Drug Reconstitution at the Point-of-Care: Therapeutic Markets, Technologies, Strategies, and Prospects

• Publication date: January 2012

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 powd...

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.

Highlights

• Analyzes therapeutic demand drivers and evaluates the market impact and potential of commercial drug reconstitution systems
• Provides analysis of injectable lyophilized drugs and assess key market segments, market dynamics and market demographics
• Forecasts Injectable drug product demand by indication and therapy to 2016
• Profiles reconstitution system suppliers, their product activities, business strategies, and corporate alliances and affiliations

Therapy Industry

Executive Summary
Market Dynamics
Prolonging the Shelf Life of Biological Drugs
Distribution Strategies
Formulation Strategies
Lyophilization and Reconstitution at the Point of Use
Healthcare Economics and 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
Direct Connect to Cartridge
Dual Chamber Syringes
Dual Chamber Cartridges
Closed Drug Transfer
Reconstitution System Design Factors
Stability and Material Selection Issues
Disposable Drug Cartridges
Single vs Multi-Dose Devices
Human Engineering/Ergonomics
Drug Reconstitution - Therapeutic Sector Analysis
Antibiotics/Antivirals
Antibodies
Autoimmune Diseases
Arthritis
Therapeutic Strategies
Disease Demographics and Growth
Crohn’s Disease
Disease Incidence and Demographics
Lupus
The Ongoing Unmet Need
Moving Beyond Corticosteroids
Commercial Outlook
Approved Therapies Supplied as Lyophilized Drugs
Multiple Sclerosis
Disease Mechanisms and Therapeutic Strategies
The Market Opportunity
Approved Therapies Supplied as Lyophilized Drugs
Competitive Landscape
Commercial Outlook
Psoriasis
Disease Mechanisms and Therapeutic Targets
Therapeutic Options and Expanded Indications
Blood Proteins
Hepatitis
Market Sector Drivers
Hepatitis Therapies Supplied as Lyophilized Drugs
Hemostats
Hormone Replacement
Human Growth Hormone
Competitive Climate
hGH Therapies Supplied as Lyophilized Drugs
Oncology
Osteoporosis
Reproductive Medicine
Vaccines
Market Sector Drivers
Competitive Climate
Osteoporosis Therapies Supplied as Lyophilized Drugs
Reproductive Health
Reproductive Therapies Supplied as Lyophilized Drugs
Market Factors
Syringe Disposal
Regulatory Issues
Patient Compliance
Healthcare Economics
Drug Reconstitution Systems - Company Profiles