Table of Contents
Overview
New York, NY – July 01, 2025 – Global Biliary Stents Market size is expected to be worth around US$ 243.7 Million by 2034 from US$ 148.2 Million in 2024, growing at a CAGR of 5.1% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 44.1% share with a revenue of US$ 65.4 Million.
The global biliary stents market is witnessing significant growth owing to the increasing prevalence of biliary tract diseases such as gallstones, bile duct strictures, and malignancies. Biliary stents are small tubes inserted into the bile duct to relieve obstructions and ensure proper bile flow from the liver to the intestine. These devices are critical in the management of both benign and malignant biliary conditions, supporting palliative care and post-operative recovery.
Technological advancements in stent materials, including the introduction of bioabsorbable and drug-eluting stents, are enhancing clinical outcomes and reducing complication rates. Additionally, the growing preference for minimally invasive endoscopic procedures is positively influencing the demand for biliary stents across healthcare systems globally.
Hospitals, specialty clinics, and ambulatory surgical centers remain the primary end-users, with endoscopic retrograde cholangiopancreatography (ERCP) procedures forming a major application area. North America holds a dominant position in the market due to its advanced healthcare infrastructure and higher diagnosis rates, while Asia-Pacific is expected to grow at a faster pace driven by increasing awareness and improving access to medical technologies.
The market is expected to benefit from rising geriatric populations, who are more prone to biliary and pancreatic disorders. As demand continues to rise, manufacturers are focusing on product innovation and strategic partnerships to expand their global footprint and meet the evolving needs of the clinical community.
Key Takeaways
- In 2024, the global biliary stents market generated revenue of US$ 148.2 million and is projected to reach US$ 243.7 million by 2034, expanding at a compound annual growth rate (CAGR) of 5.1% over the forecast period.
- By product type, the market is segmented into metal, plastic, and polymer stents. Among these, metal stents emerged as the leading category in 2023, accounting for 46.7% of the total market share.
- Based on application, the market is categorized into gallstones, bilio-pancreatic leakages, pancreatic cancer, benign biliary strictures, and others. Of these, gallstones represented the largest application segment, contributing to 36.8% of the market share.
- With respect to end users, the market is divided into hospitals, ambulatory surgical centers, and others. Hospitals dominated the segment with a significant revenue share of 61.5%, reflecting the high adoption of biliary stents in institutional healthcare settings.
- Regionally, North America led the global biliary stents market in 2023, capturing a 44.1% share, attributed to well-established healthcare infrastructure, early adoption of advanced technologies, and higher diagnostic rates for biliary disorders.
Segmentation Analysis
- Product Type Analysis: In 2023, metal stents accounted for 46.7% of the market due to their superior durability and biocompatibility compared to plastic and polymer variants. Their enhanced radial strength and lower migration risk make them ideal for complex, long-term biliary obstructions. Technological advancements, including drug-eluting metal stents, improve patency and reduce restenosis, supporting wider clinical adoption. These benefits, combined with lower replacement frequency and cost efficiency, are driving increased preference among healthcare providers and patients alike.
- Application Analysis: The gallstones segment held a 36.8% share owing to the high global prevalence of gallstone-related biliary obstructions. This growth is driven by rising obesity rates, lifestyle changes, and improved diagnostic imaging. Biliary stents play a vital role in minimally invasive procedures by effectively draining obstructed bile ducts. Increasing awareness among clinicians and demand for palliative interventions in complicated gallstone cases continue to support segment expansion. The growing use of endoscopic techniques also enhances gallstone-related stent placement outcomes.
- End-user Analysis: Hospitals dominated the biliary stents market with a 61.5% revenue share due to their high patient volume and advanced infrastructure. The ability to perform complex stenting procedures using specialized equipment and trained professionals has positioned hospitals as key end users. Rising hospital admissions for biliary disorders, favorable reimbursement policies, and growing adoption of minimally invasive surgeries are further accelerating segment growth. Collaborations with device manufacturers for technology upgrades and staff training also contribute to their leading position.
Market Segments
By Product Type
- Metal
- Plastic
- Polymer
By Application
- Bilio-pancreatic Leakages
- Pancreatic Cancer
- Gallstones
- Benign Biliary Structures
- Others
By End-user
- Hospitals
- Ambulatory Surgical Centers
- Others
Regional Analysis
North America Leads the Global Biliary Stents Market
North America accounted for the largest revenue share of 44.1% in the global biliary stents market, primarily driven by the high incidence of biliary disorders requiring interventional procedures. The presence of strong clinical guidelines, such as those provided by the American Society for Gastrointestinal Endoscopy (ASGE), emphasizes the therapeutic use of biliary stents in managing both benign and malignant obstructions.
Additionally, the U.S. Food and Drug Administration (FDA) enforces stringent regulatory standards that ensure the safety and efficacy of biliary stents, encouraging physician confidence and broad clinical adoption. Technological advancements in stent design and materials further support improved patient outcomes and sustained market leadership.
Asia Pacific Expected to Register the Fastest Growth
The Asia Pacific region is projected to witness the highest compound annual growth rate (CAGR) over the forecast period. According to World Bank 2022 data, healthcare expenditure in East Asia & Pacific reached 5.43% of GDP, highlighting growing investment in health services. Increased access to endoscopic procedures such as ERCP, expanding healthcare infrastructure, and adoption of advanced medical technologies are key drivers expected to accelerate the demand for biliary stenting across the region.
Emerging Trends
- Biodegradable Materials: Research on fully absorbable stents is advancing rapidly. Biodegradable polymers and magnesium alloys are being tested to avoid lifelong implants and reduce the need for removal procedures.
- Drug-Eluting and Covered Metal Stents: Self-expandable metal stents coated with anti-inflammatory or antiproliferative drugs are gaining traction to extend patency and lower tissue ingrowth. The FDA’s updated 510(k) guidance confirms growing regulatory support for these devices.
- Bioengineered and Organoid-Loaded Scaffolds: Innovative designs now incorporate cell-laden scaffolds to encourage bile-duct healing and regeneration. Early lab studies show stable mechanics and good biocompatibility, pointing toward next-generation regenerative stents.
- Minimally Invasive Delivery Techniques: Endoscopic and percutaneous approaches are being refined. Over 20 clinical trials are currently assessing percutaneous insertion of biodegradable stents for benign strictures, reflecting a shift toward less invasive therapies.
Use Cases
- Palliation of Malignant Obstructions: In patients with cholangiocarcinoma or pancreatic head tumors, stents relieve jaundice and improve quality of life. However, 3.9% of patients require repeat ERCP within 30 days, highlighting the need for durable designs.
- Management of Benign Biliary Strictures: Biodegradable stents are under pilot evaluation for strictures and cystic duct leaks. Early studies involve 10–30 patients per trial, demonstrating safe placement and gradual absorption over months.
- Failed Common Bile Duct (CBD) Stone Extraction: When stone removal fails endoscopically, temporary stents maintain bile flow while planning further intervention. Clinical guidelines list this indication as standard practice.
- Control of Post-Surgical Bile Leaks: After liver resections or gallbladder surgery, covered stents seal leaks and prevent bile collections. Case reports show resolution in over 85% of patients within four weeks.
- Preoperative Biliary Drainage: For periampullary tumors causing obstructive jaundice, preoperative stenting can reduce bilirubin levels. Although usage is debated, it remains common in 40–60% of high-risk surgical candidates.
Conclusion
The global biliary stents market is poised for steady growth, driven by the increasing prevalence of biliary tract disorders, advancements in stent technologies, and the growing preference for minimally invasive procedures. The market benefits from strong clinical guidelines, robust regulatory support, and rising geriatric populations prone to hepatobiliary complications.
With North America leading in adoption and Asia Pacific emerging as the fastest-growing region, manufacturers are focusing on innovation and strategic collaborations to meet evolving clinical demands. Emerging technologies such as biodegradable and drug-eluting stents are expected to redefine treatment outcomes and expand therapeutic applications globally.
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