What Does Pharmaceutical 3D Printing Cost? A Framework and Case Study with Hydrocortisone for Adrenal Insufficiency.

Abstract

Background: Pharmaceutical three-dimensional printing (3DP) technology offers an automated platform that can be utilized to manufacture personalized medicine, improving pharmacotherapy. Although 3D-printed products have entered clinical trials, no costing studies have been performed yet. Cost insights can aid researchers and industry in making informed decisions about the feasibility and scalability of 3DP.

Objective: The aim of this research was therefore to develop a framework that can be utilized to estimate the manufacturing cost of one 3D tablet in a hospital pharmacy setting.

Methods: To develop the costing framework, general manufacturing phases were identified, consisting of (i) pre-printing, (ii) printing, and (iii) post-printing. For each phase, cost categories were defined, including personnel, materials, equipment, facility, and quality assurance. The three phases combined with the categories formed the base of the costing framework. An earlier developed 3D-printed hydrocortisone formulation (M3DICORT) was used as a case study. Costs were expressed in 2022 euros (€). The framework was applied to M3DICORT in four scenarios: a base case scenario, worst-case scenario, best-case scenario, and a scaling scenario. In the scaling scenario, we assumed that 3D inks were mass produced.

Results: Costs of manufacturing a single M3DICORT tablet were €1.97-3.11 (best-case-worst-case) and €1.58-2.26 for the scaling scenario.

Conclusion: Manufacturing costs of 3D-printed pharmaceuticals were thus far unknown. The framework is translated into an open-access costing tool to facilitate adoption by other parties, and is also applicable for other pharmaceutical 3DP techniques.