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 2009 to 2019 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 265 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 479 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 800 references, 62 tables and 12 figures
TABLE OF CONTENTS
0. Executive Summary 19
1. Introduction 21
Definitions 21
Historical aspects of biomarkers 21
Classification of biomarkers 22
Biological marker as response to therapeutic intervention 23
Pharmacokinetic/pharmacodynamics biomarkers 23
Predictive biomarkers 23
Valid biomarkers 24
Types of biomarkers 24
Genes as biomarkers 24
Proteins as biomarkers 25
Proteomics 25
DNA biomarkers 26
Mitochondrial DNA 26
Mitochondrial mutations 26
RNA biomarkers 26
Transcriptomics 27
MicroRNAs 28
Metabolomics 28
Glycomics 28
Single nucleotide p
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