Molecular Diagnostics in Cancer Testing Market Size, Share and Research Report 2016

In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer.

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Major Points From Table of Contents

1. Overview 9

2. Introduction to Molecular Diagnostics 17

3. Cancer Diagnostics Molecular Testing Market 35

4. Molecular Diagnostic Tests for Cancer 47

5. Business 135

6. Reimbursement and Billing 171

7. Government Regulation 184

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development 193

9. Company Profiles 205

List of Figures

Figure 2.1: Finding Genes with Microassays 18

Figure 2.2: Use of Microassays for Studying Gene Expression 18

Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 19

Figure 2.4: Microarrays for Prediction of Survival in Cancer 21

Figure 2.5: Finding New Drugs with Microarrays 26

Figure 2.6: Using Gene Expression Patterns to Chose Treatment 26

Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2014 36

Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2014 36

Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Market 37

Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 44

Figure 4.1: Using DNA Microassays to Measure Gene Expression 49

Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 50

Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 63

Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 65

Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 65

Figure 4.6: Action of Herceptin in Breast Cancer Patients 66

Figure 4.7: Analysis of Cancer Tissue by Microarray 68

Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2014 75

Figure 4.9: Incidence of CRC by Age Group 80

Figure 4.10: HNPCC Mutation Increases Risk of Cancer 89

Figure 4.11: APC Mutation Increases Risk of Cancer 90

Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2014 93

Figure 4.13: Prostate-Specific Membrane Antigen 99

Figure 4.14: PCA3 Score Nomogram 101

Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 102

Figure 4.16: Ovarian Cancer Types 115

Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2014 120

Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 144

Figure 5.2: Segmentation of the Biomarker Development Market 166

Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 177

Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 191

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