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Global Molecular Diagnostics Industry

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SOURCE Reportlinker

NEW YORK, March 20, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Molecular Diagnostics Industry

http://www.reportlinker.com/p090566/Global-Molecular-Diagnostics-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

This report analyzes the worldwide markets for Molecular Diagnostics in US$ million by the following Product Segments: Infectious Disease Testing, Pharmacogenomics, and Cancer Screening. 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 2010 through 2018. A six-year historic analysis is also provided for these markets. The report profiles 103 companies including many key and niche players such as Abbott Laboratories, Abbott Molecular, Life Technologies Corporation, Celera, Biomérieux, CytoCore Inc., ELITech Group, GE Healthcare, Genzyme Corporation, Hologic, Inc., Laboratory Corporation of America® Holdings, MiraiBio, Inc., Novartis Diagnostics, QIAGEN N. V, Quest Diagnostics, Inc., Roche Diagnostics, Siemens Healthcare Diagnostics, and Tecan Group Ltd. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-2Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3Infectious Diseases Testing I-3Pharmacogenomics I-4Cancer Screening I-4II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1

Global Market Outlook II-1

Molecular Diagnostics - A Quick Primer II-1

Molecular Diagnostics - The Fastest Growing Medical

Diagnostic Technology II-1

Key Challenges to Growth II-2

Current and Future analysis II-2

US and Europe - Leaders in Molecular Diagnostics Adoption II-3

Developing Nations Offer Immense Potential II-3

Going Strong II-3

New Applications Hold Promising Potential II-4

Infectious Disease Testing Drives the Diagnostics Market II-4

The Future in Store II-5

2. A REVIEW OF MEDICAL DIAGNOSTICS MARKET II-6Clinical Diagnostics Industry - Trends and Tendencies II-6Table 1: Worldwide In Vitro Diagnostics (IVD) Market (2010) -Market Share Breakdown by Value Sales for RocheDiagnostics, Abbott Laboratories, Siemens, J&J, BeckmanCoulter, bioMerieux, and Others (includes correspondingGraph/Chart) II-6

Table 2: Global In-Vitro Diagnostics (IVD) Market (2010) -

Value Sales (in US$ Billion) and Percentage Share Breakdown

for Point of Care, Immunity Tests, Clinical Chemistry,

Nucleic Acid Tests, Histology/Cytology, Microbiology,

Haematology and Others (includes corresponding Graph/Chart) II-7

Diagnostic Tests - Classification II-7

Nucleic Acid Diagnostics Market - An Overview II-8

Molecular Diagnostics - Growth Drivers II-9

Molecular Diagnostics - A Replacement and Enabling Technology II-10

Molecular Diagnostics for Lymphoid Malignancies II-10

3. COMPETITIVE DYNAMICS IN THE MOLECULAR DIAGNOSTICS MARKET II-11Competitive Landscape II-11Table 3: Worldwide Molecular Diagnostics Market (2011) -Percentage Share Breakdown by Value Sales for RocheDiagnostics, Qiagen, Abbott, Hologic (Gen-Probe), Siemens,Becton, Dickinson & Company and Others (includescorresponding Graph/Chart) II-11Key Players and Their Technologies II-11The Top Tier II-11Mid-Sized and Small Companies II-12New Entrants Eye Unmet Needs II-12

4. MARKET TRENDS & ISSUES II-13

Market Consolidations on the Way to Integrate in Vivo and in

Vitro Diagnostics II-13

Global Molecular Diagnostics on a High Growth Curve II-13

Automation Driving Global Market II-13

Molecular Diagnostics: Marking the Convergence of Numerous

Technologies II-13

MDx Market for Infectious Diseases Zooming Ahead II-13

Aging Population, Disease Incidence - Fundamental Drivers of

Growth II-14

Pharmaceutical Firms Carving Their Niche in Molecular

Diagnostic Market II-14

Towards Tailoring the Right Treatment for the Right Disease II-14

Limited Reimbursements by Third Party Payers - A Stumbling Block II-15

Disease-Specific Molecular Diagnostics to Deliver Improved

Clinical Outcomes II-15

Molecular Diagnostics and Intellectual Property II-15

Business Opportunities in the Offing II-16

Medical Training and Practice Challenges II-16

Hurdles All the Way for Companies Eyeing Molecular Diagnostics II-16

Product Marketing - Key to Commercial Success II-17

Integration of Molecular Diagnostics into Therapeutics II-17

Molecular Diagnostics - Moving from Centralization to

Decentralization II-18

Migrating to Decentralized Format II-18

Going Ahead with Decentralization II-18

5. PRODUCT & TECHNOLOGY OVERVIEW II-20Molecular Diagnostics - Definition & Scope II-20Molecular Diagnostics - Impact on Healthcare II-20Utility of Molecular Diagnostic Tests II-21Background of Molecular Diagnostics II-21Major Molecular Diagnostics Products II-21Major Test Launches in Molecular Diagnostics in the Recent Past II-22Unabated Developments in Molecular Diagnostics Technology II-22Signal Amplification Technologies II-22PCR - New Developments II-22Major Applications of Real-Time PCR II-23Quantitative Real-Time PCR for Molecular Diagnostics II-23Signal Detection and Quantification II-23Quantitative Real-Time RT-PCR Analysis II-24Applications of Quantitative Real-Time PCR Analysis II-24Viral Detection and Viral-Load Monitoring II-24Sensitive Detection of Infectious Disease Agents II-24Predisposition Testing II-24Non-PCR Methods II-24Other Signal Amplification Technologies II-24DNA Probe Based Products II-24Direct Detection of Specific Nucleic Acid Sequences II-25Nucleic Acid Amplification and Detection II-25DNA Sequencing and Gene Detection II-26Arrays of Immobilized Probes (DNA Chips) in Gene Detection II-26RNA Diagnostics II-26Complementary Molecular Diagnostic Technologies II-27Fluorescent In-Situ Hybridization (FISH) II-27DNA Biochips / Microarrays II-27Biosensors II-28Proteomic Technologies for Molecular Diagnostics II-29Nanotechnology for Molecular Diagnostics II-29Technologies on the Anvil II-29Haplotype Analysis - A Distant Possibility II-29Chronic Multi-Gene Defects Now Diagnosable II-30

6. AN INSIGHT INTO APPLICATIONS OF MOLECULAR DIAGNOSTICS II-31

Infectious Diseases Testing II-31

Activity in the Field II-31

Identifying Multidrug Resistance II-32

Infectious Disease Treatment Monitoring II-32

Other Infectious Diseases Applications II-32

Genetic Disease Testing Applications II-32

Pharmacogenomics - Prognosis Based on Genomics II-33

Cancer Screening & Diagnosis II-33

Molecular Tests Lead the Way for Cancer IVD Market Growth II-34

Other Testing Applications II-35

7. RECENT INDUSTRY ACTIVITY II-36Trovagene Acquires MultiGEN's Clinical Laboratory Assets II-36Qiagen Acquires Intelligent Bio-Systems II-36Siemens Inks Agreements with Tocagen and ViiV Healthcare toDevelop Companion Tests II-36HTG Molecular Diagnostics Collaborates with Sanofi US II-36DaAn Gene and Life Technologies Form Joint Venture II-37Exosome Diagnostics and Life Technologies Ink Agreement II-37GE Healthcare Acquires SeqWright II-38Phthisis Diagnostics Expands its Distribution Network II-38Luminex to Acquire GenturaDx II-39Phthisis Diagnostics Inks Distribution Agreement with GenetixBiotech Asia II-39Life Technologies Acquires Navigenics II-40Abbott to Join Forces with Merck II-40Signal Genetics to Acquire ChipDX LLC II-41Quest Diagnostics Acquires S.E.D. Medical Laboratories II-41Hologic Acquires Gen-Probe II-41Accelerate Brain Cancer Cure Joins Hands with ExosomeDiagnostics II-42QIAGEN Collaborates with Cardinal Health II-42LabCorp Acquires MEDTOX II-42Genzyme Inks Agreement with Veracyte to Market Afirma ThyroidFNA Analysis Solution II-43Celera Enters into Distribution Agreement with Abbott II-43Sanofi-Aventis Acquires Genzyme II-43Genzyme Divests Diagnostic Products Business to Sekisui Chemical II-43Fortis Healthcare's Offshore Subsidiary Acquires ControllingStake in RadLink II-44Agilent Technologies Inks Partnership Agreement withIntegrated Diagnostics II-44Genzyme to Divest Pharmaceutical Intermediates Business toICIG's Affiliate II-44Hologic Acquires Interlace Medical II-45Applied BioCode Inks License and Supply Agreement with Hologic II-45WuXi AppTec Partners with Qiagen II-45OCM Acquisition Takes over Orchid Cellmark II-46Modern Mobility Aids to Take Over LumiGene Technologies II-46AmerisourceBergen Takes over Premier Source II-46QIAGEN Acquires Cellestis II-47QIAGEN Signs Agreement to Acquire Majority Interest in Ipsogen II-47Novartis to Acquire Genoptix II-47Vermillion Concludes Purchase of Correlogic's Ovarian CancerDiagnostics Business II-47VitaPath Genetics and Alere Enter into Strategic Partnershipfor Molecular Diagnostics II-48Mingyuan Medicare to Purchase 70% Stake in Yuangi Bio II-48Quest Diagnostics Acquires Athena Diagnostics II-48Luminex Takes Over Eragen Biosciences II-49Life Technologies Enters into Distribution CommercialAgreement for Quidel Assays II-49BD and Diagenode Announce Agreement II-49Gamma-Dynacare Buys Warnex Medical Laboratories II-50OraSure Technologies to Takeover DNA Genotek II-50Hologic Takes Over TCT International II-51Affymetrix to Purchase eBioscience II-51Sequenom Enters into Licensing Partnership with LifeCodexx II-51LABSCO Inks Agreement with Cepheid II-52Abbott to Expand GSK Agreement for Cancer CompanionDiagnostic Test II-52IntegenX Signs Distribution Agreement with Promega forRapidHIT Human Identification System II-52BD Diagnostics Partners with Biodiversity for BD MAXMolecular Diagnostic Assays II-53bioMérieux Acquires ARGENE II-53Caliper Partners with Seegene to Expand Diagnostic Tests II-54Enzo Clinical Labs Enters into Agreement with IncellDx II-54Akonni and Seegene Ink Licensing Agreement II-55Tecan Signs OEM Agreement with Major Diagnostics Company II-55Tecan Inks License and Collaboration Agreement with Enigma II-55Myriad Genetics Secures Option to Buy Crescendo Bioscience II-55PerkinElmer Takes Over chemagen Biopolymer- Technologie AG II-56Mayo Clinic Enters into Agreement with Rheonix II-56Qiagen and Epigenomics Ink Option Agreement II-57

8. INDUSTRY ACTIVITY IN RECENT PAST - A PERSPECTIVE BUILDER II-58

ExonHit Therapeutics to Acquire RedPath Integrated Pathology II-58

Life Technologies Acquires AcroMetrix of Benicia II-58

Bar Harbor BioTechnology Establishes New Division II-58

SIRS-Lab Partners with Analytik Jena II-58

QIAGEN Enters into a Partnership with Genome Diagnostics II-59

IncellDx Enters into Supply Contract with Accuri II-59

BioMerieux Partners with Knome II-59

Caliper Enters into an Agreement with Access Genetics II-60

Debiopharm Group Forms Partnership with Biocartis II-60

AdnaGen AG Enters into a Contract with TATAA Molecular

Diagnostics II-60

Roche Diagnostics Enters into Partnership with CapitalBio II-61

Epigenomics Signs Distribution Agreement with Epi proColon II-61

Genomic Health Selects IDBS to Provide Tools for Clinical

Research II-61

TriLink BioTechnologies Signs Agreement with Biofortuna II-61

Pathwork Diagnostics Enters into Partnership with Novartis II-62

Affymetrix Signs Agreement with Signature Diagnostics II-62

Knome and bioMerieux Ink Exclusive Strategic Agreement II-62

GenMark Receives License to Innogenetics HCV Genotyping Patent II-63

GE Healthcare Takes Over Clarient II-63

Cypress to Sell Diagnostics Unit to Exagen II-63

EB Analytics Acquires EnviroLogix II-64

IRIS Takes over AlliedPath II-64

bioMerieux Takes Over Selected Assets of AnagnosTec II-64

Hologic Takes Over Sentinelle Medical II-64

Gen-Probe Takes Over GTI Diagnostics II-65

LabCorp Takes Over Genzyme Genetics II-65

bioMérieux Inks Agreement with Biocartis II-66

Genzyme Sells Genzyme Genetics to LabCorp II-66

Life Technologies Obtains IVD Marking for 7500 Fast Dx PCR

Instrument II-66

Xenomics Changes Name to TrovaGene II-67

Abbott and GSK Team Up in the Area of Molecular Diagnosis II-67

Asuragen Enters Into Collaborations for Pancreatic Cancer Tests II-67

Transgenomic Licenses Intellectual Property from Integragen II-67

Health Discovery Inks Agreement with Pancreas, Biliary and

Liver Surgery Center of New York II-68

Qiagen Enters into Agreement with Celera II-68

The Tecan Group Inks Agreement with Enigma II-68

Northeast Pharmaceuticals to Establish Biopharma JV with

Shenyang II-69

Wescor Divests Microarray Technology Related Assets to Gamida

For Life Group II-69

Predictive Biosciences Takes Over OncoDiagnostic Laboratory II-69

Applied Biosystems Obtains Approval for AmpFlSTR® MiniFiler™

PCR Amplification Kit II-70

Life Technologies Acquires AcroMetrix II-70

Ipsogen SA and The Institut Curie Enters into Scientific

Collaboration Agreement II-70

bioTheranostics and Ferrer inCode Enters into Commercial

Agreement II-70

Quidel Corp Signs Definitive Agreement to Purchase Diagnostic

Hybrids II-71

Abbott Obtains CE Marking for New Diagnostic Test II-71

Transgenomic Enters into Licensing Agreement with Gene Solutions II-71

QIAGEN Acquires SABiosciences II-72

Corgenix Medical and BG Medicine Inks Supply Agreement II-72

Roche receives FDA Approval for Additional Usage of cobas®

TaqScreen MPX Test II-72

Gen-Probe Obtains FDA Approval for Marketing of ProParaflu+TM

Assay II-73

bioMerieux Enters into Agreement with GSK II-73

Tecan Group and Hologic Sign Agreement II-73

QIAGEN Takes Over DxS II-74

Tyrian Ends Partnership with Becton, Dickinson and Co II-74

Becton, Dickinson and Co to Purchase HandyLab II-74

Quidel and BioHelix Enter into Agreement II-75

Gen-Probe to Take Over Prodesse II-75

Summit Partners Acquires Stake in ApoCell II-75

Merck to form Alliance with QIAGEN II-75

Gen-Probe to Spin Off Industrial Testing Assets II-76

ImClone Systems and Bristol-Myers Squibb Enter into

Collaboration with DxS II-76

Danaher to Acquire A Joint Venture Company II-76

Abbott Enters into Alliance with Pfizer for Molecular

Diagnostic Test II-77

Rosetta and Warnex Ink Distribution Agreement II-77

ViraCor Laboratories Merges with IBT Laboratories II-77

ELITech Takes Over Assets of Nanogen II-77

LabCorp Signs Definitive Agreement with Monogram Biosciences II-78

Axial Biotech and University of Utah Enter into Collaboration II-78

Celera and Bayer Schering Pharma Sign Licensing Agreement II-78

AVESTHAGEN Enters into Collaboration with VTT Technical

Research Centre II-79

3M Terminates Collaboration Agreement with Gen-Probe II-79

BioGenex and Abbott Expand Joint Development and Distribution

Agreement II-79

Pfizer Extends Collaboration Agreement with Monogram Biosciences II-80

BD Diagnostics Inks Agreement with HandyLab II-80

TriLink BioTechnologies and Osmetech Molecular Diagnostics

Ink Agreement II-80

PerkinElmer Buys Analytica of Branford II-81

Ipsogen Signs Agreement with Arup Laboratories II-81

Prometheus Laboratories and Rosetta Genomics Ink Agreement II-81

AMDL and Precision Diagnostic Laboratory Signs Agreement II-81

Osmetech Signs Agreement with Fisher HealthCare II-82

Interleukin Genetics Inks Licensing Agreement with LABEC Pharma II-82

deCODE Genetics Inks Licensing Agreements with Celera II-82

Nuvera Biosciences Signs Licensing Agreement with Veridex II-83

GE Healthcare Inks Research Agreement with Brigham and

Women's Hospital II-83

Gen-Probe Purchases Tepnel Life Sciences II-83

AdnaGen AG Receives US Patent II-83

Agilent Technologies Selects Asuragen as Certified Service

Provider II-83

Genstruct Enters into Partnership with Gene Logic II-84

Lab21 Takes Over Biotec Laboratories II-84

ProGenTech and Innovative Biosensors Jointly Sign Extension

Agreement II-84

Nanogen Signs and Scandinavian Gene Synthesis Inks Agreement II-85

Health Discovery Corporation Inks Licensing Agreement with

Abbott II-85

BD Diagnostics Receives CE Marking for Amplified DNA Assays II-85

Transgenomic Signs Licensing Agreement Power3 Medical Products II-86

Rubicon Genomics and Abbott Enter into Licensing Agreement II-86

Novartis Extends Collaboration with Gen-Probe II-86

Eurogentec Receives ISO-Certification for IVD Oligonucleotides II-87

Dako and OSI Pharmaceuticals Enter into Collaboration II-87

Combimatrix Molecular Diagnostics and Lenetix Enter into

Partnership II-87

Sequenom to Acquire AttoSense™ Tests of SensiGen II-87

Epigenomics AG and Sysmex Ink Research and Development

Collaboration Deal II-88

Gene Express and Biogenuix Medsystems Signs Distribution

Agreement II-88

Gene Express and Funakoshi Enter into Distribution Agreement II-89

BD and Company Obtains FDA Approval for Marketing GeneOhm™

Cdiff Test II-89

XDx and Bristol-Myers Squibb Company Signs Collaborative

Agreement II-89

Rosetta Genomics and Teva Pharmaceutical Industries Signs

Distribution Agreement II-90

9. PRODUCT DEVELOPMENTS/ INTRODUCTIONS II-91Quest Diagnostics Introduces Cervical Cancer TERC Test II-91BD Diagnostics Introduces Range of Open System Extraction andMaster Mix Kits II-91Pro-Lab Diagnostics Launches Portrait Analyser II-92Quest Diagnostics Introduces Molecular Tests for Thyroid Cancer II-92Seegene to Launch Quantitative TOCE Highly MultiplexedQuantitative Real-Time Molecular Technology II-92ELITech Molecular Diagnostics Unveils 2nd Generation MRSA/SAELITe MGB® Kit II-93MDxHealth Introduces ConfirmMDx™ for Prostate Cancer Test II-93Ipsos Healthcare Unveils Molecular Diagnostic Monitor Line II-94Seegene Launches Anyplex™ MDR-TB Test II-94Berg Diagnostics Introduces Molecular Diagnostics Offerings II-94Life Technologies Unveils VetMAX™-Gold SIV Detection Kit II-95Life Technologies Obtains Chinese Approval for AppliedBiosystems 3500 Dx / 3500xL Dx Genetic Analyzer II-95LabCorp Launches HCV GenoSure NS3/4A II-96Quest Diagnostics Launches AccuType IL28B Test II-96Quest Diagnostics Unveils Simplexa™ Direct Test II-96Quest Diagnostics Unveils Simplexa™ Dengue Test II-96

10. PRODUCT LAUNCHES IN RECENT PAST - A PERSPECTIVE BUILDER II-98

Quest Diagnostics Unveils Molecular Blood Test II-98

LabCorp Unveils IL-28B Test II-98

Gen-Probe Unveils ELUCIGENE™ KRAS.BRAF Kit II-98

QIAGEN Unveils QIAsymphony RGQ System II-99

Gen-Probe Unveils PANTHER™ System II-99

Life Technologies Unveils ViralSEQ™ Vesivirus Detection Kit II-99

Applied Biosystems New Forensic DNA Kits II-100

Quest Diagnostics Launches ColoVantage™ Test II-100

QIAGEN Introduces CE-labeled KRAS Kit II-100

Roche Introduces Cobas 4800 II-101

bioMérieux Launches Upgraded Version of NucliSENS EasyQ®

Influenza A/B Test II-101

bioMérieux Introduces NucliSENS EasyQ® MRSA II-101

Roche Launches AMPLILINK 3.3 Series Software and cobas p 630

Instrument II-102

Applied Biosystems Unveils 3500 Series and 3500 DX Series

Genetic Analyzer II-102

Prometheus Laboratories Introduces New Range of Cancer

Diagnostic Products II-103

Sequenom Introduces SensiGene Cystic Fibrosis Carrier

Screening Test II-103

Triplex and MedMira to Unveil New Rapid Tests II-103

Applied Biosystems to Introduce New Range of TaqMan® PCR Assays II-104

Quest Diagnostics Unveils HIV-1 Coreceptor Tropism Test II-104

Luminex introduced New Range of Cystic Fibrosis Tests II-104

bioMérieux Introduces VIDAS® EBV Test II-105

Luminex Unveils Two Novel Cystic Fibrosis Tests II-105

MEDomics Launches MitoDx™ for Diagnosing Mitochondrial Diseases II-105

Exagen Diagnostics Unveils eXaIBStest and eXaIBD Blood Tests II-106

bioMérieux Introduces NucliSENS EasyQ® HIV-1 v2.0 Test II-106

PreAnalytiX Introduces PAXgene® Blood miRNA Kit II-106

ViraCor Laboratories Introduces New JCV Test II-106

ViraCor Laboratories Rolls Out JC Virus Detection Test II-107

Focus Diagnostics Laboratory Introduces PCR Test II-107

Siemens Launches CLINITEK AUWi Urine Analyzing System II-107

Ocimum Biosolutions to Introduce New H1N1 Virus Detection Test II-108

Myriad Genetics Introduces OnDose for Cancer Diagnosis II-108

Applied Biosystems Introduces TaqMan® Array Gene Signature

Plates II-108

GeneNews to Develop Blood-Based Diagnostic Tests II-109

Seegene Rolls Out Seeplex® Diarrhea ACE Detection Test II-109

Seegene Unveils Seeplex® Meningitis ACE Detection test II-109

Cepheid Introduces Xpert MRSA/SA Nasal Diagnostic Test II-110

Roche to Launch LightCycler Test II-110

Xenomics Unveils New Technology for Analyzing in Vivo Cell Death II-110

bioMerieux Unveils NucliSENS EasyQ® HPV Molecular Analytical

Test II-111

Xenomics to Introduce Innovative Gender Prediction Test II-111

Evogen Unveils New EvoCycler™ HD12 Molecular Diagnostics System II-111

Siemens Healthcare Launches Innovance Antithrombin Test II-112

Rosetta Genomics Launches miRview™ meso Diagnostic Test II-112

ViraCor Laboratories Introduces Cytomegalovirus Antiviral

Resistance Test II-112

Abbott Launches Diagnostic Test for HPV Detection II-113

Pathwork Diagnostics Introduces Tissue of Origin Test II-113

Evogen to Offer Diagnostic Tests II-114

11. FOCUS ON SELECT GLOBAL PLAYERS II-115Abbott Laboratories (US) II-115Abbott Molecular (US) II-115Life Technologies Corporation (US) II-115Celera (US) II-116bioMérieux (France) II-116CytoCore Inc. (US) II-117ELITech Group (France) II-117GE Healthcare (US) II-117Genzyme Corp. (US) II-118Hologic, Inc. (US) II-118Laboratory Corporation of America® Holdings (US) II-119MiraiBio, Inc. (US) II-119Novartis Diagnostics (US) II-120QIAGEN N.V (The Netherlands) II-120Quest Diagnostics, Inc. (US) II-121Roche Diagnostics (Switzerland) II-121Siemens Healthcare Diagnostics Inc. (US) II-121Tecan Group Ltd. (Switzerland) II-122

12. GLOBAL MARKET PERSPECTIVE II-123

Table 4: World Recent Past, Current & Future Market Analysis

for Molecular Diagnostics by Geographic Region - US, Canada,

Japan, Europe, Asia-Pacific (excluding Japan) and Rest of

World Markets Independently Analyzed with Annual Sales Figures

in US$ Million for Years 2010 through 2018 (includes

corresponding Graph/Chart) II-123

Table 5: World Historic Review for Molecular Diagnostics byGeographic Region - US, Canada, Japan, Europe, Asia-Pacific(excluding Japan) and Rest of World Markets IndependentlyAnalyzed with Annual Sales Figures in US$ Million for Years2004 through 2009 (includes corresponding Graph/Chart) II-124

Table 6: World 15-Year Perspective for Molecular Diagnostics

by Geographic Region - Percentage Breakdown of Dollar Sales

for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan)

and Rest of World Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) II-125

Molecular Diagnostics Market by Application II-126

Table 7: World Recent Past, Current & Future Market Analysis

for Molecular Diagnostics (Infectious Disease Testing) by

Geographic Region - US, Canada, Japan, Europe, Asia-Pacific

(excluding Japan), and Rest of World Markets Independently

Analyzed with Annual Sales Figures in US$ Million for Years

2010 through 2018 (includes corresponding Graph/Chart) II-126

Table 8: World Historic Review for Molecular Diagnostics(Infectious Disease Testing) by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), andRest of World Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2004 through 2009 (includescorresponding Graph/Chart) II-127

Table 9: World 15-Year Perspective for Molecular Diagnostics

(Infectious Disease Testing) by Geographic Region -

Percentage Breakdown of Dollar Sales for US, Canada, Japan,

Europe, Asia-Pacific (excluding Japan), and Rest of World

Markets for Years 2004, 2011 and 2018 (includes corresponding

Graph/Chart) II-128

Table 10: World Recent Past, Current & Future Market Analysisfor Molecular Diagnostics (Pharmacogenomics) by GeographicRegion - US, Canada, Japan, Europe, Asia-Pacific (excludingJapan), and Rest of World Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2010 through2018 (includes corresponding Graph/Chart) II-129

Table 11: World Historic Review for Molecular Diagnostics

(Pharmacogenomics) by Geographic Region - The US, Canada,

Japan, Europe, Asia-Pacific (excluding Japan), and Rest of

World Markets Independently Analyzed with Annual Sales Figures

in US$ Million for Years 2004 through 2009 (includes

corresponding Graph/Chart) II-130

Table 12: World 15-Year Perspective for Molecular Diagnostics(Pharmacogenomics) by Geographic Region - PercentageBreakdown of Dollar Sales for US, Canada, Japan, Europe,Asia-Pacific (excluding Japan), and Rest of World Marketsfor Years 2004, 2011 and 2018 (includes correspondingGraph/Chart) II-131

Table 13: World Recent Past, Current & Future Market Analysis

for Molecular Diagnostics (Cancer Screening) by Geographic

Region - US, Canada, Japan, Europe, Asia-Pacific (excluding

Japan), and Rest of World Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2010 through

2018 (includes corresponding Graph/Chart) II-132

Table 14: World Historic Review for Molecular Diagnostics(Cancer Screening) by Geographic Region - US, Canada, Japan,Europe, Asia-Pacific (excluding Japan) and Rest of WorldMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2004 through 2009 (includescorresponding Graph/Chart) II-133

Table 15: World 15-Year Perspective for Molecular Diagnostics

(Cancer Screening) by Geographic Region - Percentage

Breakdown of Dollar Sales for the US, Canada, Japan, Europe,

Asia-Pacific (excluding Japan), and Rest of World Markets

for Years 2004, 2011 and 2018 (includes corresponding

Graph/Chart) II-134

III. MARKET

1. THE UNITED STATES III-1

A.Market Analysis III-1

Current and Future Analysis III-1

A Precursor to the Molecular Diagnostics Market in the US III-1

US Diagnostic Market: An Overview III-1

Molecular Diagnostics Heavily Tied to Proteomics and Genomics III-1

Burgeoning Potential for Genetic Testing III-2

Regulatory Environment III-2

Regulations Out for Molecular Diagnostic Testing of HPV III-2

Limited Reimbursements - A Major Hindrance III-3

Strategic Corporate Developments III-3

Product Launches III-20

Key players III-23

B.Market Analytics III-29

Table 16: US Recent Past, Current & Future Analysis for

Molecular Diagnostics by Application - Infectious Disease

Testing, Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-29

Table 17: US Historic Review for Molecular Diagnostics byApplication - Infectious Disease Testing, Pharmacogenomics,and Cancer Screening Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2004 through2009 (includes corresponding Graph/Chart) III-30

Table 18: US 15-Year Perspective for Molecular Diagnostics

by Application - Percentage Breakdown of Dollar Sales for

Infectious Disease Testing, Pharmacogenomics, and Cancer

Screening Markets for Years 2004, 2011 & 2018 (includes

corresponding Graph/Chart) III-31

2. CANADA III-32A.Market Analysis III-32Current and Future Analysis III-32Strategic Corporate Development III-32B.Market Analytics III-33Table 19: Canadian Recent Past, Current & Future Analysisfor Molecular Diagnostics by Application - InfectiousDisease Testing, Pharmacogenomics, and Cancer ScreeningMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2010 through 2018 (includescorresponding Graph/Chart) III-33

Table 20: Canadian Historic Review for Molecular Diagnostics

by Application - Infectious Disease Testing,

Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2004 through 2009 (includes

corresponding Graph/Chart) III-34

Table 21: Canadian 15-Year Perspective for MolecularDiagnostics by Application - Percentage Breakdown of DollarSales for Infectious Disease Testing, Pharmacogenomics,and Cancer Screening Markets for Years 2004, 2011 and 2018(includes corresponding Graph/Chart) III-35

3. JAPAN III-36

A.Market Analysis III-36

Current and Future Analysis III-36

B.Market Analytics III-37

Table 22: Japanese Recent Past, Current & Future Analysis

for Molecular Diagnostics by Application - Infectious

Disease Testing, Pharmacogenomics, and Cancer Screening

Markets Independently Analyzed with Annual Sales Figures in

US$ Million for Years 2010 through 2018 (includes

corresponding Graph/Chart) III-37

Table 23: Japanese Historic Review for Molecular Diagnosticsby Application - Infectious Disease Testing,Pharmacogenomics, and Cancer Screening MarketsIndependently Analyzed with Annual Sales Figures in US$Million for Years 2004 through 2009 (includescorresponding Graph/Chart) III-38

Table 24: Japanese 15-Year Perspective for Molecular

Diagnostics by Application - Percentage Breakdown of Dollar

Sales for Infectious Disease Testing, Pharmacogenomics,

and Cancer Screening Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) III-39

4. EUROPE III-40A.Market Analysis III-40Current and Future Analysis III-40Insight into Molecular Diagnostics Markets in Europe III-40Table 25: European IVD Market for Select Countries (2010) -Market Value in US$ Million for Spain, UK, Germany,Italy, France, Poland, Netherlands, Belgium, Denmark,Portugal, Austria, Sweden, Bulgaria and Lithuania(includes corresponding Graph/Chart) III-41B.Market Analytics III-42Table 26: European Recent Past, Current & Future Analysisfor Molecular Diagnostics by Geographic Region - France,Germany, Italy, UK, and Rest of Europe MarketsIndependently Analyzed with Annual Sales Figures in US$Million for Years 2010 through 2018 (includescorresponding Graph/Chart) III-42

Table 27: European Historic Review for Molecular Diagnostics

by Geographic Region - France, Germany, Italy, UK, and Rest

of Europe Markets Independently Analyzed with Annual Sales

Figures in US$ Million for Years 2004 through 2009

(includes corresponding Graph/Chart) III-43

Table 28: European 15-Year Perspective for MolecularDiagnostics by Geographic Region - Percentage Breakdown ofDollar Sales for France, Germany, Italy, UK, and Rest ofEurope Markets for Years 2004, 2011 and 2018 (includescorresponding Graph/Chart) III-44

Table 29: European Recent Past, Current & Future Analysis

for Molecular Diagnostics by Application - Infectious

Disease Testing, Pharmacogenomics, and Cancer Screening

Markets Independently Analyzed with Annual Sales Figures in

US$ Million for Years 2010 through 2018 (includes

corresponding Graph/Chart) III-45

Table 30: European Historic Review for MolecularDiagnostics by Application - Infectious Disease Testing,Pharmacogenomics, and Cancer Screening MarketsIndependently Analyzed with Annual Sales Figures in US$Million for Years 2004 through 2009 (includes correspondingGraph/Chart) III-46

Table 31: European 15-Year Perspective for Molecular

Diagnostics by Application - Percentage Breakdown of Dollar

Sales for Infectious Disease Testing, Pharmacogenomics and

Cancer Screening Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) III-47

4a. FRANCE III-48A.Market Analysis III-48Current and Future Analysis III-48Strategic Corporate Developments III-48Product Launch III-49Key players III-49B.Market Analytics III-51Table 32: French Recent Past, Current & Future Analysis forMolecular Diagnostics by Application - Infectious DiseaseTesting, Pharmacogenomics, and Cancer Screening MarketsIndependently Analyzed with Annual Sales Figures in US$Million for Years 2010 through 2018 (includes correspondingGraph/Chart) III-51

Table 33: French Historic Review for Molecular Diagnostics

by Application - Infectious Disease Testing,

Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2004 through 2009 (includes

corresponding Graph/Chart) III-52

Table 34: French 15-Year Perspective for MolecularDiagnostics by Application - Percentage Breakdown of DollarSales for Infectious Disease Testing, Pharmacogenomics, andCancer Screening Markets for Years 2004, 2011 and 2018(includes corresponding Graph/Chart) III-53

4b. GERMANY III-54

A.Market Analysis III-54

Current and Future Analysis III-54

Overview III-54

Table 35: German Market for Laboratory Product (2010) -

Market Value (in US$ Million) and Percentage Share for

Clinical Chemistry Reagents, Immunochemistry Reagents,

Hematology, Infectious Immunology,

Consumables/Instruments, Microbiology Reagents and

Services/Spare Parts (includes corresponding Graph/Chart) III-55

Strategic Corporate Development III-55

B.Market Analytics III-56

Table 36: German Recent Past, Current & Future Analysis for

Molecular Diagnostics by Application - Infectious Disease

Testing, Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2010 through 2018 (includes corresponding

Graph/Chart) III-56

Table 37: German Historic Review for Molecular Diagnosticsby Application - Infectious Disease Testing,Pharmacogenomics, and Cancer Screening Markets IndependentlyAnalyzed with Annual Sales Figures in US$ Million for Years2004 through 2009 (includes corresponding Graph/Chart) III-57

Table 38: German 15-Year Perspective for Molecular

Diagnostics by Application - Percentage Breakdown of Dollar

Sales for Infectious Disease Testing, Pharmacogenomics, and

Cancer Screening Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) III-58

4c. ITALY III-59A.Market Analysis III-59Current and Future Analysis III-59B.Market Analytics III-60Table 39: Italian Recent Past, Current & Future Analysisfor Molecular Diagnostics by Application - InfectiousDisease Testing, Pharmacogenomics, and Cancer ScreeningMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2010 through 2018 (includescorresponding Graph/Chart) III-60

Table 40: Italian Historic Review for Molecular Diagnostics

by Application - Infectious Disease Testing,

Pharmacogenomics, and Cancer Screening Markets Independently

Analyzed with Annual Sales Figures in US$ Million for Years

2004 through 2009 (includes corresponding Graph/Chart) III-61

Table 41: Italian 15Year Perspective for MolecularDiagnostics by Application - Percentage Breakdown of DollarSales for Infectious Disease Testing, Pharmacogenomics, andCancer Screening Markets for Years 2004, 2011 and 2018(includes corresponding Graph/Chart) III-62

4d. THE UNITED KINGDOM III-63

A.Market Analysis III-63

Current and Future Analysis III-63

Strategic Corporate Development III-63

Product Launch III-63

B.Market Analytics III-64

Table 42: The UK Recent Past, Current & Future Analysis for

Molecular Diagnostics by Application - Infectious Disease

Testing, Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2010 through 2018 (includes

corresponding Graph/Chart) III-64

Table 43: The UK Historic Review for Molecular Diagnosticsby Application - Infectious Disease Testing,Pharmacogenomics, and Cancer Screening Markets IndependentlyAnalyzed with Annual Sales Figures in US$ Million for Years2004 through 2009 (includes corresponding Graph/Chart) III-65

Table 44: The UK 15-Year Perspective for Molecular

Diagnostics by Application - Percentage Breakdown of Dollar

Sales for Infectious Disease Testing, Pharmacogenomics, and

Cancer Screening Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) III-66

4e. REST OF EUROPE III-67A.Market Analysis III-67Current and Future Analysis III-67Strategic Corporate Developments III-67Product Launches III-70Key players III-70B.Market Analytics III-72Table 45: Rest of European Recent Past, Current & FutureAnalysis for Molecular Diagnostics by Application -Infectious Disease Testing, Pharmacogenomics, and CancerScreening Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2010 through 2018(includes corresponding Graph/Chart) III-72

Table 46: Rest of European Historic Review for Molecular

Diagnostics by Application - Infectious Disease Testing,

Pharmacogenomics, and Cancer Screening Markets

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2004 through 2009 (includes corresponding

Graph/Chart) III-73

Table 47: Rest of European 15-Year Perspective forMolecular Diagnostics by Application - Percentage Breakdownof Dollar Sales for Infectious Disease Testing,Pharmacogenomics, and Cancer Screening Markets for 2004,2011 and 2018 (includes corresponding Graph/Chart) III-74

5. ASIA-PACIFIC III-75

A.Market Analysis III-75

Current and Future Analysis III-75

Diagnostic Market in India III-75

Key Statistics III-76

Table 48: Leading Players in the Chinese IVD Market (2010) -

Percentage Share Breakdown of Value Sales for Roche,

Beckman/Danaher, Abbott, Siemens, Symex, Mindray, Hitachi,

bioMerieux, J&J, DAAN and Others (includes corresponding

Graph/Chart) III-76

Strategic Corporate Developments III-76

Product Launches III-77

B.Market Analytics III-79

Table 49: Asia-Pacific Recent Past, Current & Future

Analysis for Molecular Diagnostics by Application -

Infectious Disease Testing, Pharmacogenomics, and Cancer

Screening Markets Independently Analyzed with Annual Sales

Figures in US$ Million for Years 2010 through 2018

(includes corresponding Graph/Chart) III-79

Table 50: Asia-Pacific Historic Review for MolecularDiagnostics by Application - Infectious Disease Testing,Pharmacogenomics, and Cancer Screening Markets IndependentlyAnalyzed with Annual Sales Figures in US$ Million for Years2004 through 2009 (includes corresponding Graph/Chart) III-80

Table 51: Asia-Pacific 15-Year Perspective for Molecular

Diagnostics by Application - Percentage Breakdown of Dollar

Sales for Infectious Disease Testing, Pharmacogenomics, and

Cancer Screening Markets for Years 2004, 2011 and 2018

(includes corresponding Graph/Chart) III-81

6. REST OF WORLD III-82A.Market Analysis III-82Current and Future Analysis III-82Product Launches III-82B.Market Analytics III-83Table 52: Rest of World Recent Past, Current & FutureAnalysis for Molecular Diagnostics by Application -Infectious Disease Testing, Pharmacogenomics, and CancerScreening Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2010 through 2018(includes corresponding Graph/Chart) III-83

Table 53: Rest of World Historic Review for Molecular

Diagnostics by Application - Infectious Disease Testing,

Pharmacogenomics and Cancer Screening Markets Independently

Analyzed with Annual Sales Figures in US$ Million for Years

2004 through 2009 (includes corresponding Graph/Chart) III-84

Table 54: Rest of World 15-Year Perspective for MolecularDiagnostics by Application - Percentage Breakdown of DollarSales for Infectious Disease Testing, Pharmacogenomics andCancer Screening Markets for Years 2004, 2011 and 2018(includes corresponding Graph/Chart) III-85IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 103 (including Divisions/Subsidiaries - (121)

The United States (85)Canada (4)Japan (1)Europe (23)- France (5)- Germany (5)- The United Kingdom (4)- Rest of Europe (9)Asia-Pacific (Excluding Japan) (7)Middle East (1)

To order this report:Diagnostics Industry: Global Molecular Diagnostics Industry

Contact Clare: clare@reportlinker.com
US:(339) 368 6001
Intl:+1 339 368 6001

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