全球的癌症診斷檢查市場 是由出版商Trimark Publications在2011年07月所出版的。
這份英文市場調查報告書包含267 Pages 價格從美金3400起跳。
癌症檢查為診斷領域在今後3∼5年間，最重要的成長領域之一。根據National Cancer Institute的預測，約有1,000萬美國人罹患各種癌症。年間成本為總額1,260億美元。藥廠針對癌症開發了300種以上的新藥，不過，一部分尚在開發當中，而有超過500項進行中的研發計畫。
本報告，彙整腫瘤標記檢查裝置市場的概要、美國以及全球的業績動向、市場規模、參與企業的檔案資料、課題、新技術領域和今後的預測等，由下列摘要形式闡述。
第1章 概要
第2章 癌症的生物學與診斷業界的概要
- 癌症
- 生物科技與診斷業界的促進因子
- 腫瘤標記的展望
第3章 腫瘤標記市場區塊分析：規模、成長、以及市佔率
- 市場概要
- 臨床診斷用血清腫瘤標記
- PSA檢查市場規模
- DNA標記
- 血清蛋白質
- 酵素
- 潛血
- 組織學與In Situ的複合化
- 子宮頸細胞診斷
- 免疫細胞化學
- 活體內癌症檢查用產品
- 物理放射核種與X光檢查產品
- HPV檢查
- 膀胱癌檢查
- 補充化學療法的腫瘤檢查
第4章 發現癌症的診斷方法
- 各種器官的腫瘤標記
- 腫瘤標記測量的臨床檢驗方式
- 癌症診斷的新技術
- 癌症診斷的臨床方法
第5章 分子生物學於新癌症診斷檢查上的影響
第6章 持有新技術平台的癌症診斷市場參與企業
第7章 癌症診斷檢查業界的商業動向
- 業界的整合化
- 各種產品與價格設定
- 醫療機器的相關政府規範
- 腫瘤標記的商業機會
- 腫瘤細胞成長抑制劑
- 生物業界的動向
- 製藥業界的動向
- 腫瘤標記檢查的銷售、市場行銷策略
第8章 腫瘤標記檢查的重要課題
- 病患照護與醫療報銷的動向
- 醫療報銷的動向
- CLIA（臨床檢驗改善法）
- 癌症市場的未滿足需求
第9章 重要的新技術領域
- 蛋白質
- 核酸定序
- 人體基因計劃
- 液相層析
- 聚合酶連鎖反應（PCR）
- 毛細管電泳
- 蛋白質體學
- 定序上的質量分析應用
- 高通量有機合成
第10章 基礎研究上的新癌症市場
第11章 市場的動向與預測
- 超高感度癌症檢查
- 診斷企業的M&A
- RT-PCR
- 遺傳性癌症風險的基因檢測
- DNA分析
- 潛在的新標記的技術・實用課題
- 基因檔案
- 染色體套數
- 肺癌初期診斷的唾液分析的進步
- 癌症的藥理基因體學檢查
- 全球的醫療支出額
- 研發費用
附錄
圖表
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.
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 IHC
- 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)
- 4.1.14 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 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
- 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 mAbs
- 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
- 4.3.14 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 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.
- 6.12 BioCurex
- 6.13 Biomedical Diagnostics
- 6.14 Biomerica
- 6.15 bioMerieux
- 6.16 BioModa, Inc.
- 6.17 Bruker Daltonics
- 6.18 Byk Gulden
- 6.19 Cepheid
- 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
- 6.42 Ipsogen
- 6.43 LabCorp
- 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
- 6.55 Qiagen
- 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
- 7.8.2.1 Europe
- 7.8.2.2 Central and South America
- 7.8.2.3 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 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)
- 10.3 Telomeres
- 10.4 Diseases
- 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
- 10.5.4 Cytokeratins
- 10.5.5 RAK Antigens
- 10.5.6 Serum Urokinase Receptors
- 10.5.7 Survivin
- 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
- 10.5.13 YKL-40
- 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 Technology
- 10.6.1 Chips
- 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
- 11.8 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
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
- Figure 4.2: Progression of CRC Development
- Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer:
Equivocal Results with IHC
- Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results
by FISH
- Figure 4.5: The BTA stat Test vs. Cytology
- Figure 10.1: PCA3 Test Volume in U.S., 2005-2008
INDEX OF TABLES
- Table 2.1: Organ-Specific Medicines in Development for Cancer
- Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the
U.S. by Sex
- Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of
Cancer
- Table 2.4: Number of New Cancer Cases and Deaths by Region
- Table 2.5: Cancer-Associated Genes
- Table 2.6: Carcinogens in the Workplace
- Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010
- Table 2.8: Herceptin Worldwide Sales, 2000-2015
- Table 2.9: Classes of Drugs Used to Treat Breast Cancer
- Table 3.1: Tumor Biomarkers Currently in Common Use
- Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth
Rates, 2005-2015
- Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays
Product Market, 2001-2015
- Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays
Product Market, 2001-2015
- Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size,
2001-2015
- Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size,
2001-2015
- Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size,
2001-2015
- Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size,
2001-2015
- Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker
Diagnostics Market
- Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets
- Table 3.11: Worldwide PSA Sales, 2000-2015
- Table 3.12: U.S. PSA Sales, 2000-2015
- Table 3.13: Serum Markers Used Clinically
- Table 3.14: Drivers of IHC Growth
- Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany
- Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015
- Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015
- Table 3.18: Worldwide NMP22 Sales, 2001-2015
- Table 3.19: Breast Cancer Products and Product Opportunities, 2006
- Table 3.20: Products in Various Stages of Development for Cancers Other
than Breast Cancer
- Table 4.1: CRC Stages
- Table 4.2: Worldwide CEA Sales, 2001-2015
- Table 4.3: U.S. CEA Sales, 2001-2015
- Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50
Years of Age
- Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL
- Table 4.6: Worldwide CA 19-9 Sales, 2001-2015
- Table 4.7: U.S. CA 19-9 Sales, 2001-2015
- Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer
- Table 4.9: Worldwide CA 15-3 Sales, 2001-2015
- Table 4.10: U.S. CA 15-3 Sales, 2001-2015
- Table 4.11: TPA Marker Sensitivity
- Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to
Interpret Test Results
- Table 4.13: Oncogene Science Biomarker Group Reagents
- Table 4.14: Worldwide CA-125 Sales, 2001-2015
- Table 4.15: U.S. CA-125 Sales, 2001-2015
- Table 4.16: Number of Pap Smears Performed by Country
- Table 4.17: Lung Cancer Survival Rates
- Table 4.18: American Cancer Society Lung Cancer Facts
- Table 4.19: Tests Identifying Molecular Markers in Urine
- Table 4.20: Patient Category Applications
- Table 4.21: Worldwide AFP Marker Sales, 2001-2015
- Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015
- Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management
- Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the
Prostate, Breast and Intestine
- Table 4.25: MammaPrint: Key Features
- Table 6.1: Tumor Marker Tests
- Table 6.2: Tumor Diagnosis Immunoassays
- Table 6.3: Tumor Diagnosis Radioimmunoassays
- Table 6.4: 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: Categories of Oncogenes
- Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes
- 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
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