Europe Closed System Transfer Devices Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2034

Closed System Transfer Devices (CSTDs) are devices are meticulously designed to create a sealed, closed system that effectively prevents the escape of hazardous drugs during transfer processes. The closed system nature of CSTDs significantly reduces the risk of exposure to healthcare workers and patients by minimizing the potential for drug contamination and inhalation. This is achieved through a series of specialized components such as vial adapters, syringes, and connectors, all meticulously engineered to maintain an airtight seal throughout the drug transfer process.

The primary benefits of CSTDs are their ability to provide a robust barrier between healthcare workers and hazardous drugs, thus mitigating the risk of occupational exposure. The preventing feature from direct contact and inhalation of hazardous substances, CSTDs play a vital role in safeguarding the health and safety of medical personnel involved in drug handling and administration. CSTDs also contribute to minimizing the risk of drug spills, which can occur during the transfer process. The use of CSTDs ensures compliance with stringent safety regulations and guidelines established by organizations such as OSHA and NIOSH, healthcare facilities must adhere to these regulations to maintain a safe working environment and protect the well-being of both staff and patients.

MARKET OVERVIEW

The Europe Closed System Transfer Devices Market was valued at approximately USD 994 Million in 2023 and is projected to reach USD 3.5 Billion in 2034 exhibiting a CAGR of 10.5 % during the forecast period of 2024-2034. Closed System Transfer Devices enhances safety and well-being of healthcare workers and patients. The market is aligned with the healthcare sector, which makes it a sustainable and growing market.

GROWTH DRIVERS

The rising frequency of cancer globally, including in Europe, is driving the demand for Closed System Transfer Devices (CSTDs), chemotherapy remains a key treatment of cancer, the need for safe handling of hazardous drugs using CSTDs is paramount to protect healthcare workers and patients. According to the World Health Organization (WHO), Europe experiences over 3.7 million new cancer cases and 1.9 million cancer deaths each year. Cancer is the second leading cause of death and illness in Europe.

The stringent safety regulations and guidelines set forth by regulatory bodies such as the European Medicines Agency (EMA) and the European Society of Medical Oncology (ESMO) mandate the use of CSTDs in healthcare settings where hazardous drugs are handled. Compliance with these regulations drives the adoption of CSTDs across European healthcare facilities, contributing to market growth. Occupational safety concerns related to the handling of hazardous drugs in oncology and pharmacy, are fueling the demand for CSTDs.

Healthcare workers face the risk of exposure to cytotoxic drugs, which can lead to adverse health effects. CSTDs provide an effective barrier against exposure, thereby addressing these safety concerns and driving market growth. The rising healthcare expenditure in Europe like High-Tech Grunderfonds (HTGF) and InvestEU is supporting the growth of the CSTD market. Healthcare facilities allocate resources to procure advanced medical devices, including CSTDs, to enhance safety standards and ensure compliance with regulatory requirements. The technological advancements in CSTDs, such as improved sealing mechanisms, innovative design features, and enhanced compatibility with existing drug delivery systems, are driving market growth.

These advancements aim to enhance the efficacy and safety of CSTDs, making them more appealing to healthcare facilities in Europe. B. Braun Holding GmbH & Co. KG is a leading global healthcare company, its product OnGuard® is a closed system transfer device features a needle-free design and a closed system that prevents leakage and contamination during drug preparation and administration. InVision-Plus® CSTD features a unique double-seal design and mechanical needle retraction mechanism to ensure safe and reliable drug transfer while minimizing the risk of needle stick injuries and contamination.

MARKET SEGMENTATION:

·         By Type – membrane-to-membrane systems, needless systems

·         By Closing Mechanism Type – Luer Lock Systems, push-to-turn system, click-to-lock system, color-to-color alignment system

·         By Component Type – vial access components, male Luers, bag spikes, female components and others

·         By Technology – diaphragm-based devices, compartmentalized devices and air cleaning/filtration devices

Europe Closed System Transfer Devices Market by Type Segment Review:

Membrane-to-membrane CSTDs utilize a membrane interface to create a closed system for transferring hazardous drugs. These systems typically feature a vial adapter with a membrane that connects to a receiving device, such as a syringe or IV bag, forming a sealed pathway for drug transfer. The membrane-to-membrane design ensures that the hazardous drug remains contained within a closed environment throughout the transfer process, minimizing the risk of exposure to healthcare workers and patients.

These systems are commonly used in chemotherapy infusion centers, pharmacies, and hospitals to safely handle and administer chemotherapy medications and other hazardous drugs. Needless CSTDs are designed to eliminate the need for needles during drug transfer, further reducing the risk of needlestick injuries and contamination. These systems utilize innovative mechanisms such as luer-lock connectors or twist-and-lock mechanisms to securely connect drug vials to syringes or IV lines without the use of needles. Through eliminating needles from the drug transfer process, needless CSTDs offer an additional layer of safety for healthcare workers and patients, particularly during the preparation and administration of hazardous drugs. These systems are widely adopted in oncology clinics, infusion centers, and other healthcare settings where hazardous drug handling is very common.

Europe Closed System Transfer Devices Market by Closing Mechanism Type Segment Review:

Luer lock systems utilize a threaded connection mechanism to securely attach components such as vial adapters, syringes, and IV lines. The threaded design ensures a tight and leak-proof seal, minimizing the risk of drug spills and exposure to hazardous substances. Luer lock systems are widely used in healthcare settings for the safe transfer and administration of chemotherapy medications. Push-to-turn systems feature a locking mechanism that requires users to push and rotate components to securely connect them.

This locking mechanism provides an added layer of security, preventing accidental disconnection during drug transfer. Push-to-turn systems are preferred in environments where extra precautions are necessary to prevent leaks and contamination. Click-to-lock systems utilize a clicking mechanism to indicate when components are securely connected. The user pushes the components together until they hear or feel a click, signaling that the connection is locked and sealed. Click-to-lock systems offer a user-friendly and intuitive way to ensure proper closure. Color-to-color alignment systems use color-coded indicators to help users align and connect components correctly. Each component is assigned a specific color, and users must match the colors to ensure proper alignment and closure.

Europe Closed System Transfer Devices Market by Component Type Segment Review:

Vial access components are designed to provide a secure and contamination-free way to access drug vials during the transfer process. These components typically include vial adapters or spikes that penetrate the rubber stopper of the vial, allowing for the withdrawal or addition of medication without exposing healthcare workers to hazardous substances. Vial access components come in different sizes and configurations to accommodate various vial types and drug formulations. Male Luers are connector components with a tapered and threaded design that allows for the secure attachment of syringes, IV lines, and other medical devices.

These components play a crucial role in maintaining a closed system during drug transfer, ensuring a leak-proof connection between different components. Male Luers are commonly used in conjunction with female components to create a sealed and airtight connection for the safe administration of hazardous drugs. Bag spikes are specialized components used to access and transfer medication from intravenous (IV) bags or infusion containers. These spikes feature a sharp, pointed tip that pierces the septum of the IV bag, allowing for the withdrawal or addition of fluids without compromising the integrity of the container.

Bag spikes are essential for ensuring the closed and aseptic transfer of drugs during IV administration, minimizing the risk of contamination and exposure to hazardous substances. Female components serve as receptacles or connectors that receive and mate with male Luers or other compatible devices. These components play a crucial role in creating a sealed and airtight connection during drug transfer, preventing leaks and minimizing the risk of exposure to hazardous drugs. Female components come in various shapes and sizes to accommodate different types of connectors and ensure compatibility with existing equipment and protocols.

Europe Closed System Transfer Devices Market by Technology Type Segment Review:

Diaphragm-based devices utilize a flexible diaphragm or membrane to create a barrier between the drug and the environment, preventing the spillage of hazardous substances during transfer. These devices feature a sealed chamber or compartment that houses the drug vial or container, with a diaphragm that allows for the insertion and withdrawal of needles or syringes. Compartmentalized devices feature multiple chambers or compartments that isolate different components of the drug transfer process, ensuring a closed and airtight system at each stage.

These devices typically include separate compartments for accessing drug vials, withdrawing medication, and connecting to administration sets or patient delivery devices. Compartmentalized devices incorporate features such as valves, seals, or interlocking mechanisms to further enhance the integrity of the system and prevent leaks or spills. Air cleaning or filtration devices utilize advanced filtration technologies to remove airborne contaminants and particulate matter from the surrounding environment during drug transfer.

These devices include filters, activated carbon filters, or other filtration systems designed to capture hazardous particles and prevent their dispersion into the air. Air cleaning/filtration devices are often used in conjunction with other CSTD components to provide an additional layer of protection against exposure to hazardous drugs. These devices help maintain a clean and safe working environment for healthcare workers involved in drug handling and administration.

Key Challenges:

The high cost associated with the implementation of CSTDs, it requires significant upfront investment in purchasing specialized equipment and training healthcare personnel on proper use and handling procedures. The cost of CSTDs may vary depending on factors such as technology type, brand, and additional features. Healthcare facilities may encounter budget constraints which is a significant challenge for the market. The compatibility issues between CSTDs and existing drug delivery systems, such as IV administration sets and syringes, may pose significant challenges. Healthcare facilities may encounter difficulties integrating CSTDs with their existing infrastructure, leading to operational inefficiencies and workflow difficulties. Moreover, meeting the regulatory requirements and obtaining necessary approvals for CSTDs may be a complex and time-consuming process. The potential delays in obtaining regulatory clearance or approvals can impact market growth.

Competitive Landscape:

In the highly competitive Europe Closed System Transfer Devices market, companies are investing heavily in research and development to innovate and improve the product and services. They are also collaborating, forming strategic partnerships, or acquiring other companies to gain access to new market segments, enhance distribution networks, and increase market share. Recent developments includes Vygon SA(France) acquired Macatt Medica, in March 2022. Pulse NeedleFree Systems launched vaccination devices with needle-free livestock, in May 2022. Zimmer Biomet Holdings, Inc. acquired Embody, Inc. in February 2023.

Global Key Players:

·         B. Braun Holding GmbH and Co. KG

·         Caragen Ltd.