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Cancer Diagnostic Testing World Markets

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.

Just as important as improved therapeutics is better diagnostics explaining why cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. 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: 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.

By Purchasing This Report You Will Have:

• An improved understanding of the current state and future of the cancer diagnostic testing market
• The latest information on the leading companies engaged in research and development and products in the pipeline
• The leading perspective of recent cancer diagnostic developments and revelations.
• Knowledge of the cancer diagnostics market as an area of growth, research and investment.

Analysis includes the use of charts and graphs measuring product growth and trends within the marketplace. In addition, a discussion of research into the cancer diagnostics arena provides the reader with a deeper understanding of the possibilities for future treatment and avenues for possible research and development budgets.

Company-specific information, including sales figures, product pipeline status and research and development trends is provided throughout the report. The report will:

• Identify viable technology drivers through a comprehensive look at platform technologies for cancer diagnostics, including, probe-based nucleic acid assays, microarrays and sequencing
• Obtain a complete understanding of the chief cancer diagnostics tests predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic-from their basic principles to their applications
• Discover feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas, focusing on the biggest and expanding markets in oncology
• Focus on global industry development through an in-depth analysis of the major world markets for cancer diagnostics, including growth forecasts.

This report answers the following questions in this report:

• What are the near-term business opportunities in the cancer diagnostics market?
• What are the current and forecasted sizes of the cancer diagnostics market?
• What are the business models currently used by companies in cancer diagnostics?
• How will manufacturers, researchers, physicians, patients and payers influence the cancer diagnostics market?
• What are the drivers and bottlenecks influencing the cancer diagnostics market?
• What are the technologies used in the cancer diagnostics sector?
• Who holds the proprietary rights to cancer diagnostics market technology?
• What are current applications of this technology?
• What regulatory processes must cancer diagnostics undergo in the United States, Japan and Europe?
• How will new cancer diagnostics change treatment and payment paradigms?
• How will cancer diagnostic testing reduce healthcare expenditures?

Table of Contents

• 1.Overview8
  • 1.1Statement of Report8
  • 1.2About This Report8
  • 1.3Scope of the Report9
  • 1.4Objectives10
  • 1.5 Methodology10
  • 1.6Executive Summary11
  
  
• 2.Introduction to Cancer Biology and the Diagnostic Industry14
  • 2.1Cancer14
    • 2.1.1The Disease14
    • 2.1.2Metastasis14
    • 2.1.3Demographics and Statistics of Cancer14
  • 2.2The Drivers of the Biotech and Diagnostics Industry19
    • 2.2.1Technological Innovation20
    • 2.2.2Government Funding21
  • 2.3Outlook for Tumor Markers21
  
  
• 3.Tumor Markers Market Segment Analysis: Size, Growth and Share23
  • 3.1Market Description24
  • 3.2Clinical Diagnostic Serum Based Cancer Markers31
  • 3.3PSA Testing Market Size32
  • 3.4DNA Markers33
  • 3.5Serum Proteins33
  • 3.6Enzymes34
  • 3.7Occult Blood34
  • 3.8Histology and In Situ Hybridization (ISH)35
  • 3.9Cervical Cytology36
  • 3.10Immunohistochemistry38
  • 3.11In Vivo Detection Cancer Products39
  • 3.12Radionuclides and X-Ray Detection Products39
  • 3.13Human Papillomavirus (HPV) Testing39
  • 3.14Bladder Cancer Testing43
  • 3.15Tumor Assays for Adjuvant Chemotherapy46
  
  
• 4. Diagnostic Methods for Cancer Detection59
  • 4.1Organ Specific Tumor Markers59
    • 4.1.1Colon Cancer59
    • 4.1.2Prostate Cancer66
    • 4.1.3Pancreatic Cancer83
    • 4.1.4Breast Cancer85
    • 4.1.5Ovarian Cancer94
    • 4.1.6Cervical Cancer99
    • 4.1.7Lung Cancer101
    • 4.1.8Testicular Cancer106
    • 4.1.9Bladder Cancer106
    • 4.1.10Hepatic Cancer112
    • 4.1.11Stomach Cancer114
    • 4.1.12Malignant Melanoma115
    • 4.1.13Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL)115
    • 4.1.14Lymphoma116
  • 4.2Clinical Laboratory Methods for Measuring Tumor Markers117
    • 4.2.1Abbott Diagnostics AxSYM117
    • 4.2.2Roche Diagnostics Elecsys117
    • 4.2.3Beckman Coulter Diagnostics Access117
    • 4.2.4Bayer Diagnostics ADVIA Centaur118
    • 4.2.5Dade Diagnostics Stratus118
    • 4.2.6Diagnostic Products Corporation Immulite118
    • 4.2.7Tosoh Medics A1A119
    • 4.2.8CIS bio International Kryptor120
    • 4.2.9Ortho-Clinical Diagnostics Vitros ECiQ120
    • 4.2.10Fujirebio Diagnostics, Inc.120
    • 4.2.11bioMérieux Vidas121
    • 4.2.12Eisai Picolumi121
    • 4.2.13Tosoh Medics, Inc.121
  • 4.3New Technologies for Cancer Diagnostics122
    • 4.3.1New and Improved Immunoassays122
    • 4.3.2Immunohistochemical Tests123
    • 4.3.3Molecular (DNA and Genomic) Diagnostic Assays124
    • 4.3.4Genomics and Genetic Markers125
    • 4.3.5Proteomics and New Protein Markers126
      • 4.3.5.1Inside the ProteinChip System126
      • 4.3.5.2Rapid Biological Assays on a Chip126
      • 4.3.5.3Proteome Pattern Recognition127
    • 4.3.6New Platform Technologies Including Flow Cytometry127
    • 4.3.7Stem Cell Markers130
    • 4.3.8Monoclonal Antibodies130
    • 4.3.9Proteomics and Cancer Antibodies134
    • 4.3.10Pharmacogenomics and Oncology Diagnostics134
    • 4.3.11DNA Microarrays137
    • 4.3.12In Vitro Diagnostic Multivariate Index Assays (IVDMIA)139
    • 4.3.13Prostate PX Score139
    • 4.3.14Prostate-63139
    • 4.3.15Future Directions139
  • 4.4Clinical Methods for Diagnosis of Cancer140
    • 4.4.1Screening140
    • 4.4.2Sigmoidoscopy142
    • 4.4.3Imaging142
    • 4.4.4Theranostics144
    
    
• 5.Implications of Molecular Biology for New Diagnostic Cancer Tests145


• 6.Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms146
  • 6.1Abbott Diagnostics146
  • 6.2Affymetrix, Inc.147
  • 6.3Agendia BV148
  • 6.4Agensys, Inc.148
  • 6.5Ambrilla Biopharma, Inc.149
  • 6.6AMDL, Inc.149
  • 6.7Asuragen, Inc.151
  • 6.8Aureon Biosciences Corporation151
  • 6.9Bard Diagnostics, Inc.151
  • 6.10Bayer Diagnostics152
  • 6.11Beckman Coulter, Inc.152
  • 6.12Biocode S.A.154
  • 6.13BioCurex154
  • 6.14Biomedical Diagnostics154
  • 6.15Biomerica155
  • 6.16bioMérieux155
  • 6.17Biomira155
  • 6.18BioModa, Inc.156
  • 6.19Bruker Daltonics156
  • 6.20Byk Gulden156
  • 6.21Cepheid156
  • 6.22Clarient, Inc.157
  • 6.23CytoCore (Formerly known as Molecular Diagnostics, Inc.)159
  • 6.24Correlogic Systems, Inc.159
  • 6.25Cytogen Corporation159
  • 6.26diaDexus, LLC162
  • 6.27DiagnoCure, Inc.163
  • 6.28Diagnostic Products Corporation164
  • 6.29Diagnostic Systems Laboratories, Inc.164
  • 6.30DRG International, Inc.164
  • 6.31Eisai Co., Ltd.165
  • 6.32Enigma Diagnostics Ltd.166
  • 6.33Epigenomics166
  • 6.34Exact Sciences Corporation166
  • 6.35Exagen Diagnostics, Inc.167
  • 6.37Gene Logic, Inc.167
  • 6.38Gen-Probe, Inc.168
  • 6.39Genomic Health168
  • 6.40Geron Corporation169
  • 6.42Immunicon Corporation170
  • 6.43Immunomedics, Inc.174
  • 6.44Incyte Pharmaceuticals, Inc.175
  • 6.45Ipsogen175
  • 6.46LabCorp175
  • 6.47Matritech176
  • 6.48Mitsubishi Kagaku Medical180
  • 6.49Molecular Devices (Formerly known as Arcturus Bioscience, Inc.)180
  • 6.50Myriad Genetics, Inc.180
  • 6.51Poniard Corporation185
  • 6.52Nexell Therapeutics, Inc.186
  • 6.53Northwest Biotherapeutics, Inc.186
  • 6.54Nuvelo, Inc.187
  • 6.55Panacea Pharmaceuticals, Inc.187
  • 6.56Oncotech, Inc.188
  • 6.57Polymedco, Inc.189
  • 6.58Princeton BioMeditech Corporation189
  • 6.59Qiagen191
  • 6.60Sanko Junyaku Co., Ltd.192
  • 6.61Tosoh Medics, Inc.192
  • 6.62TriPath Imaging, Inc.192
  • 6.63UroCor, Inc.194
  • 6.64Ventana Medical Systems, Inc.198
  • 6.65Veridex199
  • 6.66Vermillion, Inc. (Formerly known as Ciphergen)199
  • 6.67Worldwide Medical Corporation200
  • 6.68Xenomics, Inc.200
  
  
• 7.Business Trends in the Industry201
  • 7.1Industry Consolidation201
  • 7.2Breadth of Product Offering and Pricing201
  • 7.3Government Regulation of Medical Devices202
  • 7.4Strategic Business and Marketing Considerations203
  • 7.5Commercial Opportunities in Cancer Markers204
  • 7.6Moderators of Growth205
  • 7.7Biotechnology Industry Trends205
  • 7.8Pharmaceutical Industry Trends206
  • 7.9Acquisition, License Agreement, Partnerships208
  • 7.10Legal Developments210
  • 7.11Sales and Marketing Strategies for Tumor Marker Tests211
    • 7.11.1North American Market212
    • 7.11.2International Markets213
      • 7.11.2.1Europe213
      • 7.11.2.2Central and South America214
      • 7.11.2.3Asia/Pacific214
      
      
• 8.Tumor Marker Testing: Important Issues215
  • 8.1Trends in Patient Care and Reimbursement215
  • 8.2Trends in Reimbursement Practice216
  • 8.3Clinical Laboratory Improvement Act (CLIA)218
  • 8.4Unmet Needs in Tumor Markers219
  
  
• 9.Important New Technology Areas220
  • 9.1Proteins220
  • 9.2DNA Sequencing221
  • 9.3The Human Genome Project (HGP)222
  • 9.4Liquid Phase Chromatography223
  • 9.5Polymerase Chain Reaction (PCR)223
  • 9.6Capillary Electrophoresis224
  • 9.7Proteomics225
  • 9.8Use of Mass Spectroscopy in Sequencing226
  • 9.9High-Throughput Organic Synthesis230
  
  
• 10.New Cancer Markers in Basic Research232
  • 10.1Genetics of Cancer232
  • 10.2Telomerase235
  • 10.3Stomach Cancer237
  • 10.4Head and Neck Cancer238
  • 10.5Breast Cancer239
  • 10.6Prostate Cancer: p27 (Kip1) A New Molecular Marker for Prostate Cancer240
  • 10.7PSMA241
  • 10.8Cervical Cancer: NMPI79242
  • 10.9Pancreatic Cancer: Peritoneal Cytology242
  • 10.10Colorectal Cancer: CEA Doubling Time242
  • 10.11Uterine and Kidney Cancer: MN/CA9242
  • 10.12MMSC1 Scaffold Gene242
  • 10.13p16 Tumor Suppressor Gene243
  • 10.14MTS2 and p19 Cell Cycle Genes243
  • 10.15Complement Factor H Related Proteins243
  • 10.16MUC 2, 3, 4243
  • 10.17Cytokeratins244
  • 10.18Colon Cancer: Serum VEGF244
  • 10.19Ras Oncogenes244
  • 10.20Lung Cancer: Ribonucleoprotein A2/B1245
  • 10.21BCLA-4 Matrix Protein245
  • 10.22RAK Antigens245
  • 10.23Serum Urokinase Receptors245
  • 10.24Chips246
  • 10.25Survivin246
  • 10.26Human Endometrial Specific Steroid Binding Factor (hESF1)246
  • 10.27Reg-4 Protein247
  • 10.28Nox-1247
  • 10.29PSP94 Binding Protein247
  • 10.30Ettan DIGE Technology247
  • 10.31YKL-40248
  • 10.32AFP-L3248
  • 10.33DNA Methylation Technology248
  • 10.34Transthyretin and Apolipoprotein A1248
  • 10.35ADAM 12249
  • 10.36Ovarian Cancer: Vermillion\'s SELDI-based ProteinChip249
  • 10.37Lung Cancer: Labeled Porphyrin Binding249
  • 10.38C-MAP, A Cervical Cancer Screening System249
  • 10.39Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP)249
  • 10.40Prostate Cancer: PCA3249
  • 10.41Bladder Cancer: ImmunoCyt™/uCyt+™252
  • 10.42Shc Proteins252
  • 10.43Oncology Biomarker Qualification Initiative252
  • 10.44Anti-Glycan Antibodies253
  
  
• 11.Market Trends and Forecasts254
  • 11.1Ultrasensitive Cancer Tests254
  • 11.2Mergers and Acquisitions of Diagnostic Companies255
  • 11.3RT-PCR255
  • 11.4Genetic Tests of Hereditary Cancer Risk256
  • 11.5DNA Measurements256
  • 11.6Technical and Practical Issues for Potential New Markers256
  • 11.7Genetic Profiling257
  • 11.8Ploidy258
  • 11.9Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer258
  • 11.10Pharmacogenetic Tests for Cancer259
  • 11.11Worldwide Healthcare Spending260
  • 11.12R&D Expenditures260
  
  

 

Appendix 1: Web Links261

Appendix 2: Cancer Information Resources263

Appendix 3: Colon Cancer Staging264

Appendix 4: Reimbursement for Tumor Marker Testing265

Appendix 5: The Pathology of Prostate Cancer267

Appendix 6: Government Regulation of Tumor Marker Tests269

Appendix 7: The Clinical Laboratory Improvement Act (CLIA)271

Appendix 8: Marketers of Occult Blood Diagnostic Test Kits273

INDEX OF FIGURES

Figure 4.1: Model of Colorectal Cancer Development61

Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC90

Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH91

Figure 4.4: The BTA stat Test vs. Cytology111

Figure 6.1: Qiagen Global Sales192

Figure 10.1: Estimates for PCA3 Test Volume in U.S., 2005-2008251

INDEX OF TABLES

Table 2.1: Organ-Specific Medicines in Development for Cancer, 200715

Table 2.2: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex16

Table 2.3: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer16

Table 2.4: Estimated Number of New Cancer Cases and Deaths by Region17

Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country18

Table 2.6: Cancer Associated Genes18

Table 2.7: Carcinogens in the Workplace19

Table 2.8: Private Funding Levels for the Biotechnology Segment, 1995-200620

Table 2.9: Herceptin Worldwide Sales, 2000-200721

Table 2.10: Classes of Drugs Used to Treat Breast Cancer22

Table 3.1: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 200724

Table 3.2: Tumor Markers Currently in Common Use26

Table 3.3: Global IVD Cancer Tumor Marker Testing Market Segments Projected Growth Rates, 2005-201028

Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-201028

Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-201028

Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201029

Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201029

Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201030

Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201030

Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 200530

Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market31

Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets31

Table 3.13: Worldwide PSA Sales, 2000-201032

Table 3.14: U.S. PSA Sales, 2000-201033

Table 3.15: Serum Markers Used Clinically33

Table 3.16: ASCO-CAP Guidelines for HER-2 Testing in Breast Cancer38

Table 3.17: Drivers of IHC Growth39

Table 3.18: Bladder Cancer Testing Efforts in the U.S. and Germany43

Table 3.19: Worldwide Bladder Cancer Marker Sales, 2001-201045

Table 3.20: U.S. Bladder Cancer Marker Sales, 2001-201045

Table 3.21: Worldwide NMP22 Sales, 2001-201046

Table 3.22: Current Breast Cancer Product and Product Opportunities54

Table 3.23: Products in Various Stages of Development for Cancers Other than Breast Cancer55

Table 4.1: Colorectal Cancer Stages60

Table 4.2: Worldwide CEA Sales, 2001-201062

Table 4.3: U.S. CEA Sales, 2001-201062

Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age71

Table 4.5: PSA Doubling Time and Time to Reach PSA of 1,00072

Table 4.6: PSA Doubling Times72

Table 4.7: Worldwide CA-19-9 Sales, 2001-201084

Table 4.8: U.S. CA-19-9 Sales, 2001-201084

Table 4.9: CA-19-9 Levels in Management of Pancreatic Cancer85

Table 4.10: Worldwide CA-15-3 Sales, 2001-201086

Table 4.11: U.S. CA-15-3 Sales, 2001-201086

Table 4.12: TPA Marker Sensitivity88

Table 4.13: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results89

Table 4.14: Siemens Oncogene Science Biomarker Group Reagents92

Table 4.15: Worldwide CA-125 Sales, 2001-201095

Table 4.16: U.S. CA-125 Sales, 2001-201096

Table 4.17: Number of Pap Smears Performed by Country101

Table 4.18: Lung Cancer Survival Rates102

Table 4.19: Lung Cancer Facts103

Table 4.20: Patient Category Applications108

Table 4.21: Worldwide AFP Marker Sales, 2001-2010113

Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2010114

Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management124

Table 4.24: Colorectal Cancer Monoclonal Antibody Imaging Kits132

Table 6.1: Product Sales as a Percent of Total Product Sales, 2004-2006153

Table 6.2: Tumor Diagnosis Immunoassay165

Table 6.3: Tumor Diagnosis Radioimmunoassay165

Table 6.4: Summary of Matritech\'s Product Development Programs178

Table 6.5: Statements of Operations Data for Matritech, 2002-2006178

Table 6.6: Results of Operations of Matritech, 2005 and 2006179

Table 6.7: PBM Product List190

Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests202

Table 8.1: CPT Codes for Tumor Markers217

Table 10.1: Familial Cancer Syndromes and Tumor Suppressor Genes233

Table 10.2: Oncogenes and Anti-oncogenes233

Table A3: TNM Classification264

Table A7: Financial Comparison for Moderate and Waived CLIA Labs271

Table A8: List of Marketers of Occult Blood Diagnostic Test Kits273

 

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