CLOSED SYSTEM TRANSFER DEVICE MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Market Size and Trends

The closed system transfer device market is estimated to be valued at USD 1.40 Bn in 2024 and is expected to reach USD 4.07 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 16.5% from 2024 to 2031.

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The market is driven by the need to curb needlestick injuries and exposure to hazardous drugs. Closed system transfer devices provide an extra layer of safety compared to traditional methods during drug preparation and administration.

The closed system transfer device market is expected to witness significant growth over the forecast period. With increasing awareness about potential dangers of cytotoxic drug exposure and regulatory mandates to curb occupational hazards, healthcare providers are widely adopting closed drug transfer systems. Also, growing chemotherapy patient population and cancer cases worldwide is further expected to drive the demand for safer handling of hazardous drugs. Market players are also launching innovative product variants to better address needs across various therapeutic areas.

Market Drivers: Safety regulations to prevent needlestick injuries

With the growing risk of infections associated with needlestick injuries, major regulatory bodies have introduced stringent safety norms and guidelines to curb this hazard in healthcare settings. The Centers for Disease Control and Prevention (CDC) in the U.S. has issued mandatory sharps injury prevention regulations via the Needlestick Safety and Prevention Act to protect healthcare workers from accidental needlestick injuries and exposure to bloodborne pathogens. Likewise, the European Union has rolled out several directives focusing on safe handling of sharps and injection devices.

The implementation of these regulations has posed immense pressure on healthcare facilities to phase out the use of conventional syringes and vials that may lead to needlestick injuries during the reconstitution or administration of drugs. This has boosted the demand for advanced closed drug transfer systems that enable contained operations and zero exposure risk. Unlike conventional open vial systems, closed drug transfer devices ensure complete protection against accidental pricks by encapsulating the needle or cannula and isolating the drug product from the external environment. The focus on safer handling of hazardous drugs like antineoplastic injectables has further stimulated the adoption of these engineered safety solutions across hospitals, clinics, and other healthcare settings.

Market Concentration and Competitive Landscape

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Tremendous advancements in drug delivery technologies that enhance patient safety, therapeutic efficacy, and optimize workflows have been witnessed. Closed drug transfer systems are pioneering technologies that leverage engineering prowess to address one of the most pressing issues concerning hazardous drug exposures faced by healthcare professionals worldwide. Beyond fulfilling safety compliance requirements, these systems allow for more efficient large scale compounding operations as they automate transfer and eliminate spillage risks. Their seamless integration with robotic infusion technology and workflow automation modules have enabled next-generation pharmacy compounding centers to achieve higher throughput while guaranteeing sterility.

Growing oncology drug pipelines have catalyzed the demand for specialized injectable preparations in healthcare facilities. At the same time, rapid technological evolution has equipped clinical staff with more potent and precise options for administering cancer therapeutics. In this scenario, closed drug transfer equipment have emerged as an indispensable tool supporting safe and reliable reconstitution of antineoplastic drugs. Their sophisticated mechanical designs combining hermetically sealed enclosures, automated cannula shielding mechanisms, and fluid handling modules offer a robust platform for advanced compounding needs. As novel biologic therapies enter the scene, healthcare providers are willing to strengthen workflow safety with cutting-edge closed drug transfer solutions.

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Regulatory compliance is driving adoption but also increasing compliance costs for manufacturers. Healthcare facilities must invest in updating older equipment to be compatible with newer closed system technologies. Low awareness among healthcare workers regarding the safety benefits of closed systems hampers their full potential. Training medical staff takes time and resources, and achieving company-wide implementation presents logistical hurdles.

Market Opportunities: Potential in emerging markets

As regulations tighten around hazardous drug handling, the demand will continue growing. Larger hospitals and oncology centers in particular represent a sizable addressable market. Innovation in closed system designs may help reduce costs and complexity of use. Increasing compatibility of closed systems with existing medical equipment expands applicability. Rising awareness about occupational exposure risks also heightens the appeal of closed systems' safety benefits among hospitals and staff.

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In terms of type, membrane to membrane systems is expected contribute the highest share of the market owing 63.7% in 2024 to their superior safety features that reduce risk of exposure during drug preparation and administration. Membrane to membrane systems provide an aseptic barrier between the drug vial and syringe, allowing for transfer of fluids without potential contamination from needle punctures or leakage. The double membrane design allows for safe transfers even with vulnerable patient populations like chemotherapy and immunocompromised patients. Hospitals have increasingly adopted these systems for hazardous medications to better protect healthcare workers as well. Membrane to membrane technologies also aid adherence to hazardous drug handling guidelines from organizations like NIOSH and ASHP. Their self-contained, touchless design lowers the chances of accidental needlestick injuries compared to other CSTD varieties. As safety hazards continue prompting regulatory action, membrane to membrane models will likely capture more market share due to their unmatched contamination prevention capabilities.

Insights By, Closing Mechanism- Precision Engineering is Fueling the Rapid Uptake of Colour to Colour Alignment Systems

In terms of closing mechanism, colour to colour alignment systems contributes the highest share owing 37.2% in 2024 due to their user-friendly design enabled by sophisticated manufacturing. These systems rely on color-coding and precise fitting of components to securely and intuitively lock medications in place. The color alignment features guide technicians through the proper connection sequence, minimizing human errors in assembly. Tighter production tolerances mean these connections engage seamlessly with guaranteed sealing every time. Leading manufacturers have also incorporated haptic and tactile feedback into the interfaces to further streamline the process. As one of the easiest CSTDs to train staff on safely operating, color alignment technology sees rising popularity in large healthcare networks aiming for efficiency and scale. Its engineering excellence sets the standard for plug-and-play usability in the market.

Insights By, Component - Access to Broader Range of Medications is Driving the Demand for Syringe Safety Devices

In terms of component, syringe safety devices contributes the highest share owing 42.5% in 2024 as they provide safe access to the widest variety of injectable drugs. These syringe-based CSTDs attach directly to vial access points, tubing, or IV bag ports to administer substances without potential exposure to needles. While vial and bag access instruments work for select applications, syringe devices offer universal compatibility with all injectable formulas administered intramuscularly, subcutaneously, or intravenously. This broad coverage addresses a core pain point in preparing diverse drug therapies across departments like oncology, critical care, and emergency medicine. Syringe safety instruments also accommodate small volumes better than some alternate designs. As healthcare evolves to offer more complex personalized treatments, the all-purpose functionality of syringe CSTDs will be paramount to protecting staff handling an increasing array of medication formulations.

Regional Insights

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North America has emerged as the dominant region in the closed system transfer device market owing 35.3% in 2024. The region accounts for the largest share owing to stringent regulatory mandates and growing awareness about safe medication practices. The U.S., being the highest spender on healthcare, has implemented strict guidelines through the National Institute for Occupational Safety and Health (NIOSH) to curb needlestick injuries and exposure to hazardous drugs. Most healthcare organizations in the country have adopted closed system drug transfer technologies to comply with the regulatory norms. The presence of leading manufacturers such as Becton, Dickinson and Company along with the availability of numerous generic versions has further boosted product adoption.

Asia Pacific, on the other hand, is identified as the fastest growing regional market. Factors such as increasing healthcare expenditure, rising incidence of chronic diseases, and growing geriatric population have augmented demand for injectable drugs across hospitals and clinics in the region. Countries like China, India, and Japan are at the forefront of healthcare infrastructure development which is supporting market expansion. Furthermore, shifting focus towards quality medical practices as well as worker safety is encouraging healthcare facilities to incorporate closed drug transfer solutions. While regulations still lag compared to developed markets, growing awareness among healthcare providers regarding needlestick injuries and exposure risks is propelling the Asia Pacific closed system transfer device market upward.

The increasing number of specialty pharmaceutical manufacturing sites and biotechnology hubs in North America have led to a rise in pharmaceutical imports and exports between the region and other parts of the world. This has positively impacted the demand for closed system transfer devices to streamline drug reconstitution processes and uphold global safety and quality standards during transportation. On the pricing front, the availability of cost-effective alternatives from domestic manufacturers in North America and Asia Pacific has rendered the market more affordable for healthcare organizations of all sizes.

Market Report Scope

Key Developments

• In January 2022, ICU Medical, Inc. (US) specializes in developing, manufacturing, and selling medical devices for infusion therapy, vascular access, and vital care applications globally. bought Smiths Medical a prominent medical device manufacturer, specializes in products such as syringe and ambulatory infusion devices, vascular access, and vital care products. to expand its range of products, including syringe & ambulatory infusion devices, vascular access, and vital care products
• In March 2022, Baxter International (US) is a global leader in medical products and services. agreed with a Pfizer Inc. subsidiary to acquire the rights to Zosyn, a premixed frozen piperacillin-tazobactam product, for North America. Zosyn is used to treat intra-abdominal infections, nosocomial pneumonia, skin and skin structure infections, female pelvic infections, and community-acquired pneumonia
• In October 2023, EQUASHIELD LLC. (US) is a company that specializes in providing closed system transfer devices (CSTDs) for the safe handling of hazardous drugs in healthcare settings. Syringe Unit received additional Food and Drug Association approval for full-volume use, providing a cost-effective solution for medication compounding & administering needs
• In March 2022, Vygon SA (France) is a global medical device company specializing in single-use medical and surgical products for healthcare professionals. acquired Macatt Medica, a distribution company in Lima, Peru, to expand Vygon’s presence in South America. Macatt Medica primarily sold Vygon's products in Peru, including a line of enteral nutrition products.

*Definition: The closed system transfer device market provides products that minimize the risk of environmental contamination and exposure during the transferring of hazardous drugs. These closed system drug transfer devices provide either mechanical or mechanical with air filtration systems to transfer liquids between containers while preventing the escape of toxic vapor particles into the surrounding environment. They are commonly used in hospitals and oncology clinics when preparing and administering chemotherapy drugs and other hazardous medications to improve workplace safety.

Market Segmentation

•  Type Insights (Revenue, USD BN, 2019 - 2031)
  • Needless Systems
  • Membrane to Membrane Systems
•  Closing Mechanism Insights (Revenue, USD BN, 2019 - 2031)
  • Colour to Colour Alignment Systems
  • Lueker Lock Systems
  • Push to Turn systems
  • Click to Lock Systems
•  Component Insights (Revenue, USD BN, 2019 - 2031)
  • Syringe Safety Devices
  • Vial Access Devices
  • Bag Access Devices
  • Other
•  Technology Insights (Revenue, USD BN, 2019 - 2031)
  • Compartmentalize Devices
  • Diaphragm Based Devices
  • Air Filtration Devices
•  End Use Insights (Revenue, USD BN, 2019 - 2031)
  • Hospitals & Clinics
  • Ambulatory Surgery Centres
  • Research Laboratories
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Rest of Middle East & Africa
• Key Players
  • General Electric
  • Molded Fiber Glass
  • Vesta
  • AREVA WIND
  • Bora Energy AVANTIS Energy
  • DeWind, ENERCON
  • EWT
  • GBT Composites Technology
  • Xinjiang Goldwind Science and Technology
  • Hexcel
  • Indutch composites technology
  • Inoxwind
  • Reliance Industries
  • Leitner
  • NORDEX
  • ReGen Powertech