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Global HPV Testing Industry

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NEW YORK, Feb. 14, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global HPV Testing Industry
http://www.reportlinker.com/p01375510/Global-HPV-Testing-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

This report analyzes the worldwide markets for HPV Testing in US$ Thousand.

The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

The report profiles 43 companies including many key and niche players such as -
Abbott Molecular, Inc.
Arbor Vita Corporation
Becton
Dickinson and Company
CytoCore, Inc.
DaAn Gene Co., Ltd.
F. Hoffmann-La Roche Ltd.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
HPV Testing Market - Quick Facts II-1
Global HPV Testing Market II-1
Table 1: Number of HPV Tests by Geographic Region (2012) (In
million) (includes corresponding Graph/Chart) II-3
Cervical Cancer: Rising Incidence & Mortality Enhances Need
for Testing II-3
Table 2: Number of New Cervical Cancer Cases in the World by
Region and Age Group (2012) (includes corresponding
Graph/Chart) II-4

Table 3: World Age-Standardized Cervical Cancer Incidence
Rates (2012): Breakdown by Region (includes corresponding
Graph/Chart) II-5

Table 4: Worldwide Cervical Cancer Mortality by Leading
Countries (2012): Ranked by Number of Deaths (in '000s)
(includes corresponding Graph/Chart) II-5
Rising Significance of hrHPV testing in Cervical Cancer
Screening II-6
Table 5: Cervical Screening Penetration in Select Countries
(2012): % of Women in 20-69 Age Group Screened for Cervical
Screening (includes corresponding Graph/Chart) II-6
Co-testing of Pap Cytology and HPV for Enhanced Determination
of Cervical Cancer Risk II-7
Cervical Cytology Screening: An Abstract II-7
Conventional Pap Smear Tests Give Way to Liquid-based
Cytology Tests II-8
Table 6: Pap Tests Market in Select Countries (2012):
Percentage Share Breakdown of Number of Tests by
Conventional Cytology Tests and Liquid-based Cytology Tests
(includes corresponding Graph/Chart) II-8

Table 7: Pap Smear Tests by Geography (2012): Percentage
Breakdown by Number of Tests for US, EU and Asia & Latin
America (includes corresponding Graph/Chart) II-9
HPV Testing: A Fast Growing Segment in the STD Diagnostic
Testing Market II-9
Reimbursement Coverage Influences Adoption of HPV Testing II-9
Cervical Cancer Screening: Focus on Detection of CIN2 and CIN3
Cancers II-10
Novel Technological Innovations to Enhance Accuracy of
Screening Procedures II-10
Regular HPV Screening Enhances Treatment and Survival Options II-10
Need for Genotyping of HPV Subtypes Beyond 16 & 18 II-10
Detecting E6 and E7 Oncoproteins to Improve Efficacy of
Cervical Cancer Screening II-11
Increase in Instances of HPV-Linked Oral Cancer - A Cause of
Deep Concern II-11
Research Findings Indicate Two Vaccination Doses Equal Three II-11
Men Found to be More Susceptible to Oral HPV Infections II-12
Favorable Guidelines: A Key Growth Driving Factor II-12
Capitulation of Cervical Cancer Screening Guidelines (2009-2012) II-12
FDA to Implement Stringent Measures on HPV Testing II-14
New Guidelines for Cervical Cancer Screening II-14
HPV Test to be a Part of the New Cervical Cancer Screening
Guidelines in the US II-15
US Government Proposes Administration of HPV Vaccine for Males II-15

Frequent Pap and HPV Test Recommendations for Cervical Cancer
Screening in the US II-16
US Cytology Screening Guidelines Support Co-testing of
Cytology with HPV II-16
Stringent NHS Guidelines for Cytology Laboratories II-16
NCSP to Screen Women in New Zealand for Cervical Cancer II-17
HPV Vaccination Programs: Assessing the Impact on HPV Testing
Market II-17
Gardasil - A Biohazard? II-18
Side-effects of Gardasil More Apparent among Preteens II-18
Inhalable Cervical Cancer Vaccines to Grow in Popularity II-19
HPV Vaccine Proves Beneficial in Prevention of Genital Warts
in Men II-19
HPV Vaccination Initiatives in Select Countries II-19
HPV Vaccine Implementation: HPV Immunization Schedule and
Population Coverage by Country II-20

2. COMPETITIVE LANDSCAPE II-22
QIAGEN: The Leading Player II-22
Table 8: Leading Players in the Global HPV Testing Market
(2012): Percentage Share Breakdown of Revenues for QIAGEN,
Hologic/Gen-Probe, Roche, Abbott, Becton Dickinson, and
Others (includes corresponding Graph/Chart) II-22
Comparative Analysis of HPV Testing Products II-22
A Review of Select HPV Tests II-23

3. OVERVIEW OF CYTOLOGY AND HPV TESTING II-26
What is HPV? II-26
Types of HPV II-26
Commonly Known Diseases and Related HPV Test Types II-26
Common Types of HPV Diseases II-27
Lung Cancer II-27
Cutaneous HPVs II-27
Genital HPVs II-27
Throat Cancer II-28
Causes of Infection II-28
Cervical Cancer and HPV II-28
HPV and Other Cancers II-29
Techniques for Detecting HPV II-29
Signal-Amplified Nucleic Acid Assays II-29
Target-Amplified HPV Assays II-29
What is HPV Testing? II-29

Test of HPV in Men II-29
Test of HPV in Women II-30
HPV Test Results II-30
Positive HPV Test II-30
Negative HPV Test II-30
Limitations of HPV Testing II-31
Advantages of HPV Testing II-31
Cervical Cytology Observation/Screening II-31
Pap Smear Screening II-32
Requirements for Pap Smear Test II-32
Advantages of Pap smear Test II-33
Limitations of Cytologic Screening II-33
HPV Testing vs. Cytology Testing II-33

4. PRODUCT/SERVICE INTRODUCTIONS II-34
QIAGEN Launches careHPV Test II-34
Cancer Genetics Introduces FHACT™ Test II-34
CureHealth Diagnostics Unveils New HPV Detection Technology in
India II-34
Abbott Rolls Out RealTime High Risk HPV Test in Canada II-34
Trovagene Launches HPV-HR Test II-35
Roche Introduces cobas HPV Test Application for iPad Users II-35
Delphi Bioscience Asia Launches Delphi Screener in Thailand II-35
GenPath Women's Health Rolls Out GenCerv HPV Test II-35
Seegene Unveils QuantPlex HPV28 Genotyping Assay II-36
Biodis to Launch Citofem® Cervical Cancer Screening Test II-36
QIAGEN Launches QIAensemble Decapper Sample Preparation
Automation System in Europe II-36
Lab21 Launches Molecular Analysis Service Offerings II-37
OncoHealth to Launch Protein-based Assay for HPV Testing II-37
Independent Histopathology Services Launches Roche cobas 4800
System II-38
Sensovation Introduces FLAIR Compact Fluorescent Array Imaging
Reader II-38
mtm Laboratories Unveils CINtec® PLUS Advanced Cervical Cancer
Screening Product II-38
Hoffmann-La Roche Launches cobas 4800 System II-39
Roche Diagnostics Canada Launches cobas® 4800 Clinical
Laboratory System II-39
Histopathology & Specialty Laboratory Launches HPV Testing Range II-40
AcroMetrix Introduces OptiQual® HPV Genotype Panel II-40
SeraCare Life Sciences Introduces SeraCare HPV Genotype
Performance Panel II-41
Abbott Molecular Introduces PCR-Based Real-Time Diagnostic

Test for HPV II-41

5. ACCREDITATIONS/APPROVALS/ CERTIFICATIONS II-42
Hologic Secures Approval for Aptima HPV Assay from US FDA II-42
Roche Seeks Initial Screening Indication for Cobas HPV Test II-42
FDA Grants Approval for Gen-Probe's PANTHER® System II-42
Hologic Bags FDA Approval for Using APTIMA HPV 16 18/45
Genotype Assay with TIGRIS System II-43
Gen-Probe Receives FDA Approval for APTIMA® HPV Assay II-43
Roche Receives FDA Approval for cobas HPV Test II-43
mtm Laboratories Plans FDA Filings for Cervical Disease Tests II-43
Arbor Vita Corp Announces Interim Results of START-UP Clinical
Trial for HPV E6 Test II-44
Merck Obtains FDA Approval for GARDASIL II-44
QIAGEN Obtains CE Mark for careHPV Test II-44
Hologic Receives Approval from FDA for Two HPV Tests II-45

6. RECENT INDUSTRY ACTIVITY II-46
Enzo Ties up with IncellDx Inc II-46
IncellDx Inks Agreement with GeneCell Diagnostics II-46
IncellDx and Kindstar Global Ink Agreement II-46
QIAGEN and Calmette Hospital Enter into Partnership II-47
VWR International Takes Over Switch and Labonord II-47
York Renews Contract with Source BioScience for Liquid-Based
Cytology II-47
Hologic Acquires Gen-Probe II-47
QIAGEN Enters into Co-Marketing Agreement with KingMed
Diagnostics II-48
Gynecor Implements cobas® 4800 Analyzer for HPV Test II-48
Molecular Pathology Laboratory Network to Adopt Hologic/Gen-
Probe APTIMA HPV Assay II-48
Trovagene Inks Agreement with Strand Life Sciences II-48
Bio-Reference Laboratories Acquires Stake in InCellDx II-49
QIAGEN Inks Co-Marketing Agreement with KingMed Diagnostics II-49
Roche Signs Agreement with Unilabs-IHS to Expand Access to HPV
Testing in UK II-49
Roche Takes Over mtm Laboratories II-50
Roche and MTM Laboratories Ink Agreement II-50
Government of Rwanda Introduces New Initiative to Prevent
Cervical Cancer II-51
Roche Inks Contract with Karolinska University Hospital for
Cervical Cancer Screening II-51

QIAGEN Establishes QIAGEN India II-51
QIAGEN Signs Agreement with Abbott Laboratories II-52
CytoCore Signs Agreement with Guangdong Prosper Channel
Medicine Company II-52
Life Technologies Takes Over AcroMetrix II-52
Roche Molecular Systems Enters Into Research Collaboration
with DKFZ II-53
Xenomics Changes Name to TrovaGene II-53
mtm Laboratories Inks Agreement with MetaSystems II-53
CytoCore® and Amsino International Ink Agreement II-54
Merck Collaborates with QIAGEN for Access to HPV DNA Testing II-54
CytoCore® Inks Agreement with Synermed Select Partners II-55
Xenomics Files Patent for New HPV Detection Test II-55

7. FOCUS ON SELECT GLOBAL PLAYERS II-56
Abbott Molecular, Inc. (US) II-56
Arbor Vita Corporation (US) II-56
Becton, Dickinson and Company (US) II-57
CytoCore®, Inc. (US) II-57
DaAn Gene Co., Ltd. (China) II-58
F. Hoffmann-La Roche Ltd. (Switzerland) II-58
Ventana Medical Systems, Inc. (US) II-58
Hologic, Inc. (US) II-59
Hologic Gen-Probe Incorporated (US) II-59
QIAGEN NV (The Netherlands) II-60
Seegene, Inc. (South Korea) II-60

8. GLOBAL MARKET PERSPECTIVE II-61
Table 9: World Recent Past, Current and Future Analysis for
HPV Testing by Geographic Region/ Country - US, Japan, Europe,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Thousand for Years 2009 through 2018
(includes corresponding Graph/Chart) II-61

Table 10: World 10-Year Perspective for HPV Testing by
Geographic Region/Country - Percentage Breakdown of Revenues
for US, Japan, Europe, and Rest of World Markets for Years
2009, 2013 and 2018 (includes corresponding Graph/Chart) II-62

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Cervical Cancer in the US - Key Statistics & Findings III-1
Table 11: Prevalence of HPV in the US by Age (includes
corresponding Graph/Chart) III-1
Table 12: Number of New Cervical Cancer Cases by US State
(2013) III-2
HPV Testing Market - A Review III-2
Table 13: Cervical Cancer by HPV Type (2012): Percentage
Share Breakdown of Cervical Cancer Cases by HPV Type
(includes corresponding Graph/Chart) III-3
Competitive Landscape III-4
Table 14: Leading Players in the US HPV Testing Market
(2010 & 2011): Percentage Share Breakdown of Number of
Tests for QIAGEN, Hologic, and Roche (includes
corresponding Graph/Chart) III-4
Cytology Testing Market - An Insight III-5
Table 15: Pap Tests Market in the US (2012): Percentage
Share Breakdown of Number of Tests by Conventional Cytology
Tests and Liquid-based Cytology Tests (includes
corresponding Graph/Chart) III-5

HPV Vaccine Implementation III-5
Reimbursement of Screening Procedures III-5
Regulatory Landscape III-6
Overview of Cervical Cancer Screening Guidelines III-6
FDA to Implement Strict Measures for Cervical Cancer
Screening Tests III-8
New Guidelines for Cervical Cancer Screening III-8
US Government Proposes Administration of HPV Vaccine for Males III-9
Frequent Pap and HPV Test Recommendations for Cervical
Cancer Screening in the US III-9
Cervical Cytology Screening Guidelines III-10
NHS Guidelines for Cytology Laboratories III-10
HPV Vaccine Implementation in the US Sates III-11
HPV Vaccines Legislations Passed by Individual US States
(2011-2012) III-11
Product Innovations/Introductions III-12
Strategic Corporate Developments III-15
Accreditations/Approvals/Certifications III-20
Key Players III-21
B.Market Analytics III-24
Table 16: US Recent Past, Current and Future Analysis for
HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-24

2. JAPAN III-25
A.Market Analysis III-25
Outlook III-25
Table 17: Japanese HPV Market (2012): Leading HPV Types
Causing Cervical Cancer (includes corresponding
Graph/Chart) III-25
Japan Discontinues Recommendation of FDA Approved HPV Drugs III-25
B.Market Analytics III-26
Table 18: Japanese Recent Past, Current and Future Analysis
for HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-26

3. EUROPE III-27
A.Market Analysis III-27
Outlook III-27
Cervical Cancer Screening in Europe - A Review III-27
Table 19: Cervical Cancer Incidence and Mortality in
European Countries (2012) III-28

Table 20: Prevalence of Cervical Cancer in European
Countries (2012) III-29

Table 21: European HPV Testing Market (2011): Breakdown by %
of Women Tested; HPV Prevalence Rate and Cervical Cancer
Mortality Rates (includes corresponding Graph/Chart) III-30
Increasing Effectiveness of Cervical Cancer Screening Programs III-30
Need for Repeat Testing III-30
HPV - The Preferred Primary Screening for Cervical Cancer in
Europe III-31
B.Market Analytics III-32
Table 22: 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$ Thousand for Years 2009
through 2018 (includes corresponding Graph/Chart) III-32

Table 23: European 10-Year Perspective for HPV Testing by
Geographic Region/ Country - Percentage Breakdown of
Revenues for France, Germany, Italy, UK and Rest of Europe
Markets for Years 2009, 2013 and 2018 (includes
corresponding Graph/Chart) III-33

3a. FRANCE III-34
A.Market Analysis III-34
Outlook III-34
HPV Vaccine Implementation III-34
B.Market Analytics III-35
Table 24: French Recent Past, Current and Future Analysis
for HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-35

3b. GERMANY III-36
A.Market Analysis III-36
Outlook III-36
Strategic Corporate Developments III-36
Product Innovations/Introductions III-36
Accreditations/Approvals/Certifications III-37
B.Market Analytics III-39
Table 25: German Recent Past, Current and Future Analysis
for HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-39

3c. ITALY III-40
Market Analysis III-40
Table 26: Italian Recent Past, Current and Future Analysis
for HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-40

3d. THE UNITED KINGDOM III-41
A.Market Analysis III-41
Outlook III-41
Market Overview III-41
Cervical Cancer - Key Statistics III-41
Impact of HPV Vaccine Implementation III-41
Strategic Corporate Developments III-42
B.Market Analytics III-43
Table 27: UK Recent Past, Current and Future Analysis for
HPV Testing Analyzed with Annual Revenue Figures in US$
Thousand for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-43

3e. REST OF EUROPE III-44
A.Market Analysis III-44
Outlook III-44
Spain III-44
Table 28: Cervical Cancer in Spain (2012): Percentage Share
Breakdown of New Cases by Age-Group (includes corresponding
Graph/Chart) III-44
Sweden III-44
The Netherlands III-44
Strategic Corporate Developments III-45
Product Innovations/Introductions III-47
Accreditations/Approvals/Certifications III-48
Key Players III-49
B.Market Analytics III-50
Table 29: Rest of Europe Recent Past, Current and Future
Analysis for HPV Testing Analyzed with Annual Revenue
Figures in US$ Thousand for Years 2009 through 2018
(includes corresponding Graph/Chart) III-50

4. REST OF WORLD III-51
A.Market Analysis III-51
Outlook III-51
Focus on Select Markets III-51
Canada III-51
Table 30: Number of New Cervical Cancer Cases in Canada by
Province (2012) (includes corresponding Graph/Chart) III-52
Asia-Pacific III-52
Table 31: Asian HPV Testing Market (2011): Breakdown by %
of Women Tested; HPV Prevalence Rate and Cervical Cancer
Mortality Rates (includes corresponding Graph/Chart) III-52
China III-53
Introduction III-53
New Testing Technologies Gain Traction III-53
Hospitals and Laboratories to Fuel Growth III-53
Competitive Landscape III-54
Table 32: Leading Players in China's HPV Market (2012):
Percentage Share Breakdown of Value for Digene, Kaipu,
Yaneng, Mingyuan and Others (includes corresponding
Graph/Chart) III-54
India III-54

HPV Testing - A Nascent Market III-54
Table 33: HPV in India - Breakdown of Type-Distribution
and HPV Prevalence (includes corresponding Graph/Chart) III-55
Cervical Cancer Screening in India - Still a Long Way to Go III-55
Australia III-56
National Cervical Screening Program Continues to Taste
Success III-56
Cervarix® and Gardasil® to Combat Cervical Cancer III-56
New Zealand III-57
Latin America III-57
Table 34: Latin America HPV Testing Market (2011):
Breakdown by % of Women Tested; HPV Prevalence Rate and
Cervical Cancer Mortality Rates (includes corresponding
Graph/Chart) III-57
Brazil III-58
Mexico III-58
Africa III-58
Table 35: African HPV Testing Market (2011): Breakdown by %
of Women Tested; HPV Prevalence Rate and Cervical Cancer
Mortality Rates (includes corresponding Graph/Chart) III-59
Strategic Corporate Developments III-60
Product Launches III-63
Key Players III-65
B.Market Analytics III-66
Table 36: Rest of World Recent Past, Current and Future
Analysis for HPV Testing Analyzed with Annual Revenue
Figures in US$ Thousand for Years 2009 through 2018
(includes corresponding Graph/Chart) III-66

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 43 (including Divisions/Subsidiaries - 51)

The United States (25)
Canada (2)
Europe (17)
- Germany (3)
- The United Kingdom (3)
- Italy (2)
- Spain (1)
- Rest of Europe (8)
Asia-Pacific (Excluding Japan) (7)

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