The future of 3D bioprinting: From functional tissues to standardized manufacturing and clinical translation

Three-dimensional (3D) bioprinting has evolved from demonstrating the feasibility of fabricating complex tissue architectures to engineering increasingly functional biological constructs. However, advances in biological functionality have not been matched by comparable progress in standardized evaluation, manufacturing consistency, and clinical translation. Here, we propose a Bioprinting 1.0 to 5.0 evolutionary framework that describes the progression of the field from engineering feasibility and biological compatibility to biological functionality, standardized manufacturing, and clinical translation. We discuss emerging standardization efforts across extrusion-, jetting-, and vat photopolymerization–based bioprinting and highlight the need for quantitative, reproducible benchmarks spanning bio-ink properties, printing performance, construct quality, and biological function. We further examine the manufacturing, safety, regulatory, and clinical requirements needed to translate functional bioprinted tissues into therapeutic products. This framework provides a roadmap for advancing 3D bioprinting from laboratory-scale demonstrations toward reproducible and clinically translatable tissue engineering.