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Kalorama 2010 Ultra Diagnostics Research Bundle

This bundle provides customers with three of the most intensely researched Kalorama Information reports covering the diagnostic industry authored by Shara Rosen, R.T., M.B.A. in 2010 and 2011 These reports will be provided in one PDF, each with its own table of contents. The bundle allows customers to save almost $4,500 off the cost of the individual reports.

  • THE WORLDWIDE MARKET FOR IN VITRO DIAGNOSTIC TESTS, 7th Edition This 900+ page report contains coverage of all segments of In Vitro Diagnostics including Core Lab, Point of Care, Molecular Testing, Hematology, Blood Banking, Microbiology, Coagulation, as well as a robust discussion of trends in the IVD market. It also includes profiles of over two hundred top tier, status quo and innovator companies.


  • PHYSICIAN OFFICE LABS MARKET, 2nd Edition Kalorama Information was one of the first market research publishers to render visible the market for diagnostic reagents, POC tests and equipment sold to physician labs. In this edition, Shara Rosen provides detailed analysis of this important subsegment of in vitro diagnostics, and speculates on the future of the trend.


  • MOLECULAR DIAGNOSTICS, 4th Edition No part of the IVD market is as fast-moving as molecular testing. While the predictions about the market have not always borne out, it remains a strong category for growth. In this volume, Rosen details how molecular technologies have found their way into the IVD market, and provides realistic predictions about the industry.
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The Worldwide Market for In Vitro Diagnostic Tests, 7th Edition
TABLE OF CONTENTS

CHAPTER 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 Market

CHAPTER 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 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
    • 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, 2003-2009
  • 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)

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