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Molecular Diagnostics - Global Strategic Business Report

Description:
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.


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Contents:
MOLECULAR DIAGNOSTICS
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


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
Infectious Diseases Testing I-3
Pharmacogenomics I-4
Cancer Screening I-4


II. 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-6
Clinical Diagnostics Industry - Trends and Tendencies II-6
Table 1: Worldwide In Vitro Diagnostics (IVD) Market (2010) -
Market Share Breakdown by Value Sales for Roche
Diagnostics, Abbott Laboratories, Siemens, J&J, Beckman
Coulter, bioMerieux, and Others (includes corresponding
Graph/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-11
Competitive Landscape II-11
Table 3: Worldwide Molecular Diagnostics Market (2011) -
Percentage Share Breakdown by Value Sales for Roche
Diagnostics, Qiagen, Abbott, Hologic (Gen-Probe), Siemens,
Becton, Dickinson & Company and Others (includes
corresponding Graph/Chart) II-11
Key Players and Their Technologies II-11
The Top Tier II-11
Mid-Sized and Small Companies II-12
New 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-20
Molecular Diagnostics - Definition & Scope II-20
Molecular Diagnostics - Impact on Healthcare II-20
Utility of Molecular Diagnostic Tests II-21
Background of Molecular Diagnostics II-21
Major Molecular Diagnostics Products II-21
Major Test Launches in Molecular Diagnostics in the Recent Past II-22
Unabated Developments in Molecular Diagnostics Technology II-22
Signal Amplification Technologies II-22
PCR - New Developments II-22
Major Applications of Real-Time PCR II-23
Quantitative Real-Time PCR for Molecular Diagnostics II-23
Signal Detection and Quantification II-23
Quantitative Real-Time RT-PCR Analysis II-24
Applications of Quantitative Real-Time PCR Analysis II-24
Viral Detection and Viral-Load Monitoring II-24
Sensitive Detection of Infectious Disease Agents II-24
Predisposition Testing II-24
Non-PCR Methods II-24
Other Signal Amplification Technologies II-24
DNA Probe Based Products II-24
Direct Detection of Specific Nucleic Acid Sequences II-25
Nucleic Acid Amplification and Detection II-25
DNA Sequencing and Gene Detection II-26
Arrays of Immobilized Probes (DNA Chips) in Gene Detection II-26
RNA Diagnostics II-26
Complementary Molecular Diagnostic Technologies II-27
Fluorescent In-Situ Hybridization (FISH) II-27
DNA Biochips / Microarrays II-27
Biosensors II-28
Proteomic Technologies for Molecular Diagnostics II-29
Nanotechnology for Molecular Diagnostics II-29
Technologies on the Anvil II-29
Haplotype Analysis - A Distant Possibility II-29
Chronic 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-36
Trovagene Acquires MultiGENs Clinical Laboratory Assets II-36
Qiagen Acquires Intelligent Bio-Systems II-36
Siemens Inks Agreements with Tocagen and ViiV Healthcare to
Develop Companion Tests II-36
HTG Molecular Diagnostics Collaborates with Sanofi US II-36
DaAn Gene and Life Technologies Form Joint Venture II-37
Exosome Diagnostics and Life Technologies Ink Agreement II-37
GE Healthcare Acquires SeqWright II-38
Phthisis Diagnostics Expands its Distribution Network II-38
Luminex to Acquire GenturaDx II-39
Phthisis Diagnostics Inks Distribution Agreement with Genetix
Biotech Asia II-39
Life Technologies Acquires Navigenics II-40
Abbott to Join Forces with Merck II-40
Signal Genetics to Acquire ChipDX LLC II-41
Quest Diagnostics Acquires S.E.D. Medical Laboratories II-41
Hologic Acquires Gen-Probe II-41
Accelerate Brain Cancer Cure Joins Hands with Exosome
Diagnostics II-42
QIAGEN Collaborates with Cardinal Health II-42
LabCorp Acquires MEDTOX II-42
Genzyme Inks Agreement with Veracyte to Market Afirma Thyroid
FNA Analysis Solution II-43
Celera Enters into Distribution Agreement with Abbott II-43
Sanofi-Aventis Acquires Genzyme II-43
Genzyme Divests Diagnostic Products Business to Sekisui Chemical II-43
Fortis Healthcares Offshore Subsidiary Acquires Controlling
Stake in RadLink II-44
Agilent Technologies Inks Partnership Agreement with
Integrated Diagnostics II-44
Genzyme to Divest Pharmaceutical Intermediates Business to
ICIGs Affiliate II-44
Hologic Acquires Interlace Medical II-45
Applied BioCode Inks License and Supply Agreement with Hologic II-45
WuXi AppTec Partners with Qiagen II-45
OCM Acquisition Takes over Orchid Cellmark II-46
Modern Mobility Aids to Take Over LumiGene Technologies II-46
AmerisourceBergen Takes over Premier Source II-46
QIAGEN Acquires Cellestis II-47
QIAGEN Signs Agreement to Acquire Majority Interest in Ipsogen II-47
Novartis to Acquire Genoptix II-47
Vermillion Concludes Purchase of Correlogic's Ovarian Cancer
Diagnostics Business II-47
VitaPath Genetics and Alere Enter into Strategic Partnership
for Molecular Diagnostics II-48
Mingyuan Medicare to Purchase 70% Stake in Yuangi Bio II-48
Quest Diagnostics Acquires Athena Diagnostics II-48
Luminex Takes Over Eragen Biosciences II-49
Life Technologies Enters into Distribution Commercial
Agreement for Quidel Assays II-49
BD and Diagenode Announce Agreement II-49
Gamma-Dynacare Buys Warnex Medical Laboratories II-50
OraSure Technologies to Takeover DNA Genotek II-50
Hologic Takes Over TCT International II-51
Affymetrix to Purchase eBioscience II-51
Sequenom Enters into Licensing Partnership with LifeCodexx II-51
LABSCO Inks Agreement with Cepheid II-52
Abbott to Expand GSK Agreement for Cancer Companion
Diagnostic Test II-52
IntegenX Signs Distribution Agreement with Promega for
RapidHIT Human Identification System II-52
BD Diagnostics Partners with Biodiversity for BD MAX
Molecular Diagnostic Assays II-53
bioMérieux Acquires ARGENE II-53
Caliper Partners with Seegene to Expand Diagnostic Tests II-54
Enzo Clinical Labs Enters into Agreement with IncellDx II-54
Akonni and Seegene Ink Licensing Agreement II-55
Tecan Signs OEM Agreement with Major Diagnostics Company II-55
Tecan Inks License and Collaboration Agreement with Enigma II-55
Myriad Genetics Secures Option to Buy Crescendo Bioscience II-55
PerkinElmer Takes Over chemagen Biopolymer- Technologie AG II-56
Mayo Clinic Enters into Agreement with Rheonix II-56
Qiagen 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
Womens 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-91
Quest Diagnostics Introduces Cervical Cancer TERC Test II-91
BD Diagnostics Introduces Range of Open System Extraction and
Master Mix Kits II-91
Pro-Lab Diagnostics Launches Portrait Analyser II-92
Quest Diagnostics Introduces Molecular Tests for Thyroid Cancer II-92
Seegene to Launch Quantitative TOCE Highly Multiplexed
Quantitative Real-Time Molecular Technology II-92
ELITech Molecular Diagnostics Unveils 2nd Generation MRSA/SA
ELITe MGB® Kit II-93
MDxHealth Introduces ConfirmMDx™ for Prostate Cancer Test II-93
Ipsos Healthcare Unveils Molecular Diagnostic Monitor Line II-94
Seegene Launches Anyplex™ MDR-TB Test II-94
Berg Diagnostics Introduces Molecular Diagnostics Offerings II-94
Life Technologies Unveils VetMAX™-Gold SIV Detection Kit II-95
Life Technologies Obtains Chinese Approval for Applied
Biosystems 3500 Dx / 3500xL Dx Genetic Analyzer II-95
LabCorp Launches HCV GenoSure NS3/4A II-96
Quest Diagnostics Launches AccuType IL28B Test II-96
Quest Diagnostics Unveils Simplexa™ Direct Test II-96
Quest 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-115
Abbott Laboratories (US) II-115
Abbott Molecular (US) II-115
Life Technologies Corporation (US) II-115
Celera (US) II-116
bioMérieux (France) II-116
CytoCore Inc. (US) II-117
ELITech Group (France) II-117
GE Healthcare (US) II-117
Genzyme Corp. (US) II-118
Hologic, Inc. (US) II-118
Laboratory Corporation of America® Holdings (US) II-119
MiraiBio, Inc. (US) II-119
Novartis Diagnostics (US) II-120
QIAGEN N.V (The Netherlands) II-120
Quest Diagnostics, Inc. (US) II-121
Roche Diagnostics (Switzerland) II-121
Siemens Healthcare Diagnostics Inc. (US) II-121
Tecan 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 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
2004 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), and
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2004 through 2009 (includes
corresponding 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 Analysis
for Molecular Diagnostics (Pharmacogenomics) 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-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 - 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-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 World
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2004 through 2009 (includes
corresponding 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 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-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-32
A.Market Analysis III-32
Current and Future Analysis III-32
Strategic Corporate Development III-32
B.Market Analytics III-33
Table 19: Canadian 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-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 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-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 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-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-40
A.Market Analysis III-40
Current and Future Analysis III-40
Insight into Molecular Diagnostics Markets in Europe III-40
Table 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-41
B.Market Analytics III-42
Table 26: European Recent Past, Current & Future Analysis
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 2010 through 2018 (includes
corresponding 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 Molecular
Diagnostics by Geographic Region - Percentage Breakdown of
Dollar Sales for France, Germany, Italy, UK, and Rest of
Europe Markets for Years 2004, 2011 and 2018 (includes
corresponding 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 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-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-48
A.Market Analysis III-48
Current and Future Analysis III-48
Strategic Corporate Developments III-48
Product Launch III-49
Key players III-49
B.Market Analytics III-51
Table 32: French 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-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 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-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 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-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-59
A.Market Analysis III-59
Current and Future Analysis III-59
B.Market Analytics III-60
Table 39: Italian 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-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 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-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 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-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-67
A.Market Analysis III-67
Current and Future Analysis III-67
Strategic Corporate Developments III-67
Product Launches III-70
Key players III-70
B.Market Analytics III-72
Table 45: Rest of 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-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 for
Molecular Diagnostics by Application - Percentage Breakdown
of 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 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-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-82
A.Market Analysis III-82
Current and Future Analysis III-82
Product Launches III-82
B.Market Analytics III-83
Table 52: Rest of World 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-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 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-85


IV. 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)
 
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