According to Food and Drug Administration (FDA), a biological marker or biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or biological responses to a therapeutic intervention. It can define a physiologic, pathologic or anatomic characteristic or measurement that is thought to relate to some aspect of normal or abnormal biologic function. Changes in biomarkers following treatment may identify safety problems related to a drug candidate or reveal a pharmacological activity that predicts an eventual benefit from treatment. Biomarkers may reduce uncertainty in drug development and evaluation by providing quantitative predictions about drug performance.
Before the application of biomarkers in drug discovery, the process had various drawbacks such as high attrition rates, high costs and erroneous predictions about drug safety and efficacy. The integration of biomarkers has addressed these issues and made the drug discovery process smoother and less costly. The conventional symptom-based drug R&D process, also called the "one-size-fits-all" or "blockbuster" model, is being replaced by personalized medicine so that targeted treatment can be designed for individuals based on their genetic codes
GBI Research analysis indicates that the global biomarkers market has seen substantial growth since 2004, due to improvements in technology and the creation of favorable regulatory norms for the application of biomarkers in drug discovery.
This report focuses on the applications of biomarkers in drug development, the market characterization, and promising biomarkers in various therapy areas. Historic and future trends, strategic con
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