The inherent instability of protein drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed – a requirement referred to as the ‘cold chain’. Alternatively, proteins can be formulated as powders (lyophilization). Lyophilized proteins must be reconstituted prior to injection. Lyophilized drugs are increasingly being sold with reconstitution vial systems, or packaged in special injection devices (e.g., pens, needle-free injectors, two-part syringes) that allow reconstitution to take place in the device prior to injection. Drug Reconstitution Systems for Self-Administration examines the impact of reconstitution at the point of self-administration on injectable drug markets.
What You Will Learn
• What is the impact of lyophilized injectable drugs on today’s therapeutic market, and who markets them?
• Who are the suppliers of point-of-care reconstitution devices, and what is their market impact?
• What are the major factors driving point-of-care drug reconstitution demand?
• What is the relative impact of integrated reconstitution systems to standard reconstitution devices and how will this change by the end of the decade?
• What are the essential design factors, material selection issues, technologies and market development issues for drug reconstitution systems and devices?
• What is the role of point-of-care drug reconstitution systems on drug life cycle management?
• What are the significant economic, technology, and regulatory factors affecting the market for injectable drugs and reconstitution systems?
Summary of Contents
The Drug Reconstitution Market Landscape
Injectable Drug Growth
Reconstitution – A Fact of Biological Drug Life
The Economic Rationale for lyophilized Drugs
User-Friendly Reconstitution – The Market Opportunity
The Trend toward Self-Administration
Patient Compliance and Adherence
Chronic Disease Incidence and Prevalence
Therapeutic Demand Drivers
Recon Market Segments & the Total Addressable
Drugs for SC/IM Injection
Drugs for Infusion
Other Market Segments
Drug Reconstitution Device Design & Selection Factors
Simplicity and Ease of Use
Patient Population Factors
Therapeutic Factors and Limitations
User Feedback and Confirmation
Drug Reconstitution Devices – Profiles and Analysis
Prefilled Diluent Syringes
Proprietary Reconstitution Devices
Single Step Dual Chamber Devices
New and Emerging Devices
Self-Administered Reconstitution Therapeutic Sector
Other Important Therapeutic Classes