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 |