Cytology and Hpv Testing World Markets

Content

• 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 Technological Innovation
    • 2.2.2 Government Funding
    • 2.2.3 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 HPV
  • 4.3 Histology Market Overview
• 5. Cytology Market Structure
  • 5.1 Key Players
    • 5.1.1 TriPath Imaging
    • 5.1.2 Cytyc
    • 5.1.3 Molecular Diagnostics, Inc
  • 5.2 TriPath Products
    • 5.2.1. Cervical Cytology Product Line
      • 5.2.1.1 The SurePath Test Pack
      • 5.2.1.2 PrepStain Slide Processor
      • 5.2.1.3 FocalPoint Imaging System
      • 5.2.1.4 SlideWizard Product Line
      • 5.2.1.5 Molecular Diagnostics Products
      • 5.2.1.6 Molecular Imaging Systems
      • 5.2.1.7 Blood-based Reagents
    • 5.2.2 Cytycs 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 Molecular Diagnostics Products and Services
      • 5.2.3.1 InPath System Key
  • 5.3 Marketing and Sales Strategies
    • 5.3.1 TriPath Imaging Sales and Marketing
      • 5.3.1.1 Total Sales and Marketing
      • 5.3.1.2 Commercial Operations
      • 5.3.1.3 TriPath Oncology Sales and Marketing
      • 5.3.1.4 Marketing Strategy
      • 5.3.1.5 TriPaths Molecular Diagnostic Products
    • 5.3.2 Cytyc Marketing and Sales
      • 5.3.2.1 Sales and Marketing Costs
      • 5.3.2.2 Cytycs 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 TriPath, SurePath and 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
      • 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
  • 6.3 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 Cytyc Barriers
    • 11.1.2 Digene 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 Cytyc Acquisition Activity  Acquisition of Novacept
• 13. Research & Development Activity
  • 13.1 Cytyc In-Process R&D and Developed Technology
  • 13.2 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 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
      • 14.2.3.1 Trademark
  • 14.3 Ventana Patents and Proprietary Rights
• 15. Cytyc Profile
  • 15.1 Company Information
    • 15.1.1 Contact
    • 15.1.2 About the Cytyc Corporation
  • 15.2 Products/Business Segments
    • 15.2.1 Diagnostic Products
    • 15.2.2 The ThinPrep Process
  • 15.3 Management
    • 15.3.1 Top Executives and Salaries
    • 15.3.2 Board of Directors
• 16. Analytical Section
  • 16.1 Financial Analysis
  • 16.2 Companys 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 Digenes HPV Tests
    • 17.6.2 Digenes Chlamydia and Gonorrhea Tests
    • 17.6.3 Digenes Blood Virus Tests
    • 17.6.4 Digenes Instrumentation and Accessory Products
• 18. Digene Management
  • 18.1 Board of Directors
  • 18.2 Top Executives and Salaries
  • 18.3 Analytical Section
    • 18.3.1 Financial Analysis
  • 18.4 Companys 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 Companys Outlook on the Industry
  • 19.2 Trends, Issues, Challenges and Opportunities - An Analysis
  • 19.3 Competitive Landscape
  • 19.4 Competition
    • 19.4.1 Digenes Competitive Advantage
    • 19.4.2 Molecular Diagnostic Reagents
    • 19.4.3 TriPath Imaging, Inc
  • 19.5 Products/Business Segments
    • 19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line)
      • 19.5.1.1 PrepStain Slide Processor
      • 19.5.1.2 FocalPoint Imaging System
      • 19.5.1.3 SlideWizard Product Line
    • 19.5.2 Molecular Diagnostics Products
      • 19.5.2.1 Microscopic Slide Based Reagents
      • 19.5.2.2 Molecular Imaging Systems
      • 19.5.2.3 Blood-Based Reagents
  • 19.6 Management
    • 19.6.1 Top Executives and Salaries
• 20. Analytical Section
  • 20.1 Financial Analysis
    • 20.1.2 TriPath Oncology Revenues
  • 20.2 Companys 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 Companys 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 TriPaths 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: Number of Cancer Cases and Deaths by Type of Cancer
  • Table 2.5: Cancer Cases and Deaths by Region
  • 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 2005
  • Table 2.10: Top Ten Biotech Corporations
  • Table 2.11: Global Pharmaceutical Industry R&D Spending, 1980 to 2004
  • Table 2.12: U.S. Government NIH Research Budget, 1995 to 2004
  • Table 2.13: Herceptin Worldwide Sales, 1999 to 2005
  • Table 2.14: Classes of Drugs Used to Treat Breast Cancer
  • Table 2.15: Womens Cancers in the U.S., 2005
  • Table 2.16: Five-Year Disease Free Survival by Stage at Diagnosis
  • Table 3.1: Number of Pap Smears Performed by Country
  • Table 4.1: Digene Product Revenues and Assets
  • Table 5.1: TriPath Product Sales Share Overview
  • Table 5.2: Cytyc Product Overview
  • Table 5.3: Pap Tests in Top European Markets
  • Table 5.4: Pap Tests in Top Asian Markets
  • Table 5.5: Cytyc Annual Sales
  • Table 5.6: Cytyc Annual Net Income
  • 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 16.1: Percentage of Cytycs Net Sales
  • Table 17.1: Market Share of Cytology Products
  • Table 17.2: Diagnostic Test Kit Products and Markets