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 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.
1.1 Statement of Report
1.2 About this Report
1.3 Scope of the Report
1.6 Executive Summary
2. Introduction to Cancer Biology and the Diagnostic Industry
2.1.1 The Disease
2.1.3 Demographics and Statistics of Cancer
2.2 The Drivers of the Biotech and Diagnostics Industry
2.2.1 Technological Innovation
2.2.2 Government Funding
2.3 Outlook for Tumor Markers
3. Tumor Markers Market Segment Analysis: Size, Growth and Share
3.1 Market Description
3.2 Clinical Diagnostic Serum-Based Cancer Markers
3.3 PSA Testing Market Size
3.4 DNA Markers
3.5 Serum Proteins
3.7 Occult Blood
3.8 Histology and In Situ Hybridization (ISH)
3.9 Cervical Cytology
3.11 In Vivo Detection Cancer Products
3.12 Radionuclides and X-Ray Detection Products
3.13 HPV Testing
3.14 Bladder Cancer Testing
3.15 Tumor Assays for Adjuvant Chemotherapy
4. Diagnostic Methods for Cancer Detection
4.1 Organ-Specific Tumor Markers
4.1.1 Colon Cancer
4.1.2 Prostate Cancer
4.1.3 Pancreatic Cancer
4.1.4 Breast Cancer
4.1.5 Ovarian Cancer
4.1.6 Cervical Cancer
4.1.7 Lung Cancer
4.1.8 Testicular Cancer
4.1.9 Bladder Cancer
4.1.10 Hepatic Cancer
4.1.11 Stomach Cancer
4.1.12 Malignant Melanoma
4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL)
4.2 Clinical Laboratory Methods for Measuring Tumor Markers
4.2.1 Abbott Diagnostics AxSYM
4.2.2 Roche Diagnostics Elecsys
4.2.3 Beckman Coulter Diagnostics Access Systems
4.2.4 Siemens Healthcare Diagnostics ADVIA Centaur
4.2.5 Siemens Healthcare Diagnostics Immulite
4.2.6 Tosoh Bioscience AIA-2000
4.2.7 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR
4.2.8 Ortho-Clinical Diagnostics Vitros ECiQ
4.2.9 Fujirebio Diagnostics, Inc.
4.2.10 bioMerieux Vidas
4.3 New Technologies for Cancer Diagnostics
4.3.1 New and Improved Immunoassays
4.3.2 IHC Tests
4.3.3 Molecular (DNA and Genomic) Diagnostic Assays
4.3.4 Genomics and Genetic Markers
4.3.5 Proteomics and New Protein Markers
188.8.131.52 Inside the ProteinChip System
184.108.40.206 Rapid Biological Assays on a Chip
220.127.116.11 Proteome Pattern Recognition
4.3.6 New Platform Technologies Including Flow Cytometry
4.3.7 Stem Cell Markers
4.3.9 Proteomics and Cancer Antibodies
4.3.10 Pharmacogenomics and Oncology Diagnostics
4.3.11 DNA Microarrays
4.3.12 In Vitro Diagnostic Multi-variate Index Assays (IVDMIA)
4.3.13 Prostate PX Score
4.3.15 Future Directions
4.4 Clinical Methods for Diagnosis of Cancer
5. Implications of Molecular Biology for New Diagnostic Cancer Tests
6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms
6.1 Abbott Diagnostics
6.2 Affymetrix, Inc.
6.3 Agendia BV
6.4 Ambrilia Biopharma, Inc.
6.5 Radient Pharmaceuticals
6.6 Asuragen, Inc.
6.7 Aureon Biosciences, Inc.
6.8 C. R. Bard
6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath
6.10 Beckman Coulter, Inc.
6.11 Biocode S.A.
6.13 Biomedical Diagnostics
6.16 BioModa, Inc.
6.17 Bruker Daltonics
6.18 Byk Gulden
6.20 Clarient, Inc.
6.21 Correlogic Systems, Inc.
6.22 CytoCore (formerly Molecular Diagnostics, Inc.)
6.23 Cytogen Corporation (now EUSA Pharma)
6.24 diaDexus, Inc.
6.25 DiagnoCure, Inc.
6.26 Diagnostic Automation / Cortez Diagnostics, Inc.
6.27 DRG International, Inc.
6.28 Eisai Co., Ltd.
6.29 Enigma Diagnostics Ltd.
6.30 Epigenomics AG
6.31 Exact Sciences Corporation
6.32 Exagen Diagnostics, Inc.
6.33 Fujirebio Diagnostics, Inc.
6.34 Gene Logic, Inc.
6.35 Gen-Probe, Inc.
6.36 Genomic Health
6.37 Geron Corporation
6.38 Hologic, Inc. (formerly Cytyc Corporation)
6.39 Immunicon Corporation (now Veridex, LLC)
6.40 Immunomedics, Inc.
6.41 Incyte Corporation
6.44 Mitsubishi Kagaku Medical
6.45 Molecular Devices (formerly Arcturus Bioscience, Inc.)
6.46 Myriad Genetics, Inc.
6.47 Northwest Biotherapeutics, Inc.
6.48 ARCA Biopharma
6.49 Oncotech, Inc.
6.50 Oncothyreon, Inc. (formerly Biomira)
6.51 Panacea Pharmaceuticals, Inc.
6.52 Poniard Pharmaceuticals, Inc.
6.53 Polymedco, Inc.
6.54 Princeton BioMeditech Corporation
6.56 Roche (F. Hoffman-La Roche, Ltd.)
6.57 Sanko Junyaku Co., Ltd.
6.58 Siemens Heathcare Diagnostics
6.59 Tosoh Corporation (Bioscience division)
6.60 Ventana Medical Systems, Inc.
6.62 Veridex, LLC
6.63 Vermillion, Inc.
6.63 Worldwide Medical Corporation
6.64 Xenomics, Inc. (TrovaGene, Inc.)
7. Business Trends in the Industry
7.1 Industry Consolidation
7.2 Breadth of Product Offering and Pricing
7.3 Government Regulation of Medical Devices
7.4 Commercial Opportunities in Cancer Markers
7.5 Moderators of Growth
7.6 Biotechnology Industry Trends
7.7 Pharmaceutical Industry Trends
7.8 Sales and Marketing Strategies for Tumor Marker Tests
7.8.1 North American Market
7.8.2 International Markets
18.104.22.168 Central and South America
8. Tumor Marker Testing: Important Issues
8.1 Trends in Patient Care and Reimbursement
8.2 Trends in Reimbursement Practice
8.3 Clinical Laboratory Improvement Act (CLIA)
8.4 Unmet Needs in Tumor Markers
9. Important New Technology Areas
9.2 DNA Sequencing
9.3 The Human Genome Project (HGP)
9.4 Liquid Phase Chromatography
9.5 Polymerase Chain Reaction (PCR)
9.6 Capillary Electrophoresis
9.8 Use of MS in Sequencing
9.9 High-Throughput Organic Synthesis
10. New Cancer Markers in Basic Research
10.1 Genetics of Cancer
10.1.1 Activator genes (Oncogenes)
10.1.2 Inactivating Genes (Tumor Suppressor Genes)
10.2 DNA Mismatch Repair Genes (MMRs)
10.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL)
10.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL)
10.4.3 Retinoblastoma and Constitutional 13q14 Deletion
10.4.4 Stomach Cancer
10.4.5 Head and Neck Cancer
10.4.6 Breast and Ovarian Cancers
10.4.7 Prostate Cancer
10.4.8 Cervical Cancer: NMPI79
10.4.9 Uterine and Kidney Cancer: MN/CA9
10.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF)
10.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers
10.5 Tumor Markers
10.5.1 Oncology Biomarker Qualification Initiative
10.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time
10.5.3 MUC1, 2, 3 and 4
10.5.5 RAK Antigens
10.5.6 Serum Urokinase Receptors
10.5.8 Reg-4 Protein
10.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2)
10.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein
10.5.11 Shc Proteins
10.5.12 Anti-Glycan Antibodies
10.5.14 Alpha-fetoprotein (AFP)-L3
10.5.15 Transthyretin and Apolipoprotein A1 (Apo A1)
10.5.16 A Disintegrin and Metalloproteinase (ADAM)
10.6.2 Ettan DIGE Technology
10.6.3 DNA Methylation Technology
10.7 Disease-specific technology
10.7.1 Ovarian Cancer: Bio-Rad's SELDI-based ProteinChip
10.7.2 Lung Cancer: Labeled Porphyrin Binding
10.7.3 C-MAP, A Cervical Cancer Screening System
10.7.4 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP)
10.7.5 Prostate Cancer: PCA3
10.7.6 Bladder Cancer: ImmunoCyt/uCyt+
11. Market Trends and Forecasts
11.1 Ultrasensitive Cancer Tests
11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies
11.3 Reverse transcriptase-polymerase chain reaction (RT-PCR)
11.4 Genetic Tests of Hereditary Cancer Risk
11.5 DNA Measurements
11.6 Technical and Practical Issues for Potential New Markers
11.7 Genetic Profiling
11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer
11.10 Pharmacogenetic Tests for Cancer
11.11 Worldwide Healthcare Spending
Appendix 1: Web Links
Appendix 2: Cancer Information Resources
Appendix 3: Colon Cancer Staging
Appendix 4: Reimbursement for Tumor Marker Testing
Appendix 5: The Pathology of Prostate Cancer
Appendix 6: Government Regulation of Tumor Marker Tests
Appendix 7: The Clinical Laboratory Improvement Act (CLIA)
Appendix 8: Marketers of Occult Blood Diagnostic Test Kits
INDEX OF FIGURES
Figure 4.1: Model of CRC Development 63
Figure 4.2: Progression of CRC Development 63
Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 96
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 97
Figure 4.5: The BTA stat Test vs. Cytology 115
Figure 10.1: PCA3 Test Volume in U.S., 2005-2008 244
INDEX OF TABLES
Table 2.1: Organ-Specific Medicines in Development for Cancer 17
Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex 18
Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer 18
Table 2.4: Number of New Cancer Cases and Deaths by Region 19
Table 2.5: Cancer-Associated Genes 19
Table 2.6: Carcinogens in the Workplace 20
Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010 21
Table 2.8: Herceptin Worldwide Sales, 2000-2015 23
Table 2.9: Classes of Drugs Used to Treat Breast Cancer 23
Table 3.1: Tumor Biomarkers Currently in Common Use 27
Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, 2005-2015 28
Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 29
Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015 29
Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 30
Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31
Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015 31
Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 32
Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets 32
Table 3.11: Worldwide PSA Sales, 2000-2015 34
Table 3.12: U.S. PSA Sales, 2000-2015 34
Table 3.13: Serum Markers Used Clinically 35
Table 3.14: Drivers of IHC Growth 40
Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany 44
Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015 46
Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015 46
Table 3.18: Worldwide NMP22 Sales, 2001-2015 47
Table 3.19: Breast Cancer Products and Product Opportunities, 2006 55
Table 3.20: Products in Various Stages of Development for Cancers Other than Breast Cancer 56
Table 4.1: CRC Stages 61
Table 4.2: Worldwide CEA Sales, 2001-2015 64
Table 4.3: U.S. CEA Sales, 2001-2015 64
Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age 74
Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL 75
Table 4.6: Worldwide CA 19-9 Sales, 2001-2015 88
Table 4.7: U.S. CA 19-9 Sales, 2001-2015 88
Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer 89
Table 4.9: Worldwide CA 15-3 Sales, 2001-2015 90
Table 4.10: U.S. CA 15-3 Sales, 2001-2015 90
Table 4.11: TPA Marker Sensitivity 93
Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 95
Table 4.13: Oncogene Science Biomarker Group Reagents 98
Table 4.14: Worldwide CA-125 Sales, 2001-2015 100
Table 4.15: U.S. CA-125 Sales, 2001-2015 100
Table 4.16: Number of Pap Smears Performed by Country 105
Table 4.17: Lung Cancer Survival Rates 106
Table 4.18: American Cancer Society Lung Cancer Facts 107
Table 4.19: Tests Identifying Molecular Markers in Urine 112
Table 4.20: Patient Category Applications 113
Table 4.21: Worldwide AFP Marker Sales, 2001-2015 118
Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015 118
Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management 128
Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine 134
Table 4.25: MammaPrint: Key Features 140
Table 6.1: Tumor Marker Tests 162
Table 6.2: Tumor Diagnosis Immunoassays 163
Table 6.3: Tumor Diagnosis Radioimmunoassays 163
Table 6.4: PBM Product List 182
Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests 189
Table 8.1: CPT Codes for Tumor Markers 202
Table 10.1: Categories of Oncogenes 220
Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes 223
Table A3: TNM Classification 256
Table A7: Financial Comparison for Moderate and Waived CLIA Labs 265
Table A8: List of Marketers of Occult Blood Diagnostic Test Kits 267
- Abbott Diagnostics
- Affymetrix, Inc.
- Agendia BV
- Ambrilia Biopharma, Inc.
- AMDL, Inc.
- Asuragen, Inc.
- Aureon Laboratories, Inc.
- Bard Diagnostics, Inc.
- Beckman, Dickinson and Company (BD) Diagnostics - TriPath
- Beckman Coulter, Inc.
- Biocode S.A.
- Biomedical Diagnostics
- BioModa, Inc.
- Bruker Daltonics
- Byk Gulden
- Clarient, Inc.
- Correlogic Systems, Inc.
- CytoCore (formerly Molecular Diagnostics, Inc.)
- Cytogen Corporation (now EUSA Pharma)
- diaDexus, Inc.
- DiagnoCure, Inc.
- Diagnostic Automation / Cortez Diagnostics, Inc.
- DRG International, Inc.
- Eisai Co., Ltd.
- Enigma Diagnostics Ltd.
- Epigenomics AG
- Exact Sciences Corporation
- Exagen Diagnostics, Inc.
- Fujirebio Diagnostics, Inc.
- Gene Logic, Inc.
- Gen-Probe, Inc.
- Genomic Health
- Geron Corporation
- Hologic, Inc. (formerly Cytyc Corporation)
- Immunicon Corporation (now Veridex, LLC)
- Immunomedics, Inc.
- Incyte Pharmaceuticals, Inc.
- Mitsubishi Kagaku Medical
- Molecular Devices (formerly Arcturus Bioscience, Inc.)
- Myriad Genetics, Inc.
- Nexell Therapeutics, Inc.
- Northwest Biotherapeutics, Inc.
- Nuvelo, Inc.
- Oncotech, Inc.
- Oncothyreon, Inc. (formerly Biomira)
- Panacea Pharmaceuticals, Inc.
- Poniard Pharmaceuticals, Inc.
- Polymedco, Inc.
- Princeton BioMeditech Corporation
- Roche (F. Hoffman-La Roche, Ltd.)
- Sanko Junyaku Co., Ltd.
- Siemens Heathcare Diagnostics
- Tosoh Corporation (Bioscience division)
- Ventana Medical Systems, Inc.
- Veridex, LLC
- Vermillion, Inc.
- Worldwide Medical Corporation
- Xenomics, Inc. (TrovaGene, Inc.)