全球細胞試驗及人類乳突病毒（HPV）檢查市場

本報告已在2011年05月06日停止出版。

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全球細胞學及人類乳突病毒（HPV）檢測市場

Cytology and HPV Testing World Markets

出版日期 : 2011年01月

商品編碼: 191460

簡介

目錄

Abstract

Cancer is a group of diseases characterized by uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can result in death. Cancer is caused by both external (chemicals, radiation and viruses) and internal (hormones, immune conditions and inherited mutations) factors. Causal factors may act together or in sequence to initiate or promote carcinogenesis. Ten or more years often pass between exposures or mutations and detectable cancer. Cancer is treated by surgery, radiation, chemotherapy, hormones and immunotherapy. The purpose of this TriMark Publications report is to describe the specific segment of the diagnostic market aimed at analysis cytology (the examination of cells using optical microscopy methods) specimens derived from the human female reproductive tract. It examines the measurement devices and their reagents and supplies used in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the diagnosis and monitoring of disease. The study describes the analytical methods used to separate, isolate, characterize and quantitate cells, DNA and proteins complex in biological systems related to the diagnosis and treatment of disease of the female reproductive tract, such as the cervix and vagina. The emphasis is on those companies and products that are actively developing and marketing laboratory instrumentation, reagents and supplies for performing cytology and related molecular diagnostic tests, such as human papillomavirus (HPV) and other inflammatory and sexually-transmitted diseases.

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
• 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 Top Ten Biotech Corporations
    • 2.2.2 Technological Innovation
    • 2.2.3 Government Funding
    • 2.2.4 Pharmaceutical Development
  • 2.3 Outlook for Tumor Markers
  • 2.4 The Cancer Market
• 3. Cervical Cytology Testing Overview
  • 3.1 Sector Background
  • 3.2 Market Opportunity
  • 3.3 Cervical Cancer
    • 3.3.1 Screening for Cervical Cancer
    • 3.3.2 Screening Procedures and Pap Smear Technology
• 4. Human Papillomavirus (HPV) Testing Overview
  • 4.1 Market Overview
    • 4.1.1 Human Papillomavirus
    • 4.1.2 North American Market
    • 4.1.3 European Market
    • 4.1.4 Latin American Market
  • 4.2 Hybrid Capture 2 Technology
  • 4.3 Histology Market Overview
• 5. Cytology Market Structure
  • 5.1 Key Players
    • 5.1.1 BD, TriPath
    • 5.1.2 Cytyc (Acquired by Hologic)
    • 5.1.3 CytoCore, Inc. (formerly known as Molecular Diagnostics, Inc.)
  • 5.2 BD, TriPath Products
    • 5.2.1. Cervical Cytology Product Line
      • 5.2.1.1 BD SurePath Pap Test
      • 5.2.1.2 BD PrepStain Slide Processor
      • 5.2.1.3 BD FocalPoint GS Imaging System
      • 5.2.1.4 BD FocalPoint Slide Profiler
      • 5.2.1.5 Molecular Oncology
      • 5.2.1.6 Molecular Imaging Systems
      • 5.2.1.7 Blood-based Reagents
    • 5.2.2 Hologic Products
      • 5.2.2.1 The ThinPrep System
      • 5.2.2.1.1 Additional Applications of the ThinPrep System
      • 5.2.2.2 The ThinPrep Process
      • 5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test
      • 5.2.2.4 Competition
      • 5.2.2.5 Surgical Products
      • 5.2.2.6 The NovaSure System
      • 5.2.2.7 Competition
    • 5.2.3 CytoCore Inc., Products and Services
      • 5.2.3.1 SoftPAP Cervical Cell Collector
  • 5.3 Marketing and Sales Strategies
    • 5.3.1 BD, TriPath Sales and Marketing
      • 5.3.1.1 Total Sales and Marketing
      • 5.3.1.2 Commercial Operations
      • 5.3.1.3 Marketing Strategy
      • 5.3.1.4 BD, TriPath' s Molecular Diagnostic Products
    • 5.3.2 Cytyc (Acquired by Hologic) Marketing and Sales
      • 5.3.2.1 Sales and Marketing Costs
      • 5.3.2.2 Hologic' s Marketing and Sales Strategy
        • 5.3.2.2.1 Domestic Strategy
        • 5.3.2.2.2 International Strategy
      • 5.3.2.3 Sales Strategy - Cervical Cytology Product Line
        • 5.3.2.3.1 Molecular Diagnostics
        • 5.3.2.3.2 Marketing and Sales Organizations
        • 5.3.2.3.3 Outside the U.S. with the Exception of Canada
  • 5.4 Manufacturing BD, TriPath, BD SurePath and BD PrepStain
    • 5.4.1 Manufacturing Standards for Diagnostic Products
  • 5.5 Competition
    • 5.5.1 Molecular Diagnostic Reagents
• 6. Human Papillomavirus (HPV) Testing Market Structure
  • 6.1 Key Players
    • 6.1.1 Digene (Acquired by QIAGEN)
      • 6.1.1.1 Digene Products
    • 6.1.2 Ventana Medical Systems
  • 6.2 Products
    • 6.2.1 HPV Tests
    • 6.2.2 Chlamydia and Gonorrhea Tests
    • 6.2.3 Blood Virus Tests
    • 6.2.4 Instrumentation and Accessory Products
    • 6.2.5 Vaccine
  • 6.3 Sales and Marketing
    • 6.3.1 International Markets
    • 6.3.2 Europe
    • 6.3.3 Central and South America
    • 6.3.4 Asia/Pacific
    • 6.3.5 Strategy
  • 6.4 Manufacturing
  • 6.5 Competition
    • 6.5.1 Ventana
  • 6.6 Ventana Staining Products
    • 6.6.1 Ventana Products
• 7. Business Trends in the Industry
  • 7.1 Industry Consolidation
  • 7.2 Breath 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 and Partnerships
  • 7.10 Legal Developments
  • 7.11 Sales and Marketing Strategies for Tumor Marker Tests
    • 7.11.1 North American Market
• 8. Government Regulation
  • 8.1 Government Regulation
  • 8.2 U.S. FDA Approval
    • 8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
    • 8.2.2 Foreign Regulatory Approval
• 9. Legal Developments
  • 9.1 Cytyc Legal Proceedings
  • 9.2 Ventana Legal Proceedings
• 10. Third-Party Reimbursement
  • 10.1 Limited Reimbursements by Third-party Payers Obstruct Sales
  • 10.2 Cytyc ThinPrep
  • 10.3 CPT Codes and HCPCS Codes
  • 10.4 Professional Component Fee
  • 10.5 Regional Payer Relations Managers
  • 10.6 Reimbursement Codes Classification
    • 10.6.1 Reporting Screening and Diagnostic Pap Smears
    • 10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions
    • 10.6.3 CPT (Current Procedural Terminology) Code Definitions
  • 10.7 A Note on Statutory Limitations
  • 10.8 Cervical Cytology Product Line
  • 10.9 Molecular Diagnostic Products and Imaging Systems
• 11. Barriers in Business
  • 11.1 Barriers in the Business Section
    • 11.1.1 Hologic Barriers
    • 11.1.2 QIAGEN Risk Factors
    • 11.1.3 Ventana
      • 11.1.3.1 Ventana factors that could affect future results
• 12. Acquisition Activity
  • 12.1 Acquisition
  • 12.2 Hologic Acquires Cytyc
• 13. Research & Development Activity
  • 13.1 Hologic In-Process R&D and Developed Technology
  • 13.2 BD, TriPath Research & Development
    • 13.2.1 Development of Molecular Diagnostic Products
  • 13.3 Digene Research & Development
  • 13.4 Ventana Research & Development
    • 13.4.1 Instrumentation Development Projects
    • 13.4.2 Reagent Development Projects
• 14. Intellectual Property
  • 14.1 BD, TriPath Proprietary Technology and Intellectual Property
  • 14.2 Digene Intellectual Property
    • 14.2.1 Hybrid Capture Technology
    • 14.2.2 Rights to HPV Types
    • 14.2.3 Other Intellectual Property
  • 14.3 Ventana Patents and Proprietary Rights
• 15. Hologic and Cytyc Profile
  • 15.1 Company Information
    • 15.1.1 Contact
    • 15.1.2 About Cytyc and Hologic Together
  • 15.2 Products/Business Segments
    • 15.2.1 Diagnostic Products
    • 15.2.2 The ThinPrep Process
• 16. Analytical Section
  • 16.1 Financial Analysis
  • 16.2 Company' s Strategies
  • 16.3 SWOT Analysis
• 17. Industry/Market Landscape
  • 17.1 Industry Overview
    • 17.1.1 Industry Key Players
      • 17.1.1.1 Cytology Screening Testing Market Structure
      • 17.1.1.2 Human papillomavirus (HPV) Testing Market Structure
  • 17.2 Outlook on the Industry
  • 17.3 Trends, Issues, Challenges and Opportunities: An Analysis
  • 17.4 Molecular Diagnostics Products
    • 17.4.1 Microscopic Slide Based Reagents
    • 17.4.2 Molecular Imaging Systems
    • 17.4.3 Blood-Based Reagents
  • 17.5 Competitive Landscape
  • 17.6 Products/Business Segments
    • 17.6.1 Digene' s HPV Tests
    • 17.6.2 Digene' s Chlamydia and Gonorrhea Tests
    • 17.6.3 Digene' s Blood Virus Tests
    • 17.6.4 Digene' s Instrumentation and Accessory Products
• 18. QIAGEN
  • 18.3 Analytical Section
    • 18.3.1 Financial Analysis
  • 18.4 Company' s Strategies
  • 18.5 SWOT Analysis
• 19. Industry/Market Landscape
  • 19.1 Digene Industry Overview
    • 19.1.1 Industry Definition
      • 19.1.1.1 Cytology Products
    • 19.1.2 Industry Key Players
    • 19.1.3 Company' s Outlook on the Industry
  • 19.2 Trends, Issues, Challenges and Opportunities - An Analysis
  • 19.3 Competitive Landscape
  • 19.4 Competition
    • 19.4.1 Digene' s Competitive Advantage
    • 19.4.2 Molecular Diagnostic Reagents
    • 19.4.3 BD, TriPath
  • 19.5 Products/Business Segments
    • 19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line)
      • 19.5.1.1 BD PrepStain Slide Processor
      • 19.5.1.2 BD FocalPoint Imaging System
      • 19.5.1.3 BD SlideWizard Product Line
    • 19.5.2 Molecular Oncology Products
      • 19.5.2.1 Microscopic Slide Based Reagents
      • 19.5.2.2 Molecular Imaging Systems
      • 19.5.2.3 Blood-Based Reagents
• 20. Analytical Section
  • 20.1 Financial Analysis
    • 20.1.2 BD, TriPath Oncology Revenues
  • 20.2 Company' s Strategies
  • 20.3 SWOT Analysis
• 21. Industry/Market Landscape
  • 21.1 Industry Overview
    • 21.1.1 Industry Definition
      • 21.1.1.1 Cytology Products
      • 21.1.1.2 Molecular Diagnostic Products
    • 21.1.2 Industry Key Players
  • 21.2 Company' s Outlook on the Industry
  • 21.3 Trends, Issues, Challenges and Opportunities: An Analysis
  • 21.4 Molecular Diagnostics Products
    • 21.4.1 Blood-Based Reagents
  • 21.5 Competitive Landscape
    • 21.5.1 Competition
      • 21.5.1.2 BD, TriPath' s Competitive Advantage
      • 21.5.1.3 Molecular Diagnostic Reagents
      • 21.5.1.4 Ventana
• Appendix 1: Breast Cancer
• Appendix 2: Ovarian Cancer
• Appendix 3: Malignant Melanoma

INDEX OF TABLES

• Table 2.1: Drug Development by Type of Cancer
• Table 2.2: The 402 Organ Specific Medicines in Development for Cancer
• Table 2.3: Leading Sites of Cancer Cases and Deaths in the U.S. by Sex
• Table 2.4: Estimated New Cancer Cases and Deaths by Type of Cancer, 2008
• Table 2.5: Estimated Number of New Cancer Cases and Deaths by World Area 2007
• Table 2.6: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country
• Table 2.7: Cancer-Associated Genes
• Table 2.8: Carcinogens in the Workplace
• Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995 to 2007
• Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995 to 2007
• Table 2.11: U.S. Government NIH Research Budget, 1995 to 2008
• Table 2.12: Herceptin Worldwide Sales, 1999 to 2007
• Table 2.13: Classes of Drugs Used to Treat Breast Cancer
• Table 2.14: Women' s Cancers in the U.S., 2008
• Table 2.15: Five-Year Relative Survival Rates by Stage at Diagnosis
• Table 3.1: Number of Pap Smears Performed by Country
• Table 5.1: Pap Tests in Top European Markets
• Table 5.2: Pap Tests in Top Asian Markets
• Table 6.1: HPV Market Size, 2003 to 2011
• Table 6.2: Product, Infection and Market
• Table 6.3: Instrumentation and Accessories, Infection and Market
• Table 7.1: List and Discounted Pricing for Abbott Tumor Marker Tests
• Table 10.1: CPT and HCPCS Codes
• Table 10.2: National Limitation Amounts
• Table 10.3: NLAs for Various CPT Codes
• Table 14.1: HPV Types Status and Patents
• Table 17.1: Diagnostic Test Kit Products and Markets

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