Report Highlights

Single-Use Endoscopy in the United States: Market Overview

The United States is the largest single-use endoscope market globally, holding roughly 40 percent of worldwide revenue in 2024. Demand concentrates in urology, pulmonology and gastroenterology, where reusable instruments carry high repair and reprocessing costs. Unlike European markets shaped by public tenders, U.S. adoption is decided hospital by hospital through value analysis committees and group purchasing contracts. Ambulatory surgical centers and office-based practices now represent the fastest-growing buyer group, since they operate without the sterile processing departments that hospitals rely on.

The market totaled USD 1.18 billion in 2024 and is projected to reach USD 2.32 billion by 2032, a CAGR of 8.8 percent. Ureteroscopes represent the largest product category by revenue, followed by bronchoscopes, which benefit from Ambu's aScope Broncho platform and Medicare coverage of bronchoscopic procedures. Competition is consolidated, with Ambu, Boston Scientific and Olympus holding the majority of installed disposable capacity. Pricing is set per instrument on annual contracts rather than spot purchases, which locks in incumbents for three to five years.

Growth Drivers Behind U.S. Single-Use Endoscopes

Infection-prevention rules have sharpened scrutiny of reusable instruments since FDA's 2015 safety communication on duodenoscope transmission of carbapenem-resistant Enterobacteriaceae. The agency's Safer Technologies Program, which prioritizes devices that reduce patient risk, has pushed hospitals to evaluate disposable alternatives. Joint Commission and CDC reprocessing guidance further raises the compliance cost of maintaining reusable fleets. Hospitals now budget for these scopes as a patient-safety expense rather than a discretionary capital item.

Demographics expand procedure volume directly. The National Institute of Diabetes and Digestive and Kidney Diseases estimates that about 1 in 11 Americans will have kidney stones at some point, and the 65-and-older population will grow by more than 9 million people between 2024 and 2030. CMS's annual Ambulatory Surgical Center Covered Procedures List updates also move endoscopic urology and pulmonary procedures into outpatient settings, creating new per-procedure disposable demand.

Market Restraints and Entry Barriers

Per-unit cost remains the central barrier. Disposable ureteroscopes typically cost hospitals several hundred to over one thousand dollars per use, forcing value analysis committees to justify each conversion against reusable repair contracts. Medicare's Outpatient Prospective Payment System bundles most endoscopic procedure payments, so hospitals absorb single-use costs without a separate reimbursement line. Incumbent Olympus and Karl Storz reusable fleets, already amortized on hospital balance sheets, lower the effective switching cost of staying put.

Regulatory and supply-chain barriers compound the problem. Each new disposable scope requires FDA 510(k) clearance under 21 CFR 876.1500, a process that adds months to launch timelines for new entrants. Incumbents also secure exclusive distribution and group purchasing terms, leaving new suppliers to compete on price for secondary contracts. Environmental pressure is rising as well, since hospitals face medical-waste disposal costs for single-use plastics.

Market Opportunities in the United States

Ambulatory surgical centers offer the most accessible near-term entry point. Office-based urology and ASC procedures lack sterile processing infrastructure, making single-use scopes operationally simpler. Buyers in this channel represent an addressable segment estimated at roughly USD 310 million in 2024, growing faster than hospital demand as CMS adds endoscopic procedures to the ASC list. Direct-to-clinic distribution avoids group purchasing gatekeeping and rewards suppliers that offer per-procedure billing support.

Pulmonology presents the second opportunity, with lung nodule and cancer diagnostics expanding bronchoscopy volumes. Appalachian and Southeastern hospitals, where chronic obstructive pulmonary disease rates are highest, offer concentrated demand for low-cost single-use bronchoscopes. Entrants that partner with rural health systems can access volumes that large academic centers do not sell into, with lower contract competition.

Market at a Glance

Leading Market Participants

• Ambu A/S
• Boston Scientific
• Olympus Corporation
• Karl Storz
• Medtronic
• Cook Medical
• Stryker
• Endo International
• Conmed Corporation
• Richard Wolf

Regulatory and Policy Environment

FDA regulates disposable endoscopes as Class II devices, typically through 510(k) premarket notification under 21 CFR 876.1500, with MDUFA V setting review performance goals. Manufacturers must also comply with the Quality Management System Regulation, which aligns with ISO 13485 and takes effect in February 2026. Post-market surveillance follows Medical Device Reporting requirements under 21 CFR Part 803, with reports due within 30 days of awareness of a reportable event.

CMS sets outpatient payment through the Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center payment system, updated annually in final rules published each November. Hospitals can apply for New Technology Add-On Payments under Section 1886(d)(5)(K), which reimburse up to 65 percent of eligible device costs above the standard DRG payment. Entrants should budget 12 to 18 months from submission to first U.S. revenue.

Long-Term Outlook for Single-Use Endoscopy in the United States

By 2032 the U.S. market will reach USD 2.32 billion, with disposable ureteroscopes and bronchoscopes accounting for most incremental growth. Hospitals will standardize on hybrid fleets, retaining reusable colonoscopes and gastroscopes for high-volume gastroenterology while shifting urology and pulmonology to single-use. Unit prices will decline as domestic manufacturing and sterilization scale improve, though total spend will rise.

The competitive map will shift toward ambulatory channels and integrated supply contracts. Suppliers that bundle scopes with service agreements and billing support will capture share from incumbents that compete on instrument price alone. Regulatory exposure will also shift as the QMSR takes effect and FDA intensifies its focus on cybersecurity for digital scope platforms.