Challenges and enablers of pharmaceutical 3Dprinting at point-of-care

Abstract

Background: Additive manufacturing (AM) using threedimensional (3D) printing presents a promising opportunity for producing personalised pharmaceutical dosage forms at the point-of-care (POC). By enabling decentralised manufacture in settings such as hospitals, primary care pharmacies and potentially patients’ homes, AM could enhance treatment individualisation, improve accessibility and support patient-centred care. Despite these advantages, translation into routine clinical practice remains limited. This study aimed to identify principal challenges and enabling factors associated with pharmaceutical AM to support safe integration of AM technologies in real-world pharmaceutical scenarios. Method: A systematic review was conducted in January 2025 to identify challenges and enablers associated with pharmaceutical AM, with emphasis on decentralised and POC applications. Searches were performed across leading electronic databases supplemented by reference list screening and regulatory authority websites. The review followed the PRISMA framework, and eligible studies were appraised using the CASP qualitative checklist. Data were analysed using inductive thematic analysis, with a subset independently double-coded to ensure inter-rater reliability. A validated structured POC manufacturing gap analysis tool was developed to assess Good Manufacturing Practice (GMP) compliance and readiness for AM implementation within healthcare environments. Results: The systematic search yielded 49 studies eligible for full-text assessment. Inductive coding identified 161 unique subtheme codes across the dataset, generating 747 coded entries capturing distinct concepts related to pharmaceutical AM. These subthemes were synthesised into ten overarching descriptive themes representing both enabling and limiting factors for implementation. Key enablers included stakeholder collaboration and professional education, emerging technological developments, future implementation pathways, and the potential of AM to support personalised and patient-centred therapeutic approaches. Major barriers included challenges related to quality control and Quality by Design (QbD) integration, regulatory gaps and uncertainty, technical implementation and scalability limitations, and the ambiguity between pharmaceutical compounding and industrial manufacturing frameworks. Additional constraints related to digital maturity and secure data exchange infrastructure; as well as ethical, legal and social considerations surrounding decentralised pharmaceutical production. A structured POC manufacturing gap analysis tool was developed, comprising nine sections aligned with the chapters of EudraLex Volume 4, Part I, reflecting core GMP principles. Each section incorporates weighted scoring criteria contributing to an overall compliance score, enabling the assessment of a facility’s level of GMP alignment and readiness for safe AM integration. Conclusion: The findings indicate that adoption of pharmaceutical 3D printing is constrained less by technological capability than by regulatory and infrastructural rigidity. Ambiguity between extemporaneous compounding and industrial manufacturing frameworks represents a critical bottleneck for implementation in decentralised healthcare settings. However, emerging regulatory sandboxes such as hospital exemptions and POC manufacturing frameworks together with harmonised international approaches may provide viable pathways to support responsible innovation. Successful integration of pharmaceutical AM requires coordinated progress in regulatory clarity, digital infrastructure and operational readiness. Addressing these interconnected barriers depends on collaborative efforts across research, policy development and clinical practice. Ultimately, embedding AM within transparent, patientcentred, and ethically robust governance frameworks is essential to realise its potential for safe, scalable and equitable personalised medicine at the POC.