Biliary stents are small tubes designed to hold bile duct open that have been blocked or partially blocked. A blockage in the bile duct prevents bile (bilirubin) from flowing into the duodenum, which aids digestion. This can result in a build-up of bile in the liver, resulting in symptoms including jaundice, stomach pain, and nausea. A biliary stent is inserted into the bile duct to minimize or eliminate the blockage. Once the stent is placed in the obstructed location, it is designed to extend and open the channel that allows the fluids to flow continuously to the intestine.

Market Growth Drivers:

• Rising occurrences of bile duct and pancreatic disorders
• Robust demand from minimally invasive disease
• Rising number of obesity cases that are prone to high risk of liver diseases
• Growing awareness among population about the biliary stent procedures

Market Restraints

• Strict guidelines for product approval
• Post-operative complications

Market Opportunities:

• Development of biodegradable stents
• Growing technological advancements in the stent industry

Report Coverage: 

Covid-19 Impact on the Global Biliary Stents Industry

The beginning of the COVID-19 pandemic has caused a dramatic shift in the market. The number of PTC and ERCP procedures for pancreatic and biliary stenting decreased because most gastrointestinal treatments were postponed during the pandemic. According to the UK's National Endoscopy Database (NED), endoscopic cancer detection decreased by 58% overall in 2020. A decline in cancer detection has resulted in a reduction in pancreatic cancer surgical procedures. As a result, the global biliary stents market was negatively impacted during the pandemic. However, the market is likely to recover from the setback during the projected years.

Market Dynamics

The significant rise in the prevalence of bile duct and pancreatic cancer is the major factor driving the growth of global biliary stent market. According to the American Cancer Society, Inc., about 8,000 people in the United States are diagnosed with bile duct cancer each year. This includes both intrahepatic and extrahepatic (inside and outside the liver) bile duct cancers. In addition, according to the National Cancer Institute statistics (2018), more than 83,000 people were living with pancreatic cancer in the United States. The rate of new pancreatic cancer cases was 13.2 per 100,000 men and women per year. Thus, there is a surge in awareness about different types of biliary diseases among people. Bile duct disorders are also caused due to conditions such as gallstones, liver cancer, large intestine, radiation therapy, etc. The high prevalence of these conditions worldwide is also likely to expand the growth of the biliary stents market.

Increasing awareness about minimally invasive surgeries such as laparoscopic surgery for treating kidney stone disease (nephrolithiasis) is poised to create significant demand in the market. Numerous research studies suggest that there are more than 1 million cases of kidney stones in India per year. Growing urbanization leading to a sedentary lifestyle along with the growing elderly population are some of the aspects that are also likely to propel market growth. However, stringent government regulations for product approval could cause a barricade in the market growth. FDA continues to have safety and effectiveness concerns about the use of biliary stents for certain applications unless the device has been approved for specific use through a separate premarket approval application. As a result, FDA continues to limit significant equivalence determinations for biliary stents in the majority of cases. In addition, the stent procedures also cause post-operative complications which are again expected to limit the market growth in the long-run.

Furthermore, the development of biodegradable biliary stents and growing technological advancement in the industry are likely to generate traction in the market during the forecast period 2021 – 2028. For instance, in 2019 – Innovate UK funded a £1.1 million in a study to produce biodegradable stents for patients with severe vascular disease, which affects over one million people in the UK. The initiative, an alliance between the University of Bristol's Translational Biomedical Research Centre (TBRC) and the UK-based medical device business Arterius will produce a new form of a bioresorbable stent that avoids the difficulties that metal stents can cause.

Market Segmentation

The global biliary stents industry is segmented on the basis of product type, application, end-use, and geography.

Market By Product Type

• Metal Stents
• Plastic Stents

Among product types, the metal stents segment accounted for the majority of the share in 2020. Metal is the material of choice for biliary stents due to advantages such as lower rates of stent fracture, flexibility, and biocompatibility. Metal stents are mesh-like tubes made up of thin wires that come in a wide range of lengths and diameters. The post-expansion diameter of the self-expandable metal stents ranges from 6 to 10 mm. The self-expandable metal stents come in two choices - covered and uncovered. Compared with the uncovered metal stents, covered metal stents have longer patency and a lower rate of tumor growth, but have higher rate of stent migration. The growing application of self-expandable metal stents in malignant biliary obstruction due to pancreatic cancer, direct tumor infiltration, adjacent inflammation, and extrinsic compression is driving the growth of the metal stents segment.

Market By Application

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

Based on application, the gallstones segment witnessed the largest market growth during the forecast period. Gallstones are hard, pebble-like particles of material that form in your gallbladder and are usually formed of cholesterol or bilirubin. According to the World Journal of Emergency Surgery article (2020), the overall occurrence of gallstones is approximately 10%–15% in the general population. Furthermore, in India there are more than 10 million gallstones cases diagnosed every year.

Market By End-Use

• Hospitals
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

Growing number of surgical procedures, favorable health reimbursement policies, and post-administration monitoring are some of the key aspects that are creating a significant demand for the hospitals segment. In addition, the presence of skilled medical professionals, presence of emergency units and quick treatment possibilities are the factors that are making people opt for hospitals for treatment as compared to others. Thus, the segment is anticipated to continue its dominance throughout the forecast period from 2021 to 2028. However, the specialty clinics segment stood at the second rank in terms of market share in 2020.

Biliary Stents Market Regional Overview

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Latin America

• Brazil
• Mexico
• Rest of Latin America

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa

Increasing availability of a wide range of biliary stents in the US fuels the North America market

Among the regions, North America dominated the market for biliary stents in 2020 due to the increasing number of pancreatic cancers among the population. For instance, according to the American Cancer Society (2019), pancreatic cancer accounts for approximately 3% of all cancers in the United States and approximately 7% of all cancer deaths. The presence of advanced healthcare infrastructure coupled with the presence of advanced technology for the diagnosis and treatment is expected to boost the demand for the biliary stents market in North America. The European market accounted for the second-largest share due to the increasing awareness and improved healthcare infrastructure. Furthermore, the Asia-Pacific region is anticipated to attain the fastest growth rate during the forecast period due to the growing pancreatic and bile duct infections and rising government initiatives in countries such as China and India.

Competitive Landscape

This section of the research identifies a number of significant market players some of which include Abbott Laboratories, B. Braun Melsungen AG, Becton Dickinson and Company, Boston Scientific Corporation, Cardinal Health, CONMED Corporation, Cook Medical Inc., ENDO-FLEX GmbH, M.I. Tech, Medtronic plc, Merit Medical Systems, and Olympus Corporation.