Global Genetic Testing Industry

Nov 26, 2015, 17:15 ET from ReportBuyer

LONDON, Nov. 26, 2015 /PRNewswire/ -- This report analyzes the worldwide markets for Genetic Testing in US$ Million by the following Product Segments: Prenatal and Newborn Genetic Testing, Pharmacogenomic Testing, and Predictive Diagnostics. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2014 through 2020. Also, a seven-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 86 companies including many key and niche players such as -

Abbott Laboratories
AutoGenomics, Inc.
BioRad Laboratories
ELITech Group S.P.A
PerkinElmer, Inc.

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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 Prenatal Diagnosis and Newborn Genetic Testing I-3 Pharmacogenetics/Pharmacogenomics I-4 Predictive Diagnostics..............I-4

II. EXECUTIVE SUMMARY

1. GLOBAL MARKET OVERVIEW..............II-1 A Curtain Raiser.............. II-1 Top Ten Genetic Disorders Worldwide II-2 Genetic Testing: Heralding a New Era II-3 Genetic Testing Paves the Way for Personalized Medicine II-4 Table 1: Drug Ineffectiveness for Select Therapeutic Categories - Necessitating Personalized Medicine (includes corresponding Graph/Chart)..............II-4 Ballooning Global Population Offers Increased Growth Opportunities.............. II-5 Table 2: Top 25 Countries Worldwide in Terms of Population: 2007, 2010 & 2015 (As of May'15) II-5 Aging Population Drives the Genetic Testing Market II-6 Table 3: Global Population Statistics for the 65+ Age Group (2014) (includes corresponding Graph/Chart) II-7

Table 4: Elderly Population (60+ Years) as a Percentage of the Total Population (2012 & 2050) (includes corresponding Graph/Chart).............. II-8

Table 5: Life Expectancy at Age 60 and 80 Years - (2010-2015), (2020-2025) & (2045-2050) (includes corresponding Graph/Chart)..............II-8

Table 6: Global Aging Population by Age Group: 1975-2050 (includes corresponding Graph/Chart) II-9 Improving Healthcare Expenditure to Drive Demand II-9 Table 7: Per-Capita Healthcare Expenditure in Select Regions: 2014 (includes corresponding Graph/Chart) II-10

Table 8: Healthcare Spending as a Percentage of GDP by Region: 2014 (includes corresponding Graph/Chart) II-10 Genetic Testing - A Critical Part of the Rapidly Developing In-Vitro Diagnostics (IVD) Market II-11 Table 9: Global In Vitro Diagnostics (IVD) Market by Geographic Region (2014): Percentage Share Breakdown of Revenues for the United States, Europe, and Rest of World (includes corresponding Graph/Chart) II-11

Table 10: Global In-Vitro Diagnostics Market by Sector (2014): Percentage Breakdown of Revenues for Hospital & Commercial Laboratories, and Decentralized & Patient Self-Testing (includes corresponding Graph/Chart) II-11

Table 11: Global In-Vitro Diagnostics Market by Segment (2014): Percentage Breakdown of Value Sales for Hematology, Hemostasis, Immunochemistry, Microbiology, Molecular Diagnostics, Point-of-Care Diagnostics, Self-Monitoring Blood Glucose, and Tissue Diagnostics (includes corresponding Graph/Chart).............. II-12

Table 12: Global In Vitro Diagnostics Market by Leading Player (2014): Percentage Share Breakdown of Revenues for Abbott, Biomerieux, Danaher, J&J, Roche, Siemens and Others (includes corresponding Graph/Chart) II-12 Genetic Testing: The Rapidly Growing Segment of Molecular Diagnostics Market.............. II-12 Table 13: Global Molecular Diagnostics Market (2014): Percentage Breakdown of Market Revenues of Infectious Disease Testing, Genomics, and Blood Donor Screening (includes corresponding Graph/Chart)..............II-13 Biomarker Discovery Leads to Advanced Genetic Testing II-13 List of US-FDA Approved Biomarkers for Cancer II-14

2. SEGMENTAL REVIEW.............. II-16 Prenatal Testing Market to Rise..............II-16 List of Genetic Disorders by Event, Genetic Manifestation and Prevalence.............. II-16 Prenatal Testing - Changing the World of Pregnancy Care II-17 Prenatal Testing - A Rudimentary Overview II-17 List of Available Prenatal Screening and Diagnostic Tests by Indication.............. II-17 Conventional Pre-Natal Diagnostic Techniques - A Risky Affair II-18 Other Negativities of Existing Invasive Techniques II-18 Emergence of Non-Invasive Prenatal Diagnosis (NIPD) II-18 Competition Intensifies in the NIPD Market II-19 Commercially Available NIPD (Genetic) Tests for Aneuploidy in the US.............. II-20 NIPD Eliminates Risks and Uncertainty of Conventional Diagnostic Procedures..............II-20 Opposition to NIPD Technique - A Significant Hurdle to Adoption II-20 Ethical Issues Bog Down Benefits and Proliferation of Prenatal Testing..............II-21 Benefits Outweigh Snags in NIPD Tests II-21 Major Factors Influencing Penetration of NIPD Tests II-21 Table 14: Price Comparison of Existing Tests and Screening Procedures for Down's Syndrome II-22 Diversity in NIPD Usage on the Cards II-22 Expanded Newborn Screening..............II-22 Predictive Diagnostics..............II-23 Breast Cancer Gene Testing Market to Expand Strongly II-23 Myriad Genetics - The Unquestioned Leader in Breast Cancer Testing.............. II-24 Routine Clinical Testing Vs. Predictive Genetic Testing II-24 Increasing Incidence and Prevalence of CDDs: A Major Growth Driver.............. II-25 Discovery of Novel Biomarkers Crucial to Predictive Diagnostics II-25 Unresolved Issues Hamper Widespread Implementation of Genetic Diagnosis and Testing for Monogenetic Disease II-26 Dearth of Genetic Counselors - A Major Hurdle for the Predictive Genetic Testing..............II-27 Pharmacogenomics Development Augurs Growth of Genetic Testing Market.............. II-27

3. MARKET TRENDS.............. II-28 Direct-to-Consumer Genetic Testing - A Key Trend in the Genetic Testing Market..............II-28 Creating a Platform for New Companies II-28 Business Models for DTC Genetic Testing Firms II-29 Growing Prominence of DTC Genetic Testing: A Boon or a Curse? II-29 Pre-implantation Genetic Diagnosis (PGD) - A Major Driver for the Genetic Testing Market..............II-30 Whole Genome Sequencing - Boon or Bane to Genetic Testing? II-30 Validity of Emerging Genetic Tests for Alzheimer's II-31 Utility of Genetic Testing for Warfarin Study II-31 Oncology - A Key Focus Area for Genetic Testing II-31 Table 15: 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).............. II-32

Table 16: New Cancer Cases in the World by Affected Site (2012) (in Thousands) (includes corresponding Graph/Chart) II-33

Table 17: Cancer Incidence in Developed Nations By Site: 2012 (includes corresponding Graph/Chart) II-34

Table 18: Global Incidence of Common Cancers in Men (2012): Number of New Cases Reported in Thousands for Lung & Bronchus, Prostate, Colorectal, and Liver Cancers (includes corresponding Graph/Chart)..............II-35

Table 19: Global Incidence of Common Cancers in Women (2012): Number of New Cases Reported in Thousands for Breast, Colorectal, Lung & Bronchus, and Liver Cancers (includes corresponding Graph/Chart)..............II-35

Table 20: 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) II-36 Genetic Testing May Aid CNS Disease Therapeutics II-36 Neurodegenerative Diseases - Major Focus Area for Genetic Testing II-37 Alzheimer's Disease..............II-37 Huntington's Disease..............II-38 Genetic Testing - An Indispensible Tool for Cystic Fibrosis II-40 Table 21: Most Common Mutations and Worldwide Frequency (includes corresponding Graph/Chart) II-40 Histocompatibility Testing..............II-41 Table 22: Global HLA Testing Market (2012-2016E): Revenue Estimates for 2012, 2013, 2014, 2015, and 2016 (includes corresponding Graph/Chart)..............II-41 Next-Generation Sequencing - A Giant Leap in Genome Sequencing II-41 Pediatric Genetic Testing for Screening Adult Onset Disorders Fast Gaining Acceptance..............II-42 Better Regulatory Safeguards Required for Global Genetic Testing Industry.............. II-42 Challenges Faced.............. II-43 Genetic Counseling: Gaining Momentum II-44 Online Approach Gains Momentum II-44 Recommendations of ACOG and ACGM Augments Demand for Cystic Fibrosis Testing.............. II-44 Ethical Issues & Need for Appropriate Regulating Policies II-45 Issues Related to Genetic Tests for Obesity II-46 Diagnosis and Treatment during Pregnancy - An Effective Way of Alleviating Syphilis Related Deaths and Stillbirths II-46

4. MOLECULAR DIAGNOSTICS MARKET - AN INSIGHT II-47 Global Molecular Diagnostics on a High Growth Curve II-47 Automation Driving Global Market II-47 Molecular Diagnostics: Marking the Convergence of Numerous Technologies.............. II-47 MDx Market for Infectious Diseases Zooming Ahead II-47 Aging Population, Disease Incidence - Fundamental Drivers of Growth.............. II-47 Pharmaceutical Firms Carving Their Niche in Molecular Diagnostics Market.............. II-48 Towards Tailoring the Right Treatment for the Right Disease II-48 Limited Reimbursements by Third Party Payers - A Stumbling Block II-48 Disease-Specific Molecular Diagnostics to Deliver Improved Clinical Outcomes..............II-49 Molecular Diagnostics and Intellectual Property II-49 Business Opportunities in the Offing II-49 Medical Training and Practice Challenges II-50 Hurdles All the Way for Companies Eyeing Molecular Diagnostics II-50 Product Marketing - Key to Commercial Success II-51 Integration of Molecular Diagnostics into Therapeutics II-51 Molecular Diagnostics - Moving from Centralization to Decentralization.............. II-51 Competitive Landscape of the Molecular Diagnostics Market II-52 Table 23: Leading Players in the Global Molecular Diagnostics Market (2014): Percentage Share Breakdown by Value Sales for Abbott, Becton, Dickinson & Company, bioMérieux, Cepheid, Hologic/Gen-Probe, Novartis, Qiagen, Roche Diagnostics, Siemens and Others (includes corresponding Graph/Chart) II-53 Other Noteworthy Companies and their Competitive Position by Segment.............. II-53 New Entrants Eye Unmet Needs..............II-54

5. PRODUCT OVERVIEW.............. II-55 Preface to Genetic Testing..............II-55 Genetic Testing and its Applications II-55 Gene Candidate and Genome Screen II-56 'DNA Chip' to Chip into Genetic Field II-56 Techniques Used to Identify Changes in Genes II-57 Types of Genetic Testing..............II-57 Prenatal Diagnosis.............. II-57 Cancer Testing.............. II-57 Carrier Identification..............II-58 Newborn Screening..............II-58 Predictive Testing.............. II-58 Pre-Symptomatic Testing..............II-58 Cytogenetic Tests..............II-58 Steps in Genetic Testing Process II-59 Limitations.............. II-59 Risks and Other Limitations of Genetic Testing II-59 Medical Institutions to Reap the Benefit of Genetic Testing II-59 Pharmacogenetics/Pharmacogenomics II-60 Review of Select Genetic Tests II-60 Cystic Fibrosis.............. II-60 Breast and Ovarian Cancer (BRCA) II-60 Alzheimer's disease..............II-60 Colorectal Cancer..............II-60 Haemochromatosis (HH)..............II-61 Cowden Syndrome.............. II-61 Huntington's disease (HD)..............II-61 Costs of Select Tests..............II-61 Table 24: Costs of Select Genetic Tests II-61 Genetic Testing Techniques..............II-61 Signal Amplification Technologies II-61 PCR - New Developments..............II-61 Quantitative Real-Time PCR for Molecular Diagnostics II-62 Signal Detection and Quantification II-62 Quantitative Real-Time RT-PCR Analysis II-63 Applications of Quantitative Real-Time PCR Analysis II-63 Viral Detection and Viral-Load Monitoring II-63 Sensitive Detection of Infectious Disease Agents II-63 Predisposition Testing..............II-63 Non-PCR Methods.............. II-63 Other Signal Amplification Technologies II-63 DNA Probe Based Products..............II-63 Direct Detection of Specific Nucleic Acid Sequences II-64 Nucleic Acid Amplification and Detection II-64 DNA Sequencing and Gene Detection II-64 Arrays of Immobilized Probes (DNA Chips) in Gene Detection II-65 RNA Diagnostics.............. II-65

6. PRODUCT LAUNCHES/INNOVATIONS..............II-66 PerkinElmer Launches Genetic Screening Processor® Instruments in China.............. II-66 Mayo Clinic Launches Eight NGS Panels for Cardiac Disorders II-66 Sequenom Laboratories and Recombine Launch HerediT® UNIVERSAL Test.............. II-66 Multipicom NV Launches ADH MASTR™ v2 assay II-66 23andMe Launches Drug Development Unit II-66 Quest Diagnostics Launches Neurome™ Exome Sequencing Service II-66 Roche Launches cobas 6800/8800 Systems II-66 Agena Biosciences Launches MassARRAY 24-Well System II-67 FDA Grants Marketing Approval to 23andMe's DTC Bloom Syndrome Carrier Genetic Test..............II-67 Transgenomic to Launch ICE COLD-PCR™ Technology II-67 Rosetta Launches Sequencing-based Oncology Tests by Admera Health II-67 MedGenome Labs Launches Panorama Prenatal Test II-67 Ambry Genetics Launches CVD Genetic Testing Panels II-67 Exceltox Launches Pharmacogenomic Testing II-67 PerkinElmer Launches SCID Screening Test in North America II-68 Quest Diagnostics Introduces BRCAvantage Plus™ II-68 Genetic Technologies Launches BREVAGenplus Test II-68 Sophia Genetics Receives CE-IVD Certification for Genetic Testing II-68 Response Genetics Launches Immuno- Oncology Assay II-68 DeNA Life Science Launches Mycode Genetic Testing Service II-68 Pathway Genomics Launches BRCATrue™ Test II-68 Courtagen Launches Genetic Sequencing Tests for Neurodevelopmental Disorders..............II-69 Myriad Genetics Launches EndoPredict® Breast Cancer Test II-69 Assurex Health Expands GeneSight® Pharmacogenomic Testing Platform.............. II-69 Illumina to Launch VeriSeq Embryo Screening Tool II-69 GENEWIZ Launches PGxOne™ Pharmacogenomic Test II-69 Ambry Genetics Launches ExomeNext™ and ExomeNext-Rapid™ Genetic Tests.............. II-69 Pathway Genomics Launches Genetic Test to Detect Risk of Colorectal Cancer..............II-70 Mount Sinai Laboratory Develops Accurate Genetic Test for SMA II-70 Sequenom Launches Non-Invasive Prenatal Test by Laboratoire Cerba II-70 CSL Behring Launches Antitrypsin Deficiency Screening Test II-70 Interleukin Genetics Launches PerioPredict™ II-70 US Genomic Health Reports Positive Data from Oncotype DX Prostate Cancer Study..............II-70 Assurex Health Launches GeneSight Test to Predict Folic Acid Conversion and Treat Depression II-71 Verifi ® Prenatal Test Available Through California Prenatal Screening Program..............II-71 Children's Mercy Launches TaGSCAN Test II-71 General Genetics and Estrogen Gene Test Launch EstroGene™ Test II-71 Genetic Analysis Launches GA-map™ Test II-71 Myriad Genetics Launches myRisk™ Hereditary Cancer Test II-71 GeneDx Launches Genetic Tests for Cancer II-72 ArcticDx Launches Vita Risk Pharmacogenetic Test for AMD Patients II-72 Quest Diagnostics Launches CYP450 Biomarker- based Diagnostic Test.............. II-72 Blueprint Genetics Launches Gene Sequencing Tests II-72 Bioiberica Farma Launches Genetic Test for Osteoarthritis II-72 Illumina, The Wellcome Trust Centre and the Institute of Cancer Research Roll out Genetic Test II-72 Aviir to Launch Genetic Testing for Inherited Cardiovascular Disease.............. II-73 Oxford University Hospitals Launches 46-gene Sequencing Test for Cancer.............. II-73

7. RECENT INDUSTRY ACTIVITY..............II-74 ESPERITE Acquires InKaryo..............II-74 Transgenomic Signs Agreement with Exiqon A/S II-74 Quest Diagnostics and Myriad Genetics End BRCA Gene Patent Litigation.............. II-74 Roche to Acquire Majority Share of Foundation Medicine II-74 Roche Acquires Ariosa Diagnostics II-74 GSK Collaborates with GE on Oncology Genetic Testing II-74 Cancer Genetics to Acquire Gentris Corporation II-75 Natera Partners with Mount Sinai Genetic Testing Laboratory II-75 Transgenomic to Sell SURVEYOR Nuclease Technology to Integrated DNA Technogies..............II-75 Transgenomic Collaborates with Raptor Pharmaceuticals for Genetic Testing Services..............II-75 AutoGenomic Signs Agreement with Genomas II-75 Cancer Genetics Acquires BioServe Biotechnologies II-75 PerkinElmer to Close Its Signature Genomics Testing Business II-75 LifeLabs Medical Laboratory Services Buys out Centogene's Canadian Business..............II-76 CytoScan Dx Assay by Affymetrix Receives FDA Approval II-76 NextGxDx Enters Agreement with PreventionGenetics II-76 Neogen Acquires Scidera Genomics II-76 Sequenom and CombiMatrix Enter Marketing Agreement for Chromosomal Microarray Analysis II-76 Illumina Acquires Verinata Health II-76

8. FOCUS ON SELECT GLOBAL PLAYERS..............II-77 Abbott Laboratories (US)..............II-77 Abbott Molecular, Inc. (US)..............II-77 AutoGenomics, Inc. (US)..............II-78 BioRad Laboratories (US)..............II-78 ELITech Group S.P.A. (France)..............II-79 PerkinElmer, Inc. (US)..............II-80 Quest Diagnostics, Inc. (US)..............II-80 Roche Diagnostics Corp. (Switzerland) II-81 Roche Molecular Diagnostics, Inc. (US) II-82 Thermo Fisher Scientific (US)..............II-82 Transgenomic, Inc. (US)..............II-83

9. GLOBAL MARKET PERSPECTIVE..............II-85 Table 25: World Recent Past, Current & Future Analysis for Genetic Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) II-85

Table 26: World Historic Review for Genetic Testing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) II-86

Table 27: World 14-Year Perspective for Genetic Testing by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart).............. II-87

III. MARKET

1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 The US: Leading Market for Genetic Testing Globally III-1 Demographic Changes Offer Growth Opportunities III-1 Table 28: North American Aging Population by Age Group: 1975-2050 (includes corresponding Graph/Chart) III-2 Burgeoning Potential for Genetic Testing III-2 Predictive Screening: Another Growth Area III-3 An important Market for Personalized Medicine III-3 Epidemic Proportion of Cancer in the US - Driver for Cancer Genetic Testing..............III-3 Table 29: US Cancer Incidence by Gender (2014): No. of Reported New Cases for Men and Women (includes corresponding Graph/Chart)..............III-4

Table 30: US Incidence of Common Cancers (2014): Number of New Cases Reported by Affected Site (includes corresponding Graph/Chart).............. III-4 Newborn Testing Gains Ground III-5 Success Stories..............III-5 Favorable Reimbursement Policies III-6 Favorable Insurance Coverage for Cystic Fibrosis Genetic Testing.............. III-6 Table 31: CF Carrier Screening: Percentage Breakdown of Population by Coverage Policy: 2012 (includes corresponding Graph/Chart).............. III-6

Table 32: CF Diagnostic Testing: Percentage Breakdown of Population by Coverage Policy: 2012 (includes corresponding Graph/Chart).............. III-7 Popularity of Screening and ACOG Guidelines Sink Invasive Prenatal Diagnosis Numbers..............III-7 Table 33: US Annual Pregnancies by Age Group/Risk Profile: 2010 (includes corresponding Graph/Chart) III-7 Tough Market Prospects for Sex Determination Tests III-8 Sequenom Bets Big on MaterniT21 III-8 IP Landscape of NIPD Tests..............III-8 US Patents of cff DNA-based NIPD Tests III-9 Direct-to-Consumer Testing - A Growing Market III-10 DTC Genetic Tests Provide POCT for Patients in Hospice Care III-10 Regulatory Environment..............III-10 Genetic Information Nondiscrimination Act Boosts Genetic Testing.............. III-11 NIH Launches Public Database..............III-11 Stricter Regulations for DTC Genetic Testing III-11 Product Launches..............III-12 Strategic Corporate Developments III-18 Select Key Players..............III-20 B.Market Analytics..............III-27 Table 34: The US Recent Past, Current & Future Analysis for Genetic Testing by Segment - Prenatal and Newborn Genetic Testing, Pharmacogenomic Testing, and Predictive Medicine Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-27

Table 35: The US Historic Review for Genetic Testing by Segment - Prenatal and Newborn Genetic Testing, Pharmacogenomic Testing, and Predictive Medicine Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-28

Table 36: The US 14-Year Perspective for Genetic Testing by Segment - Percentage Breakdown of Dollar Sales for Prenatal and Newborn Genetic Testing, Pharmacogenomic Testing, and Predictive Medicine Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-29

2. CANADA.............. III-30 A.Market Analysis.............. III-30 Regulatory Scenario..............III-30 Rising Incidence of Chronic Diseases Spurs Genetic Testing Demand.............. III-30 Table 37: New Cancer Cases in Canada by Gender and Affected Site: 2012 (includes corresponding Graph/Chart) III-31

Table 38: New Cancer Cases in Canada by Province: 2012 (includes corresponding Graph/Chart) III-32

Table 39: New Cancer Cases in Canada by Age Group and Gender: 2012 (includes corresponding Graph/Chart) III-33 Product Launch.............. III-33 Strategic Corporate Development III-34 B.Market Analytics..............III-34 Table 40: Canadian Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-34

Table 41: Canadian Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-35

3. JAPAN.............. III-36 A.Market Analysis.............. III-36 Demographics Drive Market Growth III-36 Table 42: Japanese Elderly (65+ Years) Population: 2000-2020 (includes corresponding Graph/Chart) III-36 DTC Genetic Testing Regulatory Scenario III-36 Product Launch.............. III-37 B.Market Analytics..............III-37 Table 43: Japanese Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-37

Table 44: Japanese Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-38

4. EUROPE.............. III-39 A.Market Analysis.............. III-39 Debt Crisis in Europe Affects Healthcare Industry III-39 European Healthcare System: In a State of Transition III-39 An Insight into Molecular Diagnostics Markets in Europe III-40 Cancer Trends.............. III-40 Table 45: Cancer Incidence in Europe by Site: 2012 (in Thousands) (includes corresponding Graph/Chart) III-41 Aging Population to Drive Demand for Genetic Testing III-42 Table 46: Population Breakup by Age Group for Select European Countries: 2013 (as a Percentage of Total Population) (includes corresponding Graph/Chart) III-42 European Personalized Medicine Market to Exhibit Robust Growth III-43 Legislations/Regulatory Policies in Select European Countries III-43 Legislations Governing Genetic Testing in Select European Countries.............. III-44 B.Market Analytics..............III-45 Table 47: European Recent Past, Current & Future Analysis for Genetic Testing by Geographic Region - France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) III-45

Table 48: European Historic Review for Genetic Testing by Geographic Region - France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)..............III-46

Table 49: European 14-Year Perspective for Genetic Testing by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, and Rest of Europe Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart).............. III-47

4a. FRANCE.............. III-48 A.Market Analysis.............. III-48 Regulatory Environment in France III-48 Product Launch.............. III-48 Elitech Group S.P.A. - A Key Player III-48 B.Market Analytics..............III-49 Table 50: French Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-49

Table 51: French Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-50

4b. GERMANY.............. III-51 A.Market Analysis.............. III-51 Parliamentary Regulations..............III-51 B.Market Analytics..............III-52 Table 52: German Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-52

Table 53: German Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-53

4c. ITALY.............. III-54 Market Analysis.............. III-54 Table 54: Italian Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-54

Table 55: Italian Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-55

4d. THE UNITED KINGDOM..............III-56 A.Market Analysis.............. III-56 Increased Support for Personalized Medicine to Drive Genetic Testing.............. III-56 SMIP for Pharmacogenomic Testing III-56 Increasing Need for Less Risky Prenatal Diagnostic Methods in the UK.............. III-56 Regulatory Scenario..............III-57 Non-consensual Analysis of DNA Made Illegal III-57 Principles for DTC Genetic Testing Laid out by HGC III-57 Product Launches..............III-57 B.Market Analytics..............III-58 Table 56: The UK Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-58

Table 57: The UK Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-59

4e. REST OF EUROPE.............. III-60 A.Market Analysis.............. III-60 Product Launches..............III-60 Strategic Corporate Developments III-61 Roche Diagnostics Corp. - A Key Player (Switzerland) III-61 B.Market Analytics..............III-63 Table 58: Rest of European Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) III-63

Table 59: Rest of European Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-64

5. ASIA-PACIFIC.............. III-65 A.Market Analysis.............. III-65 Healthcare Spending in Asia-Pacific: On the Rise III-65 Select Regional Markets..............III-65 China.............. III-65 China's FDA Curbs Prenatal Testing III-65 Table 60: China - The Most Populous Country Worldwide (July 2013): Total Population (in Millions) by Age Group 0-14 Years, 15-44 Years, 45-64 Years, and 65+ Years for China Vis-a-Vis Other Countries (includes corresponding Graph/Chart).............. III-66

Table 61: China - The Most Populous Country Worldwide (July 2013): Percentage Population by Age Group 0-14 Years, 15-44 Years, 45-64 Years, and 65+ Years for China Vis-a-Vis Other Countries (includes corresponding Graph/Chart).............. III-67 Diagnostics Market in India III-67 Australia and New Zealand..............III-68 Approval of Experiments on Human Embryos in New Zealand III-68 Singapore Sets Guidelines for Genetic Research and Testing III-68 Product Launches..............III-68 Strategic Corporate Development III-69 B.Market Analytics..............III-70 Table 62: Asia-Pacific Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) III-70

Table 63: Asia-Pacific Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-71

6. REST OF WORLD.............. III-72 Market Analysis.............. III-72 Table 64: Rest of World Recent Past, Current & Future Analysis for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) III-72

Table 65: Rest of World Historic Review for Genetic Testing Market Analyzed with Annual Revenue Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-73

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 86 (including Divisions/Subsidiaries - 90)

The United States (58) Canada (4) Japan (1) Europe (21) - France (2) - Germany (3) - The United Kingdom (3) - Spain (1) - Rest of Europe (12) Asia-Pacific (Excluding Japan) (6)
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