Analytical Framework for Examining the Value of Antibacterial Products. 4.2.3 Pre-Clinical, Clinical, and BLA Submission Phase Durations


As with drugs, private ENPV for vaccine development is dependent on the duration of each phase and the distribution of out-of-pocket costs throughout each phase.  To estimate the lengths of these phases, we consulted DiMasi & Grabowski (2006), in which phase lengths of 52.0, 19.5, 29.3, and 32.9 months are reported for the pre-clinical phase, Phase 1, Phase 2, and Phase 3, respectively.  The regulatory review period is estimated by the authors to last 16 months (for a total time-to-market of 12.5 years).  These phase lengths, applicable to biopharmaceutical compounds, translate to point estimates with the following bounds (in years):

  • Pre-clinical: Lower bound of 3.5, upper bound of 5.2, point estimate of 4.3 years,
  • Phase 1: Lower bound of 1.3, upper bound of 2.0, point estimate of 1.6 years,
  • Phase 2: Lower bound of 2.0, upper bound of 2.9, point estimate of 2.4 years,
  • Phase 3: Lower bound of 2.2, upper bound of 3.3, point estimate of 2.7 years, and
  • Regulatory Review: Lower bound of 1.1, upper bound of 1.6, point estimate of 1.3 years.

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