As currently formulated, a significant number of therapeutic drugs require dosage volumes or possess viscosities well in excess of the upper range for traditional subcutaneous delivery. These drugs are currently delivered via infusion.
The demographics of patient populations and the current trend in therapeutic drug development are converging to create an increasingly steep demand curve for infusion. The costs and logistics of this convergence are a major driver of the energy behind small form factor subcutaneous infusion devices.
As the adoption of and acceptance of self-administered therapies grows, patients are spending less time with physicians and are playing a greater role in the delivery and management of their treatments. This dramatic shift in healthcare delivery is creating a need for devices that mask an underlying layer of complexity via design initiatives that are patient friendly.
What You Will Learn
- What delivery systems are currently marketed or in development for IV therapeutics repositioning, who are the suppliers, and what are the device specifics?
- What are the therapeutic markets being targeted by IV to subcutaneous delivery systems?
- What are the essential design factors, material selection issues, technologies and market development issues for qualifying SC delivery systems for IV drug administration?
- What are the major factors that will drive ambulatory subcutaneous infusion systems demand?
- What is the addressable market for subcutaneous infusion systems?
- What is the expected impact of subcutaneous infusion systems on drug delivery markets?
- Who are the significant players in this segment? What are their strategies? Who are their alliance partners?
Table of Contents
Executive Summary
Injectable/Infusible Market Segment Dynamics
Drug Development Trends
- Drug Delivery Device Evolution
- The Trend toward Patient Self-Administration
- Enabling Technology
- Lyophilized Drugs/Reconstitution
Subcutaneous Infusion Systems - Design Factors
- Volumes and Viscosities
- Primary Packaging
- Injection Method
- Device Electronics
Subcutaneous Infusion Devices - Market Segments
- The Cost and Logistical Burden of Out-patient Infusion
- Biologicals
- High Volume Drugs
- Duration Dependent Administration Drugs
Subcutaneous Infusion Systems Device Analysis
- enFuse (Enable Injections)
- Libertas (Becton Dickinson)
- Evolve (Becton Dickinson)
- SensePatch (Sensile Medical/Gerresheimer)
- SmartDose (West Pharmaceuticals)
- SmartDose Preloaded (West Pharmaceuticals)
- Unbranded Device (Sorrel Medical)
- Unbranded Device (Subcuject)
- YpsoDose (Ypsomed)
- E3D Patch Pump (Elcam)
- Pod (Stevanato)
Market Factors
- Self-Administration and Patient Compliance
- Regulatory Guidance and Product Approvals
- Healthcare Economics
- Drug Product Differentiation
Market Participant Profiles
Samples
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Companies Mentioned
- Becton Dickinson
- CSL Behring
- E3D Patch Pump (Elcam)
- Elcam
- enFuse (Enable Injections)
- Evolve (Becton Dickinson)
- Gerresheimer/Sensile Medical
- Libertas (Becton Dickinson)
- SenseAir (Sensile Medical/Gerresheimer)
- SG EZ-be Pod (Stevanato)
- SmartDose (West Pharmaceuticals)
- SmartDose Preloaded (West Pharmaceuticals)
- Sorrel Medical
- Subcuject WBI
- Unbranded Device (Sorrel Medical)
- West Pharmaceutical Services
- YpsoDose (Ypsomed)
- Ypsomed