Companion Biomarkers in Drug Development

Companion biomarkers are diagnostic tests that are specifically linked to a therapeutic drug either during its development or in the clinic. This linkage can be an important component of the drug development process; alternatively, the companion biomarker can be useful in ameliorating the regulatory process for the drug, or acting as an aid to therapeutic use in the clinic. Market opportunities for companion biomarkers are focused in drug development targets, drug development efficacy and clinical end points in four main therapeutic areas: oncology, cardiovascular, neurology and autoimmune. Using companion biomarkers yields safer and more efficacious drug products, reduces clinical trial and development costs, improves post-marketing safety profiles and salvages therapies that otherwise would not be granted approval. This TriMark Publications report focuses on the role of companion diagnostic tests in drug development. It provides an in-depth discussion and analysis of the application of companion biomarkers to drug development and targeted therapeutics, as well as their use in clinical trials and the regulatory forum. The examination emphasizes new and developing technology platforms meant to aid in development of drugs for therapeutic use, and sometimes to be available as companion tests for these drugs in the clinic. This report also examines companies that are actively developing and marketing companion biomarkers around the world. Detailed tables and charts with sales forecasts and marketshare data are also included.