Biliary Stents Market

Biliary Stents Market Outlook (2025 to 2035)

The global Biliary Stents Market is expected to reach USD 712 million by 2035, up from USD 346 million in 2024. During the forecast period, the industry is projected to expand at a CAGR of 7.0%. The increasing prevalence of biliary diseases, such as bile duct strictures and cholangiocarcinoma, is driving the demand for biliary stents. Advancements in minimally invasive procedures and biodegradable stent technologies are boosting market growth.

Over the next ten years, the industry is poised to grow 1.9X with an absolute dollar opportunity of USD 350 million from 2025 to 2035. This indicates a promising outlook for the biliary stents market, with considerable potential for expansion and investment.

Metric	Value
Industry Size (2025E)	USD 362 million
Industry Value (2035F)	USD 712 million
CAGR (2025 to 2035)	7.0%

What are the drivers of biliary stents market?

The rising prevalence of diseases such as bile duct obstruction, gallstones, and cholangiocarcinoma, which require stenting, is escalating the demand for the biliary stents market. Rising prevalence of pancreatic cancer and hepatobiliary conditions propels the adoption of such devices.

The industry's ongoing development of self-expandable metal stents (SEMS) and biodegradable stents enhances patient outcomes, generating both a customized market opportunity and technology transfer.

The increasing elderly population and rising number of diseases related to biliary diseases, together with an increase in demand for minimally invasive procedures and diverse advancements in endoscopic retrograde cholangiopancreatography (ERCP), are upturning procedural efficiency, which is helping to reduce recovery time, which in turn is driving growth in the biliary cancer market.

The developed regions and emerging economies account for the market growth, owing to the good reimbursement policies and increasing healthcare expenditure. Infection complications, particularly stent occlusion, are still a pivotal concern.

What are the regional trends of biliary stents market?

The biliary stents market is heavily impacted by regional patterns, which are propelled by factors such as the regional healthcare infrastructure, the rate of disease prevalence across the region, and the adoption of technologies. North America currently dominates the market due to the high prevalence of biliary and pancreatic cancers in the region, better access to advanced healthcare facilities, and excellent reimbursement policies.

The growth is aided by the growing acceptance of minimally invasive procedures, coupled with the presence of major market-specific players. The next landscape is Europe, where Germany, the U.K., and France are the significant contributors, driven by a rising aging population base and increasing demand for endoscopic procedures.

Owing to the rapidly expanding healthcare sector, raising awareness regarding biliary diseases, and a growing geriatric population, Asia-Pacific has the fastest growth in the region. China and India are witnessing increased uptake of biliary stents, supported by enhanced healthcare access.

Moderate Growth in Latin America and the Middle East & Africa Driven by Continued Investment in Medical Infrastructure and Insufficient Healthcare Access. In general, the regional dynamics blatantly mirror the immense potential for the market's growth.

What are the challenges and restraining factors of biliary stents market?

Several challenges and restraining factors exist in the biliary stent market that could hamper market growth. Stent occlusion and restenosis become a cause of concern, leading to infections through additional replacement of the stent and further interventions.

The risk of complications such as bile duct perforation, migration, and infections further limits their widespread adoption. The cost of these advanced stents is high, limiting even a significant patient population in underdeveloped regions. One of the major barriers to the market's growth is the limited awareness of the treatment in emerging economies, along with the inappropriate healthcare infrastructure.

Regulatory restrictions, such as tough approval pathways for innovative new stents, lead to slow product launches and slower innovation. The availability of adjunctive treatments, like surgical resection and percutaneous biliary drainage, may decrease the need for biliary stenting.

These challenges remain persistent market concerns even with technological innovations and ongoing research efforts to enhance stent performance and reduce potential complications.

Shifts in the Biliary Stents Market from (2020 to 2024) and Future Trends (2025 to 2035)

The biliary stents market will significantly change from 2020 to 2024 due to the rising development and innovation of minimally invasive procedures and the rising population and prevalence of biliary diseases.

The growing cases of cholangiocarcinoma, pancreatic cancer, and benign biliary stricture, among others, have boosted the demand for endoscopic and percutaneous stenting solutions. In recent years, we have also witnessed technical revolutions, such as the rise of outpatient surgical facilities, bioresorbable stents, and drug-eluting stents.

In the time frame of 2025 to 2035, the market will mainly witness the rise in technologies such as biodegradable stents, increase in AI-assisted endoscopic procedures, and improvement in accessibility to healthcare in emerging economies.

As the regulatory frameworks in the EU and US shift to enable more innovative stent designs and with an increasing emphasis on patient-specific implants, the future of this market will be different from the past.

Market Shift	2020 to 2024
Regulatory Landscape	Strict regulations on stent materials and approvals by FDA, EMA, and other regulatory bodies. Concerns over metal-based stents' long-term complications.
Technological Advancements	Development of self-expandable metallic stents (SEMS) and plastic stents (PS) for biliary drainage. Advancements in coating materials to reduce biofilm formation.
Industry-Specific Demand	High demand from hospitals, specialty clinics, and ambulatory surgical centers (ASCs). Growing preference for minimally invasive treatments over traditional surgeries.
Sustainability & Circular Economy	Concerns over plastic-based stents leading to increased medical waste. Limited options for biodegradable solutions.
Production & Supply Chain	Supply chain disruptions, material shortages, and dependency on imported raw materials.
Market Growth Drivers	Rising prevalence of biliary tract cancers, gallstones, and liver diseases. Growth in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Increasing healthcare spending and government initiatives.

Market Shift	2025 to 2035
Regulatory Landscape	Introduction of biodegradable and bioresorbable biliary stents with faster approval pathways for patient-specific designs. Stricter biocompatibility and performance standards.
Technological Advancements	AI-assisted stent placement, robotic-assisted endoscopic procedures, and integration of drug-eluting coatings to minimize restenosis and infections. Adoption of 3D printing for patient-customized stents.
Industry-Specific Demand	Expansion of telemedicine-guided endoscopy. Increased focus on home healthcare devices and portable endoscopic solutions for remote access.
Sustainability & Circular Economy	Development of fully degradable biliary stents, improved recyclability of materials, and focus on biocompatible polymers with reduced environmental impact.
Production & Supply Chain	Increased local manufacturing, adoption of AI-driven demand forecasting, and diversification of supply chains to minimize dependence on limited suppliers.
Market Growth Drivers	Continuous innovation in stent materials and coatings, integration of smart sensors for real-time monitoring, and expansion in Asia-Pacific and Latin American markets due to improving healthcare infrastructure.

The new biodegradable and customized stents in the industry are expected to expand the group of products provided by manufacturers for biliary stents. Smart stents with embedded micro-sensors, which are able to monitor both bile flow and obstruction, are one such innovation that will help revolutionize the treatment regime following stenting. The year in endoscopic stenting AI and robotics: the news narrative

The Asia-Pacific region is expected to be the fastest-growing region through the forecast period owing to extensive developments in the healthcare sector, an increase in the incidence of hepatobiliary disorders, and greater awareness regarding the utilization of minimally invasive therapies.

In contrast, the technology followers in other regions, such as North America and Europe, will still drive the advances in technology and new regulations for stents appropriate to continue to drive innovation in new stent designs.

Country-Wise Outlook

United States (U.S.)

Increase in incidence of biliary disorders, pancreatic cancer, and gallstones along with growing population of geriatrics is expected to drive the Market in the U.S. Technologies like self-expanding metal stents (SEMS) and bioresorbable stents are also improving outcomes for patients and making these products more widely used.

Market growth is further supported by a presence of key medical device manufacturers and a well-established healthcare infrastructure. Novel stents and regulatory advancements (such as the FDA approval of drug-eluting stents and biodegradable stents) are increasing the choices available in the space.

Stringent reimbursement policies and high cost of advanced stents may not be without challenges. The increasing R&D investments in stent coating and stent materials are the key growth driver responsible for the expansion of the market.

China

China biliary stents market is growing at a faster pace due to ageing population, rising incidence of hepatobiliary diseases, and increased healthcare expenditure. There is a move towards minimally invasive approaches in the country, as advances in endoscopic retrograde cholangiopancreatography (ERCP) methods drive this trend forward.

Policies such as reforms to the government healthcare sector and the further expansion of a universal insurance coverage system facilitate access to biliary stent treatment. Moreover, the local medical device manufacturers are capturing market share with more affordable local alternatives to imported stents, thus helping to promote local manufacturing.

But bureaucratic issues surrounding imported medical devices, and quality issues with lower-cost stents, remain challenges in India. Growing penetration of drug-eluting and biodegradable stents coupled with an upsurge of hospital investments based on advanced endoscopic technologies will further take this market forward.

Japan

The growth of the biliary stents market further provides a favorable step in Japan specifically, owing to the country's advanced healthcare system, stringent regulatory approach, and reliance on such innovations. With a higher prevalence of pancreatic and biliary tract cancers in the country, the demand for effective stent solutions is only set to grow.

Recent technical advances have led to the development of innovative biliary stents, including radiofrequency ablation (RFA)-assisted biliary stent and coated metal stents to enhance patient outcomes and decrease complication rates.

The Aging population also helps market growth, since biliary disorders are more common in older people Japan’s stringent medical device regulations (PMDA approvals) also guarantee high-quality standards which may delay the entry of new stent technologies.

Strong collaborations among hospitals and research institutions to develop next-generation biliary stents support market expansion. Furthermore, the growing preference for endoscopy as compared to surgical intervention and the increasing investment in healthcare are likely to maintain the growth pattern of this market.

Country Wise Insights

Country	Attributes
United States (CAGR)	4.6%
China(CAGR)	9.1%
Japan (CAGR)	5.9%

Category-Wise Analysis

Metal - By Type

The segmented market is dominated by metal stents, which are preferred over plastic stents owing to their strength, patency, and maintenance. Their main indication is prolonged biliary drainage in malignant obstruction, biliopancreatic leaks, and chronic biliary strictures.

The intrinsically self-expanding microscopic design allows it to fit perfectly into the bile duct, reducing the likelihood of migration and obstruction. Hospitals and healthcare institutions prefer metal stents because they offer prolonged relief to patients, especially those with pancreatic cancer and gallbladder diseases in late stages.

Metal stents are more expensive than plastic stents initially, but they last longer and require fewer replacements, so that they can be more cost-effective in the long term. Innovations like drug-eluting stents and biodegradable metal stents for reducing inflammation in the limbs and preventing restenosis in heart diseases enable the growth of these segments.

North America and Europe account for a majority share of the metal stents market due to advanced healthcare infrastructure and favourable reimbursement policies, while emerging markets are witnessing gradual adoption as healthcare accessibility improves.

Pancreatic Cancer - By Application

Pancreatic cancer is highly prevalent among patients who need biliary stents, due to the possibility of developing biliary obstruction by the tumoral growth compressing the bile duct once patients have pancreatic cancer.

In these cases, stenting is a key palliative intervention to restore biliary flow, relieve jaundice, and improve quality of life. However, plastic and metal stents are currently used, the latter for prolonged drainage and the former for relief or preoperative drainage.

According to the recent global rise in incidences of pancreatic cancer, especially in older generations and high-risk groups, the need for less invasive solutions for biliary drainage is also increasing. Advances in endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous procedures also further improve the efficacy of stenting in the treatment of biliary complications of pancreatic cancer.

North America and Europe will be the various other top contenders in the segment, led by early diagnosis ability and the simple accessibility of advanced cancer treatment. However, Asia Pacific is also witnessing major growth owing to enhanced understanding concerning the disease and wonderful healthcare infrastructure.

Trends of the future of the market are predicted to be represented positively by the drive towards drug eluting stent along with the inclination towards biodegradable ones.

Ambulatory Surgical Centers - By End User

Due to the growing need for outpatient-based, lower-cost, and minimally invasive procedures, ambulatory surgical centers (ASCs) are expected to offer the largest share in the biliary stents market.

ASCs offer an alternative to traditional hospital environments with shorter procedure times, lower costs, and faster patient recovery. In particular, plastic stent placements, which are common in patients with benign biliary strictures, gallstones, or temporary biliary drainage indications, are well suited for these facilities.

The proliferation of ASCs is driven by the trend of same-day discharge protocols and decreasing hospitalization cost, with a particular growth in developed healthcare markets such as North America and Europe. The increased use of ERCP in ASCs have further solidified their role in biliary stenting.

Innovations in self-expanding stents as well as bioresorbable stent technology can allow these procedures to be performed as outpatient procedures with improved outcomes and lower total healthcare costs. Given the growing healthcare systems and infrastructure in several emerging economies, the region market will witness lucrative growth in the ASC segment, thereby extending the access to biliary interventions in non-hospital settings in the region.

Competitive Analysis

The global biliary stents market has a highly competitive structure, with numerous players and an increasing investment in research and development for innovative biliary stent products. There is a transition in the market towards minimally invasive procedures, which is projected to further surge the demand for biodegradable and fully covered stents.

One of the significant strategies is geographic expansion, especially in emerging markets, to gain a larger customer base. Competition is primarily price sensitive, with affordability vs premium being balanced by brands. These developments are underpinned by partnerships with healthcare providers and research organizations to conduct clinical trials and validate effectiveness, and evolving regulatory and reimbursement frameworks that continue to guide competitive forces in the industry.

Key players are Boston Medical Products, B. Braun Melsungen AG, Cook Medical Inc., Olympus Corporation, CONMED Corporation, M.I. Tech, Becton, Dickinson and Company, ENDO-FLEX GmbH, Cardinal Health and other players.

Market Share Analysis by Company

Company Name	Estimated Market Share (%)
Top 5 Players	~45-55%
Tier II Players	~20-30%
Other Players	~15-35%

Key Company Offerings and Activities

Company Name	Key Offerings & Activities
Boston Medical Products	Specializes in innovative stents for minimally invasive procedures.
B. Braun Melsungen AG	Focuses on high-quality metal and polymer biliary stents.
Cook Medical Inc.	Leading in drug-eluting stents; strong R&D investment.
Olympus Corporation	Offers advanced endoscopic stents with cutting-edge imaging.
CONMED Corporation	Develops niche stents for GI and hepatobiliary conditions.
M.I. Tech	Specializes in self-expanding metallic stents.
Becton, Dickinson & Co.	Expanding presence with innovative stent technologies.
ENDO-FLEX GmbH	Focuses on cost-effective solutions for biliary interventions.
Cardinal Health	Strong global distribution network for biliary stents.

Olympus Corporation

Olympus Corporation is a global technology innovator focusing on making people's lives healthier, safer, and more fulfilling, with leading positions in the markets it serves including the biliary stents market. Utilizing its deep experience in advanced imaging and endoscopic interventions, the company creates best-in-class biliary stenting solutions that help improve procedural accuracy and clinical results.

Olympus’ stents are combined with high-resolution imaging capabilities that help physicians achieve better precision in stent placement. Olympus also has a strong foothold in North America, Europe, and Asia-Pacific, and expands through strategic partnerships and acquisitions.

Medtronic is also investing in next-generation drug-eluting and biodegradable stents to enhance patient outcomes and decrease repeat procedures. Olympus' commitment to innovation, compliance, and physician training programs solidifies its leadership position in the market.

• In January 2024, Olympus has incorporated Taewoong's innovative metallic stent designs into its product offerings. This integration has expanded Olympus's capabilities in providing advanced stenting solutions for the biliary tract, esophagus, colon, and duodenum, enhancing treatment options for patients with gastrointestinal conditions.

Cook Medical Inc.

The research and development aspect is its biggest strength, and type and coatings of stents are being worked upon constantly for a higher degree of patient outcome. Cook Medical stents are popular in minimally invasive biliary procedures, due to their higher flexibility, patency, and biocompatibility.

Updates its model with cutting-edge manufacturing capabilities. It is also conducting clinical trials to provide evidence of next-generation biliary stents efficacy, highlighting the innovation focus of Cook Medical. Cook Medical is a strong player in the global biliary stents market through a broad product portfolio, regulatory approvals in key markets, and extensive distribution network.

B. Braun Melsungen AG

B. Braun Melsungen AG is one of the top-quality manufacturers, which specializes in various medical devices that include various biliary stents. The company focuses on high-purity materials and infection-resistant coatings to extend the life of its stents and smooth patient safety. B. Braun's biliary stent features proven durability and biocompatibility, making it a market leader in Europe and other regions.

Its FDA and CE approvals show its strong commitment to regulatory compliance and help expand its reach. B. Braun is also engaged in developing polymer-based and self-expanding metallic stents to meet different clinical requirements.

It has formed strategic partnerships with hospitals and surgical centers to help integrate its product and train physicians on its use. Through technological innovation, focused market expansion, and sustainability, B. Braun Melsungen AG is able to cement itself in the competitive baniary stents market.

• In June 2024, B. Braun Interventional Systems Inc., a subsidiary of B. Braun Melsungen AG, announced the release of the ACCEL® All-Purpose and Biliary Stone Extraction Balloons. These devices are designed to enhance the efficiency of biliary stone removal procedures, offering improved control and versatility for healthcare professionals.

Market Outlook

Biliary Stents Market Featuring Trends, Promises, Production and Revenue 2023 Rising incidence of biliary obstruction caused by factors such as gallstones, tumors, and stricture is expected to propel demand for biliary stents. Innovative technologies including drug-eluting and bioabsorbable stents are delivering better treatment results.

Increased adoption of endoscopic retrograde cholangiopancreatography (ERCP) procedures along with growing healthcare infrastructure in emerging markets are also driving market growth.

North-America holds the largest market share owing high healthcare expenditure coupled with rapid adoption of innovative stent technologies; however, Asia-Pacific will still offer the most lucrative prospects, owing to increasing access to healthcare services. In order to expand their product portfolio and strengthen their market presence, key players are engaged in R&D and strategic partnerships.

 Fact.MR has provided detailed information about the price points of key manufacturers of Biliary Stents Market positioned across regions, sales growth, production capacity, and speculative technological expansion, in the recently published report.

Segmentation of Biliary stents market

• By Type :

  • Metal
  • Plastic

• By Application :

  • Bilio-pancreatic Leakages
  • Pancreatic Cancer
  • Benign Biliary Structures
  • Gallstones
  • Others

• By End User :

  • Hospitals
  • Speciality Clinics
  • Ambulatory Surgical Centres
  • Others