Biliary Stents Market Size & Share 2026-2035

Biliary Stents Market Size

The global biliary stents market was valued at USD 492.3 million in 2025. The market is expected to reach USD 530.3 million in 2026 to USD 916.4 million in 2035, growing at a CAGR of 6.3% during the forecast period, according to the latest report published by Global Market Insights Inc.

The high market growth is attributed to the rising prevalence of biliary disorders and cancers, growing adoption of minimally invasive procedures, and technological advancements in stents design, among other contributing factors

Biliary stents are small, tubular devices used to treat blockages or obstructions in the bile ducts. They are employed in managing conditions such as biliary strictures, biliary leaks, or cholangitis, which are often associated with pancreatic or liver diseases, including cancer.

The major players in the biliary stents market are Boston Scientific, Cook Medical, OLYMPUS, Medtronic, and CONMED. These companies maintain their competitive position through ongoing product innovation, global market presence, and substantial investment in the market.

The market increased from USD 394.8 million in 2022 to USD 455.3 million in 2024, registering a historical growth rate of 7.4%. This growth is primarily attributed to the rising prevalence of biliary and hepatopancreatic disorders, including gallstones, biliary strictures, pancreatic cancer, and cholangiocarcinoma. Additionally, the increasing adoption of minimally invasive procedures such as ERCP and PTC, advancements in stent materials and design, improved diagnostic capabilities, and expanding healthcare infrastructure have supported market expansion.

Furthermore, the growing incidence of biliary conditions such as cholangitis, biliary strictures, and pancreatic cancers continues to drive demand for biliary stents. Pancreatic and liver cancers frequently lead to bile duct obstructions, necessitating stent placement for palliative care and symptom management. In addition, chronic pancreatitis and post-surgical biliary complications often require stenting to restore bile flow. The increasing global burden of these conditions, driven by ageing populations and lifestyle-related risk factors, is significantly contributing to market growth.

Biliary Stents Market Trends

Several trends are shaping the market. The growing preference for minimally invasive interventional procedures, such as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC), is significantly driving the adoption of biliary stents. These approaches offer advantages such as reduced procedural risk, shorter hospital stays, and faster recovery compared to open surgical interventions, reinforcing biliary stenting as a first-line treatment option for biliary obstructions.

• Advancements in stent materials and design represent another key trend influencing market evolution. The adoption of nitinol, a shape-memory alloy, has enhanced stent flexibility, radial strength, and self-expansion properties, enabling better conformity to bile duct anatomy and improved long-term patency. In parallel, the use of biocompatible polymers such as polyethylene and polyurethane in plastic stents has increased, supporting better resistance to clogging and extending functional lifespan, particularly in short-term or benign indications.
• Additionally, progress in imaging and manufacturing technologies, including three-dimensional (3D) imaging and computer-assisted design (CAD), is enabling the development of customized biliary stents tailored to individual patient anatomies. These patient-specific solutions improve placement accuracy, reduce the risk of migration and complications, and enhance clinical outcomes, particularly in complex cases such as hilar strictures.

Biliary Stents Market Analysis

Based on type, the market is segmented into metal stents and polymer stents. The metal stents segment has asserted its dominance in the market by securing a significant market share of 67.8% in 2025 owing to their superior radial strength, reduced risk of occlusion, and increasing clinical preference for self‑expandable metal stents in the management of malignant biliary obstructions, which require durable and long‑term drainage solutions. The segment is expected to reach USD 609.2 million by 2035, growing at a CAGR of 6.1% during the forecast period.

• The rising incidence of malignant biliary obstructions, particularly those associated with pancreatic cancer and cholangiocarcinoma, is a key factor driving the adoption of metal biliary stents. These conditions often require durable, long-term drainage solutions, making self-expanding metal stents (SEMS) the preferred choice due to their ability to maintain duct patency and reduce procedure-related complications in palliative care settings.
• Ongoing innovation in metal stent design is further supporting segment expansion. Advanced configurations, including fully covered and partially covered stents, help prevent tumor ingrowth while minimizing the risk of stent migration.
• In addition, the development of biodegradable and drug-eluting metal stents is gaining clinical attention, as these technologies aim to enhance therapeutic outcomes, extend stent functionality, and address limitations associated with conventional designs.
• The polymer stents segment accounted for USD 158.4 million in 2025 and is projected to expand at a CAGR of 6.7% from 2026 to 2035. The segmental growth is driven by cost-effectiveness, ease of placement and removal, and widespread use in benign biliary conditions requiring short-term drainage. Polymer stents are commonly utilized in postoperative strictures, bile leaks, and as a temporary solution prior to definitive surgical or endoscopic intervention.

Based on application, the biliary stents market is classified into gallstones, pancreatic cancer, bilio-pancreatic leakages, benign biliary strictures, and other applications. The gallstones segment dominated the market with a revenue share of 52.1% in 2025 and is expected to reach USD 475.8 million within the forecast period.

• The high global prevalence of gallstones, particularly in developed regions, is a major factor driving the adoption of biliary stents in this segment. Lifestyle factors such as high-fat diets, obesity, and sedentary behavior have contributed to a rising incidence of gallstones, increasing the number of patients requiring interventional management for biliary obstruction and related complications.
• ERCP-based treatment protocols have become the standard of care for gallstone-related biliary obstructions, with biliary stent placement playing a critical role in restoring bile flow, alleviating symptoms, and preventing complications such as cholangitis and pancreatitis. The widespread availability of ERCP across hospital and specialty gastroenterology settings continues to support strong procedural demand for biliary stents.
• Additionally, advancements in diagnostic imaging, including ultrasonography and magnetic resonance imaging (MRI), have enabled earlier and more accurate detection of gallstones and associated biliary complications. This has increased the use of biliary stents as both preventive and therapeutic interventions, contributing to the sustained dominance of the gallstones segment in the overall market.
• The pancreatic cancer segment accounted for USD 138.1 million in 2025 and is projected to grow at a CAGR of 6.8% over the forecast period. Growth is primarily driven by the rising global incidence of pancreatic cancer, a significant proportion of which presents with malignant biliary obstruction at diagnosis.
• The bilio-pancreatic leakages segment accounted for USD 27.6 million in 2025 and is expected to expand at a CAGR of 5.4% from 2026 to 2035. This growth is attributed to the increasing incidence of post-surgical bile leaks, particularly following procedures such as cholecystectomy, liver transplantation, and other hepatobiliary surgeries.
• The benign biliary strictures segment accounted for USD 22 million in 2025 and is anticipated to grow at a CAGR of 5% during the forecast period. Demand is driven by the rising prevalence of postoperative strictures, chronic pancreatitis-related complications, and inflammatory biliary conditions.

 

Based on end use, the biliary stents market is classified into hospitals, ambulatory surgical centers, and other end users. The hospitals segment dominated the market with a revenue share of 74.1% in 2025 and is expected to reach USD 671.3 million within the forecast period.

• Hospitals represent the primary end user segment in the market, as they are equipped with the advanced infrastructure and clinical expertise required to perform complex diagnostic and therapeutic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC). These procedures rely on high‑end imaging systems and skilled interventional gastroenterologists for accurate stent placement, positioning hospitals as the central point of care for biliary obstruction management.
• Additionally, ongoing advancements in biliary stent materials, designs, and placement techniques have enabled hospitals to deliver improved clinical outcomes and more effective management of complex biliary disorders. Enhanced stent performance, longer patency, and reduced complication rates support higher procedural success, reinforcing hospital preference for biliary stenting as a standard treatment approach.   
• The ambulatory surgical centers segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 7% over the forecast period. Growth in this segment is driven by the increasing shift of routine and minimally invasive biliary procedures to outpatient settings, supported by advancements in ERCP techniques and same‑day discharge protocols. ASCs are increasingly adopting biliary stents for uncomplicated cases to improve procedural efficiency, reduce hospital burden, and offer cost‑effective care.

North America Biliary Stents Market

North America dominated the market with the highest market share of 35% in 2025.

• The U.S. market was valued at USD 133.9 million and USD 141.9 million in 2022 and 2023, respectively. The market size reached USD 159.8 million in 2025, growing from USD 149.9 million in 2024, and is anticipated to grow at a CAGR of 4.7% from 2026 to 2035.
• North America, particularly the U.S., represents a significant market for biliary stents, supported by the high prevalence of biliary and hepatopancreatic diseases. Conditions such as biliary obstructions, gallstones, cholangitis, pancreatic cancer, and cholangiocarcinoma are widely observed in the region, driven by risk factors including obesity, an ageing population, and lifestyle-related metabolic disorders. This substantial disease burden continues to drive demand for endoscopic and percutaneous stenting procedures.
• The region benefits from a well-established healthcare infrastructure and widespread adoption of advanced diagnostic and interventional techniques, including ERCP and PTC. The availability of skilled gastroenterologists and interventional radiologists supports early diagnosis and effective management of complex cases, reinforcing strong utilization of biliary stents across hospital and specialty care settings.
• Additionally, favorable reimbursement frameworks in the U.S., including coverage under Medicare and Medicaid, enhance patient access to biliary stent placement procedures. As stenting is considered a standard of care for managing biliary obstructions, insurance coverage reduces financial barriers and supports higher procedural volumes. This reimbursement support, combined with early adoption of advanced stent technologies, positions North America as a mature and high-value market.

Europe Biliary Stents Market

Europe market accounted for USD 154 million in 2025 and is anticipated to show lucrative growth over the forecast period.

• Europe represents a significant and steadily growing market for biliary stents, supported by the rising prevalence of biliary and hepatopancreatic diseases across the region. In countries such as France, biliary stents are widely used to manage malignant biliary obstructions associated with cancers including pancreatic cancer and cholangiocarcinoma. Increasing cancer incidence driven by ageing populations, lifestyle changes, and higher smoking rates has led to greater reliance on biliary stenting for palliative care and symptom management.
• Many European countries benefit from well‑established healthcare systems with universal or near‑universal coverage, ensuring broad patient access to advanced gastroenterology and hepatobiliary interventions. Hospitals across the region are equipped with modern endoscopy units capable of performing ERCP and other minimally invasive procedures, which supports consistent utilization of biliary stents in both malignant and benign indications.
• Additionally, continuous healthcare advancements and adherence to evidence‑based clinical guidelines are encouraging the adoption of newer and more effective biliary stent technologies. As stent designs improve and gain regulatory approval under the EU medical device framework, hospitals particularly in Western Europe are increasingly incorporating advanced solutions into standard care pathways.

Asia Pacific Biliary Stents Market

The Asia Pacific market is anticipated to grow at the highest CAGR of 8.3% during the analysis timeframe.

• Asia Pacific represents a rapidly growing market for biliary stents, driven by significant demographic shifts and rising disease prevalence. Countries such as Japan, which has one of the world’s fastest‑ageing populations, are witnessing a higher incidence of age‑related biliary conditions including bile duct cancer, gallstones, and chronic pancreatitis. As older adults are more prone to biliary obstructions, the demand for interventional solutions such as biliary stent placement has increased substantially across the region.
• Healthcare systems in the region, particularly in developed Asia Pacific markets like Japan, South Korea, and Australia are increasingly emphasizing minimally invasive, patient‑centric treatment approaches. Hospitals and specialty care centers are performing a growing number of ERCP‑based procedures for biliary stent placement, supported by advanced imaging and endoscopic capabilities. The preference for minimally invasive techniques, which offer reduced recovery time and lower procedural risk compared to surgery, is driving wider adoption of biliary stents.

Latin America Biliary Stents Market

The Latin America market is experiencing robust growth over the analysis timeframe.

• Latin America represents an emerging market for biliary stents, supported by the steady expansion of private healthcare facilities and specialty gastroenterology centers across the region. Private hospitals in countries such as Brazil, Mexico, and Argentina are increasingly investing in advanced endoscopic equipment and interventional capabilities to manage complex biliary conditions, including gallstones, biliary strictures, and malignant obstructions. This expansion of private-sector healthcare infrastructure is driving greater adoption of biliary stents for minimally invasive treatment.
• Additionally, ongoing improvements in healthcare access and referral networks are strengthening the diagnosis and treatment of biliary diseases across Latin America. The growing availability of ERCP services in urban hospitals and specialty centers is enabling earlier intervention and effective management of biliary obstructions using stent placement. Increased physician training and modernization of endoscopy units are further supporting procedural growth.
• Furthermore, rising awareness of minimally invasive treatment options and gradual increases in healthcare spending by both public and private providers are enhancing the uptake of biliary stents in the region. As healthcare systems continue to modernize and focus on improving outcomes for hepatobiliary disorders, the deployment of biliary stents is expected to increase steadily across Latin America over the forecast period.

Middle East & Africa Biliary Stents Market

The Middle East & Africa (MEA) market is experiencing robust growth over the analysis timeframe.

• The Middle East & Africa (MEA) represents a developing market for biliary stents, driven by the rising prevalence of lifestyle‑ and age‑related conditions that increase the risk of biliary and hepatopancreatic disorders. Factors such as obesity, diabetes, and metabolic syndromes particularly prevalent in Middle Eastern countries are associated with a higher incidence of gallstones, biliary obstructions, and related complications. This growing disease burden is prompting greater demand for interventional solutions such as biliary stent placement.
• Countries in the Gulf Cooperation Council (GCC) are making substantial investments in healthcare infrastructure, including the development of advanced hospitals, tertiary care centers, and specialized gastroenterology facilities. These investments are improving access to modern diagnostic tools and minimally invasive procedures such as ERCP, enabling more effective management of biliary conditions and supporting increased utilization of biliary stents.

Biliary Stents Market Share

The market is characterized by moderate to high competition, driven by continuous product innovation, expanding endoscopic portfolios, and a strong focus on improving clinical outcomes in hepatobiliary care. Manufacturers are actively investing in the development of advanced biliary stents featuring enhanced patency, anti‑migration designs, improved biocompatibility, and ease of deployment through ERCP‑ and PTC‑based procedures.

Key players in the market include Boston Scientific, Cook Medical, OLYMPUS, Medtronic, and CONMED, which collectively account for approximately ~68% of the total global market share. These companies maintain strong global distribution networks and long‑standing relationships with hospitals and gastroenterology specialists. Significant investments in research and development enable continuous product launches, including self‑expandable metal stents (SEMS), covered and partially covered variants, and next‑generation delivery systems designed to improve procedural success rates.

In addition to major multinational players, several regional and specialized manufacturers contribute to market competition by offering cost‑effective polymer stents and targeting specific clinical applications or geographic markets. These players typically focus on price‑sensitive regions and outpatient care settings. As healthcare infrastructure expands in emerging economies and demand for minimally invasive biliary interventions continues to rise, competition in the market is expected to intensify, with manufacturers prioritizing innovation, clinical evidence generation, and strategic collaborations to strengthen their market positioning.

Biliary Stents Market Companies

A few of the prominent players operating in the biliary stents industry include:

• Allium Medical
• Becton, Dickinson and Company
• Boston Scientific
• CONMED
• Cook Medical
• Cordis
• ELLA – CS
• ENDO-FLEX
• M.I Tech
• Medtronic
• Merit Medical Systems
• MICRO-TECH
• OLYMPUS
• S&G Biotech
• Taewoong Medical
• OLYMPUS

OLYMPUS holds a strong position in the market through its integrated endoscopy‑driven approach to hepatobiliary disease management. The company’s strength lies in its comprehensive ecosystem of ERCP systems, endoscopic accessories, and biliary stenting solutions, enabling seamless procedural compatibility.

• Medtronic

Medtronic is a key player in the market, supported by its broad minimally invasive therapies portfolio and strong global distribution network. The company offers both metal and polymer biliary stents designed to address benign and malignant biliary obstructions. Medtronic emphasizes clinical reliability, ease of deployment, and long‑term patency, making its stents well suited for palliative care and complex biliary interventions.

• CONMED

CONMED has established a notable presence in the market by offering cost‑effective and clinically efficient endoscopic solutions tailored to routine and complex biliary procedures. The company’s biliary stent portfolio is designed to support reliable drainage, reduced complication risks, and compatibility with standard ERCP techniques.

Biliary Stents Industry News

• In May 2026, TaeWoong Medical USA received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Niti‑S SPAXUS Stent, expanding its endoscopic ultrasound (EUS)‑guided therapeutic portfolio. This regulatory clearance enables the commercial launch of the fully covered, self‑expanding metallic SPAXUS stent in the U.S. The FDA clearance strengthens TaeWoong Medical’s advanced biliary and EUS‑guided interventional offerings, supports broader adoption of minimally invasive biliary drainage procedures, and enhances the company’s competitive positioning in the U.S. biliary stents and therapeutic endoscopy market.
• In December 2025, Olympus Corporation, W. L. Gore & Associates, and ConMed Corporation announced the transition of commercial support and distribution for the GORE VIABIL Biliary Endoprosthesis in the U.S. This strategic realignment enhances Olympus’s footprint in the U.S. fully covered metal biliary stents segment, strengthens market access for the VIABIL biliary stent through Olympus’s established endotherapy sales network, and reinforces competitive positioning within the U.S. market.
• In July 2024, CGBIO received product approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its ARISTENT biliary stents. This regulatory milestone enables the commercial launch of ARISTENT in the Japanese market, where the product is gaining early traction. The approval strengthens CGBIO’s biliary stent portfolio and supports the company’s strategy to accelerate global expansion, enhancing its market reach and competitive positioning in the market.

The biliary stents market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2022 – 2035 for the following segments:

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Market, By Type

• Metal stents
• Polymer stents

Market, By Application

• Gallstones
• Pancreatic cancer
• Bilio-pancreatic leakages
• Benign biliary strictures
• Other applications

Market, By End Use

• Hospitals
• Ambulatory surgical centers
• Other end users

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

• 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
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE