Financial Feasibility of Developing Sustained-Release Incrementally Modified Drugs in Thailand's Pharmaceutical Industry: Mixed Methods Study.

Background: Thailand's pharmaceutical industry is prioritizing innovation and self-reliance through the development of incrementally modified drugs (IMDs), particularly sustained-release dosage forms. However, the financial feasibility of IMD development remains underexplored.

Objective: This study evaluates the financial feasibility of developing sustained-release IMDs in Thailand, focusing on costs, timelines, and investment requirements to inform strategic decision-making.

Methods: A mixed methods approach was used, combining literature reviews, expert interviews, and financial modeling. Two scenarios were analyzed: (1) only development (phase I) and (2) full clinical trials (phase I to III). Sensitivity analysis was used to assess the impact of key variables on financial feasibility.

Results: The research and development (R&D) process for sustained-release IMDs takes 7 years for phase I-only development, costing US $1.46-3.09 million, and 11 years for full clinical trials, costing US $18.60-20.23 million. Process validation batches accounted for 60% of costs in phase I-only scenarios, while clinical trials represented 70% of costs in full clinical trial scenarios. The annual income required for a 5-year payback period ranged from US $0.20-1.80 million (phase I only) to US $3.01-27.11 million (full trials). Shorter R&D durations and longer payback periods substantially improved feasibility.

Conclusions: Developing sustained-release IMDs in Thailand involves substantial costs and extended timelines but offers a lower-risk alternative to new chemical entities. Strategic investments, efficient R&D processes, and supportive policies are essential to enhance feasibility and alignment with national goals of innovation and self-reliance.