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藥物遞輸設備

市場調查報告書

商品編碼

1654723

全球封閉系統傳輸設備 (CSTD) 市場 - 2025 至 2033 年

Global Closed System Transfer Devices (CSTD) Market - 2025-2033

出版日期: 2025年02月13日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2024 年全球封閉系統轉移設備 (CSTD) 市場規模達到 7.1829 億美元，預計到 2033 年將達到 19.6826 億美元，在 2025-2033 年預測期內的複合年成長率為 11.7%。

封閉系統藥物轉移裝置 (CSTD) 是一種專門的醫療設備，旨在促進危險藥物的安全轉移，同時防止外部來源的污染並阻止危險物質或蒸氣的逸出。 CSTD 的主要功能是創造一個安全的環境，顯著降低接觸危險藥物的風險，這些藥物可能導致醫療專業人員和患者出現嚴重的健康問題，包括皮膚刺激、生殖問題甚至癌症。透過建立封閉系統，CSTD 對於保護處理這些強效藥物的每個人的健康和安全至關重要。

CSTD 通常遵循以下兩種設計理念之一：物理屏障 CSTD 和空氣清潔 CSTD。物理屏障 CSTD 採用機械方式防止藥物蒸氣、氣溶膠和液體釋放到環境中，同時阻止污染物進入無菌藥物通道。相較之下，空氣淨化 CSTD 採用清潔系統內空氣的技術，以確保有害物質不會逸出，進而進一步提高藥物處理過程中的安全性。

市場動態：

促進因素與約束因素

科技進步的崛起

預計不斷進步的技術將極大地推動封閉系統藥物轉移裝置 (CSTD) 市場的成長。材料科學和設計方面的創新提高了 CSTD 的效率和耐用性，使其更加方便用戶使用，能夠有效地保護個人免受有害藥物的侵害。功能性流體通道、直覺的鎖定機制以及與各種藥物容器和輸送系統的兼容性提高等關鍵特性促使其在醫療保健領域的應用日益廣泛。這些進步不僅提高了安全性，也簡化了危險藥物的處理和管理，滿足了醫療環境中對有效安全措施日益成長的需求。例如，2024 年 12 月，Zephyrus Innovations 在馬薩諸塞州波士頓舉行的藥物輸送合作機會會議上推出了其最新產品 VaporShield，這是世界上第一個可注射封閉系統轉移裝置。

然而，研發將繼續致力於開發更便宜、更有效率的解決方案，預計這將繼續成為 CSTD 市場未來技術的主要驅動力。

與設備相關的高成本

封閉系統藥物傳輸裝置（CSTD）因其安全優勢而越來越受到青睞，但也有幾個因素導致其成本高昂。其中包括先進的技術、嚴格的規定、生產所使用的材料。例如，PhaSeal CSTD 在三個月內的成本約為 92,072.28 美元，平均每種製劑 40.92 美元。預計每年的成本約為 368,289.14 美元，與傳統的注射器針頭方法相比，需額外花費 35,670.64 美元。

此外，定期維護、對醫護人員進行專門培訓以及確保與現有醫療系統的兼容性等需求也增加了費用。這些財務挑戰對於發展中地區的醫療機構來說尤其重要，因為預算限制可能會阻礙 CSTD 的廣泛採用。儘管這些設備在提高安全性和最大限度地減少接觸有害藥物方面具有長期效益，但初始投資和持續成本可能會阻止許多醫療保健提供者採用這些設備。

A closed system drug transfer device (CSTD) is a specialized medical device engineered to facilitate the safe transfer of hazardous drugs while preventing contamination from external sources and blocking the escape of hazardous substances or vapors. The primary function of CSTDs is to create a secure environment that significantly reduces the risk of exposure to dangerous drugs, which can lead to serious health issues for both healthcare professionals and patients, including skin irritations, reproductive problems, and even cancer. By establishing a closed system, CSTDs are vital in protecting the health and safety of everyone involved in handling these potent medications.

CSTDs typically follow one of two design concepts: physical barrier CSTDs and air-cleaning CSTDs. Physical barrier CSTDs employ mechanical means to prevent the release of drug vapors, aerosols, and liquids into the environment while also blocking contaminants from entering the sterile drug pathway. In contrast, air-cleaning CSTDs utilize technologies that clean the air within the system to ensure that hazardous substances do not escape, further enhancing safety during drug handling.

Market Dynamics: Drivers & Restraints

Rise in the Technological Advancements

Rising technological advancements are anticipated to significantly propel the growth of the closed-system drug transfer device (CSTD) market. Innovations in material science and design have enhanced the efficiency and durability of CSTDs, making them more user-friendly and effective in protecting individuals from hazardous drug exposure. Key features such as functional fluid pathways, intuitive locking mechanisms, and improved compatibility with various drug containers and delivery systems have contributed to their increased adoption in healthcare settings. These advancements not only enhance safety but also streamline the handling and administration of hazardous drugs, addressing the growing demand for effective safety measures in medical environments. For instance, in December 2024, Zephyrus Innovations unveiled its latest product, VaporShield, the world's first injectable closed system transfer device, at the Partnership Opportunities in Drug Delivery conference in Boston, MA.

However, research and development will keep being geared towards developing cheaper solutions with higher efficiency, and this is expected to remain a key driving force toward the future of technology in the CSTD market.

High Cost Associated with the Devices

Closed System Drug Transfer Devices (CSTDs) are increasingly favored for their safety benefits, but several factors contribute to their high costs. These include advanced technology, stringent regulations, and the materials used in their production. For example, the PhaSeal CSTD incurs a cost of approximately US$ 92,072.28 over three months, averaging US$ 40.92 per preparation. This results in an estimated annual cost of around US$ 368,289.14, which is an additional US$ 35,670.64 compared to the conventional syringe-needle method.

Furthermore, expenses are compounded by the need for regular maintenance, specialized training for healthcare staff, and ensuring compatibility with existing medical systems. These financial challenges are particularly significant for healthcare facilities in developing regions, where budget constraints can hinder the widespread adoption of CSTDs. The initial investment and ongoing costs may deter many healthcare providers from implementing these devices despite their long-term benefits in enhancing safety and minimizing exposure to hazardous drugs.

Segment Analysis

The global closed system transfer devices (CSTD) market is segmented based on product type, component, closing mechanism, technology, end user, and region.

Product Type:

Membrane-to-membrane closed systems segment is expected to dominate the global closed system transfer devices (CSTD) market share

Membrane-to-membrane closed systems for drug transfer function similarly to closed system drug transfer devices (CSTDs), utilizing a membrane seal to facilitate the transfer of hazardous drugs between containers while safeguarding the environment from contaminants. The growth of the membrane-to-membrane systems segment is driven by several factors, including significant product launches, heightened promotion of established CSTD devices for chronic disease management, and the increasing use of safety devices within this segment.

These membrane-to-membrane needle pathway CSTDs employ two adjacent membranes engaged by needles to facilitate drug removal and pressure equalization. When disengaged, the needles are scrubbed of any drug residue by the membranes, ensuring secure storage within the system. Recent studies indicate that systems like the Equashield II effectively minimize leakage and spills during drug compounding. This underscores the importance of carefully selecting CSTDs based on their design and functionality to enhance safety outcomes in healthcare settings.

Geographical Analysis

North America is expected to hold a significant position in the global closed system transfer devices (CSTD) market share

North America is projected to hold a significant share of the closed system drug transfer devices (CSTD) market, driven by several key factors. The region benefits from high technology adoption and a well-developed healthcare infrastructure, which are expected to sustain strong demand for safe and effective drug delivery systems in the near future. Regulatory bodies such as the U.S. FDA and EU impose stringent requirements for CSTDs, further promoting market growth. Additionally, the increasing prevalence of cancer and the rising use of hazardous drugs in chemotherapy have heightened the need for these devices.

Product launches by various companies and government initiatives supporting the use of closed systems will also contribute significantly to market expansion. Awareness campaigns focusing on occupational safety for healthcare personnel underscore the importance of CSTDs in protecting workers from hazardous drug exposure. As a result, the North American CSTD market is poised for robust growth, reflecting both the urgency of addressing safety concerns and the commitment to advancing healthcare practices. For instance, in September 2023, EQUASHIELD 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.

Competitive Landscape

The major global players in the closed system transfer devices (CSTD) market include Becton, Dickinson and Company, ICU Medical, Inc., EQUASHIELD, B. Braun SE, Yukon Medical, Simplivia Healthcare, LLC, JMS Co.Ltd., West Pharmaceutical Services, Inc, Cormed., and Epic Medical among others.

Key Developments

In December 2024, Zephyrus Innovations VaporShield, the world's first injectable closed system transfer device, at the Partnership Opportunities in Drug Delivery conference in Boston, MA.
In February 2024, Zephyrus Innovations received its first product 510(k) Marketing Clearance from the US FDA for its Aeroject 3ml safety syringe

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The Global Closed System Transfer Devices (CSTD) Market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Component
3.3. Snippet by Closing Mechanism
3.4. Snippet by Technology
3.5. Snippet by End-User
3.6. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rise in the Technological Advancements
- 4.1.2. Restraints
  - 4.1.2.1. High Cost Associated with the Devices
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Patent Analysis
5.5. Regulatory Analysis
5.6. SWOT Analysis
5.7. Unmet Needs

6. By Product Type

6.1. Introduction
- 6.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Membrane-to-Membrane Systems*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Needleless Systems

7. By Component

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 7.1.2. Market Attractiveness Index, By Component
7.2. Vial Access Devices*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Syringe Safety Devices
7.4. Bag Spikes
7.5. Male and Female Luer Components

8. By Closing Mechanism

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 8.1.2. Market Attractiveness Index, By Closing Mechanism
8.2. Click-to-Lock Systems*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Luer-Lock Systems
8.4. Push-to-Turn
8.5. Color-to-Color Systems

9. By Technology

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 9.1.2. Market Attractiveness Index, By Technology
9.2. Diaphragm-Based Devices*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Air Filtration Devices

10. By End-User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Clinics
10.4. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.8.1. U.S.
  - 11.2.8.2. Canada
  - 11.2.8.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.8.1. Germany
  - 11.3.8.2. U.K.
  - 11.3.8.3. France
  - 11.3.8.4. Spain
  - 11.3.8.5. Italy
  - 11.3.8.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.8.1. Brazil
  - 11.4.8.2. Argentina
  - 11.4.8.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.5.8.1. China
  - 11.5.8.2. India
  - 11.5.8.3. Japan
  - 11.5.8.4. South Korea
  - 11.5.8.5. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Closing Mechanism
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

Key Market Players

13.1. Becton, Dickinson and Company*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio
  - 13.1.2.1. Product Description
  - 13.1.2.2. Product Key Performance Indicators (KPIs)
  - 13.1.2.3. Historic and Forecasted Product Sales
  - 13.1.2.4. Product Sales Volume
- 13.1.3. Financial Overview
  - 13.1.3.1. Company Revenue's
  - 13.1.3.2. Geographical Revenue Shares
  - 13.1.3.3. Revenue Forecasts
- 13.1.4. Key Developments
  - 13.1.4.1. Mergers & Acquisitions
  - 13.1.4.2. Key Product Development Activities
  - 13.1.4.3. Regulatory Approvals etc.
- 13.1.5. SWOT Analysis
13.2. ICU Medical, Inc.
13.3. EQUASHIELD
13.4. B. Braun SE
13.5. Yukon Medical
13.6. Simplivia Healthcare, LLC
13.7. JMS Co.Ltd.
13.8. West Pharmaceutical Services, Inc
13.9. Cormed.
13.10. Epic Medical
Similar data will be provided for each market player.