Abstract
Summary
This report follows the broad definition of a biomarker as a characteristic
that can be objectively measured and evaluated as an indicator of normal
biological or pathogenic processes as well as pharmacological responses to a
therapeutic intervention. Tests based on biomarkers have been around for more
than half a century, but interest in their application for diagnostics and
drug discovery as well as development has increased remarkably since the
beginning of the 21st century. This report describes different types of
biomarkers and their discovery using various “-omics” technologies
such as proteomics and metabolomics. Molecular diagnostics technologies are
used for the discovery of biomarkers and new tests are also based on biomarker.
Currently the most important applications of biomarkers are in drug discovery
and development. The role of biomarkers in various therapeutic areas
particularly cancer, cardiovascular diseases and disorders of the central
nervous system, is described. Biomarkers are useful not only for diagnosis of
some of these diseases but also for understanding the pathomechanism as well
as a basis for development of therapeutics.
Biomarkers will facilitate the combination of therapeutics with diagnostics
and will thus play an important role in the development of personalized
medicine. Biomarkers play a role in use of pharmacogenetics, pharmacogenomics
and pharmacoproteomics for development of personalized medicine.
Many of the regulatory issues concerning biomarkers are related to genomics,
proteomics, molecular diagnostics and pharmacogenomics/pharmacogenetics.
Validation of biomarkers and their role in clinical trials is discussed.
Biomarker markets are estimated from 2008 to 2018 according to share of
markets for various technologies and applications: proteomics, metabolomics,
molecular diagnostics, drug discovery, clinical trials, and bioinformatics.
Market values are further split according to therapeutic applications and
major geographical areas. Unfulfilled needs in biomarkers are identified as
well as the drivers for biomarker markets. Challenges facing the biomarker
industry and strategies for developing biomarker markets are discussed.
A large number of companies with varying technical backgrounds are involved in
biomarkers and 267 of these are profiled in part 2 of the report with
classification into various categories.These also include major pharmaceutical
companies. There is tabulation of 480 collaborations between companies and
additional academic collaborations are mentioned in the individual profiles of
companies. The report is supplemented by 800 references, 60 tables and 12
figures
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