US Closed System Transfer Devices Market
US Closed System Transfer Devices Market by Closing Mechanism (Color-to-Color System), Type (Needleless Systems), Component (Female Components, Male Luers), Technology (Air Cleaning/Filtration Devices), End User (Hospitals, Clinics) – Forecast to 2031
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The US Closed System Transfer Devices market, valued at USD 0.61 billion in 2025, stood at USD 0.67 billion in 2026 and is projected to advance at a resilient CAGR of 5.0% from 2026 to 2031, culminating in a forecasted valuation of USD 0.86 billion by the end of the period. Mandatory compliance with USP <800>, the increased presence of oncology and hazardous drugs, and growing attention to protecting healthcare worker exposure are the main drivers for the CSTD market in the US. There are several restraints, including the high costs of devices and consumables, budgetary constraints of smaller facilities, and workflow integration challenges. Major opportunities include extending CSTD applications beyond oncology to include biologics and specialty injectables; rapid growth of outpatient and home infusion centers; and continued innovations in technology to increase ease of use and compatibility with systems.
KEY TAKEAWAYS
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BY CLOSING MECHANISMBy closing mechanism, Luer lock system led the market, with a share of 30.4%, in 2025.
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BY TYPEBy type, the membrane-to-membrane systems segment dominated the market, with a share of 68.1% in 2025.
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BY COMPONENTBy component, vial access components will be the fastest-growing segment during the forecast period.
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BY TECHNOLOGYBy technology, the diaphragm-based devices segment led the market, with a share of 38.9% in 2025
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BY END USERBy end user, the oncology centers segment is expected to register the highest CAGR of 8.4%.
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COMPETITIVE LANDSCAPE - Key PlayersBD, ICU Medical, and B. Braun were identified as Star players in the US CSTD market, as they have focused on innovation, broad industry coverage, and strong operational & financial strengths.
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COMPETITIVE LANDSCAPE - Start UpsCaragen, Needleless, and Epic Medical distinguished themselves among startups and SMEs due to their strong product portfolio and business strategy.
The US CSTD market is driven by USP <800> compliance, rising oncology and hazardous drug use, and growing focus on healthcare worker safety. Restraints include high device and consumable costs, budget constraints in smaller facilities, and workflow integration challenges. Opportunities include expanding use beyond oncology into biologics and specialty injectables, growth of ambulatory infusion centers, and technological advancements improving usability and compatibility.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The US CSTD market is progressing continuously with increasing volumes of anticancer and other dangerous injectable medications, coupled with stricter enforcement of USP <800> standards. Occupational safety is increasingly prioritized by healthcare providers, leading to the acceptance of CSTDs across hospital pharmacies and infusion settings. The devices' ergonomics, compatibility with existing drug delivery systems, and ease of use have also accelerated acceptance. The adoption of specialty injectables and biologics is prompting the providers to rethink hazardous drug-handling practices. In response, manufacturers are innovating next-gen CSTDs with enhanced containment, improved workflow efficiency, and greater reliability.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
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USP <800> regulatory compliance mandates

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Rising oncology and hazardous drug use
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Budget constraints in smaller facilities
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Expansion beyond oncology applications
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Pricing pressure from GPOs
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Rising oncology and hazardous drug use
The rise of oncology and potentially dangerous drugs is the major driver for CSTD markets in the US. The incidence of cancer continues to rise; therefore, higher volumes of chemotherapy and specialty injectable drugs are prepared and administered each day. Most of these agents are classified as hazardous because they are carcinogenic, mutagenic, or have reproductive effects, and have a high risk of exposure to potential carcinogens for healthcare workers. In addition, as more drug volumes are managed by both hospitals and infusion centers, the need for highly effective containment of drugs during compounding, transfer, and administration also increases. CSTDs mitigate leakage, aerosolization, and drug vapor release, making them essential for worker safety and regulatory compliance.
Restraint: Budget constraints in smaller facilities
Budget constraints in smaller facilities are a significant barrier in the US CSTD market, as CSTDs require high upfront costs and additional expenses for proprietary consumables. Community hospitals, rural clinics, and small oncology practices generally operate on tight margins. This situation makes it difficult for them to justify the costly expenditure, although it provides safety benefits. Limited capital budgets and pressure from reimbursement requirements require these facilities to prioritize essential equipment over safety-enhancing technologies. This implementation also requires staff training, modifications to the workflow, and the addition of other indirect costs. Hence, adoption either decelerates or becomes partial in smaller settings, thereby restricting broader market penetration in small health institutions.
Opportunity: Expansion beyond oncology applications
CSTD opportunities that transcend oncology applications would greatly expand the market for US CSTDs, as hazardous drugs are increasingly used across therapeutic areas such as rheumatology, neurology, immunology, and infectious diseases. Biologics, antivirals, and gene and cell therapies mostly involve toxic or sensitizing agents that create occupational exposure risks similar to those caused by chemotherapy. Hospitals and infusion centers, recognizing these dangers, have increased their demand for CSTDs in practice beyond oncology. The demand for extended use across specialty injectables, wards, and ambulatory infusion centers could significantly increase device volumes and recurring consumable sales, alongside long-term market growth.
Challenge: Pricing pressure from GPOs
The major factor hindering the US CSTD market is price pressure from group purchasing organizations (GPOs). GPOs have bargaining power over large-volume contracts for hospitals and health systems, and base their contracts on cost reduction rather than pricing premium products. This limits the manufacturers' room to raise prices because they still incur costs related to R&D, regulatory compliance, and product improvement. The competitive bidding process favors lower-priced alternatives and squeezes margins for established players as competition intensifies. Additionally, GPO-locked hospitals do not have much flexibility in adopting the new or differentiated CSTD technologies until the pricing is hung on the contract, which retards the diversity of adoption and market profitability.
US CLOSED SYSTEM TRANSFER DEVICES MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
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Offers the PhaSeal closed system transfer devices widely used for hazardous drug compounding and administration in hospitals and oncology pharmacies | Provides industry-leading protection against drug exposure | Supports USP <800> compliance | Improves worker safety | Benefits from a large installed base and strong clinical trust |
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Provides ChemoLock and ChemoClave CSTDs, integrated with its infusion and IV therapy systems, for the safe preparation and administration of hazardous drugs | Enhances workflow efficiency | Reduces contamination risk | Enables regulatory compliance | Offers interoperability with broader infusion platforms |
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Supplies proprietary CSTDs as part of an integrated medication safety and pharmacy compounding portfolio across the US healthcare facilities | Supports end-to-end hazardous drug safety | Improves supply reliability | Simplifies procurement | Helps hospitals meet USP <800> requirements cost-effectively |
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Manufactures CSTDs compatible with its IV containers, pumps, and pharmacy compounding solutions | Improves safety during drug transfer | Supports standardized workflows | Reduces exposure risk | Strengthens compliance through system integration |
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Develops fully closed, membrane-to-membrane CSTD systems focused on preventing vapor and aerosol escape during drug preparation and delivery | Delivers high protection levels | Minimizes environmental contamination | Enhances clinician confidence | Supports advanced oncology and specialty pharmacy needs |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
In the US, the CSTD market is part of a regulated healthcare ecosystem comprising device manufacturers, distributors, healthcare providers, and regulatory agencies. Manufacturers develop CSTDs with safe, effective containment of hazardous drugs, compatible with currently available vial, syringe, and infusion systems. Distributors and group purchasing organizations improve market access for hospitals, oncology clinics, and infusion centers. Selected products will depend heavily on the opinions of pharmacists, nurses, and occupational safety teams regarding ease of use, safety performance, and workflow efficiency. Hospitals and payers regulate and shape adoption through purchasing contracts and budget controls. Regulatory bodies and safety organizations define standards that will guide practices in the long run.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
US CSTD Market, By Closing Mechanism
CSTD luer locking systems dominate the market in the US owing to their universal compatibility with standard syringes, vials, and IV administration sets already employed in hospitals and clinics. The secure, leak-proof locking mechanisms ensure a safe transfer of drugs while maintaining the integrity of the closed system. Simple integration into existing pharmacy and infusion workflows minimizes training requirements and associated implementation costs. The broad clinician familiarity, along with a massive installed base and strong compliance to USP <800> standards, only makes it stronger through the usage of luer lock CSTD systems.
US CSTD Market, By Type
Owing to the fact that they provide an accurate closed connection from dry-to-dry, excessive leakage of hazardous drugs will be prevented from these systems; vapor releases and aerosol formations by means of the membrane-to-membrane connection are probably the most clinically validated and therefore the most widely set up in hospitals due to compatibility with guidelines from USP <800> and NIOSH. Membrane-to-membrane systems enjoy high confidence among clinicians, especially for the preparation and administration of commonly used drugs, due to their early market entry and large installed base, thereby reinforcing this preference in direct conflict with other designs.
US CSTD Market, By Component
Female components hold the largest share of the US CSTD market due to their extensive use across multiple stages of drug preparation, transfer, and administration. Compared with male components, female components such as vial access devices, syringe adaptors, and infusion sets are consumed in significantly higher volumes. Their critical role in maintaining closed-system integrity, compatibility with standard luer connections, and frequent replacement requirements further drive demand, making female components predominant in routine hazardous drug handling workflows.
US CSTD Market, By Technology
The US market holds the largest share of diaphragm-based CSTD devices, which provide highly reliable containment of hazardous drugs through mechanical sealing and effective pressure equalization for outgassing. Their effectiveness in preventing the release of vapors, aerosols, and liquid leakage engenders strong trust in their compliance with USP <800> and NIOSH guidelines. Long acceptance in clinical use, extensive validation data, and implementation through large systems have built clinician trust and reinforced the preference for diaphragm-based technology over any alternatives.
US CSTD Market, By End User
There is a greater market share in the CSTD market of the US enjoyed by hospitals and clinics because they deal with the highest volumes of hazardous drugs like chemotherapy and specialty injectables. Such settings are bound by compliance requirements under USP <800> and occupational safety, thus mandating CSTD implementation. The factors supporting large-scale usage in these settings include centralized pharmacy compounding, higher patient volume, and established procurement contracts, while a continued focus on staff safety and liability reduction assures consistent demand in hospitals and clinics.
US CLOSED SYSTEM TRANSFER DEVICES MARKET: COMPANY EVALUATION MATRIX
In the US CSTD market, ICU Medical (Star) holds a leading position due to its established product portfolio, strong hospital penetration, and extensive distribution network. Baxter (Emerging Leader) is gaining momentum through product innovation and its strong presence in infusion and medication safety; however, its CSTD business is still in the scaling phase, with growth dependent on broader adoption and deeper integration into hospital safety protocols.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
- Becton, Dickinson and Company (US)
- ICU Medical, Inc. (US)
- Equashield LLC (US)
- B Braun Melsungen AG (Germany)
- JMS Co., Ltd. (Japan)
- Baxter International, Inc. (US)
- Simplivia Healthcare Ltd. (Israel)
- Yukon Medical (US)
- CODAN Medizinische Geräte GmbH (Germany)
- West Pharmaceutical Services, Inc. (US)
- Vygon SA (US)
- PractiVet, Inc. (US)
- Terumo Corporation (Japan)
- Elcam Medical (Israel)
- Amsino International, Inc. (US)
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2026 (Value) | USD 0.67 BN |
| Market Size in 2031 (Value) | USD 0.86 BN |
| Growth Rate | 5.00% |
| Years Considered | 2024–2031 |
| Base Year | 2025 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD MN/BN), Volume (Thousand Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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| Country Covered | US |
WHAT IS IN IT FOR YOU: US CLOSED SYSTEM TRANSFER DEVICES MARKET REPORT CONTENT GUIDE

DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Product Analysis | Comparison of CSTDs based on technology type (Diaphragm-Based, Compartmentalized, Air Cleaning/Filtration Devices), design mechanism, connectivity, and compatibility with hazardous drug delivery systems | Evaluation of product performance, containment efficiency, ease of use, and integration with automated pharmacy compounding and oncology drug delivery workflows |
| Company Information | Profiles of leading CSTD manufacturers, including BD (US), ICU Medical (US), Equashield (Israel), Simplivia Healthcare (Israel), and Corvida Medical (US) | Market share benchmarking, strategic partnership mapping, and competitive landscape analysis of key players across North America, Europe, and Asia Pacific |
| Geographic Analysis | In-depth regional assessment of North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa with country-level data on adoption trends and regulatory frameworks | Country-level analysis of market adoption drivers, USP <800> and NIOSH compliance rates, oncology drug handling infrastructure, and emerging opportunities in high-growth markets such as China, India, and South Korea |
RECENT DEVELOPMENTS
- May 2023 : B. Braun’s Malaysian subsidiary, BMI, expanded its manufacturing base by expanding its product lines to strengthen automation and innovation capabilities.
- June 2022 : B. Braun expanded its production facility for IV fluids in Nairobi, Kenya.
- May 2022 : Baxter entered into an agreement with a subsidiary of Pfizer Inc. to acquire the rights to Zosyn, a premixed frozen piperacillin-tazobactam product, to be supplied in North America. This product is used for the treatment of intra-abdominal infections, nosocomial pneumonia, skin and skin structure infections, female pelvic infections, and community-acquired pneumonia.
- January 2022 : ICU Medical acquired Smiths Medical with the aim of broadening its product portfolio with the inclusion of syringe & ambulatory infusion devices, vascular access, and vital care products.
Table of Contents
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Methodology
The study involved major activities in estimating the current market size of the US closed system transfer devices market. Exhaustive secondary research was done to collect information on the US closed system transfer devices market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain using primary research. Different approaches, such as top-down and bottom-up, were employed to estimate the total market size. After that, the market breakup and data triangulation procedures were used to estimate the market size of the segments and subsegments of the US closed system transfer devices market.
Secondary Research
This research study involved the wide use of secondary sources, directories, and databases such as Dun & Bradstreet, Bloomberg Businessweek, Factiva, whitepapers, and companies’ house documents. Secondary research was undertaken to identify and collect information for this extensive, technical, market-oriented, and commercial study of the US closed system transfer devices market. It was also used to obtain important information about the top players, market classification, and segmentation according to industry trends to the bottom-most level, geographic markets, and key developments related to the market. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various supply- and demand-side sources were interviewed to obtain qualitative and quantitative information for this report. Primary sources from the supply side included industry experts such as CEOs, vice presidents, marketing and sales directors, technology & innovation directors, engineers, and related key executives from various companies and organizations operating in the US closed system transfer devices market. Primary sources from the demand side included hospitals, clinics, researchers, lab technicians, purchase managers, and stakeholders in corporate & government bodies.
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the US closed system transfer devices market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

Data Triangulation
The entire market was split into five segments when the market size was determined. Data triangulation and market breakdown processes were used where necessary to complete the entire market engineering process and arrive at precise statistics for all segments.
Approach to derive the market size and estimate market growth.
Using secondary data from paid and unpaid sources, the market rankings for the major players were determined following a thorough analysis of their sales of CSTD. Due to data restrictions, the revenue share in certain cases was determined after a thorough analysis of the product portfolio of big corporations and their individual sales performance. This information was verified at each stage by in-depth interviews with professionals in the field.
Market Definition
Closed system transfer devices are highly specialized devices that mechanically prohibit the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. These devices are uniquely designed to protect healthcare providers and patients from exposure to hazardous drugs.
Stakeholders
- CSTD Manufacturers
- CSTD Suppliers & Distributors
- Original Equipment Manufacturers (OEMs)
- Hospitals and Clinics
- Oncology Centers
- Medical Device Research and Consulting Firms
- Contract Research Organizations (CROs)
- Academic & Research Institutes
- Government Associations
- Market Research and Consulting Firms
- Venture Capitalists and Investors
Report Objectives
- To define, describe, and forecast the US closed system transfer devices market based on closing mechanism, type, component, technology, end user, and region
- To provide detailed information regarding the major factors influencing the market growth (drivers, restraints, opportunities, and challenges)
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the overall US closed system transfer devices market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To analyze the impact of the economic recession on the growth of the US closed system transfer devices market
- To strategically profile the key players in the US CSTD market and comprehensively analyze their core competencies
- To track and analyze competitive developments, such as product approvals, launches, expansions, and acquisitions, of the leading players in the market
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Growth opportunities and latent adjacency in US Closed System Transfer Devices Market