Financial feasibility study of incremental modified drugs development by domestic pharmaceutical industry

Abstract

The Thai pharmaceutical industry aims to achieve self-reliance in vaccines, drugs, and biologics as per the National Strategic Master Plan. Challenges include low research capacity and higher drug imports compared to domestic production. To promote self-reliance, more research on incrementally modified drugs (IMDs) is essential. This study analyzes the financial feasibility of developing IMD dosage forms for policy and investment decisions. A mixed-method approach, including type selection, investment models, cost structures, and financial analysis, was employed. Results favor sustained release, oro-dispersible tablet, and nasal spray formulations. IMD research and development took 7 to 13 years due to formulation complexity and higher failure rates. Development costs ranged from 50.95 to 708 million THB. Longer payback periods correlated with lower annual income requirements, influenced by factors like drug life cycle, sales growth rate, competition, and government policies. The findings underscore the importance of clinical studies, research duration, drug selection, and market feasibility in investment decisions. Policymakers can utilize this insight to foster the growth and sustainability of Thailand's pharmaceutical sector.