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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
2. 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
3. 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.
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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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