Plastic Biliary Stents Market by Material, Shape, Application, End User

Description

List of Tables

[192 Pages Report] The Plastic Biliary Stents Market size was estimated at USD 165.15 million in 2023 and expected to reach USD 172.95 million in 2024, at a CAGR 4.80% to reach USD 229.35 million by 2030.

Plastic biliary stents are slender, tubular devices made from non-absorbable synthetic materials, such as polyethylene or polyurethane, designed for the temporary drainage and patency of bile ducts obstructed by conditions, including tumors, stones, strictures, or after certain surgeries. The use of plastic biliary stents is expanding due to several factors, which include their lower cost compared to metal stents, ease of insertion, and removal during endoscopic procedures. Technological advances that improve stent design and patient comfort have also contributed to their widespread adoption. The growing prevalence of gallstone diseases, biliary cancers, and the global aging population experiencing these conditions fuel the need for biliary stenting. However, their predilection for occlusion over time due to bacterial biofilm formation and sludge accumulation can impede their utility. Continual innovations in stent materials and coatings are underway to reduce bacterial adherence and extend the functional life of the stent. The integration of advanced imaging and delivery systems for precision placement is expected to improve procedural success rates. Tailoring stent design to individual patient anatomy through custom solutions and exploring novel materials are potential areas for researchers in the biliary stent space.

KEY MARKET STATISTICS
Base Year [2023]	USD 165.15 million
Estimated Year [2024]	USD 172.95 million
Forecast Year [2030]	USD 229.35 million
CAGR (%)	4.80%

Material: High adoption of fluorinated ethylene propylene to manage adverse reactions of stents and offer improved compatibility with organs

Ethylene-vinyl acetate is a copolymer known for its flexibility and strong adhesive qualities, which makes it a suitable candidate for biliary stent applications where malleability and secure placement in the bile duct are important. Stents made from EVA can be beneficial in cases where patient anatomy requires a flexible stent structure. Fluorinated ethylene propylene is a non-reactive, non-stick polymer with a high chemical resistance, making it ideal for biliary stenting in patients who may have adverse reactions to other materials. Additionally, FEP's smooth surface can help in preventing the buildup of bile and other bodily fluids. It is preferred for long-term implantation within the body due to its resilience and compatibility. Polyethylene is a common material in biliary stents due to its excellent mechanical properties and lower cost. PE stents are often favored for their ease of insertion and removal, as well as their balance of flexibility and strength. They are typically used in both temporary and permanent intervention treatments. Polyurethane is chosen for its good biocompatibility and superior mechanical strength compared to other polymers. These characteristics make it appropriate for scenarios requiring durable stents that can withstand the mechanical stress of the biliary system. Known for its non-adherent properties and chemical inertness, teflon is used in biliary stents for its ability to reduce tissue ingrowth and for being less prone to encrustation. Its slick surface facilitates easy insertion and removal, usually in temporary stenting procedures.

Shape: Preference for angled stents owing to their precise deployment and conformability to ductal curvatures

Angled stents are designed with a bend near the distal end that helps navigate the stent through complex anatomy. These stents are often preferred in cases where the bile duct has tight turns or where there is a need for precise stent placement. They may be favored in specific clinical situations, such as the treatment of hilar cholangiocarcinoma, where sharper angles in the bile duct require a more targeted approach for efficient drainage. Bended or curved stents have a gentle curve throughout their length, which allows them to conform to the natural curvature of the bile duct. This can be especially useful in cases of benign biliary strictures where the stent needs to align closely with the duct structure to prevent migration and maintain patency. Their design can differ subtly from angled stents, which are generally more sharply bent at a specific point rather than curved over their entire length. Pigtailed stents are known for their coiled ends, which resemble the curl at the end of a pig's tail. This configuration prevents stent migration by anchoring the stent in place within the duct. This stent design is often chosen for its anti-migration properties and is especially useful in cases where previous stents have dislodged or in anatomies that predispose to stent migration. Straight stents are linear in shape and lack any internal curves or angles. These stents are universally applicable and are frequently used due to their versatility. They are particularly suited for dilating straight portions of the bile duct or in cases where there is less need for anatomical conformity. They tend to have fewer complications with insertion and are often easier to deploy.

End-User: Need for plastic biliary stents with advanced features or customized solutions in hospitals

Ambulatory surgical centers (ASCs) are healthcare facilities that offer outpatient surgical care, including procedures such as the placement of plastic biliary stents for endoscopic retrograde cholangiopancreatography (ERCP). These centers are designed to provide a convenient and cost-effective alternative to hospitals. In an ASC setting, patients with less complex conditions requiring biliary stent procedures may prefer this option due to the typically lower costs and faster turnaround times when compared to hospitals. Additionally, ASCs aim to reduce the risk of hospital-acquired infections, a factor of significant importance when it comes to endoscopic procedures. Hospitals serve as the primary end-user for plastic biliary stents due to their comprehensive care facilities, which include emergency services, intensive care, and the availability of a wide range of specialists. Hospitals are the preferred choice for more complex biliary disease cases due to their full-scale facilities and ability to provide immediate, comprehensive care. They are equipped to handle any complications that may arise during or after the placement of biliary stents.

Application: Effective use of biliary stents to manage biliary leaks due to their easy removability

Plastic biliary stents are frequently used in the treatment of biliary leaks, which occur due to complications after hepatobiliary surgery or trauma or, less commonly, as a result of an endoscopic procedure. The primary need is to bridge the area of the leak and facilitate the rerouting of bile flow while the underlying lesion heals. In cases where gallstones cause biliary obstruction, the need for plastic biliary stents is often driven by the necessity to alleviate jaundice, relieve pain, and prevent cholangitis. Stents are also placed preoperatively to assist in the management of cholelithiasis in high-risk patients. The placement of biliary stents is usually temporary and acts as a bridge to surgery or until definitive stone removal can be performed. Plastic biliary stents are widely used for palliative treatment in malignant biliary obstructions such as those caused by tumors. While metal stents are often preferred for their longer patency periods, plastic stents may be utilized in cases where the expected survival is relatively short or when a less invasive approach is desired. They are also used during preoperative neoadjuvant therapy or when there is uncertainty about the nature of the obstruction.

Regional Insights

In the Americas, the utilization of plastic biliary stents is propelled by advanced healthcare practices, with a strong emphasis on minimally invasive techniques for managing biliary tract diseases. The region commands robust production capabilities, supported by stringent FDA regulations that assure product safety and effectiveness, with major companies at the forefront of innovation and market presence. The APAC region presents a rapid need for plastic biliary stents to treat an increasing prevalence of biliary diseases and support medical tourism. China and India are increasingly contributing to production, with local manufacturers expanding their footprint, albeit facing regulatory heterogeneity across the region that influences product availability and standards. Western European countries exhibit a high adoption rate of innovative medical devices, including plastic biliary stents, with well-established healthcare systems and consistent demand. Production in the region is marked by the presence of global players as well as specialized regional manufacturers, which provide tailored solutions. Regulatory mechanisms across EMEA are diverse but generally harmonized within the European Union under the CE marking system, ensuring a standardized level of product quality control.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Plastic Biliary Stents Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Plastic Biliary Stents Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Plastic Biliary Stents Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Ace Medical Devices Pvt. Ltd., Advin Health Care, Bassil Scientific Private Limited, Boston Scientific Corporation, Conmed Corporation, Cook Group Inc., Diagmed Healthcare Ltd., Duomed Group, ELLA - CS, s.r.o., ENDO-FLEX GmbH, Focuz Medical, Hobbs Medical Inc., JDmeditech, Leufen Medical GmbH, Medorah Meditek Pvt. Ltd., Medtronic PLC, Merit Medical Systems, Micro-Tech (Nanjing) Co., Ltd., Olympus Corporation, Q3 Medical Devices Limited, and Surgimedex.

Market Segmentation & Coverage

This research report categorizes the Plastic Biliary Stents Market to forecast the revenues and analyze trends in each of the following sub-markets:

Material
- Ethylene Vinyl Acetate
- Fluorinated Ethylene Propylene
- Polyethylene
- Polyurethane
- Teflon

Shape
- Angled
- Bended/Curved
- Pigtailed
  - Double Pigtailed
  - Single Pigtailed

Straight

Application
- Biliary leaks
- Gallstones
- Tumor

End User
- Ambulatory Surgical Centres
- Hospitals

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Plastic Biliary Stents Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Plastic Biliary Stents Market?

3. What are the technology trends and regulatory frameworks in the Plastic Biliary Stents Market?

4. What is the market share of the leading vendors in the Plastic Biliary Stents Market?

5. Which modes and strategic moves are suitable for entering the Plastic Biliary Stents Market?

Product Code: MRR-43539E5D35C3

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising prevalence of biliary tract diseases among global population
  - 5.1.1.2. Preference for minimally invasive medical procedures for biliary tract disease treatment
- 5.1.2. Restraints
  - 5.1.2.1. Adverse recalls of plastic biliary stents
- 5.1.3. Opportunities
  - 5.1.3.1. Advancements in the designs and making of plastic biliary stents
  - 5.1.3.2. Improvements in reimbursement for plastic biliary stents
- 5.1.4. Challenges
  - 5.1.4.1. Availability of alternative stents and complications of plastic biliary stents
5.2. Market Segmentation Analysis
- 5.2.1. Material: High adoption of fluorinated ethylene propylene to manage adverse reactions of stents and offer improved compatibility with organs
- 5.2.2. Shape: Preference for angled stents owing to their precise deployment and conformability to ductal curvatures
- 5.2.3. End-User: Need for plastic biliary stents with advanced features or customized solutions in hospitals
- 5.2.4. Application: Effective use of biliary stents to manage biliary leaks due to their easy removability
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Plastic Biliary Stents Market, by Material

6.1. Introduction
6.2. Ethylene Vinyl Acetate
6.3. Fluorinated Ethylene Propylene
6.4. Polyethylene
6.5. Polyurethane
6.6. Teflon

7. Plastic Biliary Stents Market, by Shape

7.1. Introduction
7.2. Angled
7.3. Bended/Curved
7.4. Pigtailed
7.5. Straight

8. Plastic Biliary Stents Market, by Application

8.1. Introduction
8.2. Biliary leaks
8.3. Gallstones
8.4. Tumor

9. Plastic Biliary Stents Market, by End User

9.1. Introduction
9.2. Ambulatory Surgical Centres
9.3. Hospitals

10. Americas Plastic Biliary Stents Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Plastic Biliary Stents Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Plastic Biliary Stents Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. Medical Tech Firm Medtronic to Invest INR 3,000 Crore for Hyderabad R&D Center
- 13.3.2. Olympus Will Acquire the Korean Gastrointestinal Stent Company Taewoong Medical Co., Ltd.
13.4. Strategy Analysis & Recommendation

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio