⚙️ Configure Your Estimates

Therapeutic Area

Drug Modality

Company Size

NAMs Integration Level

% of preclinical using NAMs

Preclinical 31 mo

$31M

Discovery, lead optimization, IND-enabling

Animal Studies $12M

In Vitro / NAMs $4M

Other R&D $15M

↓ $3.2M with NAMs

Phase I 18 mo

$5.2M

Safety, tolerability, PK (20-80 subjects)

Clinical Operations $2.8M

Per-Subject Cost $60K

Phase II 30 mo

$18M

Efficacy, dose-finding (100-300 subjects)

Clinical Operations $10M

Per-Subject Cost $45K

Phase III 36 mo

$350M

Pivotal efficacy (1,000-5,000 subjects)

Clinical Operations $180M

Per-Subject Cost $50K

Total Program Cost 115 mo (~9.5 yrs)

$404M

Full development to NDA/BLA submission

📊 Traditional vs. NAMs-Enhanced Development

Traditional Approach

Preclin

III

$407M

NAMs-Enhanced (50%)

Preclin

III

$404M

Preclinical Savings
$3.2M
10% reduction in preclinical costs

Timeline Acceleration

4 mo

Faster preclinical completion

Risk-Adjusted Value

$8.5M

Including improved translation

📈 Success Rates by Therapeutic Area

Therapeutic Area	Phase I → II	Phase II → III	Phase III → Approval	Overall Success	Avg. Cost to Market
Oncology	63%	33%	58%	5.3%	$2.6B
Cardiovascular	70%	24%	62%	6.2%	$1.9B
CNS / Neurology	65%	28%	50%	6.0%	$2.1B
Metabolic	71%	43%	65%	12.0%	$1.1B
Immunology	69%	38%	60%	9.5%	$1.4B
Infectious Disease	75%	45%	68%	15.2%	$0.9B
Rare Disease	72%	40%	66%	17.5%	$0.8B

📋 Cost Assumptions

Costs are median industry values (2024 data)
Phase III varies significantly by indication
Does not include cost of failures
Excludes regulatory filing fees ($3-5M)
Manufacturing scale-up not included

🔬 NAMs Value Drivers

Replace 40-60% of preclinical animal studies
Reduce late-stage attrition by 10-20%
Accelerate go/no-go decisions
Enable patient stratification earlier
Better human translatability data

📊 Data Sources

Tufts CSDD drug development studies
BIO Industry Analysis reports
FDA clinical trial databases
Pharma company financial disclosures
Academic cost-effectiveness analyses

Drug Development Cost Estimator