July 16, 2008 14:23 ET

Learn about the Cytology and HPV Testing World Markets

LONDON, UNITED KINGDOM--(Marketwire - July 16, 2008) - announces that a new market research report related to the Medical devices industry is available in its catalogue.

Cytology and HPV Testing World Markets

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.

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 

2.1.1The 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 The SurePath Test Pack PrepStain Slide Processor FocalPoint Imaging System SlideWizard Product Line Molecular Diagnostics Products Molecular Imaging Systems Blood-based Reagents 

5.2.2 Cytyc's Products The ThinPrep System Additional Applications of the ThinPrep System The ThinPrep Process Clinical Studies Evaluating the ThinPrep Pap Test Competition Surgical Products The NovaSure System Competition 

5.2.3 Molecular Diagnostics' Products and Services InPath System Key 

5.3 Marketing and Sales Strategies 

5.3.1 TriPath Imaging Sales and Marketing Total Sales and Marketing Commercial Operations TriPath Oncology Sales and Marketing Marketing Strategy TriPath's Molecular Diagnostic Products 

5.3.2 Cytyc Marketing and Sales Sales and Marketing Costs Cytyc's Marketing and Sales Strategy Domestic Strategy International Strategy Sales Strategy - Cervical Cytology Product Line Molecular Diagnostics Marketing and Sales Organizations 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 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 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 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 Company's Strategies 

16.3 SWOT Analysis 

17. Industry/Market Landscape 

17.1 Industry Overview 

17.1.1 Industry Key Players Cytology Screening Testing Market Structure 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. Digene Management 

18.1 Board of Directors 

18.2 Top Executives and Salaries 

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 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 TriPath Imaging, Inc. 

19.5 Products/Business Segments 

19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line) PrepStain Slide Processor FocalPoint Imaging System SlideWizard Product Line 

19.5.2 Molecular Diagnostics Products Microscopic Slide Based Reagents Molecular Imaging Systems 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 Company's Strategies 

20.3 SWOT Analysis 

21. Industry/Market Landscape 

21.1 Industry Overview 

21.1.1 Industry Definition Cytology Products 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 TriPath's Competitive Advantage Molecular Diagnostic Reagents Ventana 

Appendix 1: Breast Cancer 

Appendix 2: Ovarian Cancer 

Appendix 3: Malignant Melanoma 


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 

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: Women's 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 Cytyc's Net Sales 

Table 17.1: Market Share of Cytology Products 

Table 17.2: Diagnostic Test Kit Products and Markets 

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Cytology and HPV Testing World Markets

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