The biliary stents market is expected to develop at a CAGR of XX% between 2024 and 2031. The market value is estimated to reach USD XX billion in 2024 and USD YY billion in 2031. North America is expected to lead the market throughout the projection period. Key metrics include the rising prevalence of biliary disorders, technological advances in stent design, and the world's growing elderly population.
The biliary stents market is steadily expanding, owing to rising incidences of biliary tract illnesses, advances in minimally invasive procedures, and increased use of endoscopic techniques. The use of biodegradable materials and drug-eluting technology in stent design is revolutionising biliary obstruction management, resulting in better patient outcomes and fewer problems.
Market Trend: Adoption of biodegradable stents gains momentum in biliary tract interventions.
The biliary stents market is seeing a considerable shift towards the use of biodegradable stents for bile system treatments. These novel stents are intended to gradually disintegrate in the body after their use, avoiding the need for removal procedures and lowering the risk of long-term issues associated with permanent stents. Biodegradable stents provide various benefits, including decreased inflammation, a lower risk of stent migration, and higher long-term patency rates.
A 2023 study in the Journal of Hepatology, for example, found that biodegradable biliary stents reduced stent-related problems by 20% when compared to standard metal stents. Leading medical device firms are investing substantially in R&D to create superior biodegradable materials that can give excellent mechanical support while allowing for regulated disintegration. This trend is driving market innovation, with companies such as Boston Scientific and Cook Medical introducing novel biodegradable stent prototypes in clinical trials, paving the way for a new generation of biliary stents that could significantly improve patient care while also lowering healthcare costs associated with repeat procedures.
Market Driver: Increasing prevalence of biliary disorders and pancreatic cancer fuels market growth.
The increasing global frequency of biliary diseases and pancreatic cancer is driving the biliary stents market. Biliary tract illnesses such as gallstones, strictures, and cholangiocarcinoma are becoming more common, particularly in older populations.
The World Health Organisation (WHO) predicts that the global incidence of pancreatic cancer will rise by 77.7% by 2040, with over 800,000 new cases diagnosed each year. The increased disease burden is driving the need for effective biliary drainage options, with stents playing an important role in controlling blockages and enhancing patients' quality of life. Furthermore, the American Cancer Society says that around 70% of pancreatic cancer patients develop biliary blockage, necessitating the implantation of a stent to alleviate symptoms. The growing use of minimally invasive endoscopic procedures for biliary stenting is also driving market expansion since these techniques provide shorter recovery times and lower complication rates than older surgical treatments. Major healthcare providers and insurance companies are recognising the cost-effectiveness of biliarystenting in treating malignant blockages, which is driving market growth.
Market Restraint: Complications associated with stent placement and high procedural costs hinder market adoption
Despite rising demand for biliary stents, various variables represent barriers to wider market adoption. Complications from stent installation, such as stent migration, occlusion, and perforation, continue to be major concerns for healthcare providers and patients. A meta-analysis published in the World Journal of Gastroenterology in 2022 found that the overall complication rate for biliary stent insertion was between 8% and 12%, with stent occlusion being the most prevalent concern. These issues frequently demand repeat treatments, which raises healthcare expenses and causes patient suffering. Furthermore, the high cost of modern biliary stents, particularly metal and drug-eluting types, may limit their availability in resource-constrained healthcare settings.
For example, the average cost of a self-expanding metal biliary stent in the United States is between $1,000 and $3,000, which may be prohibitively expensive for some patients and healthcare systems. The need for specialised training and equipment for stent implantation procedures adds to the total economic burden. These factors may hinder market expansion, particularly in emerging economies with inadequate healthcare infrastructure, until more cost-effective alternatives and better stent designs that reduce problems are developed and deployed.
The Metal Stents segment is expected to dominate the Biliary Stents Market during the forecast period.
Metal stents, particularly self-expanding metal stents (SEMS), have emerged as the dominant segment in the biliary stents market, owing to higher patency rates and better clinical results in the treatment of malignant biliary obstruction. The preference for metal stents is based on significant clinical evidence proving their efficacy and cost-effectiveness in long-term biliary drainage. A study published in the Gastrointestinal Endoscopy journal in 2023 found that metal stents had a 30% longer patency duration than plastic stents in patients with malignant biliary strictures, leading to fewer re-interventions and a higher quality of life.
Metal stent technology has advanced in recent years, solidifying their market leadership. In 2022, Boston Scientific developed the WallFlex Biliary RX Fully Covered Stent, which has a revolutionary anti-migration design and improved conformability to the biliary anatomy. This breakthrough addressed one of the key issues with metal stents, stent migration, and was found to lower migration rates by up to 40% in clinical trials.
Metal biliary stents have grown in popularity, particularly in the oncology sector. The rising frequency of pancreatic and biliary tract malignancies has created a significant demand for efficient palliative care options. A retrospective study published in the Journal of Gastrointestinal Oncology in 2023 discovered that metal stents resulted in a 25% reduction in hospital readmission rates for individuals with inoperable pancreatic cancer when compared to plastic stents. This has resulted in collaborations between stent makers and oncology centres to create integrated care pathways. Medtronic, for example, joined together with six major cancer institutes in 2023 to develop a comprehensive biliary care program that incorporates advanced metal stent implantation as a critical component of palliative care for pancreaticobiliary malignancies.
North America is expected to dominate the biliary stents market during the forecast period.
North America has established itself as the market leader in biliary stents, owing to its advanced healthcare infrastructure, high prevalence of biliary illnesses, and robust reimbursement policies for endoscopic operations. The United States, in particular, has been at the forefront of biliary stent technology adoption, with a strong ecosystem of medical device companies, research institutions, and specialised healthcare professionals focused on gastrointestinal and hepatobiliary procedures.
Recent developments in the region highlight its market dominance. In 2023, the FDA granted breakthrough device designation to a unique drug-eluting biliary stent created by a California-based medical device business. This certification demonstrates the region's commitment to promoting innovation in biliary stent technology and accelerating the availability of innovative treatment options for patients.
Key figures reinforce North America's dominance in the biliary stents market. The American Cancer Society estimates that 57,600 new cases of pancreatic cancer will be identified in the United States in 2023, with a considerable proportion requiring biliary stenting as part of their treatment. This high disease load creates a significant market for biliary stent technologies.
In terms of healthcare spending, the United States is the leader in investing in modern medical technologies. According to the Centres for Medicare and Medicaid Services (CMS), national health spending will reach $4.1 trillion in 2022, with a sizable share going towards medical devices and minimally invasive procedures, such as biliary interventions.
Canada has also emerged as a significant contributor in biliary stent development and adoption. The Canadian Institute for Health Information estimated a 15% increase in biliary stent surgeries in Canadian hospitals between 2020 and 2023, indicating that these devices are becoming more widely accepted in the treatment of biliary problems. Furthermore, Canadian research institutions have been at the forefront of clinical trials testing next-generation biliary stents, helping the area maintain its leadership in improving stent technologies.
The biliary stents market is characterised by high rivalry and ongoing innovation among prominent competitors. To obtain a competitive advantage, major corporations are investing in innovative stent designs, improving biocompatibility, and increasing long-term patency rates. Market giants such as Boston Scientific Corporation, Cook Medical, and Medtronic plc have sizable market shares because of their excellent R&D skills and expansive distribution networks.
Mergers and acquisitions have been an important method for expanding markets and acquiring new technologies. Merit Medical Systems, for example, paid $35 million in 2019 to purchase Brightwater Medical, adding biliary stents and drainage devices to its portfolio. Product introductions have also been common, with companies offering new stent designs and materials. Cook Medical introduced its Evolution Biliary Controlled-Release Stent in 2022, which has a unique delivery method that allows for precise stent insertion.
Financial performance varies by player, with leading corporations reporting consistent growth in the endoscopy and interventional areas. Boston Scientific, for example, recorded $12.7 billion in revenue in 2022, with its endoscopy segment, which includes biliary stents, accounting for a large portion of total sales. Market players are also forging strategic alliances with healthcare providers and research institutes to conduct clinical trials and collect real-world evidence about stent performance.
In the future, the market is projected to experience more competition from developing competitors, particularly those focused on biodegradable and drug-eluting stent technologies. The emphasis on cost-effectiveness and improved patient outcomes is likely to define future initiatives, with companies creating stents with longer patency lengths and lower complication rates to meet the rising demand for minimally invasive biliary procedures.
The biliary stents market is about to undergo a dramatic transition as we reach 2024 and beyond. The combination of material science, nanotechnology, and precision medicine is creating opportunities for more effective and personalised biliary stent solutions.
One emerging trend is the creation of "smart" biliary stents that include sensors and wireless communication capabilities. These revolutionary devices can track bile flow, detect early signs of blockage, and even administer targeted medicine therapy. This real-time monitoring could transform post-procedural care by allowing for proactive interventions before difficulties emerge, thus lowering the need for repeat surgeries.
Another notable trend is the growing emphasis on patient-specific stent design. Advanced imaging technologies and 3D printing are being used to build custom-fit biliary stents that are perfectly tailored to a patient's individual bile anatomy. This personalised strategy has the potential to greatly increase stent efficacy, lower the likelihood of migration, and improve overall treatment outcomes.
The use of artificial intelligence (AI) in stent selection and installation procedures is another new area to watch. AI algorithms are being developed to analyse patient data, imaging results, and procedural parameters and recommend the best stent type and placement technique for each case. This could result in more consistent and successful treatment methods across healthcare facilities.
Finally, the concept of "combination therapy" stents is gaining popularity among researchers. These multifunctional stents could include characteristics like localised drug administration, photodynamic treatment capabilities, and even tissue engineering components to aid with bile duct healing. Such comprehensive treatment platforms have the ability to address various facets of biliary illness at the same time, improving patient outcomes in the long run.
As these trends develop, we anticipate that the biliary stents industry will expand and innovate rapidly. Companies that effectively traverse these technical breakthroughs and meet the growing demand for minimally invasive, personalised biliary therapies will undoubtedly emerge as market leaders. The future of biliary stenting lies not only in mechanical support but also in intelligent, adaptable solutions that can considerably improve biliary disease management and patient quality of life.
Boston Scientific Corporation
Cook Medical
Medtronic plc
Olympus Corporation
CONMED Corporation
Taewoong Medical Co., Ltd.
Merit Medical Systems, Inc.
Abbott Laboratories
Becton, Dickinson, and Company (C.R. Bard)
M.I. Tech Co., Ltd.
Boston Scientific Corporation got FDA approval for its next-generation drug-eluting biliary stent in May 2024, with the goal of lowering stent occlusion rates in malignant strictures.
In March 2024, Medtronic plc announced a strategic agreement with a prominent AI startup to create an AI-powered platform for optimising biliary stent selection and placement.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope and Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking—Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies List by Country) (Premium)
5. COMPANY PROFILES
5.1. Boston Scientific Corporation
5.2. Cook Medical
5.3. Medtronic plc
5.4. Olympus Corporation
5.5. CONMED Corporation
5.6. Taewoong Medical Co., Ltd.
5.7. Merit Medical Systems, Inc.
5.8. Abbott Laboratories
5.9. Becton, Dickinson and Company (C.R. Bard)
5.10. M.I. Tech Co., Ltd. (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Adoption of biodegradable stents gains momentum in biliary tract interventions
6.1.2. Development of "smart" biliary stents with sensor and communication capabilities
6.1.3. Integration of artificial intelligence in stent selection and placement procedures
6.2. Market Drivers
6.2.1. Increasing prevalence of biliary disorders and pancreatic cancer fuels market growth
6.2.2. Technological advancements in stent design and materials
6.2.3. Growing adoption of minimally invasive endoscopic procedures
6.3. Market Restraints
6.3.1. Complications associated with stent placement and high procedural costs hinder market adoption
6.3.2. Limited reimbursement policies in developing countries
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY MATERIAL TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Metal Stents
7.1.1. Self-Expanding Metal Stents (SEMS)
7.1.2. Balloon-Expandable Metal Stents
7.2. Plastic Stents
7.2.1. Polyethylene Stents
7.2.2. Teflon Stents
8. BY PRODUCT TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
8.1. Self-Expanding Stents
8.1.1. Covered Self-Expanding Stents
8.1.2. Uncovered Self-Expanding Stents
8.2. Balloon-Expandable Stents
9. BY APPLICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Malignant Obstruction
9.1.1. Pancreatic Cancer
9.1.2. Cholangiocarcinoma
9.1.3. Other Malignancies
9.2. Benign Biliary Strictures
9.3. Biliary Leaks
10. BY END-USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. Hospitals
10.2. Ambulatory Surgical Centres
10.3. Speciality Clinics
11. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
11.1. North America
11.1.1. United States
11.1.2. Canada
11.1.3. Mexico
11.2. South America
11.2.1. Brazil
11.2.2. Argentina
11.2.3. Rest of South America
11.3. Europe
11.3.1. Germany
11.3.2. United Kingdom
11.3.3. France
11.3.4. Italy
11.3.5. Spain
11.3.6. Russia
11.3.7. Rest of Europe
11.4. Asia-Pacific
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia
11.4.5. South Korea
11.4.6. Rest of Asia-Pacific
11.5. Middle-East
11.5.1. UAE
11.5.2. Saudi Arabia
11.5.3. Turkey
11.5.4. Rest of Middle East
11.6. Africa
11.6.1. South Africa
11.6.2. Egypt
11.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (2020-2031)
By Material Type:
Metal Stents
Plastic Stents
By Product Type:
Self-Expanding Stents
Balloon-Expandable Stents
By Application:
malignant obstruction
Benign Biliary Strictures
Biliary Leaks
By End-User:
Hospitals
Ambulatory Surgical Centres
Speciality Clinics
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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