Health knowledge made personal
Join this community!
› Share page:
Go
Search posts:

Cytology and HPV Testing World Markets --- Aarkstore Enterprise

Posted Nov 19 2010 11:28am
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 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 7 1.4 Objectives 8 1.5 Methodology 8 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 18 2.2.1 Top Ten Biotech Corporations 19 2.2.2 Technological Innovation 19 2.2.3 Government Funding 20 2.2.4 Pharmaceutical Development 20 2.3 Outlook for Tumor Markers 21 2.4 The Cancer Market 22 3. Cervical Cytology Testing Overview 25 3.1 Sector Background 25 3.2 Market Opportunity 25 3.3 Cervical Cancer 25 3.3.1 Screening for Cervical Cancer 26 3.3.2 Screening Procedures and Pap Smear Technology 27 4. Human Papillomavirus (HPV) Testing Overview 31 4.1 Market Overview 31 4.1.1 Human Papillomavirus 31 4.1.2 North American Market 34 4.1.3 European Market 35 4.1.4 Latin American Market 35 4.2 Hybrid Capture 2 Technology 35 4.3 Histology Market Overview 37 5. Cytology Market Structure 40 5.1 Key Players 40 5.1.1 BD, TriPath 40 5.1.2 Cytyc (Acquired by Hologic) 40 5.1.3 CytoCore, Inc. (formerly known as Molecular Diagnostics, Inc.) 41 5.2 BD, TriPath Products 42 5.2.1. Cervical Cytology Product Line 42 5.2.1.1 BD SurePath Pap Test 42 5.2.1.2 BD PrepStain Slide Processor 43 5.2.1.3 BD FocalPoint GS Imaging System 43 5.2.1.4 BD FocalPoint Slide Profiler 44 5.2.1.5 Molecular Oncology 44 5.2.1.6 Molecular Imaging Systems 45 5.2.1.7 Blood-based Reagents 45 5.2.2 Hologic Products 45 5.2.2.1 The ThinPrep System 45 5.2.2.1.1 Additional Applications of the ThinPrep System 46 5.2.2.2 The ThinPrep Process 47 5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test 47 5.2.2.4 Competition 48 5.2.2.5 Surgical Products 48 5.2.2.6 The NovaSure System 49 5.2.2.7 Competition 50 5.2.3 CytoCore Inc., Products and Services 50 5.2.3.1 SoftPAP Cervical Cell Collector 51 5.3 Marketing and Sales Strategies 51 5.3.1 BD, TriPath Sales and Marketing 52 5.3.1.1 Total Sales and Marketing 52 5.3.1.2 Commercial Operations 52 5.3.1.3 Marketing Strategy 53 5.3.1.4 BD, TriPath’s Molecular Diagnostic Products 55 5.3.2 Cytyc (Acquired by Hologic) Marketing and Sales 56 5.3.2.1 Sales and Marketing Costs 57 5.3.2.2 Hologic’s Marketing and Sales Strategy 57 5.3.2.2.1 Domestic Strategy 57 5.3.2.2.2 International Strategy 58 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 59 5.3.2.3.3 Outside the U.S. with the Exception of Canada 59 5.4 Manufacturing BD, TriPath, BD SurePath and BD PrepStain 60 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 (Acquired by QIAGEN) 63 6.1.1.1 Digene Products 64 6.1.2 Ventana Medical Systems 64 6.2 Products 65 6.2.1 HPV Tests 66 6.2.2 Chlamydia and Gonorrhea Tests 66 6.2.3 Blood Virus Tests 66 6.2.4 Instrumentation and Accessory Products 67 6.2.5 Vaccine 67 6.3 Sales and Marketing 68 6.3.1 International Markets 68 6.3.2 Europe 68 6.3.3 Central and South America 69 6.3.4 Asia/Pacific 69 6.3.5 Strategy 70 6.4 Manufacturing 70 6.5 Competition 71 6.5.1 Ventana 73 6.6 Ventana Staining Products 73 6.6.1 Ventana Products 73 7. Business Trends in the Industry 76 7.1 Industry Consolidation 76 7.2 Breath of Product Offering and Pricing 77 7.3 Government Regulation of Medical Devices 77 7.4 Strategic Business and Marketing Considerations 78 7.5 Commercial Opportunities in Cancer Markers 79 7.6 Moderators of Growth 80 7.7 Biotechnology Industry Trends 81 7.8 Pharmaceutical Industry Trends 81 7.9 Acquisition, License Agreement and Partnerships 82 7.10 Legal Developments 83 7.11 Sales and Marketing Strategies for Tumor Marker Tests 84 7.11.1 North American Market 85 8. Government Regulation 86 8.1 Government Regulation 86 8.2 U.S. FDA Approval 87 8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 89 8.2.2 Foreign Regulatory Approval 89 9. Legal Developments 91 9.1 Cytyc Legal Proceedings 91 9.2 Ventana Legal Proceedings 92 10. Third-Party Reimbursement 96 10.1 Limited Reimbursements by Third-party Payers Obstruct Sales 96 10.2 Cytyc ThinPrep 96 10.3 CPT Codes and HCPCS Codes 97 10.4 Professional Component Fee 98 10.5 Regional Payer Relations Managers 98 10.6 Reimbursement Codes Classification 98 10.6.1 Reporting Screening and Diagnostic Pap Smears 98 10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions 98 10.6.3 CPT (Current Procedural Terminology) Code Definitions 99 10.7 A Note on Statutory Limitations 99 10.8 Cervical Cytology Product Line 99 10.9 Molecular Diagnostic Products and Imaging Systems 100 11. Barriers in Business 102 11.1 Barriers in the Business Section 102 11.1.1 Hologic Barriers 102 11.1.2 QIAGEN Risk Factors 108 11.1.3 Ventana 116 11.1.3.1 Ventana factors that could affect future results 116 12. Acquisition Activity 120 12.1 Acquisition 120 12.2 Hologic Acquires Cytyc 120 13. Research & Development Activity 121 13.1 Hologic In-Process R&D and Developed Technology 121 13.2 BD, 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 125 14.1 BD, TriPath Proprietary Technology and Intellectual Property 125 14.2 Digene Intellectual Property 126 14.2.1 Hybrid Capture Technology 126 14.2.2 Rights to HPV Types 126 14.2.3 Other Intellectual Property 128 14.3 Ventana Patents and Proprietary Rights 128 15. Hologic and Cytyc Profile 129 15.1 Company Information 129 15.1.1 Contact 129 15.1.2 About Cytyc and Hologic Together 129 15.2 Products/Business Segments 129 15.2.1 Diagnostic Products 129 15.2.2 The ThinPrep Process 130 16. Analytical Section 131 16.1 Financial Analysis 131 16.2 Company’s Strategies 131 16.3 SWOT Analysis 132 17. Industry/Market Landscape 135 17.1 Industry Overview 135 17.1.1 Industry Key Players 135 17.1.1.1 Cytology Screening Testing Market Structure 135 17.1.1.2 Human papillomavirus (HPV) Testing Market Structure 135 17.2 Outlook on the Industry 135 17.3 Trends, Issues, Challenges and Opportunities: An Analysis 137 17.4 Molecular Diagnostics Products 139 17.4.1 Microscopic Slide Based Reagents 139 17.4.2 Molecular Imaging Systems 140 17.4.3 Blood-Based Reagents 140 17.5 Competitive Landscape 141 17.6 Products/Business Segments 142 17.6.1 Digene’s HPV Tests 144 17.6.2 Digene’s Chlamydia and Gonorrhea Tests 144 17.6.3 Digene’s Blood Virus Tests 144 17.6.4 Digene’s Instrumentation and Accessory Products 145 18. QIAGEN 146 18.3 Analytical Section 146 18.3.1 Financial Analysis 146 18.4 Company’s Strategies 146 18.5 SWOT Analysis 147 19. Industry/Market Landscape 150 19.1 Digene Industry Overview 150 19.1.1 Industry Definition 150 19.1.1.1 Cytology Products 150 19.1.2 Industry Key Players 151 19.1.3 Company’s Outlook on the Industry 151 19.2 Trends, Issues, Challenges and Opportunities - An Analysis 152 For more information, please visit :http://www.aarkstore.com/reports/Cytology-and-HPV-Testing-World-Markets-1309.ht Contact :Sanaa Aarkstore Enterprise Tel : +912227453309 Mobile No: +919272852585 Email : contact@aarkstore.com
Post a comment
Write a comment:

Related Searches