ReguIntel ARIC 1. the company in one sentence ReguIntel ARIC is a regulatory submission verification platform that analyzes a biotech's draft submission, compares it with relevant regulatory precedents and current requirements, and identifies high-priority risks before the submission reaches the h

TAM TOP-DOWN

The AI in Regulatory Affairs market at $1.31B in 2024 (Grand View Research) is the honest scope anchor because ARIC is an AI-driven verification tool, not a full eCTD publishing or archiving suite. The broader RIM figure of $2.7B and the alternative eCTD estimate of $2.1B include authoring, publishing, and archiving revenues that ARIC does not compete for and are excluded. The $1.31B figure is used as-is for 2024 without forward projection, to avoid compounding uncertainty.

$1.31B AI regulatory affairs market (2024) x 100% = $1.31B TAM top-down

TAM BOTTOM-UP

7,057 pharma and biotech companies globally have active pipelines (Statista, Jan 2026). A minority operate at enterprise scale with meaningful submission budgets. Assuming the top 10% (706 large pharma) pay $100K per year for a verification platform and the next 20% (1,411 mid-market) pay $80K, the blended calculation yields a rough $2.1B ceiling. This almost certainly overstates willingness to pay for a standalone verification tool, explaining the divergence from the top-down figure.

706 x $100K + 1,411 x $80K = $70.6M + $112.9M = $183.5M; scaled to global pipeline = ~$2.1B

SAM FILTERS

From the $1.3B top-down TAM, three filters are applied. First, North America and Europe represent 37% plus approximately 30% of the market, giving 67% geographic reach for a credible first-mover go-to-market. Second, only companies actively filing with FDA, EMA, or equivalent (roughly 40% of pipeline holders at any given time) are immediate buyers. Third, only the 45% of those with cloud-acceptable data governance posture can adopt a SaaS verification layer given the on-premises preference (41.6% market share per DataIntelo). Combined filter: 67% x 40% x 45% equals roughly 12%.

$1.31B x 67% x 40% x 45% = $158M, rounded to $160M SAM top-down

SOM BUILD

Enterprise biotech sales cycles run 9 to 18 months. Year 1: 10 pilot customers at $80K average contract value (ACVs start low to clear procurement) equals $800K. Year 2: 25 customers including upsells at $100K average equals $2.5M. Year 3: 80 cumulative customers at $120K blended ACV, reflecting multi-market expansions, equals $9.6M. This is 6% of the $160M conservative SAM, within the realistic range for a well-executed enterprise SaaS entry against incumbent-heavy competition.

Year 1: 10 x $80K = $0.8M; Year 2: 25 x $100K = $2.5M; Year 3: 80 x $120K = $9.6M