Biliary Stents Market

Market Overview

The global biliary stents market size was valued at USD 446.3 million in 2023 and is projected to reach USD 728.9 million by 2032, registering a CAGR of 5.6% during the forecast period (2024-2032). The rising frequency of biliary problems and chronic liver diseases is significantly responsible for the biliary stents market growth.

Biliary stents are medical devices that help to clear obstructions in the biliary system, which includes the bile ducts and biliary tree. These stents are typically used endoscopically or percutaneously to restore bile flow in patients suffering from a variety of biliary obstruction conditions, including biliary strictures, cholangiocarcinoma, pancreatic cancer, and benign biliary diseases. Biliary stents are intended to maintain patency within the bile ducts, relieving symptoms of obstructive jaundice such as jaundice, pruritus, and liver dysfunction. 

The rising prevalence of gallstones and pancreatic and bile duct cancer is pushing up demand for biliary stents. Furthermore, the global biliary stent market is expected to grow as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC) become more widely used, both of which provide precise results in the detection of bile and pancreatic channel issues. PTC biliary stents direct bile flow away from the bile leaking site. The market is also predicted to grow due to the fast-expanding number of minimally invasive surgeries and robotics, which allow surgeons to perform a wide range of complex treatments with precision and flexibility. Furthermore, compared to traditional surgery, robotic-assisted bile duct surgical procedures provide shorter hospital stays, lower infection risks, and faster recovery.

Highlights

• Metal occupies the maximum share of the market by type.
• Gallstones influenced the market growth by application.
• Hospitals generate the highest revenue share by end-users.

Market Dynamics

Global Biliary Stents Market Drivers:

Rising Incidence of Biliary Diseases

The rising incidence of biliary diseases such as biliary strictures, cholangiocarcinoma, and pancreatic cancer adds to the demand for biliary stents. Aging populations, lifestyle changes, and the rising incidence of risk factors such as obesity and chronic liver disease are all contributing to the global prevalence of these conditions. According to the American Cancer Society, the incidence of biliary tract cancers, including cholangiocarcinoma, has steadily increased in recent decades. The American Cancer Society predicts that 41,630 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the United States in 2023, with 28,000 men and 13,630 women. This number includes hepatocellular carcinoma. The American Cancer Society also predicts that 29,840 people (19,120 men and 10,720 women) will die from these cancers by 2023.

Similarly, pancreatic cancer, which frequently requires biliary stenting, is one of the leading causes of cancer-related deaths worldwide. The rising prevalence of these diseases highlights the growing need for biliary stents to treat biliary obstructions and relieve symptoms in patients. Pancreatic cancer is expected to affect 64,050 adults in the United States in 2023, accounting for approximately 3% of all cancer diagnoses. Pancreatic cancer is the eighth most common cancer in women and the tenth most prevalent in men. 

Furthermore, biliary strictures are estimated to occur in 4-20% of patients. The incidence of benign biliary stricture in cholecystectomy patients is estimated to be between 0.2-0.7%. Biliary stricture is more common in laparoscopic cholecystectomy (0.5-0.89%) than in open cholecystectomy (0.2%). As a result, the rising incidence of biliary diseases drives global demand for biliary stents, which are essential in relieving biliary obstructions, improving bile flow, and improving the quality of life for affected patients. As healthcare systems strive to meet the needs of an increasingly burdened patient population, the biliary stents market trend is poised for sustained growth to address these rising disease trends.

Global Biliary Stents Market Restraints:

Limited Long-Term Efficacy

While biliary stents can relieve biliary obstructions and symptoms in the short term, their long-term effectiveness may be limited by stent occlusion, tissue ingrowth, and recurrent biliary strictures. Despite efforts to develop stents with improved patency and durability, long-term outcomes after biliary stent placement remain variable, with a significant proportion of patients developing stent-related complications or requiring repeat interventions over time. This limitation may impact patient satisfaction, healthcare resource utilization, and market growth.

According to research, the average life of a plastic biliary stent is 12 months, but some recommend replacing it after 3-6 months. The median patency of a 10-Fr plastic stent is 4-5 months, and the risk of occlusion increases dramatically after three months. Premature occlusion can cause serious complications such as jaundice, cholangitis, and sepsis. 

Additionally, while metal stents have longer patency than plastic stents, with median patency durations ranging from 6 months to a year, they are still susceptible to complications such as stent migration, tissue overgrowth, and recurrent strictures over time. Despite efforts to improve stent design and coating technologies, long-term outcomes after biliary stent placement remain poor, especially in patients with malignant biliary obstructions. While advances in stent technology and adjunctive therapies aim to extend stent patency and improve outcomes, the inherent limitations of current biliary stent designs and materials highlight the importance of ongoing research and innovation in biliary interventions. 

Global Biliary Stents Market Opportunity:

Advancement in Stent Design and Coating Technologies

There is an excellent opportunity for medical device manufacturers to invest in R&D to improve biliary stents' design, materials, and coating technologies. Drug-eluting stents, bioresorbable stents, and anti-migration features can improve stent performance, increase patency, and lower the risk of complications like stent occlusion and tissue overgrowth. Manufacturers can gain a competitive advantage by developing next-generation biliary stents that address unmet clinical needs and provide superior therapeutic outcomes. For example, PanTher Therapeutics (PanTher), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, announced today that the United States Patent and Trademark Office (USPTO) has issued a methods-of-use patent for a deployable anticancer drug-eluting stent, which PanTher has exclusively licensed. The patent expands the use of PanTher's Sagittari™ treatment platform, which delivers proven and novel therapeutic agents to target cancer at its source.

Additionally, medical device companies are increasingly focusing on developing novel biliary stent designs and coating technologies to overcome the limitations of traditional stents and improve patient outcomes. For example, Boston Scientific Corporation launched the WallFlex Biliary R.X. Fully Covered Stent. This proprietary drug-eluting coating reduces the risk of tissue ingrowth and stent occlusion in patients with benign biliary strictures. 

Furthermore, bioresorbable biliary stents, intended to degrade over time and promote tissue healing, are a promising area of study and development in interventional gastroenterology and hepatology. By investing in innovative stent designs and coating technologies, medical device companies can differentiate their products, increase market share, and meet the changing needs of healthcare providers and patients in the biliary stents market.

Regional Analysis

North America Dominates the Global Market

The global biliary stents market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America is the most significant global biliary stents market shareholder and is estimated to grow at a CAGR of 5.3% over the forecast period. This can be attributed to North America's increasing demand for minimally invasive procedures. According to the American Cancer Society, the incidence of bile duct cancer (cholangiocarcinoma), a rare condition with approximately 8,000 annual diagnoses in the United States, represents a unique healthcare concern. In this scenario, biliary stents emerge as critical therapeutic tools for managing bile duct cancer-related conditions, such as tumor-induced obstruction or narrowing. The high prevalence of bile duct cancer cases creates a unique and significant demand for biliary stents, emphasizing their critical role in North America's healthcare landscape.

Additionally, the United States had the largest market share in North America in 2023. The rising incidence of cancer and increased awareness of early disease detection are two significant factors expected to drive the country's growth. According to the Cleveland article, the high incidence of acute and chronic pancreatitis in the United States results in 275,000 and 86,000 hospital stays per year, respectively, highlighting the importance of biliary stents as therapeutic tools. With approximately 20% of acute cases classified as severe, the need for effective interventions, such as biliary stents, is clear. The high number of hospital stays emphasizes the importance of biliary stents in treating pancreatitis complications, which contributes to biliary stents market growth in the United States.

Asia-Pacific is anticipated to exhibit a CAGR of 5.9% over the forecast period, owing to increased patient numbers and the growing presence of prominent healthcare providers in rapidly developing economies such as India and China. The region's growing demand for healthcare services, combined with government support for improvements in healthcare utilization, creates expansion opportunities. For example, the Indian government's financial assistance to needy cancer patients under the Tertiary Care Cancer Centers (TCCC) scheme, which aims to strengthen or establish 20 State Cancer Institutes (SCI) and 50 TCCCs, is expected to boost demand for biliary stent devices, contributing to the region's overall growth. 

Furthermore, Japan's healthcare system is shifting from nursing care to preventive care in disease management due to rising healthcare costs. In February 2023, Olympus strategically acquired South Korean stent maker Taewoong Medical for approximately USD 370 million, establishing itself as a critical driver of market growth in Japan.

The European biliary stents market is characterized by an increasing prevalence of biliary disorders such as biliary strictures, pancreatic cancer, and gallstones, which drives demand for biliary stent placement procedures. Thanks to their robust healthcare systems, high disease burdens, and access to advanced medical technology, Germany, the United Kingdom, France, Italy, and Spain are among Europe's key markets for biliary stents. The European regulatory environment is favorable to medical device innovation. Companies frequently launch their products in the European market, obtaining C.E. marks before seeking approval in other regions.

Segmental Analysis

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

The market is further segmented by type into Metal, Polymer, and Plastic.

The metallic segment has emerged as the dominant force in the biliary stents market, with clear advantages over plastic stents. Metal biliary stents, usually made of nitinol or stainless steel, are widely used to treat malignant and benign biliary obstructions. These stents have several advantages, including a high radial force, excellent conformability to the biliary anatomy, and long-lasting patency. Metal stents are self-expanding and can be placed using endoscopic or percutaneous techniques, making them appropriate for various clinical scenarios. Metal stents are also radiopaque, allowing easy visualization under fluoroscopy during placement and follow-up procedures. Despite their effectiveness, metal stents can cause complications such as stent migration, tissue hyperplasia, and difficulty in removal, especially in tissue ingrowth or overgrowth cases.

Furthermore, their mesh design prevents side branch occlusion and tumor growth, making it especially useful for treating firm and scirrhous hilar tumors. Metallic stents have become the preferred choice for the palliative treatment of malignant biliary obstructions due to their longer patency duration of 4 to 6 months, as opposed to 2 to 4 months for plastic stents.

Plastic biliary stents, polyethylene or Teflon, were among the first used in biliary procedures. These stents are typically placed endoscopically and come in various lengths and diameters to fit different biliary anatomy. Plastic stents are inexpensive and straightforward to remember, making them ideal for temporary biliary drainage in patients with benign biliary strictures or post-surgical complications. However, plastic stents have limited radial force and are prone to migration, occlusion, and biofilm formation, especially when bile sludge or bacterial colonization is present. As a result, plastic stents are frequently used as a bridge to more definitive treatments or as palliative therapy in patients with a limited life expectancy.

The market can be bifurcated by application into Biliopancreatic Leakages, Pancreatic Cancer, Benign Biliary Structures, and Gallstones.

The gallstones segment dominated the biliary stents market. Biliary stents are occasionally used to treat complicated gallstone disease, particularly in cases of choledocholithiasis or Mirizzi syndrome when endoscopic or surgical stone extraction is not possible. Stents can bridge the gap between an initial diagnosis and definitive treatment, such as endoscopic retrograde cholangiopancreatography (ERCP) with stone removal or cholecystectomy. Stents relieve symptoms like biliary colic, jaundice, and cholangitis by providing temporary biliary decompression and facilitating stone passage, improving patient comfort and preparing for future interventions. However, the efficacy of prophylactic biliary stenting for patients with gallstones (G.S.) and common bile duct stones (CBDS) is still debated.

Biliopancreatic leakages are abnormal communications or fistulas between the bile ducts, pancreas, and other structures. These leaks can be caused by trauma, surgery, or pathological conditions like pancreatitis or pancreatic pseudocysts. Biliary stents are frequently used to treat biliopancreatic leaks, redirect bile or pancreatic secretions away from the leak site, promote healing, and prevent complications like peritonitis or abscess formation. Stent placement can be done endoscopically or percutaneously, depending on the location and severity of the leak. Fully or partially covered stents are commonly used in this application to reduce the risk of stent migration and make removal easier once the leak has healed.

Based on end-use, the market is fragmented into Hospitals and ambulatory Surgical Centers. 

Hospitals accounted for the largest biliary stents market share. Hospitals are the primary setting for complex biliary interventions, including stent placement procedures, due to their extensive facilities, specialized medical staff, and advanced equipment. Hospitals provide various healthcare services, including diagnostic imaging, surgical suites, intensive care units, and interventional radiology departments. These are critical for treating patients with biliary disorders that necessitate stent placement. Biliary stent placement procedures are frequently performed in hospitals, either inpatient or outpatient, depending on the patient's clinical condition and treatment plan. Hospitals typically have multidisciplinary teams of gastroenterologists, interventional radiologists, surgeons, and nurses who work together to provide comprehensive care to patients undergoing biliary procedures.

Ambulatory surgical centers (ASCs) are outpatient facilities that offer same-day surgical and procedural services, such as biliary stent placement procedures. ASCs provide a convenient and cost-effective alternative to hospitals for patients who need elective or minimally invasive procedures, such as biliary stenting, but do not require overnight hospitalization. ASCs are outfitted with cutting-edge operating rooms, endoscopy suites, and recovery areas, enabling efficient and streamlined patient care delivery. Biliary stent placement procedures performed in ASCs are usually less complex and have lower associated healthcare costs than those performed in hospitals. ASCs play an essential role in meeting the growing demand for outpatient biliary interventions while reducing the strain on hospital resources, especially for low-risk patients who require routine stent placement or follow-up procedures.

Recent Developments

• March 2024- Boston Scientific Corporation (NYSE: BSX) received FDA approval for the AGENT™ Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is defined as the obstruction or narrowing of a stented vessel caused by plaque or scar tissue.
• March 2024- B.D. collaborated with GOCC to combat Sepsis in Poland.
• January 2024- The FDA approved Medtronic's Percept™ RC neurostimulator with exclusive BrainSense™ technology.