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Learn about the Cytology and HPV Testing World Markets

2008-07-16 13:23:00

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

Cytology and HPV Testing World Markets

http://www.reportlinker.com/p090975/Cytology-and-HPV-Testing-World-Markets.html

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 



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 Cytyc's 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 TriPath's Molecular Diagnostic Products 



5.3.2 Cytyc Marketing and Sales 



5.3.2.1 Sales and Marketing Costs 



5.3.2.2 Cytyc'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 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 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. 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 



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 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 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 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: 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: 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

http://www.reportlinker.com/p090975/Cytology-and-HPV-Testing-World-Markets.html

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