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Health & Life Sciences: intangible asset value under regulatory pressure
In health and life sciences sectors, the real value of an organisation lies in its clinical data, protocols and governance. Analysis of certification and transfer issues for European HealthTech and pharma players.
The European Medical Device Regulation (MDR 2017/745) has transformed HealthTech asset valuation. An organisation whose compliance is documented and verifiable is structurally worth more than one that cannot defend it.
278 Mrd EUR
estimated global digital health market 2028 (Grand View Research 2024)
+42%
HealthTech M&A growth Europe 2022-2024 (Dealroom 2024)
89%
of pharma due diligences blocked by data documentation gaps (EY 2023)
Clinical data: an asset to document before any transfer
Clinical data represents the most valuable and most difficult to transfer capital of a healthcare organisation. Subject to GDPR, the NIS2 directive and EMA/ANSM regulations, they require rigorous governance documentation to be valued in an M&A process.
Independent certification in pharma transactions
CIFSO 5000 Certification fills a blind spot in HealthTech transactions: quality of patient data, robustness of validation protocols, dependencies on scientific teams, MDR/IVDR compliance — dimensions that conventional financial auditors do not cover.
This article was written with the assistance of artificial intelligence and reviewed under Aegryn editorial responsibility. In accordance with Article 50 of the EU AI Act, we assume editorial responsibility for this content.
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