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.
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
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.
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. 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.