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Length:200 pages

Date Published:May 2011

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Dan Miller
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Commercializing Biomarkers in Therapeutic and Diagnostic Applications - Overview


Author: Lucy Sannes, MBA, PhD

Report Cover ImageBiomarkers feature in thousands of published articles each year, evidencing the high level of interest and research in this field. This report focuses on issues that must be addressed to utilize this growing knowledge about biomarkers and successfully commercialize them in therapeutic and diagnostic applications. Included in this publication:  

  • Biomarker definitions and guidelines for their development and validation
  • Applications of biomarkers in oncology, cardiology, neurology, drug safety, and other areas
  • Selected companies in the biomarker research products/tools and services market
  • Strategies for successful commercialization of biomarkers in the therapeutics and diagnostics markets
  • Forty key companies to watch, plus the activities of 175 companies that are commercializing biomarkers and/or systems for their detection and measurement
  • Expert interviews 

Biomarkers can be valuable tools in clinical diagnostics as well as in therapeutic discovery and development. They can be used to predict response to therapy or risk of side effects for personalized medicine applications. Additional types include predisposition, screening, diagnostic, prognostic, toxicity, pharmacodynamic, and other biomarkers.

Commercializing Biomarkers in Therapeutic and Diagnostic Applications: From Development to Validated Product focuses on questions that must be addressed to successfully take advantage of the potential of biomarkers. The analysis begins with a discussion of biomarker definitions and related terms, followed by an overview of the different types and applications of biomarkers. This is followed by brief summaries of the range of technologies that may be used to discover, identify, and measure biomarkers. Discussion then turns to a very critical issue: biomarker validation. This includes a discussion of recommendations and guidelines that have been made by many different groups and organizations for biomarker development and validation.

Next, examples are provided of the wide range of current and potential emerging applications of biomarkers in different fields such as oncology, cardiology, neurology, safety, and others. An examination of the market for research products (tools) and services in the field of biomarkers includes a discussion of selected companies and their activities, plus agreements and acquisitions in this area.

As part of a dual focus, Commercializing Biomarkers in Therapeutic and Diagnostic Applications: From Development to Validated Product then analyzes biomarker strategies for diagnostic companies, considering what is required to successfully commercialize biomarkers in the diagnostics market. Discussion includes: identification of novel biomarkers, analytical validation of diagnostic tests for new biomarkers, clinical validation and clinical utility of biomarkers, research and other information needs regarding biomarkers, models and options for diagnostic companies in the field of personalized medicine, strategic options for the delivery of novel biomarker assays, health economics and reimbursement, and other issues.
Similarly, this report also focuses on biomarker strategies for therapeutic development. This includes a discussion of the potential roles of biomarkers in various aspects of drug development, validation of biomarkers, regulatory issues, options for companies developing drug/diagnostic combinations, health economics and reimbursement in personalized medicine, and other issues. Also included is a compilation of agreements between pharmaceutical and diagnostic companies.

Forty key companies to watch are identified, plus 175 companies that are commercializing biomarkers and/or systems for their detection and measurement. The report concludes with Insight Pharma Reports’ interviews with experts in this field.

About the AuthorLucy J. Sannes, MBA, PhD, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.