MOLECULAR DIAGNOSTICS - A GLOBAL STRATEGIC BUSINESS REPORT   

Research Abstract

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.

Code : MCP-1226
Price : $4500
Companies : 101
Pages : 659
Date : October 2010
Market Data Tables : 54

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 TABLE OF CONTENTS


 
   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
  
   Global Market Outlook........5
Molecular Diagnostics – The Fastest Growing Medical Diagnostic Technology........5
Current and Future Analysis........5
1$100
   Growth Opportunities Abound Molecular Diagnostics Arena........6
Market for Molecular Diagnostics - An Introduction........6
1$100
   Opportunities Galore for Market Participants........7
New Applications Hold Promising Potential........7
Automated Systems – Prime Target........7
1$100
   Infectious Disease Testing Drives the Diagnostics Market........8
The Future in Store........8
1$100
   Clinical Diagnostics Industry – Trends and Tendencies........9 1$100
   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
1$350
   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
1$350
   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 corresponding Graph/Chart)........12
Nucleic Acid Diagnostics Market – An Overview........12
1$350
   Molecular Diagnostics – Growth Drivers........131$100
   Molecular Diagnostics – A Replacement and Enabling Technology........14
Molecular Diagnostics for Lymphoid Malignancies........14
1$100
   Key Players and Their Technologies........15
The Top Tier........15
Mid-Sized and Small Companies........15
2$200
   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
1$100
   Disease-Specific Molecular Diagnostics to Deliver Improved Clinical Outcomes........18
Molecular Diagnostics and Intellectual Property........18
Business Opportunities in the Offing........18
1$100
   Challenges Facing the Molecular Diagnostic Market........19
Medical Training and Practice Challenges........19
1$100
   Shortcomings to Overcome........20
Limited Reimbursements by Third Party Payers – A Stumbling Block........20
Hurdles All the Way for Companies Eyeing Molecular Diagnostics........20
1$100
   Product Marketing – Key to Commercial Success........21
Integration of Molecular Diagnostics into Therapeutics........21
1$100
   Molecular Diagnostics – Moving from Centralization to Decentralization........22
Migrating to Decentralized Format........22
1$100
   Going Ahead with Decentralization........23
1$100
   Molecular Diagnostics – Definition & Scope........24
Molecular Diagnostics – Impact on Healthcare........24
1$100
   Utility of Molecular Diagnostic Tests........25
Background of Molecular Diagnostics........25
Major Molecular Diagnostics Products........25
1$100
   Major Test Launches in Molecular Diagnostics in the Recent Past........26
Unabated Developments in Molecular Diagnostics Technology........26
1$100
   Signal Amplification Technologies........27
PCR – New Developments........27
Major Applications of Real-Time PCR........27
Quantitative Real-Time PCR for Molecular Diagnostics........27
1$100
   Signal Detection and Quantification........28
Quantitative Real-Time RT-PCR Analysis........28
Applications of Quantitative Real-Time PCR Analysis........28
Non-PCR Methods........28
1$100
   Other Signal Amplification Technologies........29
DNA Probe Based Products........29
Direct Detection of Specific Nucleic Acid Sequences........29
Nucleic Acid Amplification and Detection........29
1$100
   DNA Sequencing and Gene Detection........30
Arrays of Immobilized Probes (DNA Chips) in Gene Detection........30
1$100
   RNA Diagnostics........31
Complementary Molecular Diagnostic Technologies........31
Fluorescent in situ hybridization (FISH)........31
1$100
   DNA Biochips / Microarrays........321$100
   Biosensors........33
Proteomic Technologies for Molecular Diagnostics........33
Nanotechnology for Molecular Diagnostics........33
1$100
   Technologies on the Anvil........34
Haplotype Analysis – A Distant Possibility........34
Chronic Multi-Gene Defects Now Diagnosable........34
1$100
   Infectious Diseases Testing........35
Activity in the Field........35
1$100
   Identifying Multidrug Resistance........36
Infectious Disease Treatment Monitoring........36
Other Infectious Diseases Applications........36
Genetic Disease Testing Applications........36
1$100
   Pharmacogenomics – Prognosis Based on Genomics........371$100
   Cancer Screening & Diagnosis........381$100
   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
1$350
   Other Testing Applications........40
1$100
   Life Technologies Unveils ViralSEQTM Vesivirus Detection Kit........41
Applied Biosystems New Forensic DNA Kits........41
Quest Diagnostics Launches ColoVantage™ Test........41
1$100
   QIAGEN Introduces CE-labeled KRAS Kit........42
Roche Introduces Cobas 4800........42
1$100
   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
1$100
   Applied Biosystems Unveils 3500 Series and 3500 DX Series Genetic Analyzer........44
Prometheus Laboratories Introduces New Range of Cancer Diagnostic Products........44
1$100
   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
1$100
   Quest Diagnostics Unveils HIV-1 Coreceptor Tropism Test........46
Luminex introduced New Range of Cystic Fibrosis Tests........46
bioMérieux Introduces VIDAS® EBV Test........46
1$100
   Luminex Unveils Two Novel Cystic Fibrosis Tests........47
MEDomics Launches MitoDx™ for Diagnosing Mitochondrial Diseases........47
1$100
   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
1$100
   ViraCor Laboratories Rolls Out JC Virus Detection Test........49
Focus Diagnostics Laboratory Introduces PCR Test........49
Siemens Launches CLINITEK AUWi Urine Analyzing System........49
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   Siemens Healthcare Launches Innovance Antithrombin Test........54
Rosetta Genomics Launches miRview™ meso Diagnostic Test........54
1$100
   ViraCor Laboratories Introduces Cytomegalovirus Antiviral Resistance Test........55
Abbott Launches Diagnostic Test for HPV Detection........55
Pathwork Diagnostics Introduces Tissue of Origin Test........55
1$100
   Evogen to Offer Diagnostic Tests........56
Axial Unveils a Test for Detecting AIS........56
Myriad Introduces Prezeon........56
1$100
   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
1$100
   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
1$100
   QIAGEN Introduces miScript miRNA Inhibitors® and miScript miRNA Mimics® Test
  Technologies........59
QIAGEN Introduces New Kits for Gene Expression and Function Analysis........59
1$100
   QIAGEN Introduces New Products in EpiTect Product Line........60
QIAGEN Launches QIAsymphony® Novel Modular Platform........60
1$100
   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
1$100
   Genzyme Genetics Introduces KRAS Mutation Analysis........62
China Medical Develops a Test for Prostate Cancer........62
Palex Medical to Introduce SoftPAP™........62
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   Wescor Divests Microarray Technology Related Assets to Gamida For Life Group........73
Predictive Biosciences Takes Over OncoDiagnostic Laboratory........73
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   QIAGEN Takes Over DxS........78
Tyrian Ends Partnership with Becton, Dickinson and Co........78
Becton, Dickinson and Co to Purchase HandyLab........78
1$100
   Quidel and BioHelix Enter into Agreement........79
Gen-Probe to Take Over Prodesse........79
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   TriLink BioTechnologies and Osmetech Molecular Diagnostics Ink Agreement........85
PerkinElmer Buys Analytica of Branford........85
1$100
   Ipsogen Signs Agreement with Arup Laboratories........86
Prometheus Laboratories and Rosetta Genomics Ink Agreement........86
AMDL and Precision Diagnostic Laboratory Signs Agreement........86
1$100
   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
1$100
   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
1$100
   Genstruct Enters into Partnership with Gene Logic........89
Lab21 Takes Over Biotec Laboratories........89
ProGenTech and Innovative Biosensors Jointly Sign Extension Agreement........89
1$100
   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
1$100
   Transgenomic Signs Licensing Agreement Power3 Medical Products........91
Rubicon Genomics and Abbott Enter into Licensing Agreement........91
Novartis Extends Collaboration with Gen-Probe........91
1$100
   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
1$100
   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
1$100
   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
1$100
   Rosetta Genomics and Teva Pharmaceutical Industries Signs Distribution
  Agreement........95
ProGenTech Inks Deal with Center for Disease Control and Prevention in China........95
1$100
   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
1$100
   Quintiles Transnational Purchases Targeted Molecular Diagnostics........97
Invitrogen Merges with Applied Biosystems........97
Gen-Probe Receives CE-Mark for APTIMA® HPV Test........97
1$100
   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
1$100
   EraGen Biosciences Signs Distribution Agreement with Inter Medico........99
Spartan Bioscience Enters into Agreement with NorDiag........99
Celera and Nanogen Extend License Agreement........99
1$100
   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
1$100
   China Medical and Molecular Diagnostics Technologies Ink Agreement........1011$100
   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
1$100
   bioMérieux Acquires AviaraDx........103
Pall Takes Over GeneSystems........103
1$100
   Corgenix Medical and BG Medicine Ink Agreement........104
Diatherix Laboratories Receives CLIA Certificate........104
Novartis Diagnostics Secures FDA Authorization for PROCLEIX® ULTRIO® Assay........104
1$100
   Bio-Reference Laboratories to Start K-ras Mutation Testing........105
Hologic Purchases Third Wave Technologies........105
Asuragen and Affymetrix Ink an Agreement........105
1$100
   Health Discovery and DCL Medical Laboratories Sign an Agreement........106
Osmetech Receives the US Food and Drug Administration Clearance........106
1$100
   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
1$100
   QIAGEN Obtains CE Mark Approval for Borrelia and HIV PCR Kits........108
Gen-Probe Receives License from Xceed Molecular........108
1$100
   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
1$100
   Siemens Healthcare Diagnostics Licenses Certain Testing Rights........110
bioMérieux Signs MoU with Foundation for Innovative New Diagnostics........110
QIAGEN Collaborates with GENEART........110
1$100
   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
1$100
   Gen-Probe and Agreement DiagnoCure Amends 2003 License Agreement........112
OccuLogix Purchases Remaining Stake in OcuSense........112
1$100
   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
1$100
   Immucor to Buy BioArray Solutions........114
Epigenomics Partners with Abbott Molecular........114
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   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
1$100
   Abbott Laboratories (US)........140
Abbott Molecular........140
Applera Corp. (US)........140
Celera (US)........140
1$100
   Biomérieux (France)........141
CytoCore Inc. (US)........141
1$100
   ELITech Group (France)........142
GE Healthcare (US)........142
1$100
   Gen-Probe, Inc. (US)........143
Genzyme Corp. (US)........143
Genzyme Genetics (US)........143
1$100
   MiraiBio, Inc. (US)........144
Novartis Vaccines & Diagnostics, Inc. (US)........144
QIAGEN N.V (The Netherlands)........144
1$100
   Quest Diagnostics, Inc. (USA)........145
Roche Diagnostics (Switzerland)........145
1$100
   Siemens Healthcare Diagnostics (US)........146
Tecan Group Ltd. (Switzerland)........146
1$100
   Table 6: World Recent Past, Current & Future Market Analysis for Molecular Diagnostics by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........1471$350
   Table 7: World Historic Review for Molecular Diagnostics by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1481$350
   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 (includes corresponding Graph/Chart)........1491$350
   Table 9: World Recent Past, Current & Future Market Analysis for Molecular Diagnostics (Infectious Disease Testing) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........1501$350
   Table 10: World Historic Review for Molecular Diagnostics (Infectious Disease Testing) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1511$350
   Table 11: World 11-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 2005, 2010 & 2015 (includes corresponding Graph/Chart)........1521$350
   Table 12: World Recent Past, Current & Future Market Analysis for Molecular Diagnostics (Pharmacogenomics) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........1531$350
   Table 13: World Historic Review for Molecular Diagnostics (Pharmacogenomics) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1541$350
   Table 14: World 11-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 2005, 2010 & 2015 (includes corresponding Graph/Chart)........1551$350
   Table 15: World Recent Past, Current & Future Market Analysis for Molecular Diagnostics (Cancer Screening) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........1561$350
   Table 16: World Historic Review for Molecular Diagnostics (Cancer Screening) by Geographic Region – US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1571$350
   Table 17: World 11-Year Perspective for Molecular Diagnostics (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
1$350
   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
1$100
   Regulatory Environment........160
Regulations Out for Molecular Diagnostic Testing of HPV........160
1$100
   Limited Reimbursements - A Major Hindrance........161
B. Market Analytics........161
Table 18: The US Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........161
1$350
   Table 19: The US Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ 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 corresponding Graph/Chart)........162
1$350
   Market Analysis........163
Table 21: Canadian Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........163
1$350
   Table 22: Canadian Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........164

Table 23: Canadian 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........164
1$350
   Market Analysis........165
Table 24: Japanese Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........165
1$350
   Table 25: Japanese Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........166

Table 26: Japanese 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........166
1$350
   A. Market Analysis........167
Insight into Molecular Diagnostics Markets in Europe........167
1$100
   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)........1681$350
   B. Market Analytics........169
Table 28: European Recent Past, Current & Future Analysis for Molecular Diagnostics by Geographic Region – France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........169
1$350
   Table 29: European Historic Review for Molecular Diagnostics by Geographic Region – France, Germany, Italy, UK, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1701$350
   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 corresponding Graph/Chart)........1711$350
   Table 31: European Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........1721$350
   Table 32: European Historic Review for Molecular Diagnostics by Application –Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1731$350
   Table 33: European 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics and Cancer Screening Markets for Years 2005, 2010 & 2015 (includes corresponding Graph/Chart)........174
1$350
   Market Analysis........175
Table 34: French Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........175
1$350
   Table 35: French Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........176

Table 36: French 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........176
1$350
   Market Analysis........177
Table 37: German Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........177
1$350
   Table 38: German Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........178

Table 39: German 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........178
1$350
   Market Analysis........179
Table 40: Italian Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........179
1$350
   Table 41: Italian Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........180

Table 42: Italian 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........180
1$350
   Market Analysis........181
Table 43: The UK Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........181
1$350
   Table 44: The UK Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........182

Table 45: The UK 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........182
1$350
   Market Analysis........183
Table 46: Rest of European Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........183
1$350
   Table 47: Rest of European Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1841$350
   Table 48: Rest of European 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........185
1$350
   A. Market Analysis........186
Indian Diagnostic Market........186
B. Market Analytics........186
Table 49: Asia-Pacific Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........186
1$350
   Table 50: Asia-Pacific Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1871$350
   Table 51: Asia-Pacific 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........188
1$350
   Market Analysis........189
Table 52: Rest of World Recent Past, Current & Future Analysis for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)........189
1$350
   Table 53: Rest of World Historic Review for Molecular Diagnostics by Application – Infectious Disease Testing, Pharmacogenomics and Cancer Screening Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2006 (includes corresponding Graph/Chart)........1901$350
   Table 54: Rest of World 11-Year Perspective for Molecular Diagnostics by Application – Percentage Breakdown of Dollar Sales for Infectious Disease Testing, Pharmacogenomics, and Cancer Screening Markets for 2005, 2010 & 2015 (includes corresponding Graph/Chart)........1911$350
  
Total Companies Profiled: 101 (including Divisions/Subsidiaries - 121)

Region/Country Players

The United States 88 Canada 5 Europe 26 France 3 Germany 6 The United Kingdom 5 Rest of Europe 12 Asia-Pacific (Excluding Japan) 2
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