Industry Background:
Biliary stents are small mesh-like tubes, which do not contain any coating or covering. Stents are inserted into the liver to treat hepatic blockage and obstructive hepatic diseases, such as jaundice, cholecystitis, hepato-biliary diseases, and cholangitis. Biliary stents are utilized to treat obstruction present in the bile duct. The developments in biliary stenting procedures will increase the efficiency of stent placement. Such novel approaches in the treatment of biliary diseases will offer lucrative opportunities in the growth of the global biliary stents market in the upcoming years.This growth is primarily driven by Increase in demand for minimally invasive techniques, and Rising Awareness among Population and Increase in Demand for Bioresorbable Stents.
Globally, a noticeable market trend is evident Technological Advancements in Biliary Stents by Major Market Players. Major Players, such as Abbott Laboratories (United States), Boston Scientific Corporation (United States), CONMED Corporation (United States), Cook Medical (United States), B. Braun Melsungen AG (Germany), Medtronic (Ireland), Terumo Corporation (Japan), Biotronik SE & Co. KG (Germany) and Taewoong Medical ( South Korea) etc have either set up their manufacturing facilities or are planning to start new provision in the dominated region in the upcoming years.
Regulatory Insights:
"The US Food and Drug Administration (FDA) issued final guidance on July 2019 to aid sponsors of metal expandable biliary stents in preparing 510(k) submissions to seek premarket clearance. FDA’s Center for Devices and Radiological Health (CDRH) seeks to address concerns with reported use of metal expandable biliary stents for vascular applications by offering updated recommendations on the content of 510(k)s and continuing to impose limitations on substantial equivalence determinations."
Market Drivers
- Increase in demand for minimally invasive techniques,
- Rising Awareness among Population and Increase in Demand for Bioresorbable Stents
Market Trend
- Technological Advancements in Biliary Stents by Major Market Players
Restraints
- Complications Associated With Biliary Stents Implementation
Opportunities
Increasing Geriatric Populations Globally and Development of Biodegradable and Drug-Eluting Biliary Stents
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