drug reconstitution systems for self administration   Published May 2015  •  Catalog no. DRS755K  •  Price US $3,850

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.

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Reconstitution Technical Challenges


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Blue document   Report Order Form (PDF)

Drug Reconstitution Systems for Self Administration – 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?


Drug Reconstitution Systems for Self Administration – Summary of Contents

Executive Summary

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
Shifting Demographics
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
Cytotoxic Drugs
Other Market Segments

Drug Reconstitution Device Design & Selection Factors
Simplicity and Ease of Use
Human Engineering/Ergonomics
Patient Population Factors
Therapeutic Factors and Limitations
User Feedback and Confirmation

Drug Reconstitution Devices – Profiles and Analysis
Marketed Devices
Prefilled Diluent Syringes
Proprietary Reconstitution Devices
Single Step Dual Chamber Devices
New and Emerging Devices

Self-Administered Reconstitution Therapeutic Sector
Autoimmune Diseases
Blood Factors
Infectious Diseases
Metabolic Conditions
Reproductive Health
Other Important Therapeutic Classes

Market Factors
Regulatory Issues
Patient Safety
Healthcare Economics

Company Profiles