미국의 대동맥판 치환 디바이스 시장 규모, 점유율, 동향 분석 : 제품별, 판막엽 재료별, 프레임 재료별, 최종 용도별, 부문별 예측(2025-2033년)

U.S. Aortic Valve Replacement Devices Market Summary

The U.S. aortic valve replacement devices market size was estimated at USD 4.08 billion in 2024 and is projected to reach USD 9.35 billion by 2033, growing at a CAGR of 9.4% from 2025 to 2033. The market is primarily driven by the increasing prevalence of aortic stenosis in an aging population and favorable clinical outcomes from surgical and transcatheter approaches.

With a growing number of patients over age 65, demand for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) continues to rise. Clinical outcomes have improved significantly over the past decade, with TAVR gaining wider acceptance due to its less invasive nature and reduced recovery times. As per the article on the Southwestern Medical Center website, approximately 100,000 TAVR procedures are performed annually in the U.S and as of November 2024, the medical centre had performed more than 1,000 transcatheter aortic valve replacement (TAVR) procedures.

Innovation remains a critical driving force within this market, with a strong focus on enhancing device durability and improving delivery systems for less invasive procedures. Manufacturers are continuously investing in research and development to extend the lifespan of prosthetic valves, which is crucial for younger patients who may live longer with their implanted devices.

Merger and acquisition is moderately high, driven by strategic efforts to gain technological advantages or market access. In July 2024, Edwards Lifesciences announced a strategic investment of around USD 1.2 billion to acquire JenaValve Technology and Endotronix, expanding its structural heart portfolio. Acquiring JenaValve Technology enhances Edward's position in the U.S. aortic valve replacement devices industry, targeting the underserved aortic regurgitation segment. The purchase of Endotronix, following an earlier investment, allows Edwards to enter heart failure management with its FDA-approved Cordella sensor. These strategic moves aim to address unmet patient needs and support long-term growth.

The FDA requires extensive clinical trials and post-market surveillance, which can delay product launches and ensure high safety standards. In May 2025, the FDA approved Edwards Lifesciences Sapien 3 Ultra Resilia TAVR valves for treating asymptomatic severe aortic stenosis (AS).

U.S. Aortic Valve Replacement Devices Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. aortic valve replacement devices market report based on product, leaflet material, frame material, and end use.

• Product Outlook (Revenue, USD Billion, 2021 - 2033)
• Balloon-expandable
• Self-expandable
• Mechanically expandable
• Aortic regurgitation
• Leaflet Material Outlook (Revenue, USD Billion, 2021 - 2033)
• Bovine pericardium
• Porcine pericardium
• Frame Material Outlook (Revenue, USD Billion, 2021 - 2033)
• Cobalt-chromium
• Nitinol
• Others
• End Use Outlook (Revenue, USD Billion, 2021 - 2033)
• Inpatient Facilities
• Outpatient Facilities

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Research Methodology
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources
  • 1.3.4. Primary Research
• 1.4. Information/Data Analysis
• 1.5. Market Formulation & Visualization
• 1.6. Data Validation & Publishing
• 1.7. Model Details
• 1.8. List of Secondary Sources

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Aortic Valve Replacement Devices Market Variable Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market
  • 3.1.2. Ancillary Market
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Market Opportunity Analysis
  • 3.2.4. Market Challenge Analysis
• 3.3. U.S. Aortic Valve Replacement Devices Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Bargaining power of suppliers
    • 3.3.1.2. Bargaining power of buyers
    • 3.3.1.3. Threat of substitution
    • 3.3.1.4. Threat of new entrants
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political & Legal landscape
    • 3.3.2.2. Economic and Social landscape
    • 3.3.2.3. Technological landscape
    • 3.3.2.4. Environmental landscape
  • 3.3.3. Regulatory Framework

Chapter 4. U.S. Aortic Valve Replacement Devices Market: Product Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. U.S. Aortic Valve Replacement Devices Market: Product Movement Analysis
• 4.3. U.S. Aortic Valve Replacement Devices Market Size & Trend Analysis, by product, 2021 to 2033 (USD Billion)
• 4.4. Balloon-expandable
  • 4.4.1. Balloon-expandable Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.5. Self-expandable
  • 4.5.1. Self-expandable Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.6. Mechanically expandable
  • 4.6.1. Mechanically expandable Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 4.7. Aortic regurgitation
  • 4.7.1. Aortic regurgitation Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 5. U.S. Aortic Valve Replacement Devices Market: Leaflet Material Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. U.S. Aortic Valve Replacement Devices Market: Leaflet Material Movement Analysis
• 5.3. U.S. Aortic Valve Replacement Devices Market Size & Trend Analysis, by leaflet material, 2021 to 2033 (USD Billion)
• 5.4. Bovine pericardium
  • 5.4.1. Bovine Pericardium Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
• 5.5. Porcine pericardium
  • 5.5.1. Porcine Pericardium Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 6. U.S. Aortic Valve Replacement Devices Market: By Frame Material Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. U.S. Aortic Valve Replacement Devices Market: By Frame Material Movement Analysis
• 6.3. U.S. Aortic Valve Replacement Devices Market Size & Trend Analysis, by frame material, 2021 to 2033 (USD Billion)
  • 6.3.1. Cobalt-chromium
    • 6.3.1.1. Cobalt-chromium Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 6.3.2. Nitinol
    • 6.3.2.1. Nitinol Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 6.3.3. Others
    • 6.3.3.1. Other Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 7. U.S. Aortic Valve Replacement Devices Market: By End Use Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. U.S. Aortic Valve Replacement Devices Market: By End Use Movement Analysis
• 7.3. U.S. Aortic Valve Replacement Devices Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Billion)
  • 7.3.1. Inpatient Facilities
    • 7.3.1.1. Inpatient Facilities Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)
  • 7.3.2. Outpatient Facilities
    • 7.3.2.1. Outpatient Facilities Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Billion)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
• 8.2. Company Market Position Analysis/ Heap Map Analysis
• 8.3. Company Profiles
  • 8.3.1. Boston Scientific Corporation
    • 8.3.1.1. Participant's Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Product Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Artivion, Inc
    • 8.3.2.1. Participant's Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Product Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Edwards Lifesciences Corporation
    • 8.3.3.1. Participant's Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Product Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. LivaNova PLC
    • 8.3.4.1. Participant's Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Product Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Medtronic
    • 8.3.5.1. Participant's Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Product Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Abbott
    • 8.3.6.1. Participant's Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Product Benchmarking
    • 8.3.6.4. Strategic Initiatives