CHALLENGES IN THE PRODUCTION OF ORIGINAL ACTIVE PHARMACEUTICAL INGREDIENTS AND BIOPHARMACEUTICALS IN TÜRKİYE: AN ANALYTIC HIERARCHY PROCESS-BASED ANALYSIS

Abstract

In the pharmaceutical industry, the strategic importance of biotechnological products is steadily increasing globally. Countries are accelerating efforts to enhance R&D capabilities and positioning production capacity expansion as a strategic priority. Although there have been developments in biosimilar drug production in Türkiye’s pharmaceutical sector, a similar momentum is not observed in the manufacturing of original biotechnological drugs and active pharmaceutical ingredients (APIs). This study aims to identify the challenges encountered in the production of biopharmaceuticals and original APIs in Türkiye and to prioritize these challenges based on their relative importance using the Analytic Hierarchy Process (AHP) method. A structured AHP-based survey was conducted with 11 pharmaceutical industry executives. Based on a literature review and expert opinions, three main criteria (financial; infrastructure, human resources, and market; bureaucratic/legal processes) and 13 related sub-criteria were defined. According to the pairwise comparison results, “infrastructure, human resources, and market” was determined as the highest-priority area with a weight of 68.2%, followed by “financial” (18.3%) and “bureaucratic/legal” (13.6%) difficulties. Based on global weights, the most critical challenge was “insufficiency of qualified human resources” (28.8%), followed by “lack of pharmaceutical/biotechnology enterprise ecosystem” (16.7%) and “insufficiency of technoparks” (9.8%). Sensitivity analysis showed that the highest-ranked challenge remained unchanged across all tested scenarios, supporting the robustness of the main prioritization result. This study reveals that Türkiye’s pharmaceutical sector faces not only operational but also complex structural and systemic challenges requiring a holistic approach. The findings highlight the need for a strategic governance framework to boost predictability, strengthen institutional capacity, and ensure long-term financial sustainability. Prioritization results from the AHP method offer decision-makers a practical, sustainable roadmap, contributing to Türkiye’s global competitiveness in biopharmaceutical and original API production.