OBJECTIVES: This study assesses the financial feasibility of developing a dosage form for IMDs, aiding policy and investment decisions.

METHODS: This study employed a mixed-method approach and encompassed four main stages: selecting suitable types of IMDs, devising investment models tailored to the local pharmaceutical industry, identifying cost structures and estimating expenses associated with investment in the IMD manufacturing sector, and conducting a financial feasibility analysis of IMDs, which included sensitivity analysis and scenario analysis.

RESULTS: A feasibility analysis conducted on nasal spray demonstrated a preference for its implementation within the local pharmaceutical industry. The study utilized a distinctive financial model to assess the payback period.The research and development of IMDs nasal spray took about 13 years, longer than the development of new generic drugs. Factors such as formulation and analytical method development, as well as the need for non-clinical and clinical studies, contributed to the extended duration. Developing new drugs from existing chemical drugs incurred higher fixed costs compared to new generics.(approximately 19.80-19.85 million USD) The majority of costs and time were dedicated to clinical trials due to the change in administration route, affecting pharmacological effects. Feasibility relied on factors like payback period, business nature, drug type, and research capabilities.

CONCLUSIONS: Key findings from the financial and investment analysis of IMDs in the domestic pharmaceutical industry emphasize the impact of clinical studies on costs, the importance of research duration and registration processes, drug selection in investment decisions, and market feasibility assessment.