Reportlinker Adds Global Molecular Diagnostics Industry

NEW YORK, Nov. 17, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Molecular Diagnostics Industry

http://www.reportlinker.com/p090566/Global-Molecular-Diagnostics-Industry.html

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, Biomerieux, 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.

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

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

corresponding Graph/Chart) 12

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

bioMerieux Launches Upgraded Version of NucliSENS EasyQ®

Influenza A/B Test 43

bioMerieux 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

bioMerieux 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

bioMerieux 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

bioMerieux 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

bioMerieux 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

Biomerieux (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

(includes corresponding Graph/Chart) 149

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) 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

corresponding Graph/Chart) 151

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) 152

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) 153

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) 154

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) 155

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) 156

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) 157

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

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

Independently Analyzed with Annual Sales Figures in US$

Million for Years 2007 through 2015 (includes corresponding

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

corresponding Graph/Chart) 162

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

corresponding Graph/Chart) 163

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

16. JAPAN 165

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

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

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

Analyzed with Annual Sales Figures in US$ Million for Years

2007 through 2015 (includes corresponding Graph/Chart) 169

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) 170

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) 171

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) 172

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) 173

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

17a. FRANCE 175

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

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

17b. GERMANY 177

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

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

17c. ITALY 179

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

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

17d. UNITED KINGDOM 181

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

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

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