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世界の癌診断検査市場

Cancer Diagnostic Testing World Markets

発行 TriMark Publications 商品コード 203885
出版日 ページ情報 英文 264 Pages
納期: 即日から翌営業日
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2016年12月31日まで 年末キャンペーン割引: TriMark Publications社発行レポート
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世界の癌診断検査市場 Cancer Diagnostic Testing World Markets
出版日: 2016年01月01日 ページ情報: 英文 264 Pages
担当者のコメント
米国ニューヨークに本社を置くTriMark Publicationsは、医療分野の市場分析に定評のある調査会社です。世界市場の中でもアメリカ市場の分析を得意としています。本レポートでもアメリカの主要な企業の情報が網羅されております。TriMark Publicationsが発行するレポートは、比較的短いスパンで情報が更新される商品が多く、最新データが網羅されているとして継続的に購入されるお客様の多い人気のシリーズです。
概要

癌検査は診断領域において今後3〜5年の間、最重要の成長分野のひとつです。National Cancer Instituteの予測によると、約1,000万人の米国人がなんらかの癌を患っているとみられています。製薬会社は癌のための新薬を300以上開発していますが、一部は開発中で、500を超える継続中の研究開発プロジェクトがあります。

当レポートは、腫瘍マーカー検査装置市場の概要、米国および世界の売上動向、市場規模とともに、参入企業のプロファイル、課題、新技術分野や今後の予測などについて取り上げています。

第1章 概要

第2章 癌の生物学と診断業界の概要

    • 疾患
    • 転移
    • 癌の人口統計と統計学
  • バイオテクノロジーと診断業界の促進因子
    • 技術革新
    • 政府の資金援助
  • 腫瘍マーカーの展望

第3章 腫瘍マーカー市場セグメント分析:規模、成長、およびシェア

  • 市場概要
  • 臨床診断用血清腫瘍マーカー
  • PSA 検査市場規模
  • DNA マーカー
  • 血清蛋白質
  • 酵素
  • 潜血
  • 組織学とIn Situのハイブリッド化
  • 子宮頸細胞診
  • 免疫細胞化学
  • インビボ癌検査用製品
  • 放射性核種とX線検査製品
  • HPV検査
  • 膀胱癌検査
  • 補足的化学療法のための腫瘍検査

第4章 癌発見のための診断方法

  • 各種器官の腫瘍マーカー
  • 腫瘍マーカー計測のための臨床検査手法
  • 癌診断のための新技術

第5章 新技術プラットフォームを有する癌診断市場参入企業

第6章 癌診断検査業界のビジネス動向

  • 業界の統合化
  • 様々な製品と価格設定
  • 医療機器に関する政府規制
  • 腫瘍マーカーのビジネスチャンス
  • 腫瘍細胞成長抑制剤
  • バイオ業界の動向
  • 製薬業界の動向
  • 腫瘍マーカー検査の販売、マーケティング戦略
  • 診断企業のM&A

第7章 基礎研究における新しい癌市場

  • 癌の遺伝的特徴
  • DNA不適正塩基対の修正遺伝子 (MMRs)
  • テロメア(染色体末端部位)
  • 癌の種類
  • 腫瘍マーカー
  • 技術
  • 疾患別技術
  • 超高感度癌検診
  • 逆転写ポリメラーゼ連鎖反応(RT-PCR)
  • 遺伝性癌のリスクの遺伝子検査
  • 潜在的な新たなマーカーに対する技術的および実用上の課題
  • 遺伝子プロファイリング
  • 倍数性
  • 世界的な医療支出額

付録

図表

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目次
Product Code: TMRCDTWM16-1101

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. 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 Immunohistochemistry (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
    • 4.2.2 Roche Diagnostics Systems
    • 4.2.3 Beckman Coulter Diagnostics Immunoassay Systems
    • 4.2.4 Siemens Healthcare Diagnostics ADVIA Centaur CP Immunoassay System, the ADVIA Centaur XP Immunoassay System and ADVIA Centuar XPT Immunoassay System
    • 4.2.5 Tosoh Bioscience AIA-2000
    • 4.2.6 Thermo Fisher Scientific B.R.A.H.M.S. KRYPTOR
    • 4.2.7 Ortho-Clinical Diagnostics Vitros ECiQ (Johnson and Johnson)
    • 4.2.8 Fujirebio Diagnostics, Inc.
    • 4.2.9 bioMérieux 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 Pharmacogenomics and Oncology Diagnostics
    • 4.3.10 DNA Microarrays
    • 4.3.11 In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
    • 4.3.12 Prostate-63
    • 4.3.13 Future Directions

5. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms

  • 5.1 Abbott Diagnostics
  • 5.2 Agendia BV
  • 5.3 bioMérieux
  • 5.4 DRG International, Inc.
  • 5.5 Eisai Co., Ltd.
  • 5.6 Exact Sciences Corporation
  • 5.7 Fujirebio Diagnostics, Inc.
  • 5.8 Genomic Health, Inc.
  • 5.9 Hologic, Inc.
  • 5.10 LabCorp
  • 5.11 Myriad Genetics, Inc.
  • 5.12 Neogenomics
  • 5.13 Roche
  • 5.14 Siemens
  • 5.15 Tosoh Corporation (Bioscience Division)

6. Business Trends in the Industry

  • 6.1 Industry Consolidation
  • 6.2 Breadth of Product Offering and Pricing
  • 6.3 Government Regulation of Medical Devices
  • 6.4 Commercial Opportunities in Cancer Markers
  • 6.5 Moderators of Growth
  • 6.6 Biotechnology Industry Trends
  • 6.7 Pharmaceutical Industry Trends
  • 6.8 Sales and Marketing Strategies for Tumor Marker Tests
    • 6.8.1 North American Market
    • 6.8.2 International Markets
      • 6.8.2.1 Europe
      • 6.8.2.2 Central and South America
      • 6.8.2.3 Asia-Pacific
  • 6.9 Mergers and Acquisitions (M&As) of Diagnostic Companies

7. New Cancer Markers in Basic Research

  • 7.1 Genetics of Cancer
    • 7.1.1 Activator Genes (Oncogenes)
    • 7.1.2 Inactivating Genes (Tumor Suppressor Genes)
  • 7.2 DNA Mismatch Repair Genes (MMRs)
  • 7.3 Telomeres
  • 7.4 Diseases
    • 7.4.1 t(15;17) in Acute Promyelocytic Leukemia (APL)
    • 7.4.2 t(12;21) in Acute Lymphoblastic Leukemia (ALL)
    • 7.4.3 Retinoblastoma and Constitutional 13q14 Deletion
    • 7.4.4 Stomach Cancer
    • 7.4.5 Head and Neck Cancer
    • 7.4.6 Breast and Ovarian Cancers
    • 7.4.7 Prostate Cancer
    • 7.4.8 Cervical Cancer: NMPI79
    • 7.4.9 Uterine and Kidney Cancer: Transmembrane Protein Carbonic Anhydrase IX (CA IX)
    • 7.4.10 Colon Cancer: Serum Vascular Endothelial Growth factor (VEGF)
    • 7.4.11 Lung Cancer: Ribonucleoprotein A2/B1 and microRNA Markers
  • 7.5 Tumor Markers
    • 7.5.1 Oncology Biomarker Qualification Initiative
    • 7.5.2 CRC: Carcinoembryonic Antigen (CEA) Doubling Time
    • 7.5.3 MUC1, 2, 3 and 4
    • 7.5.4 Cytokeratins
    • 7.5.5 RAK Antigens
    • 7.5.6 Serum Amyloid A (SAA)
    • 7.5.7 Survivin
    • 7.5.8 Reg-4 Protein
    • 7.5.9 NADPH Oxidases 1 and 2 (NOX1 and NOX2)
    • 7.5.10 Prostate Secretory Protein 94- (PSP94)-Binding Protein
    • 7.5.11 Shc Proteins
    • 7.5.12 Anti-Glycan Antibodies
    • 7.5.13 YKL-40
    • 7.5.14 Alpha-Fetoprotein (AFP)-L3
    • 7.5.15 Transthyretin and Apo Lipoprotein A1 (Apo A1)
    • 7.5.16 A Disintegrin and Metalloproteinase (ADAM)
  • 7.6 Technology
    • 7.6.1 Chips
    • 7.6.2 Ettan DIGE Technology
    • 7.6.3 DNA Methylation Technology
  • 7.7 Disease-Specific Technology
    • 7.7.1 Ovarian Cancer: Bio-Rad's SELDI-Based ProteinChip
    • 7.7.2 Lung Cancer: Labeled Porphyrin Binding
    • 7.7.3 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP)
    • 7.7.4 Prostate Cancer: PCA3
    • 7.7.5 Bladder Cancer: ImmunoCyt/uCyt+
  • 7.8 Ultrasensitive Cancer Tests
  • 7.9 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
  • 7.10 Genetic Tests of Hereditary Cancer Risk
  • 7.11 Technical and Practical Issues for Potential New Markers
  • 7.12 Genetic Profiling
  • 7.13 Ploidy
  • 7.14 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 1.1: Medicines in Development in Cancer
  • Figure 4.1: Bowel Cancer including Anal Cancer: Estimates: World Age-Standardized Incidence Rates per 100,000 Population, World Regions
  • Figure 4.2: Percentage of Adults Aged 50-75 Years Who Reported Being Up-to-Date with Colorectal Test Screening, by State Behavioral Risk Factor Surveillance System in the U.S., 2010
  • Figure 4.3: Progression of CRC Development
  • Figure 4.4: Prostate Cancer (C61): Estimates: World Age-Standardized Incidence Rates per 100,000 Population, Males, World Regions
  • Figure 4.5: Prostate Cancer (C61): Estimated Incidence
  • Figure 4.6: Estimates for PCA3 Test Volume in U.S., 2005-2012
  • Figure 4.7: Pancreatic Cancer: Estimates: World Age-Standardized Incidence Rates per 100,000 Population, Male and Females, World Regions
  • Figure 4.8: Breast Cancer: Estimates: World Age-Standardized Incidence Rates per 100,000 Population, Females, World Regions
  • Figure 4.9: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer, 2013
  • Figure 4.10: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer, 2013
  • Figure 4.11: Ovarian Cancer: Estimates: European Age-Standardized Incidence Rates per 100,000 Population, Females, World Regions
  • Figure 4.12: Cervical Cancer: Estimates: World Age-Standardized Incidence Rates per 100,000 Population, Females, World Regions
  • Figure 4.13: Lung Cancer: Estimates: World Age-Standardized Incidence Rates per 100,000 Population, World Regions
  • Figure 4.14: The BTA stat Test vs. Cytology

INDEX OF TABLES

  • Table 2.1: Organ-Specific Medicines in Development for Cancer
  • Table 2.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2015
  • Table 2.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2015
  • Table 2.4: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer (Men)
  • Table 2.5: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer (Women)
  • Table 2.6: Estimated Incidence, Mortality and Prevalence Worldwide in 2012
  • Table 2.7: Cancer-Associated Genes
  • Table 2.8: Carcinogens in the Workplace
  • Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995-2014
  • Table 2.10: Herceptin Worldwide Sales, 2000-2017
  • Table 2.11: 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, 2011-2021
  • Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2011-2021
  • Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2011-2021
  • Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2011-2021
  • Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2011-2021
  • Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2011-2021
  • Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2011-2021
  • 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 Market
  • Table 3.11: Worldwide PSA Sales, 2011-2021
  • Table 3.12: U.S. PSA Sales, 2011-2021
  • 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, 2011-2021
  • Table 3.17: U.S. Bladder Cancer Marker Sales, 2011-2021
  • Table 3.18: Worldwide NMP22 Sales, 2011-2021
  • Table 3.19: Breast Cancer Products and Product Opportunities
  • Table 3.20: Products in Various Stages of Development for Cancers Other than Breast Cancer
  • Table 4.1: CRC Stages
  • Table 4.2: Colon Cancer Facts
  • Table 4.3: Number of Procedures Based on Patients Aged ≥50 Years who Reported Receiving a Fecal Occult Blood Test within One Year or a Lower Endoscopy within Ten Years, by Age and Sex in the U.S.
  • Table 4.4: Worldwide CEA Sales, 2011-2021
  • Table 4.5: U.S. CEA Sales, 2011-2021
  • Table 4.6: Japan CEA Sales, 2011-2021
  • Table 4.7: Europe CEA Sales, 2011-2021
  • Table 4.8: Rest of the World CEA Sales, 2011-2021
  • Table 4.9: Worldwide PSA Sales, 2011-2021
  • Table 4.10: U.S. PSA Sales, 2011-2021
  • Table 4.11: Japan PSA Sales, 2011-2021
  • Table 4.12: Europe PSA Sales, 2011-2021
  • Table 4.13: Rest of the World PSA Sales, 2011-2021
  • Table 4.14: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age
  • Table 4.15: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL
  • Table 4.16: Human tissue Kallikreins as Cancer Markers
  • Table 4.17: New Diagnostic Tests for Prostate Cancer
  • Table 4.18: Gen-Probe Genetic Testing Product Line
  • Table 4.19: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
  • Table 4.20: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
  • Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
  • Table 4.22: Worldwide CA 19-9 Sales, 2011-2021
  • Table 4.23: U.S. CA 19-9 Sales, 2011-2021
  • Table 4.24: Japan CA 19-9 Sales, 2011-2021
  • Table 4.25: Europe CA 19-9 Sales, 2011-2021
  • Table 4.26: Rest of the World CA 19-9 Sales, 2011-2021
  • Table 4.27: CA 19-9 Levels in Management of Pancreatic Cancer
  • Table 4.28: Worldwide CA 15-3 Sales, 2011-2021
  • Table 4.29: U.S. CA 15-3 Sales, 2011-2021
  • Table 4.30: Japan CA 15-3 Sales, 2011-2021
  • Table 4.31: Europe CA 15-3 Sales, 2011-2021
  • Table 4.32: Rest of the World CA 15-3 Sales, 2011-2021
  • Table 4.33: TPA Marker Sensitivity
  • Table 4.34: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
  • Table 4.35: Worldwide CA-125 Sales, 2011-2021
  • Table 4.36: U.S. CA-125 Sales, 2011-2021
  • Table 4.37: Japan CA-125 Sales, 2011-2021
  • Table 4.38: Europe CA-125 Sales, 2011-2021
  • Table 4.39: Rest of the World CA-125 Sales, 2011-2021
  • Table 4.40: Worldwide HVP Sales, 2011-2021
  • Table 4.41: U.S. HPV Sales, 2011-2021
  • Table 4.42: Japan HVP Sales, 2011-2021
  • Table 4.43: Europe HVP Sales, 2011-2021
  • Table 4.44: Rest of the World HVP Sales, 2011-2021
  • Table 4.45: HCPCS Codes for Screening Pap Tests
  • Table 4.46: HCPCS Codes for Screening Pap Tests Rate
  • Table 4.47: Number of Pap Smears Performed by Country
  • Table 4.48: Lung Cancer Survival Rates
  • Table 4.49: American Cancer Society Lung Cancer Facts
  • Table 4.50: Predictive and Prognostic Rates
  • Table 4.51: Tests Identifying Molecular Markers in Urine
  • Table 4.52: Worldwide NMP22/BTA Sales, 2011-2021
  • Table 4.53: U.S. NMP22/BTA Sales, 2011-2021
  • Table 4.54: Japan NMP22/BTA Sales, 2011-2021
  • Table 4.55: Europe NMP22/BTA Sales, 2011-2021
  • Table 4.56: Rest of the World NMP22/BTA Sales, 2011-2021
  • Table 4.57: Patient Category Applications
  • Table 4.58: Worldwide Alpha-Fetal Protein (AFP) Sales, 2011-2021
  • Table 4.59: U.S. Alpha-Fetal Protein (AFP) Sales, 2011-2021
  • Table 4.60: Japan Alpha-Fetal Protein (AFP) Sales, 2011-2021
  • Table 4.61: Europe Alpha-Fetal Protein (AFP) Sales, 2011-2021
  • Table 4.62: Rest of the World Alpha-Fetal Protein (AFP) Sales, 2011-2021
  • Table 4.63: Key Oncology Diagnostic Tests, Roche, 2015
  • Table 4.64: Potential Uses of Molecular Diagnostics in Cancer Management
  • Table 4.65: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine
  • Table 4.66: MammaPrint: Key Features
  • Table 5.1: Tumor Diagnosis Immunoassays
  • Table 5.2: Tumor Diagnosis Radioimmunoassays
  • Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests
  • Table 7.1: Categories of Oncogenes
  • Table 7.2: Familial Cancer Syndromes and Tumor Suppressor Genes
  • Table A7.1: Financial Comparison for Moderate and Waived CLIA Labs
  • Table A8.1: List of Marketers of Fecal Occult Blood Diagnostic Test Kits
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