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U.S. Ureteral Access Sheath Market Revenue Analysis and Forecast 2035

According to Shivani Zoting, who specializes in medical devices, urology technologies, and healthcare market intelligence, with 5+ years of experience in market research and industry analysis. My research indicates that the U.S. ureteral access sheath market is set for steady expansion, growing from USD 235.84 million in 2026 to USD 440.93 million by 2035 at a CAGR of 7.2%, supported by rising kidney stone procedures and increasing adoption of minimally invasive urological interventions. The analysis highlights strong demand for hydrophilic-coated, polymer-based, and single-use ureteral access sheaths, while kidney stone management remains the leading application segment. Across the United States, advancements in suction-assisted and pressure-controlled technologies continue to shape product development, with companies such as Boston Scientific, BD, Applied Medical Resources, Merit Medical Systems, Rocamed, and Well Lead Medical driving competitive activity and innovation within the market.

Last Updated : 23 June 2026 Category: Medical Devices Insight Code: 6796 Format: PDF / PPT / Excel
Revenue, 2025
USD 220 Million
Forecast, 2035
USD 440.93 Million
CAGR, 2026-2035
7.2%
Report Coverage
United States

The U.S. ureteral access sheath market size was estimated at USD 220 million in 2025 and is predicted to increase from USD 235.84 million in 2026 to approximately USD 440.93 million by 2035, expanding at a CAGR of 7.2% from 2026 to 2035. The U.S. ureteral access sheath market is growing due to the growing prevalence of kidney stones, the modification to minimally invasive technology, the growth in outpatient care, and better-quality patient safety.

U.S. Ureteral Access Sheath Market Size is USD 235.84 Million in 2026.

Key Takeaways

  • The United States ureteral access sheath market will likely exceed USD 235.84 million by 2026.
  • Valuation is projected to hit USD 440.93 million by 2035.
  • Estimated to grow at a CAGR of 7.2% starting from 2026 to 2035.
  • By product type, the hydrophilic-coated ureteral sheaths segment held 42% market share in 2025 and is expected to grow at the fastest CAGR of 7.50% during the forecast period.
  • By material, the polymer-based sheaths segment held the largest market share of 55% in 2025.
  • By material, the hybrid materials segment held the second-largest market share of 25% in 2025, and is expected to grow at the fastest CAGR of 7.10% during the forecast period.
  • By usage, the disposable (single-use) segment held the largest U.S. ureteral access sheath market share of 70% in 2025 and is expected to grow at the highest CAGR of 7.60% during the forecast period.
  • By application, the kidney stone management segment held the largest market share of 65% in 2025, and is expected to grow at the highest CAGR of 7.30% during the forecast period.
  • By distribution channel, the direct sales segment held the largest market share of 50% in 2025.
  • By distribution channel, the online sales segment held a notable market share of 15% in 2025 and is estimated to be the fastest growing with a CAGR of 8.10% during the forecast period.

Market Overview: What is the U.S. Ureteral Access Sheath?

The U.S. ureteral access sheath market is growing, as this type of sheath (UASs) is part of a urologist's armamentarium when performing retrograde intrarenal surgery (RIRS). Ureteral access sheaths (UASs) are applied to protect the FURS scope and lower intrarenal pressure. UASs through suction functionality are progressively used during FURS. Ureteral access sheath is a specialized tool applied during ureteroscopic and retrograde intrarenal operations. It offers an incessant access channel to the ureter and kidney, enabling safe passage of flexible tools. This sheath supports lowers trauma and maintains consistent dilation through the technology. They became broadly adopted in the 2000s as flexible ureteroscopes increased in popularity. The ureteral access sheath is a significant device in modern endourological technology, offering a balance of access, safety, and control for urologists.

How is AI governing the U.S. Ureteral Access Sheath Market?

AI-driven technology in the U.S. ureteral access sheath provides planning, execution, and postoperative assessment, which optimizes stone targeting, enhances navigation, and elevates overall action precision. The continuing development of these technologies is completed by the entrance of AI-based technology into urological procedures. AI-based systems analyse 2D fluoroscopic images to reconstruct 3D replicas of the ureter for advanced navigation and planning. AI-based support to minimize the challenges of post-operative infectious complications such as urosepsis and renal injury.

Future Outlook & Trends in the U.S. Ureteral Access Sheath Market

  • Suction-Based Technology (FANS): Using suction ureteral access sheaths (SUASs) while endoscopic stone surgery enhances short-term stone-free rates (SFRs), cuts surgical time, and reduces overall complication rates.
  • Pressure-Controlled Systems: Negative pressure UAS utilizes negative pressure suction to improve drainage, irrigation fluid, and attract stones, therefore lowering renal pelvic pressure. These technologies aim to maintain intrarenal pressure (IRP) below the 30 mmHg safety threshold.
  • Applications of Ureteral Access Sheath in Paediatric Treatment: The adoption of ureteral access sheaths (UAS) simplifies the passage to the paediatric ureter and lowers the challenges of ureteral complexities. Paediatric-specific projects in Ureteral Access Sheaths (UAS) are plotted to address the exclusive anatomical risk of children, such as narrower ureteral calibers and fragile materials

Key Indicators and Highlights

Table Scope
Market Size in 2026 USD 235.84 Million
Projected Market Size in 2035 USD 440.93 Million
CAGR (2026 - 2035) 7.2%
Key Applications Kidney stone management, ureteroscopy, laser lithotripsy, retrograde intrarenal surgery (RIRS), diagnostic ureteroscopy, ureteral tumor biopsy
Primary End Users Hospitals, Ambulatory Surgery Centers (ASCs), Specialty Urology Clinics
Key Challenges Ureteral injury risks, pricing pressure, reimbursement constraints, physician preference variability, regulatory requirements
Measurable Values USD Millions/Units/Volume
Market Segmentation By Product Type, By Material, By Size (Diameter), By Length, By End User, By Usage, By Application, By Distribution Channel
Top Key Players Applied Medical Resources Corporation, BD, Merit Medical Systems, Inc., Boston Scientific Corporation, Rocamed, Well Lead Medical

Segmentation Analysis

By Product Type Insights

U.S. Ureteral Access Sheath Market Segmentation By Product

The Hydrophilic-Coated Ureteral Access Sheaths Segment Led the U.S. Ureteral Access Sheath Market in 2025

Segment Share 2025 (%)
Standard Ureteral Access Sheaths 38%
Hydrophilic Coated Ureteral Access Sheaths 42%
Dual-Lumen Ureteral Access Sheaths 20%

The hydrophilic-coated ureteral access sheaths segment held 42% share of the U.S. ureteral access sheath market in 2025, and is estimated to grow at the highest CAGR of 7.50% as hydrophilic coating allows smooth insertion and negligible trauma. Hydrophilic coatings substantially lower the friction between the sheath and ureteral walls, enhancing insertion smoothness and patient comfort.

The standard ureteral access sheaths segment held 38% in 2025, as it offers a pathway for the entry of the ureteroscope and drainage in the ureter, helping in determining the aforementioned challenges. It allows multiple ureteral passes, enhancing time effectiveness and procedural standardization in stone management. The S-UAS facilitates effective stone dust evacuation, enhances immediate clinically acceptable SFRs, and lowers auxiliary technology rates without growing complications.

Whereas the dual-lumen ureteral access sheaths segment held a notable share of 20% in the market in 2025, as a dual-lumen catheter intended for over-the-wire placement, offering two separate working channels for second wire placement or injection. It provides simple access for delivering irrigation fluid and contrast media into the renal cavities while using ureteroscopy technology by keeping the guidewire in place.

By Material Insights

U.S. Ureteral Access Sheath Market Segmentation By Material

Polymer-based Sheaths Segment Led the U.S. Ureteral Access Sheath Market in 2025

Segment Share 2025 (%)
Polymer-based Sheaths 55%
Silicone-based Sheaths 20%
Hybrid Materials 25%

The polymer-based sheaths segment captured the largest market share of approximately 55% in 2025, as polyolefin sheath materials offer numerous benefits, including durability, chemical resistance, flexibility, thermal stability, electrical insulation properties, environmental resistance, cost-effectiveness, safety, and versatility. These advantages make them an excellent choice for protecting and insulating cables in various applications.

The hybrid materials segment held the second largest share of approximately 25% of the U.S. ureteral access sheath market in 2025, and is expected to grow at a CAGR of 7.10% during the predicted time as it enhances the balance among insertion safety, navigating challenging anatomy, and increasing surgical efficiency. The applications of ureteral access sheaths (UAS) improve both access and the process's efficiency. It offers major benefits such as lessening of intrarenal pressure, lowering the risk of infection, enhanced irrigation and drainage, and improved visualization during stone retrieval.

Whereas the silicone-based sheaths segment held a notable share of 20% in the market in 2025, as silicone is a super smooth material with an increasing degree of flexibility, making insertion easy and leading to less irritation to the urethra. They have minimal encrustation as compared to latex and are more tissue-friendly.

By Usage Insights

The Disposable (single-use) Segment held the Largest Share in the Market in 2025

Segment Share 2025 (%)
Disposable (Single-use) 70%
Reusable 30%

The disposable (single-use) segment contributed the largest market share of approximately 70% in 2025, and is expected to grow at the highest CAGR of 7.60% during the forecast period, as disposable ureteral access sheaths (UAS) are significant tools in modern retrograde intrarenal surgery (RIRS), intended to simplify safe and well-organized access to the upper urinary tract. It has evolved as a less invasive substitute to percutaneous nephrolithotomy while handling larger renal stones.

The reusable segment held the second largest share of 30% of the U.S. ureteral access sheath market in 2025. Reusable laparoscopic tools substantially lower the expenses of laparoscopic operations, without compromising the safety of patients and healthcare personnel. Reusables provide significant long-standing cost savings, particularly in amenities with specialized or lower-volume technology.

By Application Insights

The Kidney Stone Management Segment held the Largest Share of the Market in 2025

Segment Share 2025 (%)
Kidney Stone Management 65%
Ureteral Stricture Management 20%
Diagnostic Procedures 15%

The kidney stone management segment contributed the largest market share of approximately 65% in 2025, and is estimated to grow at a CAGR of 7.30% during 2026-2035 as applications of UAS for renal stones are safe with no intra-operative challenges. Ureteral access sheaths allow multiple ureteral passes, enhancing time effectiveness and technical standardization in stone management. The flexible vacuum-driven ureteral access sheath integrated with a flexible ureteroscope is effective in the treatment of large renal stones over 3 cm.

The ureteral stricture management segment held the second largest share of 20% of the U.S. ureteral access sheath market in 2025, as it offers an opportunity for the entry of the ureteroscope and drainage in the ureter, assisting in undertaking the aforementioned challenges. It enhances intraoperative visibility and lowers postoperative difficulties.

Whereas the diagnostic procedures segment held a notable share of 15% in the market in 2025, as the ureteral access sheath helps to better irrigation flow and lowers intrarenal pressure during complex stone removal technology. Facilitating easy and safe access during ureteroscopy and RIRS measures.

By Distribution Channel Insights

The Direct Sales Segment held the Largest Share of the Market in 2025

Segment Share 2025 (%)
Direct Sales 50%
Distributors 35%
Online Sales 15%

The direct sales segment contributed the largest market share of 50% in 2025, as the direct sales approach enables businesses to engage customers without intermediaries, allowing for greater control over the sales process, pricing, and customer relationships. Direct sales typically possess more control over prices because these companies don't require wholesalers and retailers or store spaces.

The distributors segment held the second largest share of 35% of the U.S. ureteral access sheath market in 2025, as distributors provide designed, local sales teams who offer immediate technical help and training to physicians, which is significant for the acceptance of specialized devices such as suction-enabled or tip-bendable UAS.

Whereas the online sales segment held a notable share of approximately 15% of the market in 2025, and is estimated to achieve the highest growth rate of 8.10%, because it provides major advantages, such as saving time and expenses, and having access to a broad range of ureteral products. Online sales of healthcare devices that provide remote patient monitoring. It is also beneficial because it provides a significant level of convenience.

Market Ecosystem Analysis

Ecosystem Segment Key Participants Role in Market
Technology Providers Boston Scientific, Olympus, BD, Cook Medical Design and development of access sheath technologies, coatings, materials, and procedural innovations
Product Manufacturers Boston Scientific, Cook Medical, Olympus, Coloplast, BD, Richard Wolf Manufacturing and commercialization of ureteral access sheaths
Service Providers Hospitals, ASCs, Urology Centers Clinical utilization during ureteroscopy and stone removal procedures
Platform Providers Olympus, Boston Scientific, Richard Wolf, Karl Storz Integrated endourology platforms combining ureteroscopes and access devices
CROs / Clinical Research Organizations IQVIA, ICON, Parexel Support clinical studies and regulatory validation of urology devices
Software Vendors Olympus Digital Solutions, Boston Scientific Digital Health Platforms Procedure workflow and imaging integration
Research Institutions Mayo Clinic, Cleveland Clinic, Johns Hopkins Medicine Clinical research and evaluation of endourology technologies
End-User Industries Hospitals, Ambulatory Surgery Centers, Specialty Urology Practices Final purchasers and users of UAS products

Supply Chain Analysis

R&D:

  • Research and development (R&D) for U.S. ureteral access sheath involves design and product development, testing and mechanical benchmarking, clinical and regulatory services, and specialized engineering support.
  • Key Players: Boston Scientific Corporation and Cook Medical  

Manufacturing Processes:

  • Manufacturing processes in the U.S. ureteral access sheath involve tube extrusion, reinforcement, tip and hub assembly, surface coating, sterilization, and packaging.
  • Key Players: Coloplast Corp and Olympus Corporation

Patient Services:

  • Patient services of U.S. ureteral access sheath, including improving safety, lowering operative time, and reducing challenges during retrograde intrarenal surgery (RIRS) and ureteroscopy, are characteristic of kidney stone management.
  • Key Players: Teleflex Incorporated and Karl Storz Endoscopy GmbH

Latest Updates of Key Players in the U.S. Ureteral Access Sheath Market

U.S. Ureteral Access Sheath Market Companies are Applied Medical Resources Corporation, BD, Merit Medical Systems, Inc., Boston Scientific Corporation

Market Share Influence Assessment

  Tier 1 Tier 2 Tier 3
Typical Market Influence 72% 20% 8%

Competitive Landscape

Tier 1
Company Name Headquarters Country Why Relevant to This Market Key Products/Services
Boston Scientific Corporation Marlborough, Massachusetts USA Market leader with extensive endourology portfolio and Navigator UAS family Navigator™ Ureteral Access Sheath, Navigator™ HD UAS 
Cook Medical Bloomington, Indiana USA Long-established leader in stone management and ureteral access technologies Flexor® Ureteral Access Sheaths
Olympus Corporation Tokyo Japan Major U.S. endourology presence and integrated ureteroscopy ecosystem Ureteroscopy systems and access sheaths
Tier 2
Company Name Headquarters Country Why Relevant to This Market Key Products/Services
Richard Wolf GmbH Knittlingen Germany Leading endourology equipment manufacturer Endoscopic urology access solutions
Applied Medical Resources Corporation Rancho Santa Margarita, California USA Active in minimally invasive surgical access technologies Urology procedural access devices
Rocamed SAM Monaco Monaco Strong European and growing U.S. urology footprint Ureteral access and stone management devices
Tier 3
Company Name Headquarters Country Why Relevant to This Market Key Products/Services
AMECATH Cairo Egypt Growing international urology device supplier Ureteral access sheaths
ACE Medical Devices Seoul South Korea Specialized disposable urology devices Access sheath portfolio
SCW Medicath Ltd Shenzhen, Guangdong China Emerging global exporter of urology consumables UAS and stone management products

SWOT Analysis

Strengths

  • The applications of UAS demonstrated several benefits to facilitate retrograde intrarenal access, reduce intrarenal pressure, protect the ureter, protect the scope, and expedite stone extraction. 
  • Ureteral access sheaths allow multiple ureteral passes, enhancing time efficiency and procedural standardization in stone treatment.

Weaknesses

  • The insertion of the UAS causes mucosal injuries, edema, or even complete perforation and avulsion of the ureter.

Opportunities

  • Advances in flexible ureteroscopes (fURS) and high-power holmium lasers (HPHL) systems have prolonged indications, making retrograde intrarenal surgery (RIRS) the preferred strategy for complex upper urinary tract stones
  • The S-UAS allows effective stone dust evacuation, enhances immediate clinically acceptable SFRs, and lowers auxiliary procedure rates without increasing challenge.

Threats

  • Major disadvantages are potential ureteral wall injury, insertion failure in thin ureters, and the trouble of balancing sheath size.

Recent Developments in the U.S. Ureteral Access Sheath Market

  • In October 2025, Dornier MedTech America (DMTA) launched in the United States its Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Dornier Axis II Slim single-use ureteroscope with a 5.6Fr. distal tip. Both products were cleared by the U.S. Food and Drug Administration.
  • In September 2025, Dornier MedTech America (DMTA) announced the full U.S. commercial launch of its Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Dornier Axis II Slim single-use ureteroscope with a 5.6Fr. distal tip.
  • In September 2025, Calyxo, Inc., a healthcare tools organization advancing innovative solutions for kidney stone treatment, today announced the launch of Reverse Deflection on its second-generation CVAC System, an improvement that empowers endourologists to perform the SURE technology using their preferred steering mode.

Segments Covered in the Report

By Product Type

  • Standard Ureteral Access Sheaths
    • Single-use Standard Sheaths
    • Reusable Standard Sheaths
  • Hydrophilic Coated Ureteral Access Sheaths 
    • Fully Hydrophilic Coated
    • Partially Hydrophilic Coated
  • Dual-Lumen Ureteral Access Sheaths
    • Active Irrigation Sheaths
    • Passive Irrigation Sheaths

By Material

  • Polymer-based Sheaths
    • Polyurethane
    • Pebax (Polyether Block Amide)
  • Silicone-based Sheaths
  • Hybrid Materials
    • Polymer + Metal Reinforcement

By Size (Diameter)

  • Small Diameter (≤10/12 Fr)
  • Medium Diameter (11/13–12/14 Fr)
  • Large Diameter (≥13/15 Fr)

By Length

  • Short Length (<25 cm)
  • Medium Length (25–35 cm)
  • Long Length (>35 cm)

By End User

  • Hospitals
    • Large Hospitals
    • Mid-size Hospitals
  • Ambulatory Surgical Centers (ASCs)
  • Specialty Clinics
    • Urology Clinics

By Usage

  • Disposable (Single-use)
  • Reusable

By Application

  • Kidney Stone Management
    • Flexible Ureteroscopy
    • Laser Lithotripsy
  • Ureteral Stricture Management
  • Diagnostic Procedures

By Distribution Channel

  • Direct Sales
  • Distributors
  • Online Sales

FAQ's

Finding : The U.S. ureteral access sheath market stands at USD 235.84 million in 2026 and is expected to reach USD 440.93 million by 2035, growing at a CAGR of 7.2% from 2026 to 2035.

Finding : Ministry of Health and Family Welfare, Government of India; National Institutes of Health, FDA, WHO, PIB, CDC.

Finding : Major future trends include Suction-based ureteral access sheath technology, Pressure-controlled systems to reduce complications, Expansion of pediatric applications

Tags

Meet the Team

Shivani Zoting

Shivani Zoting

Principal Consultant

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting
Aditi Shivarkar

Aditi Shivarkar

Reviewed By

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi ensures the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar
U.S. Ureteral Access Sheath Market
Updated Date: 23 June 2026   |   Report Code: 6796