Cytology and HPV Testing: Market Research Report
This report analyzes the worldwide markets for Cytology and HPV Testing in US$ Million.
The report provides separate comprehensive analytics for the US, Europe, and Rest of World.
Annual estimates and forecasts are provided for the period 2009 through 2018.
The report profiles 43 companies including many key and niche players such as Abbott Molecular, Inc., BD Diagnostics-TriPath, CytoCore®, Inc., DaAn Gene Co., Ltd., Gen-Probe, Inc., Hologic, Inc., Third Wave Technologies, Inc., Merck & Co., Inc., QIAGEN NV, Qiagen North American Holdings, Inc., Roche Diagnostics, Ventana Medical Systems, Inc., and Roche mtm Laboratories AG.
Market data and analytics are derived from primary and secondary research.
Company profiles are primarily based upon search engine sources in the public domain.
The report provides separate comprehensive analytics for the US, Europe, and Rest of World.
Annual estimates and forecasts are provided for the period 2009 through 2018.
The report profiles 43 companies including many key and niche players such as Abbott Molecular, Inc., BD Diagnostics-TriPath, CytoCore®, Inc., DaAn Gene Co., Ltd., Gen-Probe, Inc., Hologic, Inc., Third Wave Technologies, Inc., Merck & Co., Inc., QIAGEN NV, Qiagen North American Holdings, Inc., Roche Diagnostics, Ventana Medical Systems, Inc., and Roche mtm Laboratories AG.
Market data and analytics are derived from primary and secondary research.
Company profiles are primarily based upon search engine sources in the public domain.
I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.INDUSTRY OVERVIEW
Cytology and HPV Testing Market – Quick Facts
HPV Testing: A Prelude
Developing World Gears Up for HPV Vaccine
Current and Future Analysis
Cervical Cytology Screening: An Abstract
A Snapshot of Global Market Opportunity
Challenges Faced by HPV Testing Market
Select Side Effects of HPV Vaccines
Legislative & Regulatory Environment Worldwide
Capitulation of Cervical Cancer Screening Guidelines (2009-2012)
HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the US
US Government Proposes Administration of HPV Vaccine for Males
Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the US
US Cytology Screening Guidelines Support Co-testing of Cytology with HPV
Stringent NHS Guidelines for Cytology Laboratories
NCSP to Screen Women in New Zealand for Cervical Cancer
Reimbursement Scenario
Effect of HPV Vaccination on HPV Testing
Gardasil®
Cervarix®
HPV Vaccine Implementation Scenario
Global HPV Immunization Schedule and Population Coverage by Country
Select Market Overview
The United States
Canada
France
The United Kingdom
Australia
Mexico
Kenya
2.KEY TRENDS AND RESEARCH FINDINGS
Novel Technological Innovations to Enhance Accuracy of Screening Procedures
Regular HPV Screening Enhances Treatment and Survival Options
Co-testing of Pap Cytology and HPV for Enhanced Determination of Cervical Cancer Risk
Inhalable Cervical Cancer Vaccines to Grow in Popularity
Gardasil - A Biohazard? The Controversy Continues
Side-effects of Gardasil More Apparent Among Preteens
Increase in Instances of HPV-Linked Oral Cancer – A Cause of Deep Concern
New Research Findings Indicate Two Vaccination Doses Equal Three
HPV Vaccine Proves Beneficial in Prevention of Genital Warts in Men
Men Found to be More Susceptible to Oral HPV Infections
3.OVERVIEW OF CYTOLOGY AND HPV TESTING
What is HPV?
Types of HPV
Commonly Known Diseases and Related HPV Test Types
Common Types of HPV Diseases
Causes of Infection
Cervical Cancer and HPV
HPV and Other Cancers
Techniques for Detecting HPV
Signal-Amplified Nucleic Acid Assays
Target-Amplified HPV Assays
What is HPV Testing?
Test of HPV in Men
Test of HPV in Women
HPV Test Results
Positive HPV Test
Negative HPV Test
Limitations of HPV Testing
Advantages of HPV Testing
Cervical Cytology Observation/Screening
Pap Smear Screening
Requirements for Pap Smear Test
Advantages of Pap smear Test
Limitations of Cytologic Screening
HPV Testing vs. Cytology Testing
Future of HPV Testing
4.COMMERCIALLY AVAILABLE HPV TESTS
Digene HPV Test
careHPV Test
Hybrid Capture-II Test
5.PRODUCT/SERVICE INTRODUCTIONS
Biodis to Launch Citofem® Cervical Cancer Screening Test
QIAGEN Launches QIAensemble Decapper Sample Preparation Automation System in Europe
OncoHealth to Launch Protein-based Assay for HPV Testing
Independent Histopathology Services Launches Roche cobas 4800 System
Sensovation Introduces FLAIR Compact Fluorescent Array Imaging Reader
mtm Laboratories Unveils CINtec® PLUS Advanced Cervical Cancer Screening Product
Hoffmann-La Roche Launches cobas 4800 System
Roche Diagnostics Canada Launches cobas® 4800 Clinical Laboratory System
Histopathology & Specialty Laboratory Launches HPV Testing Range
AcroMetrix Introduces OptiQual® HPV Genotype Panel
SeraCare Life Sciences Introduces SeraCare HPV Genotype Performance Panel
Abbott Molecular Introduces PCR-Based Real-Time Diagnostic Test for HPV
6.ACCREDITATIONS/APPROVALS/ CERTIFICATIONS
FDA Grants Approval for Gen-Probe's PANTHER® System
Gen-Probe Receives FDA Approval for APTIMA® HPV Assay
Roche Receives FDA Approval for cobas HPV Test
mtm Laboratories Plans FDA Filings for Cervical Disease Tests
Merck Obtains FDA Approval for GARDASIL
QIAGEN Obtains CE Mark for careHPV Test
Hologic Receives Approval from FDA for Two HPV Tests
7.RECENT INDUSTRY ACTIVITY
Hologic Inks Definitive Agreement to Acquire Gen-Probe
Bio-Reference Laboratories Acquires Stake in InCellDx
QIAGEN Inks Co-Marketing Agreement with KingMed Diagnostics
Roche Signs Agreement with Unilabs-IHS to Expand Access to HPV Testing in UK
Roche Takes Over mtm Laboratories
Roche Inks Contract with Karolinska University Hospital for Cervical Cancer Screening
QIAGEN Establishes QIAGEN India
QIAGEN Signs Agreement with Abbott Laboratories
CytoCore Signs Agreement with Guangdong Prosper Channel Medicine Company
Life Technologies to Take Over AcroMetrix
Roche Molecular Systems Enters Into Research Collaboration with DKFZ
QIAGEN to Donate HPV DNA Test to Cancer Hospital in India
Xenomics Changes Name to TrovaGene
mtm Laboratories Inks Agreement with MetaSystems
CytoCore® and Amsino International Ink Agreement
Merck Collaborates with QIAGEN for Access to HPV DNA Testing
CytoCore® Inks Agreement with Synermed Select Partners
Xenomics Files Patent for New HPV Detection Test
8.FOCUS ON SELECT GLOBAL PLAYERS
Abbott Molecular, Inc. (US)
BD Diagnostics-TriPath (US)
CytoCore®, Inc. (US)
DaAn Gene Co., Ltd. (China)
Gen-Probe, Inc. (US)
Hologic, Inc. (US)
Third Wave Technologies, Inc. (US)
Merck & Co., Inc. (US)
QIAGEN NV (The Netherlands)
Qiagen North American Holdings, Inc. (US)
Roche Diagnostics (Switzerland)
Ventana Medical Systems, Inc. (US)
Roche mtm Laboratories AG (Germany)
9.GLOBAL MARKET PERSPECTIVE
III. MARKET
1.THE UNITED STATES
A. Market Analysis
Current and Future Analysis
Key Statistics
Market Overview
Pap and HPV Test Strongly Advised for Cervical Cancer in the US
HPV Vaccine Implementation
Reimbursement of Screening Procedures
Regulatory Scenario
Overview of Cervical Cancer Screening Guidelines (2009-2012)
HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the US
US Government Proposes Administration of HPV Vaccine for Males
Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the US
Cervical Cytology Screening Guidelines
NHS Guidelines for Cytology Laboratories
HPV Vaccine Implementation in the US Sates
HPV Vaccines Legislations Passed by Individual US States (2011-2012)
Product/Service Launches
Recent Industry Activity
Accreditations/Approvals/Certifications
Key Players
B. Market Analytics
2.EUROPE
A. Market Analysis
Current and Future Analysis
HPV Testing and Cervical Cancer Incidence Rates in Europe
HPV – The Preferred Primary Screening for Cervical Cancer in Europe
B. Market Analytics
2A.FRANCE
A. Market Analysis
Current and Future Analysis
HPV Vaccine Implementation
B. Market Analytics
2B.GERMANY
A. Market Analysis
Current and Future Analysis
Product/Service Introductions
Accreditations/Approvals/Certifications
Key Player
B. Market Analytics
2C.ITALY
A. Market Analysis
Current and Future Analysis
B. Market Analytics
2D.THE UNITED KINGDOM
A. Market Analysis
Current and Future Analysis
Market Overview
HPV Vaccine Implementation
Recent Industry Activity
Product/Service Introduction
B. Market Analytics
2E.REST OF EUROPE
A. Market Analysis
Current and Future Analysis
Recent Industry Activity
Product/Service Introductions
Accreditations/Approvals/Certifications
Key Players
B. Market Analytics
3.REST OF WORLD
A. Market Analysis
Current and Future Analysis
Focus on Select Markets
Canada
Asia-Pacific
India
Cervical Cancer Screening in India - Still a Long Way to Go
Australia
New Zealand
Latin America
Mexico
Africa
Recent Industry Activity
Product/Service Introductions
Key Player
B. Market Analytics
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 43 (including Divisions/Subsidiaries - 56)
The United States (23)
Canada (2)
Europe (20)
- France (1)
- Germany (6)
- The United Kingdom (3)
- Italy (2)
- Spain (1)
- Rest of Europe (7)
Asia-Pacific (Excluding Japan) (10)
Middle East (1)
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.INDUSTRY OVERVIEW
Cytology and HPV Testing Market – Quick Facts
HPV Testing: A Prelude
Developing World Gears Up for HPV Vaccine
Table 1. World Age-Standardized Cervical Cancer Incidence Rates (2011): Breakdown by Region (includes corresponding Graph/Chart)
Table 2. Global Cervical Cancer Mortality Rates (2011): Breakdown by Region (includes corresponding Graph/Chart)
Current and Future Analysis
Cervical Cytology Screening: An Abstract
A Snapshot of Global Market Opportunity
Table 3. Number of New Cervical Cancer Cases in the World by Region and Age Group (2010) (includes corresponding Graph/Chart)
Table 4. Global HPV Testing Market (2011): Regional Breakup by Number of Tests and Penetration Rate
Challenges Faced by HPV Testing Market
Select Side Effects of HPV Vaccines
Legislative & Regulatory Environment Worldwide
Capitulation of Cervical Cancer Screening Guidelines (2009-2012)
HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the US
US Government Proposes Administration of HPV Vaccine for Males
Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the US
US Cytology Screening Guidelines Support Co-testing of Cytology with HPV
Stringent NHS Guidelines for Cytology Laboratories
NCSP to Screen Women in New Zealand for Cervical Cancer
Reimbursement Scenario
Effect of HPV Vaccination on HPV Testing
Gardasil®
Cervarix®
HPV Vaccine Implementation Scenario
Global HPV Immunization Schedule and Population Coverage by Country
Select Market Overview
The United States
Canada
France
The United Kingdom
Australia
Mexico
Kenya
2.KEY TRENDS AND RESEARCH FINDINGS
Novel Technological Innovations to Enhance Accuracy of Screening Procedures
Regular HPV Screening Enhances Treatment and Survival Options
Co-testing of Pap Cytology and HPV for Enhanced Determination of Cervical Cancer Risk
Inhalable Cervical Cancer Vaccines to Grow in Popularity
Gardasil - A Biohazard? The Controversy Continues
Side-effects of Gardasil More Apparent Among Preteens
Increase in Instances of HPV-Linked Oral Cancer – A Cause of Deep Concern
New Research Findings Indicate Two Vaccination Doses Equal Three
HPV Vaccine Proves Beneficial in Prevention of Genital Warts in Men
Men Found to be More Susceptible to Oral HPV Infections
3.OVERVIEW OF CYTOLOGY AND HPV TESTING
What is HPV?
Types of HPV
Commonly Known Diseases and Related HPV Test Types
Common Types of HPV Diseases
Causes of Infection
Cervical Cancer and HPV
HPV and Other Cancers
Techniques for Detecting HPV
Signal-Amplified Nucleic Acid Assays
Target-Amplified HPV Assays
What is HPV Testing?
Test of HPV in Men
Test of HPV in Women
HPV Test Results
Positive HPV Test
Negative HPV Test
Limitations of HPV Testing
Advantages of HPV Testing
Cervical Cytology Observation/Screening
Pap Smear Screening
Requirements for Pap Smear Test
Advantages of Pap smear Test
Limitations of Cytologic Screening
HPV Testing vs. Cytology Testing
Future of HPV Testing
4.COMMERCIALLY AVAILABLE HPV TESTS
Digene HPV Test
careHPV Test
Hybrid Capture-II Test
5.PRODUCT/SERVICE INTRODUCTIONS
Biodis to Launch Citofem® Cervical Cancer Screening Test
QIAGEN Launches QIAensemble Decapper Sample Preparation Automation System in Europe
OncoHealth to Launch Protein-based Assay for HPV Testing
Independent Histopathology Services Launches Roche cobas 4800 System
Sensovation Introduces FLAIR Compact Fluorescent Array Imaging Reader
mtm Laboratories Unveils CINtec® PLUS Advanced Cervical Cancer Screening Product
Hoffmann-La Roche Launches cobas 4800 System
Roche Diagnostics Canada Launches cobas® 4800 Clinical Laboratory System
Histopathology & Specialty Laboratory Launches HPV Testing Range
AcroMetrix Introduces OptiQual® HPV Genotype Panel
SeraCare Life Sciences Introduces SeraCare HPV Genotype Performance Panel
Abbott Molecular Introduces PCR-Based Real-Time Diagnostic Test for HPV
6.ACCREDITATIONS/APPROVALS/ CERTIFICATIONS
FDA Grants Approval for Gen-Probe's PANTHER® System
Gen-Probe Receives FDA Approval for APTIMA® HPV Assay
Roche Receives FDA Approval for cobas HPV Test
mtm Laboratories Plans FDA Filings for Cervical Disease Tests
Merck Obtains FDA Approval for GARDASIL
QIAGEN Obtains CE Mark for careHPV Test
Hologic Receives Approval from FDA for Two HPV Tests
7.RECENT INDUSTRY ACTIVITY
Hologic Inks Definitive Agreement to Acquire Gen-Probe
Bio-Reference Laboratories Acquires Stake in InCellDx
QIAGEN Inks Co-Marketing Agreement with KingMed Diagnostics
Roche Signs Agreement with Unilabs-IHS to Expand Access to HPV Testing in UK
Roche Takes Over mtm Laboratories
Roche Inks Contract with Karolinska University Hospital for Cervical Cancer Screening
QIAGEN Establishes QIAGEN India
QIAGEN Signs Agreement with Abbott Laboratories
CytoCore Signs Agreement with Guangdong Prosper Channel Medicine Company
Life Technologies to Take Over AcroMetrix
Roche Molecular Systems Enters Into Research Collaboration with DKFZ
QIAGEN to Donate HPV DNA Test to Cancer Hospital in India
Xenomics Changes Name to TrovaGene
mtm Laboratories Inks Agreement with MetaSystems
CytoCore® and Amsino International Ink Agreement
Merck Collaborates with QIAGEN for Access to HPV DNA Testing
CytoCore® Inks Agreement with Synermed Select Partners
Xenomics Files Patent for New HPV Detection Test
8.FOCUS ON SELECT GLOBAL PLAYERS
Abbott Molecular, Inc. (US)
BD Diagnostics-TriPath (US)
CytoCore®, Inc. (US)
DaAn Gene Co., Ltd. (China)
Gen-Probe, Inc. (US)
Hologic, Inc. (US)
Third Wave Technologies, Inc. (US)
Merck & Co., Inc. (US)
QIAGEN NV (The Netherlands)
Qiagen North American Holdings, Inc. (US)
Roche Diagnostics (Switzerland)
Ventana Medical Systems, Inc. (US)
Roche mtm Laboratories AG (Germany)
9.GLOBAL MARKET PERSPECTIVE
Table 5. World Recent Past, Current and Future Analysis for HPV Testing by Geographic Region/ Country – US, Europe, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
Table 6. World 10-Year Perspective for HPV Testing by Geographic Region/Country – Percentage Breakdown of Dollar Revenues for US, Europe, and Rest of World Markets for Years 2009, 2012 and 2018 (includes corresponding Graph/Chart)
III. MARKET
1.THE UNITED STATES
A. Market Analysis
Current and Future Analysis
Key Statistics
Market Overview
Table 7. Prevalence of HPV in the US by Age (includes corresponding Graph/Chart)
Pap and HPV Test Strongly Advised for Cervical Cancer in the US
HPV Vaccine Implementation
Reimbursement of Screening Procedures
Regulatory Scenario
Overview of Cervical Cancer Screening Guidelines (2009-2012)
HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the US
US Government Proposes Administration of HPV Vaccine for Males
Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the US
Cervical Cytology Screening Guidelines
NHS Guidelines for Cytology Laboratories
HPV Vaccine Implementation in the US Sates
HPV Vaccines Legislations Passed by Individual US States (2011-2012)
Product/Service Launches
Recent Industry Activity
Accreditations/Approvals/Certifications
Key Players
B. Market Analytics
Table 8. US Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
2.EUROPE
A. Market Analysis
Current and Future Analysis
HPV Testing and Cervical Cancer Incidence Rates in Europe
Table 9. European HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart)
HPV – The Preferred Primary Screening for Cervical Cancer in Europe
B. Market Analytics
Table 10. European Recent Past, Current and Future Analysis for HPV Testing by Geographic Region – France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
Table 11. European 10-Year Perspective for HPV Testing by Geographic Region/Country – Percentage Breakdown of Dollar Revenues for France, Germany, Italy, UK and Rest of Europe Markets for Years 2009, 2012 and 2018 (includes corresponding Graph/Chart)
2A.FRANCE
A. Market Analysis
Current and Future Analysis
HPV Vaccine Implementation
B. Market Analytics
Table 12. French Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
2B.GERMANY
A. Market Analysis
Current and Future Analysis
Product/Service Introductions
Accreditations/Approvals/Certifications
Key Player
B. Market Analytics
Table 13. German Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
2C.ITALY
A. Market Analysis
Current and Future Analysis
B. Market Analytics
Table 14. Italian Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
2D.THE UNITED KINGDOM
A. Market Analysis
Current and Future Analysis
Market Overview
HPV Vaccine Implementation
Recent Industry Activity
Product/Service Introduction
B. Market Analytics
Table 15. UK Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
2E.REST OF EUROPE
A. Market Analysis
Current and Future Analysis
Recent Industry Activity
Product/Service Introductions
Accreditations/Approvals/Certifications
Key Players
B. Market Analytics
Table 16. Rest of Europe Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
3.REST OF WORLD
A. Market Analysis
Current and Future Analysis
Focus on Select Markets
Canada
Asia-Pacific
Table 17. Asian HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart)
India
Table 18. HPV in India: Breakdown of Type- Distribution and HPV Prevalence (includes corresponding Graph/Chart)
Cervical Cancer Screening in India - Still a Long Way to Go
Australia
New Zealand
Latin America
Table 19. Latin America HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart)
Mexico
Africa
Table 20. African HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart)
Recent Industry Activity
Product/Service Introductions
Key Player
B. Market Analytics
Table 21. Rest of World Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart)
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 43 (including Divisions/Subsidiaries - 56)
The United States (23)
Canada (2)
Europe (20)
- France (1)
- Germany (6)
- The United Kingdom (3)
- Italy (2)
- Spain (1)
- Rest of Europe (7)
Asia-Pacific (Excluding Japan) (10)
Middle East (1)
