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The expanding vaccine development pipeline, 1995-2008
Matthew M Davis1, Amy T Butchart, Margaret S Coleman
1Child Health Evaluation and Research Unit, Division of General Pediatrics, University of Michigan, Ann Arbor, MI 48109-5456, USA. mattdav@med.umich.edu
Vaccine
|November 26, 2009
Summary
The number of companies and vaccine products in development doubled between 1995 and 2008, primarily in early research stages. It remains uncertain if this growth will lead to more approved vaccines.
Area of Science:
- Pharmaceutical industry
- Vaccine research and development
Background:
- Recent vaccine launches contrast with industry concerns about market conditions, creating uncertainty in vaccine development.
- The study analyzes private-sector vaccine research and development (R&D) trends from 1995 to 2008.
Observation:
- A global pharmaceutical database was used to track prophylactic vaccines across preclinical and clinical trial phases (I, II, III).
- The number of companies researching/manufacturing vaccines (vaccine originators) doubled to 136.
- The number of prophylactic vaccine products in development also doubled, reaching 354.
Findings:
- The majority of growth in vaccine R&D occurred in preclinical and early-phase clinical research.
- Despite increased early-stage development, a corresponding increase in Phase III pipeline products was not observed.
Implications:
- The expansion in early-stage vaccine R&D may not immediately translate into a greater number of available vaccines.
- Future vaccine availability hinges on whether this early-stage growth progresses to later clinical trial phases and regulatory approval.
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