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Pharmaceutical 3D printing has emerged as a technically powerful approach for producing personalised, flexible, and on-demand dosage forms. Its appeal lies in the ability to vary dose, geometry, release profile, and patient acceptability without requiring a new conventional manufacturing line for every product variant. Despite this promise, the field remains constrained by a persistent mismatch between design capability and translational readiness. Many studies demonstrate sophisticated printed tablets, films, lattices, and personalised dosage forms, yet far fewer address the manufacturing controls, release strategies, and regulatory evidence needed for routine clinical implementation. This critical review evaluates pharmaceutical 3D printing through the connected lenses of design logic, manufacturing constraints, and regulatory readiness. The review treats additive manufacturing not as one technology but as a family of processes whose material requirements, process risks, and quality attributes differ substantially. The review concludes that pharmaceutical 3D printing will not translate through formulation novelty alone. A technology-agnostic, risk-proportionate regulatory pathway combined with scalable, PAT-integrated manufacturing platforms is essential to move from promise to practice.

Scalable drug delivery platforms are increasingly central to pharmaceutical innovation because they can shorten development timelines, support repeated product generation, and enable broader access when manufacturing and regulatory pathways are sufficiently stable. Yet the term “platform” is often applied before a technology has demonstrated repeatable transfer across products, indications, and production environments. This creates uncertainty about whether a delivery technology is truly mature or simply promising. Existing maturity concepts offer useful starting points but do not fully capture the pharmaceutical specificity of drug delivery platforms. Generic technology readiness models tend to emphasise proof of concept, whereas manufacturing readiness frameworks focus on production capability. Pharmaceutical platform maturity requires a broader view that also includes formulation robustness, patient-facing performance, quality system integration, regulatory precedent, and lifecycle adaptability. This article develops a conceptual model for defining and assessing pharmaceutical platform maturity in scalable drug delivery technologies. The proposed Pharmaceutical Platform Maturity Model integrates product-level, process-level, and regulatory-level maturity into a single interpretive framework. The model is designed to distinguish early innovation from repeatable platform capability. The model defines scalable delivery technology criteria, identifies maturity indicators across three interdependent dimensions, and proposes a five-level maturity scale ranging from concept to commoditised platform. Four tables support the argument by contrasting existing assessment frameworks, defining scalability criteria, summarising maturity indicators, and presenting the integrated maturity rubric. The model is intended as a strategic, analytical, and communicative tool. The article concludes that platform maturity should not be inferred from clinical success, manufacturing feasibility, or regulatory approval alone. A drug delivery platform becomes mature only when product performance, process control, and regulatory confidence co-evolve into a repeatable system. This integrated perspective can help developers, investors, regulators, and technology assessors evaluate scalable delivery technologies more consistently.