The Evolving Role of Chromatography in Pharmaceutical Drug Discovery & Development

Abstract

Chromatography serves as the analytical backbone of the modern pharmaceutical industry. It enables the progression of chemicals from early discovery to market-ready products. This narrative review is based on a systematic evaluation of peer-reviewed literatures. Mostly those published b/w 2015 to 2025. It includes authoritative regulatory documents (FDA, EMA, ISO, ICH Q2(R2), WHO and IUPAC). Key market analyses projected that growth of the chromatography market from USD 13.30 billion in 2025 to USD 19.80 billion by 2030 (CAGR 8.4%). Seminal contributions from leading researchers and high-impact journals were collected. It including Journal of Chromatography A. They were critically analyzed to synthesize current trends.

The review examines chromatographic techniques across the drug development lifecycle. I highlighted affinity chromatography and high-throughput LC-MS in early discovery. Reverse Phase and Chiral HPLC in lead optimization. Protein A/G and IMAC in biologics purification. Advanced platforms such as Supercritical Fluid Chromatography and Simulated Moving Bed chromatography are discussed in the context of green chromatography & continuous manufacturing. Regulatory-driven validation and stability-indicating applications have been discussed. It includes HPTLC, GC, and TLC-densitometry are emphasized. Collectively, the findings underscore chromatography as a central safeguard for drug safety, efficacy and quality in an era of increasingly complex and personalized medicine.