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.

Table of Contents

1. Overview 6
1.1 Statement of Report 6
1.2 About this Report 6
1.3 Scope of the Report 8
1.4 Objectives 8
1.5 Methodology 8
2. Introduction to Cancer Biology and the Diagnostic Industry 11
2.1 Cancer 11
2.1.1 The Disease 11
2.1.2 Metastasis 11
2.1.3 Demographics and Statistics of Cancer 12
2.2 The Drivers of the Biotech and Diagnostics Industry 16
2.2.1 Top Ten Biotech Corporations Based on Innovation as Determined by FastCompany Magazine 17
2.2.2 Technological Innovation 18
2.2.3 Government Funding 18
2.2.4 Pharmaceutical Development 19
2.3 Outlook for Tumor Markers 21
2.4 The Cancer Market 21
3. Cervical Cytology Testing Overview 24
3.1 Sector Background 24
3.2 Cervical Cancer 24
3.3 Market Opportunity 25
3.4 Cytology-Based Screening for Cervical Cancer 26
3.4.1 Accuracy and Limitations of Pap Smears 29
3.4.2 Liquid-Based Pap Smear Technologies and Automation 30
3.5 New Guidelines for Cervical Cancer Screenings 31
3.6 Impact of New Screening Guidelines on the Pap Smear Market 31
4. Cytology Market Structure 32
4.1 Key Players 32
4.1.1 BD Diagnostics (Acquired TriPath Imaging) 32
4.1.2 Hologic, Inc. (Acquired Cytyc) 32
4.1.3 CytoCore, Inc. (Formerly Known as Molecular Diagnostics, Inc.) 33
4.1.4 Ventana Medical Systems, Inc. (A Member of the Roche Group) 33
4.1.5 Pap Smear Market Share 34
4.2 BD-TriPath Cervical Cytology Product Line 34
4.2.1 BD SurePath Pap Test 35
4.2.2 BD Cell Enrichment Process 35
4.2.3 BD PrepStain Slide Processor 35
4.2.4 BD FocalPoint Slide Profiler 36
4.2.5 BD FocalPoint GS Imaging System 36
4.2.6 Manufacturing of BD-TriPath Cytology Products 37
4.2.7 Molecular Oncology 38
4.3 Hologic Cervical Cancer Screening Products 39
4.3.1 The ThinPrep System 39
4.4 CytoCore, Inc. Products 42
4.4.1 SoftPAP Cervical Cell Collector 42
4.4.2 CytoCore Products in Development 43
4.5 Ventana (Roche) Cervical Cancer Screening—CINtec Plus Cytology Kit 43
4.6 Latest Advances in Cervical Cancer Screening Technologies and Products 44
4.6.1 Molecular Testing for Cancer Antigens 44
4.6.2 Flow Cytometric Analysis of Cervical Cells 44
4.6.3 LuViva® Advanced Cervical Scan 44
4.6.4 MarkPap® 45
4.6.5 oncoFISH® cervical 45
4.7 Marketing and Sales Strategies 46
4.7.1 BD-TriPath Marketing and Sales 46
4.7.2 Hologic Marketing and Sales 49
5. Human Papillomavirus Testing Overview 51
5.1 Human Papillomavirus 51
5.2 HPV Testing to Detect Cervical Cancer 52
5.2.1 New U.S. Guidelines include HPV Testing for Cervical Cancer Screenings 52
5.2.2 Benefits of Pap Smear and HPV Co-Testing 54
5.2.3 Primary HPV Testing 54
5.2.4 HPV Testing in Low-Resource Regions 55
5.2.5 Self-Sampling for HPV Testing 56
6. Human Papillomavirus Testing Market Structure 57
6.1 HPV Testing Market Overview 57
6.2 U.S. Market 57
6.3 European Market 58
6.4 Latin American Market 59
6.5 Asian Market 59
6.6 HPV Vaccines—Impact on HPV Testing 60
6.6.1 Cervical Cancer Vaccines on the Market 60
6.6.2 Cervical Cancer Screening Remains Vital in the Age of HPV Vaccination 61
6.7 Sales and Marketing Strategies—Lessons from QIAGEN 61
6.8 Competition 64
6.9 Market Challenges and Strategic Recommendations 67
6.9.1 Market Drivers and Restraints 67
6.9.2 Market and Technology Trends 68
6.9.3 Strategic Recommendations 70
7. Key Players and Products in the HPV Testing Market 71
7.1 QIAGEN (Acquired Digene) 71
7.1.1 QIAGEN HPV Testing Products 72
7.2 Hologic 76
7.2.1 Invader Chemistry 77
7.2.2 Cervista HPV HR 77
7.2.3 Cervista HPV 16/18 77
7.2.4 Hologic Acquires Gen-Probe and its Product Line 78
7.3 Gen-Probe (now part of Hologic) 78
7.3.1 APTIMA HPV Assay 78
7.4 Roche (Ventana) 79
7.4.1 cobas 4800 HPV Test 79
7.4.2 Linear Array HPV Genotyping Test 79
7.4.3 Amplicor HPV Test 79
7.4.4 INFORM HPV 80
7.5 Innogenetics' INNO-LiPA HPV Genotyping Extra assay 80
7.6 Greiner Bio-One GmbH's PapilloCheck® 80
7.7 GenoID Ltd.'s GenoID Assay 80
7.8 bioMérieux Clinical Diagnostics' NucliSENS EasyQ® HPV Test 81
7.9 Trovagene, Inc. 81
8. Business Trends in the Industry 82
8.1 Industry Consolidation 82
8.2 Breadth of Product Offering 83
8.3 Government Regulation of Medical Devices 83
8.4 Strategic Business and Marketing Considerations 84
8.5 Commercial Opportunities in Cancer Markers 84
8.6 Moderators of Growth 85
8.7 Biotechnology Industry Trends 86
8.8 Pharmaceutical Industry Trends 86
8.9 Acquisition, License Agreement and Partnerships 87
8.10 Sales and Marketing Strategies for Tumor Marker Tests 87
8.10.1 North American Market 88
8.11 Recent Industry Activity 88
9. Third-Party Reimbursement 90
9.1 Reimbursement Codes Classification 90
9.2 Reimbursement for the Cervical Cytology Product Line 91
9.3 Molecular Diagnostic Products and Imaging Systems 91
10. Barriers in Business 92
10.1 Barriers in the Business Section 92
10.1.1 Barriers for Hologic 92
10.1.2 Risk Factors for QIAGEN 96
10.1.3 Ventana Medical Systems (A Member of the Roche Group) 104
11. Acquisition Activity 107
11.1 Acquisition 107
11.2 Hologic, Inc. Acquires Cytyc Corporation 107
11.3 BD Diagnostics Acquires TriPath Imaging, Inc. 107
11.4 QIAGEN Acquires Digene Corporation 108
11.5 Hologic Acquires Gen-Probe 108
11.6 Roche Acquires mtm laboratories AG 108
12. Intellectual Property 110
12.1 BD-TriPath Proprietary Technology and Intellectual Property 110
12.2 QIAGEN Intellectual Property 110
12.2.1 Hybrid Capture Technology 110
12.3 Ventana (Now a Member of the Roche Group) Patents and Proprietary Rights 111
13. Outlook on the Women's Health Industry 112
13.1 Hologic 112
13.2 BD-TriPath 114
13.3 QIAGEN 115
13.4 Trends, Issues, Challenges and Opportunities: An Analysis 115
13.4.1 Hologic 115
13.4.2 BD-TriPath 118
13.4.3 QIAGEN 119
13.5 Competitive Landscape 120
14. Analytical Section 121
14.1 Company Strategies 121
14.1.1 QIAGEN 121
14.1.2 BD-TriPath 122
14.1.3 Hologic 122
14.2 SWOT Analysis 122
14.2.1 QIAGEN 122
14.2.2 BD-TriPath 124
14.2.3 Hologic 126

List of Tables

Table 2.1: Drug Development by Type of Cancer 12
Table 2.2: Estimates for the Leading Types of New Cancer Cases and Deaths in the U.S. by Sex, 2012 12
Table 2.3: Organ-Specific Medicines in Development for Cancer 13
Table 2.4: Estimated Number of Cancer Cases and Deaths by World Area, 2008 14
Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country 15
Table 2.6: Cancer-Associated Genes 15
Table 2.7: Carcinogens in the Workplace 16
Table 2.8: U.S. Government NIH Research Grant Funding, 2000-2011 18
Table 2.9: Global R&D Spending in the Pharmaceutical Industry, 2008-2012 19
Table 2.10: Pharmaceutical Companies Ranked by Total R&D Expenditures, 2011 19
Table 2.11: Leading Therapy Classes for R&D, 2012 20
Table 2.12: Women's Cancers in the U.S., 2012 21
Table 2.13: Five-Year Relative Survival Rates by Stage at Diagnosis 22
Table 3.1: Estimated Number of Pap Smears Performed by Country, 2011 26
Table 3.2: Bethesda System of Classifying of Pap Smear Test Results 28
Table 4.1: Pap Tests in Top European Markets, 2011 46
Table 4.2: Pap Tests in Top Asian Markets, 2011 46
Table 5.1: Conditions Associated with Different HPV Types 51
Table 5.2: New Guidelines for Cervical Cancer Screenings (2012) 53
Table 6.1: Global Market for HPV Molecular Diagnostic Testing, 2009-2017 57
Table 6.2: U.S. Market for HPV Diagnostic Testing, 2009-2017 58
Table 6.3: HPV Molecular Diagnostics Market Drivers 67
Table 6.4: HPV Molecular Diagnostics Market Restraints 68
Table 7.1: HPV Tests on the Market 71

List of Figures

Figure 4.1: Liquid-Based Pap Test Market Share 34
Figure 6.1: U.S. Market Share of HPV Molecular Diagnostic Market, 2011 65