TAM/SAM/SOM Analysis: Bioscience QMS Work Order System
Date: 2026-02-13 | Classification: Strategic — Investor & Internal
Context: CODITECT WO Module — AI-Agent-Driven Change Control for Regulated Bioscience
1. Market Context
Three converging markets define CODITECT's WO module opportunity:
| Market Segment | 2025 Size | Projected | CAGR | Source |
|---|---|---|---|---|
| Biotech QMS Software | $6.07B | $21.7B (2035) | 13.6% | Future Market Insights |
| Life Sciences QMS | $4.35B (2026) | $9.47B (2033) | 12.65% | Straits Research / Grand View |
| Pharma QMS Software | $1.59B | $2.98B (2030) | 13.3% | MarketsandMarkets |
| CMMS (all verticals) | $1.3–2.35B | $3.5–5.4B (2035) | 9–11% | Grand View / Coherent MI |
| Work Order Mgmt (all) | $20.09B | $50.79B (2035) | 9.72% | MRFR |
| US Pharma QMS | $705M | $2.46B (2035) | 13.3% | Precedence Research |
Key structural signals:
- Cloud/web-based QMS captures 60–67% of deployments (2025), growing at 18% CAGR
- Change Management module growing at 13%+ CAGR — fastest QMS segment
- AI/ML integration cited as top innovation driver across all market reports
- Biotech firms segment growing at 13.67% — fastest end-user category
- CDMOs/CMOs growing at 17% CAGR — CODITECT's ideal beachhead
2. TAM — Total Addressable Market
Definition: All QMS + Work Order + CMMS spend in FDA/GxP-regulated life sciences globally.
Calculation
| Component | 2026 Est. | 2030 Est. | Basis |
|---|---|---|---|
| Life Sciences QMS | $4.35B | $7.2B | Straits Research |
| Change Management modules (13% of QMS) | $565M | $936M | Segment share data |
| CMMS in healthcare/life sciences (18% of CMMS) | $423M | $612M | Vertical share |
| Work Order Mgmt in healthcare (8.5% of WOM) | $1.87B | $2.85B | End-user segmentation |
| Total TAM | $7.2B | $11.6B |
Conservative TAM (change control + WO only): $2.85B (2026) → $4.4B (2030)
The TAM represents every dollar spent on quality-driven change control, work order management, and maintenance systems in regulated bioscience. This includes companies using ServiceNow, SAP, IBM Maximo, Veeva, MasterControl, and homegrown solutions for validated system change management.
TAM Methodology Reconciliation (B.1.1)
Note: This document uses a broad market approach (QMS + CMMS + Work Order Management = $7.2B TAM in 2026), while the refined B.1.1 analysis (docs/market/market-sizing.md) uses a focused life sciences QMS-only approach ($4.35B TAM in 2026). Both are valid:
- This document's $7.2B TAM: Includes adjacent markets (CMMS $423M, Work Order Management $1.87B) to capture the full opportunity for CODITECT's AI-native work order module, which spans QMS + CMMS functionality.
- B.1.1's $4.35B TAM: Pure-play life sciences QMS market (pharma, biotech, med device, CRO/CDMO, clinical labs), excludes CMMS and general work order management.
Recommended for investor presentations: Use B.1.1's $4.35B TAM figure (2026) as the conservative, defensible primary market size, with a note that the addressable opportunity expands to $7.2B when including adjacent CMMS/work order markets where CODITECT's AI-native platform can compete.
Cross-reference: See docs/market/market-sizing.md for detailed TAM/SAM/SOM methodology with multi-source triangulation and bottom-up validation.
3. SAM — Serviceable Addressable Market
Definition: Organizations where AI-agent-driven autonomous change control delivers measurable value over incumbent tools. Filters:
- Cloud-ready (67% of TAM) — excludes on-prem-only locked-in accounts
- Mid-market + emerging enterprise (38% of cloud-ready) — sweet spot before ServiceNow/SAP entrenchment
- Active compliance pain — organizations with 21 CFR Part 11, HIPAA, or SOC2 obligations on validated systems
- Digital transformation budget — organizations actively investing in AI/automation
Calculation
| Filter | Multiplier | Applied To |
|---|---|---|
| TAM (change control + WO) | — | $2.85B |
| Cloud-ready (67%) | 0.67 | $1.91B |
| Mid-market + emerging enterprise (38%) | 0.38 | $726M |
| Active compliance pain (80% of life sciences) | 0.80 | $581M |
| Digital transformation active (65%) | 0.65 | $378M |
| SAM | $378M |
SAM growth trajectory: $378M (2026) → $620M (2030) at ~13% CAGR
The SAM represents organizations that could adopt CODITECT's WO module as a replacement or greenfield solution. These are biotech firms, CDMOs, CROs, and mid-market pharma companies with:
- 50–5,000 employees
- Active GxP compliance requirements
- Cloud-first or hybrid infrastructure
- Budget for AI-driven quality transformation
SAM Methodology Reconciliation (B.1.1)
Note: This document's SAM ($378M) applies work-order-specific filters (cloud-ready, mid-market focus, active compliance pain, digital transformation budget) to the broad TAM. The B.1.1 analysis (docs/market/market-sizing.md) uses a different filter methodology and arrives at $412M SAM (2026):
- This document's $378M SAM: Work order module focus, emphasizing digital transformation readiness (65% filter) and mid-market sweet spot (38% filter).
- B.1.1's $412M SAM: Life sciences QMS focus, emphasizing AI receptivity (33% early adopter filter) and FDA-regulated maturity (71% filter).
Methodology difference: B.1.1 applies a more conservative AI receptivity filter (33% early adopters + early majority per Geoffrey Moore's Crossing the Chasm framework), while this document uses a broader digital transformation active filter (65%). Both are valid depending on whether the pitch emphasizes AI-native differentiation (use B.1.1's 33%) or general cloud/automation adoption (use this document's 65%).
Recommended for investor presentations: Use B.1.1's $412M SAM figure with the AI receptivity framing, as it directly supports CODITECT's core AI-native positioning and is backed by multi-source triangulation.
Cross-reference: See docs/market/market-sizing.md Section 4 for detailed SAM segmentation by customer type (biotech, med device, CRO/CDMO, pharma, clinical labs) and target account counts.
4. SOM — Serviceable Obtainable Market
Definition: Revenue CODITECT can realistically capture in Years 1–5 given team size, product maturity, and go-to-market capacity.
Year 1–5 Revenue Model
| Year | Target Customers | Avg. ACV | Revenue | Cumulative |
|---|---|---|---|---|
| Y1 (2027) | 3 design partners | $50K | $150K | $150K |
| Y2 (2028) | 12 early adopters | $85K | $1.02M | $1.17M |
| Y3 (2029) | 35 customers | $120K | $4.2M | $5.37M |
| Y4 (2030) | 80 customers | $150K | $12.0M | $17.37M |
| Y5 (2031) | 150 customers | $175K | $26.25M | $43.6M |
Y5 SOM: $26.25M ARR = ~4.2% of SAM — credible for a Series A/B stage vertical SaaS.
SOM Reconciliation (B.1.1)
Note: This document projects $26.25M ARR in Year 5 (150 customers at $175K ACV), while the B.1.1 base case analysis (docs/market/market-sizing.md) projects $21.46M ARR in Year 5 (148 customers at $145K blended ACV). Both are in the same range:
- This document's $26.25M: Assumes higher ACV ($175K) driven by compliance module upsells and platform expansion (agent marketplace, vendor coordination portal).
- B.1.1's $21.46M: More conservative blended ACV ($145K) with detailed churn modeling (30% churn in Y2, stabilizing to 12% by Y5) and bottom-up customer acquisition projections.
Key difference: This document assumes linear ACV growth to $175K; B.1.1 models more granular expansion revenue dynamics (upsells increase ACV from $50K in Y1 to $145K in Y5, but with realistic churn headwinds).
Recommended for investor presentations: Use B.1.1's $21.46M base case as the conservative projection, with $26.25M as the "bull case" scenario if compliance module adoption and platform upsells exceed expectations.
Cross-reference: See docs/market/market-sizing.md Section 5 for three-scenario modeling (Bear: $12.0M, Base: $21.4M, Bull: $32.8M at Year 5) and detailed customer acquisition/churn assumptions.
ACV Justification
| Component | Monthly/User | Seats | Annual |
|---|---|---|---|
| WO Engine (platform fee) | $2,500/mo flat | — | $30,000 |
| Per-agent-seat license | $150/mo | 20 | $36,000 |
| Compliance module add-on | $1,500/mo | — | $18,000 |
| Professional services (Y1) | — | — | $25,000 |
| Blended ACV | $85K–$175K |
Comparable benchmarks: MasterControl ($80–200K ACV), Qualio ($50–150K), Veeva QMS ($150–500K for enterprise).
5. Market Positioning — The Greenfield Intersection
┌─────────────────────────────┐
│ TRADITIONAL QMS │
│ (Veeva, MasterControl, │
│ Qualio, ComplianceQuest) │
│ │
│ Document control, CAPA, │
│ training, audit mgmt │
│ │
┌───────────┤ ├──────────────┐
│ └──────────┬──────────────────┘ │
│ │ │
│ ┌───────┴───────┐ │
│ │ │ │
│ │ GREENFIELD │ │
│ │ ★ CODITECT │ │
│ │ │ │
│ │ AI-Agent │ │
│ │ Change │ │
│ │ Control │ │
│ │ │ │
│ └───────┬───────┘ │
│ │ │
│ ┌──────────┴──────────────────┐ │
│ │ CMMS / WO MANAGEMENT │ │
│ │ (ServiceNow, IBM Maximo, │ │
│ │ UpKeep, Fiix, Makula) │ │
│ │ │ │
│ │ Asset mgmt, preventive │ │
│ │ maintenance, scheduling │ │
└───────────┤ ├──────────────┘
└─────────────────────────────┘
No incumbent occupies the intersection of:
- AI agent orchestration (autonomous, not workflow-based)
- 21 CFR Part 11 compliant change control
- Hierarchical work order management (Master/Linked)
- Multi-agent coordination with compliance gates
This is not a "better CMMS" — it's a new category: Autonomous Compliance-Native Change Control.
6. Competitive Moat Analysis
| Moat Layer | CODITECT | Incumbents | Defensibility |
|---|---|---|---|
| Agent orchestration | Native multi-agent | None (workflow-only) | High — 2–3yr head start |
| Compliance engine | Structural (DB-enforced) | Procedural (policy-based) | High — architecture advantage |
| Model routing | Cost-optimized per task | N/A | Medium — replicable but not replicated |
| Change control + WO | Unified platform | Separate tools bolted together | High — integration complexity |
| Validated system awareness | First-class concept | Asset = dumb record | Medium — domain expertise |
| Audit trail | Append-only, immutable | Varies, often mutable | High — regulatory requirement |
7. Revenue Expansion Vectors
Land: WO Module
- Change control for validated systems
- Master/Linked hierarchy, approval workflows
- $50–120K ACV
Expand: Compliance Suite
- Automated CAPA generation from WO patterns
- Deviation management linked to WO audit trails
- Training management triggered by WO completion
- $30–60K ACV add-on
Extend: Platform
- Agent marketplace (custom domain agents)
- Vendor coordination portal
- Predictive maintenance via agent analytics
- $50–100K ACV add-on
Total account potential: $130–280K ACV at maturity
8. Key Assumptions & Risks
| Assumption | Risk Level | Mitigation |
|---|---|---|
| Mid-market biotech willing to adopt AI-agent tools | Medium | Design partner validation before scaling |
| 21 CFR Part 11 compliance achievable in V1 | Low | Well-defined requirements, audit trail architecture proven |
| Cloud deployment acceptable for GxP workloads | Low | 67% already cloud; FedRAMP precedent (MasterControl) |
| ACV sustainable at $85K+ | Medium | Comparable to MasterControl/Qualio; compliance premium |
| Team can execute 12-week build | Medium | Modular architecture; prioritize core WO + audit trail |
| Sales cycle 6–9 months for regulated buyers | High | Design partners reduce cycle; compliance certification accelerates trust |
9. TAM/SAM/SOM Reconciliation Summary (B.1.1)
This section provides a side-by-side comparison of the original estimates in this document versus the refined B.1.1 analysis (docs/market/market-sizing.md) completed February 2026.
Comparative Analysis
| Metric | This Document (Original) | B.1.1 Refined Analysis | Variance | Reconciliation |
|---|---|---|---|---|
| TAM (2026) | $7.2B (QMS + CMMS + WO) | $4.35B (Life Sciences QMS only) | 1.65x | Original includes adjacent markets (CMMS $423M, WO $1.87B); B.1.1 focuses on core QMS market. Both valid depending on positioning. |
| SAM (2026) | $378M (65% digital transformation) | $412M (33% AI receptivity) | 0.92x (9% lower) | Methodology difference: original uses broad digital transformation filter (65%), B.1.1 uses conservative AI early adopter filter (33% per Geoffrey Moore). B.1.1 figure is more defensible. |
| SOM Year 5 | $26.25M (150 customers @ $175K) | $21.46M (148 customers @ $145K) | 1.22x (22% higher) | Original assumes higher ACV from upsells; B.1.1 models realistic churn (30% Y2 → 12% Y5) and conservative expansion revenue. B.1.1 base case more credible. |
| Customer Count Y5 | 150 | 148 | 1.3% | Essentially aligned — both project ~150 customers by Year 5. |
| Blended ACV Y5 | $175K | $145K | 1.21x | Original optimistic on upsell penetration; B.1.1 breaks down ACV components (Core $48K + AI $36K + Compliance $24K + Services $12K) with realistic adoption curves. |
Methodology Differences Explained
-
TAM Scope:
- Original approach: "Total opportunity where CODITECT could compete" → includes QMS + CMMS (maintenance management) + Work Order Management (broad category).
- B.1.1 approach: "Core target market for life sciences QMS" → pharma, biotech, med device, CRO/CDMO, clinical labs only, excludes adjacent markets.
- Investor guidance: Use $4.35B (B.1.1) as primary TAM in pitch decks, with footnote that addressable opportunity expands to $7.2B when including CMMS/work order adjacencies.
-
SAM Filters:
- Original approach: Broad digital transformation readiness (65% of organizations actively investing in AI/automation).
- B.1.1 approach: Conservative early adopter filter (33% innovators + early adopters per Crossing the Chasm framework), plus stricter geographic/regulatory/company size filters.
- Investor guidance: Use $412M (B.1.1) as it directly supports AI-native positioning and is backed by 5 independent analyst sources (vs. single assumption in original).
-
SOM Projections:
- Original approach: Linear ACV growth to $175K driven by compliance module + platform upsells.
- B.1.1 approach: Detailed cohort-based modeling with churn (50% in Y1, 30% Y2, 17% Y3, 12% Y5) and component-level ACV buildup validated against SaaS benchmarks (Benchling, Weights & Biases).
- Investor guidance: Use $21.46M base case (B.1.1) as primary projection, with $26.25M as bull case if upsells exceed expectations.
Reconciled "Investor Presentation" Figures
| Metric | Recommended Figure | Rationale |
|---|---|---|
| TAM (2026) | $4.35B (B.1.1 core QMS market) | Conservative, defensible, multi-source validated; footnote $7.2B including adjacencies |
| TAM (2030) | $7.01B (B.1.1 projection at 12.65% CAGR) | In line with 5 analyst projections (range 10.6%-15.3% CAGR) |
| SAM (2026) | $412M (B.1.1 AI receptivity filter) | Directly supports AI-native differentiation story; more conservative than original $378M |
| SOM Year 5 (2030) | $21.5M ARR (B.1.1 base case) | Realistic churn modeling, validated against vertical SaaS benchmarks; positions $26.25M as upside |
| Market Penetration Y5 | 3.2% of SAM (B.1.1: $21.5M / $673M SAM in 2030) | Aligns with new entrant benchmarks (2-5% at Y5 per comparable bio/healthcare SaaS) |
When to Use Which Figure
| Audience | TAM Figure | SAM Figure | SOM Y5 Figure | Rationale |
|---|---|---|---|---|
| Series A/B investors | $4.35B (B.1.1) | $412M (B.1.1) | $21.5M base (B.1.1) | Conservative, multi-source validated, de-risks projections |
| Strategic partners | $7.2B (original) | $412M (B.1.1) | $26.25M (original) | Broader market story (QMS + CMMS + WO) shows platform expansion potential |
| Design partners / early customers | $4.35B (B.1.1) | $412M (B.1.1) | Not disclosed (focus on product-market fit, not projections) | Credibility through conservative estimates |
| Internal planning | Both (range: $4.35B-$7.2B) | Both (range: $378M-$412M) | Three scenarios: $12M bear / $21.5M base / $32.8M bull | Scenario planning requires variance bounds |
Cross-References
- B.1.1 Full Analysis:
docs/market/market-sizing.md(TAM/SAM/SOM with multi-source triangulation, bottom-up validation, sensitivity analysis) - B.1.3 Competitive Landscape:
docs/market/competitive-landscape.md(10 competitor profiles, market share estimates) - B.1.4 Competitive Positioning:
docs/market/competitive-positioning.md(8-moat framework, win/loss analysis, positioning statement)
10. Investment Thesis Summary
The bioscience QMS market is $6B+ and growing at 13%+ CAGR. No incumbent offers AI-agent-driven change control. CODITECT's WO module creates a new category at the intersection of three converging markets: QMS, CMMS, and AI agent platforms.
Year 5 target: $26M ARR capturing 4.2% of a $620M SAM — achievable with 150 customers at $175K ACV in a market where comparable vendors (MasterControl, Qualio, Veeva QMS) demonstrate this pricing is accepted.
The structural moat is architectural, not feature-based: Compliance is database-enforced (not policy-based), agent orchestration is native (not bolted on), and audit trails are immutable by design. This cannot be replicated by adding an AI feature to an existing CMMS.
Copyright 2026 AZ1.AI Inc. All rights reserved. Developer: Hal Casteel, CEO/CTO Product: CODITECT-BIO-QMS | Part of the CODITECT Product Suite Classification: Internal - Confidential