Kalorama 2010 Ultra Diagnostics Research Bundle

Table of Contents

The Worldwide Market for In Vitro Diagnostic Tests, 7th EditionTABLE OF CONTENTSCHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trend – Doing More with Less

CHAPTER TWO: INTRODUCTION

• Background
• New Report Design
• Lab Medicine Disciplines And Applications
• Market Analysis of IVD Market Segments
• Consolidation and collaborations – new bedfellows
• Licenses and distribution agreements
• Top Suppliers and Niche players
• Point of View

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

• Background
• The balance between Chronic and Infectious diseases
• World Segments of the IVD Market and IVD Market Evolution
• The United States of America
• Japan
• Europe
• China
• India
• ROW

CHAPTER FOUR: TRENDS AND INNOVATION

• Background
• The Economics of Healthcare in economic stress
• The In Vivo – In Vitro Diagnostic Service
• Wireless Connectivity, Apps Everywhere
• Update on Regulatory Requirements of Novel Devices
• The Biomarker Revolution

CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS

• Overview of POC Tests
• Special Topics
• Decentralized molecular and specialized testing
• Market Analysis
• Blood Glucose Monitoring
• The Commercial Outlook for POC Tests

CHAPTER SIX: THE CORE LAB:

• Core Lab Overview
• Overview of Chemistry Tests
• Special Topics
• The Expanding the Core Lab menu
• Market Analysis : Leading Suppliers and Growth Potential
• Lab-based Chemistries
• Critical Care Chemistries
• The Commercial Outlook for the Core Lab

CHAPTER SEVEN: IMMUNOASSAYS

• Overview of Immunoassays
• Special Topics
• The Role of Immunoassays in Disease Management
• Market Analysis
• Immunoassay Test Segments – Mature and Emerging
• Point-of-care OTC and Professional Use
• The Commercial Outlook for Immunoassays

CHAPTER EIGHT: MOLECULAR ASSAY PLATFORMS

• Overview of Molecular Assays
• Special Topics
• The Promise of Personalized Medicine – the $1000 Genome
• Molecular Testing Innovation – Sequencing and Mass Spectroscopy
• Market Analysis
• Inherited Diseases
• Prenatal Testing
• Tissue Typing
• The Commercial Outlook for Molecular Tests

CHAPTER NINE: HEMATOLOGY

• Overview of Hematology
• Market Analysis : Leading Suppliers
• The Commercial Outlook for Hematology Tests

CHAPTER TEN: COAGULATION

• Overview of Coagulation / Immunohematology Tests
• Special Topic
• The PGx debate
• Market Analysis
  • Lab-based Testing
  • Decentralized Coagulation testing – Professional Use
  • Decentralized Coagulation testing – OTC
  • Leading Suppliers
• The Commercial Outlook for Coagulation Tests

11 MICROBIOLOGY AND VIROLOGY

• Overview of Microbiology / Virology Tests
• Special Topics
  • Hospital Acquired Infections
  • Emerging Organisms and the Globalization of Infectious Diseases
• Market Analysis
  • Supplies
  • Microbial Identification and Antimicrobial Sensitivity Tests
  • Blood Culture
  • Immunoassays – lab based
  • Immunoassays – rapid
  • Molecular Tests
• The Commercial Outlook for Microbiology / Virology Tests

12 BLOOD BANKING SERVICES

• Overview of Blood Banking
• The Safety Imperative
• Market Analysis
  • Blood Grouping
  • Immunoassay Screens
  • Nucleic Acid Testing Continues to Grow
  • Leading Suppliers
• The Commercial Outlook for Blood Banking

13 HISTOLOGY AND CYTOLOGY

• Overview of Histology / Cytology
• Special Topics
  • The growth of Histology/Cytology Test Services
• Market Analysis
  • Histology/Cytology
  • Tissue Microarrays
  • Flow Cytometry
• The Commercial Outlook for Histology and Cytology Tests

14 COMPANY PROFILES – THE TOP TIER

15 COMPANY PROFILES – THE SECOND TIER

16 COMPANY PROFILES – NICHE PLAYERS AND INNOVATORS

A Preliminary List of Tables 

(These are tables which may appear in this volume based on past editions; it is not a complete list and is subject to change.)

CHAPTER ONE: Executive Summary

• World In Vitro Diagnostics Market 2009-2014 ($millions)
• Worldwide In Vitro Diagnostic Reagent Sales by Country/Region 2009-2014
• Regional Market Share of In Vitro Diagnostics Market, 2009 (North America, EU, Japan, Latin America, Eastern Europe, India, China, ROW)

CHAPTER TWO: INTRODUCTION

• Worldwide IVD Market Share by Market Segment
• Selected Diagnostics Industry Acquisitions, 2008-2009
• T Revenues of Selected IVD Companies, 2007-2009

CHAPTER THREE: OVERVIEW OF WORLD IVD MARKETS

• Number of People Who Get Chronic Diseases Every Year Worldwide by Disease
• WHO Health Spending Statistics
• Health Expenditure as a Share of GDP, Developing Countries
• Health Expenditure per Capita: Private and Public
• Worldwide In Vitro Diagnostics Sales by Country/Region 2009-2014
• European Union IVD Sales by Country 2008
• Chinese Market for IVD Reagents 2009-2014
• Indian Market for IVD Reagents 2009-2014

CHAPTER FIVE: Point-of-Care Tests

• POC Sales by Test Category, worldwide 2009-2014
• World Glucose Monitoring Sales, by Company, 2007 – 2009
• Selected Blood Glucose Test Devices Innovations, 2008-2009
• T Selected Blood Glucose Test Devices Innovations, 2008-2009

CHAPTER SIX: THE CORE LAB

• Clinical Chemistry/Immunoassay Sales, 2009-2014
• Chemistry/Immunochemistry Sales of Top Five Manufacturers, 2007-2007
• Selected Workstation Innovations, 2008-2009
• Worldwide Clinical Chemistry Sales by Test Category 2009-2014 (General Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Worldwide Clinical Chemistry Sales by Test Category (General Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Selected Small Lab Workstations, 2008-2009 (Company, Location, Details, Status)

CHAPTER SEVEN: IMMUNOASSAYS

• Selected New Immunoassay Platforms, 2009
• Selected Small Footprint Immunoassay Systems
• Worldwide Lab-Based Immunoassay Sales by Analyte Type 2009-2014 (ID, Tumor Markers, Cardiac Markers, Diabetes/HbA1c, Thyroid, Proteins, Autoimmune, Anemia, Therapeutic Drugs, Fertility, Allergy, Drugs of Abuse)
• Revenue History of Leading Immunoassay Vendors, $ million 2007-2009
• Selected Tumor Marker Innovations, 2008-2009
• Selected Cardiac Marker Innovations, 2008-2009
• Selected Autoimmune Immunoassay Innovations, 2008-2009
• Selected Sepsis Marker Innovations, 2008-2009
• Selected Immunoassay Innovations, 2008-2009
• Regional Breakdown of POC Immunoassay Market
• Regional Breakdown of POC Immunoassay Market
• Growth Rate of Immunoassays (All Immunoassays, POC OTC Immunoassays and Professional POC)
• POC OTC Immunoassay Test Sales by Test Category 2009-2014 (Pregnancy/Ovulation, Fecal Occult Blood, Drugs of Abuse, Cholesterol)
• Selected OTC Test Devices, 2009
• Professional POC Testing 2007-2010 (Pregnancy, Cardiac Markers, Cholesterol/Lipids, HbA1, Fecal occult blood, Cancer Markers, Drugs of Abuse, Other)
• Selected Professional POC Tests on the Market and in Development, 2008-2009

CHAPTER EIGHT: Molecular Assays

• Selected Molecular Test Innovations, 2008/07
• Selected Nucleic Acid Testing Platforms, 2008-2009
• Table 8-3: Selected Molecular Test Services, 2009
• Worldwide Molecular Test Sales by Type, $million 2009-2014
• Molecular Test Revenues of Selected IVD Vendors, 2007-2009

CHAPTER NINE: Hematology

• Selected New Hematology Analyzer Tests 1990s – 2009
• Selected New Hematology Research Projects
• Estimated Market for Manual and Automated Sed Rates 2009-2014
• Selected Automated ESR Systems, 2009
• Estimated Share of Hematology Market by Setting (Central vs Decentralized) 2009
• Selected POC Hematology Systems, 2009 ROW)
• Market Share of Hematology Vendors 2009
• World Market for Hematology 2009-2014

CHAPTER TEN: Coagulation

• Worldwide Coagulation Sales by Segment 2009-2014
• Regional Share of Coagulation Market, 2009
• Lab-Based Coagulation Testing 2009-2014
• Selected Coagulation Automation Innovations

CHAPTER ELEVEN: Microbiology and Virology

• Worldwide Microbiology/Virology Sales by Type 2009-2014
• Revenue of Selected ID/AST Product Companies, 2009
• Selected Infectious Disease Immunoassay Innovations, 2008-2009
• Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits, GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory, Others), 2009-2014 ($ Millions)
• Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits, GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory, Others), 2009-2014
• Molecular Testing Emerging Infectious Disease vs. First Wave
• Selected Infectious Disease Molecular Test Innovations, 2008-2009

CHAPTER TWELVE: Blood Banking Services

• Selected Blood Treatment Innovations, 2009
• Worldwide Blood Bank Sales, 2009-2014 (ABO Grouping, Immunoassay Screen, NAT Screen)
• Worldwide Blood Bank Sales, 2009 and 2014 ($ millions)
• Selected Blood Bank Innovations, 2008-2009

CHAPTER THIRTEEN Histology and Cytology

• Selected IVD Cancer Markers
• Selected Microscopy and Image Analysis Product Companies
• Worldwide Histology/Cytology Sales by Type 2009-2014 ($million)
• Selected Vendors of Traditional Histology Stains
• Revenues of the Major Automated Histology Companies, 2005-2009 ($millions)
• Selected Pap Test Entrants, 2008-2009
• in situ Hybridization Market, 2009 and 2014
• Selected IHC and ISH Reagent Companies
• Selected molecular HPV tests, 2008-2009
• Revenue History of the Cytometry Imaging Market, 2008 ($ million)
• Selected Histology/Cytology Innovations, 2007
• Revenue History of Flow Cytometry by Company, 2007-2009
• Market Share of Flow Cytometry by Company, 2007 and 2009

Physician Office Lab MarketCHAPTER ONE Executive Summary

• Scope and Methodology
• Size and Growth of the Market
• Market Trends

CHAPTER TWO Introduction

• Background
• POL Definitions
• Miniaturization, Digitization, and Informatics
• The Pros and Cons of POL Testing
• Point of View

CHAPTER THREE Market and Technological Dynamics in POL Testing

• Background
• The Emergence of Non-Invasive Technologies
• Pharmacodiagnostics (PGx) on demand
• Lab-on-a-Chip
• The Wireless Revolution
• Connectivity Imperative

Chapter Four The Economics of POL Testing

• Background
• POLs and Clinical Outcomes Management
• A POL Is More than Just Device Installation
• The Regulatory Environment
• Reimbursement Issues and Trends

Chapter Five POL Status Quo

• Background
• Overview of the Worldwide POL Market
• World Segments and POL Market Evolution
  • The United States
  • Europe—A Hodgepodge
  • Germany
  • France
  • Switzerland
  • Other EU Countries
  • Japan
  • China
  • India
  • The Rest of the World
• The Future of POLs

Chapter Six Market Analysis

• Overview
• Home Monitoring of Individuals with Chronic Diseases
• The Major Players
• POL Test Segments
  • Diabetes
  • Glucose
  • Glycohemoglobin (HbA1c)
  • Cardiac Markers
  • Clinical Chemistry
  • Hematology
  • Coagulation
  • Infectious Disease
  • Immunoassays
  • Thyroid Function
  • Anemia
  • Allergy
  • Autoimmune
  • Cancer Markers
  • Pharmacodiagnostics
  • Women’s Health / Pregnancy/Fertility
  • Emerging Tests and Technologies
  • Commercial Outlook

Chapter Seven Company Profiles

• The Top IVD Companies and Their POL Offerings
  • Abbott Labs
  • ARKRAY (formerly Kyoto Daiichi)
  • Bayer Diabetes Care
  • Becton, Dickinson and Company (BD)
  • Beckman Coulter Inc.
  • Bio-Rad Laboratories Inc.
  • Instrumentation Laboratory (IL)
  • Inverness Medical Innovations, Inc.
  • Ortho Clinical Diagnostics (OCD)
  • Roche Diagnostics
  • Siemens Medical Solutions Diagnostics / Bayer Diagnostics
  • Sysmex Corporation
• POC Companies and New Frontiers
  • ABAXIS Inc.
  • Accumetrics Incorporated
  • Acrongenomics, Inc.
  • Adeza Biomedical, Inc.
  • ADIATEC
  • Advance Nanotech, Inc.
  • AESKU.Diagnostics GmbH
  • Akers Biosciences, Inc.
  • Ambri Ltd.
  • Ani Biotech Oy
  • Ark Therapeutics Limited
  • AspenBio Pharma, Inc.
  • Avitar, Inc.
  • Axis-Shield plc
  • Binax, Inc.
  • BioCurex Inc.
  • bioLytical Laboratories Inc.
  • Biomerica Inc.
  • Biosafe Medical Technologies, Inc.
  • BioScan Screening Systems, Inc.
  • Biosite Incorporated
  • Boditech Med Inc.
  • Boule Diagnostics International AB
  • Calypte Biomedical Corporation
  • Careside Medical LLC
  • Chembio Diagnostics, Inc.
  • Chempaq A/S
  • Cholestech Corporation
  • Chongqing Sungene Pharm. Co., Ltd.
  • Claros Diagnostics, Inc.
  • Cozart Bioscience Ltd.
  • Diagnostic Chemicals Ltd (DCL)
  • Diaglobal GmbH
  • Digital Bio Technology/ InCyto
  • DNAFORM
  • Ekips Technologies
  • Enterix, Inc.
  • Epocal Inc.
  • ESA Biosciences Inc.
  • Farallon Medical, Inc.
  • GenBio
  • Genzyme Corporation
  • Grant Life Sciences Inc.
  • Gryphus Diagnostics, LLC
  • Helena Laboratories
  • Hema Diagnostic Systems, LLC
  • HemoCue AB
  • HemoSense, Inc.
  • Hitachi High-Technologies Corporation
  • Home Access Health Corporation
  • Hypoguard, USA Inc.
  • ImmunoScience, Inc.
  • Innotrac Diagnostics Oy
  • International Technidyne Corp (ITC)
  • LifeAssays AB
  • Lifestream Technologies, Inc.
  • Mast Group Ltd.
  • Matritech
  • MedCap Corp.
  • Medical Services International Inc.
  • MedMira Inc.
  • Menssana Research, Inc.
  • Meretek Diagnostics Inc.
  • Meridian Bioscience, Inc.
  • Micronics, Inc.
  • Milenia Biotec GmbH
  • Mitsubishi Kagaku Iatron, Inc. (MKI)
  • Mobidiag Oy
  • Monash University
  • Mossman Associates, Inc.
  • N-Dia, Inc.
  • OraSure Technologies, Inc.
  • Orion Diagnostica OY
  • Panbio Limited
  • Philips Medical Systems
  • PlaCor, Inc.
  • PointCare Technologies, Inc.
  • Polymedco, Inc.
  • Polymer Technology Systems, Inc.
  • Princeton BioMeditech Corporation
  • PortaScience, Inc.
  • Proteome Systems Ltd
  • Provalis Diagnostics / Bayer Diabetes Care
  • QBC Diagnostics, Inc.
  • Quest Diagnostics
  • Quidel Corporation
  • Rapid Pathogen Screening
  • rennesens GmbH
  • Response Biomedical Corp.
  • SA Scientific
  • Sphere Medical Ltd.
  • StatSure Diagnostic Systems, Inc.
  • SureScreen Diagnostics, Ltd.
  • Synova Healthcare, Inc.
  • SYNTRON Bioresearch, Inc.
  • ThyroTec, Inc.
  • Trinity Biotech plc
  • Veredus Laboratories Pte
  • Wadsworth Center
  • Zonda, Inc.

List of Exhibits

CHAPTER ONE: Executive Summary

• Figure 1-1: Market Summary: Worldwide POL Diagnostic Reagent Sales 2009 and 2011

CHAPTER THREE: Market and Technological Dynamics in POL Testing

• Table 3-1: Selected New Biochip Products (Company, Target, Product) 2007
• Table 3-2: General Practitioner’s Use of EMRs in Europe and the United States by Country

Chapter Four: The Economics of POL Testing

• Table 4-1: Selected Chemistry and Hematology POL Systems (Company, Testing Area, Details, Status)
• Table 4-2: Main Categories of CLIA-Waived Tests and Their Corresponding CPT Codes
• Table 4-3: Common POL Tests, Their CLIA Status, CPT Code, Average Cost, and Reimbursement Rate

Chapter Five: POL Status Quo

• Table 5-1: Old-Age Dependency Ratios (Elderly as a Percentage of Working-Age Population) Comparative Projections by Country 2000 vs 2025
• Table 5-2: Worldwide POL Diagnostic Reagent Sales by Region (U.S., Europe, Japan, ROW) 2009-2014
• Table 5-4: Physician Office Laboratories in the United States (Number of Labs, waived POLs, non-waived POLs) 1995 to 2009
• Table 5-5: Top 25 POL Tests in the United States (CPT Code, Test, Status, Allowed Payment, Allowed Services, Reimbursement Fee) 2005

Chapter Six: Market Analysis

• Table 6-1: Worldwide Lab-Type POL Diagnostic Test Reagent Sales by Segment (15 Test Segments) 2009-2014
• Table 6-2: Worldwide Rapid POL Diagnostic Test Reagent Sales by Segment (21 Test Segments) 2009-2014
• Table 6-3: POC Test Revenues of Selected Companies (40 Companies) Estimated 2005/06 Gobal Revenues and Area of Focus
• Table 6-4: Selected Blood Glucose Test Devices on the Market (Company, Location, Product, Market Status)
• Table 6-5: Worldwide Sales of Selected Cardiac IVDs (Cardiac Markers, BNP, Cholesterol Panels, Lipids, hsCRP, CRP, Homocystine) 2009
• Table 6-6: Selected Whole Blood Chemistry System Manufacturers
• Table 6-7: World Market for Rapid Infectious Disease Testing in POLs and Clinics by Analyte (Hepatitis, Strep A, Influenza, Respiratory Viruses, HIV, Other) 2009
• Table 6-8: Top 10 CLIA-Waived Infectious Disease Tests in the POL
• Table 6-9: Worldwide POL Lab-Type Immunoassay Revenues by Test Type (Thyroid, Allergy, Anemia, Cancer Markers, CRP, hsCRP, Autoimmune, Homocystine) 2009
• Table 6-10: Worldwide POL Rapid Immunoassay Revenues by Test Type (HbA1c, Cholesterol Panel, PSA, Pregnance/LH, Flu, Hepatitis, HIV, TSH, Cardiac/Troponin, Strep A, BNP, Respiratory Viruses, Other Infectious Disease, Drugs of Abuse) 2009

Molecular DiagnosticsTABLE OF CONTENTSCHAPTER 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
  • 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 EXHIBITSCHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Exchange Rate Fluctuations, 2003-2009
• Table 1-2: Worldwide Molecular Test Sales, 2009-2014
• 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, 2009
• Table 5-3: Selected Companies With PCR-Based Products
• Table 5-4: Non-PCR Molecular Tests Sales, Worldwide, by Platform, 2009(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, 2009-2014
• Table 6-2: Breakdown Of Home-Brew Molecular Diagnostic Tests, 2009 (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, 2008-2010 (Company, Location, Test, Status)
• Table 6-9: Selected Microscopy and Image Analysis Products
• Table 6-10: Molecular Test Sales, Infectious Diseases, 2009-2014 (HIV, Hepatitis, GC/Chlamydia, Organism ID/MRSA et al, Mycobacteria/TB, Respiratory, Others)
• Table 6-11: Selected Infectious Disease Molecular Test Products, 2008-2010 (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)