PUBLISHER: iData Research Inc. | PRODUCT CODE: 1847177
PUBLISHER: iData Research Inc. | PRODUCT CODE: 1847177
Please contact us using the inquiry form for pricing information.
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
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
Stopcock Market
Intravenous Filter Market
Blood Transfusion Set Market
Blood Warmer Market
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.
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 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
Impact Of Global Tariffs
U.S. Infusion Therapy Device Market Overview
Infusion Pump Market
Intravenous Set Market
Needleless Connector Market
Stopcock Market
Intravenous Filter Market
Blood Transfusion Device Market
Blood Warmer Market
Figure 9-8 Other Blood Transfusion Device Market, U.S., 2022 - 2032
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