Cytology and HPV Testing World Markets
The purpose of this report is to describe the specific segment of the diagnostics market aimed at the cytological analysis of 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), cervical cancer and other inflammatory and sexually-transmitted diseases.
Table of Contents
- 1.Overview6
- 1.1Statement of Report6
- 1.2 About this Report6
- 1.3Scope of the Report7
- 1.4Objectives8
- 1.5 Methodology8
- 2.Introduction to Cancer Biology and the Diagnostic Industry10
- 2.1Cancer10
- 2.1.1The Disease10
- 2.1.2Metastasis10
- 2.1.3Demographics and Statistics of Cancer11
- 2.2The Drivers of the Biotech and Diagnostics Industry18
- 2.2.1Top Ten Biotech Corporations19
- 2.2.2Technological Innovation19
- 2.2.3Government Funding20
- 2.2.4Pharmaceutical Development20
- 2.3Outlook for Tumor Markers21
- 2.4The Cancer Market22
- 2.1Cancer10
- 3.Cervical Cytology Testing Overview25
- 3.1Sector Background25
- 3.2Market Opportunity25
- 3.3Cervical Cancer25
- 3.3.1Screening for Cervical Cancer26
- 3.3.2Screening Procedures and Pap Smear Technology27
- 4.Human Papillomavirus (HPV) Testing Overview31
- 4.1Market Overview31
- 4.1.1Human Papillomavirus31
- 4.1.2North American Market34
- 4.1.3European Market35
- 4.1.4 Latin American Market35
- 4.2Hybrid Capture 2 Technology35
- 4.3Histology Market Overview37
- 4.1Market Overview31
- 5.Cytology Market Structure40
- 5.1 Key Players40
- 5.1.1 BD, TriPath40
- 5.1.2 Cytyc (Acquired by Hologic)40
- 5.1.3 CytoCore, Inc. (formerly known as Molecular Diagnostics, Inc.)41
- 5.2BD, TriPath Products42
- 5.2.1.Cervical Cytology Product Line42
- 5.2.1.1BD SurePath Pap Test42
- 5.2.1.2BD PrepStain Slide Processor43
- 5.2.1.3BD FocalPoint GS Imaging System43
- 5.2.1.4BD FocalPoint Slide Profiler44
- 5.2.1.5Molecular Oncology44
- 5.2.1.6Molecular Imaging Systems45
- 5.2.1.7Blood-based Reagents45
- 5.2.2Hologic Products45
- 5.2.2.1The ThinPrep System45
- 5.2.2.1.1 Additional Applications of the ThinPrep System46
- 5.2.2.2The ThinPrep Process47
- 5.2.2.3Clinical Studies Evaluating the ThinPrep Pap Test47
- 5.2.2.4Competition48
- 5.2.2.5Surgical Products48
- 5.2.2.6The NovaSure System49
- 5.2.2.7Competition50
- 5.2.2.1The ThinPrep System45
- 5.2.3CytoCore Inc., Products and Services50
- 5.2.3.1SoftPAP Cervical Cell Collector51
- 5.2.1.Cervical Cytology Product Line42
- 5.3Marketing and Sales Strategies51
- 5.3.1BD, TriPath Sales and Marketing52
- 5.3.1.1Total Sales and Marketing52
- 5.3.1.2Commercial Operations52
- 5.3.1.3Marketing Strategy53
- 5.3.1.4BD, TriPath\'s Molecular Diagnostic Products55
- 5.3.2Cytyc (Acquired by Hologic) Marketing and Sales56
- 5.3.2.1Sales and Marketing Costs57
- 5.3.2.2Hologic\'s Marketing and Sales Strategy57
- 5.3.2.2.1 Domestic Strategy57
- 5.3.2.2.2 International Strategy58
- 5.3.2.3Sales Strategy - Cervical Cytology Product Line58
- 5.3.2.3.1 Molecular Diagnostics58
- 5.3.2.3.2 Marketing and Sales Organizations59
- 5.3.2.3.3 Outside the U.S. with the Exception of Canada59
- 5.3.1BD, TriPath Sales and Marketing52
- 5.4Manufacturing BD, TriPath, BD SurePath and BD PrepStain60
- 5.4.1Manufacturing Standards for Diagnostic Products60
- 5.5Competition61
- 5.5.1Molecular Diagnostic Reagents62
- 5.1 Key Players40
- 6.Human Papillomavirus (HPV) Testing Market Structure63
- 6.1Key Players63
- 6.1.1Digene (Acquired by QIAGEN)63
- 6.1.1.1Digene Products64
- 6.1.2Ventana Medical Systems64
- 6.1.1Digene (Acquired by QIAGEN)63
- 6.2 Products65
- 6.2.1HPV Tests66
- 6.2.2Chlamydia and Gonorrhea Tests66
- 6.2.3Blood Virus Tests66
- 6.2.4Instrumentation and Accessory Products67
- 6.2.5 Vaccine67
- 6.3Sales and Marketing68
- 6.3.1International Markets68
- 6.3.2Europe68
- 6.3.3Central and South America69
- 6.3.4Asia/Pacific69
- 6.3.5Strategy70
- 6.4Manufacturing70
- 6.5 Competition71
- 6.5.1Ventana73
- 6.6 Ventana Staining Products73
- 6.6.1Ventana Products73
- 6.1Key Players63
- 7.Business Trends in the Industry76
- 7.1Industry Consolidation76
- 7.2Breath of Product Offering and Pricing77
- 7.3Government Regulation of Medical Devices77
- 7.4Strategic Business and Marketing Considerations78
- 7.5Commercial Opportunities in Cancer Markers79
- 7.6Moderators of Growth80
- 7.7Biotechnology Industry Trends81
- 7.8Pharmaceutical Industry Trends81
- 7.9Acquisition, License Agreement and Partnerships82
- 7.10Legal Developments83
- 7.11Sales and Marketing Strategies for Tumor Marker Tests84
- 7.11.1North American Market85
- 8.Government Regulation86
- 8.1Government Regulation86
- 8.2U.S. FDA Approval87
- 8.2.1Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws89
- 8.2.2Foreign Regulatory Approval89
- 9.Legal Developments91
- 9.1Cytyc Legal Proceedings91
- 9.2Ventana Legal Proceedings92
- 10.Third-Party Reimbursement96
- 10.1Limited Reimbursements by Third-party Payers Obstruct Sales96
- 10.2Cytyc ThinPrep96
- 10.3CPT Codes and HCPCS Codes97
- 10.4Professional Component Fee98
- 10.5Regional Payer Relations Managers98
- 10.6Reimbursement Codes Classification98
- 10.6.1Reporting Screening and Diagnostic Pap Smears98
- 10.6.2HCPCS (HCFA Common Procedure Coding System) Code Definitions98
- 10.6.3CPT (Current Procedural Terminology) Code Definitions99
- 10.7A Note on Statutory Limitations99
- 10.8Cervical Cytology Product Line99
- 10.9Molecular Diagnostic Products and Imaging Systems100
- 11. Barriers in Business102
- 11.1 Barriers in the Business Section102
- 11.1.1 Hologic Barriers102
- 11.1.2QIAGEN Risk Factors108
- 11.1.3Ventana116
- 11.1.3.1Ventana factors that could affect future results116
- 11.1 Barriers in the Business Section102
- 12.Acquisition Activity120
- 12.1Acquisition120
- 12.2Hologic Acquires Cytyc120
- 13. Research & Development Activity121
- 13.1Hologic In-Process R&D and Developed Technology121
- 13.2BD, TriPath Research & Development121
- 13.2.1Development of Molecular Diagnostic Products121
- 13.3Digene Research & Development123
- 13.4Ventana Research & Development124
- 13.4.1Instrumentation Development Projects124
- 13.4.2Reagent Development Projects124
- 14.Intellectual Property125
- 14.1BD, TriPath Proprietary Technology and Intellectual Property125
- 14.2Digene Intellectual Property126
- 14.2.1Hybrid Capture Technology126
- 14.2.2Rights to HPV Types126
- 14.2.3Other Intellectual Property128
- 14.3Ventana Patents and Proprietary Rights128
- 15. Hologic and Cytyc Profile129
- 15.1 Company Information129
- 15.1.1Contact129
- 15.1.2About Cytyc and Hologic Together129
- 15.2Products/Business Segments129
- 15.2.1Diagnostic Products129
- 15.2.2The ThinPrep Process130
- 15.1 Company Information129
- 16. Analytical Section131
- 16.1 Financial Analysis131
- 16.2Company\'s Strategies131
- 16.3SWOT Analysis132
- 17.Industry/Market Landscape135
- 17.1Industry Overview135
- 17.1.1Industry Key Players135
- 17.1.1.1Cytology Screening Testing Market Structure135
- 17.1.1.2Human papillomavirus (HPV) Testing Market Structure135
- 17.1.1Industry Key Players135
- 17.2 Outlook on the Industry135
- 17.3 Trends, Issues, Challenges and Opportunities: An Analysis137
- 17.4Molecular Diagnostics Products139
- 17.4.1Microscopic Slide Based Reagents139
- 17.4.2Molecular Imaging Systems140
- 17.4.3Blood-Based Reagents140
- 17.5Competitive Landscape141
- 17.6Products/Business Segments142
- 17.6.1Digene\'s HPV Tests144
- 17.6.2Digene\'s Chlamydia and Gonorrhea Tests144
- 17.6.3Digene\'s Blood Virus Tests144
- 17.6.4Digene\'s Instrumentation and Accessory Products145
- 17.1Industry Overview135
- 18.QIAGEN146
- 18.3Analytical Section146
- 18.3.1Financial Analysis146
- 18.4Company\'s Strategies146
- 18.5SWOT Analysis147
- 18.3Analytical Section146
- 19.Industry/Market Landscape150
- 19.1Digene Industry Overview150
- 19.1.1Industry Definition150
- 19.1.1.1Cytology Products150
- 19.1.2Industry Key Players151
- 19.1.3Company\'s Outlook on the Industry151
- 19.1.1Industry Definition150
- 19.2Trends, Issues, Challenges and Opportunities - An Analysis152
- 19.3Competitive Landscape153
- 19.4Competition153
- 19.4.1Digene\'s Competitive Advantage154
- 19.4.2Molecular Diagnostic Reagents154
- 19.4.3BD, TriPath155
- 19.5Products/Business Segments156
- 19.5.1Cervical Cytology Product Line (Formerly the i3 Series Product Line)156
- 19.5.1.1BD PrepStain Slide Processor156
- 19.5.1.2BD FocalPoint Imaging System157
- 19.5.1.3BD SlideWizard Product Line158
- 19.5.2Molecular Oncology Products158
- 19.5.2.1Microscopic Slide Based Reagents158
- 19.5.2.2Molecular Imaging Systems159
- 19.5.2.3Blood-Based Reagents159
- 19.5.1Cervical Cytology Product Line (Formerly the i3 Series Product Line)156
- 19.1Digene Industry Overview150
- 20.Analytical Section160
- 20.1Financial Analysis160
- 20.1.2BD, TriPath Oncology Revenues161
- 20.2Company\'s Strategies161
- 20.3SWOT Analysis161
- 20.1Financial Analysis160
- 21.Industry/Market Landscape165
- 21.1Industry Overview165
- 21.1.1Industry Definition166
- 21.1.1.1Cytology Products166
- 21.1.1.2Molecular Diagnostic Products166
- 21.1.2Industry Key Players166
- 21.1.1Industry Definition166
- 21.2Company\'s Outlook on the Industry166
- 21.3Trends, Issues, Challenges and Opportunities: An Analysis167
- 21.4Molecular Diagnostics Products169
- 21.4.1Blood-Based Reagents169
- 21.5Competitive Landscape170
- 21.5.1Competition170
- 21.5.1.2BD, TriPath\'s Competitive Advantage170
- 21.5.1.3Molecular Diagnostic Reagents171
- 21.5.1.4Ventana172
- 21.5.1Competition170
- 21.1Industry Overview165
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