유해 약물용 폐쇄형 약물전달 기기 시장 보고서 : 동향, 예측, 경쟁 분석(-2031년)

The future of the global hazardous drug closed system transfer device market looks promising with opportunities in the hospital and clinic markets. The global hazardous drug closed system transfer device market is expected to grow with a CAGR of 18.1% from 2025 to 2031. The major drivers for this market are the increasing focus on healthcare worker safety, the rising awareness of hazardous drug exposure risks, and the growing demand for effective drug transfer systems.

• Lucintel forecasts that, within the type category, closed syringe safety device is expected to witness the highest growth over the forecast period.
• Within the application category, hospital is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the Hazardous Drug Closed System Transfer Device Market

The hazardous drug closed system transfer device market is being redefined by a combination of technological innovations and evolving healthcare practices. These trends are not only improving safety but also enhancing efficiency and data management in a significant way. The following section outlines five of the most impactful emerging trends that are shaping the future of the market.

• Integration of Smart Technology: A key trend is the integration of smart features, such as RFID tags and electronic sensors, into CSTDs. This technology enables real-time tracking of drug transfers, monitors device usage, and records compliance data. The impact is a significant enhancement in accountability and safety, allowing for better inventory management and ensuring adherence to regulatory standards.
• Focus on Needle-Free Systems: The development and increasing adoption of needle-free CSTDs is a major trend. These systems eliminate the use of needles, thereby reducing the risk of needlestick injuries and minimizing the potential for drug exposure. The impact is a safer working environment for healthcare professionals, simplified workflow, and reduced risk of contamination.
• Move Towards Full Automation: The market is seeing a push towards integrating CSTDs with automated compounding systems and IV robotics. This allows for the automated preparation of hazardous drugs, minimizing human contact throughout the process. The impact is a significant improvement in both safety and efficiency, leading to higher throughput and greater consistency in drug preparation.
• Emphasis on Ergonomic and User-Friendly Designs: Manufacturers are placing a greater emphasis on designing CSTDs that are more ergonomic and intuitive to use. This includes features like color-coded components, tactile feedback mechanisms, and easy-to-connect systems. The impact is a reduction in assembly errors and user fatigue, which improves the overall safety and efficiency of drug handling in busy clinical settings.
• Sustainable and Eco-Friendly Solutions: The market is beginning to see a trend towards developing more sustainable and eco-friendly CSTDs. This includes using recyclable materials or designing reusable components where possible. The impact is a reduction in medical waste and a more environmentally conscious approach to healthcare, aligning with broader corporate social responsibility goals and reducing long-term costs.

The hazardous drug closed system transfer device market is being reshaped by the integration of smart technology, the adoption of needle-free systems, automation, ergonomic designs, and a focus on sustainability. These trends are collectively driving the market toward a future of safer, more efficient, and environmentally responsible hazardous drug handling.

Recent Developments in the Hazardous Drug Closed System Transfer Device Market

The hazardous drug closed system transfer device market is marked by continuous innovation and strategic advancements. These developments are directly aimed at improving safety protocols, enhancing workflow efficiency, and expanding the accessibility of this vital technology. The following section highlights five key recent developments that are currently impacting the market.

• New product clearances and launches: Recent developments include the launch of new CSTD products that have received regulatory clearances (e.g., FDA). These new devices often feature improved design, enhanced sealing mechanisms, and greater compatibility with a wider range of drug vials and infusion sets, thus improving user flexibility and increasing market options for healthcare facilities.
• Increased regulatory enforcement: There is a recent trend of stricter enforcement of hazardous drug handling guidelines, particularly in the United States and Europe. This is compelling more healthcare facilities to adopt CSTDs to ensure compliance with regulations. This development is a significant market driver, as it moves the CSTD from a recommended device to a mandatory one in many settings.
• Strategic mergers and acquisitions: The market is seeing a rise in strategic mergers and acquisitions, where larger medical device companies acquire smaller, innovative CSTD manufacturers. This trend allows established players to expand their product portfolios and gain access to new technologies, while also consolidating the market and influencing competitive dynamics.
• Advancements in material science: A key development is the use of new materials that offer superior chemical resistance and durability. Manufacturers are employing advanced polymers and composites that can better withstand exposure to potent hazardous drugs without degradation. This advancement ensures the long-term integrity and reliability of the CSTD, enhancing its safety profile.
• Development of hybrid systems: Another recent development is the introduction of hybrid CSTDs that combine different technologies, such as both a physical barrier and an air-cleaning filter. These hybrid systems offer a more comprehensive containment solution, providing a higher level of protection against both liquid spills and aerosolized hazardous drugs.

Recent developments in the hazardous drug closed system transfer device market, including new product launches, stricter regulatory enforcement, strategic business moves, and material advancements, are collectively enhancing the safety and reliability of hazardous drug handling. These innovations are critical for protecting healthcare workers and are driving the market forward.

Strategic Growth Opportunities in the Hazardous Drug Closed System Transfer Device Market

The hazardous drug closed system transfer device market presents numerous strategic growth opportunities by targeting key applications and expanding into new therapeutic areas. By focusing on the unique needs of different end-users and applications, companies can develop specialized products, gain a competitive advantage, and drive market expansion.

• Oncology clinics and chemotherapy infusion: The high and rising incidence of cancer makes oncology clinics a primary growth opportunity. CSTDs are essential for the safe preparation and administration of chemotherapy drugs. Companies can gain a competitive edge by developing products that are easy to use in busy infusion centers and are compatible with a wide range of cytotoxic agents.
• Hospital pharmacies for drug compounding: The hospital pharmacy is a critical growth area where hazardous drugs are prepared and compounded. Strategic opportunities exist in offering CSTDs that are optimized for high-volume compounding and can be easily integrated into existing pharmacy automation systems. Providing products that ensure sterility and compliance is key.
• Outpatient and home infusion settings: The shift towards outpatient and home infusion for cancer and other chronic diseases is creating a new growth opportunity. This setting requires CSTDs that are compact, simple to use, and reliable for use by non-expert caregivers or patients. Developing user-friendly and portable CSTDs is a key strategy for this segment.
• Veterinary medicine and animal oncology: The veterinary medicine market, particularly for animal oncology, is a niche but growing application. As hazardous drugs are also used to treat cancer in animals, there is a need for CSTDs. Companies can expand by creating products that are suitable for veterinary settings and addressing the unique needs of animal healthcare professionals.
• Research and academic institutions: Academic and research institutions that handle hazardous drugs for preclinical and clinical research represent a significant growth opportunity. These institutions require CSTDs that can handle small volumes of drugs and ensure the integrity of samples. Opportunities lie in providing specialized, high-precision CSTDs for research-specific applications.

Strategic growth opportunities in the hazardous drug closed system transfer device market are concentrated in key applications like oncology, hospital pharmacies, and home infusion, as well as emerging segments such as veterinary medicine and research. By developing specialized products for these diverse applications, companies can expand their market presence and drive innovation across the healthcare industry.

Hazardous Drug Closed System Transfer Device Market Driver and Challenges

The hazardous drug closed system transfer device market is influenced by a dynamic combination of drivers and challenges. These forces, ranging from regulatory mandates to economic pressures, define the market landscape. Understanding these factors is crucial for companies to navigate the market effectively and predict its future trajectory.

The factors responsible for driving the hazardous drug closed system transfer device market include:

1. Increasing regulations and guidelines: Stringent regulations from bodies like the FDA and NIOSH, along with guidelines such as USP <800>, are the primary drivers. These mandates require healthcare facilities to implement CSTDs for the safe handling of hazardous drugs, creating a consistent and growing demand for the devices.

2. Growing awareness of healthcare worker safety: There is an increasing global recognition of the health risks, including cancer and reproductive issues, associated with exposure to hazardous drugs. This heightened awareness among healthcare workers, unions, and hospital administrators is a major driver for the adoption of CSTDs to ensure a safer working environment.

3. Rising incidence of cancer: The global increase in cancer cases leads to a higher volume of chemotherapy drug preparation and administration. As more patients undergo these treatments, the need for CSTDs to safely handle the cytotoxic drugs becomes more critical, thereby expanding the market.

4. Technological advancements in design: Continuous innovation in CSTD technology, such as the development of needle-free systems, ergonomic designs, and automated connectors, is a key driver. These advancements improve the safety, usability, and efficiency of CSTDs, making them more attractive to healthcare facilities seeking to modernize their practices.

5. Focus on minimizing medication errors: CSTDs are designed to prevent contamination and spills, which also helps to reduce the risk of medication errors. The increasing emphasis on patient safety and the reduction of healthcare-associated complications drives the adoption of CSTDs as a vital tool in medication management.

Challenges in the hazardous drug closed system transfer device market are:

1. High cost of devices: The initial cost of purchasing and implementing CSTDs, along with the ongoing expense of single-use components, is a significant challenge. This financial barrier can limit adoption, particularly for smaller hospitals, clinics, and healthcare systems in developing economies with limited budgets.

2. Lack of standardized testing protocols: The absence of a universal, standardized testing protocol for CSTD performance poses a challenge. This makes it difficult for healthcare facilities to compare different products and verify their efficacy, leading to confusion and hesitancy in purchasing decisions and potentially slowing down market growth.

3. User training and compliance issues: While CSTDs are designed to be user-friendly, improper use can compromise their effectiveness. The need for consistent training and ongoing compliance monitoring for all staff members is a major challenge. Non-compliance can create safety risks and a barrier to the widespread adoption of CSTDs.

The hazardous drug closed system transfer device market is being driven by strong regulatory forces, a growing emphasis on safety, and technological innovation. However, it faces significant challenges related to the high cost of devices, a lack of standardized performance protocols, and the critical need for comprehensive user training. Addressing these hurdles will be vital for the market's continued expansion.

List of Hazardous Drug Closed System Transfer Device Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies hazardous drug closed system transfer device companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the hazardous drug closed system transfer device companies profiled in this report include-

• BD Medical
• Equashield
• ICU Medical
• Simplivia Healthcare
• Corvida Medical
• B. Braun
• Yukon Medical
• JMS
• Caragen
• Epic Medical

Hazardous Drug Closed System Transfer Device Market by Segment

The study includes a forecast for the global hazardous drug closed system transfer device market by type, application, and region.

Hazardous Drug Closed System Transfer Device Market by Type [Value from 2019 to 2031]:

• Closed Vial Access Devices
• Closed Syringe Safety Devices
• Closed Bag/Line Access Devices

Hazardous Drug Closed System Transfer Device Market by Application [Value from 2019 to 2031]:

• Hospital
• Clinic

Country Wise Outlook for the Hazardous Drug Closed System Transfer Device Market

The global hazardous drug closed system transfer device market is undergoing significant evolution, driven by increasing awareness of occupational risks associated with handling potent drugs. Stringent regulations and a focus on healthcare worker safety are pushing for the adoption of more advanced, user-friendly, and integrated CSTD technologies across various international markets.

• United States: The U.S. market is a leader in CSTD adoption, driven by stringent regulations like USP <800> and NIOSH recommendations. Recent developments focus on integrating CSTDs with smart technology for real-time tracking and compliance monitoring. The market is also seeing a rise in partnerships between CSTD manufacturers and IV robotics companies to enhance automation in compounding pharmacies.
• China: China's CSTD market is experiencing rapid growth, fueled by rising cancer prevalence and government initiatives to modernize healthcare facilities. While international brands hold a significant share, local manufacturers are emerging with cost-effective solutions. The focus is on increasing the adoption of CSTDs in hospitals and oncology centers to improve safety standards for a large and expanding healthcare workforce.
• Germany: In Germany, a mature and quality-conscious market, recent developments are centered on ergonomic and highly reliable CSTD designs. Manufacturers are focused on creating devices with intuitive locking mechanisms and tactile feedback to reduce user error. The market is also driven by a strong emphasis on sustainability, with companies exploring reusable or recyclable CSTD components.
• India: The Indian CSTD market is a high-growth region, propelled by increasing healthcare expenditure and a growing number of cancer treatment centers. While the market is price-sensitive, there is a growing recognition of the importance of worker safety. Recent developments include strategic collaborations between global and domestic companies to introduce a wider range of CSTDs at competitive price points.
• Japan: Japan's market is characterized by a strong emphasis on safety, precision, and efficiency. Recent developments focus on miniaturization and the development of needle-free CSTDs that are seamlessly integrated with a variety of drug delivery systems. The market is driven by the country's aging population and a high standard of healthcare that prioritizes the protection of medical staff.

Features of the Global Hazardous Drug Closed System Transfer Device Market

• Market Size Estimates: Hazardous drug closed system transfer device market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: Hazardous drug closed system transfer device market size by type, application, and region in terms of value ($B).
• Regional Analysis: Hazardous drug closed system transfer device market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different type, application, and regions for the hazardous drug closed system transfer device market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the hazardous drug closed system transfer device market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the hazardous drug closed system transfer device market by type (closed vial access devices, closed syringe safety devices, and closed bag/line access devices), application (hospital and clinic), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Hazardous Drug Closed System Transfer Device Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Closed Vial Access Devices: Trends and Forecast (2019-2031)
• 4.4 Closed Syringe Safety Devices: Trends and Forecast (2019-2031)
• 4.5 Closed Bag/Line Access Devices: Trends and Forecast (2019-2031)

5. Global Hazardous Drug Closed System Transfer Device Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Hospital: Trends and Forecast (2019-2031)
• 5.4 Clinic: Trends and Forecast (2019-2031)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Hazardous Drug Closed System Transfer Device Market by Region

7. North American Hazardous Drug Closed System Transfer Device Market

• 7.1 Overview
• 7.2 North American Hazardous Drug Closed System Transfer Device Market by Type
• 7.3 North American Hazardous Drug Closed System Transfer Device Market by Application
• 7.4 United States Hazardous Drug Closed System Transfer Device Market
• 7.5 Mexican Hazardous Drug Closed System Transfer Device Market
• 7.6 Canadian Hazardous Drug Closed System Transfer Device Market

8. European Hazardous Drug Closed System Transfer Device Market

• 8.1 Overview
• 8.2 European Hazardous Drug Closed System Transfer Device Market by Type
• 8.3 European Hazardous Drug Closed System Transfer Device Market by Application
• 8.4 German Hazardous Drug Closed System Transfer Device Market
• 8.5 French Hazardous Drug Closed System Transfer Device Market
• 8.6 Spanish Hazardous Drug Closed System Transfer Device Market
• 8.7 Italian Hazardous Drug Closed System Transfer Device Market
• 8.8 United Kingdom Hazardous Drug Closed System Transfer Device Market

9. APAC Hazardous Drug Closed System Transfer Device Market

• 9.1 Overview
• 9.2 APAC Hazardous Drug Closed System Transfer Device Market by Type
• 9.3 APAC Hazardous Drug Closed System Transfer Device Market by Application
• 9.4 Japanese Hazardous Drug Closed System Transfer Device Market
• 9.5 Indian Hazardous Drug Closed System Transfer Device Market
• 9.6 Chinese Hazardous Drug Closed System Transfer Device Market
• 9.7 South Korean Hazardous Drug Closed System Transfer Device Market
• 9.8 Indonesian Hazardous Drug Closed System Transfer Device Market

10. ROW Hazardous Drug Closed System Transfer Device Market

• 10.1 Overview
• 10.2 ROW Hazardous Drug Closed System Transfer Device Market by Type
• 10.3 ROW Hazardous Drug Closed System Transfer Device Market by Application
• 10.4 Middle Eastern Hazardous Drug Closed System Transfer Device Market
• 10.5 South American Hazardous Drug Closed System Transfer Device Market
• 10.6 African Hazardous Drug Closed System Transfer Device Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunities by Type
  • 12.2.2 Growth Opportunities by Application
• 12.3 Emerging Trends in the Global Hazardous Drug Closed System Transfer Device Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis
• 13.2 BD Medical
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Equashield
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 ICU Medical
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Simplivia Healthcare
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Corvida Medical
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 B. Braun
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Yukon Medical
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 JMS
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Caragen
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Epic Medical
  • Company Overview
  • Hazardous Drug Closed System Transfer Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us