Table 7.
Cost of AD-modifying drug development with existing infrastructure
| Eventual outcome for a compound entering Phase I | Out-of-pocket cost ($ millions) | Cost ($ millions) capitalized to date that development stops or drug is approved | Present-value cost ($ millions) at date of Phase I start (11% discount rate) | Probability |
|---|---|---|---|---|
| Development stops after Phase I | 71 | 89 | 79 | 0.33 |
| Development stops after Phase II | 126 | 177 | 122 | 0.35 |
| Development stops after Phase III | 413 | 648 | 280 | 0.24 |
| Drug is approved | 413 | 765 | 280 | 0.07 |
| Expected present-value cost = (79 × 0.33)+(122 × 0.35)+(280 × 0.24)+(280 × 0.07) | $157 million |
| Cost per new drug approval = $157 million ÷ 0.07 | $2,087 million |
| Capitalized to date of drug approval = $2,087 million × e(109.4)(0.11/12) (Phase I starts an average of 109.4 months before approval) | $5,693 million |
Numbers may not exactly replicate because of rounding. For example, $2,087 million comes from dividing approximately $156.5 million by approximately 0.075. Confidence intervals (provided in Tables 4 through 6) are omitted here, where the purpose is to explain the relationship between the perspective of the industry and that of an individual company.