Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects. The goal of this Publications report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including: the physician office labs, hospital labs and commercial laboratories. Additionally, the numbers of institutions using this type of testing and the factors that influence purchases are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the clinical point-of-care market in the U.S. Each company is discussed in depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position.
1. Overview 8
1.1 Statement of Report 8
1.2 About This Report 8
1.3 Scope of the Report 9
1.4 Objectives 10
1.5 Methodology 10
1.6 Executive Summary 11

2. Introduction to Cancer Biology and the Diagnostic Industry 142.1 Cancer 14
2.1.1 The Disease 14
2.1.2 Metastasis 14
2.1.3 Demographics and Statistics of Cancer 14
2.2 The Drivers of the Biotech and Diagnostics Industry 19
2.2.1 Technological Innovation 20
2.2.2 Government Funding 21
2.3 Outlook for Tumor Markers 21

3. Tumor Markers Market Segment Analysis: Size, Growth and Share 233.1 Market Description 24
3.2 Clinical Diagnostic Serum Based Cancer Markers 31
3.3 PSA Testing Market Size 32
3.4 DNA Markers 33
3.5 Serum Proteins 33
3.6 Enzymes 34
3.7 Occult Blood 34
3.8 Histology and In Situ Hybridization (ISH) 35
3.9 Cervical Cytology 36
3.10 Immunohistochemistry 38
3.11 In Vivo Detection Cancer Products 39
3.12 Radionuclides and X-Ray Detection Products 39
3.13 Human Papillomavirus (HPV) Testing 39
3.14 Bladder Cancer Testing 43
3.15 Tumor Assays for Adjuvant Chemotherapy 46

4. Diagnostic Methods for Cancer Detection 594.1 Organ Specific Tumor Markers 59
4.1.1 Colon Cancer 59
4.1.2 Prostate Cancer 66
4.1.3 Pancreatic Cancer 83
4.1.4 Breast Cancer 85
4.1.5 Ovarian Cancer 94
4.1.6 Cervical Cancer 99
4.1.7 Lung Cancer 101
4.1.8 Testicular Cancer 106
4.1.9 Bladder Cancer 106
4.1.10 Hepatic Cancer 112
4.1.11 Stomach Cancer 114
4.1.12 Malignant Melanoma 115
4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL) 115
4.1.14 Lymphoma 116
4.2 Clinical Laboratory Methods for Measuring Tumor Markers 117
4.2.1 Abbott Diagnostics AxSYM 117
4.2.2 Roche Diagnostics Elecsys 117
4.2.3 Beckman Coulter Diagnostics Access 117
4.2.4 Bayer Diagnostics ADVIA Centaur 118
4.2.5 Dade Diagnostics Stratus 118
4.2.6 Diagnostic Products Corporation Immulite 118
4.2.7 Tosoh Medics A1A 119
4.2.8 CIS bio International Kryptor 120
4.2.9 Ortho-Clinical Diagnostics Vitros ECiQ 120
4.2.10 Fujirebio Diagnostics, Inc. 120
4.2.11 bioMérieux Vidas 121
4.2.12 Eisai Picolumi 121
4.2.13 Tosoh Medics, Inc. 121
4.3 New Technologies for Cancer Diagnostics 122
4.3.1 New and Improved Immunoassays 122
4.3.2 Immunohistochemical Tests 123
4.3.3 Molecular (DNA and Genomic) Diagnostic Assays 124
4.3.4 Genomics and Genetic Markers 125
4.3.5 Proteomics and New Protein Markers 126
4.3.5.1 Inside the ProteinChip System 126
4.3.5.2 Rapid Biological Assays on a Chip 126
4.3.5.3 Proteome Pattern Recognition 127
4.3.6 New Platform Technologies Including Flow Cytometry 127
4.3.7 Stem Cell Markers 130
4.3.8 Monoclonal Antibodies 130
4.3.9 Proteomics and Cancer Antibodies 134
4.3.10 Pharmacogenomics and Oncology Diagnostics 134
4.3.11 DNA Microarrays 137
4.3.12 In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 139
4.3.13 Prostate PX Score 139
4.3.14 Prostate-63 139
4.3.15 Future Directions 139
4.4 Clinical Methods for Diagnosis of Cancer 140
4.4.1 Screening 140
4.4.2 Sigmoidoscopy 142
4.4.3 Imaging 142
4.4.4 Theranostics 144
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