awareness and procedural innovations are expanding the eligible patient pool, reinforcing a strong positive growth outlook.

The increasing prevalence of structural heart diseases is a major driver for the structural heart occlusion devices market. Conditions such as atrial septal defects, patent foramen ovale, and left atrial appendage abnormalities are gaining greater clinical attention as diagnostic technologies continue to advance. The American Heart Association's 2024 Statistical Update projects that the prevalence of atrial fibrillation (AF) in the U.S. will rise from approximately 5.2 million in 2010 to 12.1 million by 2030, underscoring the growing clinical need for effective interventions. As awareness improves and diagnostic pathways become more standardized, the addressable patient population for occlusion therapies is expanding significantly, creating a strong foundation for market growth.

As the prevalence of atrial fibrillation (AF) continues to rise globally, Left Atrial Appendage Occlusion (LAAO) procedures are gaining traction within the Structural Heart Occlusion Devices market. LAAO offers a non-pharmacologic alternative to oral anticoagulants for stroke prevention in patients with non-valvular AF, particularly those at high bleeding risk. A February 2025 article published in the European Heart Journal Supplements focused on the growing adoption of LAAO for patients with contraindications to long-term oral anticoagulant therapy (OAT). The article emphasizes that despite OAT's role in stroke prevention, certain patients, especially those with a history of bleeding events, remain at high risk for ischemic strokes.

Regulatory and reimbursement initiatives are playing an increasingly important role in shaping the structural heart occlusion devices market. Favorable policy environments are essential to encourage clinical adoption, promote investment in innovation, and expand patient access to advanced therapies. In March 2025, the Centers for Medicare & Medicaid Services (CMS) approved the REDUCE-AF clinical trial under Coverage with Evidence Development (CED) to evaluate the LAmbre Plus Left Atrial Appendage Closure System. This decision reflects continued regulatory emphasis on building robust clinical evidence to support device utilization in patients with non-valvular atrial fibrillation.

Global Structural Heart Occlusion Devices Market Report Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global structural heart occlusion devices market report based on type, end-use, and region:

• Type Outlook (Revenue, USD Million, 2018 - 2030)
• Left Atrial Appendage (LAA) Occlusion Devices
• Atrial Septal Defect (ASD) Occluders
• Patent Ductus Arteriosus (PDA) Occlusion Devices
• Others
• End-use Outlook (Revenue, USD Million, 2018 - 2030)
• Hospitals
• Specialty clinics
• Academic and Research Institutes
• Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type
  • 1.2.2. End Use
  • 1.2.3. Regional scope
  • 1.2.4. Estimates and forecast timeline.
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
  • 1.4.5. Details of primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity price analysis (Model 1)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Type Segment
  • 2.2.2. End Use Segment
  • 2.2.3. Regional Outlook
• 2.3. Competitive Insights

Chapter 3. Global Structural Heart Occlusion Devices Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Rising prevalence of structural heart diseases
    • 3.2.1.2. Growth of minimally invasive cardiac interventions
    • 3.2.1.3. Regulatory and reimbursement tailwinds
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Regulatory approval delays
• 3.3. Structural Heart Occlusion Devices Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Technological landscape
    • 3.3.2.3. Economic landscape

Chapter 4. Structural Heart Occlusion Devices Market: Type Estimates & Trend Analysis

• 4.1. Structural Heart Occlusion Devices Market: Type Dashboard
• 4.2. Structural Heart Occlusion Devices Market: Type Movement Analysis
• 4.3. Structural Heart Occlusion Devices Market Size & Forecasts and Trend Analysis, by Type, 2018 to 2030 (USD Million)
• 4.4. Left Atrial Appendage (LAA) Occlusion Devices
  • 4.4.1. Market estimates and forecast 2018 to 2030 (USD Million)
• 4.5. Atrial Septal Defect (ASD) Occluders
  • 4.5.1. Market estimates and forecast 2018 to 2030 (USD Million)
• 4.6. Patent Ductus Arteriosus (PDA) Occlusion Devices
  • 4.6.1. Market estimates and forecast 2018 to 2030 (USD Million)
• 4.7. Others
  • 4.7.1. Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 5. Structural Heart Occlusion Devices Market: End Use Estimates & Trend Analysis

• 5.1. Structural Heart Occlusion Devices Market: End Use Dashboard
• 5.2. Structural Heart Occlusion Devices Market: End Use Movement Analysis
• 5.3. Structural Heart Occlusion Devices Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 5.4. Hospitals
  • 5.4.1. Market estimates and forecast 2018 to 2030 (USD Million)
• 5.5. Specialty Clinics
  • 5.5.1. Market estimates and forecast 2018 to 2030 (USD Million)
• 5.6. Academic and Research Institutes
  • 5.6.1. Market estimates and forecast 2018 to 2030 (USD Million)

Chapter 6. Structural Heart Occlusion Devices Market: Regional Estimates & Trend Analysis by Country, Type, Indication, & End Use

• 6.1. Global Structural Heart Occlusion Devices Market: Regional Dashboard
• 6.2. Market Size & Forecasts Trend Analysis, 2018 to 2030
• 6.3. North America
  • 6.3.1. Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 6.3.2. U.S.
    • 6.3.2.1. Key country dynamics
    • 6.3.2.2. Regulatory framework/ reimbursement structure
    • 6.3.2.3. Competitive scenario
    • 6.3.2.4. U.S. market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.3.3. Canada
    • 6.3.3.1. Key country dynamics
    • 6.3.3.2. Regulatory framework/ reimbursement structure
    • 6.3.3.3. Competitive scenario
    • 6.3.3.4. Canada market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.3.4. Mexico
    • 6.3.4.1. Key country dynamics
    • 6.3.4.2. Regulatory framework/ reimbursement structure
    • 6.3.4.3. Competitive scenario
    • 6.3.4.4. Mexico market estimates and forecast, 2018 - 2030 (USD Million)
• 6.4. Europe
  • 6.4.1. Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 6.4.2. UK
    • 6.4.2.1. Key country dynamics
    • 6.4.2.2. Regulatory framework/ reimbursement structure
    • 6.4.2.3. Competitive scenario
    • 6.4.2.4. UK market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.3. Germany
    • 6.4.3.1. Key country dynamics
    • 6.4.3.2. Regulatory framework/ reimbursement structure
    • 6.4.3.3. Competitive scenario
    • 6.4.3.4. Germany market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.4. France
    • 6.4.4.1. Key country dynamics
    • 6.4.4.2. Regulatory framework/ reimbursement structure
    • 6.4.4.3. Competitive scenario
    • 6.4.4.4. France market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.5. Italy
    • 6.4.5.1. Key country dynamics
    • 6.4.5.2. Regulatory framework/ reimbursement structure
    • 6.4.5.3. Competitive scenario
    • 6.4.5.4. Italy market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.6. Spain
    • 6.4.6.1. Key country dynamics
    • 6.4.6.2. Regulatory framework/ reimbursement structure
    • 6.4.6.3. Competitive scenario
    • 6.4.6.4. Spain market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.7. Sweden
    • 6.4.7.1. Key country dynamics
    • 6.4.7.2. Regulatory framework/ reimbursement structure
    • 6.4.7.3. Competitive scenario
    • 6.4.7.4. Sweden market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.8. Norway
    • 6.4.8.1. Key country dynamics
    • 6.4.8.2. Regulatory framework/ reimbursement structure
    • 6.4.8.3. Competitive scenario
    • 6.4.8.4. Norway market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.4.9. Denmark
    • 6.4.9.1. Key country dynamics
    • 6.4.9.2. Regulatory framework/ reimbursement structure
    • 6.4.9.3. Competitive scenario
    • 6.4.9.4. Denmark market estimates and forecast, 2018 - 2030 (USD Million)
• 6.5. Asia Pacific
  • 6.5.1. Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 6.5.2. China
    • 6.5.2.1. Key country dynamics
    • 6.5.2.2. Regulatory framework/ reimbursement structure
    • 6.5.2.3. Competitive scenario
    • 6.5.2.4. China market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.5.3. Japan
    • 6.5.3.1. Key country dynamics
    • 6.5.3.2. Regulatory framework/ reimbursement structure
    • 6.5.3.3. Competitive scenario
    • 6.5.3.4. Japan market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.5.4. India
    • 6.5.4.1. Key country dynamics
    • 6.5.4.2. Regulatory framework/ reimbursement structure
    • 6.5.4.3. Competitive scenario
    • 6.5.4.4. India market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.5.5. Australia
    • 6.5.5.1. Key country dynamics
    • 6.5.5.2. Regulatory framework/ reimbursement structure
    • 6.5.5.3. Competitive scenario
    • 6.5.5.4. Australia market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.5.6. Thailand
    • 6.5.6.1. Key country dynamics
    • 6.5.6.2. Regulatory framework/ reimbursement structure
    • 6.5.6.3. Competitive scenario
    • 6.5.6.4. Thailand market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.5.7. South Korea
    • 6.5.7.1. Key country dynamics
    • 6.5.7.2. Regulatory framework/ reimbursement structure
    • 6.5.7.3. Competitive scenario
    • 6.5.7.4. South Korea market estimates and forecast, 2018 - 2030 (USD Million)
• 6.6. Latin America
  • 6.6.1. Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 6.6.2. Brazil
    • 6.6.2.1. Key country dynamics
    • 6.6.2.2. Regulatory framework/ reimbursement structure
    • 6.6.2.3. Competitive scenario
    • 6.6.2.4. Brazil market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.6.3. Argentina
    • 6.6.3.1. Key country dynamics
    • 6.6.3.2. Regulatory framework/ reimbursement structure
    • 6.6.3.3. Competitive scenario
    • 6.6.3.4. Argentina market estimates and forecast, 2018 - 2030 (USD Million)
• 6.7. MEA
  • 6.7.1. Market Estimates and Forecasts 2018 to 2030 (USD Million)
  • 6.7.2. Saudi Arabia
    • 6.7.2.1. Key country dynamics
    • 6.7.2.2. Regulatory framework/ reimbursement structure
    • 6.7.2.3. Competitive scenario
    • 6.7.2.4. Saudi Arabia market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.7.3. South Africa
    • 6.7.3.1. Key country dynamics
    • 6.7.3.2. Regulatory framework/ reimbursement structure
    • 6.7.3.3. Competitive scenario
    • 6.7.3.4. South Africa market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.7.4. UAE
    • 6.7.4.1. Key country dynamics
    • 6.7.4.2. Regulatory framework/ reimbursement structure
    • 6.7.4.3. Competitive scenario
    • 6.7.4.4. UAE market estimates and forecast, 2018 - 2030 (USD Million)
  • 6.7.5. Kuwait
    • 6.7.5.1. Key country dynamics
    • 6.7.5.2. Regulatory framework/ reimbursement structure
    • 6.7.5.3. Competitive scenario
    • 6.7.5.4. Kuwait market estimates and forecast, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Recent Developments & Impact Analysis, By Key Manufacturers
• 7.2. Company/Competition Categorization
• 7.3. Key company market share analysis, 2024
  • 7.3.1. Abbott
    • 7.3.1.1. Company overview
    • 7.3.1.2. Financial performance
    • 7.3.1.3. Product benchmarking
    • 7.3.1.4. Strategic initiatives
  • 7.3.2. Boston Scientific Corporation
    • 7.3.2.1. Company overview
    • 7.3.2.2. Financial performance
    • 7.3.2.3. Product benchmarking
    • 7.3.2.4. Strategic initiatives
  • 7.3.3. Occlutech
    • 7.3.3.1. Company overview
    • 7.3.3.2. Financial performance
    • 7.3.3.3. Product benchmarking
    • 7.3.3.4. Strategic initiatives
  • 7.3.4. Lifetech Scientific
    • 7.3.4.1. Company overview
    • 7.3.4.2. Financial performance
    • 7.3.4.3. Product benchmarking
    • 7.3.4.4. Strategic initiatives
  • 7.3.5. Medtronic
    • 7.3.5.1. Company overview
    • 7.3.5.2. Financial performance
    • 7.3.5.3. Product benchmarking
    • 7.3.5.4. Strategic initiatives
  • 7.3.6. W. L. Gore & Associates
    • 7.3.6.1. Company overview
    • 7.3.6.2. Financial performance
    • 7.3.6.3. Product benchmarking
    • 7.3.6.4. Strategic initiatives
  • 7.3.7. Lepu Medical Technology (Beijing)Co.,Ltd
    • 7.3.7.1. Company overview
    • 7.3.7.2. Financial performance
    • 7.3.7.3. Product benchmarking
    • 7.3.7.4. Strategic initiatives
  • 7.3.8. Emtree Medical (Cardia Inc.)
    • 7.3.8.1. Company overview
    • 7.3.8.2. Financial performance
    • 7.3.8.3. Product benchmarking
    • 7.3.8.4. Strategic initiatives
  • 7.3.9. Biosense Webster (Johnson & Johnson)
    • 7.3.9.1. Company overview
    • 7.3.9.2. Financial performance
    • 7.3.9.3. Product benchmarking
    • 7.3.9.4. Strategic initiatives
  • 7.3.10. PFM Medical GMBH
    • 7.3.10.1. Company overview
    • 7.3.10.2. Financial performance
    • 7.3.10.3. Product benchmarking
    • 7.3.10.4. Strategic initiatives