What is a faster BE study worth?

You don’t lose money on a failed BE study. You lose it on the four months you waited for a slot. Below is where that number comes from, and what it’s worth on your molecule.

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01The timeline bridge

Where the four months come from

Built for formulation, regulatory and business development leads. Five steps on the critical path of a typical outsourced BE study, and what happens to each when the clinic, the lab and the writers sit in one building.

Where the four months come from

Outsourced CRO

24wks

≈ 18 weeks (≈ 4 months) reclaimed on the critical path

See how we calculated this: the 5-step bridge

If the pilot BE fails (industry-typical 20–30% for topicals, MR and high-variability drugs), the outsourced route restarts steps 1–2 (≈10–14 more weeks of re-contracting and re-queueing). In-house, it’s a re-slot. That’s why the saving used below is a P50 of ~4 months, not a ceiling: state it as a range, not a guarantee.

02Calculator

What are those months worth on your molecule?

Five inputs drive it. Everything else (erosion curves, repeat-study risk, discount rate) is a defaults set you can open and edit.

Target market Currency

Dosage form

Annual market value of the molecule (USD)

Dollar figures throughout (this slider, and the CRO/in-house cost defaults under Advanced assumptions) are calibrated for USD-scale amounts. Adjust them manually after switching currency.

Expected entrant position without acceleration

Gross margin, year 1

Starting margin. It erodes year over year across the product’s remaining lifecycle, see Advanced assumptions.

Advanced assumptions

Months of accelerationP50 default is 4; use 6–7 to reflect the repeat-study protection scenario. Entrant-rank positions gained Remaining product lifecycle (years) Gross margin erosion, per yearAs competitors enter and prices erode, margin typically falls 3 to 5% a year. Compounds across the lifecycle above. P(approval, first cycle) P(repeat study) Discount rate, r CRO study cost (USD) MTRL in-house study cost (USD) Incremental MTRL programme cost (USD)Denominator for the ROI multiple. Defaults to the in-house BA/BE study cost. Baseline filing target (no acceleration)

Price & share by entrant rank (auto-set by market, editable)

Rank	Price, % of brand	Share, %

One last step

Where should we show your numbers?

Enter your work email and we’ll unlock the risk-adjusted value, ROI multiple and full breakdown for this exact scenario.

Estimated impact

Filing moves from →

Entrant position:

Risk-adjusted value of the acceleration, on this molecule

ROI on programme spend:

Earlier revenue (V1)
Rank-shift margin (V2)
Cost & risk avoided (V3)

Up to ~4 months on a typical first-time filing, based on the 5-step bridge above. V2 is usually the number that lands hardest. It isn’t extra speed, it’s a permanent shift in who you are on the shelf.

Talk to us about your molecule →

Illustrative model built on typical industry timelines and price-erosion patterns. Actual timelines, approval odds and pricing depend on molecule-specific factors; figures here are planning estimates, not guarantees.