An itemized candidate-to-IND budget in about a minute. Pick your modality, species, and where the work runs; get published cost ranges for every workstream, from pilot tox to IND submission. Untick anything your program does not need. Each line links to vetted suppliers, so the estimate can become real quotes whenever you are ready.
| Include | Line item | Range | Source it |
|---|---|---|---|
Dose range finding, non-GLP (rodent + non-rodent) Sets doses for the pivotal studies. Skipping DRF to save money usually costs more in failed GLP studies. | $80K to $150K | Early toxicology | |
Single-dose / MTD rodent study, non-GLP Often folded into DRF for biologics; keep separate for small molecules with unknown acute tox. | $40K to $80K | Early toxicology | |
28-day GLP repeat-dose toxicology, rodent (with TK + recovery) 21 CFR Part 58. Group sizes, recovery arms, and TK sampling density drive the spread. | $250K to $450K | GLP toxicology | |
28-day GLP repeat-dose toxicology, non-rodent (with TK + recovery) Dog baseline; NHP typically runs 40-50% higher and books out further in advance. | $450K to $750K | GLP toxicology | |
Safety pharmacology core battery (hERG, CV telemetry, CNS, respiratory) ICH S7A/S7B. CV telemetry in the non-rodent is the expensive piece; hERG alone is cheap. | $270K to $530K | Safety pharmacology | |
Genotoxicity battery (Ames, in vitro micronucleus, in vivo micronucleus) Generally waived for mAbs and most biologics under ICH S6(R1). ADC small-molecule payloads still need it. | $75K to $135K | Genetic toxicology | |
Bioanalytical program (method development, GLP validation, TK sample analysis) Two species matrices plus study samples. ADCs need multiple analytes (antibody, payload, conjugate), hence the premium. | $150K to $350K | Bioanalytical services | |
Non-GMP API for toxicology studies Scale with your dose math: high-dose dog studies can consume kilograms. Run the API estimate before committing group sizes. | $50K to $250K | Drug substance (small molecule) | |
GMP drug substance batch (Phase 1 supply) Small molecule $250-750K; a mAb GMP DS batch commonly lands $1.5-3M at clinical scale. | $250K to $750K | Drug substance | |
Formulation development (phase-appropriate) Oral solid or injectable; lyophilized formats trend to the top of the range. | $75K to $250K | Formulation development | |
Drug product manufacturing (oral solid, clinical supply) Capsule-in-bottle keeps Phase 1 cheap; tablets with coating and packaging push toward the top. | $100K to $400K | Drug product manufacturing | |
Stability program (tox lot + ICH conditions on GMP lot) Chamber time is cheap; the pull-schedule assay math is what you are paying for. | $50K to $150K | Stability studies | |
Pre-IND meeting preparation and briefing package Cheap insurance: a clear FDA answer on your tox package can save a seven-figure study. | $30K to $80K | IND / regulatory authoring | |
IND authoring, publishing, and submission eCTD publishing plus module writing. Starts months before your last study report reads out. | $75K to $200K | IND / regulatory authoring |
How these numbers work: every range is a published industry range for 2026, kept deliberately wide, with modality, species, and geography factors applied (EU and Asia programs consistently quote 20 to 40 percent below US pricing). Real quotes vary with study design, and quotes for the same study routinely differ 2 to 3x between suppliers, which is exactly why comparing quotes matters. This tool is free, requires no signup, and is not a quote.
Common questions
How much does it cost to get from candidate to IND?
Published 2026 ranges put a small-molecule program at $2-6M over 12 to 18 months and a biologic at $4-10M over 15 to 24 months. The calculator above breaks that into line items you can adjust. Its defaults land inside those bands rather than spanning them, because a default program assumes one non-rodent species, no early DART work, and a single GMP campaign. Tick the extra lines your program needs and the total moves toward the top of the published range.
Are these real quotes?
No. They are published industry ranges, kept deliberately wide. Real quotes depend on study design, and quotes for the same study routinely differ 2 to 3x between suppliers. Posting your program on BioBridgeX and comparing quotes is how you get real numbers.
Why do EU and Asia programs cost less?
Published comparisons consistently show EU and Asia CROs quoting 20 to 40 percent below US pricing for equivalent GLP work. The trade-offs are logistics, time zones, and, for some buyers, policy considerations around specific regions.
Do I need every line item before filing an IND?
No. The package depends on your modality and clinical plan under ICH M3(R2) and ICH S6(R1). Genotoxicity is generally waived for antibodies, and embryo-fetal development work can often wait until after Phase 1 starts if WOCBP enrollment is limited. Untick what does not apply and the total updates.
Is the calculator really free?
Yes. No signup, no email, no gate. BioBridgeX makes money only when a supplier wins work through the marketplace (a 2 percent success fee paid by the supplier), so the tool exists to help you scope the program you might later put out for quotes.
Where the ranges come from
Every figure is a published 2026 industry range, cross-checked against regulatory cost guides, supplier price pages, and university rate cards, then rounded so the output never pretends to precision it does not have. For the full breakdowns behind each line, read the cost guides: GLP toxicology study costs, the cost to reach IND, bioanalytical testing costs, and GMP manufacturing costs.
When you are ready for numbers that are yours rather than the industry's, post the program once and compare quotes from qualified CROs and CDMOs. Free for buyers; you contract directly with the suppliers you choose.