CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Market Trends
- Regulatory Issues and Molecular Tests
- The Promise of Companion Diagnostics
- From Research to Clinic
- Test Services
CHAPTER TWO: TECHNOLOGICAL TRENDS
- Background
- The In Vitro/In Vivo Mix
- Miniaturization and Multiplexed Biological Assays
- The search for Non-Invasive Tools
- Mechanisms of Gene Modification, Regulation and Expression
- Methylated Gene (meDNA) Patterns
- RNA - Ribonucleic Acid
- Transcription Factors
- Circulating Cell-free Nucleic Acids
- Sample Preparation and System Automation
- PCR Patent Update
CHAPTER THREE: MEDICAL TRENDS AND MARKET ISSUES
- Background
- New Testing Opportunities - Genes and Proteins
- Reimbursement of Novel Tests
- Medicare and Medicaid
- HMOs and Managed Care
- GTE Subscription Based Model
- Commercializing Molecular Diagnostics
- Increasing Efficiency
- Successful Patents
- Lab-Developed Test Services
- Regulatory Issues and Molecular Tests
- The Promise of Companion Diagnostics
- From Research to Clinic
- Test Services
CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF MOLECULAR DIAGNOSTICS
- Background
- The In Vitro/In Vivo Mix
- Miniaturization and Multiplexed Biological Assays
- Microfluidic Devices
- Bead-Based Technologies
- The Search For Non-Invasive Tools
- Mechanisms of Gene Modification, Regulation and Expression
- Methylated Gene (meDNA) Patterns
- RNA - Ribonucleic Acid
- Transcription Factors
- Circulating Cell-free Nucleic Acids
- Sample Preparation and System Automation
- Homebrew Reagents
- DNA Test Sample Preparation Market
- PCR Patent Update
CHAPTER FIVE: PLATFORMS AT THE FOREFRONT OF MOLECULAR ASSAYS
- Background
- Components of DNA tests
- Molecular Test Platforms Market Overview
- Polymerase Chain Reaction (PCR)
- Non-PCR Amplification Technologies
- Miniaturized Platforms - Arrays and Biochips
- Mass Spectroscopy
- Laser Capture Microdissection (LCM) and Tissue Arrays
- TMAs
CHAPTER SIX: MARKET ANALYSIS
- Worldwide Opportunities for Molecular Tests
- The United States
- Europe
- China
- Molecular Diagnostics And Target Markets
- The Market for Molecular Assays in Cancer Management
- The Market for Molecular Assays In Hematology
- Towards Routine Hematology Testing
- The Market For Molecular Assays in Coagulation
- Procoagulation and Thrmobolytic Markers
- Warfarin
- The Market For Molecular Assays in Histopathology/Cytology
- Overview
- The Future of the Pap Smear & HPV Testing
- In Situ Hybridization and Digital Cytometry
- Microscopy
- The Market for Molecular Assays in Microbiology/Virology
- HIV
- STDs
- Hospital Acquired Infections (HAIs)
- Respiratory Viruses
- The Market for Molecular Assays in Blood Transfusion Medicine
- Transfusion Statistics
- Trends in Transfusion Medicine
- Blood Screening Markets
- PROCLEIX
- The Market for Molecular Assays in Tissue Transplant Management
- The Market for Molecular Assays in Prenatal and Neonatal Testing
- Prental Carrier and Fetus Screening Market
- FISH Assays
- PAP Assays
- IVF Fertilization Procedure Testing
- The Market for Molecular Assays for Inherited Diseases
- Pharmacodiagnostic Test Applications
CHAPTER SEVEN: MAJOR VENDORS AND COMPANIES TO WATCH
- Company Triage
- The Majors
- The Stars
- Participants
- Newcomers
- 2012 and Beyond
- Acquisitions, Alliances and Collaborations in Molecular Diagnostics
CHAPTER EIGHT: CONCLUSIONS AND STRATEGIC IMPLICATIONS
Conclusion One
Conclusion Two
Conclusion Three
Conclusion Four
Conclusion Five
Conclusion Six
CHAPTER NINE: MAJOR VENDORS AND COMPANIES TO WATCH
Top Companies
- Abbott Diagnostics
- Revenues
- Key Comment
- Details
- Becton, Dickinson and Company (BD)
- Revenues
- Key Comment
- Details
- Beckman Coulter Inc.
- Revenues
- Key Comment
- Details
- bioMerieux Inc.
- Revenues
- Key Comment
- Details
- Celera
- Revenues
- Key Comment
- Details
- Cepheid
- Revenues
- Key Comment
- Details
- Dako A/S
- Revenues
- Key Comment
- Details
- Digene Corporation
- Revenues
- Key Comment
- Details
- Genomic Health
- Revenues
- Key Comment
- Details
- Gen-Probe Inc.
- Revenues
- Key Comment
- Details
- Genzyme Corporation
- Revenues
- Key Comment
- Details
- Ortho Clinical Diagnostics (OCD)
- Revenues
- Key Comment
- Details
- Qiagen N.V.
- Revenues
- Key Comment
- Details
- Roche Diagnostics
- Revenues
- Key Comment
- Details
- Siemens Medical Solutions Diagnostics
- Revenues
- Key Comment
- Details
- Sysmex Corporation
- Revenues
- Key Comment
- Details
- Ventana Medical Systems. Inc.
- Revenues
- Key Comment
- Details
Other Companies
- 23andMe, Inc.
- Revenues
- Key Comment
- Details
- 454 Life Sciences Corporation
- Revenues
- Key Comment
- Details
- AdnaGen AG
- Revenues
- Key Comment
- Details
- Adnavance Technologies Inc.
- Revenues
- Key Comment
- Details
- Advanced Analytical Technologies, Inc. (AATI)
- Revenues
- Key Comment
- Details
- AdvanDx, Inc.
- Revenues
- Key Comment
- Details
- Affymetrix
- Revenues
- Key Comment
- Details
- Agendia B.V.
- Revenues
- Key Comment
- Details
- Agilent Technologies Inc.
- Revenues
- Key Comment
- Details
- Almac Diagnostics (formerly ArraDx)
- Revenues
- Key Comment
- Details
- Althea Technologies, Inc.
- Revenues
- Key Comment
- Details
- Ambry Genetics Corporation
- Revenues
- Key Comment
- Details
- Arcxis Biotechnologies
- Revenues
- Key Comment
- Details
- Asuragen, Inc.
- Revenues
- Key Comment
- Details
- Athena Diagnostics, Inc.
- Revenues
- Key Comment
- Details
- Atlas Genetics Limited
- Revenues
- Key Comment
- Details
- AutoGenomics, Inc.
- Revenues
- Key Comment
- Details
- AviaraDx (formerly Arcturus Biosciences)
- Revenues
- Key Comment
- Details
- bcs BIOTECH S.p.A.
- Revenues
- Key Comment
- Details
- BG Medicine
- Revenues
- Key Comment
- Details
- Biocept, Inc.
- Revenues
- Key Comment
- Details
- BioHelix Corporation
- Revenues
- Key Comment
- Details
- BioNanomatrix
- Revenues
- Key Comment
- Details
- Bio-Reference Laboratories, Inc. (BRLI)
- Revenues
- Key Comment
- Details
- Biotage AB (formerly Pyrosequencing Technologies)
- Revenues
- Key Comment
- Details
- Biotools, B & M Labs, S.A.
- Revenues
- Key Comment
- Details
- BioTrove, Inc.
- Revenues
- Key Comment
- Details
- China Medical Technologies, Inc.
- Revenues
- Key Comment
- Details
- Clarient Inc. (formerly ChromaVision)
- Revenues
- Key Comment
- Details
- Clinical Data, Inc.
- Revenues
- Key Comment
- Details
- CLONDIAG chip technologies GmbH
- Revenues
- Key Comment
- Details
- CombiMatrix Molecular Diagnostics (CMDX)
- Revenues
- Key Comment
- Details
- Consumer Genetics
- Revenues
- Key Comment
- Details
- Correlogic Systems, Inc.
- Revenues
- Key Comment
- Details
- Curidium Medica Plc
- Revenues
- Key Comment
- Details
- deCode Genetics Inc.
- Revenues
- Key Comment
- Details
- DiaGenic ASA
- Revenues
- Key Comment
- Details
- Diatherix Laboratories Inc.
- Revenues
- Key Comment
- Details
- DNAFORM
- Revenues
- Key Comment
- Details
- DNA Direct, Inc.
- Revenues
- Key Comment
- Details
- The DNA Repair Company (DNAR)
- Revenues
- Key Comment
- Details
- DxS Ltd.
- Revenues
- Key Comment
- Details
- eGene Inc.
- Revenues
- Key Comment
- Details
- eGenomics, Inc.
- Revenues
- Key Comment
- Details
- Eiken Chemical Co., Ltd
- Revenues
- Key Comment
- Details
- Enigma Diagnostics Limited
- Revenues
- Key Comment
- Details
- Epigenomics AG
- Revenues
- Key Comment
- Details
- Epistem Ltd.
- Revenues
- Key Comment
- Details
- Eppendorf Biochip Systems GmbH
- Revenues
- Key Comment
- Details
- EraGen Biosciences Inc.
- Revenues
- Key Comment
- Details
- EXACT Sciences Corporation
- Revenues
- Key Comment
- Details
- Exiqon A/S
- Revenues
- Key Comment
- Details
- Fluidigm Corporation
- Revenues
- Key Comment
- Details
- Focus Diagnostics, Inc.
- Revenues
- Key Comment
- Details
- Fujifilm Diagnostics (Fujifilm GmbH)
- Revenues
- Key Comment
- Details
- Gene Express, Inc.
- Revenues
- Key Comment
- Details
- GeneNews Limited
- Revenues
- Key Comment
- Details
- GenoID Ltd.
- Revenues
- Key Comment
- Details
- Genomas
- Revenues
- Key Comment
- Details
- Genoptix, Inc.
- Revenues
- Key Comment
- Details
- GENPOINT AS
- Revenues
- Key Comment
- Details
- Greiner Bio-One International AG
- Revenues
- Key Comment
- Details
- Hain Lifescience GmbH
- Revenues
- Key Comment
- Details
- Hamilton Thorne Biosciences, Inc.
- Revenues
- Key Comment
- Details
- HandyLab, Inc.
- Revenues
- Key Comment
- Details
- Health Discovery Corporation
- Revenues
- Key Comment
- Details
- HiFi DNA Tech, LLC
- Revenues
- Key Comment
- Details
- Ikonisys Inc.
- Revenues
- Key Comment
- Details
- Illumina
- Revenues
- Key Comment
- Details
- Immunicon Corporation
- Revenues
- Key Comment
- Details
- Innogenetics NV
- Revenues
- Key Comment
- Details
- InterGenetics, Inc.
- Revenues
- Key Comment
- Details
- Interleukin Genetics, Inc.
- Revenues
- Key Comment
- Details
- IntegraGen SA
- Revenues
- Key Comment
- Details
- Invitrogen Corporation
- Revenues
- Key Comment
- Details
- Ipsogen
- Revenues
- Key Comment
- Details
- Iris BioTechnologies Inc.
- Revenues
- Key Comment
- Details
- KREATECH Biotechnology B.V.
- Revenues
- Key Comment
- Details
- Lab21 Healthcare
- Revenues
- Key Comment
- Details
- Laboratory Corporation of America Holdings (LabCorp)
- Revenues
- Key Comment
- Details
- Med BioGene, Inc. (MBI)
- Revenues
- Key Comment
- Details
- Microchip Biotechnologies, Inc. (MBI)
- Revenues
- Key Comment
- Details
- Microgen Bioproducts Ltd.
- Revenues
- Key Comment
- Details
- Mobidiag Oy
- Revenues
- Key Comment
- Details
- Molzym GmbH & Co. KG
- Revenues
- Key Comment
- Details
- Monogram Biosciences, Inc. (formerly ViroLogic)
- Revenues
- Key Comment
- Details
- Myconostica, Ltd.
- Revenues
- Key Comment
- Details
- Myriad Genetics, Inc.
- Revenues
- Key Comment
- Details
- Nanogen
- Revenues
- Key Comment
- Details
- Nanosphere, Inc.
- Revenues
- Key Comment
- Details
- Navigenics
- Revenues
- Key Comment
- Details
- NeuroMark
- Revenues
- Key Comment
- Details
- NorDiag ASA
- Revenues
- Key Comment
- Details
- Novartis Vaccines and Diagnostics/Chiron
- Revenues
- Key Comment
- Details
- Nuvera Biosciences
- Revenues
- Key Comment
- Details
- OncoMethylome Sciences S.A.
- Revenues
- Key Comment
- Details
- Orchid Cellmark
- Revenues
- Key Comment
- Details
- Orion Genomics
- Revenues
- Key Comment
- Details
- Osmetech plc
- Revenues
- Key Comment
- Details
- Pacific Biosciences of California, Inc. (PacBio)
- Revenues
- Key Comment
- Details
- ParagonDx LLC
- Revenues
- Key Comment
- Details
- Pathwork Diagnostics (formerly Predicant Biosciences)
- Revenues
- Key Comment
- Details
- Perceptronix Medical Inc.
- Revenues
- Key Comment
- Details
- PerkinElmer, Inc.
- Revenues
- Key Comment
- Details
- Prediction Sciences
- Revenues
- Key Comment
- Details
- Prodesse, Inc.
- Revenues
- Key Comment
- Details
- Progenika Biopharma
- Revenues
- Key Comment
- Details
- Psynomics Incorporated
- Revenues
- Key Comment
- Details
- Q Chip Ltd.
- Revenues
- Key Comment
- Details
- Quest Diagnostics Incorporated
- Revenues
- Key Comment
- Details
- Rosetta Genomics Ltd.
- Revenues
- Key Comment
- Details
- Seegene, Inc.
- Revenues
- Key Comment
- Details
- SensiGen LLC
- Revenues
- Key Comment
- Details
- Sequenom, Inc.
- Revenues
- Key Comment
- Details
- SIRS-Lab
- Revenues
- Key Comment
- Details
- Smart Genetics
- Revenues
- Key Comment
- Details
- Tepnel Life Sciences
- Revenues
- Key Comment
- Details
- TessArae, LLC
- Revenues
- Key Comment
- Details
- TheraGenetics, Limited
- Revenues
- Key Comment
- Details
- Third Wave Technologies Inc.
- Revenues
- Key Comment
- Details
- Transgenomic Inc.
- Revenues
- Key Comment
- Details
- TrimGen Corporation
- Revenues
- Key Comment
- Details
- Veredus Laboratories Pte Ltd.
- Revenues
- Key Comment
- Details
- Veridex, LLC
- Revenues
- Key Comment
- Details
- Vita Genomics
- Revenues
- Key Comment
- Details
- Xceed Molecular
- Revenues
- Key Comment
- Details
- XDx Inc.
- Revenues
- Key Comment
- Details
- Xenomics, Inc.
- Revenues
- Key Comment
- Details
- Zila, Inc.
- Revenues
- Key Comment
- Details
- Other Participants
TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Exchange Rate Fluctuations, 2003-2007
- Table 1-2: Worldwide Molecular Test Sales, 2007-2012
- Table 1-3: Market Penetration Of Clinical Molecular Diagnostics, by Geographic Area (North America, EU Europe, Japan, ROW)
CHAPTER TWO: INTRODUCTION
- Table 2-1: Selected Events in the Evolution of DNA Testing
CHAPTER THREE: TECHNOLOGY PLATFORMS
- Table 3-1: Selected Platforms for Multiplexed Nucleic Acids and Proteins
- Table 3-2: Selected SNP - Drug Interactions
- Table 3-3: Selected Molecular Test Services Available in 2008
CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF MOLECULAR DIAGNOSTICS
- Table 4-1: Selected Multiplexed Molecular Assays, 2008
- Table 4-2: Selected Multiplexed Molecular Assays, 2008
- Table 4-3: Selected Methylated DNA Tests
- Table 4-4: Selected RNA-based Cancer Tests
- Table 4-5: Selected Nucleic Acid Sample Preparation Products
TECHNOLOGY PLATFORMS AT THE FOREFRONT OF MOLECULAR ASSAYS
- Table 5-1: Market Potential Of Key Clinical Molecular Platforms, 2008
- Table 5-2: Molecular Test Product Sales, Worldwide, by Platform, 2007
- Table 5-3: Selected Companies With PCR-Based Products
- Table 5-4: Non-PCR Molecular Tests Sales, Worldwide, by Platform, 2007(bDNA, TMA, SDA, LIPA, NASBA, Invader, Others)
- Table 5-5: Selected Non-PCR Molecular Platforms (Company, Location, Platform/Technology)
- Table 5-6: Selected New Molecular Test Platforms
- Table 5-7: Major Microfluidics Companies
- Table 5-8: Major Molecular Markers For Tissue Staining
- Table 5-9: Selected In Situ Hybridization Innovation
- Table 5-10: Selected LCM Systems on the Market, 2008
CHAPTER SIX: MARKET ANALYSIS
- Table 6-1: Worldwide Molecular Test Sales, 2007-2012
- Table 6-2: Breakdown Of Home-Brew Molecular Diagnostic Tests, 2007 (Test Type, % Number of Tests)
- Table 6-3: Market Penetration Of Clinical Molecular Diagnostics, by Geographic Area (North America, EU Europe, Japan, ROW)
- Table 6-4: Average Cost Of Selected Genetic Test Services, U.S.
- Table 6-5: Selected Reference Lab and IVD Company Collaborations
- Table 6-6: Selected IVD Cancer Markers used in Tissue Analysis
- Table 6-7: Selected Molecular Tests for Coagulation Testing (Company, Location, Details, Test, Status)
- Table 6-8: Selected Advanced HPV Tests, 2006-2008 (Company, Location, Test, Status)
- Table 6-9: Selected Microscopy and Image Analysis Products
- Table 6-10: Molecular Test Sales, Infectious Diseases, 2007-2012 (Company, Location, Details, Status)
- Table 6-11: Selected Infectious Disease Molecular Test Products, 2006-2008 (Company, Location, Details, Status)
- Table 6-13: Most Frequently Requested Genetic Tests
- Table 6-14: Selected Molecular Tests for Inherited Diseases (Company, Location, Details, Status)
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