Propellant switch
2030
The EU exemption for pMDI propellants shrinks from 2027 and ends in 2030. 44% of pMDIs sold have no declared low-GWP plan.
Compare regional deposition of your current and new-propellant formulations from your own APSD data, before you commit to bridging studies.
Source: Inhalation, Dec 2025
Generic inhalers
$45M
Industry estimate for a single clinical-endpoint bioequivalence study with more than 900 patients.
Regional deposition evidence to support an in vitro and modelling route, in line with FDA's work on model master files.
Source: ONdrugDelivery (Nanopharm), 2020
Real patients
82%
of hospitalised COPD patients misused at least one inhaler, including breaths too weak for the device.
Test weak, typical and strong breaths in different airway geometries without recruiting a single patient.
Source: Grandmaison et al., Chronic Obstr Pulm Dis, 2024