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Reportlinker Adds Markets for Emerging Pharmaceutical Technologies
Date:5/11/2011

100

Company Strategy 100

Company Strategy (Continued) 101

CHAPTER FIVE: BIOMARKERS 102

INTRODUCTION 102

TABLE 45 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($

MILLIONS) 103

ENABLING ADVANCEMENTS DRIVING MARKET GROWTH 103

BIOMARKERS DRIVE SPEED, COST AND QUALITY

IMPROVEMENTS ACROSS THE DRUG DEVELOPMENT

SPECTRUM 103

BIOMARKERS APPLICATIONS: DRUG DEVELOPMENT 104

Safety/Toxicology Biomarkers 105

Dose Selection and Dose Optimization 105

Improved Measurement of Therapeutic Efficacy 105

Outcome Biomarkers and Surrogate Endpoints 105

EARLY-STAGE CLINICAL TRIAL APPLICATIONS 106

LATE-STAGE CLINICAL TRIAL APPLICATIONS 107

Phase III 107

Phase IV 107

BIOMARKERS: CHALLENGES AND OPPORTUNITIES 107

SUMMARY 107

CLINICAL VALIDITY: REQUIREMENTS 108

BIOMARKER OPPORTUNITIES 108

PRODUCT SUMMARY AND MARKET 108

GENOMICS 108

TABLE 46 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($

MILLIONS) 109

IMAGING 109

PROTEOMICS 110

BIOINFORMATICS 110

OTHER 111

Metabonomics 111

BIOMARKER ADOPTION BY THE PHARMACEUTICAL

INDUSTRY 111

GROWTH DRIVERS AND RESISTORS 111

FACTORS INFLUENCING BIOMARKER ADOPTION IN

CLINICAL TRIALS 111

CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE 112

IMPACT OF DRUG FAILURE IN LAST-STAGE CLINICAL

TRIALS 112

Merck: Vicriviroc 112

ADDITIONAL CAPABILITIES BY LARGE SERVICE

PLAYERS 113

TECHNOLOGICAL ADVANCEMENTS IN GENOMICS AND

PROTEOMICS 113

BIOMARKER MARKET FORECAST 114

TABLE 47 GLOBAL BIOMARKER MARKET FORECAST, THROUGH

2015 ($ MILLIONS) 114

REGULATORY ENVIRONMENT 114

INTRODUCTION 114

ROLE OF THE FOOD AND DRUG ADMINISTRATION 114

TABLE 48 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 115

EUROPEAN MEDICINES AGENCY 116

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