Duodenoscopes Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (flexible duodenoscopes, rigid duodenoscopes), By Application (diagnostics, therapeutics), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 181.80 Million
CAGR (2026-2031)	5.49%
Fastest Growing Segment	Flexible Duodenoscopes
Largest Market	North America
Market Size (2031)	USD 250.53 Million

Market Overview

The Global Duodenoscopes Market will grow from USD 181.80 Million in 2025 to USD 250.53 Million by 2031 at a 5.49% CAGR. Duodenoscopes are specialized lateral viewing endoscopes primarily utilized during Endoscopic Retrograde Cholangiopancreatography to visualize and treat pathologies within the pancreatic and bile ducts. The market is substantially supported by the growing prevalence of digestive disorders and an aging population requiring minimally invasive interventions. Underscoring this demand, according to the American Cancer Society, in 2024, an estimated 66,440 individuals in the United States were projected to be diagnosed with pancreatic cancer, necessitating robust diagnostic and therapeutic endoscopic capacities.

Nevertheless, a significant challenge impeding market expansion is the persistent risk of bacterial transmission associated with reprocessing reusable devices. The intricate mechanical design creates difficulty in cleaning and disinfection which leads to potential infections and patient safety concerns. This issue has precipitated heightened regulatory scrutiny and operational complexities for healthcare facilities, thereby acting as a critical restraint on the broader adoption of traditional reusable duodenoscopes.

Key Market Drivers

Rising global prevalence of pancreaticobiliary and gastrointestinal disorders is the primary catalyst for market growth, creating sustained demand for therapeutic interventions. As the incidence of conditions such as bile duct stones and malignancies rises, the volume of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures increases, necessitating a consistent supply of high-performance devices. This demand surge is evident in the financial results of major incumbents; according to Boston Scientific, March 2024, in the '2023 Annual Report', the company's Endoscopy segment achieved net sales of $2.482 billion, marking an 11.7% increase from the prior year. The severity of these conditions further mandates robust diagnostic capabilities to manage patient outcomes. According to the Pancreatic Cancer Action Network, January 2024, in the 'Five-Year Survival Rate for Pancreatic Cancer Increased to 13%' article, approximately 51,750 Americans were projected to die from the disease in 2024, reinforcing the critical need for effective endoscopic intervention tools.

Concurrently, a rapid shift toward single-use duodenoscopes is restructuring the market landscape to mitigate cross-contamination risks. Reusable devices, due to their complex elevator mechanisms, are difficult to disinfect completely, creating a persistent threat of patient-to-patient bacterial transmission. This safety concern is driving healthcare facilities to adopt sterile, disposable scopes, which eliminate reprocessing requirements and reduce infection liability. This transition is gaining significant commercial traction as manufacturers expand their disposable portfolios. Underscoring this momentum, according to Ambu A/S, November 2024, in the 'Annual Report 2023/24', the company reported organic revenue growth of 19.7% in its Endoscopy Solutions business, a performance attributed to the widening adoption of its single-use technologies. This trend reflects a broader industry move towards disposable platforms to ensure compliance with tightening regulatory infection control standards.

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Key Market Challenges

The persistent risk of bacterial transmission associated with reprocessing reusable devices constitutes a significant restraint on the Global Duodenoscopes Market. The intricate mechanical design of these instruments creates substantial difficulties in cleaning and disinfection, which significantly increases the potential for patient infections. This safety challenge compels healthcare facilities to implement highly rigorous and time-consuming sterilization protocols that reduce procedural throughput and escalate operational costs. Consequently, the heightened scrutiny and liability concerns discourage the widespread uptake of traditional reusable models and hamper overall market growth.

Substantiating this restraint, according to ECRI, in 2024, insufficient or onerous device cleaning instructions were ranked as the second highest health technology hazard. This classification highlights the industry-wide struggle with reprocessing complex medical instruments, validating the high level of operational burden that restricts the scalability of the reusable duodenoscope segment.

Key Market Trends

The Development of Next-Generation Visualization Technologies for Biliary Imaging is shifting clinical standards by enhancing the visualization of mucosal structures during complex endoscopic procedures. Innovations such as advanced image processing and high-definition contrast modes are increasingly replacing standard white-light imaging, enabling endoscopists to better visualize the papilla and pancreatobiliary anatomy for improved cannulation rates. This technological shift is gaining rapid commercial acceptance as hospitals upgrade their capital equipment to support superior diagnostic capabilities. Highlighting this adoption, according to Olympus Corporation, May 2024, in the 'Consolidated Financial Results for Fiscal 2024' presentation, the sales ratio of the company's advanced EVIS X1 series rose to approximately 30 percent of its total gastrointestinal endoscopy sales in the fourth quarter, signaling a strong market preference for enhanced imaging platforms.

Concurrently, the Expansion of Specific Reimbursement Codes for Disposable Endoscopic Procedures is dismantling the financial barriers that historically impeded the uptake of single-use devices. While the clinical shift toward sterile instruments is recognized, the recent implementation of transitional pass-through payments and distinct billing codes has been the decisive factor in making these high-cost consumables economically viable for healthcare providers. This financial enablement is directly correlating with increased utilization rates of disposable duodenoscopes as hospitals leverage these economic frameworks to balance their budgets. Validating this trend, according to Boston Scientific, October 2024, in the 'Boston Scientific Announces Results for Third Quarter 2024' report, the company's Endoscopy segment achieved double-digit revenue growth for the Exalt Model D single-use duodenoscope, demonstrating how improved reimbursement structures are accelerating the commercial scalability of disposable solutions.

Segmental Insights

The Flexible Duodenoscopes segment is currently establishing itself as the fastest-growing category within the global market, driven by the indispensable role of these devices in minimally invasive endoscopic retrograde cholangiopancreatography (ERCP) procedures. This rapid expansion is primarily attributed to technological advancements in video duodenoscopes, which now offer superior high-definition imaging and maneuverability for complex diagnostic tasks. Furthermore, the segment is witnessing accelerated demand due to strict safety communications from the U.S. Food and Drug Administration (FDA), which recommend transitioning to innovative flexible designs with disposable components to mitigate cross-contamination risks. These drivers are compelling healthcare facilities to upgrade their inventories, sustaining the segment's robust upward trajectory.

Regional Insights

North America maintains a dominant share of the global duodenoscopes market, driven by the rising incidence of pancreatic and biliary diseases requiring Endoscopic Retrograde Cholangiopancreatography interventions. The region's leadership is strongly influenced by the U.S. Food and Drug Administration, which actively urges healthcare facilities to transition toward devices with disposable components to eliminate infection risks. This regulatory stance has accelerated the adoption of innovative, single-use technologies among providers. Furthermore, established healthcare infrastructure and comprehensive reimbursement policies enable the rapid integration of these advanced medical solutions.

Recent Developments

• In September 2025, Fujifilm Healthcare Europe announced the commercial launch of its new ED-840T video duodenoscope, specifically designed for Hepato-Pancreato-Biliary (HPB) procedures. This addition to the company's ELUXEO endoscopy platform was engineered to offer enhanced maneuverability and visualization capabilities for complex therapeutic interventions. The launch introduced advanced features aimed at improving clinical outcomes in ERCP, such as a redesigned elevator mechanism and improved access for cleaning, directly catering to the evolving demands of medical professionals in the Global Duodenoscopes Market for high-performance and hygienic device solutions.
• In August 2024, Pentax Medical secured FDA clearance for an expanded sterilization capability for its DEC Duodenoscope (ED34-i10T2s). This regulatory milestone was achieved through a collaboration with Advanced Sterilization Products (ASP), verifying the device's compatibility with the STERRAD 100NX Sterilizer. The approval allowed the duodenoscope to be reprocessed using hydrogen peroxide gas plasma sterilization, offering healthcare facilities a validated method to reduce the risk of infection. This development marked a significant advancement in the safety protocols for reusable duodenoscopes, addressing ongoing industry concerns regarding the effective cleaning and disinfection of complex endoscopic instruments.
• In August 2024, Karl Storz United States and Fujifilm Healthcare Americas Corporation entered into a strategic collaboration to jointly market endoscopic solutions in the U.S. healthcare sector. Under this commercial partnership, Karl Storz agreed to distribute Fujifilm’s portfolio of flexible gastrointestinal endoscopes, including duodenoscopes used for ERCP, alongside its own operating room integration systems. The alliance aimed to provide hospitals and ambulatory surgery centers with a comprehensive package of advanced imaging technologies and surgical integration, thereby expanding the commercial reach and availability of Fujifilm’s duodenoscope technology within the competitive Global Duodenoscopes Market.
• In April 2024, Ambu A/S announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest single-use duodenoscope solution. The approved device, known as the aScope Duodeno 2, was designed to address the critical need for infection control in endoscopic retrograde cholangiopancreatography (ERCP) procedures by eliminating the risk of patient-to-patient cross-contamination associated with reusable devices. This new generation of sterile, disposable duodenoscopes featured improved ergonomics and was developed in close consultation with gastroenterologists to enhance procedural performance and workflow efficiency in the Global Duodenoscopes Market.

Key Market Players

• Custom Ultrasonics, Inc.
• Fujifilm Holdings Corporation
• Hoya Corporation
• KARL STORZ GmbH & Co. KG
• Olympus Corporation
• PENTAX Medical Company
• Ambu A/S
• Boston Scientific Corporation
• EndoMed Systems
• HOYA Corp.

By Product	By Application	By End User	By Region
flexible duodenoscopes rigid duodenoscopes	diagnostics therapeutics	Hospitals & Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Duodenoscopes Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Duodenoscopes Market, By Product:

• flexible duodenoscopes
• rigid duodenoscopes

• Duodenoscopes Market, By Application:

• diagnostics
• therapeutics

• Duodenoscopes Market, By End User:

• Hospitals & Clinics
• Ambulatory Care Centers
• Others

• Duodenoscopes Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE