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Market Research Report||Companion Diagnostics in Personalized Medicine and Cancer Therapy

Posted May 10 2011 8:55am

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 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 :
1 Overview 6
1.1 Statement of Report 6
1.2 About This Report 6
1.3 Scope of the Report 6
1.4 Objectives 7
1.5 Methodology 8
1.6 Executive Summary 9

2 Companion Diagnostics and Personalized Medicine 13
2.1 Scope of this Section 13
2.2 Introduction to Companion Diagnostics and Personalized Medicine 13
2.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine 17
2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 21
2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 24
2.6 The Personalized Medicine Coalition (PMC) 26
2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 29
2.7.1 The Changing Regulatory Landscape for Personalized Medicine 31
2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 32
2.9 Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed 33
2.9.1 Epidermal Growth Factor Receptor (EGFR) Assay 33
2.9.2 Individualized Warfarin Therapy 35
2.9.3 UGT1A1 Molecular Assay for Camptosar 36
2.9.4 Response to Gleevec in GIST 36
2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 36
2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 36
2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 37

3 Companion Diagnostics: Qualitative and Quantitative Market Analysis 38
3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 38
3.2 Costs of Companion Diagnostics in Healthcare Expenditures 39
3.3 Molecular Diagnostic Market 40
3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 42
3.5 Snapshot of Companion Diagnostics Industry Structure 44
3.6 The Case for Theranostics 45
3.7 Companion Diagnostics Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 46
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