A near-term market opportunity for cancer companion diagnostic tests exists in
drug selection for cancer therapy. Co-development of molecular diagnostics and
targeted therapeutics has already been proven to be a successful strategy in
the development of novel anti-cancer drugs. Adoption of biomarker development
in clinical research provides great opportunities to identify patient
subpopulations with differential drug responses and to uncover the underlying
mechanisms. These data could help to explain if clinical trials of new drugs
are adequate, and offer the possibility of creating a clear prescription path
based on predictive biomarkers. The purpose of this TriMark Publications
report is to describe the specific segment of the diagnostics market that
develops new technology platforms for evaluating the metabolism of therapeutic
agents, or for evaluating which therapeutic regimes are most effective for a
particular type of disease. The term companion diagnostic means that the
particular diagnostic test under evaluation is specifically linked to a known
therapeutic drug. This linkage could be important in the therapeutic
application and clinical outcome of a drug (personalized medicine), or an
important component of the drug development process. This report focuses on
the former linkage, i.e., the use of companion diagnostic tests in
personalized medicine.
Table of Contents
Table of Contents
1. Overview
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary
2. Companion Diagnostics and Personalized Medicine
2.1 Scope of This Section
2.2 Introduction to Companion Diagnostics and Personalized Medicine
2.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine
2.4 Examples of Personalized Medicine and Companion Diagnostic Tests
2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline
2.6 The Personalized Medicine Coalition (PMC)
2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space
2.7.1 The Changing Regulatory Landscape for Personalized Medicine
2.8 Companion Diagnostics Play an Increasing Role in Cancer Care
2.9 Specific Examples of Clinical Situations where Companion Diagnostics
are being Deployed
Figure 3.7: Molecular Diagnostics Market Segmentation by Technology
Figure 3.8: Market Survey Respondent Demographics
Figure 3.9: Breakout of the Respondent Pool by Affiliation
Figure 3.10: Segmentation of the Personalized Medicine Market
Figure 4.1: Personalized Medicine Market Drivers
Figure 4.2: Challenges in the Personalized Medicine Space
Figure 5.1: Carcinogenesis is a Multi-Step Process
Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer:
Equivocal Results with IHC
Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results
by FISH
Figure 5.4: MGMT Methylation Status Correlates to Survival Rate
INDEX OF TABLES
Table 2.1: Timeline for Development of Companion Diagnostics
Table 2.2: Personalized Medicine at the Nexus Point
Table 2.3: Percentage of Non-Responders in Various Drug Classes
Table 2.4: High-Profile Drug Withdrawals from the Marketplace
Table 2.5: Metabolism of Drugs by Hepatic Enzymes
Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity
Table 2.7: Population Frequency of the Various Cytochromes
Table 2.8: Selected List of Personalized Medicine Tests
Table 2.9: Personalized Medicine Product Pipeline
Table 2.10: Typical Response Rates in Therapeutic Areas
Table 2.11: Prevalence of People Taking Medications Metabolized by Liver
Enzymes
Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan
Table 2.13: Current Product Labels: Enzyme Metabolism
Table 3.1: Timeline for Impact of Various Molecular Diagnostics
Technologies on Personalized Medicine
Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic
Areas in Personalized Medicine
Table 3.3: Challenges of Various Molecular Diagnostics Technology
Platforms in Personalized Medicine
Table 3.4: FDA Classification of Diagnostics by Risk
Table 4.1: Personalized Medicine Industry SWOT Analysis
Table 4.2: Market Opportunities in Personalized Medicine
Table 4.3: Challenges for Market Adoption of Various Personalized Medicine
Tests
Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics
Development
Table 4.5: Timeline of Impact in Areas of Personalized Medicine
Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas
Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics
Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug
Development
Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to
Interpret Test Results
Table 5.4: Device Submission Elements for the FDA
Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests
Table 6.2: Summary of Biomarker Use in the Commercialization of Novel
Oncology Pharmacotherapeutics
Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers
as Companion
Diagnostic Tests
Table 7.1: Major Players in Companion Diagnostic Sector
Table 7.2: Tumor Diagnosis Immunoassay
Table 7.3: Tumor Diagnosis Radioimmunoassay
Table 7.4: Summary of Matritech' s Product Development Programs
Companion Diagnostics in Personalized Medicine and Cancer Therapy published by Trimark Publications in February 1, 2012. This report consists of 214 Pages and the price starts from US $ 3400.
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