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CYTOLOGY AND HPV TESTING - A GLOBAL STRATEGIC BUSINESS REPORT   

Research Abstract

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 44 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.

Code : MCP-6893
Price : $3950
Companies : 44
Pages : 435
Date : July 2012
Market Data Tables : 95

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 TABLE OF CONTENTS

  CYTOLOGY AND HPV TESTING (Complete Report) Pages : 435   | $3950
 
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 SUMMARY50$2250
  1. INDUSTRY OVERVIEW.....II-114 $1450  
   Cytology and HPV Testing Market – Quick Facts.....II-11$100
   HPV Testing: A Prelude.....II-2
Developing World Gears Up for HPV Vaccine.....II-2
1$100
   Table 1: World Age-Standardized Cervical Cancer Incidence Rates (2011): Breakdown by Region (includes corresponding Graph/Chart).....II-3

Table 2: Global Cervical Cancer Mortality Rates (2011): Breakdown by Region (includes corresponding Graph/Chart).....II-3
Current and Future Analysis.....II-3
1$350
   Cervical Cytology Screening: An Abstract.....II-4
A Snapshot of Global Market Opportunity.....II-4
1$100
   Table 3: Number of New Cervical Cancer Cases in the World by Region and Age Group (2010) (includes corresponding Graph/Chart).....II-51$350
   Table 4: Global HPV Testing Market (2011): Regional Breakup by Number of Tests and Penetration Rate.....II-6
Challenges Faced by HPV Testing Market.....II-6
Select Side Effects of HPV Vaccines.....II-6
1$350
   Legislative & Regulatory Environment Worldwide.....II-7
Capitulation of Cervical Cancer Screening Guidelines (2009-2012).....II-7
2$200
   HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the
  US.....II-9
US Government Proposes Administration of HPV Vaccine for Males.....II-9
Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the
  US.....II-9
1$100
   US Cytology Screening Guidelines Support Co-testing of Cytology with HPV.....II-10
Stringent NHS Guidelines for Cytology Laboratories.....II-10
NCSP to Screen Women in New Zealand for Cervical Cancer.....II-10
1$100
   Reimbursement Scenario.....II-11
Effect of HPV Vaccination on HPV Testing.....II-11
Gardasil®.....II-11
Cervarix®.....II-11
1$100
   HPV Vaccine Implementation Scenario.....II-12
Global HPV Immunization Schedule and Population Coverage by Country.....II-12
1$100
   Select Market Overview.....II-13
The United States.....II-13
Canada.....II-13
France.....II-13
The United Kingdom.....II-13
Australia.....II-13
1$100
   Mexico.....II-14
Kenya.....II-14
1$100
  2. KEY TRENDS AND RESEARCH FINDINGS.....II-153 $295  
   Novel Technological Innovations to Enhance Accuracy of Screening Procedures.....II-15
Regular HPV Screening Enhances Treatment and Survival Options.....II-15
Co-testing of Pap Cytology and HPV for Enhanced Determination of Cervical Cancer
  Risk.....II-15
Inhalable Cervical Cancer Vaccines to Grow in Popularity.....II-15
1$100
   Gardasil - A Biohazard? The Controversy Continues.....II-16
Side-effects of Gardasil More Apparent Among Preteens.....II-16
Increase in Instances of HPV-Linked Oral Cancer – A Cause of Deep Concern.....II-16
1$100
   New Research Findings Indicate Two Vaccination Doses Equal Three.....II-17
HPV Vaccine Proves Beneficial in Prevention of Genital Warts in Men.....II-17
Men Found to be More Susceptible to Oral HPV Infections.....II-17
1$100
  3. OVERVIEW OF CYTOLOGY AND HPV TESTING.....II-189 $595  
   What is HPV?.....II-18
Types of HPV.....II-18
1$100
   Commonly Known Diseases and Related HPV Test Types.....II-19
Common Types of HPV Diseases.....II-19
1$100
   Causes of Infection.....II-20
Cervical Cancer and HPV.....II-20
1$100
   HPV and Other Cancers.....II-21
Techniques for Detecting HPV.....II-21
Signal-Amplified Nucleic Acid Assays.....II-21
Target-Amplified HPV Assays.....II-21
What is HPV Testing?.....II-21
Test of HPV in Men.....II-21
1$100
   Test of HPV in Women.....II-22
HPV Test Results.....II-22
Positive HPV Test.....II-22
1$100
   Negative HPV Test.....II-23
Limitations of HPV Testing.....II-23
Advantages of HPV Testing.....II-23
Cervical Cytology Observation/Screening.....II-23
1$100
   Pap Smear Screening.....II-24
Requirements for Pap Smear Test.....II-24
1$100
   Advantages of Pap smear Test.....II-25
Limitations of Cytologic Screening.....II-25
HPV Testing vs. Cytology Testing.....II-25
1$100
   Future of HPV Testing.....II-261$100
  4. COMMERCIALLY AVAILABLE HPV TESTS.....II-271 $100  
   Digene HPV Test.....II-27
careHPV Test.....II-27
Hybrid Capture-II Test.....II-27
1$100
  5. PRODUCT/SERVICE INTRODUCTIONS.....II-286 $495  
   Biodis to Launch Citofem® Cervical Cancer Screening Test.....II-28
QIAGEN Launches QIAensemble Decapper Sample Preparation Automation System in
  Europe.....II-28
1$100
   OncoHealth to Launch Protein-based Assay for HPV Testing.....II-29
Independent Histopathology Services Launches Roche cobas 4800 System.....II-29
Sensovation Introduces FLAIR Compact Fluorescent Array Imaging Reader.....II-29
1$100
   mtm Laboratories Unveils CINtec® PLUS Advanced Cervical Cancer Screening
  Product.....II-30
Hoffmann-La Roche Launches cobas 4800 System.....II-30
1$100
   Roche Diagnostics Canada Launches cobas® 4800 Clinical Laboratory System.....II-31
Histopathology & Specialty Laboratory Launches HPV Testing Range.....II-31
AcroMetrix Introduces OptiQual® HPV Genotype Panel.....II-31
1$100
   SeraCare Life Sciences Introduces SeraCare HPV Genotype Performance Panel.....II-32
Abbott Molecular Introduces PCR-Based Real-Time Diagnostic Test for HPV.....II-32
2$200
  6. ACCREDITATIONS/APPROVALS/ CERTIFICATIONS.....II-343 $295  
   FDA Grants Approval for Gen-Probe's PANTHER® System.....II-34
Gen-Probe Receives FDA Approval for APTIMA® HPV Assay.....II-34
Roche Receives FDA Approval for cobas HPV Test.....II-34
1$100
   mtm Laboratories Plans FDA Filings for Cervical Disease Tests.....II-35
Arbor Vita Corp Announces Interim Results of START-UP Clinical Trial for HPV E6
  Test.....II-35
Merck Obtains FDA Approval for GARDASIL.....II-35
1$100
   QIAGEN Obtains CE Mark for careHPV Test.....II-36
Hologic Receives Approval from FDA for Two HPV Tests.....II-36
1$100
  7. RECENT INDUSTRY ACTIVITY.....II-377 $595  
   Hologic Inks Definitive Agreement to Acquire Gen-Probe.....II-37
Bio-Reference Laboratories Acquires Stake in InCellDx.....II-37
1$100
   QIAGEN Inks Co-Marketing Agreement with KingMed Diagnostics.....II-38
Roche Signs Agreement with Unilabs-IHS to Expand Access to HPV Testing in UK.....II-38
Roche Takes Over mtm Laboratories.....II-38
Roche Inks Contract with Karolinska University Hospital for Cervical Cancer
  Screening.....II-38
1$100
   QIAGEN Establishes QIAGEN India.....II-39
QIAGEN Signs Agreement with Abbott Laboratories.....II-39
CytoCore Signs Agreement with Guangdong Prosper Channel Medicine Company.....II-39
1$100
   Life Technologies to Take Over AcroMetrix.....II-40
Roche Molecular Systems Enters Into Research Collaboration with DKFZ.....II-40
1$100
   QIAGEN to Donate HPV DNA Test to Cancer Hospital in India.....II-41
Xenomics Changes Name to TrovaGene.....II-41
mtm Laboratories Inks Agreement with MetaSystems.....II-41
1$100
   CytoCore® and Amsino International Ink Agreement.....II-42
Merck Collaborates with QIAGEN for Access to HPV DNA Testing.....II-42
1$100
   CytoCore® Inks Agreement with Synermed Select Partners.....II-43
Xenomics Files Patent for New HPV Detection Test.....II-43
1$100
  8. FOCUS ON SELECT GLOBAL PLAYERS.....II-445 $495  
   Abbott Molecular, Inc. (US).....II-44
BD Diagnostics-TriPath (US).....II-44
CytoCore®, Inc. (US).....II-44
1$100
   DaAn Gene Co., Ltd. (China).....II-45
Gen-Probe, Inc. (US).....II-45
Hologic, Inc. (US).....II-45
1$100
   Third Wave Technologies, Inc. (US).....II-46
Merck & Co., Inc. (US).....II-46
QIAGEN NV (The Netherlands).....II-46
1$100
   Qiagen North American Holdings, Inc. (US).....II-47
Roche Diagnostics (Switzerland).....II-47
Ventana Medical Systems, Inc. (US).....II-47
1$100
   Roche mtm Laboratories AG (Germany).....II-481$100
  9. GLOBAL MARKET PERSPECTIVE.....II-49   
   Table 5: World Recent Past, Current and Future Analysis for HPV Testing by Geographic Region/ Country – US, Europe, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....II-491$350
   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).....II-501$350
III. MARKET44$1950
  1. THE UNITED STATES.....III-119 $1450  
   A. Market Analysis.....III-1
Current and Future Analysis.....III-1
Key Statistics.....III-1
Market Overview.....III-1
1$75
   Table 7: Prevalence of HPV in the US by Age (includes corresponding Graph/Chart).....III-2
Pap and HPV Test Strongly Advised for Cervical Cancer in the US.....III-2
HPV Vaccine Implementation.....III-2
1$200
   Reimbursement of Screening Procedures.....III-3
Regulatory Scenario.....III-3
Overview of Cervical Cancer Screening Guidelines (2009-2012).....III-3
2$150
   HPV Test to be a Part of the New Cervical Cancer Screening Guidelines in the
  US.....III-5
US Government Proposes Administration of HPV Vaccine for Males.....III-5
1$75
   Frequent Pap and HPV Test Recommendations for Cervical Cancer Screening in the
  US.....III-6
Cervical Cytology Screening Guidelines.....III-6
1$75
   NHS Guidelines for Cytology Laboratories.....III-7
HPV Vaccine Implementation in the US Sates.....III-7
HPV Vaccines Legislations Passed by Individual US States (2011-2012).....III-7
1$75
   Product/Service Launches.....III-82$150
   Recent Industry Activity.....III-104$300
   Accreditations/Approvals/Certifications.....III-141$75
   Key Players.....III-154$300
   B. Market Analytics.....III-19
Table 8: US Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-19
1$200
  2. EUROPE.....III-203 $595  
   A. Market Analysis.....III-20
Current and Future Analysis.....III-20
HPV Testing and Cervical Cancer Incidence Rates in Europe.....III-20
Table 9: European HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart).....III-20
HPV – The Preferred Primary Screening for Cervical Cancer in Europe.....III-20
1$200
   B. Market Analytics.....III-21
Table 10: European Recent Past, Current and Future Analysis for HPV Testing by Geographic Region – France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-21
1$200
   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).....III-221$200
  2a. FRANCE.....III-231 $200  
   A. Market Analysis.....III-23
Current and Future Analysis.....III-23
HPV Vaccine Implementation.....III-23
B. Market Analytics.....III-23
Table 12: French Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-23
1$200
  2b. GERMANY.....III-244 $395  
   A. Market Analysis.....III-24
Current and Future Analysis.....III-24
Product/Service Introductions.....III-24
1$75
   Accreditations/Approvals/Certifications.....III-251$75
   Key Player.....III-261$75
   B. Market Analytics.....III-27
Table 13: German Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-27
1$200
  2c. ITALY.....III-281 $200  
   A. Market Analysis.....III-28
Current and Future Analysis.....III-28
B. Market Analytics.....III-28
Table 14: Italian Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-28
1$200
  2d. UNITED KINGDOM.....III-292 $200  
   A. Market Analysis.....III-29
Current and Future Analysis.....III-29
Market Overview.....III-29
HPV Vaccine Implementation.....III-29
Recent Industry Activity.....III-29
1$75
   Product/Service Introduction.....III-30
B. Market Analytics.....III-30
Table 15: UK Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-30
1$200
  2e. REST OF EUROPE.....III-316 $395  
   A. Market Analysis.....III-31
Current and Future Analysis.....III-31
Recent Industry Activity.....III-31
2$150
   Product/Service Introductions.....III-331$75
   Accreditations/Approvals/Certifications.....III-34
Key Players.....III-34
2$150
   B. Market Analytics.....III-36
Table 16: Rest of Europe Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-36
1$200
  3. REST OF WORLD.....III-378 $950  
   A. Market Analysis.....III-37
Current and Future Analysis.....III-37
Focus on Select Markets.....III-37
Canada.....III-37
Asia-Pacific.....III-37
Table 17: Asian HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart).....III-37
1$200
   India.....III-38
Table 18: HPV in India: Breakdown of Type- Distribution and HPV Prevalence (includes corresponding Graph/Chart).....III-38
Cervical Cancer Screening in India - Still a Long Way to Go.....III-38
1$200
   Australia.....III-39
New Zealand.....III-39
1$75
   Latin America.....III-40
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).....III-40
Mexico.....III-40
1$200
   Africa.....III-41
Table 20: African HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart).....III-41
Recent Industry Activity.....III-41
1$200
   Product/Service Introductions.....III-421$75
   Key Player.....III-431$75
   B. Market Analytics.....III-44
Table 21: Rest of World Recent Past, Current and Future Analysis for HPV Testing Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2018 (includes corresponding Graph/Chart).....III-44
1$200
IV. COMPETITIVE LANDSCAPE 330$995
  
Total Companies Profiled: 43 (including Divisions/Subsidiaries - 56)

Region/Country                 Players

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
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