Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes

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Biomarkers Offer Personal Touch to Patient Treatment

The traditional ‘blockbuster model’ of drug development is coming under fire, as scientists increasingly look towards personalized medicines as the future of pharmaceuticals, states a new report by healthcare experts GBI Research.

The new report* argues that biomarkers are making waves in drug discovery, revealing the possibility of analyzing an individual’s medical nature and needs remotely.

According to the Food and Drug Administration (FDA), a biomarker is a characteristic that can be objectively measured and evaluated as an indicator of biologic processes, or as biological responses to a therapeutic treatment, generally existing as specific enzyme or hormone concentrations. The report notes that biomarkers therefore hold the potential to predict disease susceptibility, can detect and monitor disease progression for CNS, CVS, cancer, autoimmune, metabolic and infectious diseases, and can also act as a guiding force in drug development and evaluation.

Historically, drug R&D processes considered the response to a drug on the majority of patients, representing a ‘one-size-fits-all’ approach, or ’blockbuster’ model. Now, an emergence of personalized medicine allows an individual’s treatment to be designed according to genetic codes, ensuring a reduction in drug discovery costs and an increase in treatment success.

Promising biomarkers that have already been discovered include biomarkers of neurodegeneration, which correlate better than Aß biomarkers with the clinical symptoms of Alzheimer’s Disease (AD) and are better suited for use in clinical trials. A huge number of potential biomarkers of prognosis and diagnosis in Rheumatoid Arthritis (RA) have also been investigated, and autoantibody tests and inflammatory markers are routinely tested in clinical practice. In addition to this, novel, new, non-invasive serum markers are being developed to monitor the progression of Hepatitis C and its response to therapy, in comparison to previously-used liver biopsies.

GBI Research valued the biomarkers market at $3.5 billion in 2004, increasing to $13 billion in 2011 at a Compound Annual Growth Rate (CAGR) of 20.1%. The majority of revenue was generated through the application of biomarkers in the discovery, testing and prescription of oncology therapeutics, according to their analysis, with other leading therapeutics areas being Central Nervous System (CNS) and Cardiovascular System (CVS) disorders.

*Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes

This report provides information and analysis on the major trends and issues affecting biomarkers in the drug discovery process. It describes the history of biomarkers and their role in fulfilling the unmet needs of the conventional drug discovery process. The drivers and barriers for the biomarkers market, along with the key issues faced in the application of biomarkers in the drug discovery process, are also highlighted.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.