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 2010 to 2020 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 277 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 514 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 1,000 references, 66 tables and 13 figures
TABLE OF CONTENTS
0. Executive Summary 21
1. Introduction 23
Historical aspects of biomarkers 23
Classification of biomarkers 24
Biological marker as response to therapeutic intervention 25
Pharmacokinetic/pharmacodynamics biomarkers 25
Predictive biomarkers 25
Valid biomarkers 26
Types of biomarkers 26
Genes as biomarkers 26
Proteins as biomarkers 27
DNA biomarkers 28
Mitochondrial DNA 28
Mitochondrial mutations 28
RNA biomarkers 28
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