ReguIntel ARIC 1. company in one sentence ReguIntel ARIC is an evidence-backed regulatory decision intelligence platform that connects a biotech's development and regulatory strategy with historical regulatory decisions, precedents, current requirements, and observed regulatory concerns to identif

TAM TOP-DOWN

Start from the AI in regulatory affairs global market of $1.31B in 2024 (Grand View Research). This is the narrowest published segment matching ARIC's core value proposition: AI-driven regulatory decision support, not broad RIM document management. The broader regulatory intelligence platform market ($2.8B, Dataintelo) and RIM market ($2.7B, FMI) both include submission tracking and compliance workflows outside ARIC's scope, so they are used only as upper bounds. The AI segment is the conservative anchor.

$1.31B AI regulatory affairs market (2024) = TAM top-down anchor; broader $2.7-2.8B RIM market used as upper bound only

TAM BOTTOM-UP

Global biotech company count of 962,832 (CompanyData) is implausibly large for enterprise software buyers; the relevant universe is companies with active IND/NDA/BLA/MA programs or late-stage pipelines. Applying a 1% filter for companies with genuine regulatory submission activity yields roughly 9,600 addressable firms. Pricing evidence shows enterprise regulatory intelligence platforms from $52K median (LogicGate) to $1M+ (MetricStream); a mid-market assumption of $280K annual contract is used for companies in active development. 9,600 firms x $280K = $2.69B.

962,832 global biotech firms x 1% active-program filter = 9,628 firms x $280K mid-market ACV = $2.69B

SAM FILTERS

Filter 1: Geography. US (37.45% of AI regulatory affairs market, Grand View) plus EU (estimated 25% based on UK investment leadership and European pharma concentration) = 62% of TAM. Filter 2: Use-case specificity. ARIC targets decision intelligence, not full RIM suites; estimated 30% of regulatory software buyers are seeking this specific capability rather than document or submission management. TAM lower bound $1.31B x 62% x 32% = $260M. Bottom-up: 9,628 firms x 62% geo x 30% use-case = 1,791 firms x $270K = $483M.

$1.31B x 62% (US+EU) x 32% (decision-intelligence subset) = $260M top-down; 9,628 x 62% x 30% x $270K = $483M bottom-up

SOM BUILD

Using conservative SAM of $260M. Year-1 target: 1% SAM share = $2.6M, roughly 13 to 17 enterprise clients at $150-200K ARR, consistent with a credible enterprise sales motion in a high-scrutiny market. Year-2: expand to 3% = $7.8M as case studies accumulate and RegASK-style partnerships become available. Year-3: reach 6% = $15.6M, approximately 75 to 100 clients. This is deliberately below the 8% ceiling given documented incumbent switching costs and procurement-as-credibility-filter headwinds from AFS Law evidence.

Year-1: $260M x 1% = $2.6M; Year-2: $260M x 3% = $7.8M; Year-3: $260M x 6% = $15.6M; ~90 clients x $175K ARR = $15.75M check