Biliary Stents Market Size, Share, Growth and Forecast (2026 - 2036)

Biliary Stents Analysis and Forecast by Fact.MR

• The Biliary Stents Market is expected to grow from USD 370.2 million in 2026 to USD 728.3 million by 2036, at a 7.0% CAGR.
• Driven by rising biliary and pancreatic cancer incidence, expanding ERCP-trained physician capacity and procedure volumes, and self-expanding metal stent adoption lifting category value, with Plastic Biliary Stents accounting for 44.7% of the product segment in 2026 and Malignant Biliary Obstruction contributing 73.6% share as providers prioritize earlier detection, treatment-selection accuracy, and resource efficiency across clinical settings.

Summary of Biliary Stents Market

• Market Snapshot
  • In 2025, the global Biliary Stents Market was valued at approximately USD 346.0 million.
  • The market is estimated to reach USD 370.2 million in 2026 and is projected to attain USD 728.3 million by 2036.
  • The market is likely to expand at a CAGR of 7.0% during the forecast period.
  • The market is anticipated to create an absolute dollar opportunity of USD 358.1 million between 2026 and 2036.
  • Plastic Biliary Stents account for 44.7% of product share in 2026.
  • China (9.4%) and India (8.8%) are the key growth markets during the forecast period.
• Demand and Growth Drivers
  • Rising biliary and pancreatic cancer incidence is expanding the pool requiring stent placement for malignant biliary obstruction, the dominant application.
  • Growth of ERCP-trained physician capacity and procedure volumes across emerging markets widens access to therapeutic biliary stenting.
  • Self-expanding metal stent adoption is lifting average selling prices relative to plastic alternatives, supporting value growth.
  • Drug-eluting and biodegradable stent technologies create differentiation through reduced occlusion and elimination of retrieval procedures.
  • Expanding ERCP training programs are creating a larger base of practitioners able to place stents across more clinical settings.
• Product and Segment View
  • Plastic Biliary Stents accounts for 44.7% of the product segment in 2026, emerging as the leading category.
  • Malignant Biliary Obstruction accounts for 73.6% of the application segment in 2026, making it the dominant use setting.
  • Key segmentation includes:
    • Product: Plastic Biliary Stents, Metal Biliary Stents, Biodegradable Stents, Expandable Stents
    • Application: Malignant Biliary Obstruction, Benign Biliary Strictures, Gallstone Related Obstruction, Post Liver Transplant Complications
    • End Use: Hospitals, Specialty Gastroenterology Clinics, Ambulatory Surgical Centers, Academic & Research Institutes
    • Technology: Endoscopic Stenting Technology, Self Expanding Metal Technology, Drug Eluting Technology, Imaging & Navigation Technology
    • Formulation: Polymer Based Stent Systems, Metal Alloy Formulations, Drug Coated Formulations
    • Distribution Channel: Direct Hospital Supply, Medical Device Distributors, Online Medical Platforms, Specialty Service Providers
  • These systems enable:
    • Biliary obstruction relief and drainage
    • Palliative and bridge-to-surgery stenting
    • Endoscopic fluoroscopy-guided placement
• Geography and Competitive Outlook
  • North America leads on ERCP procedure volumes, established gastroenterology networks, and reimbursement supporting biliary stent placement.
  • Europe demand reflects structured oncology and gastroenterology pathways and EU MDR compliance shaping stent qualification.
  • Expanding ERCP-trained physician capacity and rising biliary disease burden in China and India produce the steepest Asia Pacific growth, widening stenting volumes.
  • China (9.4%) and India (8.8%) lead country growth, with other major markets showing steady demand.
  • Key companies include Boston Scientific Corporation, Cook Medical (Cook Group), Olympus Corporation, Medtronic plc, CONMED Corporation, BD (Becton, Dickinson and Company).
• Analyst Opinion
  • Shambhu Nath Jha, Principal Consultant at Fact.MR, says "Biliary stenting demand tracks two forces: rising biliary cancer incidence and expanding ERCP-trained physician capacity. Plastic stents still lead by volume, but self-expanding metal formats are lifting average selling prices and shifting the value mix. Drug-eluting and biodegradable stents are the next frontier, offering reduced occlusion and potential elimination of retrieval. China and India are the fastest-growing markets as ERCP access widens through training programs and private hospital investment. Suppliers that pair validated stent technology with strong clinical evidence and procedural support hold the advantage, since gastroenterologists choose based on patency, delivery ease, and compatibility with their installed endoscopy suites."

Key Growth Drivers, Constraints, and Opportunities

Key Factors Driving Growth

• Rising biliary and pancreatic cancer incidence is expanding the pool requiring stent placement for malignant biliary obstruction, the dominant application.
• Growth of ERCP-trained physician capacity and procedure volumes across emerging markets widens access to therapeutic biliary stenting.
• Self-expanding metal stent adoption is lifting average selling prices relative to plastic alternatives, supporting value growth.

Key Market Constraints

• Stent occlusion, migration, and the need for replacement procedures limit the durability advantage of individual placements.
• High procedure cost and limited ERCP access in lower-resource settings constrain penetration in some markets.
• Competitive pressure from plastic stents, which remain cost-effective for shorter-term drainage, limits full migration to metal and drug-eluting formats.

Key Opportunity Areas

• Drug-eluting and biodegradable stent technologies create differentiation through reduced occlusion and elimination of retrieval procedures.
• Expanding ERCP training programs are creating a larger base of practitioners able to place stents across more clinical settings.
• Growth in ambulatory surgical center ERCP volumes opens a lower-cost stenting channel.

Segment-wise Analysis of the Biliary Stents

• Plastic Biliary Stents holds 44.7% of the product segment in 2026, supported by clinical preference and procurement scale.
• Malignant Biliary Obstruction represents 73.6% of the application segment in 2026, anchored by its dominant care setting.

The Biliary Stents Market is segmented by product, application, end use, technology, formulation, distribution channel. Demand is shaped by clinical pathway choices, reimbursement exposure, and procurement structure, with leading segments anchored in higher-volume care settings while faster-growing categories capture incremental demand as adoption broadens.

Which Product Segment Dominates the Biliary Stents?

Plastic Biliary Stents lead the product segment with 44.7% share in 2026, reflecting their established role in ERCP-based biliary drainage and their lower cost relative to metal alternatives. Plastic stents remain the first-line choice for shorter-term obstruction management.

The segment is expected to retain volume leadership, though self-expanding metal stents continue to grow their share of value through higher average selling prices and longer patency. Drug-eluting and biodegradable stents represent the next competitive frontier within the category.

Which Application Segment Dominates the Biliary Stents?

Malignant Biliary Obstruction leads the application segment with 73.6% share in 2026, driven by the concentration of stent demand in patients with biliary and pancreatic cancers requiring palliative or bridge-to-surgery drainage. Stent placement is integral to these care pathways.

The application is likely to hold its dominant share as cancer incidence sustains procedure demand. Benign stricture and gallstone-related applications grow alongside, but malignant obstruction anchors the largest application volume through its clinical centrality.

Which Product Trend is Shaping the Next Phase of Growth in the Biliary Stents?

Plastic Biliary Stents lead the product segment at 44.7%, but the defining shift is the rising adoption of self-expanding metal stents that lift average selling prices and support value growth. Endoscopic stenting technology anchors the largest technology share, with demand concentrated in malignant biliary obstruction where stent placement is integral to palliative and bridge-to-surgery care pathways.

Drug-eluting and biodegradable stent technologies are the most disruptive direction, offering reduced occlusion rates and the potential to eliminate retrieval procedures. Polymer-based stent systems anchor the largest formulation share, while metal-alloy and drug-coated formats grow as clinical evidence supports longer patency.

Regional Outlook Across Key Markets

• North America leads on ERCP procedure volumes, established gastroenterology networks, and reimbursement supporting biliary stent placement.
• Europe demand reflects structured oncology and gastroenterology pathways and EU MDR compliance shaping stent qualification.
• Expanding ERCP-trained physician capacity and rising biliary disease burden in China and India produce the steepest Asia Pacific growth, widening stenting volumes.
• Japan shows steady demand anchored in advanced endoscopic practice and high-volume academic centers.

CAGR Table

Source: Fact.MR analysis, based on proprietary forecasting model and primary research.

Market Outlook for Biliary Stents in China

The China Biliary Stents market is projected to grow at a CAGR of 9.4% through 2036. Domestic medical-device manufacturing and ERCP procedure growth across provincial hospitals are reshaping biliary stent supply. Centralized procurement steers pricing, while expanding endoscopy training widens the base of physicians able to perform therapeutic stenting for malignant biliary obstruction.

• Expanding ERCP training programs are widening stent placement access across provincial hospitals.
• Centralized procurement is steering biliary stent purchasing toward cost-competitive suppliers.

India Biliary Stents Demand Trends

The India Biliary Stents market is projected to grow at a CAGR of 8.8% through 2036. Demand is concentrated in metropolitan gastroenterology centers where rising biliary and pancreatic cancer incidence drives ERCP stenting volumes. Cost-effectiveness favors plastic biliary stents for shorter-term drainage, while private hospital investment widens access to self-expanding metal stent placement.

• Private hospital investment is widening ERCP access and biliary stent placement volumes.
• Cost-effectiveness favors plastic stents for shorter-term drainage in emerging clinical settings.

Biliary Stents Growth Assessment in Germany

The Germany Biliary Stents market is projected to grow at a CAGR of 8.1% through 2036. EU MDR compliance governs how biliary stent systems qualify and are validated across German hospitals, raising documentation requirements. The GKV reimbursement framework and structured gastroenterology pathways shape funding for both plastic and metal stent placements, favoring validated endoscopic stenting technology.

• EU MDR validation requirements concentrate stent supply among fully documented manufacturers.
• GKV reimbursement shapes funding for endoscopic biliary stent placement across clinical pathways.

United States Biliary Stents Market Opportunity Outlook

The United States Biliary Stents market is projected to grow at a CAGR of 6.7% through 2036. Established gastroenterology and oncology networks anchor demand, with biliary stenting embedded in ERCP-based palliative and bridge-to-surgery care. FDA pathways and the reimbursement landscape shape stent adoption, while self-expanding metal stent penetration supports value growth in a mature procedural market.

• Self-expanding metal stent adoption supports value growth within mature ERCP procedure volumes.
• Established gastroenterology networks sustain demand for both plastic and metal biliary stent systems.

Biliary Stents Demand Analysis in Japan

The Japan Biliary Stents market is projected to grow at a CAGR of 5.2% through 2036. Advanced endoscopic practice and high-volume academic centers sustain biliary stent demand. PMDA approval pathways and preference for validated platforms shape procurement, while aging-population biliary disease incidence supports steady ERCP procedure and stent-replacement volumes.

• Advanced endoscopic practice sustains demand for biliary stent systems in academic centers.
• Aging-population biliary disease incidence supports steady ERCP stenting volumes.

Competitive Benchmarking and Company Positioning

Biliary Stents Analysis By Company

• Boston Scientific, Cook Medical, and Olympus hold leading positions across biliary stent and ERCP accessory portfolios, supported by clinical validation, broad product lines, and entrenched hospital relationships.
• Medtronic, CONMED, BD, and M.I.Tech compete through stent delivery systems and endoscopic accessories where design performance and procedural fit shape gastroenterologist preference.
• Stent technology differentiation, including drug-eluting and self-expanding formats, increasingly separates leaders from commodity plastic suppliers.

The competitive landscape is moderately consolidated, with differentiation driven by stent design, delivery-system performance, and the breadth of ERCP accessory portfolios. Boston Scientific, Cook Medical, and Olympus lead through extensive clinical evidence, broad stent lines, and deep relationships with high-volume gastroenterology centers.

Below the leaders, Medtronic, CONMED, BD, M.I.Tech, and ENDO-FLEX maintain positions through stent design, pricing, and regional distribution strength. Competition turns on patency duration, delivery ease, and compatibility with installed endoscopy platforms rather than brand alone.

Drug-eluting and biodegradable stent development represent the next competitive frontier, offering reduced occlusion and potential elimination of retrieval. Suppliers that pair validated stent technology with strong clinical evidence and procedural support are positioned to defend accounts as metal-stent adoption lifts average selling prices.

Key Companies in the Biliary Stents

• Leading companies in the biliary stents market include Boston Scientific Corporation, Cook Medical (Cook Group), Olympus Corporation, Medtronic plc, which hold strong positions through portfolio breadth, clinical evidence, and broad distribution.
• CONMED Corporation, BD (Becton, Dickinson and Company), M.I.Tech Co., Ltd., ENDO-FLEX GmbH maintain established positions across specific segments and channels, competing on stent performance, patency duration, service, and regional reach.
• Merit Medical Systems, Inc., Hobbs Medical Inc. and other specialists compete through focused offerings and niche strength, reinforcing relevance in a competitive but evolving market.

Recent Industry Developments

Gore Selects New International Distribution Partner for the GORE® VIABIL® Biliary Endoprosthesis for Endoscopic Placement (2025)

• Gore appointed Olympus as the exclusive international distributor for its VIABIL biliary stent platform, expanding global commercialization and physician access to the product.

Dragonfly™ Pancreaticobiliary Scope System Receives FDA 510(k) Clearance (2024)

• Dragonfly received FDA clearance for its rotatable pancreaticobiliary scope system designed for cholangioscopy and pancreatoscopy procedures. Improved visualization and access can support more precise biliary stent placement and management.

Leading Companies Shaping the Biliary Stents

• Boston Scientific Corporation
• Cook Medical (Cook Group)
• Olympus Corporation
• Medtronic plc
• CONMED Corporation
• BD (Becton, Dickinson and Company)
• M.I.Tech Co., Ltd.
• ENDO-FLEX GmbH
• Merit Medical Systems, Inc.
• Hobbs Medical Inc.

Sources and Research References

• Olympus America Inc. (2025). Olympus and W. L. Gore & Associates enter international distribution agreement to expand Olympus EndoTherapy portfolio. Olympus America. 
• Dragonfly Endoscopy, Inc. (2024). Dragonfly Endoscopy announces FDA 510(k) clearance of innovative pancreaticobiliary scope. Dragonfly Endoscopy. 

This bibliography is provided for reader reference and is not exhaustive. The full report contains the complete reference list and detailed citations.

Key Questions This Report Addresses

• What is the current and future size of the Biliary Stents Market?
• How fast is the Biliary Stents Market expected to grow between 2026 and 2036?
• Which product segment is likely to lead the market by 2026?
• Which application segment is expected to account for the highest demand by 2026?
• What factors are driving demand in the biliary stents market globally?
• Which countries are projected to show the fastest growth through 2036?
• What is driving market expansion in China and India?
• Who are the key companies active in the biliary stents market?
• How does self-expanding metal stent adoption affect category value growth?
• What role do drug-eluting and biodegradable stents play in clinical differentiation?
• How does Fact.MR estimate and validate the biliary stents market forecast?

Biliary Stents Market Definition

The biliary stents market covers plastic, metal, biodegradable, and expandable stents used to relieve biliary obstruction. It spans endoscopic stenting, self-expanding metal, drug-eluting, and imaging and navigation technologies delivered through polymer-based, metal-alloy, and drug-coated formulations across hospitals, specialty gastroenterology clinics, and ambulatory surgical centers for malignant, benign, gallstone-related, and post-transplant biliary management.

Biliary Stents Market Inclusions

• The scope covers global and regional market size and forecasts for 2026 to 2036 across product type, application, end use, technology, formulation, and distribution channel.
• It includes demand tied to ERCP procedure volumes, pancreatic and biliary cancer incidence, and stent-replacement cycles.
• Pricing analysis spans plastic and self-expanding metal stent systems across hospital and ambulatory channels.
• Coverage includes drug-eluting and biodegradable stent technologies and their clinical adoption.

Biliary Stents Market Exclusions

• The scope excludes general gastrointestinal stents outside the biliary definition.
• It excludes ERCP endoscopes and accessories without a stent component.
• Non-biliary vascular and urological stents are excluded.
• Consumer digestive products without a biliary-obstruction management function are excluded.

Biliary Stents Market Research Methodology

• The methodology combines secondary research, primary interviews, and demand-side modeling.
• It draws on 110 plus secondary sources and benchmarks 50 plus stent and device portfolios.
• Market sizing covers 30 plus countries through an ERCP-volume and biliary-disease incidence model with top-down validation.
• Key inputs include biliary and pancreatic cancer incidence, gallstone prevalence, ERCP procedure rates, and stent-replacement cycles.
• The model cross-checks demand with stent shipments, pricing trends, and hospital procurement patterns.
• Primary validation includes 20 plus interviews across gastroenterologists, endoscopists, hospital procurement, and distributors.
• Final estimates pass through procedure-volume reconciliation and sensitivity testing.