Plastic Biliary Stents

Plastic Biliary Stents Market by Material (Ethylene Vinyl Acetate, Fluorinated Ethylene Propylene, Polyethylene), Shape (Angled, Bended/Curved, Pigtailed), Application, End User - Global Forecast 2024-2030

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[196 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 Market
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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.

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.

Market Dynamics

The market dynamics represent an ever-changing landscape of the Plastic Biliary Stents Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

  • Market Drivers
    • Rising prevalence of biliary tract diseases among global population
    • Preference for minimally invasive medical procedures for biliary tract disease treatment
  • Market Restraints
    • Adverse recalls of plastic biliary stents
  • Market Opportunities
    • Advancements in the designs and making of plastic biliary stents
    • Improvements in reimbursement for plastic biliary stents
  • Market Challenges
    • Availability of alternative stents and complications of plastic biliary stents
Market Segmentation Analysis
  • 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.

Market Disruption Analysis

The market disruption analysis delves into the core elements associated with market-influencing changes, including breakthrough technological advancements that introduce novel features, integration capabilities, regulatory shifts that could drive or restrain market growth, and the emergence of innovative market players challenging traditional paradigms. This analysis facilitates a competitive advantage by preparing players in the Plastic Biliary Stents Market to pre-emptively adapt to these market-influencing changes, enhances risk management by early identification of threats, informs calculated investment decisions, and drives innovation toward areas with the highest demand in the Plastic Biliary Stents Market.

Porter’s Five Forces Analysis

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Plastic Biliary Stents Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

Value Chain & Critical Path Analysis

The value chain of the Plastic Biliary Stents Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of the <> market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.

Pricing Analysis

The pricing analysis comprehensively evaluates how a product or service is priced within the Plastic Biliary Stents Market. This evaluation encompasses various factors that impact the price of a product, including production costs, competition, demand, customer value perception, and changing margins. An essential aspect of this analysis is understanding price elasticity, which measures how sensitive the market for a product is to its price change. It provides insight into competitive pricing strategies, enabling businesses to position their products advantageously in the Plastic Biliary Stents Market.

Technology Analysis

The technology analysis involves evaluating the current and emerging technologies relevant to a specific industry or market. This analysis includes breakthrough trends across the value chain that directly define the future course of long-term profitability and overall advancement in the Plastic Biliary Stents Market.

Patent Analysis

The patent analysis involves evaluating patent filing trends, assessing patent ownership, analyzing the legal status and compliance, and collecting competitive intelligence from patents within the Plastic Biliary Stents Market and its parent industry. Analyzing the ownership of patents, assessing their legal status, and interpreting the patents to gather insights into competitors' technology strategies assist businesses in strategizing and optimizing product positioning and investment decisions.

Trade Analysis

The trade analysis of the Plastic Biliary Stents Market explores the complex interplay of import and export activities, emphasizing the critical role played by key trading nations. This analysis identifies geographical discrepancies in trade flows, offering a deep insight into regional disparities to identify geographic areas suitable for market expansion. A detailed analysis of the regulatory landscape focuses on tariffs, taxes, and customs procedures that significantly determine international trade flows. This analysis is crucial for understanding the overarching legal framework that businesses must navigate.

Regulatory Framework Analysis

The regulatory framework analysis for the Plastic Biliary Stents Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Plastic Biliary Stents Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment 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, namely 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 assessment of the current state of vendors in the Plastic Biliary Stents Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. 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 these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • Medical Tech Firm Medtronic to Invest INR 3,000 Crore for Hyderabad R&D Center

    Medtronic PLC has escalated its commitment to innovation with a substantial INR 3,000 crore (approximately USD 350 million) investment in establishing its largest Research and Development center in Hyderabad, India. The expanded facility is aimed to focus on cutting-edge fields such as robotics, imaging, navigation, and surgical and implantable technologies, enhancing business presence in India. [Published On: 2023-05-18]

  • Olympus Will Acquire the Korean Gastrointestinal Stent Company Taewoong Medical Co., Ltd.

    Olympus Corporation has acquired Taewoong Medical Co., Ltd., a medical device manufacturer known for its sophisticated gastrointestinal stents. Olympus aims to leverage Taewoong Medical’s prowess in crafting stents crucial for minimally invasive treatment of biliary tract obstructions indicative of cancer. Renowned for their high radial strength and exceptional flexibility, Taewoong’s stents ensure resilience and adaptability within complex anatomies, greatly enhancing patient recovery prospects. [Published On: 2023-01-24]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Plastic Biliary Stents Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

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.

Plastic Biliary Stents Market - Global Forecast 2024-2030
To learn more about this report, request a free PDF copy
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

This research report offers invaluable insights into various crucial aspects of the Plastic Biliary Stents Market:

  1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
  2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
  3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
  4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
  5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

Additionally, the report addresses key questions to assist stakeholders in making informed decisions:

  1. What is the current market size and projected growth?
  2. Which products, segments, applications, and regions offer promising investment opportunities?
  3. What are the prevailing technology trends and regulatory frameworks?
  4. What is the market share and positioning of the leading vendors?
  5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Plastic Biliary Stents Market, by Material
  7. Plastic Biliary Stents Market, by Shape
  8. Plastic Biliary Stents Market, by Application
  9. Plastic Biliary Stents Market, by End User
  10. Americas Plastic Biliary Stents Market
  11. Asia-Pacific Plastic Biliary Stents Market
  12. Europe, Middle East & Africa Plastic Biliary Stents Market
  13. Competitive Landscape
  14. Competitive Portfolio
  15. List of Figures [Total: 24]
  16. List of Tables [Total: 468]
  17. List of Companies Mentioned [Total: 22]
Frequently Asked Questions
  1. How big is the Plastic Biliary Stents Market?
    Ans. The Global Plastic Biliary Stents Market size was estimated at USD 165.15 million in 2023 and expected to reach USD 172.95 million in 2024.
  2. What is the Plastic Biliary Stents Market growth?
    Ans. The Global Plastic Biliary Stents Market to grow USD 229.35 million by 2030, at a CAGR of 4.80%
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