Contents:

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 5.2.1.1 BD SurePath Pap Test 5.2.1.2 BD PrepStain Slide Processor 5.2.1.3 BD FocalPoint Slide Profiler 5.2.1.4 Molecular Oncology 5.2.1.5 Molecular Imaging Systems 5.2.1.6 Blood-based Reagents 5.3 Hologic Products 5.3.1 The ThinPrep System 5.3.1.1 Additional Applications of the ThinPrep System 5.3.1.2 The ThinPrep Process 5.3.1.3 Clinical Studies Evaluating the ThinPrep Pap Test 5.3.1.4 Selenia Dimensions System 5.3.1.5 Competition 5.3.2 Surgical Products 5.3.2.1 The NovaSure System 5.3.2.2 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) 10.1.3.1 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 14.1.1.1 Cytology Products 14.1.1.2 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 14.4.2.1 BD-TriPath's Competitive Advantage 14.4.2.2 Molecular Diagnostic Reagents 14.4.2.3 Collaboration with Ventana/Roche 14.4.3 QIAGEN's Competition 14.4.3.1 QIAGEN's Competitive Advantage 14.4.3.2 Collaboration with Abbott Diagnostics 14.4.3.3 Molecular Diagnostic Reagents 14.5 Products/Business Segments 14.5.1 Hologic 14.5.1.1 Diagnostic Products 14.5.1.2 The ThinPrep Process 14.5.1.3 Surgical Products 14.5.1.4 The NovaSure System 14.5.2 BD-TriPath 14.5.2.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line) 14.5.2.2 Molecular Oncology Products 14.5.3 QIAGEN 14.5.3.1 digene HPV Tests 14.5.3.2 Chlamydia and Gonorrhea Tests 14.5.3.3 Blood Virus Tests 14.5.3.4 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 INDEX OF TABLES 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