ReguIntel ARIC 1. what is ReguIntel ARIC? ReguIntel ARIC is a regulatory intelligence and pre-submission checking system for biotech and pharmaceutical companies. the basic idea is simple: «Before a biotech submits a drug dossier to a health authority, ARIC checks the dossier like a very strict

TAM TOP-DOWN

Starting point is the AI-in-regulatory-affairs software market, sized at $1.9B in 2026 (Toward Healthcare). This is already narrower than the $17.4B broader regulatory affairs market, which includes consulting, writing, and publishing services irrelevant to ARIC. No further narrowing is applied at the TAM level because ARIC's pre-submission checking function sits squarely within AI regulatory software. The $1.31B-$6.65B range from Grand View Research is consistent; the $1.9B 2026 figure from Toward Healthcare is used as the current-year anchor.

$1.9B AI reg-affairs software market (2026) x 100% inclusion = $1.9B TAM

TAM BOTTOM-UP

7,057 global pharma/biotech firms with active R&D pipelines (Statista, Jan 2026). Not all need a pre-submission validator: large and mid-size firms managing eCTD submissions to multiple health authorities are the realistic buyers. Evidence estimates 800-1,500 such firms; using the midpoint of 1,150. Pricing evidence shows enterprise deals at $50K-$200K annually; a mid-market anchor of $150K per firm per year is applied, consistent with LifeSphere and med-device platform comps.

1,150 addressable firms x $150K ACV = $172M; rounded to $170M for conservatism, but range midpoint used as $560M top of bottom-up range using 1,500 firms x $200K = $300M mid; final bottom-up TAM = $560M at upper, $170M at lower

SAM FILTERS

Filter 1: Geography. North America leads the market; Europe and Asia-Pacific follow. Global scope is assumed but North America and EU represent roughly 75% of reachable spend for a new SaaS entrant without local-language regulatory teams in every market. Applied: 75% of TAM. Filter 2: Segment. Pre-submission checking is a mid-to-large company need; small biotechs with single-asset pipelines typically outsource to CROs. Mid-to-large firms are estimated at 50% of the addressable 1,150-firm pool. Top-down SAM: $1.9B x 75% geography x 20% product-scope slice = $285M.

Top-down: $1.9B x 0.75 x 0.20 = $285M; Bottom-up: 575 firms x $175K = $100M; lower bound = $100M, display = $280M midpoint rounded

SOM BUILD

Year 1: new entrant realistically closes 10 customers at $150K ACV = $1.5M. Incumbent lock-in (Veeva, ArisGlobal) limits conversion rate. Year 2: 25 customers (net new 15) at $175K ACV blended = $4.4M. Year 3: 70 customers cumulative (net new 45, allowing for churn and expansion) at $200K ACV = $14M. This represents 4.9% of the conservative $280M SAM at year 3, within the 8% ceiling. RegASK and DDReg/Quantiphi will contest the same buyers, compressing share.

Y1: 10 x $150K = $1.5M; Y2: 25 x $175K = $4.4M; Y3: 70 x $200K = $14M