Clinical Trial Attrition & Drug Pipeline Simulator

Quantitative biopharma development modeling: probability of success (POS), attrition cliffs, & capital economics.

Source Grounding: Modeling the empirical reality that ~90% of investigational candidates fail clinical trials before FDA/EMA approval.
Overall Cumulative POS
9.6%
Overall Attrition: 90.4%
Expected Approvals
9.6
From 100 Initial Leads
Total Direct R&D Cost
$1,450M
Across All 100 Candidates
Cap. Cost Per Approved Drug
$151.0M
Includes Sunk Attrition Costs
Mean Trial Cycle Time
8.5 Yrs
P1 Entry to Regulatory Decision

Pipeline Parameters Oncology Baseline

Phase I (Safety & PK) 62% POS
Phase II (Proof of Concept) 32% POS
Phase III (Pivotal Efficacy) 55% POS
FDA / EMA Regulatory Filing (NDA/BLA) 88% POS

Drug Attrition Funnel Waterfall Deterministic Expectation vs Drop-off

The "Valley of Death" (Phase II Cliff): Phase II represents the single largest bottleneck in drug development, where human therapeutic proof-of-concept is first tested at scale. Often under 35% of molecules survive Phase II.

R&D Capital Deployment by Phase

Monte Carlo Simulation Distribution

Sample 100-Candidate Lead Fate Visualizer ■ Approved ■ P3 Drop ■ P2 Drop ■ P1 Drop

Running stochastic simulation on current pipeline...

Biomedical Drug Development Economic Frameworks

1. Why 90% of Drugs Fail

Preclinical animal assays and cell cultures frequently fail to recapitulate human biological complexity, disease heterogeneity, off-target toxicity, and metabolic clearance pathways. Failures are concentrated in Phase II (lack of clinical efficacy) and Phase III (inability to demonstrate superiority over standard-of-care).

2. Capitalized R&D Accounting

The true cost of developing a single approved therapeutic ($1B - $2.5B+ according to DiMasi et al. Tufts CSDD studies) is dominated by the cost of dry holes—subsidizing the 9 out of 10 molecules that failed across earlier clinical trial stages.

3. Portfolio Risk Mitigation

Biotech venture funds and large pharma employ portfolio diversification, biomarker-driven patient stratification, and accelerated regulatory designations (Breakthrough, Fast Track, Accelerated Approval) to elevate cumulative POS above the 9.6% industry mean.