Biliary Stents Market Size, Share & Forecast 2026-2033

Overview

The Global Biliary Stents Market size was valued at USD 165 million in 2025 and is expected to reach USD 249.4 million by 2033, growing with a CAGR of 5.3% during the forecast period 2026-2033. The global biliary stents market is growing steadily, driven by the rising incidence of liver cancer and other hepatobiliary diseases, along with the increasing adoption of minimally invasive endoscopic procedures such as ERCP for the management of biliary obstructions. Technological advancements are further shaping the market through the development of smart, sensor-enabled, and multifunctional biliary stents that incorporate features such as real-time monitoring, antimicrobial and drug-eluting coatings, and anti-adhesion surfaces to improve stent patency, reduce complications, and enhance long-term patient outcomes. These innovations, combined with ongoing research, strategic industry collaborations, and expanding clinical adoption, are accelerating the transition toward next-generation biliary stenting solutions.

The market is also benefiting from the increasing volume of therapeutic endoscopic procedures used to manage biliary disorders. According to the American Society for Gastrointestinal Endoscopy, more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed annually in the United States alone, with biliary obstruction representing one of the leading indications for intervention. In parallel, demographic trends continue to expand the addressable patient population. According to the United Nations, the global population aged 65 years and older is projected to increase from about 857 million in 2025 to more than 1.2 billion by 2035, increasing the prevalence of age-related hepatobiliary disorders such as gallstones, biliary strictures, and pancreaticobiliary malignancies that frequently require biliary stenting.

Drivers

Rising Global Incidence of Liver Cancer

The rising global incidence of liver cancer is a major factor driving demand in the biliary stents market, as many patients develop biliary obstruction caused by tumors compressing or invading the bile ducts. Biliary stents play a critical role in restoring bile flow, relieving jaundice, reducing the risk of cholangitis, and improving quality of life, particularly for patients with advanced or inoperable liver cancers. Their use is also essential in enabling patients to undergo chemotherapy, immunotherapy, or palliative care by improving liver function and minimizing complications associated with blocked bile ducts. As healthcare providers increasingly prioritize minimally invasive interventions, endoscopic biliary stenting has become a preferred treatment option, further supporting market growth.

The growing burden of liver cancer underscores the expanding need for biliary stenting procedures worldwide. According to a study published by the NIH, global primary liver cancer cases are projected to exceed 1.5 million annually by 2030, reflecting a substantial increase in disease prevalence. Additionally, the 2024 World Health Organization (WHO) reported approximately 905,677 new liver cancer cases and 830,180 deaths globally, highlighting the disease's significant mortality and healthcare impact. As the number of patients requiring effective management of biliary complications continues to rise, demand for advanced biliary stents—including self-expanding metal stents and drug-eluting stents—is expected to grow, encouraging innovation and broader adoption across hospitals and specialized gastroenterology centers.

Growing Adoption of Minimally Invasive Surgical and Endoscopic Procedures

The growing adoption of minimally invasive surgical and endoscopic procedures is a key driver of the biliary stents market, as these techniques offer effective treatment for biliary obstructions while reducing patient trauma, hospital stays, recovery time, and the risk of postoperative complications. Endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) have become the standard approach for placing biliary stents in patients with malignant and benign biliary strictures, replacing more invasive surgical alternatives in many cases. Increasing preference among healthcare providers and patients for minimally invasive interventions, coupled with advancements in stent design, delivery systems, and imaging technologies, continues to expand the adoption of biliary stents across hospitals and specialty gastroenterology centers.

Industry developments further reflect the growing focus on minimally invasive biliary therapies and the strengthening of market distribution networks. 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 United States. This strategic realignment expands Olympus’s presence in the U.S. fully covered metal biliary stents segment, improves market access for the VIABIL biliary stent through Olympus’s established endotherapy sales network, and enhances the company's competitive position in the growing minimally invasive biliary intervention market. Such strategic collaborations are expected to accelerate product availability, increase physician adoption, and support continued growth of the global biliary stents market.

Restraint

High Cost of Biliary Stents and the Procedures

The high cost of biliary stents and the procedures required for their placement is a significant restraint on the growth of the biliary stents market, particularly in low- and middle-income countries. Advanced self-expanding metal stents (SEMS), fully covered stents, and drug-eluting stents are considerably more expensive than conventional plastic stents, making them less accessible for many patients and healthcare providers with limited budgets. In addition to the cost of the stent itself, patients incur expenses related to diagnostic imaging, endoscopic retrograde cholangiopancreatography (ERCP), anesthesia, hospitalization, physician fees, and post-procedure follow-up, substantially increasing the overall cost of treatment. These financial barriers can delay treatment or lead healthcare providers to choose lower-cost alternatives, even when more advanced stents may offer superior long-term outcomes.

The economic burden is further amplified in healthcare systems with limited reimbursement coverage or high out-of-pocket expenses, where affordability remains a critical challenge. Although metal biliary stents often provide longer patency and reduce the need for repeat interventions, their higher upfront cost can discourage widespread adoption, especially in resource-constrained settings. Smaller hospitals and ambulatory care centers may also face budget limitations that restrict the procurement of premium biliary stents and advanced endoscopic equipment. As a result, cost considerations continue to influence treatment decisions, limit market penetration of innovative stent technologies, and create disparities in access to minimally invasive biliary care across different regions.

Biliary Stents Market Trends & Opportunities

Shift Toward Smart and Sensor-Enabled Stent Technologies

The shift toward smart and sensor-enabled stent technologies is emerging as a significant trend in the biliary stents market, driven by the need to improve patient monitoring, enable early detection of stent-related complications, and reduce the frequency of emergency interventions. Unlike conventional biliary stents, smart stents equipped with integrated sensing technologies can provide real-time information on stent patency and obstruction, supporting more proactive and personalized patient management.

This trend is gaining momentum through ongoing research and innovation. For example, in November 2024, researchers at the University of Michigan developed a miniature, batteryless magnetoelastic sensor capable of detecting early biliary stent blockages by monitoring frequency shifts caused by sludge accumulation. Successfully tested in animal models, the technology enables non-invasive, real-time monitoring and facilitates timely clinical intervention before severe complications such as cholangitis or complete stent occlusion occur. Such advancements are expected to enhance treatment outcomes, reduce healthcare costs associated with repeat procedures, and accelerate the adoption of next-generation biliary stent technologies.

Shift Toward Smart and Multifunctional Biliary Stents

The shift toward smart and multifunctional biliary stents is emerging as a key trend in the biliary stents market, driven by the need to enhance stent performance, reduce procedure-related complications, and improve long-term patient outcomes. Manufacturers and researchers are increasingly focusing on next-generation stents that combine multiple functionalities, including antimicrobial protection, controlled drug delivery, anti-adhesion surfaces, and real-time monitoring capabilities, to address the limitations of conventional stents.

Supporting this trend, an October 2025 published review titled "Research Progress on Biliary Stent Materials and Coatings" highlighted significant advances in biliary stent materials and surface coatings, emphasizing innovations such as antimicrobial, drug-eluting, and anti-adhesion coatings that improve stent patency and reduce infection and sludge formation. The review also identified emerging technologies, including 3D-printed patient-specific stents and smart sensor-enabled stents, while underscoring the need for continued research into biodegradable materials, multifunctional coatings, and long-term clinical validation to accelerate the adoption of advanced biliary stent technologies.

Segment Analysis

The global biliary stents industry is segmented based on type, by application, by end-use and region.

Metal Segment Dominates Due to Superior Clinical Performance

Metal biliary stents market segment held the largest market revenue share of more than 65% in the year 2025. The metal stents segment is experiencing strong growth in the biliary stents market due to its superior clinical performance, longer patency, and lower need for repeat interventions compared to plastic stents. Self-expanding metal stents (SEMS) are widely preferred for managing malignant biliary obstructions because they offer larger lumen diameters, improved bile drainage, greater resistance to occlusion, and enhanced patient outcomes, making them more cost-effective over the long term despite their higher initial price.

Continuous advancements in stent materials, flexible designs, and fully covered and partially covered metal stents have further expanded their clinical applications. Reflecting this trend, in January 2024, Olympus Corporation integrated Taewoong’s advanced metallic stent designs into its gastrointestinal treatment portfolio, strengthening its offerings across biliary, esophageal, colon, and duodenal stenting. Such product innovations and strategic portfolio expansions are accelerating physician adoption and reinforcing the dominance of the metal segment in the global biliary stents market.

Increasing Global Prevalence of Gallstone Disease

The gallstones segment accounted for the largest application share in the biliary stents market in 2025, driven by the widespread use of biliary stents during ERCP for managing complex choledocholithiasis and gallstone-related biliary obstruction. In routine clinical practice, temporary plastic biliary stents are frequently placed when complete stone extraction cannot be achieved during the initial ERCP because of large stone burden, difficult anatomy, distal strictures, or patient instability. Stenting maintains biliary drainage, reduces intraductal pressure, prevents recurrent cholangitis and obstructive jaundice, and serves as a bridge to repeat ERCP or definitive surgical management. Biliary stents are also routinely used after lithotripsy or incomplete stone clearance to facilitate spontaneous stone fragmentation and improve the success of subsequent stone removal procedures. These well-established clinical applications make gallstone disease the largest indication for biliary stent placement worldwide.

The expanding burden of gallstone disease continues to support procedure volumes. According to research published in ScienceDirect in October 2024, approximately 6% of the global population has gallstones, highlighting the substantial patient population requiring diagnosis and treatment. As the incidence of gallstone-related biliary disorders rises alongside aging populations and increasing rates of obesity and metabolic diseases, demand for ERCP procedures and biliary stent placement is expected to continue growing.

Ambulatory Surgical Centers (ASCs) Segment is the Fastest-Growing End-Use Segment

The ambulatory surgical centers (ASCs) market segment is growing in the biliary stents market report due to the increasing shift toward minimally invasive endoscopic procedures that can be performed safely in outpatient settings. Advances in endoscopic retrograde cholangiopancreatography (ERCP), improved biliary stent technologies, and enhanced perioperative care have enabled many biliary stenting procedures to be completed without prolonged hospitalization, reducing healthcare costs and improving patient convenience. ASCs offer shorter wait times, streamlined workflows, lower procedural costs compared to hospitals, and faster patient recovery, making them an attractive option for eligible patients requiring treatment for benign biliary strictures, gallstone-related obstructions, and selected malignant biliary conditions. Additionally, growing investments in advanced endoscopy equipment and the expansion of specialized gastroenterology services within ASCs are further driving the adoption of biliary stenting procedures in these facilities, supporting the segment's growth in the global biliary stents market.

Geographical Penetration

North America Biliary Stents Market: Driven by the Region's High Prevalence of Hepatobiliary Diseases

North America held the largest market revenue share of 44% in the year 2025. The North America biliary stents market is growing due to the region's high prevalence of hepatobiliary diseases, well-established healthcare infrastructure, widespread adoption of advanced endoscopic procedures, and increasing incidence of cancers that cause biliary obstruction. Liver and intrahepatic bile duct cancers remain major contributors to the demand for biliary stenting, as these conditions frequently require stents to relieve bile duct blockages, alleviate jaundice, and improve eligibility for cancer therapies.

According to the American Cancer Society, an estimated 42,240 new cases of liver and intrahepatic bile duct cancer were expected in the United States in 2025, creating sustained demand for biliary drainage devices. In addition, pancreatic disorders are a significant growth driver for the market. According to a Cleveland Clinic article, the substantial incidence of acute and chronic pancreatitis in the U.S. results in approximately 275,000 and 86,000 hospitalizations annually, respectively. Since pancreatitis and related pancreatic conditions can lead to biliary strictures and obstructions requiring endoscopic intervention, the rising burden of these diseases continues to increase the utilization of biliary stents across hospitals and specialized gastroenterology centers, supporting the region's market growth.

Europe Biliary Stents Market: Driven by Rising Liver Disease Burden and Continuous Technological Advancements

Biliary stents market report in Europe is growing due to the rising burden of hepatobiliary diseases, increasing adoption of minimally invasive endoscopic procedures, and continuous advancements in biliary stent technologies. The growing prevalence of chronic liver disease and liver cancer is creating a larger patient population requiring biliary drainage procedures to manage malignant biliary obstructions and improve quality of life.

According to the European Commission, cirrhosis and liver cancer together account for approximately 284,000 deaths annually in Europe (May 2025), highlighting the significant clinical need for effective biliary interventions. In addition, technological innovation is accelerating market growth. A May 2025 Japan–Europe multicenter prospective study demonstrated the safety and efficacy of Zeon Medical's Hook Stent, a dedicated partially covered laser-cut metal stent featuring antimigration hooks for endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) in patients with malignant biliary obstruction. Although the device was developed in Japan, the multicenter European participation supports the adoption of next-generation biliary stent technologies across Europe, reinforcing physician confidence and expanding the use of advanced metal stents in complex biliary procedures.

Asia-Pacific Biliary Stents Market: Asia-Pacific is the Fastest-Growing Region Driven by Technological Advancement and Active Clinical Research Across the Region

Asia-Pacific is the fastest-growing regional market for biliary stents, driven by technological advancement and active clinical research across the region. In September 2024, researchers from Chongqing University, Tongji University, and collaborators in China published a comprehensive review on active materials and surface modifications for biliary stents, highlighting innovations such as biodegradable polymer stents, biodegradable metal stents, multifunctional coatings, tissue engineering approaches, 3D-printed stents, and shape-memory stents.

Similarly, in India, the Asian Institute of Gastroenterology, Hyderabad conducted a comparative study showing that combining endobiliary radiofrequency ablation with self-expanding metal stents improved outcomes in unresectable malignant hilar biliary obstruction. Furthermore, in April 2026, the Japan-led SBSFLUX randomized controlled trial evaluating slim fully covered metal stents versu plastic stents for malignant hilar biliary obstruction reflects the region’s strong clinical focus on improving long-term stent performance. Collectively, these innovations and clinical advancements are positioning Asia-Pacific as a key growth hub for the biliary stents market.

Key Developments

·         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.

·         July 2024, CGBIO announced that it has received product approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its ARISTENT biliary stents. The product is gaining traction in the Japanese market and the company is accelerating for global expansion. This product approval will enhance company's portfolio and market reach.