Catheter Introducer Sheaths Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

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.

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 Drivers

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 Challenges

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 Players Profiled in the Catheter Introducer Sheaths Market

• 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:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

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

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