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市场调查报告书
商品编码
1967726

导管导入鞘套市场－全球产业规模、份额、趋势、机会、预测：按产品、最终用户、地区和竞争对手划分，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个工作天内

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简介目录

全球导管插入鞘套市场预计将从 2025 年的 15.1 亿美元成长到 2031 年的 19.4 亿美元，复合年增长率达到 4.26%。

这些专用器械对于确保介入器械安全有效地插入血管系统至关重要。市场成长的主要驱动因素是全球心血管疾病盛行率的不断上升以及微创诊断和治疗方法的显着转变。此外，全球人口老化导致血管照护需求日益增长，也进一步推动了这项需求。根据美国心臟协会 (AHA) 最新发布的 2024 年统计数据，心血管疾病每年在全球造成约 2,000 万人死亡，凸显了对高效介入器械的迫切需求。

市场概览
预测期 2027-2031
市场规模：2025年 15.1亿美元
市场规模：2031年 19.4亿美元
复合年增长率：2026-2031年 4.26%
成长最快的细分市场 一体式导引鞘
最大的市场 北美洲

市场成长的主要障碍是医疗设备认证方面严格的监管环境。製造商面临复杂的合规义务和严格的安全标准，这增加了研发成本，并延长了新产品的上市时间。这些监管壁垒常常阻碍小规模企业进入该行业，并延缓了创新型鞘套技术的商业化进程。

市场驱动因素

结构性心臟病治疗领域对大口径鞘套的需求不断增长，是全球导管鞘鞘套市场的主要驱动力。随着经导管治疗从主动脉瓣置换术发展到复杂的二尖瓣和三尖瓣手术，对专用介入器材的需求也日益增长。这些治疗需要更大口径的鞘套，以便容纳先进的输送系统，同时保持低轮廓设计，从而最大限度地减少併发症并确保安全闭合。这一趋势在行业的快速成长中得到了清晰的体现。爱德华生命科学公司在2024年7月的财报中指出，经导管二尖瓣和三尖瓣治疗（TMTT）的销售额年增了75%，凸显了这些基于导管的介入治疗技术的广泛应用。

此外，鞘套设计和生物相容性材料的技术进步正在加速市场扩张，使更复杂的手术成为可能，并提高病患安全性。製造商正在开发具有亲水涂层、抗弯曲编织层和可操控鞘套等特性的鞘管，以便在复杂的解剖结构中进行操作，尤其是在电生理和神经血管领域。这些创新正在推动主要企业的收入成长。波士顿科学公司2025年2月的报告指出，其电生理部门在2024财年实现了139%的内部成长，主要得益于FARAPULSE系统的推动。同样，Medtronic在2024年5月的报告显示，其心血管产品组合在2024财年创造了118亿美元的收入，反映出全球对介入器材的持续需求。

市场挑战

医疗设备认证的严格法规环境严重阻碍了全球导管鞘套市场的成长。製造商必须遵守复杂的合规框架和严格的安全标准，这需要进行大规模临床试验并提交详细的文件。这些必要的流程显着延长了产品开发週期，造成了瓶颈，延缓了创新鞘套技术的商业化进程，并阻碍了企业快速回应市场需求。

这些监管障碍也造成了沉重的财务负担，限制了市场准入和扩张。高昂的合规成本实际上将缺乏资金来应对漫长核可阶段的中小型企业拒之门外，削弱了市场竞争。这些成本的影响巨大；根据 MedTech Europe 在 2024 年的报告显示，医疗设备法规 (MDR) 下的认证和维修成本比先前的指令高出 100%。营运成本的增加迫使製造商转移研发资金，导致新产品推出停滞不前，并减缓了整体市场成长。

市场趋势

受门诊手术安全性和成本效益的驱动，市场参与企业正在加强其血管通路产品组合，以满足门诊手术中心 (ASC) 的需求。这种转变催生了对能够快速止血和提高患者周转率的导引鞘的需求，而这对于门诊手术中心的盈利至关重要。这种结构性转变正在推动市场规模的成长。美国心血管血管造影术和介入学会 (SCAI) 在 2025 年 5 月的一项研究中预测，2024 年至 2034 年间，门诊手术中心接受心臟介入治疗的患者数量将增加 21%。

同时，为了减少出血併发症并促进早期活动，血管介入治疗中经桡动脉入路（TRA）的应用日益增加。这一趋势要求开发壁更薄、亲水涂层更优化的桡动脉专用鞘套，以最大程度地减少动脉痉挛。这种设计理念有助于推进当日出院通讯协定。该技术的应用已十分广泛。 2025年7月，TCTMD报告称，美国经皮冠状动脉介入治疗（PCI）中桡动脉入路的使用率已达到57.5%，巩固了其作为主要入路策略的地位。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球导管鞘套市场展望

  • 市场规模及预测
    • 按金额
  • 市占率及预测
    • 产品类型（一体成型导管插入鞘套，分离式导管插入鞘套）
    • 依最终使用者（医院/诊所、门诊中心、其他）划分
    • 按地区
    • 按公司（2025 年）
  • 市场地图

第六章：北美导管鞘套市场概览

  • 市场规模及预测
  • 市占率及预测
  • 北美洲：国别分析
    • 我们
    • 加拿大
    • 墨西哥

第七章：欧洲导管鞘套市场展望

  • 市场规模及预测
  • 市占率及预测
  • 欧洲：国别分析
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙

第八章：亚太地区导管鞘套市场展望

  • 市场规模及预测
  • 市占率及预测
  • 亚太地区：国别分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳洲

第九章：中东和非洲导管鞘套市场展望

  • 市场规模及预测
  • 市占率及预测
  • 中东与非洲：国别分析
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 南非

第十章：南美洲导管鞘套市场展望

  • 市场规模及预测
  • 市占率及预测
  • 南美洲：国别分析
    • 巴西
    • 哥伦比亚
    • 阿根廷

第十一章 市场动态

  • 促进因素
  • 任务

第十二章 市场趋势与发展

  • 併购
  • 产品发布
  • 近期趋势

第十三章：全球导管鞘套市场：SWOT分析

第十四章：波特五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的议价能力
  • 顾客权力
  • 替代品的威胁

第十五章 竞争格局

  • 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

第十六章 策略建议

第十七章：关于研究公司及免责声明

简介目录
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

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