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Biomarkers are indicators of normal biological or pathogenic processes or pharmacological responses to a therapeutic intervention. In the last few years, pharmaceutical companies have shown interest in biomarkers. They incorporated biomarkers into company’s drug development program and used them as companion tests for targeted therapeutics. The pharmaceutical industries have witnessed a dramatic increase in the biomarkers market in the last 7 years. The volume of business generated demonstrates demarcated IP filings in the last 5 years. Biomarkers’ discovery and development is a complex process, which involves research, assay development, and commercialization. The research includes discovery and identification of biomarkers using different methods, whereas assay development includes exploratory phase, probable valid phase and known valid phase, following the commercialization of biomarkers with FDA approval. This chapter discusses in detail about types of biomarkers, the volume of biomarkers business, discovery and development of biomarkers, and applications of biomarkers. |
