Financial Feasibility Study and policy recommendations of Incremental Modified Drugs Development by the Domestic Pharmaceutical Industry

The Thai pharmaceutical industry aims to strengthen its drug system in accordance with the National Strategic Master Plan, emphasizing sustainable development, particularly in biologics and herbal products, to achieve self-reliance. Current efforts are mainly focused on generic drug production, but there's a significant need for Research and Development (R&D) in Innovative Medicines (IMDs). This study explores the financial feasibility of locally developing an IMDs dosage form. To assess this feasibility, a mixed-methods approach was used, incorporating a literature review, surveys, and interviews. This process involved selecting types of IMDs, constructing financial models, determining cost structures, and conducting a thorough feasibility analysis. The results indicated that a sustained-release dosage form was the most viable option. The analysis took into account total development costs, payback periods, growth rates, and the revenue required to recoup investments. It was found that IMD development is associated with higher costs and longer durations compared to new generic drugs.The study identified several challenges, such as the high cost of clinical studies, extended development times, market feasibility, and drug selection difficulties. Policy recommendations were made to address these challenges, including incentives for clinical studies and fostering industry expertise through collaborative efforts and supportive government policies.In conclusion, the financial feasibility of developing IMDs requires strategic policies and collaboration to overcome these challenges and ensure sustainability. The findings of this study are intended to aid stakeholders in making informed R&D investment decisions.