The World Market for Molecular Diagnostics

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
  • Breath
  • Hair
  • Serum
• 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
  • CUP/TUO
  • Herceptin
• 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
  • Implication
• Conclusion Two
  • Implication
• Conclusion Three
  • Implication
• Conclusion Four
  • Implication
• Conclusion Five
  • Implication
• Conclusion Six
  • Implication

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
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• 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
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• 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
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• Siemens Medical Solutions Diagnostics
  • Revenues
  • Key Comment
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• 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

CHAPTER FIVE: 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)