Implementation of Pharma 4.0 projects in emerging economies: an empirical prioritization of opportunities and challenges in Brazil

This study evaluates the opportunities and challenges influencing the transition toward the established Pharma 4.0 paradigm within an emerging economy context. Contrasting empirical findings with the general manufacturing literature, it prioritizes the strategic factors necessary to optimize operations in the highly regulated pharmaceutical sector. Following a systematic literature review, a mixed-method approach was adopted, comprising 22 in-depth interviews with senior industry experts in Brazil. To ensure analytical rigor, the study introduces the Expert Judgment Reliability Protocol to validate qualitative data. Prioritization was performed using a hybrid Multi-Criteria Decision-Making (MCDM) model, integrating Information Entropy Weight (IEW) and TOPSIS. Results indicate that the primary opportunities for Pharma 4.0 involve advanced product traceability (Ci = 0.696), strategic market perception of modernity (Ci = 0.692), and quality improvement (Ci = 0.664). Conversely, implementation is hindered by critical structural challenges: specialized labor shortages (Ci = 0.177), the need for new management skills (Ci = 0.175), and insufficient government support (Ci = 0.167). This research fills a critical gap by providing empirical evidence of a technological plateau in emerging markets, where institutional voids and human capital scarcity limit advanced technology adoption. By linking MCDM rankings to an actionable Integrative Operations Framework, the study provides operations managers and policymakers with specific guidelines to foster digital maturity, thereby advancing Operations Management (OM) theory and practice.