查看購物車
  • English
  • Japanese
  • Korean
封面
市場調查報告書
商品編碼
1967726

導管導入鞘套市場－全球產業規模、佔有率、趨勢、機會、預測：按產品、最終用戶、地區和競爭對手分類，2021-2031年

Catheter Introducer Sheaths Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By End user, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3個工作天內

價格

We offer 8 hour analyst time for an additional research. Please contact us for the details.

簡介目錄

全球導管插入鞘套市場預計將從 2025 年的 15.1 億美元成長到 2031 年的 19.4 億美元，複合年成長率達到 4.26%。

這些專用器械對於確保介入器械安全有效地插入血管系統至關重要。市場成長的主要促進因素是全球心血管疾病盛行率的不斷上升以及微創診斷和治療方法的顯著轉變。此外，全球人口老化導致血管照護需求日益成長，也進一步推動了這項需求。根據美國心臟協會 (AHA) 最新發布的 2024 年統計數據，心血管疾病每年在全球造成約 2,000 萬人死亡，凸顯了對高效介入器械的迫切需求。

市場概覽
預測期 2027-2031
市場規模：2025年 15.1億美元
市場規模：2031年 19.4億美元
複合年成長率：2026-2031年 4.26%
成長最快的細分市場 一體式導引鞘
最大的市場 北美洲

市場成長的主要障礙是醫療設備認證方面嚴格的監管環境。製造商面臨複雜的合規義務和嚴格的安全標準，這增加了研發成本，並延長了新產品的上市時間。這些監管壁壘常常阻礙小規模企業進入該行業，並延緩了創新型鞘套技術的商業化進程。

市場促進因素

結構性心臟病治療領域對大口徑鞘套的需求不斷成長，是全球導管鞘鞘套市場的主要驅動力。隨著經導管治療從主動脈瓣置換術發展到複雜的二尖瓣和三尖瓣手術，對專用介入器材的需求也日益成長。這些治療需要更大口徑的鞘套，以便容納先進的輸送系統，同時保持低輪廓設計，從而最大限度地減少併發症並確保安全閉合。這一趨勢在行業的快速成長中得到了清晰的體現。愛德華生命科學公司在2024年7月的財報中指出，經導管二尖瓣和三尖瓣治療（TMTT）的銷售額年增了75%，凸顯了這些基於導管的介入治療技術的廣泛應用。

此外，鞘套設計和生物相容性材料的技術進步正在加速市場擴張，使更複雜的手術成為可能，並提高病患安全性。製造商正在開發具有親水塗層、抗彎曲編織層和可操控鞘套等特性的鞘管，以便在複雜的解剖結構中進行操作，尤其是在電生理和神經血管領域。這些創新正在推動主要企業的收入成長。波士頓科學公司2025年2月的報告指出，其電生理部門在2024會計年度實現了139%的內部成長，主要得益於FARAPULSE系統的推動。同樣，Medtronic在2024年5月的報告顯示，其心血管產品組合在2024會計年度創造了118億美元的收入，反映出全球對介入器材的持續需求。

市場挑戰

醫療設備認證的嚴格法規環境嚴重阻礙了全球導管鞘套市場的成長。製造商必須遵守複雜的合規框架和嚴格的安全標準，這需要進行大規模臨床試驗並提交詳細的文件。這些必要的流程顯著延長了產品開發週期，造成了瓶頸，延緩了創新鞘套技術的商業化進程，並阻礙了企業快速回應市場需求。

這些監管障礙也造成了沉重的財務負擔，限制了市場准入和擴張。高昂的合規成本實際上將缺乏資金來應對漫長核可階段的中小型企業拒之門外，削弱了市場競爭。這些成本的影響巨大；根據 MedTech Europe 在 2024 年的報告顯示，醫療設備法規 (MDR) 下的認證和維修成本比先前的指令高出 100%。營運成本的增加迫使製造商轉移研發資金，導致新產品推出停滯不前，並減緩了整體市場成長。

市場趨勢

受門診手術安全性和成本效益的驅動，市場參與企業正在加強其血管通路產品組合，以滿足門診手術中心 (ASC) 的需求。這種轉變催生了對能夠快速止血和提高患者周轉率的導引鞘的需求，而這對於門診手術中心的盈利至關重要。這種結構性轉變正在推動市場規模的成長。美國心血管血管造影術和介入學會 (SCAI) 在 2025 年 5 月的一項研究中預測，2024 年至 2034 年間，門診手術中心接受心臟介入治療的患者數量將增加 21%。

同時，為了減少出血併發症並促進早期活動，血管介入治療中經橈動脈入路（TRA）的應用日益增加。這一趨勢要求開發壁更薄、親水塗層更最佳化的橈動脈專用鞘套，以最大程度地減少動脈痙攣。這種設計理念有助於推進當日出院通訊協定。該技術的應用已十分廣泛。 2025年7月，TCTMD報告稱，美國經皮冠狀動脈介入治療（PCI）中橈動脈入路的使用率已達到57.5%，鞏固了其作為主要入路策略的地位。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球導管鞘套市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 產品類型（一體成型導管插入鞘套，分離式導管插入鞘套）
    • 依最終使用者（醫院/診所、門診中心、其他）分類
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美導管鞘套市場概覽

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲導管鞘套市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區導管鞘套市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲導管鞘套市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲導管鞘套市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球導管鞘套市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Terumo Corporation
  • Merit Medical Systems, Inc.
  • Medtronic plc
  • Galt Medical Corporation
  • Cordis Corporation
  • Oscor Inc
  • Abbott Laboratories
  • Stryker Corporation
  • Becton, Dickinson and Company
  • B. Braun Interventional Systems Inc

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 21972

The Global Catheter Introducer Sheaths Market is projected to expand from USD 1.51 Billion in 2025 to USD 1.94 Billion by 2031, achieving a CAGR of 4.26%. These specialized devices are essential for creating a secure, haemostatic entry point to insert interventional tools into the vascular system. Market growth is primarily driven by the increasing global prevalence of cardiovascular diseases and a significant transition toward minimally invasive diagnostic and therapeutic treatments. This demand is further intensified by an aging global population requiring frequent vascular care; according to the American Heart Association's updated 2024 statistics, cardiovascular disease causes nearly 20 million deaths annually worldwide, underscoring the urgent need for effective procedural tools.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 1.51 Billion
Market Size 2031USD 1.94 Billion
CAGR 2026-20314.26%
Fastest Growing SegmentIntegrated Introducer Sheaths
Largest MarketNorth America

A major obstacle to market growth is the strict regulatory landscape governing medical device approvals. Manufacturers face complex compliance obligations and rigorous safety standards that elevate development costs and extend the timeline for bringing new products to market. These regulatory barriers often prevent smaller companies from entering the industry and delay the commercialization of innovative sheath technologies.

Market Driver

The Global Catheter Introducer Sheaths Market is being significantly propelled by the rising demand for large-bore sheaths in structural heart procedures. As transcatheter therapies evolve beyond aortic valve replacements to include complex mitral and tricuspid interventions, the requirement for specialized access devices has intensified. These procedures demand sheaths with larger inner diameters to accommodate advanced delivery systems while maintaining a low profile to minimize complications and ensure safe closure. This trend is evident in the sector's rapid growth; Edwards Lifesciences reported in their July 2024 results that Transcatheter Mitral and Tricuspid Therapies (TMTT) sales increased by 75% over the previous year, highlighting the surge in adoption of these catheter-based interventions.

Furthermore, technological advancements in sheath design and biocompatible materials are accelerating market expansion by enabling more complex procedures and enhancing patient safety. Manufacturers are developing sheaths with features such as hydrophilic coatings, kink-resistant braiding, and steerable tips to navigate difficult anatomies, particularly in electrophysiology and neurovascular applications. These innovations are driving revenue growth for major players; Boston Scientific's February 2025 report noted a 139% organic growth in their Electrophysiology segment for 2024, largely due to the FARAPULSE system. Similarly, Medtronic reported in May 2024 that their Cardiovascular Portfolio generated $11.8 billion in fiscal year 2024 revenue, reflecting sustained global demand for interventional tools.

Market Challenge

The growth of the Global Catheter Introducer Sheaths Market is significantly impeded by a stringent regulatory environment for medical device approvals. Manufacturers must adhere to complex compliance frameworks and rigorous safety standards, which require extensive clinical trials and detailed documentation. These mandatory processes considerably prolong the product development lifecycle, creating a bottleneck that delays the commercial release of innovative sheath technologies and prevents companies from quickly meeting market demands.

These regulatory hurdles also impose heavy financial burdens that restrict market entry and expansion. High compliance costs effectively exclude smaller enterprises that lack the capital to survive lengthy approval phases, thereby reducing competition. The impact of these costs is substantial; MedTech Europe reported in 2024 that certification and maintenance costs under the Medical Device Regulation rose by up to 100% compared to previous directives. This increase in operational expenses forces manufacturers to divert funds from research and development, stalling new product introductions and slowing overall market growth.

Market Trends

Market participants are increasingly tailoring their vascular access portfolios to suit the needs of Ambulatory Surgical Centers (ASCs), driven by the safety and cost-effectiveness of outpatient interventions. This shift creates a demand for introducer sheaths that ensure rapid hemostasis and faster patient turnaround, which are vital for ASC profitability. This structural transition supports volume growth; the Society for Cardiovascular Angiography & Interventions (SCAI) noted in a May 2025 study that ASC patient volumes for cardiac interventions are expected to rise by 21% between 2024 and 2034.

Simultaneously, the industry is transitioning toward transradial access (TRA) for vascular interventions to reduce bleeding complications and promote early ambulation. This trend necessitates the engineering of radial-specific sheaths with thinner walls and optimized hydrophilic coatings to minimize arterial spasm. This design philosophy supports the push for same-day discharge protocols. The adoption of this technique is widespread; TCTMD reported in July 2025 that radial access utilization for percutaneous coronary interventions in the U.S. has reached 57.5%, confirming its status as the dominant access strategy.

Key Market Players

  • Terumo Corporation
  • Merit Medical Systems, Inc.
  • Medtronic plc
  • Galt Medical Corporation
  • Cordis Corporation
  • Oscor Inc
  • Abbott Laboratories
  • Stryker Corporation
  • Becton, Dickinson and Company
  • B. Braun Interventional Systems Inc

Report Scope

In this report, the Global Catheter Introducer Sheaths Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Catheter Introducer Sheaths Market, By Product

  • Integrated Introducer Sheaths
  • Separable Introducer Sheaths

Catheter Introducer Sheaths Market, By End user

  • Hospitals & Clinics
  • Ambulatory Care Centers
  • Others

Catheter Introducer Sheaths Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Catheter Introducer Sheaths Market.

Available Customizations:

Global Catheter Introducer Sheaths Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Catheter Introducer Sheaths Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Product (Integrated Introducer Sheaths, Separable Introducer Sheaths)
    • 5.2.2. By End user (Hospitals & Clinics, Ambulatory Care Centers, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Catheter Introducer Sheaths Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Product
    • 6.2.2. By End user
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Catheter Introducer Sheaths Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Product
        • 6.3.1.2.2. By End user
    • 6.3.2. Canada Catheter Introducer Sheaths Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Product
        • 6.3.2.2.2. By End user
    • 6.3.3. Mexico Catheter Introducer Sheaths Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Product
        • 6.3.3.2.2. By End user

7. Europe Catheter Introducer Sheaths Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Product
    • 7.2.2. By End user
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Catheter Introducer Sheaths Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Product
        • 7.3.1.2.2. By End user
    • 7.3.2. France Catheter Introducer Sheaths Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Product
        • 7.3.2.2.2. By End user
    • 7.3.3. United Kingdom Catheter Introducer Sheaths Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Product
        • 7.3.3.2.2. By End user
    • 7.3.4. Italy Catheter Introducer Sheaths Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Product
        • 7.3.4.2.2. By End user
    • 7.3.5. Spain Catheter Introducer Sheaths Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Product
        • 7.3.5.2.2. By End user

8. Asia Pacific Catheter Introducer Sheaths Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Product
    • 8.2.2. By End user
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Catheter Introducer Sheaths Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Product
        • 8.3.1.2.2. By End user
    • 8.3.2. India Catheter Introducer Sheaths Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Product
        • 8.3.2.2.2. By End user
    • 8.3.3. Japan Catheter Introducer Sheaths Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Product
        • 8.3.3.2.2. By End user
    • 8.3.4. South Korea Catheter Introducer Sheaths Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Product
        • 8.3.4.2.2. By End user
    • 8.3.5. Australia Catheter Introducer Sheaths Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Product
        • 8.3.5.2.2. By End user

9. Middle East & Africa Catheter Introducer Sheaths Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Product
    • 9.2.2. By End user
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Catheter Introducer Sheaths Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Product
        • 9.3.1.2.2. By End user
    • 9.3.2. UAE Catheter Introducer Sheaths Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Product
        • 9.3.2.2.2. By End user
    • 9.3.3. South Africa Catheter Introducer Sheaths Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Product
        • 9.3.3.2.2. By End user

10. South America Catheter Introducer Sheaths Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Product
    • 10.2.2. By End user
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Catheter Introducer Sheaths Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Product
        • 10.3.1.2.2. By End user
    • 10.3.2. Colombia Catheter Introducer Sheaths Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Product
        • 10.3.2.2.2. By End user
    • 10.3.3. Argentina Catheter Introducer Sheaths Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Product
        • 10.3.3.2.2. By End user

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Catheter Introducer Sheaths Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Terumo Corporation
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Merit Medical Systems, Inc.
  • 15.3. Medtronic plc
  • 15.4. Galt Medical Corporation
  • 15.5. Cordis Corporation
  • 15.6. Oscor Inc
  • 15.7. Abbott Laboratories
  • 15.8. Stryker Corporation
  • 15.9. Becton, Dickinson and Company
  • 15.10. B. Braun Interventional Systems Inc

16. Strategic Recommendations

17. About Us & Disclaimer