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药物递输设备

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1654723

全球封闭系统传输设备 (CSTD) 市场 - 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个工作天内

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简介目录

2024 年全球封闭系统转移设备 (CSTD) 市场规模达到 7.1829 亿美元，预计到 2033 年将达到 19.6826 亿美元，在 2025-2033 年预测期内的复合年增长率为 11.7%。

封闭系统药物转移装置 (CSTD) 是一种专门的医疗设备，旨在促进危险药物的安全转移，同时防止外部来源的污染并阻止危险物质或蒸气的逸出。 CSTD 的主要功能是创造一个安全的环境，显着降低接触危险药物的风险，这些药物可能导致医疗专业人员和患者出现严重的健康问题，包括皮肤刺激、生殖问题甚至癌症。透过建立封闭系统，CSTD 对于保护处理这些强效药物的每个人的健康和安全至关重要。

CSTD 通常遵循以下两种设计理念之一：物理屏障 CSTD 和空气清洁 CSTD。物理屏障 CSTD 采用机械方式防止药物蒸气、气溶胶和液体释放到环境中，同时阻止污染物进入无菌药物通道。相较之下，空气净化 CSTD 采用清洁系统内空气的技术，以确保有害物质不会逸出，进而进一步提高药物处理过程中的安全性。

市场动态：

驱动因素与约束因素

科技进步的崛起

预计不断进步的技术将极大地推动封闭系统药物转移装置 (CSTD) 市场的成长。材料科学和设计方面的创新提高了 CSTD 的效率和耐用性，使其更加用户友好，能够有效地保护个人免受有害药物的侵害。功能性流体通道、直觉的锁定机制以及与各种药物容器和输送系统的兼容性提高等关键特性促使其在医疗保健领域的应用日益广泛。这些进步不仅提高了安全性，也简化了危险药物的处理和管理，满足了医疗环境中对有效安全措施日益增长的需求。例如，2024 年 12 月，Zephyrus Innovations 在马萨诸塞州波士顿举行的药物输送合作机会会议上推出了其最新产品 VaporShield，这是世界上第一个可注射封闭系统转移装置。

然而，研发将继续致力于开发更便宜、更有效率的解决方案，预计这将继续成为 CSTD 市场未来技术的主要驱动力。

与设备相关的高成本

封闭系统药物传输装置（CSTD）因其安全优势而越来越受到青睐，但也有几个因素导致其成本高昂。其中包括先进的技术、严格的规定、生产所使用的材料。例如，PhaSeal CSTD 在三个月内的成本约为 92,072.28 美元，平均每种製剂 40.92 美元。预计每年的成本约为 368,289.14 美元，与传统的注射器针头方法相比，需额外花费 35,670.64 美元。

此外，定期维护、对医护人员进行专门培训以及确保与现有医疗系统的兼容性等需求也增加了费用。这些财务挑战对于发展中地区的医疗机构来说尤其重要，因为预算限制可能会阻碍 CSTD 的广泛采用。儘管这些设备在提高安全性和最大限度地减少接触有害药物方面具有长期效益，但初始投资和持续成本可能会阻止许多医疗保健提供者采用这些设备。

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.