Point-of-Use Drug Reconstitution Systems

The inherent instability of biological 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 distribution strategy 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 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. As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of specialty devices will increase.

Publication Date: January 2010

Summary of Contents (see Prospectus for full Contents)

Executive Summary

Market Dynamics

Prolonging the Shelf Life of Biological Drugs

Distribution Strategies

Formulation Strategies

Lyophilization and Reconstitution at the Point of Use

The Economics of Reconstitution Systems

What’s Driving the Growth in Engineered Reconstitution Systems?

Biological Drugs Proliferating

The Trend toward Self-Administration

Shifting Demographics

Innovation in Disposable Device Designs

Therapeutic Demand Drivers

Competitive Landscape

Risk Factors

Drug Reconstitution Systems – Commercial Devices

Vial Adapters

Vial-to-Vial Systems

Needle-less Transfer Devices

Direct Connect to Vial

Dual Chamber Syringes

Single Chamber Syringes

Reconstitution System Design Factors

Stability and Material Selection Issues

Disposable Drug Cartridges

Single vs Multi-Dose Devices

Human Engineering/Ergonomics

Drug Reconstitution - User Segment Analysis

Self-Administration

Healthcare Provider/Care-giver

Acute Care Facilities

Chronic/Long-term Facilities

Public Health

Drug Reconstitution - Therapeutic Sector Analysis

Antibiotics/Antivirals

Monoclonal Antibodies

Autoimmune Diseases

Hepatitis

Hematopoietics

Hormone_Replacement

Osteoporosis

Reproductive Health

Vaccines

Market Factors

Syringe Disposal

Regulatory Issues

Patient Compliance

Healthcare Economics

Drug Reconstitution Systems- Company Profiles

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