Single-use endoscopy systems Market Outlook 2026–2034: Growth Drivers, Key Companies, Strategic Developments & Adoption Forecast — A Meticulous Next™ Foresight Brief
What This Brief Covers
This Meticulous Next™ brief examines single-use endoscopy, disposable scopes that replace reusable endoscopes that must be cleaned and disinfected between patients. It tests how far these scopes can move from a few urology and bronchoscopy procedures to a standard choice across several specialties by 2034.
Growth is already visible at the leading specialist. Ambu reported third quarter fiscal 2025/26 revenue of DKK 1,640 million on 25 August 2026, up 10.3% organically, with Endoscopy Solutions up 16.0% organically, and it launched SureSight Mobile in the United States and the United Kingdom. The conclusion is that single-use scopes are growing faster than the rest of the company, and demand is strong enough to support new launches.
New entrants are arriving in urology. Verathon announced its first single-use flexible cystoscope, CFlex, on 15 May 2026 with FDA 510(k) clearance, a 15 Fr tube and a handle made with 80% bio-based plastic by mass balance, and Ambu cleared its aScope 5 Uretero ureteroscope in June 2024. The conclusion is that urology is the first specialty with several suppliers, and competition on price and image quality is starting.
The case began with infection risk. Boston Scientific cleared the first fully disposable duodenoscope, Exalt Model D, in late 2019 and Ambu followed in July 2020, after the FDA encouraged a move to duodenoscopes with disposable parts, because reusable duodenoscopes used in about half a million ERCP procedures a year can host serious infections. The conclusion is that safety first moved hospitals to disposable scopes, and cost and convenience now extend the case to other specialties.
The brief treats single-use endoscopy as an accelerating signal with an eight year horizon to 2034. It identifies which makers and specialties move first and what each means for endoscope makers, hospitals and suppliers. It is a focused 103-page decision brief that presents an indicative trajectory rather than a segmented market model.
| Parameter | Details |
|---|---|
| Forward horizon | 2026–2034 (8 years) |
| Emerging force | Single-use endoscopy: disposable scopes displacing reprocessing in several specialties |
| Technology readiness | Urology and bronchoscopy scopes in routine use; duodenoscopes cleared since 2019 and 2020; GI and ENT scopes in earlier use |
| Indicative market size & forecast | The single-use endoscopy market, covering single-use urology, bronchoscopy, ENT, duodenoscopy and gastrointestinal endoscopes with their displays and processors, and excluding reusable endoscopes, reprocessing equipment and endoscopic accessories, is valued at USD 1.5–2.2 billion in 2026 and is projected to reach USD 4.28–6.28 billion by 2034, at a CAGR of 14% |
| Mainstream inflection | ~2029, when image quality matches reusable scopes in the main specialties, cost per procedure is at parity and hospitals switch whole departments |
| Signal strength | Ambu Endoscopy Solutions growth of 16.0% organic in the third quarter of fiscal 2025/26 and a new cystoscope entrant in May 2026 |
| Primary beneficiaries | Makers with broad single-use portfolios; makers with low-cost manufacturing; makers with infection outcome data |
| Brief length / format | 103 pages · PDF + executive summary deck · instant delivery |
Understanding the Technology
A reusable endoscope must be flushed, brushed, disinfected and dried after each patient, in a process that takes time, staff and equipment, and that can fail. A single-use endoscope arrives sterile, is used once and is discarded, with a display and processor that stay in the room. The trade is the cost and waste of the scope against the cost and risk of reprocessing.
Urology shows the competitive pattern. Ambu offers the aScope 4 Cysto, the aScope 5 Cysto HD and the aScope 5 Uretero with the aBox 2 system, and Verathon claims up to 70% more flow during instrument use for CFlex than the aScope 4 in bench testing. Ambu states that its ureteroscope is made with bioplastics that cut the carbon footprint of handle production by 70% against regular ABS plastic. The conclusion is that makers now compete on flow, image quality and environmental claims, and the claims are company-reported.
Safety evidence began in the duodenoscope. FDA encouraged providers and manufacturers in August 2019 to move to duodenoscopes with disposable parts, and Boston Scientific and Ambu launched fully disposable versions. The conclusion is that regulators support the shift where infection risk is highest, and the same case is made for bronchoscopes and other scopes.
Environmental pressure runs the other way. Single-use scopes add plastic waste, and makers respond with bioplastics, such as the SureSight blades made with bioplastics under the Ambu Recircle programme. The conclusion is that waste handling and recycling become part of the purchase decision, and makers with take-back programmes gain.
The limits are image quality against reusable scopes, cost per procedure, waste and the training needed for new scopes. The brief tests each limit against the cost trajectory to 2034.
Market Outlook
The single-use endoscopy market, covering single-use urology, bronchoscopy, ENT, duodenoscopy and gastrointestinal endoscopes with their displays and processors, and excluding reusable endoscopes, reprocessing equipment and endoscopic accessories, is valued at USD 1.5–2.2 billion in 2026 and is projected to reach USD 4.28–6.28 billion by 2034, at a CAGR of 14%.
The 2026 base rests on single-use scopes sold mainly in the United States and Europe, with growing sales in Asia. Growth then follows the number of specialties with cleared scopes, the cost per procedure against reprocessing and hospital-wide switching.
The forecast is sensitive to image quality, cost per procedure, waste rules and the pace at which hospitals close reprocessing capacity.
Scenarios
The base case assumes image quality reaches parity in the main specialties and hospitals switch department by department, bringing the inflection to about 2029 and a 2034 value near the middle of the range. An accelerated case assumes quick cost parity and stricter infection rules, bringing the inflection to 2027 and lifting the 2034 value to the top of the range. A delayed case assumes waste rules and cost per procedure slow switching, moving the inflection to 2032 and holding growth at the bottom of the range.
Factors Behind Growth
Growth drivers
- Endoscopy procedure volumes.
- Procedures where reprocessing is costly.
- Outcomes against reusable scopes.
- Wider specialties.
Enablers
- Camera advances.
- Low-cost cameras and bioplastics.
- Purchasing and infection evidence.
- Infection prevention programmes.
Restraints and barriers
- Image quality against reusable scopes.
- Reprocessing and waste capacity.
- Cost per procedure and waste.
- Scope handling training.
The Forces at Play
The direction of single-use endoscopy is set by clearances, hospital purchasing, infection control pressure, camera and handle advances and the capacity for reprocessing and waste handling.
Adoption Outlook
How the shift is likely to unfold across three time horizons.
New urology and bronchoscopy scopes launch and hospitals add single-use scopes to routine procedures.
Hospitals switch whole departments and GI and ENT scopes reach routine use.
Single-use endoscopy is a standard option across the main specialties.
Latest Strategic Developments
| Date | Development | Type | Significance |
|---|---|---|---|
| Jul 2020 | Ambu announces FDA clearance of a single-use duodenoscope system, following the Boston Scientific Exalt Model D in late 2019 | Regulatory clearance | Makes fully disposable duodenoscopes available from two makers |
| Jun 2024 | Ambu announces FDA 510(k) clearance of the aScope 5 Uretero single-use ureteroscope with the aBox 2 system | Regulatory clearance | Adds a single-use ureteroscope to the Ambu urology range |
| May 2026 | Verathon announces CFlex, its first single-use flexible cystoscope, with FDA 510(k) clearance | Product launch | Adds a new supplier in single-use urology |
| Aug 2026 | Ambu reports third quarter fiscal 2025/26 revenue of DKK 1,640 million, with Endoscopy Solutions up 16.0% organically | Company results | Shows strong demand for single-use scopes |
Key Players & Competitive Landscape
The key participants in single-use endoscopy include Ambu A/S, Boston Scientific Corporation, Olympus Corporation, KARL STORZ SE & Co. KG, Roper Technologies, Inc., HOYA Corporation, Fujifilm Holdings Corporation, Shanghai Aohua Photoelectricity Endoscope Co., Ltd., Hangzhou AGS MedTech Co., Ltd., STERIS plc, Ecolab Inc., Cook Group Incorporated, Teleflex Incorporated, Stryker Corporation, Medtronic plc, Johnson & Johnson, HCA Healthcare, Inc., Mayo Clinic, Cleveland Clinic, Kaiser Foundation Health Plan, Inc., Henry Schein, Inc., Cardinal Health, Inc., Owens & Minor, Inc., the American Society for Gastrointestinal Endoscopy, the American Urological Association, the Society of Gastroenterology Nurses and Associates, the Association for the Advancement of Medical Instrumentation, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services and the Food and Drug Administration.
The brief profiles representative participants in each archetype and assesses which are positioned to lead as single-use scopes enter more specialties.
Ambu and Boston Scientific lead among single-use makers, Olympus and KARL STORZ lead among reusable makers adding disposable options, and Verathon and Chinese makers add new scopes. Competitive intensity is rising, with specialists and large makers in the same procedures.
| Archetype | Representative players | Position | Outlook |
|---|---|---|---|
| Established endoscope makers | Olympus, KARL STORZ, HOYA, Fujifilm, Stryker, Medtronic, Johnson & Johnson | Reusable scopes and platforms | Add single-use options and protect reusable base |
| Single-use specialists | Ambu, Boston Scientific, Roper Technologies, Shanghai Aohua Photoelectricity Endoscope, Hangzhou AGS MedTech, Cook Group, Teleflex | Single-use scopes across specialties | Widen specialties and lower cost |
| Reprocessing and waste companies | STERIS, Ecolab | Reprocessing, cleaning and waste services | Adapt to lower reprocessing volumes |
| Hospitals and payers | HCA Healthcare, Mayo Clinic, Cleveland Clinic, Kaiser Foundation Health Plan, Henry Schein, Cardinal Health, Owens & Minor | Care delivery, supply and payment | Decide purchases and switching |
| Professional bodies and regulators | American Society for Gastrointestinal Endoscopy, American Urological Association, Society of Gastroenterology Nurses and Associates, AAMI, CDC, CMS, FDA | Guidelines, standards and clearance | Set reprocessing standards and clearance |
Where value migrates.
In 2026 value sits with single-use urology and bronchoscopy scopes and the displays sold with them. By 2029 it moves toward makers with broad portfolios and low-cost manufacturing as GI and ENT scopes reach routine use and hospitals switch departments. By 2034 it settles with single-use endoscopy as a standard option, where cost per procedure, image quality and waste programmes carry the margin. Margins hold for makers with scale and take-back programmes, and narrow for makers of a single scope.
Who Will Win — and Why
The archetypes best positioned to capture value as the shift matures.
A range of scopes lets a hospital switch a whole department with one supplier.
Cost per scope decides parity with reprocessing and drives hospital-wide switching.
Infection data support hospital purchasing and regulator guidance.
Regulatory Landscape
| Jurisdiction | Milestone | Indicative timing | Effect on adoption |
|---|---|---|---|
| United States, FDA 510(k) clearance of CFlex | Clearance of a single-use flexible cystoscope for examination of the lower urinary tract in adults | May 2026 | Adds a new supplier in single-use urology |
| United States, FDA 510(k) clearance of aScope 5 Uretero | Clearance of a single-use digital flexible ureteroscope with the aBox 2 system | June 2024 | Adds a single-use ureteroscope to the Ambu urology range |
| United States, FDA guidance on duodenoscopes | FDA encourages providers and manufacturers to move to duodenoscopes with disposable parts | August 2019 | Supports the move to disposable duodenoscopes |
Investment Signals
The signals converge on a market where single-use scopes are growing and new makers are entering. Ambu Endoscopy Solutions growth of 16.0% organic, cleared single-use scopes in urology and duodenoscopy and a new cystoscope entrant support growth, while image quality, cost per procedure and waste hold back adoption.
Structural limits show where progress could slow: cost parity with reprocessing, plastic waste rules, image quality in demanding procedures and the speed of hospital switching. The brief therefore tracks four indicators: single-use procedures per year, cleared scopes by specialty, cost per procedure and infection outcome data.
Urology and bronchoscopy first, then GI and ENT and hospital-wide switching, then standard option status is the expected order of change.
Questions This Brief Answers
Strategic Implications
- Endoscope makers: widen single-use portfolios and cut cost per scope, because cost parity decides switching.
- Hospitals: compare single-use cost against reprocessing cost and infection risk by specialty and plan waste handling.
- Reprocessing companies: shift to waste, recycling and services that serve single-use departments.
- Investors: favour makers with broad portfolios, low-cost manufacturing and take-back programmes over makers of one scope.
- Regulators and professional bodies: set clear standards for reprocessing and single-use scopes and fund infection outcome studies.
"The scope used to come back from the cleaning room. The next eight years decide how many never do."
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