PFOアンプラッツァ市場規模、シェア、成長分析、製品別、用途別、エンドユーザー別、地域別 - 産業予測、2025-2032年

世界のPFOアンプラッツァ市場規模は、2023年に1億2,869万米ドルと評価され、2024年の1億4,388万米ドルから2032年には3億5,117万米ドルに成長し、予測期間中（2025-2032年）にCAGR 11.8%で成長する見通しです。

Amplatzer PFO Occluderは、ニチノールワイヤーメッシュ製の二重ディスクの自己拡張型デバイスで、卵円孔開存（PFO）を効果的に閉鎖するように設計されています。二重のディスクは細いウエストで連結されており、ポリエステル生地が密閉性を高めています。各ディスクはポリエステル糸で丁寧に縫製されており、耐久性に優れています。両端にはX線不透過性のマーカーバンドがあり、手技中の画像化を容易にします。さらに、近位端のスクリュー機構が展開と送達を助け、正確な配置を保証します。また、安全性と有効性を確保するため、エチレンオキサイド滅菌が施されています。革新的なデザインと素材により、Amplatzer PFO Occluderは心血管インターベンションの進歩に大きく貢献しています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• ケーススタディ
• 技術の進歩
• 規制情勢
• 特許分析

PFOアンプラッツァ市場規模：製品別

• 市場概要
• アンプラッツァーPFO閉塞器
• その他のPFO閉塞器具

PFOアンプラッツァ市場規模：用途別

• 市場概要
• 病院
• クリニック
• 外来手術センター（ASC）

PFOアンプラッツァ市場規模：エンドユーザー別

• 市場概要
• 小児患者
• 成人患者

PFOアンプラッツァ市場規模

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Abbott Laboratories（US）
• Boston Scientific Corporation（US）
• Medtronic plc（Ireland）
• W. L. Gore & Associates, Inc.（US）
• Occlutech Holding AG（Switzerland）
• Lifetech Scientific Corporation（China）
• MicroPort Scientific Corporation（China）
• Terumo Corporation（Japan）
• B. Braun Melsungen AG（Germany）
• Edwards Lifesciences Corporation（US）
• Cook Medical Inc.（US）
• Biotronik SE & Co. KG（Germany）

結論と推奨事項

Global PFO Amplatzer Market size was valued at USD 128.69 million in 2023 and is poised to grow from USD 143.88 million in 2024 to USD 351.17 million by 2032, growing at a CAGR of 11.8% during the forecast period (2025-2032).

The Amplatzer PFO Occluder, a double-disc, self-expandable device made from Nitinol wire mesh, is designed for effective closure of patent foramen ovale (PFO). Its dual discs are interconnected by a slender waist, featuring a polyester fabric that enhances its sealing capability. Each disc is meticulously sewn with polyester thread for durability. The design incorporates radiopaque marker bands at both ends to facilitate imaging during procedures. Additionally, a screw mechanism on the proximal end aids in deployment and delivery, ensuring precision in placement. The device is also subjected to ethylene oxide sterilization to ensure safety and efficacy. With its innovative design and materials, the Amplatzer PFO Occluder significantly contributes to advancements in cardiovascular interventions.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pfo Amplatzer market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Pfo Amplatzer Market Segmental Analysis

Global PFO Amplatzer Market is segmented by Product, Application, End-User and region. Based on Product, the market is segmented into Amplatzer PFO Occluder and Other PFO Occluders. Based on Application, the market is segmented into Hospitals, Clinics and Ambulatory Surgical Centers (ASCs). Based on End-User, the market is segmented into Pediatric Patients and Adult Patients. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Pfo Amplatzer Market

The growth of the global PFO Amplatzer market is largely driven by the rising incidence of ischemic strokes, which represent a significant health burden worldwide, accounting for approximately 87% of all strokes according to the American Stroke Association. Lifestyle-related risk factors, including smoking, alcohol consumption, and sedentary habits, exacerbate the likelihood of stroke occurrences. Additionally, the prevalence of congenital heart defects contributes to the demand for PFO closure devices, with an estimated 40,000 infants born with such conditions each year in the U.S. New product launches, like the GORE CARDIOFORM Septal Occluder, and ongoing clinical trials further propel market expansion, indicating a robust future for PFO Amplatzer solutions in the healthcare industry.

Restraints in the Global Pfo Amplatzer Market

The global PFO Amplatzer market faces significant constraints primarily due to product recalls and discontinuations. Several manufacturers, including W. L. Gore and Associates, Inc., have halted production of items like the GORE HELEX Septal Occluder, following patent infringement lawsuits. Additionally, St. Jude Medical's review of the Amplatzer PFO Occluder, classified as a Class I item by the FDA in 2013, highlights regulatory challenges within the industry. Furthermore, the high cost of these devices may hinder market growth, particularly in developing nations such as Brazil, Argentina, and India, where affordability remains a critical issue. These factors combined may impede market expansion.

Market Trends of the Global Pfo Amplatzer Market

The global PFO Amplatzer market is experiencing a robust upward trend, driven by the alarming rise in ischemic stroke incidents, which remains the second leading cause of mortality worldwide. Increasing prevalence of lifestyle-related risk factors, such as smoking, alcohol consumption, and sedentary behaviors, is anticipated to elevate stroke risks further. Additionally, the burgeoning incidence of congenital heart diseases is likely to propel demand for PFO closure devices, including the Amplatzer Occluder. As healthcare professionals and patients increasingly recognize the importance of preventative measures and innovative treatment options, the market is primed for substantial growth in the coming years.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Case Studies
• Technology Advancement
• Regulatory Landscape
• Patent Analysis

Global PFO Amplatzer Market Size by Product & CAGR (2025-2032)

• Market Overview
• Amplatzer PFO Occluder
• Other PFO Occluders

Global PFO Amplatzer Market Size by Application & CAGR (2025-2032)

• Market Overview
• Hospitals
• Clinics
• Ambulatory Surgical Centers (ASCs)

Global PFO Amplatzer Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Pediatric Patients
• Adult Patients

Global PFO Amplatzer Market Size & CAGR (2025-2032)

• North America (Product, Application, End-User)
  • US
  • Canada
• Europe (Product, Application, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product, Application, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product, Application, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product, Application, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Abbott Laboratories (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Boston Scientific Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medtronic plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• W. L. Gore & Associates, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Occlutech Holding AG (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lifetech Scientific Corporation (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• MicroPort Scientific Corporation (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Terumo Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• B. Braun Melsungen AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Edwards Lifesciences Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cook Medical Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biotronik SE & Co. KG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations