市場調查報告書
商品編碼
1560829
全球封閉系統藥物轉移設備市場 - 2024 - 2031Global Closed System Drug Transfer Devices Market - 2024 - 2031 |
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報告概述
全球封閉系統藥物轉移器材市場將於 2023 年達到 12.5 億美元,預計到 2031 年將達到 43.7 億美元,2024-2031 年預測期間複合年成長率為 14.8%。
封閉系統藥物轉移裝置(CSTD)是一種專門的醫療設備,旨在透過防止外部污染物進入系統並阻止危險藥物物質或蒸氣釋放到系統外來安全地轉移危險藥物。
CSTD 的主要目的是建立一個安全的環境,顯著降低接觸危險物質的風險。接觸這些危險藥物可能會對醫療保健專業人員和患者造成嚴重的健康後果,包括皮膚刺激、生殖問題,甚至癌症。透過創建封閉系統,CSTD 在保障參與處理這些強效藥物的每個人的福祉方面發揮著至關重要的作用。
CSTD 通常遵循兩種設計理念之一:物理屏障 CSTD 和空氣淨化 CSTD。物理屏障 CSTD 使用機械性手段阻止藥物蒸氣、氣溶膠和液體逃脫到周圍環境中。它們還可以防止環境中的污染物進入無菌藥物途徑。物理屏障可防止危險藥物與環境或醫護人員之間的直接接觸。它創造了一個難以穿透的邊界來容納藥物並保持無菌。
另一種是空氣淨化 CSTD 使用過濾技術去除氣流中的藥物污染物,防止其釋放到環境中。它們還過濾進入的空氣,以去除環境污染物,然後再進入無菌藥物通道。
物理屏障和空氣淨化 CSTD 的設計目的都是為了實現相同的目標,即保護醫護人員和環境免受危險藥物的影響,同時保持藥物途徑的無菌性。兩者之間的選擇取決於藥物特性、設施佈局和使用者偏好等因素。如果使用得當,CSTD 可以顯著降低與處理危險藥物相關的風險。
司機
癌症盛行率上升和技術進步
全球封閉系統藥物轉移裝置(CSDT)市場的需求是由多種因素所驅動的。主要因素之一是癌症盛行率的上升和技術的進步。全球癌症發生率正在迅速增加,導致對化療和其他危險藥物的需求。
使用封閉系統藥物轉移裝置 (CSTD) 對於保護醫護人員免受危險藥物的職業接觸至關重要。這些設備經過專門設計,旨在降低與處理強效藥物(尤其是化療藥物)相關的風險,如果醫護人員無意接觸化療藥物,可能會造成嚴重的健康威脅。
根據世界衛生組織2024年2月的資料,2022年,全球報告了約2,000萬新發癌症病例,導致近970萬人死亡。當年最受歡迎的癌症類型包括肺癌,有 250 萬例(佔所有癌症的 12.4%),乳癌有 230 萬例(11.6%),大腸癌有 190 萬例(9.6%)。
肺癌是癌症相關死亡的主要原因,約造成 180 萬人死亡(18.7%),其次是大腸直腸癌,約 90 萬人死亡(9.3%),肝癌約 76 萬人死亡(7.8%)。預測表明,到 2050 年,癌症病例數可能會增加到 3500 萬,這主要是由於人口成長。因此,癌症病例的增加增加了對封閉系統藥物轉移裝置 (CSTD) 的需求,以促進這些強效藥物的安全處理。
此外,封閉系統藥物轉移裝置(CSTD)技術的創新,例如引入無針系統和增強的密封機制,顯著提高了可用性和安全性,從而推動了其在醫療保健環境中的採用。
此外,該行業的技術進步、意識計劃和關鍵發展的關鍵參與者正在推動市場成長。例如,2022 年 9 月,在 Oxford Global 組織的 Formulation UK 2021 活動期間,賽諾菲生物製劑藥品開發藥品團隊負責人 Heloise Audat 深入概述了賽諾菲評估封閉系統藥物轉移裝置 (CSTD) 的方法。第一項關於 CSTD 的法規於 2004 年左右訂定,旨在保護醫護人員免受系統性接觸危險藥物的風險。
同樣,BD 推出的危險藥品表面污染監測計劃是一個全面的端到端解決方案,旨在幫助醫療機構評估其當前的做法,制定有效的測試計劃,並實施危險藥品表面污染的永續監測計劃。該計劃旨在保護醫護人員在準備和給藥過程中免受危險藥物的潛在接觸。
此外,2022 年 3 月,全球著名醫療設備開發商 Simplivia Healthcare Ltd. 宣布即將發布新型封閉系統轉移設備 (CSTD) Chemfort。該設備專為提高參與危險藥物製備和管理的醫療保健專業人員的安全而設計。
限制
CSTD 實施成本高昂、監管挑戰以及個人缺乏意識等因素預計將阻礙市場發展。
細分市場分析
全球封閉系統藥物轉移裝置 (CSDT) 市場根據類型、組件、封閉機制、技術、最終用戶和地區進行細分。
無針系統部分約佔全球封閉系統藥物轉移裝置 (CSDT) 市場佔有率的 74.3%
無針系統領域預計將在預測期內佔據最大的市場佔有率。無針系統專門設計用於防止針刺傷,這對於處理危險藥物的醫護人員來說是一個重大危險。這些系統消除了對傳統針頭的需求,從而降低了意外接觸有毒物質的風險。
此外,該行業的主要參與者推出創新設備和發布有助於推動該細分市場的成長。例如,ICU Medical, Inc.推出了化學鎖封閉系統轉移裝置(CSTD),採用機械和微生物封閉的無針設計,可防止有害藥物蒸氣逸出,並在配製和給藥過程中保持藥物的無菌狀態。
同樣,Yukon Medical 推出了 Arisure 封閉系統轉移裝置 (CSTD),旨在保護醫護人員在化療和其他危險藥物的配製、運輸和管理過程中免受危險藥物蒸氣的影響。 Arisure CSTD 採用無針魯爾鎖連接系統,直覺且易於使用。與傳統的基於針的系統相比,這消除了針刺傷害的風險。連接小瓶、注射器和靜脈輸液袋時,魯爾鎖連接可形成安全、氣密的密封。
此外,2023 年 11 月,BD(Becton、Dickinson and Company)推出了一種名為 PIVO Pro 的新型無針抽血技術,旨在增強患者護理並支持公司「一次性住院」的願景。此創新設備已獲得美國食品藥物管理局 (FDA) 的 510(k) 許可,並且是第一個與整合式長外周 IV 導管相容的設備,包括具有近端口 IV 通路的 Nexiva 封閉式 IV 導管系統。
市場地理分析
北美約佔全球封閉系統藥物轉移裝置 (CSDT) 市場佔有率的 45.2%
由於北美癌症病例數量的增加是封閉系統藥物轉移設備(CSTD)市場的重要驅動力,預計北美地區將在預測期內佔據最大的市場佔有率。隨著越來越多的患者需要化療和其他危險藥物治療,對 CSTD 等安全處理解決方案的需求也隨之增加。
根據美國癌症協會估計,到 2022 年,美國將新增約 190 萬例癌症病例,約 609,360 例癌症相關死亡。癌症對封閉系統藥物轉移裝置(CSDT)市場的巨大需求負擔。
在該地區,大量關鍵參與者的存在、技術進步、產品發布和批准、先進的醫療保健基礎設施以及不斷成長的腫瘤藥物批准正在推動該市場的成長。
例如,2023 年 9 月,封閉系統傳輸設備 (CSTD) 和自動化製藥配製解決方案的領先供應商 EQUASHIELD 連續五年被《Pharmacy Purchasing & Products》雜誌評為危險藥物製備和管理中最常用的設備。這項非凡成就凸顯了 EQUASHIELD 致力於提高醫療保健環境的安全性和效率。
同樣,2023 年 12 月,注射給藥系統創新解決方案的全球領導者 West Pharmaceutical Services, Inc. 宣布獲得 FDA 510(k) 許可並推出其 Vial2Bag Advanced 13mm 混合裝置。
此外,2021 年 12 月,貝朗醫療公司 (B. Braun Medical Inc.) 宣佈在美國推出 OnGuard 2 封閉系統轉移設備 (CSTD),這代表著對其前身(原始 OnGuard 型號)的進步。這款新設備包含多項增強功能,旨在提高處理危險藥物的醫療保健專業人員的可用性和安全性。
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