[Report] Global Cytology & HPV Testing Market Research, Trends, Analysis TOC

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

Cytology and HPV Testing World Markets

Table of Contents

INDEX OF TABLES