Cytology and HPV Testing World Markets

Published by: Trimark Publications

Published: Jul. 1, 2008 - 177 Pages

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

2.1.1The 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 Technological Innovation

2.2.2 Government Funding

2.2.3 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 (HPV) 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 HPV

4.3 Histology Market Overview

5. Cytology Market Structure

5.1 Key Players

5.1.1 TriPath Imaging

5.1.2 Cytyc

5.1.3 Molecular Diagnostics, Inc.

5.2 TriPath Products

5.2.1. Cervical Cytology Product Line

5.2.1.1 The SurePath Test Pack

5.2.1.2 PrepStain Slide Processor

5.2.1.3 FocalPoint Imaging System

5.2.1.4 SlideWizard Product Line

5.2.1.5 Molecular Diagnostics Products

5.2.1.6 Molecular Imaging Systems

5.2.1.7 Blood-based Reagents

5.2.2 Cytyc’s Products

5.2.2.1 The ThinPrep System

5.2.2.1.1 Additional Applications of the ThinPrep System

5.2.2.2 The ThinPrep Process

5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test

5.2.2.4 Competition

5.2.2.5 Surgical Products

5.2.2.6 The NovaSure System

5.2.2.7 Competition

5.2.3 Molecular Diagnostics’ Products and Services

5.2.3.1 InPath System Key

5.3 Marketing and Sales Strategies

5.3.1 TriPath Imaging Sales and Marketing

5.3.1.1 Total Sales and Marketing

5.3.1.2 Commercial Operations

5.3.1.3 TriPath Oncology Sales and Marketing

5.3.1.4 Marketing Strategy

5.3.1.5 TriPath’s Molecular Diagnostic Products

5.3.2 Cytyc Marketing and Sales

5.3.2.1 Sales and Marketing Costs

5.3.2.2 Cytyc’s Marketing and Sales Strategy

5.3.2.2.1 Domestic Strategy

5.3.2.2.2 International Strategy

5.3.2.3 Sales Strategy - Cervical Cytology Product Line

5.3.2.3.1 Molecular Diagnostics

5.3.2.3.2 Marketing and Sales Organizations

5.3.2.3.3 Outside the U.S. with the Exception of Canada

5.4 Manufacturing TriPath, SurePath and PrepStain

5.4.1 Manufacturing Standards for Diagnostic Products

5.5 Competition

5.5.1 Molecular Diagnostic Reagents

6. Human Papillomavirus (HPV) Testing Market Structure

6.1 Key Players

6.1.1 Digene

6.1.1.1 Digene Products

6.1.2 Ventana Medical Systems

6.2 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 Manufacturing

6.5 Competition

6.5.1 Ventana

6.6 Ventana Staining Products

6.6.1 Ventana Products

7. Business Trends in the Industry

7.1 Industry Consolidation

7.2 Breath of Product Offering and Pricing

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 Legal Developments

7.11 Sales and Marketing Strategies for Tumor Marker Tests

7.11.1 North American Market

8. Government Regulation

8.1 Government Regulation

8.2 U.S. FDA Approval

8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws

8.2.2 Foreign Regulatory Approval

9. Legal Developments

9.1 Cytyc Legal Proceedings

9.2 Ventana Legal Proceedings

10. Third-Party Reimbursement

10.1 Limited Reimbursements by Third-party Payers Obstruct Sales

10.2 Cytyc ThinPrep

10.3 CPT Codes and HCPCS Codes

10.4 Professional Component Fee

10.5 Regional Payer Relations Managers

10.6 Reimbursement Codes Classification

10.6.1 Reporting Screening and Diagnostic Pap Smears

10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions

10.6.3 CPT (Current Procedural Terminology) Code Definitions

10.7 A Note on Statutory Limitations

10.8 Cervical Cytology Product Line

10.9 Molecular Diagnostic Products and Imaging Systems

11. Barriers in Business

11.1 Barriers in the Business Section

11.1.1 Cytyc Barriers

11.1.2 Digene Risk Factors

11.1.3 Ventana

11.1.3.1 Ventana factors that could affect future results

12. Acquisition Activity

12.1 Acquisition

12.2 Cytyc Acquisition Activity & Acquisition of Novacept

13. Research & Development Activity

13.1 Cytyc In-Process R&D and Developed Technology

13.2 TriPath Research & Development

13.2.1 Development of Molecular Diagnostic Products

13.3 Digene Research & Development

13.4 Ventana Research & Development

13.4.1 Instrumentation Development Projects

13.4.2 Reagent Development Projects

14. Intellectual Property

14.1 TriPath Proprietary Technology and Intellectual Property

14.2 Digene Intellectual Property

14.2.1 Hybrid Capture Technology

14.2.2 Rights to HPV Types

14.2.3 Other Intellectual Property

14.2.3.1 Trademark

14.3 Ventana Patents and Proprietary Rights

15. Cytyc Profile

15.1 Company Information

15.1.1 Contact

15.1.2 About the Cytyc Corporation

15.2 Products/Business Segments

15.2.1 Diagnostic Products

15.2.2 The ThinPrep Process

15.3 Management

15.3.1 Top Executives and Salaries

15.3.2 Board of Directors

16. Analytical Section

16.1 Financial Analysis

16.2 Company’s Strategies

16.3 SWOT Analysis

17. Industry/Market Landscape

17.1 Industry Overview

17.1.1 Industry Key Players

17.1.1.1 Cytology Screening Testing Market Structure

17.1.1.2 Human papillomavirus (HPV) Testing Market Structure

17.2 Outlook on the Industry

17.3 Trends, Issues, Challenges and Opportunities: An Analysis

17.4 Molecular Diagnostics Products

17.4.1 Microscopic Slide Based Reagents

17.4.2 Molecular Imaging Systems

17.4.3 Blood-Based Reagents

17.5 Competitive Landscape

17.6 Products/Business Segments

17.6.1 Digene’s HPV Tests

17.6.2 Digene’s Chlamydia and Gonorrhea Tests

17.6.3 Digene’s Blood Virus Tests

17.6.4 Digene’s Instrumentation and Accessory Products

18. Digene Management

18.1 Board of Directors

18.2 Top Executives and Salaries

18.3 Analytical Section

18.3.1 Financial Analysis

18.4 Company’s Strategies

18.5 SWOT Analysis

19. Industry/Market Landscape

19.1 Digene Industry Overview

19.1.1 Industry Definition

19.1.1.1 Cytology Products

19.1.2 Industry Key Players

19.1.3 Company’s Outlook on the Industry

19.2 Trends, Issues, Challenges and Opportunities - An Analysis

19.3 Competitive Landscape

19.4 Competition

19.4.1 Digene’s Competitive Advantage

19.4.2 Molecular Diagnostic Reagents

19.4.3 TriPath Imaging, Inc.

19.5 Products/Business Segments

19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line)

19.5.1.1 PrepStain Slide Processor

19.5.1.2 FocalPoint Imaging System

19.5.1.3 SlideWizard Product Line

19.5.2 Molecular Diagnostics Products

19.5.2.1 Microscopic Slide Based Reagents

19.5.2.2 Molecular Imaging Systems

19.5.2.3 Blood-Based Reagents

19.6 Management

19.6.1 Top Executives and Salaries

20. Analytical Section

20.1 Financial Analysis

20.1.2 TriPath Oncology Revenues

20.2 Company’s Strategies

20.3 SWOT Analysis

21. Industry/Market Landscape

21.1 Industry Overview

21.1.1 Industry Definition

21.1.1.1 Cytology Products

21.1.1.2 Molecular Diagnostic Products

21.1.2 Industry Key Players

21.2 Company’s Outlook on the Industry

21.3 Trends, Issues, Challenges and Opportunities: An Analysis

21.4 Molecular Diagnostics Products

21.4.1 Blood-Based Reagents

21.5 Competitive Landscape

21.5.1 Competition

21.5.1.2 TriPath’s Competitive Advantage

21.5.1.3 Molecular Diagnostic Reagents

21.5.1.4 Ventana

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: The 402 Organ Specific Medicines in Development for Cancer

Table 2.3: Leading Sites of Cancer Cases and Deaths in the U.S. by Sex

Table 2.4: Number of Cancer Cases and Deaths by Type of Cancer

Table 2.5: Cancer Cases and Deaths by Region

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 to 2005

Table 2.10: Top Ten Biotech Corporations

Table 2.11: Global Pharmaceutical Industry R&D Spending, 1980 to 2004

Table 2.12: U.S. Government NIH Research Budget, 1995 to 2004

Table 2.13: Herceptin Worldwide Sales, 1999 to 2005

Table 2.14: Classes of Drugs Used to Treat Breast Cancer

Table 2.15: Women’s Cancers in the U.S., 2005

Table 2.16: Five-Year Disease — Free Survival by Stage at Diagnosis

Table 3.1: Number of Pap Smears Performed by Country

Table 4.1: Digene Product Revenues and Assets

Table 5.1: TriPath Product Sales Share Overview

Table 5.2: Cytyc Product Overview

Table 5.3: Pap Tests in Top European Markets

Table 5.4: Pap Tests in Top Asian Markets

Table 5.5: Cytyc Annual Sales

Table 5.6: Cytyc Annual Net Income

Table 6.1: HPV Market Size, 2003 to 2011

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 10.1: CPT and HCPCS Codes

Table 10.2: National Limitation Amounts

Table 10.3: NLAs for Various CPT Codes

Table 14.1: HPV Types Status and Patents

Table 16.1: Percentage of Cytyc’s Net Sales

Table 17.1: Market Share of Cytology Products

Table 17.2: Diagnostic Test Kit Products and Markets

Abstract

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