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Point-of-Use Drug Reconstitution Systems
Greystone Associates, Jan 2010
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.
Feature Summary
- Provides detailed analysis of injectable lyophilized drugs and assess key market segments, market dynamics and market demographics
- Analyzes therapeutic demand drivers and evaluates the market impact and potential of commercial reconstitution systems
- Analyzes design factors, material selection issues, technologies and market development issues
- Charts data, market share, and forecasts to 2012
- Profiles reconstitution system suppliers, their product activities, business strategies, and corporate alliances and affiliations
- Assesses the importance of pharma-device alliances and design partnerships on reconstitution systems
- Evaluates the impact of economic, technology, and regulatory factors
Report Format and Availability
This report is available electronic format. A site license for a single physical location and an Enterprise license are also available.
Methodology
Research methodology is based on primary research in the form of in-depth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations.
Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations.
Forecasts and projections of market demand and future market activity are derived using standard modeling and statistical techniques.
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