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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.

Table of Contents

• 1. Overview 7
  • 1.1 Statement of Report 7
  • 1.2 About this Report 7
  • 1.3 Scope of the Report 8
  • 1.4 Objectives 9
  • 1.5 Methodology 9
  
  
• 2. Introduction to Cancer Biology and the Diagnostic Industry 10
  • 2.1 Cancer 10
    • 2.1.1 The Disease 10
    • 2.1.2 Metastasis 10
    • 2.1.3 Demographics and Statistics of Cancer 11
  • 2.2 The Drivers of the Biotech and Diagnostics Industry 17
    • 2.2.1 Technological Innovation 19
    • 2.2.2 Government Funding 19
    • 2.2.3 Pharmaceutical Development 20
  • 2.3 Outlook for Tumor Markers 20
  • 2.4 The Cancer Market 21
  
  
• 3. Cervical Cytology Testing Overview 24
  • 3.1 Sector Background 24
  • 3.2 Market Opportunity 24
  • 3.3 Cervical Cancer 24
    • 3.3.1 Screening for Cervical Cancer 25
    • 3.3.2 Screening Procedures and Pap Smear Technology 26
    
    
• 4. Human Papillomavirus (HPV) Testing Overview 30
  • 4.1 Market Overview 30
    • 4.1.1 Human Papillomavirus 30
    • 4.1.2 North American Market 32
    • 4.1.3 European Market 33
    • 4.1.4 Latin American Market 33
  • 4.2 Hybrid Capture 2 HPV 33
  • 4.3 Histology Market Overview 34
  
  
• 5. Cytology Market Structure 38
  • 5.1 Key Players 38
    • 5.1.1 TriPath Imaging 38
    • 5.1.2 Cytyc 38
    • 5.1.3 Molecular Diagnostics, Inc. 39
  • 5.2 TriPath Products 41
    • 5.2.1. Cervical Cytology Product Line 42
      • 5.2.1.1 The SurePath Test Pack 42
      • 5.2.1.2 PrepStain Slide Processor 42
      • 5.2.1.3 FocalPoint Imaging System 43
      • 5.2.1.4 SlideWizard Product Line 44
      • 5.2.1.5 Molecular Diagnostics Products 44
      • 5.2.1.6 Molecular Imaging Systems 45
      • 5.2.1.7 Blood-based Reagents 46
    • 5.2.2 Cytyc's Products 46
      • 5.2.2.1 The ThinPrep System 46
        • 5.2.2.1.1 Additional Applications of the ThinPrep System 47
      • 5.2.2.2 The ThinPrep Process 47
      • 5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test 48
      • 5.2.2.4 Competition 48
      • 5.2.2.5 Surgical Products 49
      • 5.2.2.6 The NovaSure System 49
      • 5.2.2.7 Competition 50
    • 5.2.3 Molecular Diagnostics' Products and Services 51
      • 5.2.3.1 InPath System Key 51
  • 5.3 Marketing and Sales Strategies 51
    • 5.3.1 TriPath Imaging Sales and Marketing 52
      • 5.3.1.1 Total Sales and Marketing 52
      • 5.3.1.2 Commercial Operations 52
      • 5.3.1.3 TriPath Oncology Sales and Marketing 53
      • 5.3.1.4 Marketing Strategy 53
      • 5.3.1.5 TriPath's Molecular Diagnostic Products 55
    • 5.3.2 Cytyc Marketing and Sales 55
      • 5.3.2.1 Sales and Marketing Costs 56
      • 5.3.2.2 Cytyc's Marketing and Sales Strategy 57
        • 5.3.2.2.1 Domestic Strategy 57
        • 5.3.2.2.2 International Strategy 57
      • 5.3.2.3 Sales Strategy - Cervical Cytology Product Line 58
        • 5.3.2.3.1 Molecular Diagnostics 58
        • 5.3.2.3.2 Marketing and Sales Organizations 58
        • 5.3.2.3.3 Outside the U.S. with the Exception of Canada 59
  • 5.4 Manufacturing TriPath, SurePath and PrepStain 59
    • 5.4.1 Manufacturing Standards for Diagnostic Products 60
  • 5.5 Competition 61
    • 5.5.1 Molecular Diagnostic Reagents 62
    
    
• 6. Human Papillomavirus (HPV) Testing Market Structure 63
  • 6.1 Key Players 63
    • 6.1.1 Digene 63
      • 6.1.1.1 Digene Products 64
    • 6.1.2 Ventana Medical Systems 64
  • 6.2 Products 64
    • 6.2.1 HPV Tests 65
    • 6.2.2 Chlamydia and Gonorrhea Tests 66
    • 6.2.3 Blood Virus Tests 66
    • 6.2.4 Instrumentation and Accessory Products 67
  • 6.3 Sales and Marketing 67
    • 6.3.1 International Markets 67
    • 6.3.2 Europe 67
    • 6.3.3 Central and South America 68
    • 6.3.4 Asia/Pacific 68
    • 6.3.5 Strategy 69
  • 6.4 Manufacturing 69
  • 6.5 Competition 70
    • 6.5.1 Ventana 72
  • 6.6 Ventana Staining Products 72
    • 6.6.1 Ventana Products 72
    
    
• 7. Business Trends in the Industry 75
  • 7.1 Industry Consolidation 75
  • 7.2 Breath of Product Offering and Pricing 76
  • 7.3 Government Regulation of Medical Devices 76
  • 7.4 Strategic Business and Marketing Considerations 77
  • 7.5 Commercial Opportunities in Cancer Markers 78
  • 7.6 Moderators of Growth 79
  • 7.7 Biotechnology Industry Trends 80
  • 7.8 Pharmaceutical Industry Trends 80
  • 7.9 Acquisition, License Agreement and Partnerships 81
  • 7.10 Legal Developments 82
  • 7.11 Sales and Marketing Strategies for Tumor Marker Tests 83
    • 7.11.1 North American Market 83
    
    
• 8. Government Regulation 85
  • 8.1 Government Regulation 85
  • 8.2 U.S. FDA Approval 86
    • 8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 88
    • 8.2.2 Foreign Regulatory Approval 88
    
    
• 9. Legal Developments 90
  • 9.1 Cytyc Legal Proceedings 90
  • 9.2 Ventana Legal Proceedings 92
  
  
• 10. Third-Party Reimbursement 95
  • 10.1 Limited Reimbursements by Third-party Payers Obstruct Sales 95
  • 10.2 Cytyc ThinPrep 95
  • 10.3 CPT Codes and HCPCS Codes 96
  • 10.4 Professional Component Fee 97
  • 10.5 Regional Payer Relations Managers 97
  • 10.6 Reimbursement Codes Classification 97
    • 10.6.1 Reporting Screening and Diagnostic Pap Smears 97
    • 10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions 97
    • 10.6.3 CPT (Current Procedural Terminology) Code Definitions 98
  • 10.7 A Note on Statutory Limitations 98
  • 10.8 Cervical Cytology Product Line 98
  • 10.9 Molecular Diagnostic Products and Imaging Systems 99
  
  
• 11. Barriers in Business 101
  • 11.1 Barriers in the Business Section 101
    • 11.1.1 Cytyc Barriers 101
    • 11.1.2 Digene Risk Factors 107
    • 11.1.3 Ventana 114
      • 11.1.3.1 Ventana factors that could affect future results 114
      
      
• 12. Acquisition Activity 119
  • 12.1 Acquisition 119
  • 12.2 Cytyc Acquisition Activity þu Acquisition of Novacept 119
  
  
• 13. Research & Development Activity 121
  • 13.1 Cytyc In-Process R&D and Developed Technology 121
  • 13.2 TriPath Research & Development 121
    • 13.2.1 Development of Molecular Diagnostic Products 121
  • 13.3 Digene Research & Development 123
  • 13.4 Ventana Research & Development 124
    • 13.4.1 Instrumentation Development Projects 124
    • 13.4.2 Reagent Development Projects 124
    
    
• 14. Intellectual Property 126
  • 14.1 TriPath Proprietary Technology and Intellectual Property 126
  • 14.2 Digene Intellectual Property 127
    • 14.2.1 Hybrid Capture Technology 127
    • 14.2.2 Rights to HPV Types 127
    • 14.2.3 Other Intellectual Property 129
      • 14.2.3.1 Trademark 129
  • 14.3 Ventana Patents and Proprietary Rights 129
  
  
• 15. Cytyc Profile 131
  • 15.1 Company Information 131
    • 15.1.1 Contact 131
    • 15.1.2 About the Cytyc Corporation 131
  • 15.2 Products/Business Segments 131
    • 15.2.1 Diagnostic Products 131
    • 15.2.2 The ThinPrep Process 132
  • 15.3 Management 133
    • 15.3.1 Top Executives and Salaries 133
    • 15.3.2 Board of Directors 133
    
    
• 16. Analytical Section 134
  • 16.1 Financial Analysis 134
  • 16.2 Company's Strategies 134
  • 16.3 SWOT Analysis 135
  
  
• 17. Industry/Market Landscape 139
  • 17.1 Industry Overview 139
    • 17.1.1 Industry Key Players 139
      • 17.1.1.1 Cytology Screening Testing Market Structure 139
      • 17.1.1.2 Human papillomavirus (HPV) Testing Market Structure 139
  • 17.2 Outlook on the Industry 139
  • 17.3 Trends, Issues, Challenges and Opportunities: An Analysis 142
  • 17.4 Molecular Diagnostics Products 143
    • 17.4.1 Microscopic Slide Based Reagents 144
    • 17.4.2 Molecular Imaging Systems 144
    • 17.4.3 Blood-Based Reagents 145
  • 17.5 Competitive Landscape 145
  • 17.6 Products/Business Segments 147
    • 17.6.1 Digene's HPV Tests 148
    • 17.6.2 Digene's Chlamydia and Gonorrhea Tests 149
    • 17.6.3 Digene's Blood Virus Tests 149
    • 17.6.4 Digene's Instrumentation and Accessory Products 149
    
    
• 18. Digene Management 151
  • 18.1 Board of Directors 151
  • 18.2 Top Executives and Salaries 151
  • 18.3 Analytical Section 151
    • 18.3.1 Financial Analysis 151
  • 18.4 Company's Strategies 151
  • 18.5 SWOT Analysis 153
  
  
• 19. Industry/Market Landscape 156
  • 19.1 Digene Industry Overview 156
    • 19.1.1 Industry Definition 156
      • 19.1.1.1 Cytology Products 156
    • 19.1.2 Industry Key Players 157
    • 19.1.3 Company's Outlook on the Industry 157
  • 19.2 Trends, Issues, Challenges and Opportunities - An Analysis 158
  • 19.3 Competitive Landscape 159
  • 19.4 Competition 159
    • 19.4.1 Digene's Competitive Advantage 160
    • 19.4.2 Molecular Diagnostic Reagents 160
    • 19.4.3 TriPath Imaging, Inc. 161
  • 19.5 Products/Business Segments 162
    • 19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line) 162
      • 19.5.1.1 PrepStain Slide Processor 162
      • 19.5.1.2 FocalPoint Imaging System 163
      • 19.5.1.3 SlideWizard Product Line 163
    • 19.5.2 Molecular Diagnostics Products 164
      • 19.5.2.1 Microscopic Slide Based Reagents 164
      • 19.5.2.2 Molecular Imaging Systems 165
      • 19.5.2.3 Blood-Based Reagents 165
  • 19.6 Management 165
    • 19.6.1 Top Executives and Salaries 165
    
    
• 20. Analytical Section 166
  • 20.1 Financial Analysis 166
    • 20.1.2 TriPath Oncology Revenues 167
  • 20.2 Company's Strategies 167
  • 20.3 SWOT Analysis 168
  
  
• 21. Industry/Market Landscape 171
  • 21.1 Industry Overview 171
    • 21.1.1 Industry Definition 172
      • 21.1.1.1 Cytology Products 172
      • 21.1.1.2 Molecular Diagnostic Products 172
    • 21.1.2 Industry Key Players 172
  • 21.2 Company's Outlook on the Industry 172
  • 21.3 Trends, Issues, Challenges and Opportunities: An Analysis 173
  • 21.4 Molecular Diagnostics Products 175
    • 21.4.1 Blood-Based Reagents 175
  • 21.5 Competitive Landscape 176
    • 21.5.1 Competition 176
      • 21.5.1.2 TriPath's Competitive Advantage 176
      • 21.5.1.3 Molecular Diagnostic Reagents 177
      • 21.5.1.4 Ventana 178
      
      

Appendix 1: Breast Cancer 179

Appendix 2: Ovarian Cancer 181

Appendix 3: Malignant Melanoma 182

INDEX OF TABLES

Table 2.1: Drug Development by Type of Cancer 11

Table 2.2: The 402 Organ Specific Medicines in Development for Cancer 12

Table 2.3: Leading Sites of Cancer Cases and Deaths in the U.S. by Sex 13

Table 2.4: Number of Cancer Cases and Deaths by Type of Cancer 14

Table 2.5: Cancer Cases and Deaths by Region 15

Table 2.6: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country 16

Table 2.7: Cancer-Associated Genes 16

Table 2.8: Carcinogens in the Workplace 17

Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995 to 2005 18

Table 2.10: Top Ten Biotech Corporations 19

Table 2.11: Global Pharmaceutical Industry R&D Spending, 1980 to 2004 20

Table 2.12: U.S. Government NIH Research Budget, 1995 to 2004 20

Table 2.13: Herceptin Worldwide Sales, 1999 to 2005 21

Table 2.14: Classes of Drugs Used to Treat Breast Cancer 21

Table 2.15: Women's Cancers in the U.S., 2005 22

Table 2.16: Five-Year Disease Free Survival by Stage at Diagnosis 22

Table 3.1: Number of Pap Smears Performed by Country 28

Table 4.1: Digene Product Revenues and Assets 32

Table 5.1: TriPath Product Sales Share Overview 42

Table 5.2: Cytyc Product Overview 46

Table 5.3: Pap Tests in Top European Markets 52

Table 5.4: Pap Tests in Top Asian Markets 52

Table 5.5: Cytyc Annual Sales 56

Table 5.6: Cytyc Annual Net Income 57

Table 6.1: HPV Market Size, 2003 to 2011 63

Table 6.2: Product, Infection and Market 65

Table 6.3: Instrumentation and Accessories, Infection and Market 65

Table 7.1: List and Discounted Pricing for Abbott Tumor Marker Tests 76

Table 10.1: CPT and HCPCS Codes 96

Table 10.2: National Limitation Amounts 97

Table 10.3: NLAs for Various CPT Codes 99

Table 14.1: HPV Types Status and Patents 128

Table 16.1: Percentage of Cytyc's Net Sales 136

Table 17.1: Market Share of Cytology Products 139

Table 17.2: Diagnostic Test Kit Products and Markets 148

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