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. 2018 Jul 19;2:24. Originally published 2018 Apr 26. [Version 2] doi: 10.12688/gatesopenres.12816.2

Table 3. Development cost assumptions per phase per archetype.

Archetype Cost estimates per phase ($, Millions)
Preclinical Phase 1 Phase 2 Phase 3
Lower
bound,
Upper
bound
Point
estimate
Lower
bound,
Upper
bound
Point
estimate
Lower
bound,
Upper
bound
Point
estimate
Lower
bound,
Upper
bound
Point
estimate
Vaccine Simple 3.3, 10.0 6.7 1.8, 2.7 2.2 7.4, 19.0 13.2 56.6, 165.6 111.1
Complex 8.3, 24.9 16.6 1.9, 3.0 2.5 7.8, 20.0 13.9 67.9, 198.7 133.3
New Chemical
Entity (NCE)
Simple 2.5, 7.5 5.0 1.8, 2.7 2.2 3.7, 7.9 5.8 11.5, 54.1 32.8
Innovative 5.0, 10.0 7.5 4.4, 5.3 4.8 3.9, 8.3 6.1 12.1, 55.4 34.5
Complex 7.5, 12.5 10.0 6.9, 7.9 7.4 4.1, 8.7 6.4 12.6, 59.6 36.1
Repurposed
Drug
Simple N/A N/A N/A N/A 3.7, 7.9 5.8 10.0, 25.2 17.6
Complex 2.5, 7.5 5.0 1.7, 2.7 2.2 3.7, 7.9 5.8 10.0, 25.2 17.6
Biologic Simple 5.4, 16.2 10.8 1.9, 3.0 2.4 4.5, 10.5 7.5 27.7, 80.5 54.1
Complex 16.2, 27.0 21.6 7.0, 8.3 7.6 5.0, 11.6 8.3 30.5, 88.5 59.5
Selection and
validation of markers
Development Regulated trials
beyond EUO/CE
Diagnostics Assay
development
1.0, 5.0 3.0 1.0, 3.0 2.0 1.0, 6.0 3.5
Simple technical
platform
development
N/A N/A 50.0, 150.0 100.0 1.0, 6.0 3.5