Biotech-Driven Innovation in Drug Discovery: Strategic Models for Competitive Advantage in the Global Pharmaceutical Market

Abstract

Biotechnology has significantly advanced modern drug discovery by enabling targeted, data-driven, and mechanism-based approaches. This paper explores how innovations such as high-throughput screening (HTS), molecular biology tools, synthetic biology, and precision medicine are transforming the discovery and development of therapeutic agents. Techniques like LC-MS, LC-NMR, and rational drug design offer deep insights into disease mechanisms and compound-target interactions. The identification and validation of drug targets have been enhanced through tools such as microarrays, RNA interference, and bioinformatics, while CRISPR-based genome editing allows precise genetic modifications. AI and ML help find new drugs by making new compounds, predicting how drugs will interact with their targets, and making clinical study designs better. Despite these advancements, challenges persist in drug solubility, central nervous system (CNS) drug delivery, bioavailability, and cost-effective large-scale production. Formulation strategies such as nanocrystals, lipid carriers, and complexation methods are being explored to overcome these limitations. Additionally, big data analytics and systems biology are reshaping the way researchers understand disease pathways and therapeutic responses. The convergence of these biotechnological innovations presents unprecedented opportunities to accelerate drug development.