Analytical characterisation overtakes manufacture as the binding constraint
Only 34% of adeno-associated virus particles typically carry the intended genetic payload, and empty capsids contribute immunogenicity without therapeutic benefit, which regulators now expect measured and controlled rather than simply reported. Potency assays, impurity profiling and capsid ratio determination have become the work that holds submissions up. Analytical spend has reached 27% of programme cost and compounds at 17.1% against 11.4% for the market. Analytical capacity was built far less aggressively than manufacturing capacity, which is why it now constrains timelines. Specialist analytical businesses are being acquired rather than competed with as a direct result.
Market Impact: Grows regional value at 13.5% yearl








