Interest in closed system drug transfer devices has been growing as regulatory activity and practitioner awareness surrounding hazardous drug compounding and administration continue to increase. Drugs deemed hazardous to humans has been receiving increasing amounts of scrutiny in recent years as the dangers of these substances become more clearly understood. For caregivers and their patients, the therapeutic area that is at the forefront of attempts to mitigate exposure to cytotoxic drugs is clinical oncology, a field that - in spite of promising new drugs based on therapeutic antibodies - continues to rely heavily on antineoplastics, a class that includes alkylating agents and antimetabolites, to treat a wide range of cancers.
Regulatory and industry efforts to create standards and procedures for closed system drug transfer devices are designed to protect workers and patients from accidental and incidental exposure to cytotoxics are being driven by data that suggests a causal link between exposure and health issues. This report analyzes devices, regulations, markets and participants competing in the closed system drug transfer device segment and provides insight, analysis, assessments and forecasts to assist readers in navigating this rapidly evolving sector.
What You Will Learn
- What are the key segments and addressable markets that comprise the market for cytotoxic drug delivery?
- What are the major therapeutic demand drivers for cytotoxic drug therapeutics?
- What are the design factors and technologies that are being used in commercial and development-stage closed drug transfer systems?
- What is the market share and product position in the market and what will it look like in 2024?
- Who are the companies behind the current generation of cytotoxic transfer devices and what are their business models?
- What is the role of pharma-device alliances and design partnerships in the commercialization and market access of new and emerging closed system drug transfer devices?
- What is the impact of economic, technology, and regulatory factors on CSDT device demand?
1. Evolution in Oncology Therapeutics
2. Recombinant Drugs & Personalized Medicine
- The Growth of Targeted Therapeutics
- The Evolving Role of Cytotoxic Drugs
- The Administration of Antineoplastics
- Closed System Drug Transfer (CSDT) Demand Drivers
- Regulatory Factors
- Market Factors
- Technology Factors
- Regional Factors
- CSDT Competitive Landscape
- Risks and Opportunities
3. The Market for Cytotoxic Drugs
- Usage Trends
- Evolving Prescribing Factors
- Special Considerations
4. Closed System Drug Transfer Design Factors
- Oncology Therapeutics Medication Safety
- Material Selection Issues
- Drug Reconstitution
- Oncology Drug Administration and Dosing
- Drug-Specific Dosing Modification and Individualized Dosing
- CSDT Device Performance Factors
- Vapor Containment
- Testing Protocols
5. CSDT Devices - Key Market Segments
- Teaching Hospitals
- Regional Hospital
- Oncology Centers/Clinics
6. Closed System Drug Transfer - Device Assessments
- Device Configuration
- Device-to-Device interface
- User-to-Device Interface
- Device Sharps Strategy
- Device Compliance Performance
7. Market Factors
- Regulations and Standards
- USP 800
- Caregiver Compliance
- Level of Complexity and Ease of Use
- Healthcare Economics
- Business Models and Strategies
8. Market Assessments and Forecasts
- North America
- Other Geographic Markets
9. Company Profiles
Research methodology is based on primary research in the form of in-depth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations.
Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations.
Forecasts and projections of market demand and future market activity are derived using standard modeling and statistical techniques.