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Get more info on this report! The World Market for Molecular Diagnostics
January 1, 2009 Molecular diagnostics represents a revolution postponed, perhaps, but one that is now clearly underway. DNA Testing has emerged fully from research into clinical practice and becoming a dominant platform in clinical medicine.
From Emerging to Emergent Technology
Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. At each step of the way, Kalorama Information has reported on its progress, and in this latest market research report we look at the present state of the market, and the advances that have made DNA testing routine.
Many molecular tests are CE Marked and FDA-cleared and many more are in development. The result is that molecular testing is indicated in many areas of health care.
Molecular Testing Compiled and Analyzed and Explained by a Leading Expert
Authored by lead Kalorama diagnostic analyst Shara Rosen, Kalorama Information's World Market for Molecular Diagnostics is the most comprehensive global market report available on the emergent field of molecular diagnostics.
This report covers key platforms of molecular diagnostics, including the following :
Polymerase Chain Reaction (PCR) Non-PCR Amplification Technologies, including:
o bDNA o TMA o SDA o LIPA o NASBA o Invader o Others
In-situ Hybridization Sequencing
Microarrays Laser Capture Microdissection (LCM) and Tissue Arrays Mass Spectroscopy Other Molecular Platforms
This report provides market estimates and analysis for molecular diagnostics in the following categories:
Infectious Diseases (including HIV, Hepatitis GC/Chlamydia,Organism ID, MRSA, HAI et al, Mycobacteria, TB Respiratory, Others)
Blood Screening Histology Oncology Prenatal Coagulation Tissue Typing Inherited Diseases Pharmacodiagnostics
The various clinical techniques and trends are discussed from the point of view of their present and potential market impact.
Market analysis in this report covers world markets for in vitro diagnostics, with focus on the developed areas of the globe -- North America and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers IVD products related to the globalization of diseases.
As part of its exhaustive coverage of nucleic acid testing, the report includes the following:
Market Sizes and Forecasts Profile and Assessment of Over 140 Key Competitors Breakout of Molecular Diagnostic Market by Region (N. America, W.
Europe, Asia, ROW) Medical and Technological Trends Discussion of Globalization of Markets and Diseases Information on Reimbursement of New Technologies Review of Novel Test Platforms Review of New Market Developments, Such as Consumer Genomics and
Testing Services Discussion of Market Impact of Home Brew Tests Discussion of Diagnostic Biomarkers and Genetic Indicators
All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The
dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and techniques presented in the report are expected to replace the standard of care in 2007/08, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.
Unsurpassed Breadth of Coverage
The information presented in this report is derived from publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics and molecular pathologists. Companies profiled in this study include:
Top Companies
Abbott Diagnostics Becton, Dickinson and Company (BD) Beckman Coulter Inc. bioMerieux Inc. Celera Cepheid Dako A/S Digene Corporation Genomic Health Gen-Probe Inc. Genzyme Corporation Ortho Clinical Diagnostics (OCD) Qiagen N.V. Roche Diagnostics Siemens Medical Solutions Diagnostics Sysmex Corporation Ventana Medical Systems. Inc.
Other Companies
23andMe, Inc. 454 Life Sciences Corporation AdnaGen AG Adnavance Technologies Inc. Advanced Analytical Technologies, Inc. (AATI) AdvanDx, Inc.
Affymetrix Agendia B.V. Agilent Technologies Inc. Almac Diagnostics (formerly ArraDx) Althea Technologies, Inc. Ambry Genetics Corporation Arcxis Biotechnologies Asuragen, Inc. Athena Diagnostics, Inc. Atlas Genetics Limited AutoGenomics, Inc. AviaraDx (formerly Arcturus Biosciences) bcs BIOTECH S.p.A. BG Medicine Biocept, Inc. BioHelix Corporation BioNanomatrix Bio-Reference Laboratories, Inc. (BRLI) Biotage AB (formerly Pyrosequencing Technologies) Biotools, B & M Labs, S.A. BioTrove, Inc. China Medical Technologies, Inc. Clarient Inc. (formerly ChromaVision) Clinical Data, Inc. CLONDIAG chip technologies GmbH CombiMatrix Molecular Diagnostics (CMDX) Consumer Genetics Correlogic Systems, Inc. Curidium Medica Plc deCode Genetics Inc. DiaGenic ASA Diatherix Laboratories Inc. DNAFORM DNA Direct, Inc. The DNA Repair Company (DNAR) DxS Ltd. eGene Inc. eGenomics, Inc. Eiken Chemical Co., Ltd Enigma Diagnostics Limited Epigenomics AG Epistem Ltd. Eppendorf Biochip Systems GmbH EraGen Biosciences Inc. EXACT Sciences Corporation Exiqon A/S
Fluidigm Corporation Focus Diagnostics, Inc. Fujifilm Diagnostics (Fujifilm GmbH) Gene Express, Inc. GeneNews Limited GenoID Ltd. Genomas Genoptix, Inc. GENPOINT AS Greiner Bio-One International AG Hain Lifescience GmbH Hamilton Thorne Biosciences, Inc. HandyLab, Inc. Health Discovery Corporation HiFi DNA Tech, LLC Ikonisys Inc. Illumina Immunicon Corporation Innogenetics NV InterGenetics, Inc. Interleukin Genetics, Inc. IntegraGen SA Invitrogen Corporation Ipsogen Iris BioTechnologies Inc. KREATECH Biotechnology B.V. Lab21 Healthcare Laboratory Corporation of America Holdings (LabCorp) Med BioGene, Inc. (MBI) Microchip Biotechnologies, Inc. (MBI) Microgen Bioproducts Ltd. Mobidiag Oy Molzym GmbH & Co. KG Monogram Biosciences, Inc. (formerly ViroLogic) Myconostica, Ltd. Myriad Genetics, Inc. Nanogen Nanosphere, Inc. Navigenics NeuroMark NorDiag ASA Novartis Vaccines and Diagnostics/Chiron Nuvera Biosciences OncoMethylome Sciences S.A. Orchid Cellmark Orion Genomics
Osmetech plc Pacific Biosciences of California, Inc. (PacBio) ParagonDx LLC Pathwork Diagnostics (formerly Predicant Biosciences) Perceptronix Medical Inc. PerkinElmer, Inc. Prediction Sciences Prodesse, Inc. Progenika Biopharma Psynomics Incorporated Q Chip Ltd. Quest Diagnostics Incorporated Rosetta Genomics Ltd. Seegene, Inc. SensiGen LLC Sequenom, Inc. SIRS-Lab Smart Genetics Tepnel Life Sciences TessArae, LLC TheraGenetics, Limited Third Wave Technologies Inc. Transgenomic Inc. TrimGen Corporation Veredus Laboratories Pte Ltd. Veridex, LLC Vita Genomics Xceed Molecular XDx Inc. Xenomics, Inc. Zila, Inc.
TABLE OF CONTENTS
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
o Breath o Hair o Serum
Mechanisms of Gene Modification, Regulation and Expression o Methylated Gene (meDNA) Patterns o RNA - Ribonucleic Acid
o Transcription Factors o 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
o Polymerase Chain Reaction (PCR) o Non-PCR Amplification Technologies o Miniaturized Platforms - Arrays and Biochips o Mass Spectroscopy o Laser Capture Microdissection (LCM) and Tissue Arrays o TMAs
CHAPTER SIX: MARKET ANALYSIS
Worldwide Opportunities for Molecular Tests o The United States o Europe o China
Molecular Diagnostics And Target Markets The Market for Molecular Assays in Cancer Management
o CUP/TUO o Herceptin
The Market for Molecular Assays In Hematology o Towards Routine Hematology Testing
The Market For Molecular Assays in Coagulation o Procoagulation and Thrmobolytic Markers o Warfarin
The Market For Molecular Assays in Histopathology/Cytology o Overview o The Future of the Pap Smear & HPV Testing o In Situ Hybridization and Digital Cytometry o Microscopy
The Market for Molecular Assays in Microbiology/Virology o HIV o STDs o Hospital Acquired Infections (HAIs) o Respiratory Viruses
The Market for Molecular Assays in Blood Transfusion Medicine o Transfusion Statistics
o Trends in Transfusion Medicine o Blood Screening Markets o PROCLEIX
The Market for Molecular Assays in Tissue Transplant Management The Market for Molecular Assays in Prenatal and Neonatal Testing
o Prental Carrier and Fetus Screening Market o FISH Assays o PAP Assays o 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
o Implication
Conclusion Two
o Implication
Conclusion Three
o Implication
Conclusion Four
o Implication
Conclusion Five
o Implication
Conclusion Six
o Implication
CHAPTER NINE: MAJOR VENDORS AND COMPANIES TO WATCH Top Companies
Abbott Diagnostics o Revenues o Key Comment o Details
Becton, Dickinson and Company (BD) o Revenues o Key Comment o Details
Beckman Coulter Inc. o Revenues o Key Comment o Details
bioMerieux Inc. o Revenues o Key Comment o Details
Celera o Revenues o Key Comment o Details
Cepheid o Revenues o Key Comment o Details
Dako A/S o Revenues o Key Comment o Details
Digene Corporation o Revenues o Key Comment o Details
Genomic Health o Revenues o Key Comment o Details
Gen-Probe Inc. o Revenues o Key Comment o Details
Genzyme Corporation o Revenues o Key Comment
o Details Ortho Clinical Diagnostics (OCD)
o Revenues o Key Comment o Details
Qiagen N.V. o Revenues o Key Comment o Details
Roche Diagnostics o Revenues o Key Comment o Details
Siemens Medical Solutions Diagnostics o Revenues o Key Comment o Details
Sysmex Corporation o Revenues o Key Comment o Details
Ventana Medical Systems. Inc. o Revenues o Key Comment o Details
Other Companies
23andMe, Inc. o Revenues o Key Comment o Details
454 Life Sciences Corporation o Revenues o Key Comment o Details
AdnaGen AG o Revenues o Key Comment o Details
Adnavance Technologies Inc. o Revenues o Key Comment o Details
Advanced Analytical Technologies, Inc. (AATI) o Revenues
o Key Comment o Details
AdvanDx, Inc. o Revenues o Key Comment o Details
Affymetrix o Revenues o Key Comment o Details
Agendia B.V. o Revenues o Key Comment o Details
Agilent Technologies Inc. o Revenues o Key Comment o Details
Almac Diagnostics (formerly ArraDx) o Revenues o Key Comment o Details
Althea Technologies, Inc. o Revenues o Key Comment o Details
Ambry Genetics Corporation o Revenues o Key Comment o Details
Arcxis Biotechnologies o Revenues o Key Comment o Details
Asuragen, Inc. o Revenues o Key Comment o Details
Athena Diagnostics, Inc. o Revenues o Key Comment o Details
Atlas Genetics Limited o Revenues o Key Comment o Details
AutoGenomics, Inc. o Revenues o Key Comment o Details
AviaraDx (formerly Arcturus Biosciences) o Revenues o Key Comment o Details
bcs BIOTECH S.p.A. o Revenues o Key Comment o Details
BG Medicine o Revenues o Key Comment o Details
Biocept, Inc. o Revenues o Key Comment o Details
BioHelix Corporation o Revenues o Key Comment o Details
BioNanomatrix o Revenues o Key Comment o Details
Bio-Reference Laboratories, Inc. (BRLI) o Revenues o Key Comment o Details
Biotage AB (formerly Pyrosequencing Technologies) o Revenues o Key Comment o Details
Biotools, B & M Labs, S.A. o Revenues o Key Comment o Details
BioTrove, Inc. o Revenues o Key Comment o Details
China Medical Technologies, Inc. o Revenues
o Key Comment o Details
Clarient Inc. (formerly ChromaVision) o Revenues o Key Comment o Details
Clinical Data, Inc. o Revenues o Key Comment o Details
CLONDIAG chip technologies GmbH o Revenues o Key Comment o Details
CombiMatrix Molecular Diagnostics (CMDX) o Revenues o Key Comment o Details
Consumer Genetics o Revenues o Key Comment o Details
Correlogic Systems, Inc. o Revenues o Key Comment o Details
Curidium Medica Plc o Revenues o Key Comment o Details
deCode Genetics Inc. o Revenues o Key Comment o Details
DiaGenic ASA o Revenues o Key Comment o Details
Diatherix Laboratories Inc. o Revenues o Key Comment o Details
DNAFORM o Revenues o Key Comment o Details
DNA Direct, Inc. o Revenues o Key Comment o Details
The DNA Repair Company (DNAR) o Revenues o Key Comment o Details
DxS Ltd. o Revenues o Key Comment o Details
eGene Inc. o Revenues o Key Comment o Details
eGenomics, Inc. o Revenues o Key Comment o Details
Eiken Chemical Co., Ltd o Revenues o Key Comment o Details
Enigma Diagnostics Limited o Revenues o Key Comment o Details
Epigenomics AG o Revenues o Key Comment o Details
Epistem Ltd. o Revenues o Key Comment o Details
Eppendorf Biochip Systems GmbH o Revenues o Key Comment o Details
EraGen Biosciences Inc. o Revenues o Key Comment o Details
EXACT Sciences Corporation o Revenues
o Key Comment o Details
Exiqon A/S o Revenues o Key Comment o Details
Fluidigm Corporation o Revenues o Key Comment o Details
Focus Diagnostics, Inc. o Revenues o Key Comment o Details
Fujifilm Diagnostics (Fujifilm GmbH) o Revenues o Key Comment o Details
Gene Express, Inc. o Revenues o Key Comment o Details
GeneNews Limited o Revenues o Key Comment o Details
GenoID Ltd. o Revenues o Key Comment o Details
Genomas o Revenues o Key Comment o Details
Genoptix, Inc. o Revenues o Key Comment o Details
GENPOINT AS o Revenues o Key Comment o Details
Greiner Bio-One International AG o Revenues o Key Comment o Details
Hain Lifescience GmbH o Revenues o Key Comment o Details
Hamilton Thorne Biosciences, Inc. o Revenues o Key Comment o Details
HandyLab, Inc. o Revenues o Key Comment o Details
Health Discovery Corporation o Revenues o Key Comment o Details
HiFi DNA Tech, LLC o Revenues o Key Comment o Details
Ikonisys Inc. o Revenues o Key Comment o Details
Illumina o Revenues o Key Comment o Details
Immunicon Corporation o Revenues o Key Comment o Details
Innogenetics NV o Revenues o Key Comment o Details
InterGenetics, Inc. o Revenues o Key Comment o Details
Interleukin Genetics, Inc. o Revenues o Key Comment o Details
IntegraGen SA o Revenues
o Key Comment o Details
Invitrogen Corporation o Revenues o Key Comment o Details
Ipsogen o Revenues o Key Comment o Details
Iris BioTechnologies Inc. o Revenues o Key Comment o Details
KREATECH Biotechnology B.V. o Revenues o Key Comment o Details
Lab21 Healthcare o Revenues o Key Comment o Details
Laboratory Corporation of America Holdings (LabCorp) o Revenues o Key Comment o Details
Med BioGene, Inc. (MBI) o Revenues o Key Comment o Details
Microchip Biotechnologies, Inc. (MBI) o Revenues o Key Comment o Details
Microgen Bioproducts Ltd. o Revenues o Key Comment o Details
Mobidiag Oy o Revenues o Key Comment o Details
Molzym GmbH & Co. KG o Revenues o Key Comment o Details
Monogram Biosciences, Inc. (formerly ViroLogic) o Revenues o Key Comment o Details
Myconostica, Ltd. o Revenues o Key Comment o Details
Myriad Genetics, Inc. o Revenues o Key Comment o Details
Nanogen o Revenues o Key Comment o Details
Nanosphere, Inc. o Revenues o Key Comment o Details
Navigenics o Revenues o Key Comment o Details
NeuroMark o Revenues o Key Comment o Details
NorDiag ASA o Revenues o Key Comment o Details
Novartis Vaccines and Diagnostics/Chiron o Revenues o Key Comment o Details
Nuvera Biosciences o Revenues o Key Comment o Details
OncoMethylome Sciences S.A. o Revenues o Key Comment o Details
Orchid Cellmark o Revenues
o Key Comment o Details
Orion Genomics o Revenues o Key Comment o Details
Osmetech plc o Revenues o Key Comment o Details
Pacific Biosciences of California, Inc. (PacBio) o Revenues o Key Comment o Details
ParagonDx LLC o Revenues o Key Comment o Details
Pathwork Diagnostics (formerly Predicant Biosciences) o Revenues o Key Comment o Details
Perceptronix Medical Inc. o Revenues o Key Comment o Details
PerkinElmer, Inc. o Revenues o Key Comment o Details
Prediction Sciences o Revenues o Key Comment o Details
Prodesse, Inc. o Revenues o Key Comment o Details
Progenika Biopharma o Revenues o Key Comment o Details
Psynomics Incorporated o Revenues o Key Comment o Details
Q Chip Ltd. o Revenues o Key Comment o Details
Quest Diagnostics Incorporated o Revenues o Key Comment o Details
Rosetta Genomics Ltd. o Revenues o Key Comment o Details
Seegene, Inc. o Revenues o Key Comment o Details
SensiGen LLC o Revenues o Key Comment o Details
Sequenom, Inc. o Revenues o Key Comment o Details
SIRS-Lab o Revenues o Key Comment o Details
Smart Genetics o Revenues o Key Comment o Details
Tepnel Life Sciences o Revenues o Key Comment o Details
TessArae, LLC o Revenues o Key Comment o Details
TheraGenetics, Limited o Revenues o Key Comment o Details
Third Wave Technologies Inc. o Revenues
o Key Comment o Details
Transgenomic Inc. o Revenues o Key Comment o Details
TrimGen Corporation o Revenues o Key Comment o Details
Veredus Laboratories Pte Ltd. o Revenues o Key Comment o Details
Veridex, LLC o Revenues o Key Comment o Details
Vita Genomics o Revenues o Key Comment o Details
Xceed Molecular o Revenues o Key Comment o Details
XDx Inc. o Revenues o Key Comment o Details
Xenomics, Inc. o Revenues o Key Comment o Details
Zila, Inc. o Revenues o Key Comment o Details
Other Participants
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