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Reportlinker Adds Biomarkers: Technologies and Global Markets
Date:5/3/2011

DRUG DEVELOPMENT USING BIOMARKERS: MARKET ENTRY THEORY AND IMPLICATIONS

FIGURE 4 DECISION TREE AND ECONOMICS FOR BIOMARKERS AT POINT OF CARE

Breakeven Analysis of Diagnostic-Enabled Drug Model

FIGURE 5 PRICE, COST, ADOPTION PERCENT FOR BIOMARKER ENVIRONMENT

FIGURE 6 BREAKEVEN LEVEL FOR ADOPTION OF BIOMARKER

Implications for Industry

BIOMARKERS APPLICATIONS: DRUG DEVELOPMENT

Safety/toxicology Biomarkers

TABLE 2 NOVEL SAFETY / TOXICOLOGY BIOMARKERS USED IN CANCER, CARDIO AND RENAL

Dose Selection and Dose Optimization

TABLE 3 NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE

Improved Measurement of Therapeutic Efficacy

Outcome Biomarkers and Surrogate Endpoints

TABLE 4 PATIENT OUTCOME MEASUREMENTS BIOMARKERS

EARLY-STAGE CLINICAL TRIAL APPLICATIONS

LATE-STAGE CLINICAL TRIAL APPLICATIONS

Phase III

Phase IV

BIOMARKERS: CHALLENGES AND OPPORTUNITIES

SUMMARY

CLINICAL VALIDITY: REQUIREMENTS

BIOMARKER OPPORTUNITIES

PRODUCT SUMMARY AND MARKET

GENOMICS

TABLE 5 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($ MILLIONS)

IMAGING

PROTEOMICS

BIOINFORMATICS

OTHER

Metabolomics

BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY

GROWTH DRIVERS AND RESISTORS

FACTORS INFLUENCING BIOMARKER ADOPTION IN CLINICAL TRIALS

CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE

IMPACT OF DRUG FAILURE IN LAST-STAGE CLINICAL TRIALS

Merck: Vicriviroc

Myriad: Flurizan

ADDITIONAL CAPABILITIES BY LARGE SERVICE PLAYERS

TECHNOLOGICAL ADVANCEMENTS IN GENOMICS AND PROTEOMICS

BIOMARKER MARKET FORECAST

TABLE 6 GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2015 ($ MILLIONS)

CHAPTER FOUR: REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS <
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SOURCE MDX
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