Abstract
INTRODUCTION
Biomarker-based tests have been in existence for over a few decades now but
their relevance to drug development and diagnostics applications in particular
has gained momentum only recently. This is apparent from the increased
research interest, and patent and regulatory activity with regards to
biomarkers.
Biomarker discovery has been a major by-product of genomic sequencing since
the completion of the Human Genome Project. The recent modernization in the
molecular profiling techniques has moved biomarker discovery to the front-line
of medical research. We were also interested in analyzing the impact of the
various omics technologies on molecular biomarker identification.
The compelling need for classifying molecular markers based on the
understanding of disease mechanisms has received immense emphasis owing to the
significant challenges encumbering the drug development pipeline. It has been
recognized that integration of biomarkers through the different phases of drug
development can yield safer drugs with enhanced therapeutic efficacy in a
cost-effective manner. Hence, we were interested in examining the role of
biomarkers in early-stage drug discovery, preclinical studies and late-stage
clinical trials of drug development. In order to confidently use biomarkers to
assess the biological end-point of a target therapy, clinical validation of
the marker is critical before using them on the candidate compounds.
We were also interested in gaining insight on biomarker validation from a
regulatory perspective. Biomarkers have been playing a significant role in
molecular diagnostics as well, and we analyzed the potential of these
biomarkers to address unmet needs in different facets of disease management.
These include disease screening and predisposition, monitoring disease
progression and predicting therapeutic response.
The confluence of therapeutics and diagnostics known as theranostics is
emerging and is expected to influence the use of molecular biomarkers in
personalized medicine. We were particularly interested in identifying the
advances in pharmacogenomic testing and examined their emerging potential as
companion diagnostics to targeted therapies.
SCOPE OF STUDY
This report contains:
- Descriptions of various types of biomarkers including genomics,
proteomics, bioformatics and metabolomics
- The current market status of biomarkers, trends, and forecasts for growth
over the next 5 years
- Technological issues including the latest trends and findings in different
therapeutic research areas
- An examination of the regulatory role of different federal agencies in
U.S., Europe and the rest of the world that play an active role in biomarker
discovery research
- Analysis of the biomarkers industry on a global basis, both from a market
and application perspective.
ABOUT THE AUTHOR
Vanita Khetan is an entrepreneur and market analyst. She holds a bachelors
degree in Chemistry and a Post Graduate degree in management. During the
course of her career, she has analyzed U.S., European and Asian markets in
biotechnology, pharmaceuticals, medical devices, wound care and surgical goods.
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