Companion Diagnostics Analysis in Personalized Medicine and Cancer Therapy

Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics.

This report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position. Detailed tables and charts with sales forecasts and market share data are also included.

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Table of Contents

1. Overview 9

2. Companion Diagnostics and Personalized Medicine 17

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 51

4. Trends and Overview 62

5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 72

6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 94

7. Companies Entering the Companion Diagnostics Market 127

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions 200

Appendix 2: FDA Issues Draft Companion Diagnostic Guidance 211

Appendix 3: Histochemical Markers for Cancer 213

List of Figures

Figure 2.1: Personalizing Drug Treatment 18

Figure 2.2: Approaches to Personalized Medicine 19

Figure 2.3: The Phase I and II Processes of Drug Metabolism 22

Figure 2.4: Hepatic Distribution of Human CYP450 23

Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24

Figure 2.6: Genetic Components Determine Drug Metabolism 24

Figure 2.7: Personalized Medicine Drugs in Development 29

Figure 2.8: Healthcare Value Chain 49

Figure 3.1: From Genetic Content to Personalized Medicine 52

Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52

Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53

Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54

Figure 3.5: Molecular Diagnostics Market Segmentation 55

Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55

Figure 3.7: Market Survey Respondent Demographics 60

Figure 3.8: Breakout of the Respondent Pool by Affiliation 60

Figure 3.9: Segmentation of the Personalized Medicine Market 61

Figure 4.1: Personalized Medicine Market Drivers 63

Figure 4.2: Challenges in the Personalized Medicine Space 64

Figure 5.1: Carcinogenesis is a Multi-Step Process 72

Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79

Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79

Figure 7.1: Epigenomics Product Development Pipeline 163

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