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Molecular Diagnostics - Global Strategic Business Report

  • ID: 338507
  • August 2016
  • Region: Global
  • 601 Pages
  • Global Industry Analysts, Inc
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This report analyzes the worldwide markets for Molecular Diagnostics in US$ Thousand by the following Applications: Infectious Disease Testing, Blood Screening, Cancer Screening, and Other Applications. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World.

Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. 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 145 companies including many key and niche players such as -

Abbott Laboratories
Abbott Molecular, Inc.
Becton, Dickinson and Company
bioMérieux SA
Cepheid

Note: Product cover images may vary from those shown
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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. OUTLOOK
Global In-Vitro Diagnostics (IVD) Market on a Steady Growth Path
Table 1: Global In-Vitro Diagnostics Market by Segment (2015): Percentage Breakdown of Value Sales for Immunochemistry, Self-Monitoring Blood Glucose, Point-of-Care Diagnostics, Molecular Diagnostics, Tissue Diagnostics, Hematology, Microbiology, and Hemostasis (includes corresponding Graph/Chart)
Table 2: Global In-Vitro Diagnostics Market by Geographic Region (2015): Percentage Breakdown of Value Sales for the United States, Europe, Asia-Pacific, Latin America, and Rest of World (includes corresponding Graph/Chart)
Molecular Diagnostics
A Rapidly Expanding Segment of the IVD Market
PCR Technology Leads the MDx Market
Current and Future Analysis
US and Europe
Leaders in Molecular Diagnostics Adoption
Developing Countries Excel in Growth Prospects
Major Growth Drivers
Key Market Trends in a Nutshell
Major Technology Trends
Advancements in Molecular Diagnostics
A Boon for the Industry
Major Issues and Challenges
Market Outlook

2. GROWTH DRIVERS AND MARKET TRENDS
Aging Population Drives Molecular Diagnostics Market
Global Aging Population Statistics
Opportunity Indicators
Table 3: Elderly Population (60+ Years) as a Percentage of Total Population (2015 & 2050) (includes corresponding Graph/Chart)
Table 4: Global Aging Population in Select Regions/Countries: Population of 60+ Individuals in ‘000s and as a Percentage of Total Population for 2015 & 2050 (includes corresponding Graph/Chart)
Table 5: Life Expectancy at Age 60 and 80 Years
(2010-2015), (2020-2025) & (2045-2050) (includes corresponding Graph/Chart)
Technological Innovations Set to Drive the Market
The Role of Molecular Diagnostics in Personalized Medicine
Companion Diagnostics Make Way for Personalized Medicine
List of Select FDA-Cleared Companion Diagnostic Devices
Biomarkers as Companion Diagnostics
Rise in Healthcare Spending in Developing Nations Bode Well for Market Growth
Table 6: Select Countries with Healthcare Spending as a Percentage of GDP (2014) (includes corresponding Graph/Chart)
Proteomics Technologies: Growing in Significance
New Developments in Proteomics Technologies
New Applications Hold Promising Potential
Molecular Diagnostics for Lymphoid Malignancies
Next-Generation Sequencing Technologies Keep Up the Momentum
Select Commercial NGS Technologies
Rising Emphasis on Lab Automation to Augur Well for Market Growth
List of Fully Automated and Rapid Molecular Diagnostics
Molecular Diagnostics and Intellectual Property
Molecular Diagnostics
Moving from Centralization to Decentralization
Limited Reimbursements by Third Party Payers
A Stumbling Block

3. APPLICATION AREAS OF MOLECULAR DIAGNOSTICS
Infectious Diseases
Table 7: World Molecular Diagnostics Market for Infectious Diseases by Test Type: Percentage Share Breakdown for the Year 2015 (includes corresponding Graph/Chart)
Bright Prospects Ahead for Molecular Diagnostics for Testing Infectious Diseases
Leading Players
Key Trends
Increasing Incidence of Infectious Diseases Fuels Adoption
Table 8: Reported Cases of Major Infections by Select Geographic Region: 2011
Rising Incidence of Hospital Acquired Infections Propels Market Growth
Table 9: Comparison of Different Parameters for Select C. diff MDx Tests
Rising HIV Prevalence Provides Ample Growth Opportunities
Table 10: HIV Infection Statistics Worldwide: As of 2014 (includes corresponding Graph/Chart)
Table 11: Worldwide HIV Prevalence and Incidence (in Million) by Region: 2014 (includes corresponding Graph/Chart)
Table 12: Worldwide AIDS Related Deaths by Geographic Region: 2014 (includes corresponding Graph/Chart)
Table 13: HIV Prevalence (%) in Adults (15-49 years) by Year: Prevalence Percentage in Adults in 1990, 2000, 2008 & 2014 (includes corresponding Graph/Chart)
Infectious Disease Testing
A Major Driver of Molecular Diagnostics Market
Select FDA-Cleared Molecular Diagnostic Tests for Infectious Diseases
Molecular Tests Gaining Prominence in GC/Chlamydia Testing Market
Molecular Diagnostics Opens New Avenues in Viral Hepatitis Testing
HPV Testing: A Fast Growing Segment in the Molecular Diagnostic Testing Market
List of Select HPV Molecular Diagnostic Tests by Company and Technique
Cervical Cancer: Rising Incidence & Mortality Enhances Need for Testing
Major Risk Factors to HPV/Cervical Cancer
Table 14: Number of New Cervical Cancer Cases in the World by Region and Age Group (2012) (includes corresponding Graph/Chart)
Table 15: World Age-Standardized Cervical Cancer Incidence Rates (2012): Breakdown by Region (includes corresponding Graph/Chart)
Table 16: Worldwide Cervical Cancer Mortality by Leading Countries (2012): Ranked by Number of Deaths (in ‘000s) (includes corresponding Graph/Chart)
HPV Testing for Primary Screening Indication Bodes Well for the Market’s Growth
Archaic TB Diagnostic Methods Opens Up Opportunities for Molecular Diagnostics
List of Select Commercially-Available TB Diagnostics
An Overview of Select TB Diagnostics under Development
Molecular POC Testing for Infectious Diseases: Yet to Realize Its Full Potential
PCR Plays a Vital Role in the Diagnosis of Infectious Diseases
Blood Screening
Molecular based Tests Ingrain Roots in Blood Donor Screening Segment
Cancer Screening & Diagnosis
Overview
Molecular Tests Lead the Way for Cancer IVD Market Growth
Molecular Markers to Enhance Thyroid Cancer Diagnosis
Oncology-Based Molecular Diagnostics: The Propitious Segment
List of US-FDA Approved Biomarkers for Cancer
Table 17: World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported (in Thousands) for Asia-Oceania, Europe, North America, Latin America & The Caribbean, and Africa (includes corresponding Graph/Chart)
Table 18: New Cancer Cases in the World by Affected Site (2012) (in Thousands) (includes corresponding Graph/Chart)
Table 19: World Cancer Mortality by Geographic Region and Gender (2012): Number of Cancer-Related Deaths (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart)
Growing Popularity of Chemo-Sensitivity Testing of CTCs
Cervical Cancer Screening: Focus on Detection of CIN2 and CIN3 Cancers
Other Testing Applications
Genetic Disease Testing Applications
Overview
Pharmacogenomics
Prognosis Based on Genomics
Pharmacogenomics Development Augurs Growth of Genetic Testing Market
Prospects for Genetic Diagnostics and Testing Grow Brighter
List of Select FDA-Cleared Genetic Tests by Disease
Genetic Testing
An Indispensible Tool for Cystic Fibrosis
Table 20: Most Common Mutations and Worldwide Frequency (includes corresponding Graph/Chart)
Genetic Testing Plays Pivotal Role in Diagnosing Inherited Conditions
Non-Invasive Prenatal Diagnostics
The Way Ahead
Nucleic Acid Amplification Methods for Detection of Antimicrobial Resistance
PCR-Based Nucleic Acid Amplification for Detection of Antimicrobial Agents
Histocompatibility Testing
Table 21: Global HLA Testing Market: Revenue Estimates for 2012 through 2016 (in US$ Million) (includes corresponding Graph/Chart)

4. COMPETITIVE DYNAMICS IN THE MOLECULAR DIAGNOSTICS MARKET
An Overview of Competitive Landscape in Molecular Diagnostics
Table 22: Global Molecular Diagnostics Market by Leading Player (2015): Percentage Share Breakdown by Value Sales for Roche, Qiagen, Abbott, GenProbe, Siemens, and Others (includes corresponding Graph/Chart)
Other Noteworthy Companies and their Competitive Position by Segment
Key Players and Their Technologies
The Top Tier
Mid-Sized and Small Companies
Cepheid: Unquestioned Leader in the Rapid and Automated MDx Market
Table 23: Price Comparison of Select Fully Automated and Rapid Molecular Diagnostics
Qiagen: The Leading Player in the Global HPV MDx Market
Comparative Analysis of Select HPV MDx Tests
Competitive Dynamics in the C. difficile Testing Market
Table 24: Global Molecular Diagnostics Market for Clostridium difficile by Leading Player (2015): Percentage Breakdown of Revenues for Becton Dickinson, Cepheid, Meridian, and Others (includes corresponding Graph/Chart)
List of Select Molecular C. difficile Test Products
Competition in the Blood Screening MDx Market
Table 25: Global Blood Screening MDx Market by Leading Players (2015): Percentage Market Share Breakdown of Value Sales for Hologic, Roche, and Others (includes corresponding Graph/Chart)
Pharmaceutical Firms Carving Their Niche in Molecular Diagnostic Market
Competitive Landscape in the Global RT-PCR Market
Table 26: Leading Players in Global RT-PCR Instruments Market (2012): Percentage Breakdown of Value Sales for Life Sciences Research by Leading Players
Thermo Fischer, Bio-Rad, Roche, Agilent, Qiagen and Others (includes corresponding Graph/Chart)
Select Real-Time PCR Products by Company
Competition Heats Up in dPCR Market
Table 27: Leading dPCR Systems At a Glance
Life Sciences Companies Eye on Lucrative Prostate Cancer MDx Market
Consolidation Activity Continues to Strengthen Driven by New Entrants
Major M&A Transactions in Molecular Diagnostics: 2011-2016
Product Marketing
Key to Commercial Success

5. PRODUCT & TECHNOLOGY OVERVIEW
Molecular Diagnostics
Definition & Scope
Molecular Diagnostics
Impact on Healthcare
Utility of Molecular Diagnostic Tests
Background of Molecular Diagnostics
Major Milestones in the Evolution of Molecular Diagnostics
Types of Molecular Diagnostics
Conventional Diagnostics Vs. Molecular Diagnostics
Unabated Developments in Molecular Diagnostics Technology
Signal Amplification Technologies
PCR
New Developments
Quantitative Real-Time PCR for Molecular Diagnostics
Signal Detection and Quantification
Quantitative Real-Time RT-PCR Analysis
Applications of Quantitative Real-Time PCR Analysis
Digital PCR
Non-PCR Methods
Other Signal Amplification Technologies
DNA Probe Based Products
Direct Detection of Specific Nucleic Acid Sequences
Nucleic Acid Amplification and Detection
DNA Sequencing and Gene Detection
Arrays of Immobilized Probes (DNA Chips) in Gene Detection
RNA Diagnostics
Complementary Molecular Diagnostic Technologies
Fluorescent In-Situ Hybridization (FISH)
DNA Biochips/Microarrays
Biosensors
Proteomic Technologies for Molecular Diagnostics
Nanotechnology for Molecular Diagnostics
Technologies on the Anvil
Haplotype Analysis
A Distant Possibility
Chronic Multi-Gene Defects Now Diagnosable
Whole Genome Sequencing
A Boon or a Bane to Genetic Testing?

6. PRODUCT APPROVALS/INTRODUCTIONS
Qiagen Introduces New Diagnostic Test for Cervical Cancer
GE Showcases Discovery MI and Discovery NM/CT 670 CZT
Quest Launches New Tests for Determining Hereditary Cancer
Predictive Launches Test for Spine Deformities
LabCorp® Introduces Epi proColon®
Agena Rolls Out MassARRAY® Dx
Rosetta Introduces Three New Diagnostic Offerings
bioMérieux Rolls Out GENE-UP®
Roche Introduces New cobas Range
Quest Launches Dako's PD-L1 Complementary Diagnostic Test
Quest Introduces Dako’s PD-L1 Tests for KEYTRUDA®
Clarient Rolls Out PD-L1 Test for KEYTRUDA®
Pathway Unveils CancerIntercept™
Cepheid Unveils Xpert® Carba-R update
Cepheid Launches GeneXpert® Omni
AlphaImpactRx Introduces BrandImpactDx
BioNTech AG Introduces MammaTyper®
EKF Showcases Molecular Diagnostics Products Series
Microbix Unveils New Molecular Diagnostics Range
Roche Introduces cobas® Liat System
Quest Unveils BRCAvantage Plus
Cepheid Rolls Out Xpert® TV
OpGen Introduces Acuitas™ MDRO Gene Test
DaVita Introduces Molecular Diagnostic Testing
Grifols Obtains CE-Marking for ID CORE XT Molecular Diagnostic Kit
QIAGEN Rolls Out careHPV™ Test in India
QIAGEN Gets PMA Approval from the US FDA for artus® CMV RGQ MDx Kit
Alere Obtains FDA Approval for Alere™ i Influenza A and B Test
Qiagen Obtains Approval from the US Health Regulators for Gene-Testing Kit
Immucor Obtains the US FDA Approval for PreciseType HEA Test
Biocartis Introduces Idylla™
Roche Introduces cobas 6800/8800 Systems
Roche Unveils CINtec PLUS*
Roche Rolls Out cobas® HIV-1 and cobas HCV assays

7. RECENT INDUSTRY ACTIVITY
Bio-Techne to Acquire Advanced Cell Diagnostics
Myriad Acquires Sividon Diagnostics
Siemens Acquires Neo New Oncology
Luminex to Acquire Nanosphere
DiaSorin Completes Acquisition of Focus Diagnostics
Avant Acquires Amarantus Diagnostics
HTG to Collaborate With Bristol-Myers Squibb
Miroculus to Acquire Kapplex
Cepheid’s Xpert® MRSA NxG Gets European Approval
SpeeDx Collaborates with Goffin Molecular
FDA Approves BD’s Totalys™
CE Mark Approves BioFire Diagnostics’ FilmArray®
Thermo Fisher Acquires Affymetrix
Qiagen Collaborates with Mirati
BioGenex to Commence Operations from India Center
Illumina Collaborates with investors to Launch GRAIL
Thermo Fisher Collaborates with Karolinska Institute
CE Mark Approves Aptima® HCV Quant Dx Assay by Hologic
FDA Approves BioFire Diagnostics’ FilmArray®
ERBA Acquires Lumora
Seegene Collaborates with BD Life Sciences
MDxHealth to Acquire NovioGendix
Quest’s Simplexa HSV 1 & 2 Test Gets FDA 510(k) Approval
Burning Rock Partners with Illumina
GE’s Low Dose CT Screening Approved by FDA
Roche to Acquire GeneWEAVE BioSciences
Cancer Genetics Acquires Response Genetics, Inc
OpGen Acquires AdvanDx
Hitachi Collaborates with QIAGEN
OPKO Takes Over Bio-Reference Laboratories
Sysmex Signs Agreement with IndivuTest
CE Mark Approves Xpert® HIV-1 Qual by Cepheid and FIND
Xpert® HCV Viral Load by Cepheid gets CE Mark Approval
Rosetta Acquires CynoGen
Microbix Signs Agreement with Microbiologics
Cepheid Receives Emergency Use Authorization by FDA for Ebola Test
Novigenix Acquires Colox®
Roche Takes Over Signature Diagnostics
CE Mark Approves QIAGEN’s Circulating Tumor DNA Test
Amarantus Completes Acquisition of DioGenix
Aegis Acquires Diagnovus
Empire Announces Acquisition of ID Labs
OncoGxSelect™ Receives NJDH Approval
Roche Takes Over Ariosa
FDA Approves Xpert® Norovirus by Cepheid
Cepheid’s Xpert® Flu/RSV XC Gets FDA Approval
Roche’s cobas® Strep A Test Receives 510(k) Clearance
PDI Takes Over RedPath
Veracyte Acquires Allegro Diagnostics
GTCR Takes Over XIFIN
QIAGEN to Collaborate with AstraZeneca
BD Collaborates with MD Anderson Cancer Center
Roche Acquires IQuum
Myriad to Acquire Crescendo Bioscience
Co-Diagnostics Unveils Co-Dx™
bioMérieux Acquires BioFire Diagnostics
Thermo Fisher Scientific Acquires Life Technologies
Myriad Genetics Takes Over Crescendo Bioscience
AUT University Collaborates with Roche Diagnostics
Corgenix Medical Obtains NIH Grant to Advance Development of Ebola Rapid Diagnostic Test Kit
Cepheid Collaborates with AstraZeneca, Cubist Pharmaceuticals and GSK
B Braun US and CeGaT Join Forces to Establish B Braun CeGaT
Provista Diagnostics Expands Exclusive License Agreement for Certain Biomarker and Autoantibody Technologies
Veracyte and Fleury Partner to Offer the Afirma® Gene Expression Classifier
Integrated Diagnostics Attracts Financing for Xpresys Lung Molecular Diagnostic Blood Test
MDxHealth Enters into Agreement with Galaxy Health
QIAGEN Acquires Exclusive Worldwide License to CALR Biomarker
Zyomyx Obtains $7.5 Million from UNITAID to Launch MyT4™ POC CD4 Test
Human Longevity Inc. Commences its Operations
Roche Takes Over IQuum
Myriad Genetics and Sividon Diagnostics Ink Exclusive Co- Marketing Agreement

8. FOCUS ON SELECT PLAYERS
Abbott Laboratories (US)
Abbott Molecular, Inc. (US)
Becton, Dickinson and Company (US)
bioMérieux SA (France)
Cepheid (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
RMD’s Product Portfolio by Segment
RMD’s Major Test Offerings by Application
GE Healthcare (US)
Grifols International, S.A. (Spain)
Hologic, Inc. (US)
QIAGEN N.V. (The Netherlands)
Quest Diagnostics, Inc. (US)
Siemens Healthcare GmBH (Germany)
Tecan Group Ltd. (Switzerland)
The ELITechGroup SAS (France)
Thermo Fisher Scientific (US)

9. GLOBAL MARKET PERSPECTIVE
Table 28: World Recent Past, Current & Future Analysis for Molecular Diagnostics by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 29: World Historic Review for Molecular Diagnostics by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 30: World 14-Year Perspective for Molecular Diagnostics by Geographic Region
Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Molecular Diagnostics Market by Application
Table 31: World Recent Past, Current & Future Analysis for Molecular Diagnostics in Infectious Disease Testing by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 32: World Historic Review for Molecular Diagnostics in Infectious Disease Testing by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 33: World 14-Year Perspective for Molecular Diagnostics in Infectious Disease Testing by Geographic Region
Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Table 34: World Recent Past, Current & Future Analysis for Molecular Diagnostics in Blood Screening by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 35: World Historic Review for Molecular Diagnostics in Blood Screening by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 36: World 14-Year Perspective for Molecular Diagnostics in Blood Screening by Geographic Region
Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Table 37: World Recent Past, Current & Future Analysis for Molecular Diagnostics in Cancer Screening by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 38: World Historic Review for Molecular Diagnostics in Cancer Screening by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 39: World 14-Year Perspective for Molecular Diagnostics in Cancer Screening by Geographic Region
Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Table 40: World Recent Past, Current & Future Analysis for Molecular Diagnostics in Other Applications by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 41: World Historic Review for Molecular Diagnostics in Other Applications by Geographic Region
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 42: World 14-Year Perspective for Molecular Diagnostics in Other Applications by Geographic Region
Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin America and Rest of World Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES
A.Market Analysis
US Molecular Diagnostics Market Maintain its Growth Momentum
Competitive Landscape
qPCR and dPCR Instrumentation in the US: An Overview
Ageing Demographics: Major Driving Factor
Table 43: North American Elderly Population by Age Group: 1975-2050 (includes corresponding Graph/Chart)
Increasing Incidence of Chronic Diseases Drives Focus onto Molecular Diagnostics
US Individualized Medicine Market to Witness Significant Growth
Companion Diagnostics Market in the US
List of Select FDA-Cleared Companion Diagnostics
Burgeoning Potential for Genetic Testing
Direct-to-Consumer Testing
A Growing Market
Epidemic Proportion of Cancer in the US
Key Driver for Cancer Genetic Testing
Table 44: New Cancer Cases in the US by Gender and Affected Site: 2014 (includes corresponding Graph/Chart)
Table 45: Incidence of Cancer for All Body Sites by Gender & Age Group in the US (2013): New Cancer Cases for Males & Females for the Age Groups Under 45 years; 45 years and Above; Under 65 years; 65 years and Above (includes corresponding Graph/Chart)
Favorable Insurance Coverage for Cystic Fibrosis Genetic Testing
List of FDA-Cleared CF MDx Tests
Molecular Diagnostics Tests Gaining Share in STD Testing Domain
HPV Testing Market
A Review
Table 46: Prevalence of HPV in the US by Age (includes corresponding Graph/Chart)
Table 47: Prevalence of HPV16 and HPV18 in the US by Cytology (2014) (includes corresponding Graph/Chart)
Table 48: Number of New Cervical Cancer Cases by US State (2015)
Competitive Landscape
Table 49: Leading Players in the US HPV Testing Market (2013): Percentage Share Breakdown of Revenues for Hologic, QIAGEN, and Others (includes corresponding Graph/Chart)
List of FDA Approved HPV MDx Tests
Regulatory Environment
FDA Regulations
Clinical Laboratory Improvement Amendments (CLIA)
Table 50: CLIA-Certified Laboratories in the US (2013): Percentage Share Breakdown of Number of Laboratories by Certificate Type (includes corresponding Graph/Chart)
Table 51: CLIA-Certified Laboratories in the US (2013): Percentage Share Breakdown of Number of Labs by Lab Type (includes corresponding Graph/Chart)
Genetic Testing
FDA to Implement Strict Measures for Cervical Cancer Screening Tests
Limited Reimbursements
A Major Hindrance
New MoPath Codes for Reimbursement for Molecular Diagnostics Tests
Product Launches/Approvals
Strategic Corporate Developments
Select Key Players
B.Market Analytics
Table 52: The US Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 53: The US Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 54: The US 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

2. CANADA
A.Market Analysis
Current and Future Analysis
Cancer Incidence in Canada: Opportunity Indicator
Table 55: New Cancer Cases in Canada by Gender and Affected Site: 2014 (includes corresponding Graph/Chart)
Table 56: New Cancer Cases in Canada by Province: 2014 (includes corresponding Graph/Chart)
Table 57: New Cancer Cases in Canada by Age Group: 2014 (includes corresponding Graph/Chart)
Product Approval
Strategic Corporate Development
B.Market Analytics
Table 58: Canadian Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 59: Canadian Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 60: Canadian 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

3. JAPAN
A.Market Analysis
Current and Future Analysis
Demographics Drive Market Growth
Table 61: Japanese Elderly (65+ Years) Population: 2000-2020 (includes corresponding Graph/Chart)
Strategic Corporate Development
B.Market Analytics
Table 62: Japanese Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 63: Japanese Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 64: Japanese 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4. EUROPE
A.Market Analysis
Current and Future Analysis
Insight into Molecular Diagnostics Markets in Europe
Table 65: Molecular Diagnostics Tests: Percentage Share Breakdown by Function (includes corresponding Graph/Chart)
Increasing Testing Needs of the Elderly: Business Case for Molecular Diagnostics
Table 66: European Country-wise Statistics of 60+ Population as % of Total Population: 2013 (includes corresponding Graph/Chart)
PCR Reagents in Europe: An Overview
Automated Systems Gain Preeminence
Oncology-based Molecular Diagnostics Holds Immense Potential
Table 67: Number of New Cancer Cases in Europe: 2012-2030 (includes corresponding Graph/Chart)
European Personalized Medicine Market to Exhibit Robust Growth
HPV Testing in Europe: An Overview
Table 68: HPV Testing Market in Europe by Region (2014): Breakdown by Number of Women Tested with Normal Cytology (includes corresponding Graph/Chart)
Table 69: HPV Testing Market in Europe by Region (2014): Breakdown by Number of Women Tested with Low-Grade Lesions (includes corresponding Graph/Chart)
Table 70: HPV Testing Market in Europe by Region (2014): Breakdown by Number of Women Tested with High-Grade Lesions (includes corresponding Graph/Chart)
Table 71: HPV Testing Market in Europe by Region (2014): Breakdown by Number of Women Tested with Cervical Cancer (includes corresponding Graph/Chart)
List of Select CE-Marked HPV Molecular Diagnostic Tests
Cervical Cancer Screening in Europe
A Review
Table 72: Key Facts on Cervical Cancer in Europe: 2014 (includes corresponding Graph/Chart)
Table 73: Cervical Cancer Incidence and Mortality in European Countries (2012)
Table 74: Prevalence of Cervical Cancer in European Countries (2012)
Table 75: European HPV Testing Market (2011): Breakdown by % of Women Tested; HPV Prevalence Rate and Cervical Cancer Mortality Rates (includes corresponding Graph/Chart)
Strategic Corporate Developments
B.Market Analytics
Table 76: European Recent Past, Current & Future Analysis for Molecular Diagnostics by Geographic Region
France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 77: European Historic Review for Molecular Diagnostics by Geographic Region
France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 78: European 14-Year Perspective for Molecular Diagnostics by Geographic Region
Percentage Breakdown of Revenues for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Table 79: European Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 80: European Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 81: European 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4a. FRANCE
A.Market Analysis
Current and Future Analysis
Product Launch
Strategic Corporate Developments
Select Key Players
B.Market Analytics
Table 82: French Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 83: French Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 84: French 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4b. GERMANY
A.Market Analysis
Current and Future Analysis
Product Launches
Strategic Corporate Developments
Siemens AG
A Key Player
B.Market Analytics
Table 85: German Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 86: German Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 87: German 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4c. ITALY
A.Market Analysis
Current and Future Analysis
Strategic Corporate Development
B.Market Analytics
Table 88: Italian Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 89: Italian Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 90: Italian 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4d. THE UNITED KINGDOM
A.Market Analysis
Current and Future Analysis
SMIP for Pharmacogenomic Testing
B.Market Analytics
Table 91: The UK Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 92: The UK Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 93: The UK 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4e. SPAIN
A.Market Analysis
Current and Future Analysis
Spain
Poised to become a Reckoning Force in Personalized Medicines
Strategic Corporate Development
Grifols International, S.A.
A Key Player
B.Market Analytics
Table 94: Spanish Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 95: Spanish Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 96: Spanish 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4f. RUSSIA
Market Analysis
Table 97: Russian Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 98: Russian Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 99: Russian 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

4g. REST OF EUROPE
A.Market Analysis
Current and Future Analysis
Product Launches/Approvals
Strategic Corporate Developments
Key Players
B.Market Analytics
Table 100: Rest of European Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 101: Rest of European Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 102: Rest of European 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC
A.Market Analysis
Current and Future Analysis
Healthcare Spending in Asia-Pacific: On the Rise
In-vitro Diagnostics Market: India & China Offer Significant Growth Opportunities
Table 103: China and India Leads Global Population (July 2013): Table Depicting China and India’s Huge Population Vis-a-vis Other Countries’ Population (in Million) by Age Group (includes corresponding Graph/Chart)
Table 104: Age-wise Breakup of China and India’s Population Vis-à-vis Other Populous Countries Globally: As of July 2013 (includes corresponding Graph/Chart)
Molecular Diagnostics Testing Opens New World of Possibilities
Recent Advancements in Molecular Diagnostics Market: A Quick Review
Novel Genetic Testing Methods
Development of Personalized Healthcare Approaches
Molecular Painting for Genetic Diagnosis of Diseases
New Technique to Detect H1N1 Virus
B.Market Analytics
Table 105: Asia-Pacific Recent Past, Current & Future Analysis for Molecular Diagnostics by Geographic Region
China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 106: Asia-Pacific Historic Review for Molecular Diagnostics by Geographic Region
China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 107: Asia-Pacific 14-Year Perspective for Molecular Diagnostics by Geographic Region
Percentage Breakdown of Revenues for China and Rest of Asia-Pacific Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)
Table 108: Asia-Pacific Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 109: Asia-Pacific Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 110: Asia-Pacific 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

5a. CHINA
A.Market Analysis
Current and Future Analysis
In-Vitro Diagnostics Market on the Growth Curve
HPV Testing in China: An Overview
Government Support Drives Personalized Medicine Market in China
Strategic Corporate Development
B.Market Analytics
Table 111: Chinese Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 112: Chinese Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 113: Chinese 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

5b. REST OF ASIA-PACIFIC
A.Market Analysis
Current and Future Analysis
A Focus on the Indian Molecular Diagnostics Market
Molecular Diagnostic Market in India to Witness Significant Growth
Growth Drivers in a Nut Shell
Growing Investments in Pharmacogenomics Research Drives Personalized Medicine
Indian Scientific Research towards Functional Genomics and Proteomics
Automation
The Emerging Trend in IVD Industry
Growing Investments in Pharmacogenomics Research Drives Personalized Medicine
HPV Testing Market: An Overview
Table 114: HPV in India
Breakdown of Type-Distribution and HPV Prevalence (includes corresponding Graph/Chart)
Product Launche/Approval
Strategic Corporate Developments
B.Market Analytics
Table 115: Rest of Asia-Pacific Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 116: Rest of Asia-Pacific Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 117: Rest of Asia-Pacific 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

6. LATIN AMERICA
A.Market Analysis
Current and Future Analysis
Brazilian IVD Market on the Rise
B.Market Analytics
Table 118: Latin American Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 119: Latin American Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 120: Latin American 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

7. REST OF WORLD
A.Market Analysis
Current and Future Analysis
Product Launch
B.Market Analytics
Table 121: Rest of World Recent Past, Current & Future Analysis for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 122: Rest of World Historic Review for Molecular Diagnostics by Application
Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets Independently Analyzed with Annual Revenue Figures in US$ Thousand for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 123: Rest of World 14-Year Perspective for Molecular Diagnostics by Application
Percentage Breakdown of Revenues for Infectious Disease Testing, Blood Screening, Cancer Screening and Other Applications Markets for Years 2009, 2016 and 2022 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 145 (including Divisions/Subsidiaries 162)
The United States (99)
Canada (2)
Europe (50)
- France (5)
- Germany (11)
- The United Kingdom (12)
- Italy (2)
- Spain (1)
- Rest of Europe (19)
Asia-Pacific (Excluding Japan) (10)
Middle East (1)

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