全球癌症诊断检查市场

Abstract

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 TriMark 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.

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-i.e., 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. Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 Executive Summary

2. Introduction to Cancer Biology and the Diagnostic Industry

• 2.1 Cancer
  • 2.1.1 The Disease
  • 2.1.2 Metastasis
  • 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
• 3.6 Enzymes
• 3.7 Occult Blood
• 3.8 Histology and In Situ Hybridization (ISH)
• 3.9 Cervical Cytology
• 3.10 Immunohistochemistry
• 3.11 In Vivo Detection Cancer Products
• 3.12 Radionuclides and X-Ray Detection Products
• 3.13 Human Papillomavirus (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)
  • 4.1.14 Lymphoma
• 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
  • 4.2.4 Bayer Diagnostics ADVIA Centaur
  • 4.2.5 Dade Diagnostics Stratus
  • 4.2.6 Diagnostic Products Corporation Immulite
  • 4.2.7 Tosoh Medics A1A
  • 4.2.8 CIS bio International Kryptor
  • 4.2.9 Ortho-Clinical Diagnostics Vitros ECiQ
  • 4.2.10 Fujirebio Diagnostics, Inc.
  • 4.2.11 bioMérieux Vidas
  • 4.2.12 Eisai Picolumi
  • 4.2.13 Tosoh Medics, Inc.
• 4.3 New Technologies for Cancer Diagnostics
  • 4.3.1 New and Improved Immunoassays
  • 4.3.2 Immunohistochemical 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
    • 4.3.5.1 Inside the ProteinChip System
    • 4.3.5.2 Rapid Biological Assays on a Chip
    • 4.3.5.3 Proteome Pattern Recognition
  • 4.3.6 New Platform Technologies Including Flow Cytometry
  • 4.3.7 Stem Cell Markers
  • 4.3.8 Monoclonal Antibodies
  • 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 Multivariate Index Assays (IVDMIA)
  • 4.3.13 Prostate PX Score
  • 4.3.14 Prostate-63
  • 4.3.15 Future Directions
• 4.4 Clinical Methods for Diagnosis of Cancer
  • 4.4.1 Screening
  • 4.4.2 Sigmoidoscopy
  • 4.4.3 Imaging
  • 4.4.4 Theranostics

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 Agensys, Inc.
• 6.5 Ambrilla Biopharma, Inc.
• 6.6 AMDL, Inc.
• 6.7 Asuragen, Inc.
• 6.8 Aureon Biosciences Corporation
• 6.9 Bard Diagnostics, Inc.
• 6.10 Bayer Diagnostics
• 6.11 Beckman Coulter, Inc.
• 6.12 Biocode S.A.
• 6.13 BioCurex
• 6.14 Biomedical Diagnostics
• 6.15 Biomerica
• 6.16 bioMérieux
• 6.17 Biomira
• 6.18 BioModa, Inc.
• 6.19 Bruker Daltonics
• 6.20 Byk Gulden
• 6.21 Cepheid
• 6.22 Clarient, Inc.
• 6.23 CytoCore (Formerly known as Molecular Diagnostics, Inc.)
• 6.24 Correlogic Systems, Inc.
• 6.25 Cytogen Corporation
• 6.26 diaDexus, LLC
• 6.27 DiagnoCure, Inc.
• 6.28 Diagnostic Products Corporation
• 6.29 Diagnostic Systems Laboratories, Inc.
• 6.30 DRG International, Inc.
• 6.31 Eisai Co., Ltd.
• 6.32 Enigma Diagnostics Ltd.
• 6.33 Epigenomics
• 6.34 Exact Sciences Corporation
• 6.35 Exagen Diagnostics, Inc.
• 6.37 Gene Logic, Inc.
• 6.38 Gen-Probe, Inc.
• 6.39 Genomic Health
• 6.40 Geron Corporation
• 6.42 Immunicon Corporation
• 6.43 Immunomedics, Inc.
• 6.44 Incyte Pharmaceuticals, Inc.
• 6.45 Ipsogen
• 6.46 LabCorp
• 6.47 Matritech
• 6.48 Mitsubishi Kagaku Medical
• 6.49 Molecular Devices (Formerly known as Arcturus Bioscience, Inc.)
• 6.50 Myriad Genetics, Inc.
• 6.51 Poniard Corporation
• 6.52 Nexell Therapeutics, Inc.
• 6.53 Northwest Biotherapeutics, Inc.
• 6.54 Nuvelo, Inc.
• 6.55 Panacea Pharmaceuticals, Inc.
• 6.56 Oncotech, Inc.
• 6.57 Polymedco, Inc.
• 6.58 Princeton BioMeditech Corporation
• 6.59 Qiagen
• 6.60 Sanko Junyaku Co., Ltd.
• 6.61 Tosoh Medics, Inc.
• 6.62 TriPath Imaging, Inc.
• 6.63 UroCor, Inc.
• 6.64 Ventana Medical Systems, Inc.
• 6.65 Veridex
• 6.66 Vermillion, Inc. (Formerly known as Ciphergen)
• 6.67 Worldwide Medical Corporation
• 6.68 Xenomics, 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 Strategic Business and Marketing Considerations
• 7.5 Commercial Opportunities in Cancer Markers
• 7.6 Moderators of Growth
• 7.7 Biotechnology Industry Trends
• 7.8 Pharmaceutical Industry Trends
• 7.9 Acquisition, License Agreement, Partnerships
• 7.10 Legal Developments
• 7.11 Sales and Marketing Strategies for Tumor Marker Tests
  • 7.11.1 North American Market
  • 7.11.2 International Markets
    • 7.11.2.1 Europe
    • 7.11.2.2 Central and South America
    • 7.11.2.3 Asia/Pacific

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

• 9.1 Proteins
• 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
• 9.7 Proteomics
• 9.8 Use of Mass Spectroscopy in Sequencing
• 9.9 High-Throughput Organic Synthesis

10. New Cancer Markers in Basic Research

• 10.1 Genetics of Cancer
• 10.2 Telomerase
• 10.3 Stomach Cancer
• 10.4 Head and Neck Cancer
• 10.5 Breast Cancer
• 10.6 Prostate Cancer: p27 (Kip1) A New Molecular Marker for Prostate Cancer
• 10.7 PSMA
• 10.8 Cervical Cancer: NMPI79
• 10.9 Pancreatic Cancer: Peritoneal Cytology
• 10.10 Colorectal Cancer: CEA Doubling Time
• 10.11 Uterine and Kidney Cancer: MN/CA9
• 10.12 MMSC1 Scaffold Gene
• 10.13 p16 Tumor Suppressor Gene
• 10.14 MTS2 and p19 Cell Cycle Genes
• 10.15 Complement Factor H Related Proteins
• 10.16 MUC 2, 3, 4
• 10.17 Cytokeratins
• 10.18 Colon Cancer: Serum VEGF
• 10.19 Ras Oncogenes
• 10.20 Lung Cancer: Ribonucleoprotein A2/B1
• 10.21 BCLA-4 Matrix Protein
• 10.22 RAK Antigens
• 10.23 Serum Urokinase Receptors
• 10.24 Chips
• 10.25 Survivin
• 10.26 Human Endometrial Specific Steroid Binding Factor (hESF1)
• 10.27 Reg-4 Protein
• 10.28 Nox-1
• 10.29 PSP94 Binding Protein
• 10.30 Ettan DIGE Technology
• 10.31 YKL-40
• 10.32 AFP-L3
• 10.33 DNA Methylation Technology
• 10.34 Transthyretin and Apolipoprotein A1
• 10.35 ADAM 12
• 10.36 Ovarian Cancer: Vermillion' s SELDI-based ProteinChip
• 10.37 Lung Cancer: Labeled Porphyrin Binding
• 10.38 C-MAP, A Cervical Cancer Screening System
• 10.39 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP)
• 10.40 Prostate Cancer: PCA3
• 10.41 Bladder Cancer: ImmunoCyt™/uCyt+™
• 10.42 Shc Proteins
• 10.43 Oncology Biomarker Qualification Initiative
• 10.44 Anti-Glycan Antibodies

11. Market Trends and Forecasts

• 11.1 Ultrasensitive Cancer Tests
• 11.2 Mergers and Acquisitions of Diagnostic Companies
• 11.3 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
• 11.8 Ploidy
• 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
• 11.12 R&D Expenditures

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 Colorectal Cancer Development
• Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
• Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
• Figure 4.4: The BTA stat Test vs. Cytology
• Figure 6.1: Qiagen Global Sales
• Figure 10.1: Estimates for PCA3 Test Volume in U.S., 2005-2008

INDEX OF TABLES

• Table 2.1: Organ-Specific Medicines in Development for Cancer, 2007
• Table 2.2: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex
• Table 2.3: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
• Table 2.4: Estimated Number of New Cancer Cases and Deaths by Region
• Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country
• Table 2.6: Cancer Associated Genes
• Table 2.7: Carcinogens in the Workplace
• Table 2.8: Private Funding Levels for the Biotechnology Segment, 1995-2006
• Table 2.9: Herceptin Worldwide Sales, 2000-2007
• Table 2.10: Classes of Drugs Used to Treat Breast Cancer
• Table 3.1: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007
• Table 3.2: Tumor Markers Currently in Common Use
• Table 3.3: Global IVD Cancer Tumor Marker Testing Market Segments Projected Growth Rates, 2005-2010
• Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005
• Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
• Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets
• Table 3.13: Worldwide PSA Sales, 2000-2010
• Table 3.14: U.S. PSA Sales, 2000-2010
• Table 3.15: Serum Markers Used Clinically
• Table 3.16: ASCO-CAP Guidelines for HER-2 Testing in Breast Cancer
• Table 3.17: Drivers of IHC Growth
• Table 3.18: Bladder Cancer Testing Efforts in the U.S. and Germany
• Table 3.19: Worldwide Bladder Cancer Marker Sales, 2001-2010
• Table 3.20: U.S. Bladder Cancer Marker Sales, 2001-2010
• Table 3.21: Worldwide NMP22 Sales, 2001-2010
• Table 3.22: Current Breast Cancer Product and Product Opportunities
• Table 3.23: Products in Various Stages of Development for Cancers Other than Breast Cancer
• Table 4.1: Colorectal Cancer Stages
• Table 4.2: Worldwide CEA Sales, 2001-2010
• Table 4.3: U.S. CEA Sales, 2001-2010
• Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age
• Table 4.5: PSA Doubling Time and Time to Reach PSA of 1,000
• Table 4.6: PSA Doubling Times
• Table 4.7: Worldwide CA-19-9 Sales, 2001-2010
• Table 4.8: U.S. CA-19-9 Sales, 2001-2010
• Table 4.9: CA-19-9 Levels in Management of Pancreatic Cancer
• Table 4.10: Worldwide CA-15-3 Sales, 2001-2010
• Table 4.11: U.S. CA-15-3 Sales, 2001-2010
• Table 4.12: TPA Marker Sensitivity
• Table 4.13: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
• Table 4.14: Siemens Oncogene Science Biomarker Group Reagents
• Table 4.15: Worldwide CA-125 Sales, 2001-2010
• Table 4.16: U.S. CA-125 Sales, 2001-2010
• Table 4.17: Number of Pap Smears Performed by Country
• Table 4.18: Lung Cancer Survival Rates
• Table 4.19: Lung Cancer Facts
• Table 4.20: Patient Category Applications
• Table 4.21: Worldwide AFP Marker Sales, 2001-2010
• Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2010
• Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management
• Table 4.24: Colorectal Cancer Monoclonal Antibody Imaging Kits
• Table 6.1: Product Sales as a Percent of Total Product Sales, 2004-2006
• Table 6.2: Tumor Diagnosis Immunoassay
• Table 6.3: Tumor Diagnosis Radioimmunoassay
• Table 6.4: Summary of Matritech' s Product Development Programs
• Table 6.5: Statements of Operations Data for Matritech, 2002-2006
• Table 6.6: Results of Operations of Matritech, 2005 and 2006
• Table 6.7: PBM Product List
• Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests
• Table 8.1: CPT Codes for Tumor Markers
• Table 10.1: Familial Cancer Syndromes and Tumor Suppressor Genes
• Table 10.2: Oncogenes and Anti-oncogenes
• Table A3: TNM Classification
• Table A7: Financial Comparison for Moderate and Waived CLIA Labs
• Table A8: List of Marketers of Occult Blood Diagnostic Test Kits