Global Molecular Diagnostics Industry

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Global Molecular Diagnostics Industry
Published on October 2010

Report Summary

This report analyzes the worldwide markets for Molecular Diagnostics in US$ million by the following 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 2007 through 2015. A
seven-year historic analysis is also provided for these markets. The report profiles 101 companies including many key and niche
players such as Abbott Laboratories, Abbott Molecular, Applera Corporation, Celera, Biomérieux, CytoCore Inc., ELITech Group, GE
Healthcare, Gen-Probe Inc., Genzyme Corporation, Genzyme Genetics, MiraiBio, Inc., Novartis Vaccines & Diagnostics, Inc.,
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 mostly extracted from URL research and reported
select online sources.

Table of Content

MOLECULAR DIAGNOSTICS MCP-1226
A GLOBAL STRATEGIC BUSINESS REPORT

CONTENTS

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

2. INDUSTRY OVERVIEW 5
Global Market Outlook 5
Molecular Diagnostics - The Fastest Growing Medical
Diagnostic Technology 5
Current and Future Analysis 5
Growth Opportunities Abound Molecular Diagnostics Arena 6
Market for Molecular Diagnostics - An Introduction 6
Opportunities Galore for Market Participants 7

Global Molecular Diagnostics Industry Page 1/21


New Applications Hold Promising Potential 7
Automated Systems - Prime Target 7
Infectious Disease Testing Drives the Diagnostics Market 8
The Future in Store 8

3. A REVIEW OF MEDICAL DIAGNOSTICS MARKET 9
Clinical Diagnostics Industry - Trends and Tendencies 9
Table 1: Worldwide In Vitro Diagnostics (IVD) Market by Major
Players (2009) -Market Share Breakdown by Value Sales for
Roche Diagnostics, Abbott Laboratories, Ortho/ Lifescan,
Bayer/Siemens, Beckman Coulter, Becton Dickinson, Dade
Behring/Siemens, BioMerieux, Bio-Rad, and Others (includes
corresponding Graph/Chart) 10

Table 2: Worldwide In Vitro Diagnostics (IVD) Market (2008)-
Percentage Breakdown by Value Sales for Immunochemistry,
Diabetes, Clinical Chemistry, Point-of-care testing,
Molecular Diagnostics, Hematology, Coagulation, and Others
(includes corresponding Graph/Chart) 10

Table 3: Worldwide Molecular Diagnostics Market by Leading
Players (2006 - A Recent Past Perspective) - Market Share
Breakdown by Value Sales for Roche Diagnostics, Chiron, Bayer
Diagnostics, GenProbe, Abbott Laboratories, Becton Dickinson,
and Others (includes corresponding Graph/Chart) 11
Diagnostic Tests - Classification 11
Table 4: Worldwide Genetic Testing Market by Leading Players
(2006 - A Recent Past Perspective) - Market Share Breakdown
by Value Sales for Roche Diagnostics/Affymetrix, Abbott
Laboratories, Bio-Rad Laboratories, and Others (includes
Nucleic Acid Diagnostics Market - An Overview 12
Molecular Diagnostics - Growth Drivers 13
Molecular Diagnostics - A Replacement and Enabling Technology 14
Molecular Diagnostics for Lymphoid Malignancies 14

4. COMPETITIVE DYNAMICS IN THE MOLECULAR DIAGNOSTICS MARKET 15
Key Players and Their Technologies 15
The Top Tier 15
Mid-Sized and Small Companies 15

5. MARKET TRENDS & ISSUES 17
Market Consolidations on the Way to Integrate in Vivo and in
Vitro Diagnostics 17
Global Molecular Diagnostics on High Growth Curve 17
Pharmaceutical Firms Carving Their Niche in Molecular
Diagnostic Market 17
Towards Tailoring the Right Treatment for the Right Disease 17
Disease-Specific Molecular Diagnostics to Deliver Improved
Clinical Outcomes 18



Molecular Diagnostics and Intellectual Property 18
Business Opportunities in the Offing 18
Challenges Facing the Molecular Diagnostic Market 19
Medical Training and Practice Challenges 19
Shortcomings to Overcome 20
Limited Reimbursements by Third Party Payers - A Stumbling Block 20
Hurdles All the Way for Companies Eyeing Molecular Diagnostics 20
Product Marketing - Key to Commercial Success 21
Integration of Molecular Diagnostics into Therapeutics 21
Molecular Diagnostics - Moving from Centralization to
Decentralization 22
Migrating to Decentralized Format 22
Going Ahead with Decentralization 23

6. PRODUCT & TECHNOLOGY OVERVIEW 24
Molecular Diagnostics - Definition & Scope 24
Molecular Diagnostics - Impact on Healthcare 24
Utility of Molecular Diagnostic Tests 25
Background of Molecular Diagnostics 25
Major Molecular Diagnostics Products 25
Major Test Launches in Molecular Diagnostics in the Recent Past 26
Unabated Developments in Molecular Diagnostics Technology 26
Signal Amplification Technologies 27
PCR - New Developments 27
Major Applications of Real-Time PCR 27
Quantitative Real-Time PCR for Molecular Diagnostics 27
Signal Detection and Quantification 28
Quantitative Real-Time RT-PCR Analysis 28
Applications of Quantitative Real-Time PCR Analysis 28
Non-PCR Methods 28
Other Signal Amplification Technologies 29
DNA Probe Based Products 29
Direct Detection of Specific Nucleic Acid Sequences 29
Nucleic Acid Amplification and Detection 29
DNA Sequencing and Gene Detection 30
Arrays of Immobilized Probes (DNA Chips) in Gene Detection 30
RNA Diagnostics 31
Complementary Molecular Diagnostic Technologies 31
Fluorescent in situ hybridization (FISH) 31
DNA Biochips / Microarrays 32
Biosensors 33
Proteomic Technologies for Molecular Diagnostics 33
Nanotechnology for Molecular Diagnostics 33
Technologies on the Anvil 34
Haplotype Analysis - A Distant Possibility 34
Chronic Multi-Gene Defects Now Diagnosable 34

7. AN INSIGHT INTO APPLICATIONS OF MOLECULAR DIAGNOSTICS 35
Infectious Diseases Testing 35
Activity in the Field 35



Identifying Multidrug Resistance 36
Infectious Disease Treatment Monitoring 36
Other Infectious Diseases Applications 36
Genetic Disease Testing Applications 36
Pharmacogenomics - Prognosis Based on Genomics 37
Cancer Screening & Diagnosis 38
Molecular Tests Lead the Way for Cancer IVD Market Growth 39
Table 5: Worldwide Cancer Diagnostic Testing Market (2006 -
A Recent Past Review): Percentage Breakdown of Value Sales
for Immunoassays, Histology (IHC/ISH), Pap Testing, Flow
Cytometry, Prostate-Specific Antigen, Molecular Assays, and
Fecal Occult Blood Test (includes corresponding Graph/Chart) 39
Other Testing Applications 40

8. PRODUCT DEVELOPMENTS/ INTRODUCTIONS 41
Life Technologies Unveils ViralSEQTM Vesivirus Detection Kit 41
Applied Biosystems New Forensic DNA Kits 41
Quest Diagnostics Launches ColoVantage' Test 41
QIAGEN Introduces CE-labeled KRAS Kit 42
Roche Introduces Cobas 4800 42
bioMérieux Launches Upgraded Version of NucliSENS EasyQ®
Influenza A/B Test 43
bioMérieux Introduces NucliSENS EasyQ® MRSA 43
Roche Launches AMPLILINK 3.3 Series Software and cobas p 630
Instrument 43
Applied Biosystems Unveils 3500 Series and 3500 DX Series
Genetic Analyzer 44
Prometheus Laboratories Introduces New Range of Cancer
Diagnostic Products 44
Sequenom Introduces SensiGene Cystic Fibrosis Carrier
Screening Test 45
Triplex and MedMira to Unveil New Rapid Tests 45
Applied Biosystems to Introduce New Range of TaqMan® PCR Assays 45
Quest Diagnostics Unveils HIV-1 Coreceptor Tropism Test 46
Luminex introduced New Range of Cystic Fibrosis Tests 46
bioMérieux Introduces VIDAS® EBV Test 46
Luminex Unveils Two Novel Cystic Fibrosis Tests 47
MEDomics Launches MitoDx' for Diagnosing Mitochondrial Diseases 47
Exagen Diagnostics Unveils eXaIBStest and eXaIBD Blood Tests 48
bioMérieux Introduces NucliSENS EasyQ® HIV-1 v2.0 Test 48
PreAnalytiX Introduces PAXgene® Blood miRNA Kit 48
ViraCor Laboratories Introduces New JCV Test 48
ViraCor Laboratories Rolls Out JC Virus Detection Test 49
Focus Diagnostics Laboratory Introduces PCR Test 49
Siemens Launches CLINITEK AUWi Urine Analyzing System 49
Ocimum Biosolutions to Introduce New H1N1 Virus Detection Test 50
Myriad Genetics Introduces OnDose for Cancer Diagnosis 50
Applied Biosystems Introduces TaqMan® Array Gene Signature Plates 50
GeneNews to Develop Blood-Based Diagnostic Tests 51
Seegene Rolls Out Seeplex® Diarrhea ACE Detection Test 51



Seegene Unveils Seeplex® Meningitis ACE Detection test 51
Cepheid Introduces Xpert MRSA/SA Nasal Diagnostic Test 52
Roche to Launch LightCycler Test 52
Xenomics Unveils New Technology for Analyzing In Vivo Cell Death 52
bioMerieux Unveils NucliSENS EasyQ® HPV Molecular Analytical Test 53
Xenomics to Introduce Innovative Gender Prediction Test 53
Evogen Unveils New EvoCyclerTM HD12 Molecular Diagnostics System 53
Siemens Healthcare Launches Innovance Antithrombin Test 54
Rosetta Genomics Launches miRview' meso Diagnostic Test 54
ViraCor Laboratories Introduces Cytomegalovirus Antiviral
Resistance Test 55
Abbott Launches Diagnostic Test for HPV Detection 55
Pathwork Diagnostics Introduces Tissue of Origin Test 55
Evogen to Offer Diagnostic Tests 56
Axial Unveils a Test for Detecting AIS 56
Myriad Introduces Prezeon 56
Exiqon Launches Test for Colon Cancer 57
Siemens Launches Diagnostic Tests for Testing Viral Load 57
QIAGEN Launches a Molecular Test for Testing the K-ras Gene 57
Spartan Launches DX-12 DNA Analyzer 58
ViraCor Introduces an Assay for Fungal Infections 58
Illumina Introduces mRNA-Seq 58
QIAGEN Rolls Out a New Diagnostic Test for AIDS 58
QIAGEN Introduces miScript miRNA Inhibitors® and miScript
miRNA Mimics® Test Technologies 59
QIAGEN Introduces New Kits for Gene Expression and Function
Analysis 59
QIAGEN Introduces New Products in EpiTect Product Line 60
QIAGEN Launches QIAsymphony® Novel Modular Platform 60
Q Chip Introduces ReaX' PCR Beads 61
ViraCor Rolls Out a New Test for Detecting Enterovirus 61
TMD Rolls Out New Tests for Colorectal Cancer 61
Gen-Probe Unveils APTIMAR® HPV Tests in Europe 61
Genzyme Genetics Introduces KRAS Mutation Analysis 62
China Medical Develops a Test for Prostate Cancer 62
Palex Medical to Introduce SoftPAP' 62

9. PRODUCT INTRODUCTIONS IN THE RECENT PAST - A PERSPECTIVE BUILDER 63
TMD Launches Test for K-ras Mutations in Colorectal Cancer
Patients 63
CombiMatrix Releases Updated Version of Constitutional Genetic
Array Test 63
Myriad Introduces TheraGuide 5-FU 63
CMDX Unveils First HemeScan' Prognostic 63
CombiMatrix Introduces HemeScan' MDS 63
Genzyme Rolls Out Two New Molecular Tests 64
Dade Behring Launches The Quadriga BeFree 64
BD Diagnostics Introduces The BD Viper System 64
Genzyme Introduces P53 Mutation Analysis 64
CombiMatrix Molecular Diagnostics Rolls Out A New Melanoma Test 64



Qiagen Launches Fast Cycling PCR Product Line 65
Genzyme Releases Molecular Assay for Colorectal Cancer Patients 65
Roche Diagnostics Launches LightCycler 480 System 65
Roche Diagnostics Introduces AmpliChip CYP450 Test 65
SEQUENOM Unveils iPLEX' 65
SEQUENOM Develops a Novel Process 65
Cerner Corp Develops Cerner Millennium(R) PathNet Helix (TM) 66
Roche Diagnostics Launches Amplicor HPV Test 66
Gen-Probe Launches Procleix Ultrio Assay in Europe 66
Gen-Probe Launches TIGRIS®DTS' System 66
BD Biosciences Introduces BD QZyme' Assay 66
Epoch Biosciences Releases MGB Eclipse' 66
QIAGEN Unveils BioRobot MDx DSP Device 66
Digene Unveils DNAwithPap 67
Exact Sciences Launches Non-Invasive Test for Colorectal Cancer 67
TDT Introduces GCC-B1 Blood Test to Detect Colorectal Cancer 67
AcroMetrix Joins Hands with Nabi to Introduce ViroSure 67
Orchid Cellmark Introduces DNA Express Service 67
Roche Develops New IVD Real-Time PCR Instrument 68
Nanogen Rolls Out First Ever ASR 68
Digene Introduces Hybrid Capture 68
Digene's Hybrid Capture 2 HPV DNA Test to Effectively Identify
Cervical Cancer 68
PGD to Eliminate Human Eggs Affected with Alzheimer's Disease 68
Esoterix Introduces New HCV Testing Program 68
Gen-Probe Releases New APTIMA Combo 2 Assay 69
Nycomed's NeoSpect to Identify Suspected Lung Cancer 69
DNAPrint Introduces New Services to Assist Forensic Market 69
IMBG Develops an Efficient Procedure to Treat Diseases 69

10. RECENT INDUSTRY ACTIVITY 70
Life Technologies Obtains IVD Marking for 7500 Fast Dx PCR
Instrument 70
Xenomics Changes Name to TrovaGene 70
Abbott and GSK Team Up in the Area of Molecular Diagnosis 70
Asuragen Enters Into Collaborations for Pancreatic Cancer Tests 71
Transgenomic Licenses Intellectual Property from Integragen 71
Health Discovery Inks Agreement with Pancreas, Biliary and
Liver Surgery Center of New York 71
Qiagen Enters into Agreement with Celera 72
The Tecan Group Inks Agreement with Enigma 72
AdnaGen AG and TATAA Molecular Diagnostics Inks Agreement 72
Northeast Pharmaceuticals to Establish Biopharma JV with Shenyang 72
Wescor Divests Microarray Technology Related Assets to Gamida
For Life Group 73
Predictive Biosciences Takes Over OncoDiagnostic Laboratory 73
Applied Biosystems Obtains Approval for AmpFlSTR® MiniFiler'
PCR Amplification Kit 74
Life Technologies Acquires AcroMetrix 74
Ipsogen SA and The Institut Curie Enters into Scientific



Collaboration Agreement 74
bioTheranostics and Ferrer inCode Enters into Commercial
Agreement 74
Quidel Corp Signs Definitive Agreement to Purchase Diagnostic
Hybrids 75
Abbott Obtains CE Marking for New Diagnostic Test 75
Transgenomic Enters into Licensing Agreement with Gene Solutions 75
QIAGEN Acquires SABiosciences 76
Corgenix Medical and BG Medicine Inks Supply Agreement 76
Roche receives FDA Approval for Additional Usage of cobas®
TaqScreen MPX Test 76
Gen-Probe Obtains FDA Approval for Marketing of ProParaflu+TM
Assay 77
bioMerieux Enters into Agreement with GSK 77
Tecan Group and Hologic Sign Agreement 77
QIAGEN Takes Over DxS 78
Tyrian Ends Partnership with Becton, Dickinson and Co 78
Becton, Dickinson and Co to Purchase HandyLab 78
Quidel and BioHelix Enter into Agreement 79
Gen-Probe to Take Over Prodesse 79
Summit Partners Acquires Stake in ApoCell 80
Merck to form Alliance with QIAGEN 80
Gen-Probe to Spin Off Industrial Testing Assets 80
ImClone Systems and Bristol-Myers Squibb Enter into
Collaboration with DxS 80
Danaher to Acquire A Joint Venture Company 81
Abbott Enters into Alliance with Pfizer for Molecular
Diagnostic Test 81
Rosetta and Warnex Ink Distribution Agreement 81
ViraCor Laboratories Merges with IBT Laboratories 82
ELITech Takes Over Assets of Nanogen 82
LabCorp Signs Definitive Agreement with Monogram Biosciences 82
Axial Biotech and University of Utah Enter into Collaboration 82
Celera and Bayer Schering Pharma Sign Licensing Agreement 83
AVESTHAGEN Enters into Collaboration with VTT Technical
Research Centre 83
3M Terminates Collaboration Agreement with Gen-Probe 83
BioGenex and Abbott Expand Joint Development and Distribution
Agreement 84
Pfizer Extends Collaboration Agreement with Monogram Biosciences 84
BD Diagnostics Inks Agreement with HandyLab 84
TriLink BioTechnologies and Osmetech Molecular Diagnostics Ink
Agreement 85
PerkinElmer Buys Analytica of Branford 85
Ipsogen Signs Agreement with Arup Laboratories 86
Prometheus Laboratories and Rosetta Genomics Ink Agreement 86
AMDL and Precision Diagnostic Laboratory Signs Agreement 86
Osmetech Signs Agreement with Fisher HealthCare 87
Interleukin Genetics Inks Licensing Agreement with LABEC Pharma 87
deCODE Genetics Inks Licensing Agreements with Celera 87



Nuvera Biosciences Signs Licensing Agreement with Veridex 87
GE Healthcare Inks Research Agreement with Brigham and Women's
Hospital 88
Gen-Probe Purchases Tepnel Life Sciences 88
AdnaGen AG Receives US Patent 88
Agilent Technologies Selects Asuragen as Certified Service
Provider 88
Genstruct Enters into Partnership with Gene Logic 89
Lab21 Takes Over Biotec Laboratories 89
ProGenTech and Innovative Biosensors Jointly Sign Extension
Agreement 89
Nanogen Signs and Scandinavian Gene Synthesis Inks Agreement 90
Health Discovery Corporation Inks Licensing Agreement with Abbott 90
BD Diagnostics Receives CE Marking for Amplified DNA Assays 90
Transgenomic Signs Licensing Agreement Power3 Medical Products 91
Rubicon Genomics and Abbott Enter into Licensing Agreement 91
Novartis Extends Collaboration with Gen-Probe 91
Eurogentec Receives ISO-Certification for IVD Oligonucleotides 92
Dako and OSI Pharmaceuticals Enter into Collaboration 92
Combimatrix Molecular Diagnostics and Lenetix Enter into
Partnership 92
Sequenom to Acquire AttoSense' Tests of SensiGen 93
Epigenomics AG and Sysmex Ink Research and Development
Collaboration Deal 93
Gene Express and Biogenuix Medsystems Signs Distribution
Agreement 93
Gene Express and Funakoshi Enter into Distribution Agreement 94
BD and Company Obtains FDA Approval for Marketing GeneOhm'
Cdiff Test 94
XDx and Bristol-Myers Squibb Company Signs Collaborative
Agreement 94
Rosetta Genomics and Teva Pharmaceutical Industries Signs
Distribution Agreement 95
ProGenTech Inks Deal with Center for Disease Control and
Prevention in China 95
National Jewish Health Signs Agreement with Laboratory
Corporation of America Holdings 96
DxS and Amgen Ink Agreement 96
Enigma Diagnostics Inks Term Sheet with Roche Molecular Systems 96
Quintiles Transnational Purchases Targeted Molecular Diagnostics 97
Invitrogen Merges with Applied Biosystems 97
Gen-Probe Receives CE-Mark for APTIMA® HPV Test 97
BD Receives Health Canada Licensing for BD GeneOhm' Cdiff
Molecular Assay 98
Abbott Molecular and Epigenomics Amend Licensing Agreement 98
Nanogen Inks Agreement with A. Menarini Diagnostics 98
EraGen Biosciences Signs Distribution Agreement with Inter Medico 99
Spartan Bioscience Enters into Agreement with NorDiag 99
Celera and Nanogen Extend License Agreement 99
NorDiag and Molzym Enter Into Collaboration and Distribution



Agreements 100
ZyGEM Inks Agreement with Advalytix Products 100
Response Genetics and NeoGenomics Laboratories Enter into
Agreement 100
SIRS-Lab Obtains Certification for Quality Management of In-
Vitro Diagnostics 100
China Medical and Molecular Diagnostics Technologies Ink
Agreement 101
QIAGEN Takes Over Entire Assets of Biosystems Division of Biotage 102
Cepheid Secures FDA Approval for Xpert' Test 102
Osmetech Signs Agreement with Qiagen 102
Luminex Enters into Agreement with BD Diagnostics 102
bioMérieux Acquires AviaraDx 103
Pall Takes Over GeneSystems 103
Corgenix Medical and BG Medicine Ink Agreement 104
Diatherix Laboratories Receives CLIA Certificate 104
Novartis Diagnostics Secures FDA Authorization for PROCLEIX®
ULTRIO® Assay 104
Bio-Reference Laboratories to Start K-ras Mutation Testing 105
Hologic Purchases Third Wave Technologies 105
Asuragen and Affymetrix Ink an Agreement 105
Health Discovery and DCL Medical Laboratories Sign an Agreement 106
Osmetech Receives the US Food and Drug Administration Clearance 106
BD Diagnostics Secures CE Marking for BD GeneOhmTM Cdiff
molecular Test 107
Siemens Healthcare Diagnostics Secures CE-Marking Approval 107
QIAGEN Takes Over Corbett Life Science 107
QIAGEN Obtains CE Mark Approval for Borrelia and HIV PCR Kits 108
Gen-Probe Receives License from Xceed Molecular 108
Nanogen Bags Contract from US Centers for Disease Control and
Prevention 109
Gen-Probe to Take Over Innogenetics 109
Third Wave Technologies to Buy Intellectual Property 109
Prodesse and Quidel Sign an Agreement 109
Siemens Healthcare Diagnostics Licenses Certain Testing Rights 110
bioMérieux Signs MoU with Foundation for Innovative New
Diagnostics 110
QIAGEN Collaborates with GENEART 110
Agilent Technologies and Agendia to Enter into Partnership 111
Siemens Inks Non-Exclusive Deal with Laboratory Corporation of
America® Holdings 111
BD Diagnostics Receives CE-Marking for BD GeneOhm' VanR Test 111
Health Discovery Completes Trials on Molecular Diagnostic Test
on Prostate Cancer 111
Gen-Probe and Agreement DiagnoCure Amends 2003 License Agreement 112
OccuLogix Purchases Remaining Stake in OcuSense 112
Thermo Fisher Scientific Signs Agreement with Nanogen 113
DCL Medical Laboratories and Third Wave Technologies Enter
into Partnership 113
Gen-Probe Commences Clinical Trial of APTIMA® Assay 113



Immucor to Buy BioArray Solutions 114
Epigenomics Partners with Abbott Molecular 114
Hitachi High-Technologies and bioMerieux Enter into Partnership 115
Luminex Molecular Diagnostics Signs Agreement with Abbott 115
Abbott Signs Agreement with OSI Pharmaceuticals, Roche and
Genentech 115
Exiqon Takes Over Oncotech 115
Siemens Secures FDA Authorization for VERSANT' 440 Molecular
System 116
Vermillion, Johns Hopkins Ink Agreements to Develop Molecular
Diagnostic Tests 116
Beckman Coulter Inks Licensing Agreements with National
University of Ireland 116

11. CORPORATE ACTIVITY IN THE RECENT PAST - A PERSPECTIVE BUILDER 117
Roche Takes over BioVeris 117
Siemens Acquires Dade Behring 117
DiagnoCure Acquires Catalyst Oncology 117
Burrill & Co Takes over Expression Diagnostics 117
Solis Acquires Bertrand 117
ParagonDx LLC Acquires Gentris Diagnostics 118
Beckman Collaborates to Discover CVD Symptoms 118
Exiqon to Take over Oncotech 118
Roche to Acquire Ventana 118
Qiagen Merges with Digene 118
Qiagen & Bio One Capital Collaborates 119
AGT & MAL Signs MoU 119
Qiagen Obtains Licenses to Real-Time PCR 119
Cepheid Acquires Sangtec 119
Source MDx Collaborates with Pfizer 119
Nanosphere Receives FDA Clearance for Second Molecular
Diagnostic Test 120
QIAGEN Acquires eGene 120
Quest Diagnostics Acquires AmeriPath 120
Mayo and ILMN Team up to Develop Molecular Diagnostics for
Complex Diseases 120
CHEO and ILMN Team up to Develop Molecular Diagnostics for
Newborn Screening 120
Siemens Medical Solutions USA Sets Up Siemens Medical
Solutions Diagnostics 121
Novartis Acquires Chiron 121
Quest Diagnostics Acquires Focus Diagnostics 121
Becton Dickinson Acquires GeneOhm 121
Iris International Acquires Leucadia Technologies 121
Predicant Biosciences Acquires Pathwork Informatics 121
AmeriPath Acquires Rose Pathology Associates 122
Nanogen Acquires Amplimedical's Diagnostics Division 122
Nanogen Acquires Immunoassay Test Business of Spectral
Diagnostics 122
Fisher Scientific Acquires Athena 122



Qiagen Acquires Genaco 122
Bio-Rad Acquires Blackhawk BioSystems 122
IRIS International Acquires Leucadia Technologies 122
Qiagen Acquires Shenzhen PG Biotech 123
Qiagen Acquires Artus GmbH 123
Nanogen and Fisher Increases Agreement Tenure 123
Qiagen Signs An Agreement with Gentra 123
Qiagen Inks an Agreement with VLA 123
Stratagene Signs an Agreement with AROS 124
Bayer Inks an Agreement with Hamilton Company 124
Prodesse and Invitrogen Sign a Pact 124
Illumina Forms Collaboration with ReaMetrix 124
PerkinElmer Signs an Agreement with Jacobi Medical 124
UniPath and Roche Diagnostics Sign an Accord 124
Qiagen Alliances with Eppendorf 125
Olympus and Cangen Extends their Research Collaboration 125
Toppan, Shimadzu and Third Wave Collaborate to Develop A POC
Molecular Diagnostic Instrument 125
Focus Diagnostics Signs an Agreement with Stratagene 125
Innogenetics Inks an Agreement with Roche Diagnostics 126
The University of Goettingen, Bruker Daltonik and PANATecs
Collaborate to Develop New Molecular Diagnostic Assays for
Rheumatoid Arthritis 126
Focus Diagnostics Enters into an Agreement with Luminex 126
QIAGEN Expands Strategic Alliance with Protedyne 126
Specialty Laboratories Teams Up with SEQUENOM and Siemens 126
Gen-Probe Enters into a Licensing Agreement with Corixa 127
Gen-Probe Inks a Supply and Purchase Agreement with F.
Hoffmann-La Roche 127
Gen-Probe Enters into a Licensing Agreement with AdnaGen 127
Roche Establishes New Polymerase Chain Reaction (PCR)
Manufacturing Center 127
Ambion Establishes a Subsidiary in Japan 127
Gen-Probe Gains FDA Approval for APTIMA® 127
Blood Center of Southeastern Wisconsin Adopts Ambion's
Signature' CF 2.0 ASR 128
Orchid Biosciences, Inc. Becomes Orchid Cellmark Inc 128
Roche Acquires IGEN International 128
GE Takes Over Amersham Plc 128
Nanogen Acquires SYN'X PHARMA 128
Nanogen Merges with Epoch Biosciences 128
Sequenom Enters into Collaboration with Siemens 129
TMD Joins Hands with University of Texas 129
GE Global and Two other Companies Enters into a Joint Research
Collaboration 129
Third Wave and BML Extend Partnership to Promote Molecular
Diagnostic Tests 129
ViroLogic Signs an Agreement with ACLARA 129
Abbott and BioGenex Sign an Agreement 129
Novation Signs a Pact with Bayer Diagnostics 130



Osmetech Enters into a Licensing Agreement with LGC Limited 130
Licensing Agreement between DxS Ltd and Sangtec Molecular
Diagnostics 130
EraGen Biosciences Strikes a Deal with Inter Medico 130
Nanogen Bags Patent for Molecular Diagnostics and Optical
Waveguides Systems 130
Gen-Probe Secures Regulatory Approval for PROCLEIX ® ULTRIO'
Assay 130
Gen-Probe Bags FDA Approval to Use TIGRIS DTS System for STD
Testing 131
Gen-Probe Acquires Majority Stake in MLT 131
AmeriPath in Strategic Alliance with Roche 131
Abbott and Promega to Offer Nucleic Acid Extraction Products 131
Ambion RNA to Offer Services Through BBI 131
STMicroelectronics Inks an Agreement with Mobidiag 132
BBI Contracts with IDS 132
Focus to Assist FDA in Evaluation of Antimicrobial Resistance 132
Bayer Acquires Rights to Detect HCV and HIV Antibodies 132
Cenetron in Strategic Alliance with Roche 132
Saint Luke's Health System in Alliance with Roche 133
US LABS Adds Gene Expression Profiling Capabilities on (FFPE)
Tissue 133
Bayer Acquires Visible Genetics 133
Qiagen Enters into an Agreement with RMS 133
Dabur Starts a New Molecular Diagnostic Lab 133
Roche Gains Rights for Cervical-Cancer Testing Market 134
Ventana Acquires License From MDI 134
Genzyme Genetics Gains Rights for Genzyme Molecular's Cancer
Diagnostics 134
Abbott in Strategic Alliance with Celera 134
MDI and DiagnoCure Join Hands to Integrate ImmunoCyt/uCyt with
InPath 134
MDI and PMI to Jointly Promote Lung Cancer Detection System 135
MDI in Agreement with Esoterix 135
MDI to Expand Product Base in China 135
Abbott and Tecan to Offer Devices for Molecular Diagnostic Assays 135
Invirion Extends Licensing Agreement with MDI 135
Ambion RNA Grants License to Celera 136
Morewood and IT&M to Introduce New Micro Array System 136
Ambion RNA Constructs New Manufacturing Facility 136
LabCorp Teams up with Celera 136
Athena Launches New DNA Testing for TSC 136
Genezyme Genetics Expands Cancer Testing Services 137
Promega Teams Up with Abbott 137
ChromaVision and Ventana Join Hands to Market Testing Process
that Identifies HPV 137
OraSure in Agreement with Abbott 137
Nanogen and Bionomics to Jointly Develop IVD for Epilepsy 137
DiagnoCure and Compugen Join Hands to Develop Tests to
Identify Epithelial Cancers 137



OraSure Gets FDA Approval for OraQuick Rapid HIV-1 Test 138
Ampersand and Accumed Merged to Form MDI 138
Abbott Acquires Vysis 138
Millennium and Abbott Forge 5-Year Drug Deal 138
Bode Enters into Agreement to Undertake DNA Testing 139
BD Contracts with TriPath to Develop Molecular Diagnostics 139
TriPath Installs New Interactive System 139
Archemix in Strategic Alliance with RPI 139
AmeriPath Strengthens Relationship with Genomics Collaborative 139

12. FOCUS ON SELECT GLOBAL PLAYERS 140
Abbott Laboratories (US) 140
Abbott Molecular 140
Applera Corp. (US) 140
Celera (US) 140
Biomérieux (France) 141
CytoCore Inc. (US) 141
ELITech Group (France) 142
GE Healthcare (US) 142
Gen-Probe, Inc. (US) 143
Genzyme Corp. (US) 143
Genzyme Genetics (US) 143
MiraiBio, Inc. (US) 144
Novartis Vaccines & Diagnostics, Inc. (US) 144
QIAGEN N.V (The Netherlands) 144
Quest Diagnostics, Inc. (USA) 145
Roche Diagnostics (Switzerland) 145
Siemens Healthcare Diagnostics (US) 146
Tecan Group Ltd. (Switzerland) 146

13. GLOBAL MARKET PERSPECTIVE 147
Table 6: 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 Independently Analyzed with Annual Sales Figures in US$
Million for Years 2007 through 2015 (includes corresponding
Graph/Chart) 147

Table 7: World Historic Review for Molecular Diagnostics by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan) and Rest of World Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2006 (includes corresponding Graph/Chart) 148

Table 8: World 11-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 2005, 2010 & 2015



for Molecular Diagnostics (Infectious Disease Testing) by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2007
through 2015 (includes corresponding Graph/Chart) 150

Table 10: World Historic Review for Molecular Diagnostics
(Infectious Disease Testing) by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan), and
Rest of World Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2000 through 2006 (includes

(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 2005, 2010 & 2015 (includes corresponding Graph/Chart) 152

for Molecular Diagnostics (Pharmacogenomics) by Geographic
Region - US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Rest of World Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2007 through 2015

(Pharmacogenomics) by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), and Rest of World
Independently Analyzed with Annual Sales Figures in US$
Graph/Chart) 154

(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 2005,
2010 & 2015 (includes corresponding Graph/Chart) 155

for Molecular Diagnostics (Cancer Screening) by Geographic
Region - US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), and Rest of World Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2007 through 2015

(Cancer Screening) by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan) and Rest of World



Graph/Chart) 157

(Cancer Screening) by Geographic Region - Percentage Breakdown
of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), and Rest of World Markets for Years 2005,
2010 & 2015 (includes corresponding Graph/Chart) 158

14. UNITED STATES 159
A.Market Analysis 159
A Precursor to the Molecular Diagnostics Market in the US 159
Molecular Diagnostics Heavily Tied to Proteomics and Genomics 159
Burgeoning Potential for Genetic Testing 159
Regulatory Environment 160
Regulations Out for Molecular Diagnostic Testing of HPV 160
Limited Reimbursements - A Major Hindrance 161
B.Market Analytics 161
Table 18: The US Recent Past, Current & Future Analysis for
Molecular Diagnostics by Application - Infectious Disease
Testing, Pharmacogenomics, and Cancer Screening Markets
Graph/Chart) 161

Table 19: The 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
2000 through 2006 (includes corresponding Graph/Chart) 162

Table 20: The US 11-Year Perspective for Molecular
Diagnostics by Application - Percentage Breakdown of Dollar
Sales for Infectious Disease Testing, Pharmacogenomics,
andCancer Screening Markets for 2005, 2010 & 2015(includes

15. CANADA 163
Market Analysis 163
Table 21: 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 2007 through 2015 (includes

Table 22: Canadian Historic Review for Molecular Diagnostics




Table 23: Canadian 11-Year Perspective for Molecular
Sales for Infectious Disease Testing, Pharmacogenomics, and
Cancer Screening Markets for 2005, 2010 & 2015 (includes

16. JAPAN 165
Market Analysis 165
Table 24: Japanese Recent Past, Current & Future Analysis

Table 25: Japanese Historic Review for Molecular Diagnostics

Table 26: Japanese 11-Year Perspective for Molecular

17. EUROPE 167
A.Market Analysis 167
Insight into Molecular Diagnostics Markets in Europe 167
Table 27: European Molecular Diagnostics Market by Leading
Players (2008) - Market Shares of Leading Players by Value
Sales for Roche Diagnostics, Abbott Diagnostics, Bayer
Diagnostics, Becton Dickinson, Digene Diagnostics,
BioMerieux, and Others (includes corresponding Graph/Chart) 168
B.Market Analytics 169
Table 28: European Recent Past, Current & Future Analysis
for Molecular Diagnostics by Geographic Region - France,
Germany, Italy, UK, and Rest of Europe Markets Independently

Table 29: 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 2000 through 2006 (includes



Table 30: European 11-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 2005, 2010 & 2015 (includes

Table 31: European Recent Past, Current & Future Analysis

Table 32: European Historic Review for Molecular Diagnostics
by Application -Infectious Disease Testing,

Table 33: European 11-Year Perspective for Molecular
Sales for Infectious Disease Testing, Pharmacogenomics and
Cancer Screening Markets for Years 2005, 2010 & 2015

17a. FRANCE 175
Market Analysis 175
Table 34: French Recent Past, Current & Future Analysis for
Graph/Chart) 175

Table 35: French Historic Review for Molecular Diagnostics

Table 36: French 11-Year Perspective for Molecular

17b. GERMANY 177
Market Analysis 177
Table 37: German Recent Past, Current & Future Analysis for



Graph/Chart) 177

Table 38: German Historic Review for Molecular Diagnostics

Table 39: German 11-Year Perspective for Molecular

17c. ITALY 179
Market Analysis 179
Table 40: Italian Recent Past, Current & Future Analysis for
Graph/Chart) 179

Table 41: Italian Historic Review for Molecular Diagnostics

Table 42: Italian 11-Year Perspective for Molecular

17d. UNITED KINGDOM 181
Market Analysis 181
Table 43: The UK Recent Past, Current & Future Analysis for
Graph/Chart) 181

Table 44: The UK Historic Review for Molecular Diagnostics




Table 45: The UK 11-Year Perspective for Molecular
Cancer Screening Markets for 2005, 2010



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