Navigating Digital Transformation: Overcoming Legacy Constraints in Irish Pharmaceutical Manufacturing

Abstract

Ireland's pharmaceutical sector employs over 50,000 people and generates €99.9 billion in annual exports, yet the digital transformation of its legacy manufacturing base remains significantly underexplored. Brownfield pharmaceutical sites face a distinct set of challenges compared to greenfield facilities, as they must integrate modern digital technologies into aging infrastructure whilst maintaining continuous operations, validated processes, and regulatory compliance. Digital transformation failure rates of up to 90% are reported across industries, with failures particularly pronounced in legacy environments. Despite this, limited evidence-based guidance exists for brownfield pharmaceutical sites, particularly those operating under Atmospheres Explosibles (ATEX) certification in Active Pharmaceutical Ingredient (API) manufacturing environments. This study investigates the limitations, barriers, and challenges organisations encounter when implementing digital transformation strategies at legacy pharmaceutical facilities in Ireland and develops evidence-based solutions to mitigate these challenges. A mixedmethods research design was employed, combining a quantitative online survey, qualitative semi-structured interviews, and longitudinal work-based case study data drawn from an ATEX-regulated API manufacturing facility. Findings reveal that digital transformation challenges in brownfield pharmaceutical sites are multidimensional and deeply interconnected, spanning technical, organisational, cultural, financial, and regulatory dimensions. ATEX-regulated environments face significantly heightened barriers relative to standard pharmaceutical sites, a dimension largely absent from existing literature. Critical success factors including phased implementation, strong leadership, comprehensive change management, and pilot-based approaches were consistently identified across all three data sources. Triangulation of findings confirmed the inadequacy of single-dimension transformation approaches and the necessity of integrated, context-specific strategies. In response, this research introduces the Brownfield Pharmaceutical Digital Transformation Framework (BP-DTF), an evidence-based tool designed to guide legacy pharmaceutical manufacturers through the planning and execution of digital transformation initiatives. The framework integrates technical, organisational, cultural, financial, and regulatory dimensions into a cohesive roadmap, offering practical guidance applicable beyond the Irish context to legacy pharmaceutical manufacturing globally.