全球細胞學及人類乳突病毒（HPV）檢測市場

全球細胞學及人類乳突病毒（HPV）檢測市場 是由出版商Trimark Publications在2011年01月所出版的。 這份英文市場調查報告書包含156 Pages 價格從美金3400起跳。

簡介

本報告為，分析醫院、診所、實驗室、研究機構中用於疾病診斷及監測時檢出細胞及蛋白質之檢測設備及試劑，並匯整人類乳突病毒（HPV）檢測等細胞學及相關分子診斷檢測趨勢，以下列摘要形式闡述。

第1章 概要

第2章 癌症生物學及診斷業簡介

• 癌症
• 生物科技及診斷產業之驅力
• 癌症標誌展望
• 癌症市場

第3章 子宮頸細胞學概要

• 背景資訊
• 市場機會
• 子宮頸癌

第4章 人類乳突病毒檢測概要

• 市場概要
• 核酸雜交法2大技術
• 組織學

第5章 細胞學市場結構

• 主要企業
• BD-TriPath產品
• Hologic產品
• CytoCore, Inc產品及服務
• 行銷及銷售策略

第6章 人類乳突病毒檢測市場結構

• 主要企業
• QIAGEN產品
• 行銷及銷售策略
• 製造
• 競合
• HVPV疫苗
• Ventana產品
• Ventana/Roche產品

第7章 同產業商業趨勢

• 產業整合
• 產品供應及價格
• 政府之醫療儀器法規
• 策略業務及行銷
• 癌症治療市場機會
• 成長要因
• 生技產業趨勢
• 醫療藥物產業趨勢
• 收購、授權合約及合作
• 腫瘤標誌檢測及行銷策略

第8章 產品法規

• 政府法規
• 美國FDA之許可

第9章 第三方償還

• 第三方償還限制影響銷售
• Hologic之ThinPrep
• CPT代碼及HCPCS代碼
• 償還代碼分類
• 子宮頸細胞學用產品群
• 分子診斷及影響系統

第10章 商業阻礙

第11章 收購活動

第12章 研發活動

第13章 智慧財產權

第14章 產業／市場環境

第15章 分析組別

附錄

圖表

目錄

Abstract

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

• 1.1 Statement of Report
• 1.2 About this Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology

2. Introduction to Cancer Biology and the Diagnostic Industry

• 2.1 Cancer
  • 2.1.1 The Disease
  • 2.1.2 Metastasis
  • 2.1.3 Demographics and Statistics of Cancer
• 2.2 The Drivers of the Biotech and Diagnostics Industry
  • 2.2.1 Top Ten Biotech Corporations Based on Innovation as Determined by FastCompany Magazine
  • 2.2.2 Technological Innovation
  • 2.2.3 Government Funding
  • 2.2.4 Pharmaceutical Development
• 2.3 Outlook for Tumor Markers
• 2.4 The Cancer Market

3. Cervical Cytology Testing Overview

• 3.1 Sector Background
• 3.2 Market Opportunity
• 3.3 Cervical Cancer
  • 3.3.1 Screening for Cervical Cancer
  • 3.3.2 Screening Procedures and Pap Smear Technology

4. Human Papillomavirus Testing Overview

• 4.1 Market Overview
  • 4.1.1 Human Papillomavirus
  • 4.1.2 North American Market
  • 4.1.3 European Market
  • 4.1.4 Latin American Market
• 4.2 Hybrid Capture 2 Technology
• 4.3 Histology Market Overview

5. Cytology Market Structure

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

6. Human Papillomavirus Testing Market Structure

• 6.1 Key Players
  • 6.1.1 QIAGEN (Acquired Digene)
  • 6.1.2 Ventana Medical Systems, Inc. (A Member of the Roche Group)
• 6.2 QIAGEN Products
  • 6.2.1 HPV Tests
  • 6.2.2 Chlamydia and Gonorrhea Tests
  • 6.2.3 Blood Virus Tests
  • 6.2.4 Instrumentation and Accessory Products
• 6.3 Sales and Marketing
  • 6.3.1 International Markets
  • 6.3.2 Europe
  • 6.3.3 Central and South America
  • 6.3.4 Asia-Pacific
  • 6.3.5 Strategy
• 6.4 Competition
• 6.5 HPV Vaccines
• 6.6 Ventana (A Member of the Roche Group)
  • 6.6.1 Ventana/Roche Staining Products

7. Business Trends in the Industry

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

8. Product Regulation

• 8.1 Government Regulation
• 8.2 U.S. FDA Approval
  • 8.2.1 CLIA and State Laboratory Laws
  • 8.2.2 Foreign Regulatory Approval

9. Third-Party Reimbursement

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

10. Barriers in Business

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

11. Acquisition Activity

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

12. Research & Development Activity

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

13. Intellectual Property

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

14 Industry/Market Landscape

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

15. Analytical Section

• 15.1 Company Strategies
  • 15.1.1 QIAGEN
  • 15.1.2 BD-TriPath
  • 15.1.3 Hologic
• 15.2 SWOT Analysis
  • 15.2.1 QIAGEN
  • 15.2.2 BD-TriPath
  • 15.2.3 Hologic

Appendix 1: Breast Cancer

• Appendix 2: Ovarian Cancer
• Appendix 3: Malignant Melanoma

INDEX OF TABLES

• Table 2.1: Drug Development by Type of Cancer
• Table 2.2: Organ-specific Medicines in Development for Cancer
• Table 2.3: Estimates for the Leading Types of New Cancer Cases and Deaths in the U.S. by Sex, 2010
• Table 2.4: Estimated New Cancer Cases and Deaths by Sex for All Types of Cancer
• Table 2.5: Estimated Number of Cancer Cases and Deaths by World Area
• Table 2.6: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country
• Table 2.7: Cancer-Associated Genes
• Table 2.8: Carcinogens in the Workplace
• Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995-2009
• Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995-2010
• Table 2.11: U.S. Government NIH Research Budget, 1995-2010
• Table 2.12: Herceptin Worldwide Sales, 2000-2015
• Table 2.13: Classes of Drugs Used to Treat Breast Cancer
• Table 2.14: Women' s Cancers in the U.S., 2010
• Table 2.15: Five-Year Relative Survival Rates by Stage at Diagnosis
• Table 3.1: Number of Pap Smears Performed by Country, 2009
• Table 3.2: Global Market for HPV Molecular Diagnostic Testing, 2007-2015
• Table 3.3: U.S. Market for HPV Diagnostic Testing, 2007-2015
• Table 5.1: Pap Tests in Top European Markets
• Table 5.2: Pap Tests in Top Asian Markets
• Table 6.1: HPV Market Size, 2003-2015
• Table 6.2: Product, Infection and Market
• Table 6.3: Instrumentation and Accessories, Infection and Market
• Table 7.1: List and Discounted Pricing for Abbott Tumor Marker Tests
• Table 9.1: CPT and HCPCS Codes
• Table 9.2: National Limitation Amounts (NLAs)
• Table 9.3: NLAs for Various CPT Codes
• Table 13.1: HPV Types Status and Patents
• Table 14.1: QIAGEN' s Diagnostic Test Kit Products, Instrumentation and Markets

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