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

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INTRODUCTION

ROLE OF THE FOOD AND DRUG ADMINISTRATION

TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS

EUROPEAN MEDICINES AGENCY

REGULATORY IMPACT ON DRUG SAFETY

INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING

APPROVED PATENT ANALYSIS

TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2010

COMPETITIVE LANDSCAPE

LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING

TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2010 ($ MILLIONS)

TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY

TABLE 11 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN U.S., EUROPE, JAPAN

ETHICAL CONSIDERATIONS

SUMMARY

Respect for Persons

Beneficence

Justice

BIOMARKER APPLICATIONS OF ETHICAL CONSIDERATIONS

Race and Genotype

Negligence

Informed Consent

Privacy

Market Segmentation

Professional, Media, and Opinion Leader Edification

REGULATORY IMPLICATIONS

CHAPTER FIVE: APPLICATION BY THERAPY AREA

TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2010 ($ MILLIONS)

ONCOLOGY

TABLE 13 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY

COLORECTAL CANCER

CETUXIMAB

PANITUMUMAB

ELESCLOMOL

HERCEPTIN

OTHER PREDICTIVE TESTS

TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY

BREAST CANCER

MAMMAPRINT

TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER

ONCOTYPE DX

TEST ADOPTION

OTHER PROGNOSTIC TESTS

PREDICTIVE TESTS

HORMONAL THERAPIES

TAXANES/ANTHRACYCLINES

BIOLOGICALS

TRIPLE NEGATIVE BREAST CANCER

OTHER NOVEL BIOMARKERS

LUNG CANCER


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