미국의 의료용 튜브 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the u.S. medical tubing market size is expected to grow from USD 4.40 billion in 2025 to USD 4.77 billion in 2026 and is forecast to reach USD 7.07 billion by 2031 at 8.20% CAGR over 2026-2031.

This report is Segmented by Material (Plastic, Rubber, Specialty Polymers), Structure (Single-Lumen, Multi-Lumen, Co-Extruded, Tapered/Bump, Braided, Balloon, Heat-Shrink, Micro-Extruded Tubing), Application (10 Types), End User (5 Types), Manufacturing Process (6 Types), and Geography (United States). Market Forecasts are Provided in Terms of Value (USD).

U.S. Medical Tubing Market Trends and Insights

Rising Minimally Invasive and Catheter-Based Procedure Volumes

The United States medical tubing market is experiencing significant growth, driven by the transition from open surgeries to catheter-based interventions. Transcatheter aortic valve replacements have exceeded 100,000 annual procedures, while mitral transcatheter edge-to-edge repairs have surpassed 15,000 cases annually. This increase in structural heart procedures is reshaping demand, as modern catheter systems require advanced designs with tighter tolerances, thinner walls, and layered shaft constructions. These advancements are driving demand for premium catheter liners, reinforced shafts, and multi-material tubing. Additionally, the expansion of ambulatory surgical centers is diversifying procurement channels, creating opportunities for more suppliers to enter the market.

Higher Single-Use Tubing Demand from Infection Control and Care Settings

Rising infection control requirements across inpatient, outpatient, and procedural settings are boosting demand for single-use tubing. Pre-sterilized and disposable tubing assemblies align with risk reduction protocols and reduce the burden of reprocessing. This shift increases replacement frequency, accelerating the refresh cycle for administration sets, pump tubing, and sterile fluid-transfer assemblies. The FDA's updated quality framework further supports this trend by emphasizing risk management and process control for device manufacturers.

FDA Biocompatibility and Extractables Characterization Burden

In the U.S. medical tubing market, biocompatibility and extractables assessments pose significant challenges for product developers. The FDA's alignment with ISO 10993 standards has intensified the toxicological reviews and material assessments for tubing, especially those used in drug delivery, dialysis, and infusion. New polymer designs, lacking the extensive usage history of established PVC or silicone systems, face heightened scrutiny. This not only extends development timelines but also hampers the transition from prototype to commercial production. Furthermore, the Federal Register's rulemaking on QMSR introduces additional design-control and documentation mandates, further delaying the entry of new tubing designs into regulated production.

Other drivers and restraints analyzed in the detailed report include:

1. Aging Chronic-Care Population Lifting Dialysis, Cardiovascular, and Home Care Tubing Demand
2. Home Infusion and Ambulatory Care Migration Expanding Pump and Fluid-Transfer Tubing Demand
3. Volatility in Medical-Grade Silicone, PVC, Fluoropolymer, and Specialty Material Pricing

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Specialty polymers are the fastest-growing material segment in the United States medical tubing market, with a projected CAGR of 10.18% from 2026 to 2031. Advanced catheter and drug delivery designs increasingly require properties that commodity materials cannot consistently provide. Materials like PEBA, PEEK, and thermoplastic polyurethane are preferred for tighter dimensional control, enhanced kink resistance, and superior chemical stability. This shift is most significant in vascular, neurovascular, and minimally invasive applications, where tubing performance directly impacts device handling.

In 2025, plastic tubing held a 38.12% share of the United States medical tubing market, reflecting its strong presence in high-volume disposable and IV administration applications. PVC remains popular due to its cost efficiency, processability, and extensive biocompatibility documentation. Rubber tubing, led by silicone and latex-based formats, is essential in peristaltic pump systems, respiratory circuits, and long-duration drainage applications.

Single-lumen tubing accounted for 40.25% of the United States medical tubing market in 2025, making it the largest structural format. Its simplicity suits bulk applications like IV sets and catheter shafts, ensuring production efficiency and compatibility with conventional extrusion platforms. This structure remains integral to fluid management products widely used in hospitals and ambulatory settings. Single-lumen tubing continues to dominate due to its broad demand and recurring replacement volumes.

Micro-extruded and microbore tubing is the fastest-growing structural segment, with a 10.75% CAGR from 2026 to 2031. This growth is driven by catheter miniaturization in neurovascular access and robotic-assisted systems, where smaller profiles enhance navigation and outcomes. Multi-lumen and co-extruded tubing are also gaining traction as advanced catheter shafts integrate multiple functionalities. Zeus highlighted this trend in January 2026 with the launch of the PFX platform and PFX Flex Sub-Lite-Wall, designed for modern catheter construction.

List of Companies Covered in this Report:

1. Accu-Tube LLC
2. Bentec Medical, LLC
3. Compagnie de Saint-Gobain S.A.
4. Duke Extrusion
5. Freudenberg Medical, LLC
6. Kent Elastomer Products, Inc.
7. Medical Extrusion Technologies, Inc.
8. MicroLumen, Inc.
9. Micro-Tek Corporation
10. NewAge Industries, Inc.
11. Nordson
12. One Medical Extrusion
13. Polyzen, Inc.
14. Putnam Plastics Corporation
15. Raumedic
16. Spectrum Plastics Group
17. TE Connectivity Ltd.
18. Teel Plastics, Inc.
19. Tekni-Plex, Inc.
20. Zeus Company LLC

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Minimally Invasive and Catheter-Based Procedure Volumes
  • 4.2.2 Higher Single-Use Tubing Demand from Infection Control and Care Standardization
  • 4.2.3 Aging Chronic-Care Population Lifting Dialysis, Cardiovascular, and Urology Tubing Volumes
  • 4.2.4 Home Infusion and Ambulatory Care Migration Expanding Pump and Transfer Tubing Demand
  • 4.2.5 PFAS-Free Liner Substitution Cycle Creating Redesign-Driven Replacement Demand
  • 4.2.6 Electrophysiology and Structural-Heart Device Scaling Increasing Microbore Reinforced Shaft Demand
• 4.3 Market Restraints
  • 4.3.1 FDA Biocompatibility and Extractables Characterization Burden
  • 4.3.2 Volatility in Medical-Grade Silicone, PVC, Fluoropolymer, and Specialty Resin Supply
  • 4.3.3 PFAS Phase-Down Forces Revalidation of Catheter Liners and Process Windows
  • 4.3.4 QMSR, Connector, and DEHP-Related Redesign Costs Slow Product Changeovers
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Material
  • 5.1.1 Plastic
  • 5.1.2 Rubber
  • 5.1.3 Specialty Polymers
• 5.2 By Structure
  • 5.2.1 Single-lumen Tubing
  • 5.2.2 Multi-lumen Tubing
  • 5.2.3 Co-extruded / Multi-layer Tubing
  • 5.2.4 Tapered / Bump Tubing
  • 5.2.5 Braided / Reinforced Tubing
  • 5.2.6 Balloon Tubing
  • 5.2.7 Heat-shrink Tubing
  • 5.2.8 Micro-extruded / Microbore Tubing
• 5.3 By Application
  • 5.3.1 Bulk Disposable Tubing
  • 5.3.2 Catheters & Cannulae
  • 5.3.3 Drug Delivery Systems
  • 5.3.4 Dialysis & Renal Care Tubing
  • 5.3.5 IV Infusion & Fluid Administration Tubing
  • 5.3.6 Respiratory, Anesthesia & Gas Supply Tubing
  • 5.3.7 Enteral Feeding & Gastrointestinal Tubing
  • 5.3.8 Suction, Smoke Evacuation & Drainage Tubing
  • 5.3.9 Biopharmaceutical Laboratory & Processing Tubing
  • 5.3.10 Peristaltic Pump Tubing
• 5.4 By End User
  • 5.4.1 Hospitals & Integrated Delivery Networks
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Physician Offices & Specialty Clinics
  • 5.4.4 Home Care Setting
  • 5.4.5 Medical Laboratories & Biopharmaceutical Facilities
• 5.5 By Manufacturing Process
  • 5.5.1 Single-screw Extrusion
  • 5.5.2 Twin-screw Extrusion
  • 5.5.3 Micro-extrusion
  • 5.5.4 Co-extrusion / Multi-layer Extrusion
  • 5.5.5 Braiding, Coiling & Secondary Shaft Reinforcement
  • 5.5.6 Heat-shrink & Reflow Processing

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Accu-Tube LLC
  • 6.3.2 Bentec Medical, LLC
  • 6.3.3 Compagnie de Saint-Gobain S.A.
  • 6.3.4 Duke Extrusion
  • 6.3.5 Freudenberg Medical, LLC
  • 6.3.6 Kent Elastomer Products, Inc.
  • 6.3.7 Medical Extrusion Technologies, Inc.
  • 6.3.8 MicroLumen, Inc.
  • 6.3.9 Micro-Tek Corporation
  • 6.3.10 NewAge Industries, Inc.
  • 6.3.11 Nordson Corporation
  • 6.3.12 One Medical Extrusion
  • 6.3.13 Polyzen, Inc.
  • 6.3.14 Putnam Plastics Corporation
  • 6.3.15 RAUMEDIC AG
  • 6.3.16 Spectrum Plastics Group
  • 6.3.17 TE Connectivity Ltd.
  • 6.3.18 Teel Plastics, Inc.
  • 6.3.19 Tekni-Plex, Inc.
  • 6.3.20 Zeus Company LLC

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment