Endotherapy Devices Market Size & Share 2026-2035

Endotherapy Devices Market Size

The global endotherapy devices market was valued at USD 5.6 billion in 2025 before nearly doubling to USD 11.7 billion by 2035, expanding at a compound annual growth rate (CAGR) of approximately 7.6% over the 2026–2035 forecast period.

Endotherapy devices encompass the instruments deployed through the working channels of flexible endoscopes to accomplish diagnostic sampling, therapeutic resection, hemostasis, tissue closure, duct access, and stone management within the GI tract, biliary system, and adjacent anatomical territories. The market is organized along three principal product clusters - gastrointestinal devices and accessories, ERCP devices and accessories, and other endotherapy products - each of which serves distinct procedural indications and follows its own demand dynamics.

The fundamental driver is the expanding global burden of upper and lower GI diseases. Gastroesophageal reflux disease (GERD) affected 825.60 million individuals worldwide in 2021, a rise of approximately 83% from the 450.77 million cases recorded in 1990, with its age-standardized prevalence rate expected to continue upward toward a projected 1.2 billion cases by 2050.^[1]Colorectal cancer (CRC) remains among the most prevalent malignancies globally: an estimated 2,194,143 new CRC cases were reported in 2021, representing a 139% increase compared with 1990, and CRC collectively accounts for 9.9% of all incident cancers as well as being the second-leading cause of cancer death globally.^[2] Inflammatory bowel disease (IBD) incidence has risen sharply, with 375,140 global incident cases in 2021 and an 88.3% increase in global incident cases between 1990 and 2021. Looking further ahead, a comprehensive analysis projects that the global burden of GI cancers - encompassing colorectal, gastric, liver, esophageal, and pancreatic malignancies - will reach 9.06 million incident cases by 2050, an 85% increase from 2022. Each of these conditions either requires endoscopic diagnosis using biopsy forceps and injection needles, demands therapeutic intervention such as polypectomy, ESD, or hemostasis, or requires management of biliopancreatic complications through ERCP and related accessories.

Procedure volume provides a second structural foundation. Approximately 700,000 ERCP procedures are performed annually in the United States alone, and worldwide ERCP volume approaches two million per year. Colonoscopy remains the most commonly performed CRC screening modality in the U.S., with its utilization share rising from 53.0% to 58.7% of all CRC screening between 2017 and 2023. In ambulatory surgical centers (ASCs), the average monthly GI case volume reached 176 in 2024, up from 167 in 2023, with GI achieving the highest OR block utilization among all specialties at 59.6%. These procedure counts translate directly into consumable utilization, as biopsy forceps, snares, hemoclips, guide wires, sphincterotomes, and injection needles are single-use or semi-disposable items replenished with every procedure.

At the regional level, North America commanded a 43.9% revenue share in 2025 with a market value of USD 2,477.5 million, underpinned by established reimbursement frameworks, high procedure volumes, and a technology-forward provider community. The United States alone accounted for USD 2,338.5 million of that regional total. Asia Pacific, valued at USD 1,591.0 million in 2025, is the fastest-growing region with a CAGR of 9.0%, driven by escalating GI cancer screening programs, expanding hospital infrastructure in China and India, and the region's disproportionately high burden of gastric cancer and CRC. Europe held USD 1,273.9 million in 2025 and grows at 7.3%. Latin America (USD 174.6 million, 8.6% CAGR) and the Middle East and Africa (USD 129.1 million, 7.8% CAGR) represent smaller but structurally growing markets.

Opportunities emerging over the forecast period include the increasing adoption of single-use endotherapy devices, which eliminates the infection and reprocessing risks inherent to reusable instruments - a concern that the U.S. FDA addressed through safety communications in 2019 and 2022 regarding duodenoscope-associated contamination - and the integration of robotics and artificial intelligence into endoscopic workflows. AI-assisted colonoscopy systems have demonstrated statistically significant improvements in adenoma detection rates in a meta-analysis of 43 randomized controlled trials encompassing 34,896 patients, with AI-assisted systems achieving an adenoma detection rate of 44.8% versus 37.4% for standard colonoscopy. These two opportunity vectors are particularly material to the premium-device segment and to geographies with mature screening infrastructure.

GMI Analyst View

The endotherapy devices market occupies a structurally privileged position within medical devices: its consumable nature creates recurring revenue tied to procedure volume rather than capital-equipment replacement cycles, its products serve a treatment pathway for GI cancers and obstructive biliary disorders where there are few non-invasive alternatives, and its technological frontier is advancing on multiple fronts simultaneously. The compounding effect of GI disease prevalence growth, ongoing colonoscopy program expansion, ESD adoption in oncology, and single-use device substitution creates durable demand above and beyond simple procedure-volume growth. North America's maturity does not constrain the global market because Asia Pacific - already nearly one-third of global revenue - is expanding at a rate roughly 230 basis points above the world average. Over the 2025–2035 period, the market doubles in absolute value, which implies that both existing device categories and emerging sub-segments (single-use biopsy forceps, motorized EUS needles, AI-integrated platforms) will benefit meaningfully.

This report covers the global endotherapy devices market across the 2022–2035 forecast period, with 2025 as the base year and market values expressed in USD million. The analysis spans three product segments - gastrointestinal (GI) devices and accessories, ERCP devices and accessories, and other products - with GI accessories further decomposed into biopsy forceps (single-use, reusable, hot), injection needles (EUS-FNA, EUS-FNB, other), ESD knives (needle-tipped, insulation-tipped), polypectomy snares, hemoclips, graspers, hemostasis forceps, sclerotherapy needles, and other GI accessories, while ERCP accessories span metal stents, sphincterotomes, guide wires, catheters (guiding, dilation, drainage, other), plastic stents, balloon dilation devices, extraction baskets, extraction balloons, and other ERCP accessories. Application coverage includes gastrointestinal endoscopy, laparoscopy, arthroscopy, urology endotherapy, bronchoscopy, and other applications. End-use coverage encompasses hospitals, ambulatory surgical centers, and other settings. Geographically the report covers North America (U.S., Canada), Europe (Germany, UK, France, Spain, Italy, Netherlands), Asia Pacific (China, Japan, India, Australia, South Korea), Latin America (Brazil, Mexico, Argentina), and the Middle East and Africa (South Africa, Saudi Arabia, UAE). Competitive coverage profiles 15 companies: B. Braun, Boston Scientific, CONMED, Cook Medical, Endo-Med, FUJIFILM, Johnson & Johnson, KARL STORZ, M.I. Tech, Medtronic, MICRO-TECH, Olympus, Smith+Nephew, Stryker, and Taewoong Medical.

Key takeaways: North America held the largest regional revenue share at 43.9% in 2025. Gastrointestinal devices and accessories was the dominant product segment, accounting for approximately 56.4% of total market revenue in 2025 at USD 3,185.9 million, and GI devices are projected to exceed USD 6.4 billion by 2035 at a 7.4% CAGR. ERCP devices and accessories, the fastest-growing major product segment, recorded USD 1,690.3 million in 2025 at an 8.3% CAGR, reaching USD 3,722.9 million by 2035. Within the GI accessories cluster, biopsy forceps is the largest sub-category at USD 704.5 million in 2025 growing at 8.7% CAGR, driven by the clinical migration from EUS-FNA to more diagnostically capable EUS-FNB designs; ESD knives represent USD 501.4 million growing at 8.3%; injection needles USD 553.2 million growing at 7.9%. Hospitals accounted for approximately 54.6% of end-use revenue at USD 3,080.5 million in 2025, though ambulatory surgical centers are gaining procedural share at 8.2% CAGR. Among regions, Asia Pacific posts the highest CAGR at 9.0%, followed by Latin America at 8.6% and MEA at 7.8%. Top 5 market participants - Boston Scientific, Cook Medical, Medtronic, MICRO-TECH, and Olympus - collectively held approximately 65% of market revenue in 2025, with Boston Scientific leading at more than 28% market share.

Key Drivers

Rising Prevalence of Gastrointestinal Disorders

The aggregate burden of GI conditions - spanning GERD, CRC, IBD, and upper GI malignancies - is the primary structural driver of endotherapy device demand. GERD affected 825.60 million people globally in 2021 and is projected to exceed 1.2 billion cases by 2050, creating sustained referrals for upper GI endoscopy with mucosal biopsy. CRC incidence has risen 139% since 1990 globally, with East Asia recording 684,927 new cases in 2021 - nearly one-third of the global total - and high-income regions in North America and Western Europe each carrying CRC age-standardized incidence rates above 40 per 100,000. The projected global GI cancer burden of 9.06 million incident cases by 2050 (+85% from 2022) implies a structural expansion in demand for biopsy forceps, EUS-FNB needles, polypectomy snares, and ESD knives across the entire forecast window.^[3]IBD, comprising Crohn's disease and ulcerative colitis, recorded 375,140 global incident cases in 2021 and an 88.3% cumulative increase in global case counts since 1990, requiring repeat endoscopic surveillance and mucosal biopsy.^[4]The nonmalignant digestive disease burden, including peptic ulcer disease and biliary disorders, encompasses additional procedure demand; GBD 2023 data confirm that GERD is the only cause among major digestive conditions that is showing consistently upward trends in total percent change. These concurrent epidemiological pressures translate into a durable baseline of endoscopic procedure referrals and, by extension, recurring consumption of endotherapy consumables across both diagnostic and therapeutic applications.

Growing Demand for Minimally Invasive Procedures

Clinicians and health systems have progressively substituted endoscopic techniques for open surgical approaches across GI, biliary, pancreatic, urological, and thoracic indications because endoscopy offers equivalent or superior clinical outcomes alongside markedly shorter hospital stays, reduced anesthesia risk, and lower overall cost per episode. In the colorectal polyp setting, endoscopic resection techniques - EMR and ESD - increased from 52.8 to 64.3 per 1,000 cases between 2014 and 2024, while surgical resection rates for the same indication declined from 4.1 to 3.0 per 1,000 cases over the same period. The shift is particularly pronounced for early GI neoplasms and large polyps that historically required surgical colectomy. ESD has further penetrated esophageal and gastric cancer treatment in Asia and increasingly in Western centers, driving demand for insulation-tipped and needle-tipped ESD knives. This trend toward endoscopic-first approaches creates downstream demand for hemoclips, hemostasis forceps, injection needles for submucosal lifting, and extraction devices - the full range of GI accessories required to support complex resection procedures. In the biliopancreatic domain, EUS-guided biliary drainage, lumen-apposing metal stent placement, and EUS-FNB tissue acquisition are increasingly replacing surgical bypass and diagnostic laparotomy, expanding demand for ERCP and EUS devices. In laparoscopy, the market generated USD 953.9 million in 2025 and grows at 8.4% CAGR, supported by the global adoption of laparoscopic cholecystectomy - which accounted for 120,625 registered procedures in Japan's National Clinical Database in 2024 alone - and expanding laparoscopic approaches to bariatric, colorectal, and hepatopancreatic surgery.

High Volume of Endoscopic Procedures

The procedural volume foundation for endotherapy consumable demand is both large and growing. In the U.S., colonoscopy remains the most widely used CRC screening modality at 58.7% screening-test share as of 2023, and total diagnostic, screening, and surveillance colonoscopy volume remains in the high tens of millions annually. Approximately 700,000 ERCP procedures are performed each year in the U.S. alone, with worldwide ERCP volume estimated at approximately two million procedures annually - each procedure consuming a sphincterotome, guide wire, catheter, and typically one or more extraction or dilation devices. In ambulatory surgical centers, GI case volume averaged 176 procedures per month in 2024 (up from 167 in 2023), with GI achieving 59.6% OR block utilization - the highest among all specialties surveyed - and average net revenue per case of USD 1,362 in 2024. One large analysis of 590 ASCs found that total GI case volume at those sites increased 19% in a single year, rising from 349 to 416 average monthly cases. The high per-procedure consumable content of advanced GI procedures - ESD requires an ESD knife, submucosal injection needle, hemostatic forceps, and often hemoclips; ERCP requires a sphincterotome, guide wire, catheter, and retrieval basket or extraction balloon - means that procedural volume growth amplifies device unit consumption at a rate exceeding simple head count. The ongoing expansion of GI hospitalist models further increases inpatient endoscopic procedure volume, with one controlled interrupted time-series study showing that implementation of a GI hospitalist model increased weekly inpatient endoscopic procedures by 10.9 per week at the study institution compared with a matched control hospital.

Technological Advancements in Endoscopic Devices

Device innovation is elevating the clinical standard of care, expanding indications, and creating premium price points that grow market revenue per procedure. In the EUS tissue-acquisition segment, the transition from cytology-oriented FNA needles to histology-preserving FNB designs with end-cutting geometries (Franseen tip, Fork-tip, shark-core tip) has materially improved diagnostic adequacy. A network meta-analysis of EUS-FNB needle designs found that Franseen-tip needles (e.g., Boston Scientific Acquire) significantly outperformed reverse-bevel FNB and standard FNA needles in both diagnostic accuracy and specimen adequacy for solid pancreatic lesions. Diagnostic yields exceeding 90% are now considered benchmark expectations for modern FNB needles, and the same tissue specimens support molecular profiling for precision oncology - an increasingly important clinical application as up to 20–25% of pancreatic cancers harbor actionable genomic alterations. Beyond EUS, AI-assisted colonoscopy systems that use convolutional neural networks for real-time polyp detection have demonstrated statistically significant improvements in adenoma detection rate (44.8% vs. 37.4%) and adenoma-per-colonoscopy rate across 43 randomized controlled trials with 34,896 patients. Regulatory bodies have cleared these systems - Health Canada in 2021 and several EU national agencies in 2024 - making them accessible in clinical practice. Single-use endotherapy consumables, particularly single-use biopsy forceps, represent a growing technology category: single-use biopsy forceps reached USD 410.0 million in 2025 and grows at 9.1% CAGR, the fastest pace within the GI accessories cluster, driven by infection control requirements, regulatory pressure toward disposable-component duodenoscopes, and healthcare facility interest in eliminating reprocessing costs. Fully disposable single-use duodenoscopes, of which Boston Scientific's EXALT Model D achieved 96.7% procedural success in a six-center clinical evaluation, have been cleared by the FDA and are positioned to capture share of the two-million-procedure annual ERCP market as adoption broadens beyond specialized centers.

Key Restraints

High Cost of Advanced Endotherapy Devices

Advanced endotherapy devices - including EUS fine needle biopsy systems, ESD knife platforms, metal biliary stents, and single-use duodenoscopes - carry significant per-unit acquisition costs that constrain adoption in price-sensitive healthcare systems and limit market penetration depth in low- and middle-income countries. Fully disposable duodenoscopes, while addressing the infection-control limitations of reusable instruments, carry per-unit costs that are multiples above standard reusable designs, making volume adoption economically difficult for most community hospitals even in high-income markets. In Sub-Saharan Africa, a survey found that out of 87 doctors in Ethiopia, Kenya, Malawi, and Zambia, only 6 performed ERCP and only 2 performed EUS, with cost identified as a primary barrier alongside equipment availability. Nigeria, with over 200 million inhabitants, operates only about 200 endoscopy centers, concentrated in Lagos; the country has just one public center providing sustained ERCP services. The capital cost of installing a comprehensive endoscopy suite - including the video system, light source, processor, and accessory inventory - and the recurring cost of consumables can represent a prohibitive financial burden for public hospitals operating on constrained budgets. In the U.S. and Europe, reimbursement pressure on advanced endoscopic procedures has intensified: ESD and POEM carry substantial procedure charges but are subject to under-reimbursement risk relative to total overhead, and at least one major insurer has moved to restrict monitored anesthesia coverage for certain GI endoscopic procedures. These cost and reimbursement dynamics limit market growth rates in both emerging-market settings (by suppressing access to advanced consumables) and in mature settings (by constraining the speed of new-technology adoption among community endoscopy providers).

Risk of Procedure-Related Complications

ERCP and advanced endoscopic procedures carry meaningful complication rates that impose downstream costs, increase provider liability, and may restrain the pace at which community endoscopists adopt complex device categories. A systematic review and meta-analysis of 380 studies found an overall ERCP complication rate of 4.6% for post-ERCP pancreatitis (PEP), 1.5% for bleeding, 2.5% for cholangitis, 0.5% for perforation, and 0.2% attributable mortality across approximately 293,000 patients. First-time ERCP patients experienced a PEP incidence of 6.5%. PEP is not only clinically significant - with its incidence stable at approximately 4.5% of inpatient ERCP patients in the U.S. and its associated mortality rising from 2.8% to 4.4% of PEP cases between 2011 and 2017 - but also imposes an estimated USD 200 million in annual healthcare expenditures in the U.S. alone. Boston Scientific's ERCP portfolio materials note that up to 1 in 6 ERCP patients requires unplanned hospitalization. This complication profile creates clinical hesitation among referring physicians and procedure schedulers, can delay patient acceptance of endoscopic over surgical alternatives in community settings, and generates regulatory and liability attention that influences device design decisions and training requirements. Additionally, reprocessing failures in complex endoscopes have led to MDRO transmission events, contributing to regulatory pressure that - while in part catalyzing single-use device adoption - also creates uncertainty and adoption friction for the broader ERCP device segment.

Endotherapy Devices Market Segment Analysis

By Product

Gastrointestinal devices and accessories is the largest product segment, generating USD 3,185.9 million in 2025 and representing approximately 56.4% of total market revenue. The segment grows at a 7.4% CAGR to reach USD 6,464.2 million by 2035. Revenue leadership reflects the segment's breadth - it covers the majority of consumable items used in diagnostic endoscopy, therapeutic endoscopy, and endoscopic oncology - and the high per-procedure device count of complex interventions such as ESD.

Biopsy forceps is the largest GI sub-category, generating USD 704.5 million in 2025 and growing at an 8.7% CAGR - the fastest rate within GI accessories - to reach USD 1,612.4 million by 2035. The growth is driven by the clinical transition toward EUS-FNB for pancreatic and mediastinal mass biopsy and by the rapid adoption of single-use designs. Single-use biopsy forceps, the largest sub-segment at USD 410.0 million in 2025 and a 9.1% CAGR, benefit from infection-control policies, preference for sterile single-patient instruments in immunocompromised oncology patients, and the operational simplicity of disposable instruments in high-throughput ambulatory centers. Reusable biopsy forceps (USD 223.0 million, 8.9% CAGR) maintain a significant installed base in hospital settings that reprocess and sterilize endoscopy accessories under established protocols. Hot biopsy forceps (USD 71.5 million, 5.6% CAGR) serve a specialized role in thermal coagulation of small polyps, though their share is gradually declining as cold polypectomy techniques demonstrate comparable clinical outcomes with a more favorable safety profile.

Injection needles generated USD 553.2 million in 2025 at a 7.9% CAGR. EUS-guided FNB (EUS-FNB) needles, at USD 219.8 million and an 8.3% CAGR, represent the fastest-growing injection needle sub-segment, fueled by clinical guideline endorsement of end-cutting FNB designs over legacy FNA needles for solid pancreatic lesions.^[5]The ESGE recommends end-cutting FNB needles as the preferred modality for tissue sampling of solid pancreatic lesions.^[6], and growing demand for molecular profiling of pancreatic adenocarcinoma - where up to 20–25% of cases harbor actionable alterations - further amplifies the need for tissue-adequate specimens. EUS-FNA needles (USD 271.4 million, 7.6% CAGR) maintain clinical utility in settings where rapid on-site cytological evaluation is available, though their share of the EUS tissue-acquisition market is progressively ceding to FNB designs. Other injection needles (USD 62.1 million, 7.1% CAGR) include sclerotherapy-adjacent devices and chromoendoscopy accessories.

ESD knives registered USD 501.4 million in 2025 at an 8.3% CAGR, reaching USD 1,106.2 million by 2035. Insulation-tipped (IT) knives generated USD 234.8 million in 2025 at an 8.6% CAGR - the highest pace within ESD knives - reflecting the design's long-established safety profile for colorectal ESD. Needle-tipped knives generated USD 266.6 million at an 8.1% CAGR, used in initial mucosal marking and incision steps of ESD across esophageal, gastric, and colorectal procedures. The ESD knife market's growth mirrors the increasing penetration of ESD as the preferred resection method for early GI neoplasms ≥20 mm and for en-bloc resection where EMR would carry high risk of incomplete resection - a shift particularly pronounced in Japan and South Korea, and increasingly in European expert centers.

Polypectomy snares generated USD 360.4 million in 2025 at a 6.1% CAGR. Cold snare polypectomy has largely displaced hot snare polypectomy for polyps under 10 mm on the basis of equivalent efficacy with a significantly lower complication rate, and this technique shift has influenced snare design innovation. Hemoclips (USD 272.2 million, 7.6% CAGR) serve both prophylactic and therapeutic roles in GI bleeding management and post-polypectomy closure. Graspers (USD 242.6 million, 6.4% CAGR) and hemostasis forceps (USD 223.8 million, 7.0% CAGR) are essential adjuncts in advanced resection procedures. Sclerotherapy needles (USD 132.3 million, 4.9% CAGR) maintain demand in variceal injection sclerotherapy, though band ligation has captured much of the treatment volume for esophageal varices in high-resource settings. Other GI devices (USD 195.5 million, 3.3% CAGR) is the slowest-growing sub-segment, reflecting maturity and product standardization.

ERCP devices and accessories generated USD 1,690.3 million in 2025 and represent the fastest-growing primary product segment at an 8.3% CAGR, projected to reach USD 3,722.9 million by 2035. ERCP indications - biliary stone extraction, management of malignant and benign biliary strictures, pancreatic duct drainage, and Oddi sphincter dysfunction - are expanding as imaging technologies increase detection rates for pancreaticobiliary pathology and as aging populations carry higher rates of choledocholithiasis and cholangiocarcinoma.

Guide wires are the fastest-growing ERCP sub-segment, generating USD 261.7 million in 2025 at a 9.7% CAGR to reach USD 657.9 million by 2035. Guide wire performance - diameter, stiffness gradient, tip hydrophilicity, and torque response - directly determines cannulation success rates in difficult biliary anatomy, and premium hydrophilic-tip designs command pricing above commodity alternatives. Catheters generated USD 178.0 million in 2025 at a 9.3% CAGR; drainage catheters (USD 40.3 million, 9.8% CAGR) lead within the catheter sub-segment by growth rate, followed by dilation catheters (USD 51.1 million, 9.5% CAGR) and guiding catheters (USD 72.6 million, 9.1% CAGR). Balloon dilation devices (USD 135.5 million, 8.8% CAGR) serve both biliary stone clearance via large-balloon dilation of the sphincter and pancreatic duct stricture management. Extraction baskets (USD 108.7 million, 8.1% CAGR) and extraction balloons (USD 89.2 million, 8.4% CAGR) are the core stone retrieval tools, with demand linked directly to choledocholithiasis procedure volume.

Metal stents are the largest single ERCP sub-segment at USD 356.8 million in 2025, growing at 7.6% CAGR. Self-expanding metal stents are preferred for malignant biliary obstruction due to significantly longer patency than plastic stents, and fully covered metal stents are increasingly used for benign biliary strictures. Sphincterotomes generated USD 280.5 million in 2025 at 7.8% CAGR - a mature sub-segment where competition focuses on tip geometry, cutting wire design, and preloaded guide wire configurations that reduce instrument exchanges and procedure time. Plastic stents (USD 158.6 million, 7.4% CAGR) retain clinical roles in benign strictures requiring interval stent replacement and in settings where metal stent cost is prohibitive.

Other products encompass endotherapy accessories not classified under GI or ERCP categories, including bronchoscopy accessories, urology endotherapy consumables used in a variety of diagnostic and therapeutic applications, and miscellaneous devices. The sub-segment generated USD 769.9 million in 2025 and grows at 7.0% CAGR to USD 1,501.9 million by 2035.

By Application

Gastrointestinal endoscopy is the dominant application segment, generating USD 3,079.6 million in 2025 - representing approximately 54.5% of total application revenue - and expanding at a 7.9% CAGR to USD 6,511.4 million by 2035. This application serves the largest and most active pool of endotherapy device use: colonoscopy, upper GI endoscopy (EGD), enteroscopy, and EUS procedures collectively account for the overwhelming majority of global endotherapy consumable consumption. The segment benefits from CRC screening program expansion, rising GERD and IBD surveillance demands, growing ESD adoption, and the expanding use of EUS for pancreatic and biliary disease.

Laparoscopy generated USD 953.9 million in 2025 and grows at the second-highest application CAGR of 8.4%, reaching USD 2,128.0 million by 2035. Laparoscopic endotherapy encompasses the accessories used in laparoscopic cholecystectomy, colorectal surgery, bariatric procedures, hernia repair, and hepatic resections - all of which are shifting from open to minimally invasive approaches. Japan's NCD recorded 120,625 laparoscopic cholecystectomies and 87,819 laparoscopic inguinal hernia repairs in 2024, providing a snapshot of the procedure volumes that sustain laparoscopic endotherapy demand even in a mature market. Laparoscopy is the most significant application contributor outside GI endoscopy and is growing fastest in Asia Pacific and Latin America where laparoscopic adoption is still accelerating.

Arthroscopy generated USD 646.0 million in 2025 at a 6.8% CAGR. Endotherapy devices in arthroscopy include the shavers, burs, and thermal ablation tools used in joint-cavity procedures for knee, shoulder, ankle, and hip pathology. This application is more mature in the U.S. and Europe and benefits from sports medicine growth and expanded indications for biologics-adjunct arthroscopic procedures.

Urology endotherapy generated USD 454.4 million in 2025 at a 7.4% CAGR, covering ureteroscopy, cystoscopy, and transurethral resection procedures and their associated accessories. Bronchoscopy generated USD 280.4 million in 2025 at a 6.0% CAGR, encompassing the accessories used in diagnostic and interventional pulmonary endoscopy including endobronchial ultrasound-guided biopsy. Other applications generated USD 231.8 million in 2025 at a 5.3% CAGR.

By End Use

Hospitals are the primary end-use segment, generating USD 3,080.5 million in 2025 - a 54.6% revenue share - at a 7.4% CAGR to reach USD 6,248.8 million by 2035. Hospitals concentrate advanced endotherapy procedures, including complex ERCP, ESD, EUS-FNB, and laparoscopic interventions requiring inpatient post-procedure monitoring capability, multidisciplinary team support, and anesthesia services. High-complexity biliary stenting, malignant obstruction management, and GI emergency hemostasis are predominantly hospital-conducted. The hospital segment's moderate CAGR relative to ASCs reflects partial procedural migration to outpatient settings rather than volume decline.

Ambulatory surgical centers generated USD 1,955.6 million in 2025 at an 8.2% CAGR - the fastest end-use growth rate - to reach USD 4,255.4 million by 2035. ASCs' structural advantages - lower overhead, higher scheduling efficiency, higher throughput per procedural bay, and aligned physician incentives - are driving progressive migration of colonoscopy, EGD, routine polypectomy, and increasingly advanced diagnostic EUS from hospitals. Average monthly GI case volume in U.S. ASCs rose from 167 in 2023 to 176 in 2024, OR block utilization reached 59.6%, and GI case volume at surveyed centers increased 19% year-over-year. Private equity consolidation of GI practices has further accelerated ASC development as a channel. The ASC segment is particularly important for single-use biopsy forceps, polypectomy snares, and hemoclips, where disposable instruments simplify between-case logistics in high-volume outpatient settings. Other end users generated USD 610.0 million in 2025 at a 6.9% CAGR.

Endotherapy Devices Market Regional Analysis

North America

North America is the largest regional market, valued at USD 2,477.5 million in 2025 and projected to reach USD 4,709.5 million by 2035 at a CAGR of 6.7%. The United States accounts for the overwhelming majority of regional revenue at USD 2,338.5 million in 2025, growing at a 6.6% CAGR to USD 4,379.0 million by 2035. Canada generated USD 139.0 million in 2025, growing at a 9.1% CAGR - notably faster than the U.S. - supported by provincial cancer screening program expansion and rising GI procedure volumes in its aging population.

Within North America, GI devices and accessories generated USD 1,361.9 million in 2025 (CAGR 6.5%) and ERCP devices USD 803.9 million (CAGR 7.4%). The U.S. market is anchored by the country's approximately 700,000 annual ERCPs, approximately 12–15 million colonoscopies, and a large, technology-adopting endoscopy community that generates premium-device demand. CRC screening guidelines lowered the recommended screening start age to 45 years in 2021, expanding the screening-eligible population. The ASC channel's outsized and growing role - GI case volume 176/month on average at surveyed ASCs in 2024.^[7] - is a distinctively North American market feature that shapes consumption toward single-use, high-throughput consumables. The region leads single-use biopsy forceps adoption and is the primary launch market for FDA-cleared single-use duodenoscopes. Regulatory clarity from FDA safety communications in 2019 and 2022 regarding duodenoscope reprocessing has accelerated institutional purchasing decisions toward disposable-component or fully disposable designs.^[8].

Europe

Europe generated USD 1,273.9 million in 2025 at a CAGR of 7.3%, reaching USD 2,554.1 million by 2035. Germany, the UK, France, Spain, Italy, and the Netherlands collectively drive the European market through established national endoscopy screening programs, well-developed hospital gastroenterology departments, and high ESD adoption rates - particularly in Germany and the UK, which have invested in training programs to build ESD competency following Asian models. Europe's ERCP complication management framework is guided by ESGE guidelines that quantify post-procedure pancreatitis incidence at 3.5–9.7% across prospective studies, which has sustained clinical interest in prophylactic pharmacotherapy and next-generation ERCP devices designed to reduce pancreatitis risk through more controlled cannulation techniques. The European MDR regulatory environment has raised the bar for device clearance, favoring established multinational suppliers that can absorb the compliance investment, which is gradually concentrating market share among larger players. CE marking of Olympus's cloud-AI endoscopy systems CADDIE, CADU, and SMARTIBD in October 2024 signals that AI-assisted diagnosis will become an active part of the European endoscopy value proposition.

Asia Pacific

Asia Pacific is the fastest-growing region with a 9.0% CAGR, rising from USD 1,591.0 million in 2025 to USD 3,753.3 million by 2035. The region's growth rate - approximately 230 basis points above the global average - reflects an unusual combination of high-incidence GI disease burden, expanding healthcare infrastructure investment, and sub-regional heterogeneity that provides multiple distinct growth engines.

Japan, which operates more than 60,000 installed endoscopy units with 7–8 year replacement cycles and generates strong replacement-driven consumable demand, accounted for approximately 25–30% of Asia Pacific endoscopy device revenue and is the regional center of ESD innovation. Japan's NCD registered 898,643 gastroenterological and abdominal surgical procedures in 2024, with laparoscopic cholecystectomy and inguinal hernia repair among the highest-volume categories, reflecting a mature minimally invasive surgical base. Government-mandated gastric cancer and CRC screening programs drive high colonoscopy and upper GI endoscopy procedure volumes. China is the second-largest Asia Pacific market and is growing rapidly, driven by a population of 1.4 billion with rising CRC and gastric cancer incidence - East Asia recorded 684,927 new cases in 2021, approximately 31% of the global total. Olympus established local manufacturing in Suzhou in 2023 and obtained China's first locally-produced gastroscope regulatory certification (GIF-EZ1500-C) in September 2025, a strategic move that positions the company for competitive pricing in an increasingly price-competitive market. India is the fastest-growing individual market within Asia Pacific, with endoscopy infrastructure expanding through private hospital system growth and government health insurance programs including Ayushman Bharat. South Korea's high-volume gastric cancer screening program and advanced endoscopy training centers make it a disproportionately large consumer of ESD devices relative to its population size. Australia supports above-average CRC screening participation rates with colonoscopy as the primary tool.

Latin America

Latin America generated USD 174.6 million in 2025 at an 8.6% CAGR, reaching USD 395.8 million by 2035. Brazil (the region's largest market) and Mexico are the primary contributors, with Argentina representing a smaller but meaningful base. GI disease burden - including gastric cancer in Andean populations and CRC in urbanized Brazil - drives demand, while expanding private hospital networks and growing middle-class healthcare expenditure support device adoption. The region's 8.6% CAGR - second-highest globally - reflects a favorable combination of rising income, GI disease prevalence, and the nascent state of advanced endoscopy services that can grow rapidly from a low base.

Middle East and Africa

The MEA region generated USD 129.1 million in 2025 at a 7.8% CAGR, reaching USD 276.3 million by 2035. Saudi Arabia and UAE represent established GI endotherapy markets with well-capitalized hospital systems and government-funded healthcare programs that support advanced device adoption. South Africa is the largest African market with more sophisticated endoscopy infrastructure relative to sub-Saharan peers. However, the broader African continent faces significant access barriers: gastroenterologist density of 0.33 per 100,000 in South Africa compares unfavorably with 3.9 per 100,000 in the U.S., upper GI endoscopy capacity in East Africa is below 10% of high-income country rates, and equipment maintenance logistics impose high lifecycle costs. These constraints confine the near-term MEA market to GCC states and South Africa as the primary demand centers, while the region's longer-term growth potential is tied to healthcare infrastructure development and disease screening program expansion.

Endotherapy Devices Market Share & Competitive Landscape

The global endotherapy devices market is moderately concentrated, with the top five companies - Boston Scientific, Cook Medical, Medtronic, MICRO-TECH, and Olympus - collectively holding approximately 65% of market revenue in 2025. Boston Scientific leads the market with more than 28% revenue share, reflecting its dominant position in ERCP devices, EUS needles, and the single-use duodenoscope segment. The remaining revenue is distributed across ten additional companies serving specialized device categories, regional markets, or platform adjacencies.

B. Braun is a Germany-based diversified medtech company with a broad portfolio of endoscopy and ERCP accessories including catheters, guide wires, and injection needles. B. Braun's endotherapy business benefits from its established distribution networks across Europe and Asia.

Boston Scientific leads the global endotherapy market across multiple device categories. Its ERCP portfolio includes the Autotome Pro RX sphincterotome, WallFlex biliary metal stents - the WallFlex Biliary PLUS RX Stent System received FDA 510(k) clearance in December 2024.^[9] - and extraction baskets and balloons. Its EUS portfolio includes the Acquire Franseen-tip FNB needle, validated in network meta-analysis as a superior performer for pancreatic tissue acquisition, and the RIVOS EUS Access Device, a single-device solution combining puncture, guide wire access, and electrocautery dilation for EUS-guided biliary drainage. The AXIOS Stent and Electrocautery-Enhanced Delivery System, FDA-cleared for gallbladder drainage in 2023, exemplifies Boston Scientific's push into EUS-guided therapeutic interventions. The EXALT Model D, the first fully disposable single-use duodenoscope, achieved 96.7% procedural success in a multi-center evaluation and positions Boston Scientific at the forefront of the single-use ERCP device opportunity.

CONMED offers a portfolio of GI endotherapy accessories alongside its core minimally invasive surgery and arthroscopy businesses. The company's endotherapy products include snares, forceps, and hemostatic devices targeting the polypectomy and colonoscopic treatment segments. CONMED's arthroscopy franchise, which competes in the arthroscopy application segment of the endotherapy devices market, serves as a complementary revenue driver.

Cook Medical is a leading ERCP and GI endotherapy specialist with a comprehensive consumable portfolio. In May 2024, Cook launched the EchoTip ClearCore EUS Biopsy Needle in the United States - a 22-gauge device with a Franseen cobalt-chromium tip designed for FNB of solid pancreatic and mediastinal lesions. The SureTome SW Sphincterotome with DomeTip, launched in the U.S. and Canada, is preloaded with Cook's Acrobat 2 Calibrated Tip Wire Guide and targets improved biliary access in ERCP. Cook also recently launched the Cold AcuSnare polypectomy snare and Caesar alligator rat-tooth grasping forceps in the U.S. and Canada, expanding its GI accessories portfolio with bidirectional rotatable designs. Cook Medical's deep ERCP and enteroscopy portfolio positions it among the top global ERCP consumable suppliers.

Endo-Med operates as a specialized endotherapy device manufacturer with products targeting the accessory segments used in GI endoscopy. The company serves primarily regional markets and competes on cost-competitiveness and product availability for standard-category accessories.

FUJIFILM is one of the three global leaders in flexible endoscope platforms, competing alongside Olympus and Pentax. FUJIFILM Healthcare Americas' GI endoscopes - with advanced optical technologies including BLI (Blue Light Imaging) and LCI (Linked Color Imaging) - generate complementary demand for the endotherapy accessories deployed through their working channels. FUJIFILM entered a strategic distribution partnership with KARL STORZ in August 2024 to jointly market FUJIFILM's flexible GI endoscopes alongside KARL STORZ's OR integration solutions, targeting hospital GI suites and ambulatory surgical centers.

Johnson & Johnson participates in the endotherapy market primarily through its MedTech segment, which encompasses minimally invasive instruments, energy devices, and surgical stapling systems relevant to laparoscopic and endoscopic GI surgery. Its presence in traditional GI consumable accessories is more limited than in surgical energy and robotics platforms.

KARL STORZ is a family-owned German medtech company and global leader in rigid and flexible endoscopes and OR integration. In October 2025, KARL STORZ received FDA clearance for the ENDOFLATOR+ insufflator with integrated surgical smoke evacuation system, addressing both insufflation performance and new state-level surgical smoke evacuation mandates. The August 2024 strategic relationship with FUJIFILM allows KARL STORZ to extend its OR integration expertise into GI endoscopy suite settings. KARL STORZ also acquired the medical business of T1V, a visual collaboration software company, in 2025 to advance its CollaboratOR digital surgery integration platform.

M.I. Tech is a South Korean manufacturer specializing in biliary, enteral, and vascular metallic stents. Its BONASTENT and related metal stent platforms address malignant biliary obstruction and enteral stenting indications in ERCP and therapeutic endoscopy. M.I. Tech competes on design innovation and competitive pricing in Asian and emerging markets.

Medtronic participates in the endotherapy market through its Endoscopy division, which includes the SharkCore Fork-tip FNB needle, the GI Genius AI-assisted colonoscopy module, and a range of biliary and pancreatic ERCP accessories. The GI Genius module, a convolutional neural network-based polyp detection system, highlights targeted lesions in real time and was validated in clinical practice studies including a prospective observational trial across 502 patients. In April 2025, Medtronic announced a strategic distribution agreement to commercialize the Dragonfly pancreaticobiliary system from Dragonfly Endoscopy Inc. in the U.S. - a rotatable, flexible-shaft pancreaticobiliary scope introduced into select U.S. academic and clinical centers beginning in 2025.

MICRO-TECH is a Nanjing, China-based endotherapy device manufacturer with one of the broadest GI consumable portfolios among domestic Chinese suppliers, covering biopsy forceps, hemoclips, polypectomy snares, injection needles, and ERCP accessories. MICRO-TECH is one of the five leading global endotherapy companies with approximately 65% collective share, particularly strong in the Asia Pacific region. The company competes on cost and product breadth, serving both Chinese hospital networks and export markets in Asia, Europe, and emerging regions.

Olympus is the world's leading endoscope manufacturer and a major endotherapy consumables supplier through its EndoTherapy product line. Olympus launched the Retentia HemoClip - a single-use hemostasis clip with 360° rotation and three-size configurations - in the U.S. in March 2025. In May 2025, Olympus received FDA 510(k) clearance for its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF) technology for the EVIS X1 system. Olympus entered a distribution agreement with W. L. Gore & Associates in 2025, securing exclusive international distribution rights for the GORE VIABIL Biliary Endoprosthesis - a premium covered metal stent for endoscopic biliary placement - beginning in Europe with subsequent global rollout. In October 2024, Olympus' subsidiary Odin Vision received CE approval under EU MDR for three cloud-AI endoscopy systems: CADDIE (computer-aided detection/diagnosis for polyps), CADU (AI-assisted colonoscopy), and SMARTIBD (AI-based assessment of IBD mucosal activity). Olympus expanded the EVIS X1 system into Brazil in September 2024 and obtained China's first locally-manufactured gastroscope regulatory certificate for the GIF-EZ1500-C in September 2025.

Smith+Nephew participates in the endotherapy market primarily through its arthroscopy portfolio - including visualization, mechanical shaver, and RF energy systems for joint surgery - and its wound management and orthopedic reconstruction businesses. Its endotherapy exposure is concentrated in the arthroscopy application segment.

Stryker competes in the arthroscopy and minimally invasive surgery segments, providing endotherapy-adjacent products including camera systems, shavers, fluid management, and energy ablation devices for joint procedures. Stryker's endotherapy business is particularly strong in North America, where it holds a leading arthroscopy market position.

TAEWOONG MEDICAL is a South Korean manufacturer specializing in self-expanding metal stents for biliary, esophageal, colonic, and duodenal applications. Its NITI-S stent family is among the most widely used covered and uncovered metal stents for malignant GI and biliary obstruction globally. TAEWOONG's ERCP stent portfolio competes directly in the metal stent sub-segment alongside Olympus/Gore, Boston Scientific WallFlex, and M.I. Tech BONASTENT. The company's strength in Asia Pacific and Middle Eastern distribution positions it to capture growth in regions where biliary stenting demand is expanding rapidly.

Recent Industry Developments

May 2025 - Olympus received FDA 510(k) clearance for its EZ1500 series of EVIS X1 endoscopes featuring Extended Depth of Field (EDOF) technology. The GIF-EZ1500 gastroscope and CF-EZ1500DL/I colonoscope are Olympus's most advanced imaging endoscopes, supporting TXI, NBI, and RDI visualization modalities.

May 2025 - Olympus and W. L. Gore & Associates entered into an international distribution agreement making Olympus the exclusive distributor of the GORE VIABIL Biliary Endoprosthesis for endoscopic placement, beginning commercialization in Europe with plans for global rollout.

September 2025 - Olympus obtained China's first Medical Device Registration Certificate for a locally manufactured product - the GIF-EZ1500-C gastroscope - from Jiangsu Medical Products Administration, produced at its Suzhou manufacturing and R&D facility established in 2023. The certification positions Olympus to compete competitively in China's price-sensitive hospital procurement environment.

October 2025 - KARL STORZ received FDA clearance for the ENDOFLATOR+ insufflator and integrated smoke evacuation system, addressing both insufflation performance demands and compliance with expanding state-level surgical smoke evacuation mandates.