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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.

 

TABLE OF CONTENTS

1. Overview 5
1.1 Statement of Report 5
1.2 About this Report 5
1.3 Scope of the Report 7
1.4 Objectives 7
1.5 Methodology 7

2. Introduction to Cancer Biology and the Diagnostic Industry 9
2.1 Cancer 9
2.1.1 The Disease 9
2.1.2 Metastasis 9
2.1.3 Demographics and Statistics of Cancer 10
2.2 The Drivers of the Biotech and Diagnostics Industry 15
2.2.1 Top Ten Biotech Corporations Based on Innovation as Determined by FastCompany Magazine 17
2.2.2 Technological Innovation 17
2.2.3 Government Funding 18
2.2.4 Pharmaceutical Development 18
2.3 Outlook for Tumor Markers 19
2.4 The Cancer Market 20

3. Cervical Cytology Testing Overview 23
3.1 Sector Background 23
3.2 Market Opportunity 23
3.3 Cervical Cancer 23
3.3.1 Screening for Cervical Cancer 24
3.3.2 Screening Procedures and Pap Smear Technology 25

4. Human Papillomavirus Testing Overview 29
4.1 Market Overview 29
4.1.1 Human Papillomavirus 29
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 Technology 33
4.3 Histology Market Overview 34

5. Cytology Market Structure 37
5.1 Key Players 37
5.1.1 BD Diagnostics-TriPath 37
5.1.2 Hologic, Inc. (Acquired Cytyc) 37
5.1.3 CytoCore, Inc. (Formerly Known as Molecular Diagnostics, Inc.) 38
5.2 BD-TriPath Products 38
5.2.1 Cervical Cytology Product Line 39
5.2.1.1 BD SurePath Pap Test 39
5.2.1.2 BD PrepStain Slide Processor 39
5.2.1.3 BD FocalPoint Slide Profiler 40
5.2.1.4 Molecular Oncology 41
5.2.1.5 Molecular Imaging Systems 42
5.2.1.6 Blood-based Reagents 42
5.3 Hologic Products 43
5.3.1 The ThinPrep System 43
5.3.1.1 Additional Applications of the ThinPrep System 44
5.3.1.2 The ThinPrep Process 44
5.3.1.3 Clinical Studies Evaluating the ThinPrep Pap Test 45
5.3.1.4 Selenia Dimensions System 45
5.3.1.5 Competition 46
5.3.2 Surgical Products 46
5.3.2.1 The NovaSure System 47
5.3.2.2 Competition 47
5.4 CytoCore, Inc. Products and Services 47
5.4.1 SoftPAP Cervical Cell Collector 48
5.4.2 Cocktail-CVX and Cocktail-GCI Assays 48
5.4.3 Cervical Drug Delivery System 49
5.5 Marketing and Sales Strategies 49
5.5.1 BD-TriPath Marketing and Sales 50
5.5.2 Hologic Marketing and Sales 53

6. Human Papillomavirus Testing Market Structure 55
6.1 Key Players 55
6.1.1 QIAGEN (Acquired Digene) 55
6.1.2 Ventana Medical Systems, Inc. (A Member of the Roche Group) 56
6.2 QIAGEN Products 56
6.2.1 HPV Tests 59
6.2.2 Chlamydia and Gonorrhea Tests 60
6.2.3 Blood Virus Tests 60
6.2.4 Instrumentation and Accessory Products 61
6.3 Sales and Marketing 61
6.3.1 International Markets 61
6.3.2 Europe 62
6.3.3 Central and South America 62
6.3.4 Asia-Pacific 63
6.3.5 Strategy 63
6.4 Competition 64
6.5 HPV Vaccines 66
6.6 Ventana (A Member of the Roche Group) 67
6.6.1 Ventana/Roche Staining Products 67

7. Business Trends in the Industry 70
7.1 Industry Consolidation 70
7.2 Breadth of Product Offering 71
7.3 Government Regulation of Medical Devices 71
7.4 Strategic Business and Marketing Considerations 72
7.5 Commercial Opportunities in Cancer Markers 73
7.6 Moderators of Growth 74
7.7 Biotechnology Industry Trends 75
7.8 Pharmaceutical Industry Trends 75
7.9 Acquisition, License Agreement and Partnerships 76
7.10 Sales and Marketing Strategies for Tumor Marker Tests 77
7.10.1 North American Market 77

8. Product Regulation 79
8.1 Government Regulation 79
8.2 U.S. FDA Approval 80
8.2.1 CLIA and State Laboratory Laws 82
8.2.2 Foreign Regulatory Approval 82

9. Third-Party Reimbursement 84
9.1 Limited Reimbursements by Third-Party Payers Obstruct Sales 84
9.2 Hologic ThinPrep 84
9.3 CPT Codes and Healthcare Common Procedure Coding System (HCPCS) Codes 84
9.4 Reimbursement Codes Classification 85
9.4.1 Reporting Screening and Diagnostic Pap Smears 85
9.4.2 HCPCS Code Definitions 85
9.4.3 CPT Code Definitions 86
9.5 Cervical Cytology Product Line 86
9.6 Molecular Diagnostic Products and Imaging Systems 87

10. Barriers in Business 88
10.1 Barriers in the Business Section 88
10.1.1 Hologic Barriers 88
10.1.2 QIAGEN Risk Factors 94
10.1.3 Ventana Medical Systems (A Member of the Roche Group) 102
10.1.3.1 Ventana/Roche Factors that could Affect Future Results 102

11. Acquisition Activity 105
11.1 Acquisition 105
11.2 Hologic, Inc. Acquires Cytyc Corporation 105
11.3 Becton, Dickinson and Company (BD) Diagnostics Acquires TriPath Imaging, Inc. 105
11.4 QIAGEN Acquires Digene Corporation 106

12. Research & Development Activity 107
12.1 Hologic In-Process R&D and Developed Technology 107
12.2 BD-TriPath R&D 107
12.2.1 Development of Molecular Diagnostic Products 107
12.3 QIAGEN (and Formerly Digene) R&D 109
12.4 Ventana (Subsidiary of the Roche Group) R&D 110
12.4.1 Instrumentation Development Projects 110
12.4.2 Reagent Development Projects 110

13. Intellectual Property 111
13.1 BD-TriPath Proprietary Technology and Intellectual Property 111
13.2 QIAGEN Intellectual Property 112
13.2.1 Hybrid Capture Technology 112
13.2.2 Rights to HPV Types 112
13.2.3 Other Intellectual Property 114
13.3 Ventana (Now a Member of the Roche Group) Patents and Proprietary Rights 114

14 Industry/Market Landscape 115
14.1 Industry Overview 115
14.1.1 Industry Definition 116
14.1.1.1 Cytology Products 116
14.1.1.2 Molecular Diagnostic Products 116
14.1.2 Industry Key Players 117
14.2 Outlook on the Industry 117
14.2.1 Hologic 117
14.2.2 BD-TriPath 120
14.2.3 QIAGEN 120
14.3 Trends, Issues, Challenges and Opportunities: An Analysis 121
14.3.1 Hologic 121
14.3.2 BD-TriPath 123
14.3.3 QIAGEN 124
14.4 Competitive Landscape 125
14.4.1 Hologic's Competition 126
14.4.2 BD-TriPath's Competition 128
14.4.2.1 BD-TriPath's Competitive Advantage 128
14.4.2.2 Molecular Diagnostic Reagents 128
14.4.2.3 Collaboration with Ventana/Roche 129
14.4.3 QIAGEN's Competition 130
14.4.3.1 QIAGEN's Competitive Advantage 130
14.4.3.2 Collaboration with Abbott Diagnostics 130
14.4.3.3 Molecular Diagnostic Reagents 131
14.5 Products/Business Segments 132
14.5.1 Hologic 132
14.5.1.1 Diagnostic Products 132
14.5.1.2 The ThinPrep Process 132
14.5.1.3 Surgical Products 133
14.5.1.4 The NovaSure System 133
14.5.2 BD-TriPath 134
14.5.2.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line) 134
14.5.2.2 Molecular Oncology Products 136
14.5.3 QIAGEN 137
14.5.3.1 digene HPV Tests 138
14.5.3.2 Chlamydia and Gonorrhea Tests 139
14.5.3.3 Blood Virus Tests 139
14.5.3.4 Instrumentation and Accessory Products 140

15. Analytical Section 141
15.1 Company Strategies 141
15.1.1 QIAGEN 141
15.1.2 BD-TriPath 142
15.1.3 Hologic 142
15.2 SWOT Analysis 143
15.2.1 QIAGEN 143
15.2.2 BD-TriPath 145
15.2.3 Hologic 148

Appendix 1: Breast Cancer 152
Appendix 2: Ovarian Cancer 154
Appendix 3: Malignant Melanoma 155


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