市场调查报告书
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1560829
全球封闭系统药物转移设备市场 - 2024 - 2031Global Closed System Drug Transfer Devices Market - 2024 - 2031 |
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报告概述
全球封闭系统药物转移器材市场将于 2023 年达到 12.5 亿美元,预计到 2031 年将达到 43.7 亿美元,2024-2031 年预测期间复合年增长率为 14.8%。
封闭系统药物转移装置(CSTD)是一种专门的医疗设备,旨在透过防止外部污染物进入系统并阻止危险药物物质或蒸气释放到系统外来安全地转移危险药物。
CSTD 的主要目的是建立一个安全的环境,显着降低接触危险物质的风险。接触这些危险药物可能会对医疗保健专业人员和患者造成严重的健康后果,包括皮肤刺激、生殖问题,甚至癌症。透过创建封闭系统,CSTD 在保障参与处理这些强效药物的每个人的福祉方面发挥着至关重要的作用。
CSTD 通常遵循两种设计理念之一:物理屏障 CSTD 和空气净化 CSTD。物理屏障 CSTD 使用机械性手段阻止药物蒸气、气溶胶和液体逃脱到周围环境中。它们还可以防止环境中的污染物进入无菌药物途径。物理屏障可防止危险药物与环境或医护人员之间的直接接触。它创造了一个难以穿透的边界来容纳药物并保持无菌。
另一种是空气净化 CSTD 使用过滤技术去除气流中的药物污染物,防止其释放到环境中。它们还过滤进入的空气,以去除环境污染物,然后再进入无菌药物通道。
物理屏障和空气净化 CSTD 的设计目的都是为了实现相同的目标,即保护医护人员和环境免受危险药物的影响,同时保持药物途径的无菌性。两者之间的选择取决于药物特性、设施布局和使用者偏好等因素。如果使用得当,CSTD 可以显着降低与处理危险药物相关的风险。
司机
癌症盛行率上升和技术进步
全球封闭系统药物转移装置(CSDT)市场的需求是由多种因素所驱动的。主要因素之一是癌症盛行率的上升和技术的进步。全球癌症发生率正在迅速增加,导致对化疗和其他危险药物的需求。
使用封闭系统药物转移装置 (CSTD) 对于保护医护人员免受危险药物的职业接触至关重要。这些设备经过专门设计,旨在降低与处理强效药物(尤其是化疗药物)相关的风险,如果医护人员无意接触化疗药物,可能会造成严重的健康威胁。
根据世界卫生组织2024年2月的资料,2022年,全球报告了约2,000万新发癌症病例,导致近970万人死亡。当年最受欢迎的癌症类型包括肺癌,有 250 万例(占所有癌症的 12.4%),乳癌有 230 万例(11.6%),大肠癌有 190 万例(9.6%)。
肺癌是癌症相关死亡的主要原因,约造成 180 万人死亡(18.7%),其次是大肠直肠癌,约 90 万人死亡(9.3%),肝癌约 76 万人死亡(7.8%)。预测表明,到 2050 年,癌症病例数可能会增加到 3500 万,这主要是由于人口增长。因此,癌症病例的增加增加了对封闭系统药物转移装置 (CSTD) 的需求,以促进这些强效药物的安全处理。
此外,封闭系统药物转移装置(CSTD)技术的创新,例如引入无针系统和增强的密封机制,显着提高了可用性和安全性,从而推动了其在医疗保健环境中的采用。
此外,该行业的技术进步、意识计划和关键发展的关键参与者正在推动市场成长。例如,2022 年 9 月,在 Oxford Global 组织的 Formulation UK 2021 活动期间,赛诺菲生物製剂药品开发药品团队负责人 Heloise Audat 深入概述了赛诺菲评估封闭系统药物转移装置 (CSTD) 的方法。第一项关于 CSTD 的法规于 2004 年左右出台,旨在保护医护人员免受系统性接触危险药物的风险。
同样,BD 推出的危险药品表面污染监测计划是一个全面的端到端解决方案,旨在帮助医疗机构评估其当前的做法,制定有效的测试计划,并实施危险药品表面污染的可持续监测计划。该计划旨在保护医护人员在准备和给药过程中免受危险药物的潜在接触。
此外,2022 年 3 月,全球着名医疗设备开发商 Simplivia Healthcare Ltd. 宣布即将发布新型封闭系统转移设备 (CSTD) Chemfort。该设备专为提高参与危险药物製备和管理的医疗保健专业人员的安全而设计。
限制
CSTD 实施成本高昂、监管挑战以及个人缺乏意识等因素预计将阻碍市场发展。
细分市场分析
全球封闭系统药物转移装置 (CSDT) 市场根据类型、组件、封闭机制、技术、最终用户和地区进行细分。
无针系统部分约占全球封闭系统药物转移装置 (CSDT) 市场份额的 74.3%
无针系统领域预计将在预测期内占据最大的市场份额。无针系统专门设计用于防止针刺伤,这对于处理危险药物的医护人员来说是一个重大危险。这些系统消除了对传统针头的需求,从而降低了意外接触有毒物质的风险。
此外,该行业的主要参与者推出创新设备和发布有助于推动该细分市场的成长。例如,ICU Medical, Inc.推出了化学锁封闭系统转移装置(CSTD),采用机械和微生物封闭的无针设计,可防止有害药物蒸气逸出,并在配製和给药过程中保持药物的无菌状态。
同样,Yukon Medical 推出了 Arisure 封闭系统转移装置 (CSTD),旨在保护医护人员在化疗和其他危险药物的配製、运输和管理过程中免受危险药物蒸气的影响。 Arisure CSTD 采用无针鲁尔锁连接系统,直觉且易于使用。与传统的基于针的系统相比,这消除了针刺伤害的风险。连接小瓶、注射器和静脉输液袋时,鲁尔锁连接可形成安全、气密的密封。
此外,2023 年 11 月,BD(Becton、Dickinson and Company)推出了一种名为 PIVO Pro 的新型无针抽血技术,旨在增强患者护理并支持公司「一次性住院」的愿景。此创新设备已获得美国食品药物管理局 (FDA) 的 510(k) 许可,并且是第一个与整合式长外周 IV 导管相容的设备,包括具有近端口 IV 通路的 Nexiva 封闭式 IV 导管系统。
市场地理分析
北美约占全球封闭系统药物转移装置 (CSDT) 市场份额的 45.2%
由于北美癌症病例数量的增加是封闭系统药物转移设备(CSTD)市场的重要驱动力,预计北美地区将在预测期内占据最大的市场份额。随着越来越多的患者需要化疗和其他危险药物治疗,对 CSTD 等安全处理解决方案的需求也随之增加。
根据美国癌症协会估计,到 2022 年,美国将新增约 190 万例癌症病例,约 609,360 例癌症相关死亡。癌症对封闭系统药物转移装置(CSDT)市场的巨大需求负担。
在该地区,大量关键参与者的存在、技术进步、产品发布和批准、先进的医疗保健基础设施以及不断增长的肿瘤药物批准正在推动该市场的成长。
例如,2023 年 9 月,封闭系统传输设备 (CSTD) 和自动化製药配製解决方案的领先供应商 EQUASHIELD 连续五年被《Pharmacy Purchasing & Products》杂誌评为危险药物製备和管理中最常用的设备。这项非凡成就凸显了 EQUASHIELD 致力于提高医疗保健环境的安全性和效率。
同样,2023 年 12 月,注射给药系统创新解决方案的全球领导者 West Pharmaceutical Services, Inc. 宣布获得 FDA 510(k) 许可并推出其 Vial2Bag Advanced 13mm 混合装置。
此外,2021 年 12 月,贝朗医疗公司 (B. Braun Medical Inc.) 宣布在美国推出 OnGuard 2 封闭系统转移设备 (CSTD),这代表着对其前身(原始 OnGuard 型号)的进步。这款新设备包含多项增强功能,旨在提高处理危险药物的医疗保健专业人员的可用性和安全性。
Report Overview
The Global Closed System Drug Transfer Devices Market reached US$ 1.25 billion in 2023 and is expected to reach US$ 4.37 billion by 2031 growing with a CAGR of 14.8% during the forecast period 2024-2031.
A closed system drug transfer device (CSTD) is a specialized medical equipment designed to safely transfer hazardous drugs by preventing the introduction of external contaminants into the system and blocking the release of hazardous drug substances or vapors outside the system.
The primary purpose of CSTDs is to establish a secure environment that significantly reduces the risk of exposure to dangerous substances. Exposure to these hazardous drugs can have severe health consequences for healthcare professionals and patients, including skin irritation, reproductive issues, and even cancer. By creating a closed system, CSTDs play a crucial role in safeguarding the well-being of everyone involved in the handling of these potent medications.
CSTDs generally follow one of two design concepts: physical barrier CSTDs and air cleaning CSTDs. The physical barrier CSTD uses mechanical means to block the escape of drug vapors, aerosols, and liquids into the surrounding environment. They also prevent the intake of contaminants from the environment into the sterile drug pathway. The physical barrier prevents direct contact between the hazardous drug and the environment or healthcare worker. It creates an impenetrable boundary to contain the drug and maintain sterility.
Another one is the air cleaning CSTDs use filtration technology to remove drug contaminants from the airflow, preventing their release into the environment. They also filter incoming air to remove environmental contaminants before they can enter the sterile drug pathway.
Both physical barrier and air-cleaning CSTDs are designed to achieve the same goal of protecting healthcare workers and the environment from exposure to hazardous drugs while preserving the sterility of the drug pathway. The choice between the two depends on factors like drug properties, facility layout, and user preference. When used properly, CSTDs significantly reduce the risks associated with handling hazardous medications.
Market Dynamics: Drivers
Rising prevalence of cancer and technological advancements
The demand for the global closed system drug transfer devices (CSDTs) market is driven by multiple factors. One of the primary factors is the rising prevalence of cancer and technological advancements. The global incidence of cancer is increasing rapidly, leading to a demand for chemotherapy and other hazardous medications.
Utilizing closed system drug transfer devices (CSTDs) is essential for protecting healthcare workers from occupational exposure to hazardous drugs. These devices are specifically engineered to reduce the risks linked to handling powerful medications, especially chemotherapy drugs, which can present serious health threats if healthcare personnel are unintentionally exposed.
As per WHO data in February 2024, in 2022, approximately 20 million new cancer cases were reported globally, resulting in nearly 9.7 million deaths. The most prevalent types of cancer that year included lung cancer, with 2.5 million cases (12.4% of all cancers), breast cancer at 2.3 million cases (11.6%), and colorectal cancer with 1.9 million cases (9.6%).
Lung cancer was the leading cause of cancer-related deaths, accounting for about 1.8 million fatalities (18.7%), followed by colorectal cancer with 900,000 deaths (9.3%) and liver cancer with 760,000 deaths (7.8%). Projections indicate that by 2050, the number of cancer cases could rise to 35 million, primarily due to population growth. Consequently, the rise in cancer cases demands the fueling of the need for closed system drug transfer devices (CSTDs) to facilitate the safe handling of these powerful drugs.
Moreover, innovations in closed system drug transfer device (CSTD) technology, such as the introduction of needle-free systems and enhanced sealing mechanisms, significantly improve usability and safety, thereby driving their adoption in healthcare settings.
In addition, key players in the industry's technological advancements, awareness programs, and key developments are driving the market growth. For instance, in September 2022, during the Formulation UK 2021 event organized by Oxford Global, Heloise Audat, Drug Product Team Leader for Biologics Drug Product Development at Sanofi, presented an insightful overview of Sanofi's methods for evaluating closed system drug transfer devices (CSTDs). The first regulations on CSTDs came around 2004, intending to protect healthcare workers from the risk of systematic contact with hazardous drugs.
Similarly, BD introduced the Hazardous Drug Surface Contamination Monitoring Program is a comprehensive end-to-end solution designed to help healthcare facilities assess their current practices, develop an effective testing plan, and implement a sustainable monitoring program for hazardous drug surface contamination. This program aims to protect healthcare workers from potential exposure to hazardous drugs during preparation and administration.
Also, in March 2022, Simplivia Healthcare Ltd., a prominent global developer of medical devices, announced the upcoming release of Chemfort, a new closed system transfer device (CSTD). This device is designed specifically to enhance safety for healthcare professionals involved in the preparation and administration of hazardous drugs.
Restraints
Factors such as the high cost of implementation of CSTDs, regulatory challenges, and lack of awareness among individuals, are expected to hamper the market.
Market Segment Analysis
The global closed system drug transfer devices (CSDTs) market is segmented based on type, component, closing mechanism, technology, end-user, and region.
The needleless system segment accounted for approximately 74.3% of the global closed system drug transfer devices (CSDTs) market share
The needleless system segment is expected to hold the largest market share over the forecast period. Needleless systems are specifically designed to prevent needle stick injuries, a significant hazard for healthcare workers who handle hazardous drugs. These systems eliminate the need for traditional needles, thereby reducing the risk of accidental exposure to toxic substances.
Moreover, key players in the industry introducing innovative devices & launches help to drive this segment's growth in the market. For instance, ICU Medical, Inc. introduced the chemo-lock closed system transfer device (CSTD) utilizes a mechanically and microbiologically closed, needle-free design to prevent the escape of hazardous drug vapors and maintain the sterility of the drug during compounding and administration.
Similarly, Yukon Medical introduced the Arisure closed system transfer device (CSTD) is designed to protect healthcare workers from exposure to hazardous drug vapors during the compounding, transportation, and administration of chemotherapy and other hazardous medications. The Arisure CSTD utilizes a needle-free, luer lock connection system that is intuitive and easy to use. This eliminates the risk of needlestick injuries compared to traditional needle-based systems. The luer lock connections form a secure, airtight seal when connecting vials, syringes, and IV bags.
Also, in November 2023, BD (Becton, Dickinson and Company) launched a new needle-free blood draw technology called the PIVO Pro, designed to enhance patient care and support the company's vision of a "One-Stick Hospital Stay." This innovative device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is the first to offer compatibility with integrated and long peripheral IV catheters, including the Nexiva Closed IV Catheter System with NearPort IV Access.
Market Geographical Analysis
North America accounted for approximately 45.2% of the global closed system drug transfer devices (CSDTs) market share
North America region is expected to hold the largest market share over the forecast period owing to the increasing number of cancer cases in North America is a significant driver for the closed system drug transfer devices (CSTDs) market. As more patients require chemotherapy and other hazardous drug treatments, the a demand for safe handling solutions like CSTDs.
As per the American Cancer Society, in 2022, it was estimated that there would be approximately 1.9 million new cancer cases diagnosed and around 609,360 cancer-related deaths in the United States. The significant burden of cancer demand for closed system drug transfer devices (CSDTs) market.
In this region, a major number of key player's presence, technological advancements, product launches & approvals, well-advanced healthcare infrastructure, and growing oncology drug approvals are driving this market growth.
For instance, in September 2023, EQUASHIELD, a leading provider of closed system transfer devices (CSTDs) and automated pharmacy compounding solutions, has been recognized as the most used device for hazardous drug preparation and administration for five consecutive years by Pharmacy Purchasing & Products magazine. This remarkable achievement underscores EQUASHIELD's dedication to enhancing safety and efficiency in healthcare settings.
Similarly, in December 2023, West Pharmaceutical Services, Inc. a global leader in innovative solutions for injectable drug administration systems, announced FDA 510(k) clearance and launch of its Vial2Bag Advanced 13mm admixture device.
Also, in December 2021, B. Braun Medical Inc. announced the launch of the OnGuard 2 Closed System Transfer Device (CSTD) in the United States, which represents an advancement over its predecessor, the original OnGuard model. This new device incorporates several enhancements aimed at improving usability and safety for healthcare professionals handling hazardous drugs.
Membrane-to-Membrane Systems
Needleless Systems
Vial Access Devices
Syringe Safety Devices
Bag Spikes
Male and Female Luer Components
Click-to-Lock Systems
Luer-Lock Systems
Push-to-Turn
Color-to-Color Systems
Diaphragm-Based Devices
Air Filtration Devices
Hospitals
Oncology Clinics and Centers
Others
North America
U.S.
Canada
Mexico
Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
South America
Brazil
Argentina
The rest of South America
Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
Middle East and Africa
Market Competitive Landscape
The major global players in the closed system drug transfer devices (CSDTs) market include BD, ICU Medical, Inc., EQUASHIELD, B. Braun Medical Inc., Yukon Medical, Simplivia, West Pharmaceutical Services, Inc., Baxter International Inc., JMS Co.Ltd., and Corning Incorporated among others.
In April 2023, EQUASHIELD, a leading provider of closed system transfer devices (CSTDs) for hazardous drugs, announced that its EQUASHIELD Syringe Unit has received FDA clearance for full-volume use. This means the system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume when handling hazardous drugs.
To visualize the global closed system drug transfer devices (CSDTs) market segmentation based on type, component, closing mechanism, technology, end-user, and region and understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of the closed system drug transfer devices (CSDTs) market with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping is available in excel consisting of key products of all the major players.
The global closed system drug transfer devices (CSDTs) market report would provide approximately 78 tables, 72 figures, and 184 pages.
Target Audience 2024
Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies