미국의 주입 요법 기기 시장 : 시장 규모, 점유율, 동향 분석(2026-2032년)

The U.S. infusion therapy device market was valued at over $4.1 billion in 2025. The market is expected to grow at a 2.3 percent CAGR to exceed $4.8 billion by 2031.

This report covers infusion pumps, infusion sets, needleless connectors, stopcocks, intravenous filters, and devices used for blood transfusion. It quantifies units, average selling prices, market values, growth rates, and company shares, and it analyzes growth drivers and limiters, recent M&A, recalls, and technology trends. It provides historical data to 2024 and forecasts to 2031.

The scope reflects how health systems evaluate networked smart pumps, drug libraries, dose-error reduction software, and EMR interoperability across hospitals, specialty clinics, ambulatory surgical centers, and home infusion.

Market Overview

Hospitals and health networks are moving from legacy capital replacement cycles toward fully networked infusion platforms.

These platforms combine drug libraries, dose-error reduction software, and real-time EMR communication for auto programming and auto documentation.

This shift increases upfront costs and adds ongoing fees for software licensing, analytics, cybersecurity, interface validation, training, and drug-library governance. Because security updates and new features depend on supported hardware and software baselines, fleets are refreshed more often than in the past.

As a result, market value rises through higher ASPs, subscriptions, and paid services, even when unit growth is modest. Over time, purchasing is becoming an enterprise decision that favors standardized pump fleets, system integration, and data services rather than one-off device buys.

Market Drivers

Smart pumps and interoperability. Dose-error reduction, standardized drug libraries, and bidirectional EMR integration improve safety and workflow. These features require validated interfaces and governance, which supports higher ASPs and service revenues.

Infection prevention. Hospitals carry the cost of catheter-related bloodstream infections. This drives adoption of premium infection-prevention devices and consumables, including split septum connectors, neutral displacement designs, and antimicrobial options where evidence supports use.

Alternate care sites. Home infusion and other non-acute settings are a rising share of therapy. Purchasing in these settings is fragmented and often has fewer GPO discounts, which supports higher price realization.

Lifecycle and cybersecurity. Regular security patches, recalls, and feature releases accelerate replacement cycles and keep product pipelines active.

Clinical productivity. Platforms that simplify drug-library management, alarm reduction, fleet monitoring, and analytics help large health systems run safer and leaner, which strengthens the case for networked upgrades.

Market Limiters

Adverse events and recalls. Safety issues, including pump recalls, disrupt operations and strain inventory. They also raise due diligence thresholds for new placements.

Non-device competition. New drugs and non-invasive therapies can displace device usage in select indications. An example is long-acting local analgesia in peripheral nerve block pathways, which reduced demand for some disposable ambulatory pain pumps.

Group purchasing organizations. GPOs aggregate demand and negotiate lower prices, which can limit market access for smaller manufacturers and can slow adoption of novel devices.

Evidence gaps. Some premium features, such as antimicrobial coatings on certain connectors, face slower growth where outcome evidence is limited.

Pricing pressure. A mature competitive field and contract cycles keep price gains moderate in several categories, even as software and services expand.

Market Coverage and Data Scope

Quantitative coverage

Market size, market shares, market forecasts, growth rates, units sold, and average selling prices.

Qualitative coverage

Growth trends, limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA recalls, disruptive technologies, and disease overviews that shape demand for infusion therapy.

Time frame

Base year 2025, forecasts 2026 to 2032, historical data 2022 to 2024.

Data sources

Primary interviews with industry leaders, government physician data, regulatory data, hospital private data, import and export data, and the iData Research internal database.

Method note

Revenue is modeled from units multiplied by ASP, validated with procedure and utilization inputs, and checked against installed base and replacement assumptions for pumps and sets.

Care settings

Hospitals, specialty clinics, ambulatory surgical centers, and home care.

Markets Covered and Segmentation

Infusion Pump Market

• By device type: large volume pumps, syringe pumps, patient-controlled analgesia pumps, electronic ambulatory pumps.
• By device type: disposable ambulatory pumps.
• By smart capability: smart pumps, non-smart pumps.
• By EMR integration: EMR integrated, non-EMR integrated.

Unit analysis applies to large volume and syringe pumps.

Intravenous Set Market (IV sets)

Pump sets.

Gravity sets and secondary sets.

Extension sets by material. DEHP sets and non-DEHP sets.

Needleless Connector Market

• By valve type: split septum and blunt cannula, mechanical valve.
• By device type: standalone and integrated.
• By antimicrobial coating: antimicrobial and conventional.
• By care setting: hospital, specialty clinic, ASC, home care.

Stopcock Market

• By flow type: one-way, two-way, three-way, four-way.
• By care setting: hospital, ASC, home care.

Intravenous Filter Market

• By care setting: hospital, ASC, home care.

Blood Transfusion Set Market

• By chamber: single chamber and dual chamber.
• By care setting: hospital, ASC, home care.

Blood Warmer Market

• By device type: capital equipment and disposable.

Competitive Analysis

Becton Dickinson led the U.S. infusion therapy device and consumables market in 2025. The company expanded its position in IV devices after acquiring CareFusion and holds leadership in IV sets and needleless connectors.

ICU Medical was the second-largest competitor with strong shares in infusion pumps, IV sets, and needleless connectors, and leadership in stopcocks. After acquiring Smiths Medical in 2022, the company is positioned for further product activity.

Baxter ranked third in total share with a broad presence in infusion pumps, IV sets, needleless connectors, stopcocks, and blood transfusion sets. The company is not the segment leader but maintains wide access across provider types through an extensive distribution network.

Other participants are active in selected products or care settings.

This is a concentrated market that supports sustained investment in quality, software, and services and that also raises the bar for new entrants.

Technology and Practice Trends

Drug libraries and dose-error reduction are standard requirements in large placements.

Neutral or minimal reflux connectors command a premium due to lower perceived risk of blood reflux and occlusion.

Antimicrobial or disinfectable designs gain traction where evidence and workflow support the value case.

Alarm and analytics features are used to reduce nuisance alarms, find training gaps, and plan maintenance.

Home infusion logistics and reimbursement continue to expand, which keeps the market diverse across acute and non-acute buyers.

Geography

This edition covers the United States.

Why This Report

Where is the largest and fastest growing opportunity within U.S. infusion therapy devices and which categories are most likely to gain share over the forecast period.

How does the infusion therapy device market relate to the broader economy and to hospital operations, including consolidation, cybersecurity spending, and the shift toward standardization and enterprise platforms.

What forces will shape the market going forward, including EMR interoperability, dose-error reduction, infection prevention, recalls, evidence requirements, GPO contracts, and the rise of alternate care sites.

How do smart pumps, drug libraries, and auto programming change replacement cycles and what are the implications for pricing, subscriptions, and paid services.

Which product designs are gaining traction in connectors, sets, and stopcocks based on infection risk, disinfection profiles, and ease of use.

What is the impact of recalls and adverse event reporting on provider purchasing decisions and vendor selection.

How can suppliers make a stronger business case by linking safety features, alarm management, and analytics to clinical productivity and cost control.

How should commercial teams plan for home infusion growth, fragmented purchasing, and pricing strategies outside GPO contracts.

Where are the key risks to growth, including non-device therapies that reduce device usage in specific pathways.

The U.S. infusion therapy device market report from iData Research answers these questions with procedure-aware models, company share analysis, and pricing detail.

Use it to quantify demand by category, plan product roadmaps, set pricing and contracting targets, and prioritize training and support programs that speed adoption.

TABLE OF CONTENT

Table Of Contents

List Of Figures

List Of Charts

U.S. Infusion Therapy Device Market Overview

Competitive Analysis

Emerging Markets And Technologies

Market Trends

Market Developments

Market Segmentation

Key Report Updates

Version History

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

U.S. Infusion Therapy Device Market Overview

• 3.1 Introduction
• 3.2 Market Overview & Trend Analysis
• 3.3 Drivers And Limiters
  • 3.3.1 Market Drivers
  • 3.3.2 Market Limiters
• 3.4 Competitive Market Share Analysis
• 3.5 Mergers And Acquisitions

Infusion Pump Market

• 4.1 Introduction
• 4.2 Market Overview
• 4.3 Market Analysis And Forecast
  • 4.3.1 Large-Volume Infusion Pump Market
    • 4.3.1.1 Large-Volume Infusion Pump Market By Care Setting
    • 4.3.1.1.1 Hospital Large-Volume Infusion Pump Market
    • 4.3.1.1.2 Specialty Clinics Large-Volume Infusion Pump Market
    • 4.3.1.1.3 Ambulatory Surgical Center Large-Volume Infusion Pump Market
    • 4.3.1.1.4 Home Care Setting Large-Volume Infusion Pump Market
    • 4.3.1.2 Large-Volume Infusion Pump Market By Modularity
    • 4.3.1.2.1 Modular Large-Volume Infusion Pump Market
    • 4.3.1.2.2 Non-Modular Large-Volume Infusion Pump Market
    • 4.3.1.3 Large-Volume Infusion Pump Market By Mri Compatibility
    • 4.3.1.3.1 Mri-Compatible Large-Volume Infusion Pump Market
    • 4.3.1.3.2 Non-Mri-Compatible Large-Volume Infusion Pump Market
  • 4.3.2 Syringe Infusion Pump Market
    • 4.3.2.1 Syringe Infusion Pump Market By Care Setting
    • 4.3.2.1.1 Hospital Syringe Infusion Pump Market
    • 4.3.2.1.2 Specialty Clinics Syringe Infusion Pump Market
    • 4.3.2.1.3 Ambulatory Surgical Center Syringe Infusion Pump Market
    • 4.3.2.1.4 Home Care Setting Syringe Infusion Pump Market
    • 4.3.2.2 Syringe Infusion Pump Market By Modularity
    • 4.3.2.2.1 Modular Syringe Infusion Pump Market
    • 4.3.2.2.2 Non-Modular Syringe Infusion Pump Market
  • 4.3.3 Patient-Controlled Analgesia Infusion Pump Market
    • 4.3.3.1 Patient-Controlled Analgesia Infusion Pump Market By Care Setting
    • 4.3.3.1.1 Hospital Patient-Controlled Analgesia Infusion Pump Market
    • 4.3.3.1.2 Specialty Clinics Patient-Controlled Analgesia Infusion Pump Market
    • 4.3.3.1.3 Ambulatory Surgical Center Patient-Controlled Analgesia Infusion Pump Market
    • 4.3.3.1.4 Home Care Setting Patient-Controlled Analgesia Infusion Pump Market
  • 4.3.4 Electronic Ambulatory Infusion Pump Market
    • 4.3.4.1 Electronic Ambulatory Infusion Pump Market By Care Setting
    • 4.3.4.1.1 Hospital Electronic Ambulatory Infusion Pump Market
    • 4.3.4.1.2 Specialty Clinics Electronic Ambulatory Infusion Pump Market
    • 4.3.4.1.3 Ambulatory Surgical Center Electronic Ambulatory Infusion Pump Market
    • 4.3.4.1.4 Home Care Setting Electronic Ambulatory Infusion Pump Market
  • 4.3.5 Disposable Ambulatory Infusion Pump Market
    • 4.3.5.1 Disposable Ambulatory Infusion Pump Market By Type
    • 4.3.5.1.1 Disposable Ambulatory Non-Pain Infusion Pump Market
    • 4.3.5.1.2 Disposable Ambulatory Pain Infusion Pump Market By Type
    • 4.3.5.2 Disposable Ambulatory Infusion Pump Market By Care Setting
    • 4.3.5.2.1 Hospital Disposable Ambulatory Infusion Pump Market
    • 4.3.5.2.2 Specialty Clinics Disposable Ambulatory Infusion Pump Market
    • 4.3.5.2.3 Ambulatory Surgical Center Disposable Ambulatory Infusion Pump Market
    • 4.3.5.2.4 Home Care Setting Disposable Ambulatory Infusion Pump Market
  • 4.3.6 Smart Infusion Pump Market
• 4.4 Drivers And Limiters
  • 4.4.1 Market Drivers
  • 4.4.2 Market Limiters
• 4.5 Competitive Market Share Analysis

Intravenous Set Market

• 5.1 Introduction
• 5.2 Market Overview
  • 5.2.1 Market Overview By Device Type
  • 5.2.2 Market Overview By Material
• 5.3 Market Analysis And Forecast
  • 5.3.1 Intravenous Set Market By Device Type
    • 5.3.1.1 Pump Set Market
    • 5.3.1.1.1 Pump Set Market By Device Type
    • 5.3.1.1.2 Pump Set Market By Light Protection
    • 5.3.1.1.3 Pump Set Market By Patient Age
    • 5.3.1.1.4 Pump Set Market By Care Setting
    • 5.3.1.2 Gravity Set Market
    • 5.3.1.2.1 Gravity Set Market By Application
    • 5.3.1.2.2 Gravity Set Market By Care Setting
    • 5.3.1.3 Secondary Set Market
    • 5.3.1.3.1 Secondary Set Market By Care Setting
    • 5.3.1.4 Extension Set Market
    • 5.3.1.4.1 Extension Set Market By Configuration
    • 5.3.1.4.2 Extension Set Market By Iv Filter
    • 5.3.1.4.3 Extension Set Market By Stopcock
    • 5.3.1.4.4 Extension Set Market By Flow Control
    • 5.3.1.4.5 Extension Set Market By Care Setting
  • 5.3.2 Intravenous Set Market By Material
    • 5.3.2.1 Dehp Iv Set Market
    • 5.3.2.2 Non-Dehp Iv Set Market
• 5.4 Drivers And Limiters
  • 5.4.1 Market Drivers
  • 5.4.2 Market Limiters
• 5.5 Competitive Market Share Analysis

Needleless Connector Market

• 6.1 Introduction
• 6.2 Market Overview
  • 6.2.1 Market Overview By Valve Type
  • 6.2.2 Market Overview By Device Type
  • 6.2.3 Market Overview By Antimicrobial Coating
  • 6.2.4 Market Overview By Care Setting
• 6.3 Market Analysis And Forecast
  • 6.3.1 Total Needleless Connector Market
  • 6.3.2 Needleless Connector Market By Valve Type
    • 6.3.2.1 Split Septum And Blunt Cannula Needleless Connector Market
    • 6.3.2.2 Mechanical Valve Needleless Connector Market By Device Type
    • 6.3.2.2.1 Negative Displacement Mechanical Valve Needleless Connector Market
    • 6.3.2.2.2 Positive Displacement Mechanical Valve Needleless Connector Market
    • 6.3.2.2.3 Neutral Displacement Mechanical Valve Needleless Connector Market
    • 6.3.2.2.4 Anti-Reflux Neutral Displacement Mechanical Valve Needleless Connector Market
  • 6.3.3 Needleless Connector Market By Device Type
    • 6.3.3.1 Standalone Needleless Connector Market
    • 6.3.3.2 Integrated Needleless Connector Market
  • 6.3.4 Needleless Connector Market By Antimicrobial Coating
    • 6.3.4.1 Antimicrobial Needleless Connector Market
    • 6.3.4.2 Conventional Needleless Connector Market
  • 6.3.5 Needleless Connector Market By Care Setting
    • 6.3.5.1 Hospital Needleless Connector Market
    • 6.3.5.2 Specialty Clinics Needleless Connector Market
    • 6.3.5.3 Ambulatory Surgical Center Needleless Connector Market
    • 6.3.5.4 Home Care Setting Needleless Connector Market
• 6.4 Drivers And Limiters
  • 6.4.1 Market Drivers
  • 6.4.2 Market Limiters
• 6.5 Competitive Market Share Analysis

Stopcock Market

• 7.1 Introduction
• 7.2 Market Overview
  • 7.2.1 Market Overview By Flow Type
  • 7.2.2 Market Overview By Care Setting
• 7.3 Market Analysis And Forecast
  • 7.3.1 Total Stopcock Market
  • 7.3.2 Stopcock Market By Flow Type
    • 7.3.2.1 One-Way Stopcock Market
    • 7.3.2.2 Two-Way Stopcock Market
    • 7.3.2.3 Three-Way Stopcock Market
    • 7.3.2.4 Four-Way Stopcock Market
  • 7.3.3 Stopcock Market By Care Setting
    • 7.3.3.1 Hospital Stopcock Market
    • 7.3.3.2 Specialty Clinics Stopcock Market
    • 7.3.3.3 Ambulatory Surgical Center Stopcock Market
    • 7.3.3.4 Home Care Setting Stopcock Market
• 7.4 Drivers And Limiters
  • 7.4.1 Market Drivers
  • 7.4.2 Market Limiters
• 7.5 Competitive Market Share Analysis

Intravenous Filter Market

• 8.1 Introduction
• 8.2 Market Overview
  • 8.2.1 Market Overview By Care Setting
• 8.3 Market Analysis And Forecast
  • 8.3.1 Total Intravenous Filter Market
  • 8.3.2 Intravenous Filter Market By Care Setting
    • 8.3.2.1 Hospital Intravenous Filter Market
    • 8.3.2.2 Specialty Clinics Intravenous Filter Market
    • 8.3.2.3 Ambulatory Surgical Center Intravenous Filter Market
    • 8.3.2.4 Home Care Setting Intravenous Filter Market
• 8.4 Drivers And Limiters
  • 8.4.1 Market Drivers
  • 8.4.2 Market Limiters
• 8.5 Competitive Market Share Analysis

Blood Transfusion Device Market

• 9.1 Introduction
• 9.2 Market Overview
  • 9.2.1 Market Overview By Chamber Type
  • 9.2.2 Market Overview By Care Setting
• 9.3 Market Analysis And Forecast
  • 9.3.1 Total Blood Transfusion Device Market
  • 9.3.2 Blood Transfusion Device Market By Chamber Type
    • 9.3.2.1 Single-Chamber Blood Transfusion Device Market
    • 9.3.2.2 Dual-Chamber Blood Transfusion Device Market
  • 9.3.3 Blood Transfusion Device Market By Care Setting
    • 9.3.3.1 Hospital Blood Transfusion Device Market
    • 9.3.3.2 Asc Blood Transfusion Device Market
    • 9.3.3.3 Other Blood Transfusion Device Market
• 9.4 Drivers And Limiters
  • 9.4.1 Market Drivers
  • 9.4.2 Market Limiters
• 9.5 Competitive Market Share Analysis

Blood Warmer Market

• 10.1 Introduction
• 10.2 Market Overview
• 10.3 Market Analysis And Forecast
  • 10.3.1 Total Blood Warmer Capital Equipment Market
    • 10.3.1.1 Blood Warmer Capital Equipment Market By Flow Rate
    • 10.3.1.1.1 Standard Flow Blood Warmer Market
    • 10.3.1.1.2 Rapid Infusion Blood Warmer Market
    • 10.3.1.2 Blood Warmer Capital Equipment Market By Care Setting
    • 10.3.1.2.1 Hospital Blood Warmer Market
    • 10.3.1.2.2 Ambulatory Surgical Center Market
    • 10.3.1.2.3 Other Care Setting Blood Warmer Market
  • 10.3.2 Total Disposable Blood Warmer Market
    • 10.3.2.1 Disposable Blood Warmer Market By Device Type
    • 10.3.2.1.1 Administration Set Disposable Blood Warmer Market
    • 10.3.2.1.2 Reservoir Disposable Blood Warmer Market
    • 10.3.2.1.3 Other Disposable Blood Warmer Market
    • 10.3.2.2 Disposable Blood Warmer Market By Care Setting
    • 10.3.2.2.1 Hospital Disposable Blood Warmer Market
    • 10.3.2.2.2 Ambulatory Surgical Center Disposable Blood Warmer Market
    • 10.3.2.2.3 Other Care Setting Disposable Blood Warmer Market
• 10.4 Drivers And Limiters
  • 10.4.1 Market Drivers
  • 10.4.2 Market Limiters
• 10.5 Competitive Market Share Analysis

Abbreviations