Ureteral Access Sheath Market Size | Industry Trends [2033]

Ureteral Access Sheath Market Overview

The Ureteral Access Sheath Market size was valued at USD 1387.06 million in 2024 and is expected to reach USD 2133.45 million by 2033, growing at a CAGR of 4.9% from 2025 to 2033.

The ureteral access sheath market has experienced significant growth, driven by the increasing prevalence of urological disorders and the rising adoption of minimally invasive surgical procedures. In 2024, the global market witnessed the utilization of approximately 1.8 million units of ureteral access sheaths, marking a 12% increase compared to the previous year. This surge is attributed to the growing number of ureteroscopy and percutaneous nephrolithotomy procedures performed worldwide.

Notably, the United States accounted for over 35% of the global usage, with more than 630,000 units deployed in various urological interventions. The market comprises a diverse range of products, including varying sheath sizes and designs tailored to specific clinical needs. Advancements in sheath materials and designs have enhanced procedural efficiency and patient safety, contributing to the market's expansion.

Key Findings

Top Driver reason: The escalating prevalence of kidney stones and other urological disorders has led to an increased demand for ureteral access sheaths in minimally invasive procedures.

Top Country/Region: The United States leads the market, accounting for approximately 35% of global ureteral access sheath usage in 2024.

Top Segment: Hospitals remain the dominant application segment, representing over 70% of the total market share in 2024.

Ureteral Access Sheath Market Trends

The ureteral access sheath market is witnessing several notable trends that are shaping its growth trajectory. One significant trend is the increasing preference for single-use sheaths to minimize the risk of cross-contamination and infection. In 2024, single-use sheaths accounted for approximately 65% of the total market, reflecting a 10% increase from the previous year. This shift is driven by stringent regulatory guidelines and heightened awareness of infection control measures in healthcare settings.

Another trend is the development of sheaths with enhanced flexibility and hydrophilic coatings, facilitating easier navigation through the urinary tract and reducing patient discomfort. Manufacturers have introduced sheaths with improved kink resistance and optimal torque control, leading to a 15% reduction in procedural time and a 20% decrease in intraoperative complications.

The market is also experiencing a surge in demand for sheaths compatible with advanced imaging modalities, such as fluoroscopy and endoscopic ultrasound. In 2024, approximately 40% of newly introduced sheaths featured radiopaque markers and integrated visualization capabilities, enhancing procedural accuracy and outcomes.

Furthermore, there is a growing emphasis on the development of pediatric-specific ureteral access sheaths to cater to the unique anatomical and clinical requirements of pediatric patients. In 2024, pediatric sheaths constituted 5% of the total market, with a projected annual growth rate of 8% over the next five years.

Ureteral Access Sheath Market Dynamics

Drivers

Rising Prevalence of Urological Disorders

The increasing incidence of urological conditions, such as kidney stones, ureteral strictures, and tumors, has significantly propelled the demand for ureteral access sheaths. In 2024, over 2.5 million ureteroscopy procedures were performed globally, with ureteral access sheaths utilized in approximately 72% of these cases. The growing adoption of minimally invasive techniques, which offer reduced recovery times and lower complication rates, further underscores the importance of these devices in modern urological practice.

Restraints

High Cost of Advanced Sheaths

The elevated cost associated with technologically advanced ureteral access sheaths poses a challenge to market growth, particularly in cost-sensitive regions. In 2024, the average price of a single-use advanced sheath ranged between $150 and $250, compared to $50 to $100 for standard models. This cost disparity may limit adoption in healthcare facilities with constrained budgets, thereby impacting overall market penetration.

Opportunities

Expansion in Emerging Markets

Emerging economies present substantial growth opportunities for the ureteral access sheath market. Countries such as India, Brazil, and South Africa have witnessed a 20% increase in urological procedures over the past year, driven by improving healthcare infrastructure and rising awareness of minimally invasive treatments. Manufacturers are increasingly focusing on these markets by offering cost-effective solutions and establishing local distribution networks to enhance accessibility.

Challenges

Regulatory Hurdles

Stringent regulatory requirements for medical devices can impede the timely introduction of innovative ureteral access sheaths. In 2024, the average time for regulatory approval of new sheath designs extended up to 18 months in certain regions, delaying market entry and affecting the competitive landscape. Navigating complex regulatory frameworks necessitates significant investment in compliance and clinical validation, posing challenges for manufacturers, especially smaller enterprises.

Ureteral Access Sheath Market Segmentation

By Type

Fr Below 10: Sheaths with a French size below 10 are primarily utilized in pediatric and anatomically challenging cases. In 2024, this segment accounted for 25% of the total market, with approximately 450,000 units sold globally. The demand is driven by the need for minimally invasive solutions in delicate anatomical scenarios.
Fr 10-12: This segment represents the most commonly used sheath sizes, suitable for a wide range of urological procedures. In 2024, Fr 10-12 sheaths constituted 50% of the market, with over 900,000 units deployed worldwide. Their versatility and compatibility with various endoscopic instruments contribute to their widespread adoption.
Fr 13-15: Larger sheaths in the Fr 13-15 range are employed in complex procedures requiring the passage of larger instruments. In 2024, this segment held a 25% market share, with approximately 450,000 units utilized globally. Advancements in sheath design have improved maneuverability and reduced patient discomfort, enhancing their clinical utility.

By Application

Clinic: Ambulatory surgical centers and specialized urology clinics accounted for 30% of the ureteral access sheath market in 2024, with around 540,000 units used. The increasing preference for outpatient procedures and the availability of cost-effective sheath options have fueled growth in this segment.
Hospital: Hospitals remain the primary end-users, representing 70% of the market in 2024, with over 1.26 million units deployed. The comprehensive range of urological services offered in hospital settings, coupled with the availability of advanced imaging and surgical equipment, supports the dominant position of this segment.

Ureteral Access Sheath Market Regional Outlook

North America

leads the ureteral access sheath market, accounting for 40% of global usage in 2024, with approximately 720,000 units utilized. The United States is the primary contributor, driven by a high prevalence of urological disorders, advanced healthcare infrastructure, and the presence of key market players.

Europe

holds a 30% market share in 2024, with around 540,000 units used. Countries such as Germany, France, and the United Kingdom are significant contributors, supported by well-established healthcare systems and a growing adoption of minimally invasive surgical techniques.

Asia-Pacific

The region accounts for 20% of the market in 2024, with approximately 360,000 units utilized. Rapidly developing healthcare infrastructure, increasing awareness of advanced urological treatments, and rising disposable incomes in countries like China and India are driving market growth.

Middle East & Africa

Representing 10% of the market in 2024, the region utilized around 180,000 units. Improving access to healthcare services and a growing focus on enhancing surgical capabilities are contributing to the steady expansion of the market in this region.

List of Top Ureteral Access Sheath Companies

Boston Scientific
Cook Medical
COLOPLAST
Olympus
C.R.
Bard
Applied Medical
Richard Wolf

Top Two Companies with the Highest Share

Boston Scientific: Holding a significant market share, Boston Scientific's ureteral access sheaths are widely adopted due to their advanced design features and compatibility with various endoscopic instruments.

Cook Medical: As a leading player, Cook Medical offers a comprehensive range of ureteral access sheaths known for their durability and ease of use, contributing to their substantial presence in the global market.

Investment Analysis and Opportunities

Investments in the ureteral access sheath market are being driven by the increasing prevalence of urological disorders and the demand for minimally invasive surgical procedures. In 2024, the global market witnessed the utilization of approximately 1.8 million units of ureteral access sheaths, marking a 12% increase compared to the previous year. This growth is attributed to the rising number of ureteroscopy and percutaneous nephrolithotomy procedures performed worldwide.

Advancements in sheath materials and designs have enhanced procedural efficiency and patient safety, contributing to the market's expansion. The development of sheaths with enhanced flexibility and hydrophilic coatings facilitates easier navigation through the urinary tract and reduces patient discomfort. Manufacturers have introduced sheaths with improved kink resistance and optimal torque control, leading to a 15% reduction in procedural time and a 20% decrease in intraoperative complications.

New Product Development

Innovation in the ureteral access sheath market is focused on enhancing device performance and patient outcomes. One significant development is the increasing preference for single-use sheaths to minimize the risk of cross-contamination and infection. In 2024, single-use sheaths accounted for approximately 65% of the total market, reflecting a 10% increase from the previous year. This shift is driven by stringent regulatory guidelines and heightened awareness of infection control measures in healthcare settings.

Manufacturers are also developing sheaths compatible with advanced imaging modalities, such as fluoroscopy and endoscopic ultrasound. In 2024, approximately 40% of newly introduced sheaths featured radiopaque markers and integrated visualization capabilities, enhancing procedural accuracy and outcomes.

Additionally, the market is experiencing a surge in demand for sheaths with enhanced flexibility and hydrophilic coatings, facilitating easier navigation through the urinary tract and reducing patient discomfort. These advancements have led to a 15% reduction in procedural time and a 20% decrease in intraoperative complications.

There is also a growing emphasis on the development of pediatric-specific ureteral access sheaths to cater to the unique anatomical and clinical requirements of pediatric patients. In 2024, pediatric sheaths constituted 5% of the total market, with a projected annual growth rate of 8% over the next five years.

Five Recent Developments

Boston Scientific launched a new line of ureteral access sheaths with integrated radiopaque markers, enhancing visualization during procedures.
Cook Medical introduced a sheath with improved hydrophilic coating, reducing insertion force by 25% and minimizing patient discomfort.
Coloplast developed a pediatric-specific ureteral access sheath, addressing the unique anatomical needs of younger patients.
Olympus released a sheath compatible with endoscopic ultrasound, allowing for real-time imaging and improved procedural accuracy.
Well Lead Medical expanded the distribution of its ClearPetra ureteral access sheath to over 700 Grade III Level A hospitals across China, reflecting its growing market presence.

Report Coverage of Ureteral Access Sheath Market

The ureteral access sheath market report provides a comprehensive analysis of the current market landscape, including product types, applications, and regional outlook. It covers the utilization of approximately 1.8 million units of ureteral access sheaths in 2024, marking a 12% increase compared to the previous year. The report examines the factors driving this growth, such as the rising prevalence of urological disorders and the increasing adoption of minimally invasive surgical procedures.

Segmentation analysis includes detailed insights into sheath sizes (Fr Below 10, Fr 10-12, Fr 13-15) and applications (Clinic, Hospital). The report highlights the dominance of hospitals in the market, representing over 70% of the total market share in 2024, with over 1.26 million units deployed.

Regional analysis focuses on key markets, including North America, Europe, Asia-Pacific, and the Middle East & Africa. North America leads the ureteral access sheath market, accounting for 40% of global usage in 2024, with approximately 720,000 units utilized. The report also discusses the growing emphasis on the development of pediatric-specific ureteral access sheaths to cater to the unique anatomical and clinical requirements of pediatric patients.

The report provides insights into the competitive landscape, profiling major players such as Boston Scientific, Cook Medical, Coloplast, Olympus, and Well Lead Medical. It examines recent product launches, technological advancements, and strategic initiatives undertaken by these companies to strengthen their market position.