Future scope: 2026-2035.
Most projections rest on documents already in the pipeline. Confidence is high where the regulator pen is moving · medium where industry pilots run ahead of inspector acceptance · low where the policy direction is contested.
Future scope: 2026-2035.
What's coming · with confidence indicatorsMost projections rest on documents already in the pipeline (ICH M10 v2, EMA ATMP Reflection Paper, PMDA biomarker draft). Confidence is high where the regulator pen is moving · medium where industry pilots run ahead of inspector acceptance · low where the policy direction is contested.
ICH M10 v2 Step 4.
Endorsement projected Q3 2028. Slippage risk: ATMP bioanalytics scope (may split to a separate document by 2032).High
4-6-15 / 4-6-20 retained.
30+ years embedded regulatory practice. No member signalled willingness to change.High
Tier 1/2/3 formalised.
Stevenson 2017 white paper anchors. FDA / EMA / PMDA aligned. Inspector practice already applying since 2018.High
List extends.
Expansion likely: bile acids, vitamins D / B12, neurotransmitters (serotonin, dopamine), bone markers (CTX, P1NP), cardiac markers (troponins, BNP).Medium
Context-of-use mandatory.
Pre-validation context statement codified in ICH M10 v2. EMA / ANVISA already require. Cannot validate biomarker assay registrationally without it.High
CDx-BMV convergence.
Companion diagnostics (21 CFR 809 / EU IVDR) merge with BMV under oncology PK/PD pressure. Today separate regulatory worlds.Medium
VCN assay validation.
Vector-copy-number is the most-cited 2023-2026 gap. Codification pattern established. EMA/FDA/PMDA stable case-by-case.High
Anti-vector immunogenicity.
Anti-AAV antibodies validated under ADA framework today. Already in EMA ATMP Reflection Paper draft.High
HRMS routinised.
Orbitrap / Q-TOF routine acceptance by 2028. Library + fragmentation accepted by 2030. PMDA leading. EMA cautious on library-only.High
Triple-quad workhorse.
Installed base massive. CRO infrastructure QQQ-centric. HRMS additive, not replacing.High
Reagent-lot bridging #1.
Displaces ISR as #1 483 category. ISR mature; sponsors know what to do. Reagent-lot bridging is the next frontier.Medium
Combination-product top-5.
DHF-to-BMV bridging top-5 483 by 2027. Direct QMSR consequence. Already signalled in 2026 FDA inspection cadence.High