The regulatory path for nasal sprays is complex because they are considered "Combination Products" (Drug + Device). For generic versions, manufacturers must prove "Bioequivalence" not only through blood plasma levels but also through "In Vitro" testing that compares the spray's physical characteristics to the Reference Listed Drug (RLD). This includes rigorous testing of the pump’s "Priming" and "Re-priming" capabilities, as well as the consistency of the dose at the beginning and end of the bottle’s life.

As the market moves toward 2030, there is an increasing focus on "Unit-Dose" and "Bi-Dose" devices for emergency use, such as Naloxone for opioid overdose. Trends in the standardization of nasal cast models for laboratory testing are explored in the Nasal Spray Market outlook. These models allow researchers to visualize exactly where a drug deposits in a 3D-printed replica of the human nose, ensuring that new devices are optimized for maximum therapeutic effect before they ever reach a patient.