The scale of the work
Pharmacovigilance runs at a scale that is easy to underestimate. Every individual case safety report has to be received, assessed, coded, checked and submitted within fixed timelines, and the volume never stops.
The European Medicines Agency’s 2025 annual report on EudraVigilance records 1,765,581 ICSRs received during the year, roughly 4,800 every day. By the end of 2025 the database held 31,253,245 ICSRs relating to 17,898,709 cases.
The point is not that volume is exploding: EudraVigilance volumes were broadly stable in 2025. It is that the volume is very large, constant and always on a deadline. That is exactly the kind of work automation is suited to.
Signals
Behind every reviewed signal sits detection, validation, evidence gathering and assessment. All of it depends on clean, consistently coded case data. Inconsistent coding or undetected duplicates can hide a signal or create a false one.
Where the effort goes
Industry survey data has long shown that case processing takes the largest share of pharmacovigilance budgets, with estimates ranging from 40% to 85% of spend. Analysts also report case volumes across the industry growing at 10–15% a year. Because these figures come from surveys rather than audited data, treat them as ranges, not precise current values.
What drives the pressure
- Fixed timelines. Expedited reports are due within 15 days, clinical trial SUSARs within 7 or 15 days, whatever the workload.
- More sources. Literature, patient support programmes, partner exchanges and digital channels all feed the same process.
- Broader portfolios. Vaccines, devices and combination products add their own reporting requirements.
- Global reach. Each new market brings local rules, formats and languages.
- Inspection expectations. Every step must be traceable, consistent and documented.
The response: AI
Mordor Intelligence values the AI in pharmacovigilance market at about USD 0.98 billion in 2026 and forecasts growth of around 22.5% a year to 2031. At that rate the market would more than double over five years. The chart shows the trajectory implied by that growth rate.
What the numbers mean
| The number | What it tells you | The question for your organisation |
|---|---|---|
| ≈4,800 ICSRs a day | Volume is constant and deadline-driven | How much of our case work is routine enough to automate? |
| 1,201 signals reviewed | Signal work depends on data quality | Is our data consistent enough to trust our signal detection? |
| 40–85% of spend on case processing | Most effort goes into repetitive work | What could our experts do with that time back? |
| 22.5% yearly growth in AI | Peers are investing | Are we evaluating AI with the right safeguards? |
- Volume is not the only pressure: fixed deadlines make capacity planning hard without automation.
- Case processing is the biggest cost line, so it is the first place to look for efficiency.
- Data quality drives signal quality: automation should improve consistency, not just speed.
- Use a framework such as S.A.F.E.T.Y. to adopt AI with the right controls.
Sources
- European Medicines Agency, 2025 Annual Report on EudraVigilance (March 2026).
- Deloitte, Transforming Pharmacovigilance (survey data).
- IDC, Intelligent Automation: Fueling the Transformation of Pharmacovigilance (2024, sponsored by IQVIA).
- Mordor Intelligence, AI in Pharmacovigilance Market (2026). Years after 2026 in the chart are calculated from the forecast growth rate.