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Cytology and HPV Testing World Markets

  • ID: 607343
  • Report
  • November 2012
  • Region: Global
  • 128 Pages
  • TriMark Publications
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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.
Note: Product cover images may vary from those shown
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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 Based on Innovation as Determined by FastCompany Magazine
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 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 Diagnostics-TriPath
5.1.2 Hologic, Inc. (Acquired Cytyc)
5.1.3 CytoCore, Inc. (Formerly Known as Molecular Diagnostics, Inc.)
5.2 BD-TriPath Products
5.2.1 Cervical Cytology Product Line BD SurePath Pap Test BD PrepStain Slide Processor BD FocalPoint Slide Profiler Molecular Oncology Molecular Imaging Systems Blood-based Reagents
5.3 Hologic Products
5.3.1 The ThinPrep System Additional Applications of the ThinPrep System The ThinPrep Process Clinical Studies Evaluating the ThinPrep Pap Test Selenia Dimensions System Competition
5.3.2 Surgical Products The NovaSure System Competition
5.4 CytoCore, Inc. Products and Services
5.4.1 SoftPAP Cervical Cell Collector
5.4.2 Cocktail-CVX and Cocktail-GCI Assays
5.4.3 Cervical Drug Delivery System
5.5 Marketing and Sales Strategies
5.5.1 BD-TriPath Marketing and Sales
5.5.2 Hologic Marketing and Sales

6. Human Papillomavirus Testing Market Structure
6.1 Key Players
6.1.1 QIAGEN (Acquired Digene)
6.1.2 Ventana Medical Systems, Inc. (A Member of the Roche Group)
6.2 QIAGEN 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 Competition
6.5 HPV Vaccines
6.6 Ventana (A Member of the Roche Group)
6.6.1 Ventana/Roche Staining Products

7. Business Trends in the Industry
7.1 Industry Consolidation
7.2 Breadth of Product Offering
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 Sales and Marketing Strategies for Tumor Marker Tests
7.10.1 North American Market

8. Product Regulation
8.1 Government Regulation
8.2 U.S. FDA Approval
8.2.1 CLIA and State Laboratory Laws
8.2.2 Foreign Regulatory Approval

9. Third-Party Reimbursement
9.1 Limited Reimbursements by Third-Party Payers Obstruct Sales
9.2 Hologic ThinPrep
9.3 CPT Codes and Healthcare Common Procedure Coding System (HCPCS) Codes
9.4 Reimbursement Codes Classification
9.4.1 Reporting Screening and Diagnostic Pap Smears
9.4.2 HCPCS Code Definitions
9.4.3 CPT Code Definitions
9.5 Cervical Cytology Product Line
9.6 Molecular Diagnostic Products and Imaging Systems

10. Barriers in Business
10.1 Barriers in the Business Section
10.1.1 Hologic Barriers
10.1.2 QIAGEN Risk Factors
10.1.3 Ventana Medical Systems (A Member of the Roche Group) Ventana/Roche Factors that could Affect Future Results

11. Acquisition Activity
11.1 Acquisition
11.2 Hologic, Inc. Acquires Cytyc Corporation
11.3 Becton, Dickinson and Company (BD) Diagnostics Acquires TriPath Imaging, Inc.
11.4 QIAGEN Acquires Digene Corporation

12. Research & Development Activity
12.1 Hologic In-Process R&D and Developed Technology
12.2 BD-TriPath R&D
12.2.1 Development of Molecular Diagnostic Products
12.3 QIAGEN (and Formerly Digene) R&D
12.4 Ventana (Subsidiary of the Roche Group) R&D
12.4.1 Instrumentation Development Projects
12.4.2 Reagent Development Projects

13. Intellectual Property
13.1 BD-TriPath Proprietary Technology and Intellectual Property
13.2 QIAGEN Intellectual Property
13.2.1 Hybrid Capture Technology
13.2.2 Rights to HPV Types
13.2.3 Other Intellectual Property
13.3 Ventana (Now a Member of the Roche Group) Patents and Proprietary Rights

14 Industry/Market Landscape
14.1 Industry Overview
14.1.1 Industry Definition Cytology Products Molecular Diagnostic Products
14.1.2 Industry Key Players
14.2 Outlook on the Industry
14.2.1 Hologic
14.2.2 BD-TriPath
14.2.3 QIAGEN
14.3 Trends, Issues, Challenges and Opportunities: An Analysis
14.3.1 Hologic
14.3.2 BD-TriPath
14.3.3 QIAGEN
14.4 Competitive Landscape
14.4.1 Hologic's Competition
14.4.2 BD-TriPath's Competition BD-TriPath's Competitive Advantage Molecular Diagnostic Reagents Collaboration with Ventana/Roche
14.4.3 QIAGEN's Competition QIAGEN's Competitive Advantage Collaboration with Abbott Diagnostics Molecular Diagnostic Reagents
14.5 Products/Business Segments
14.5.1 Hologic Diagnostic Products The ThinPrep Process Surgical Products The NovaSure System
14.5.2 BD-TriPath Cervical Cytology Product Line (Formerly the i3 Series Product Line) Molecular Oncology Products
14.5.3 QIAGEN digene HPV Tests Chlamydia and Gonorrhea Tests Blood Virus Tests Instrumentation and Accessory Products

15. Analytical Section
15.1 Company Strategies
15.1.1 QIAGEN
15.1.2 BD-TriPath
15.1.3 Hologic
15.2 SWOT Analysis
15.2.1 QIAGEN
15.2.2 BD-TriPath
15.2.3 Hologic

Appendix 1: Breast Cancer
Appendix 2: Ovarian Cancer
Appendix 3: Malignant Melanoma


Table 2.1: Drug Development by Type of Cancer 10
Table 2.2: Organ-specific Medicines in Development for Cancer 10
Table 2.3: Estimates for the Leading Types of New Cancer Cases and Deaths in the U.S. by Sex, 2010 11
Table 2.4: Estimated New Cancer Cases and Deaths by Sex for All Types of Cancer 12
Table 2.5: Estimated Number of Cancer Cases and Deaths by World Area 13
Table 2.6: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country 14
Table 2.7: Cancer-Associated Genes 14
Table 2.8: Carcinogens in the Workplace 15
Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995-2009 16
Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995-2010 18
Table 2.11: U.S. Government NIH Research Budget, 1995-2010 19
Table 2.12: Herceptin Worldwide Sales, 2000-2015 20
Table 2.13: Classes of Drugs Used to Treat Breast Cancer 20
Table 2.14: Women's Cancers in the U.S., 2010 21
Table 2.15: Five-Year Relative Survival Rates by Stage at Diagnosis 21
Table 3.1: Number of Pap Smears Performed by Country, 2009 26
Table 3.2: Global Market for HPV Molecular Diagnostic Testing, 2007-2015 27
Table 3.3: U.S. Market for HPV Diagnostic Testing, 2007-2015 27
Table 5.1: Pap Tests in Top European Markets 49
Table 5.2: Pap Tests in Top Asian Markets 50
Table 6.1: HPV Market Size, 2003-2015 55
Table 6.2: Product, Infection and Market 57
Table 6.3: Instrumentation and Accessories, Infection and Market 57
Table 7.1: List and Discounted Pricing for Abbott Tumor Marker Tests 71
Table 9.1: CPT and HCPCS Codes 85
Table 9.2: National Limitation Amounts (NLAs) 85
Table 9.3: NLAs for Various CPT Codes 87
Table 13.1: HPV Types Status and Patents 113
Table 14.1: QIAGEN's Diagnostic Test Kit Products, Instrumentation and Markets 138
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown