Single-use Duodenoscope Market Size & Share 2025 - 2034

Single-Use Duodenoscope Market Size

The global single-use duodenoscope market was valued at USD 158.2 million in 2024. The market is anticipated to grow from USD 207.9 million in 2025 to USD 2 billion in 2034, growing at a CAGR of 28.4% from 2025 to 2034. The high market growth can be primarily attributed to technological advancements in the devices, rising prevalence of gastrointestinal disorders, coupled with growing need for infection prevention, among other factors.

The global market is witnessing significant momentum, with rising concerns over cross-contamination and healthcare-associated infections (HAIs) associated with reusable duodenoscopes. Conventional reusable duodenoscopes are challenging to clean, thus predisposing pathogen transmission even upon high-level disinfection. This has, in turn, led regulatory bodies like the U.S. FDA to promote the transition toward single-use endoscopic devices to improve patient safety.
 

Increased consciousness among medical practitioners and facilities for infection control and compliance with regulations is driving the use of disposable alternatives worldwide. Major players are making significant contributions to this transition. Ambu A/S introduced the aScope™ Duodeno 2 in July 2020, providing an affordable, portable, and lightweight solution with enhanced navigation and clarity of images, designed for both ambulatory surgical centers and hospitals. Likewise, Boston Scientific's EXALT™ Model D Generation 4, introduced in December 2019, has improved with its exceptional design and high-definition imaging, providing streamlined ERCP procedures across different clinical environments. These technologies are especially useful in environments that do not have the required infrastructure to effectively sterilize reusable scopes.
 

Other factors driving demand include the growing number of endoscopic retrograde cholangiopancreatography (ERCP) procedures, the aging population worldwide, and rising healthcare expenditures on infection prevention. Emerging Asia-Pacific, Latin American, and Middle East economies are also seeing growing interest in single-use duodenoscopes because of reduced initial capital outlays and zero maintenance. Collectively, all these factors are expected to propel strong growth in the worldwide single use duodenoscope market during the forecast period.
 

Single use duodenoscope is a sterile, disposable endoscopic instrument employed solely for the purpose of endoscopic retrograde cholangiopancreatography (ERCP) procedures. In contrast to conventional reusable scopes, it is intended for single use to prevent cross-contamination and infection. They provide enhanced patient safety, need no reprocessing, and are gaining popularity in hospitals and ambulatory surgical centers.
 

Single-Use Duodenoscope Market Trends

• The rising incidence of gastrointestinal (GI) disorders is a major growth driver of the single use duodenoscope market. Pancreaticobiliary diseases, gallstones, bile duct cancer, and gastrointestinal cancers are increasingly prevalent all over the world because populations are aging, dietary habits are poor, physical activities are fewer, and obesity and diabetes are on the rise. These considerations have resulted in a greater need for endoscopic retrograde cholangiopancreatography (ERCP) procedures, subsequently driving the demand for duodenoscopes.
   
• Reusable duodenoscopes were traditionally used but carry a high risk of cross-contamination and infection owing to intricate design and difficulties in reprocessing. Consequently, health care providers increasingly are turning to single-use duodenoscopes to improve patient safety and adhere to rigid infection control protocols. For instance, Ambu A/S has engineered the aScope™ Duodeno 2, a disposable duodenoscope designed to deliver reliable performance without requiring reprocessing, practically eradicating the threat of patient-to-patient contamination.
   
• Boston Scientific's EXALT™ Model D Single-Use Duodenoscope Generation 4 is also a high-definition, sterile, ready-for-use solution that has been particularly engineered to conduct ERCP procedures while minimizing infection risk. These new products meet not only the increasing need for safer endoscopic devices but also the hospital and ambulatory center preferences for minimizing the weight of device maintenance and regulatory burdens.
   
• As infection-related complication awareness increases concomitantly with the rate of GI disorders, single-use duodenoscope adoption is anticipated to increase steadily. The synergy of clinical necessity, patient safety issues, and technology drives single use duodenoscopes as a pivotal solution in contemporary gastrointestinal endoscopy, thereby driving market development.
   

Single-Use Duodenoscope Market Analysis

Based on sales channel, the market is classified into direct sales and in-direct sales. The direct sales segment accounted for USD 122.4 million in market revenue in 2024 and is anticipated to grow at a CAGR of 29% between 2025 to 2034 period.
 

• The direct sales segment within the single use duodenoscope market is experiencing huge growth, fueled by hospitals and healthcare providers growing preference for simplified procurement procedures, improved control of pricing, and direct communication with producers.
   
• Direct sales allow manufacturers to provide specialized solutions, quicker response times, and personalized support services, which are particularly important to advanced, high-value devices such as single-use duodenoscopes. Moreover, increased awareness regarding infection control and the necessity of sterile endoscopy have prompted healthcare facilities to find reliable sources of supply directly from manufacturers.
   
• Businesses like Boston Scientific and Ambu A/S are using this channel to reinforce customer relationships and achieve competitive advantage. For example, Ambu A/S sells its aScope Duodeno 2, a sterile, single use duodenoscope, directly to hospitals highlighting infection protection and simplicity of use. Likewise, Boston Scientific applies direct sales in marketing its EXALT Model D Single-Use Duodenoscope Generation 4 with features on improved image quality, control, and less risk of cross-contamination.
   
• Such strategies are increasingly adopted and heavily driving growth in the direct sales segment in this market.
   

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Based on end use, the single-use duodenoscope market is segmented into hospitals, ambulatory surgical centers, and other end users. The hospitals segment dominated the market in 2024 and is anticipated to reach USD 1.3 billion by the end of the forecast period.
 

• The hospitals segment is expected to continue its leading position in the enteric disease testing market owing to several compelling drivers. Hospitals are major sites for diagnosis and treatment of infectious gastrointestinal illness, with full testing capabilities and state-of-the-art diagnostic equipment.
   
• The rising burden of enteric infections such as Clostridium difficile, norovirus, and salmonellosis has increased the demand for sensitive and specific diagnostic reagents in hospitals, enabling early diagnosis and effective infection control.
   
• Hospitals also tend to receive critical care and immunocompromised patients who are highly susceptible to enteric pathogens, making stringent diagnostic strategies necessary. The increasing deployment of cutting-edge single-use endoscopic equipment within hospitals also plays a role in driving the growth of the market. An example is Ambu A/S's aScope Duodeno 2, a sterile single use duodenoscope that facilitates infection control and procedural effectiveness, making it suitable for hospital environments with high-risk levels.
   
• Another example is Boston Scientific's EXALT Model D Single-Use Duodenoscope Generation 4, which provides improved visualization and manipulation, aligning with hospital demands for safety, sterility, and simplicity.
   
• In addition, hospitals enjoy centralized purchasing systems and reimbursement schemes facilitating the integration of such costly technologies, thus increasing procedural volume and diagnostic precision. These factors make hospitals an imperative end-use segment responsible for sustained expansion in this market.
   

The U.S. single-use duodenoscope market accounted for USD 94.1 million market revenue in 2024 and is anticipated to grow at a CAGR of 29.2% between 2025 to 2034 period.
 

• The U.S. market for single-use duodenoscopes is undergoing strong growth due to mounting concerns about the risk of cross-contamination by reusable duodenoscopes and increased regulatory attention from bodies like the FDA. Hospitals and endoscopy facilities in recent years have been increasingly turning to single-use duodenoscopes to reduce infection risks, especially following repeated outbreaks of multidrug-resistant organisms (MDROs) traced to improperly reprocessed reusable scopes.
   
• The market traction is also augmented by positive clinical guidelines and payor policies favoring safer, disposable options. Advances in technology have further optimized the performance of disposable devices and made them a credible alternative to standard models.
   
• Remarkably, in July 2020, Ambu A/S introduced its aScope Duodeno 2, a sterile, ready-to-use duodenoscope intended to minimize the risk of infection and optimize workflow in ERCP procedures. Boston Scientific, for its part, launched the EXALT Model D Single-Use Duodenoscope Generation 4 in December 2019, the first FDA-cleared disposable duodenoscope available to the U.S. market.
   
• These new technologies have established new infection prevention standards without compromising procedural effectiveness. U.S. hospitals, including facilities such as NYU Langone and AdventHealth, have started embracing these devices to improve patient safety and decrease hospital-acquired infections. With growth in awareness and adoption, the market is well poised for long-term growth.
   

Europe single-use duodenoscope market accounted for USD 52.3 million in 2024 and is anticipated to show lucrative growth over the forecast period.
 

• Growing regulatory focus on infection control in European nations has prompted healthcare professionals to use disposable equipment, especially with high-risk endoscopic procedures such as ERCP. The COVID-19 pandemic further emphasized the need to reduce the transmission of infection, hence speeding up the transition towards single-use endoscopy solutions.
   
• The demographic growth in Europe, accompanied by a growing incidence of gastrointestinal diseases like pancreaticobiliary diseases, has also increased demand for endoscopic procedures. Technology advancements and well-planned product launches have also helped fuel market growth.
   
• For example, Ambu A/S launched the aScope Duodeno 2 in July 2020, with a focus on enhanced ergonomics and better image quality and designed specifically for effective single-use performance. In the same manner, Boston Scientific released the EXALT Model D Generation 4 in December of 2019, specifically designed to provide enhanced maneuverability and visualization throughout procedures.
   
• European hospitals are also progressively shifting to value-based procurement strategies, and single-use devices are in demand because of their reduced maintenance costs and no need for reprocessing. In addition, increasing clinical validation and endorsement from prominent European gastroenterology associations further solidify support for single use duodenoscopes in the region.
   

The rest of the world’s single-use duodenoscope market contributed to around 7.7 million revenues in 2024 and is poised to grow at a CAGR of 22.8% during the forecast period.
 

• The remaining rest of the world market is witnessing impressive growth fueled by increasing hospital-acquired infection awareness, sparse availability of sophisticated reprocessing facilities, dwindling healthcare budgets, and increasing acceptance of affordable endoscopy solutions across emerging markets.
   
• Health systems in nations of Latin America, the Middle East, Africa, and Asia-Pacific regions are increasingly turning towards disposable medical devices to minimize cross-contamination threats, particularly in areas that face resource limitations and have unreliable endoscope reprocessing facilities.
   
• The large incidence rates of gastrointestinal diseases and increasing demand for minimally invasive treatments are also driving market growth. The regulatory pressure to improve infection control is also spurring hospitals to spend on sterile, single-use options. The introduction of innovative products specifically designed for these new markets has further fueled this trend.
   
• Boston Scientific's EXALT Model D Generation 4 launched in December 2019 offers enhanced maneuverability and visualization features that facilitate adoption in developing economies.
   

Single-use Duodenoscope Market Share

The market is effectively a duopoly, dominated by Boston Scientific and Ambu A/S, which together hold 100% of the market share. Boston Scientific’s EXALT Model D Generation 4, launched on December 13, 2019, holds the largest share of this space. The device is widely recognized for its advanced imaging capabilities and mobility, contributing to its strong reputation in the market. Its dominant position reflects Boston Scientific’s robust growth strategy and effective market penetration.
 

Ambu’s aScope Duodeno 2, introduced on July 17, 2020, has also gained significant traction, particularly in hospitals and ambulatory surgery centers. Ambu's success is attributed to its early entry, international expansion, and strategic focus on infection prevention and cost-effectiveness. Additionally, its targeted approach to serving infection-prone and price-sensitive facilities has supported its growth in this highly specialized market.
 

Single-use Duodenoscope Market Companies

Prominent players operating in the single use duodenoscope industry include:

• Ambu
• Boston Scientific
   

USPs:

• Ambu, while not the first to market, is among the leading players in single-use endoscopy and has built a strong portfolio of disposable devices, including the aScope Duodeno. The company specializes in single-use endoscopy platforms and has expanded rapidly across global markets. Its focus on infection prevention, cost-effectiveness, and accessibility in high-risk, price-sensitive settings has helped strengthen its position in the market.
   
• Boston Scientific is a key innovator in single use duodenoscopes, being the first company to receive FDA clearance for a fully disposable duodenoscope. The company leverages its strong presence in the GI endoscopy segment and its expertise in minimally invasive technologies to deliver high performance, single-use solutions focused on infection control and clinical efficiency.
   

Single-use Duodenoscope Industry News

• In August 2021, Boston Scientific announced that the U.S. Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) for its EXALT Model D Single-Use Duodenoscope under the Hospital Inpatient Prospective Payment System. This reimbursement initiative will provide hospitals with additional payments for using EXALT Model D in eligible inpatient cases. The approval boosts the adoption of the product and supports Boston Scientific’s market growth.
   

The single-use duodenoscope market research report includes in-depth coverage of the industry with estimates and forecasts in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Sales Channel

• Direct sales
• In-direct sales

Market, By End Use

• Hospitals
• Ambulatory surgical centers
• Other end use

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Rest of World