Cytology and HPV Testing World Markets - Biotechnology, Healthcare and Life Sciences Publishing

Home > Browse Reports > Diagnostics > Cytology and HPV Testing World Markets

Report Description

Cytology and HPV Testing World Markets
Publication Date: 10-MAR-06
Pages: 183
Study: TMRCHPV
Format/Price: PDF document / $3,400.00

Description:

View Sample PDF

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

Home | Reports | Database Tables | Conferences | Contact Us