Barriers to Industry 4.0 adoption in pharmaceutical manufacturing companies: A case study

Abstract

Purpose: This study explores the barriers to adopting Industry 4.0 technologies within the pharmaceutical manufacturing sector. Despite the potential for transformative benefits, the sector has been slow in embracing these technologies due to unique regulatory and operational challenges. This paper seeks to understand these challenges in greater depth by analyzing key obstacles that pharmaceutical companies face during their digital transformation efforts.

Design/methodology/approach: A mixed-methods approach was employed, combining maturity assessments with insights from in-depth interviews with key stakeholders in the pharmaceutical industry. The study identifies and categorizes the main barriers to Industry 4.0 adoption, providing a sector-specific analysis.

Findings: The primary barriers to Industry 4.0 adoption in pharmaceutical manufacturing were found to be "prioritization and strategic alignment," "technological challenges," and "financial constraints." Contrary to common assumptions in the literature, "regulatory and compliance challenges" were perceived as less impactful by stakeholders, as these are often ingrained in routine operations.

Research limitations/implications: The research focuses on a single pharmaceutical manufacturing company, which may limit generalizability. However, as the company operates within the broader pharmaceutical industry as a contract development and manufacturing organization (CDMO), the findings could reflect broader industry dynamics.

Practical implications: Pharmaceutical companies should prioritize overcoming strategic and technological barriers to facilitate Industry 4.0 adoption. Clear leadership direction, strategic alignment, and addressing interoperability challenges are critical for successful digital transformation in the sector.

Originality/value: This study provides a novel contribution by offering a detailed analysis of barriers to Industry 4.0 adoption specific to the pharmaceutical manufacturing sector. It challenges the traditional view of regulatory hurdles as the primary obstacle, emphasizing the increasing integration of regulatory management into daily operations and shifting the focus toward overcoming technological and strategic challenges.