France's own hospitalization database puts 2022 PNH prevalence near 1 in 94,000, below Germany's borrowed 16-per-million figure.

A 2025 real-world study drawn from France's national hospitalization database, PMSI, accessed via the CASD secure data platform and funded by Roche France, identified 897 PNH patients between 2018 and 2022, with the annual count rising from 581 to 725 and roughly 100 newly diagnosed patients added each year. That translates to a 2022 prevalence near 1 in 94,000, below the 1-in-70,000-to-80,000 range Orphanet and France's national rare disease plan had assumed. The same cohort shows 55.3% of patients on a C5 inhibitor, with eculizumab accounting for 89.9% of new treatment starts and ravulizumab 10.1%. This is one of the few PNH cohorts in Europe built entirely from administrative hospital records rather than a clinician-reported registry.

For commercial teams, the discrepancy is the finding: Germany's DGHO Onkopedia guideline borrows a PNH prevalence of 16 cases per million from UK and French registries, yet France's own current hospital-database figure, 897 patients against a population of roughly 68 million, near 10.6 per million, comes in lower. France also runs diagnostic infrastructure other countries reference, a French National Observatory of PNH Clones sitting on an inter-laboratory flow-cytometry harmonization programme spanning more than 50 French-speaking centres since 2010. A market-sizing exercise anchored only on the literature-cited 16-per-million figure will overstate the addressable French population relative to what the country's own administrative data now shows.

France's own data undercuts the very prevalence figure Germany borrows from it.

Five questions this report answers:

Q1 - How big is France's treatable PNH population versus the literature estimate used elsewhere in Europe?

Q2 - Which centres actually see and diagnose PNH patients across France?

Q3 - How long does it take a French patient to reach a confirmed PNH diagnosis?

Q4 - What share of France's PNH cohort is on eculizumab versus ravulizumab today?

Q5 - How many French-speaking centres participate in the flow-cytometry harmonization programme behind France's PNH Observatory?

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Mike || Global Pharma Commercial Marketing Head

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