Get more info on this report! Worldwide Market for In Vitro Diagnostic (IVD) Tests, 7th Edition, The

August 1, 2010

In seven best-selling editions, Shara Rosen has provided a total view of every aspect of the market for in vitro diagnostic (IVD) testing in one complete volume. The report, The Worldwide Market for In Vitro Diagnostic Tests, is a testament to the Kalorama methodology. Real industry knowledge combined with an exhaustive review of the medical, business, and company literature. Market numbers for business planning matched with a discovery of the trends that are impacting the industry. A realistic forecast five years into the future for companies already participating in or considering entry into this growing industry. The idea behind Kalorama's unique report is that the entire market can be captured in one volume and business planners can use it as a key reference. Published every two years, this volume includes coverage of the most important aspects of all of the major segments of clinical lab testing, including:

Point of Care (POC), (Professional and Self-Testing) Core Lab (General Chemistries, Workstations, Analyzers) Immunoassays (Blood Gases, Urinalysis, Critical Care) Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases,

Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal) Hematology Coagulation (Lab-Based, POC, Genetic Markers) Microbiology and Virology Blood Banking (Grouping, Immunoassay Screens, NAT Screens) Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)

For each of these sections, Shara Rosen reviews the key products dominating the market, the innovations that are occurring, and the trends that are impacting the segments. Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the segments, where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market numbers are presented for 2009, with projections given through 2014.

Kalorama Information’s Report - ‘The Bible of the IVD Industry’

Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. These are the numbers that it is very likely competitive companies will be using in their planning.

This 900+ page edition greatly expands coverage of the field and tracks the most important developments.

A Global Report

IVD is a worldwide business. While the US is a large healthcare market, much of the dynamism occurs in other areas. Many of the most interesting developments are occurring in emerging markets. As part of its coverage, the report breaks down the entire IVD market for the following regions.

North America Europe (EU) Eastern Europe South America Asia (China and India as subsegments) Rest of World

A Report Designed for a Changing Industry

In this seventh edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information has reorganized the presentation of the IVD market in a manner that better reflects how the industry has evolved.

In the past, molecular testing was a small emerging discipline that related to chlamydia, gonorrhea, TB, and some inherited diseases. Now molecular technologies are impacting several areas of diagnostics. Molecular diagnostics has its own chapter but also is present in those other areas. Trends such as pharmacodiagnostics, molecular poc and test services are put in a context.

The report's approach reflects the increasing use of automation in the lab; core lab section includes both workstation and automated panel revenues.

The report‘s profiles distinguish between companies that are leaders in all aspects of IVD, those that lead in one particular area or a few, and those that are innovative but not yet large.

We track ‘laggards’ - companies from the past few years that have failed due to financing or product failure.

IVD Companies have been busy. The report examines the major mergers as well as partnerships, distribution agreements.

A comparison and contrast of India and China - important emerging markets for IVD. But not always well-understood ones.

There is discussion of the role of the new government focus on EMR and how it impacts IVD devices.

Healthcare statistics for various countries -healthcare spending as a percent of GDP, new hospitals, cost increases and other information.

Tables that document the innovative products being developed in each area of IVD.

Country-level Breakout of IVD market for major European and Asian countries. The Impact of US Health Care Reform The Spread of Wireless Diagnostics and Remote Monitoring New Screening Guidelines and Market Impact Chronic vs. Infectious Disease Strange Bedfellows? Analysis fn the IVD Industry Consolidation The Continued Molecularization of Devices The Current Economic Situation: Recession: Post-Recession? The report looks at where non-Invasive Sampling PGx and SNP Testing IVD and the Promise of Personalized Medicine has been a discussion for

years. Now it is closer to reality. The report provides an Update on the Regulation of Novel Devices Focus on the Continued Fight against Nosocomial Infections Innovations in Blood Banking Histology/Cytology innovations; the role of FISH testing and Digital Images

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY Introduction -Doing More with Less Scope and Methodology Size and Growth of the Market Regional Breakout - Major Countries Regional Breakout- Emerging Countries IVD Market Growth Indicators Lean Industry Group Purchasing Healthcare Reform Aging Population Emerging Markets Predicted Changes in the IVD Market Top Companies Market Trends Human Genome Project Remote Monitoring Development of IVD Product Choices Educated Consumers Reimbursement Need to Document Home Care Benefits

CHAPTER TWO: INTRODUCTION New Report Design Note on Acquired Companies Lab Medicine Disciplines and Applications Definitions Market Analysis of IVD Market Segments The Big Get Bigger Licenses and Collaboration agreements Test Services Top Suppliers and Niche Players Laggards Point of View A Note on 6th Edition and 7th Edition Variances

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS Background Population and Disease Demographics, Worldwide Regional Segments of the World IVD Market and IVD Market Evolution Latin American IVD Sales, 2009 and 2014 ($ million) Special Topics Special Topics Initiatives to Support Healthcare Delivery, Worldwide China and India - Contrast and Compare India World Demand for IVD Tests and Services Insurance Costs, Worldwide An Overview of Medical Tourism Specific Country Information The United States US Healthcare Reform Japan Europe Denmark Poland China India

CHAPTER FOUR: TRENDS AND INNOVATION The Economics of Healthcare in Economic Stress IVD in Recessionary Time Hospital Market Outlook Health Care Reform EMR Update Patients Seek Test Results

Status of EMR Conversion Wireless Connectivity and Healthcare Efficiencies IVD Wireless Applications Connectivity Imperative for POC devices RALS Wireless Apps Everywhere Consumer Reaction to Wireless Devices Lab-on-a chip The search for non-invasive tools Saliva Breath Optical Techniques Patch Technology Wearable Sensors/Textiles Reimbursement Challenges and Developments The Biomarker Revolution The In Vivo - In Vitro Diagnostic Service

CHAPTER FIVE: POINT-OF-CARE TESTS Overview The Major POC Test Players DTC - The Myth of Consumerism Market Analysis Diabetes Testing - Blood Glucose Monitoring (BGM) Blood Glucose Self-Testing Continuous Self Testing Blood Glucose Testing by Professionals Diabetes Testing - Glycated Hemoglobin The Commercial Outlook for POC Tests

CHAPTER SIX: THE CORE LAB Core Lab Overview Workstations Automation Overview of Chemistry Tests Market Analysis Lab-based Chemistries Critical Care Analysis Continuous Testing Urinalysis The Commercial Outlook for Chemistry Tests

CHAPTER SEVEN: IMMUNOASSAYS Overview of Immunoassays

Special Topics The Role of Immunoassays in Disease Management Market Analysis: Leading Suppliers and Growth Potential Immunoassay Test Segments — Mature, Maturing and Emerging Mature Assay Segment Thyroid Function Therapeutic drug tests Anemia Tox/DAU Allergy Maturing Immunoassays Proteins Growth Immunoassays Tumor Markers Cardiac Markers Autoimmune Sepsis Diabetes Miscellaneous Point-of-care OTC and Professional Use Patient Self-tests (OTC) Pregnancy Testing The Commercial Outlook for Immunoassays

CHAPTER EIGHT: MOLECULAR ASSAYS Overview Special Topics The Promise of Personalized Medicine - The $1000 Genome Molecular Testing Innovation - Sequencing and Mass Spectroscopy Molecular Testing Innovation: Technology and Players Market Analysis Nucleic Acid Tests Prenatal Chromosome Analysis Tissue Typing The Commercial Outlook for Molecular Tests

CHAPTER NINE: HEMATOLOGY Overview Decentralized Hematology Testing Market Analysis: Leading Suppliers The Commercial Outlook for Hematology Tests

CHAPTER TEN: COAGULATION Overview of Coagulation and Immunohematology Tests

The PGx Debate Market Analysis Lab-based Testing Genetic Markers of Hypercoagulopathies Decentralized Coagulation testing - Professional Use Decentralized Coagulation testing - OTC Platelet Testing Leading Suppliers The Commercial Market for Coagulation Tests

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY Overview Special Topics Infectious Disease Diagnostics in 2009 Global Disease Surveillance Hospital Acquired Infections (HAIs) Emerging Organisms and the Globalization of Infectious Diseases Market Analysis Supplies Microbial Identification and Antimicrobial Sensitivity Tests Blood Culture Rapid Tests Immunoassays - Lab Based Immunoassays - Rapid TB HIV Molecular Tests Figure 8-4 The Commercial Outlook for Microbiology / Virology Tests

CHAPTER TWELVE: BLOOD BANKING SERVICES Overview Blood Management - are all these transfusions good medicine? Automation to save time Artificial Blood Products - renewed interest Market Analysis Blood Banking Diagnostics Market, 2009 and 2014 Blood Grouping Immunoassays Nucleic Acid Testing (NAT) Continues to Grow The Commercial Outlook for Blood Banking

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY Overview

Special Topics The Growth of Histology/Cytology Test Services Market Analysis Histology/Cytology Traditional Stains Immunohistochemistry and In situ hybridization Pharmacodiagnostic Histology Digital Imaging Tissue Microarrays Circulating Tumor Cells Flow Cytometry The Commercial Outlook for Histology and Cytology Tests

CHAPTER FOURTEEN: COMPANY PROFILES: THE TOP TIER Abbott Diagnostics Recent Revenue History Key Comment Immunoassays Core Lab Hematology Molecular Histology Molecular Diagnostics Infectious Diseases - Molecular Oncology Abbott Diabetes Care Blood Bank Point of Care Microbiology Information Technology ARKRAY (formerly Kyoto Daiichi) Recent Revenue History Key Comment Becton, Dickinson and Company (BD) Recent Revenue History ($ million, estimated) Key Comment Histology Flow Cytometry Molecular Microbiology BD Vacutainer Blood Collection Products (Preanalytical Systems) Beckman Coulter Inc Recent Revenue History ($ million, * estimated) Key Comment Hematology Core Lab Automation

Immunoassays Coagulation FOB Flow Cytometry Image Cytometry Molecular Research Markets The Olympus franchise Blood Bank Automation bioMérieux Inc Recent Revenue History Key Comment Microbiology Information Technology Immunoassays Molecular Bio-Rad Laboratories Inc Recent Revenue History ($ million, * estimated) Key Comment Microbiology Immunoassays Point of Care Quality Control Mass Spectroscopy Gen-Probe Inc Recent Revenue History ($ million) Key Comment Blood Bank Oncology Hologic, Inc Recent Revenue History ($ million, estimated) Key Comment Histology HPV Instrumentation Laboratory (IL) Recent Revenue History ($ million, estimated) Key Comment Coagulation Critical Care Inverness Medical Innovations Recent Revenue History ($ million, * estimated) Key Comment POC Ortho Clinical Diagnostics Recent Revenue History ($ million)

Key Comment Blood Bank Core lab Remote Sensing Immunoassays Infectious Diseases QIAGEN N.V Recent Revenue History ($ million, * estimated) Key Comment Histology Infectious diseases Oncology Radiometer A/S Recent Revenue History Key Comment Immunoassays Roche Diagnostics Recent Revenue History Key Comment Diabetes Care Point-of-Care Core Lab Histology Immunoassays H1N1 PCR Infectious Diseases Blood Bank Personalized medicine Research Siemens Healthcare Diagnostics Recent Revenue History ($ million) Key Comment Critical Care Microbiology Allergy Hematology Coagulation Immunoassays Urinalysis Core Lab Connectivity In Vivo Sysmex Corporation Recent Revenue History ($ million) Key Comment

Automation Hematology Remote Diagnostics Oncology Blood Bank Molecular IT Thermo Fisher Scientific Inc Recent Revenue History Key Comment

CHAPTER FIFTEEN: COMPANY PROFILES: THE SECOND TIER Affymetrix, Inc Recent Revenue History (product sales, $ million) Key Comment Agendia BV Recent Revenue History Key Comment Axis-Shield plc Recent Revenue History ($ million) Key Comment Bruker BioSciences Corporation Recent Revenue History Key Comment Celera Diagnostics Recent Revenue History ($ million)* Key Comment Infectious Diseases Cepheid Recent Revenue History ($ million) Key Comment Clarient Inc. (formerly ChromaVision) Recent Revenue History ($ million) Key Comment Clinical Data, Inc Recent Revenue History ($ million) Key Comment Cardiac Oncology Danaher Corporation Recent Revenue History Key Comment DiaSorin S.p.A Recent Revenue History ($ million) Key Comment Eiken Chemical Co., Ltd

Recent Revenue History (not all clinical diagnostics) ($ million) Key Comment ELITech Group Recent Revenue History ($ million) Key Comment Fujirebio Diagnostics, Inc Recent Revenue History ($ million) Key Comment Genomic Health, Inc Recent Revenue History ($ million) Key Comment Genzyme Genetics Recent Revenue History ($ million) Key Comment Innogenetics NV Recent Revenue History ($ million) Key Comment International Technidyne Corp (ITC) Recent Revenue History Key Comment IRIS International, Inc Recent Revenue History ($ million) Key Comment Urinalysis Molecular Laboratory Corporation of America Holdings (LabCorp) Recent Revenue History ($ million) Key Comment Life Technologies Key Comment Luminex Corporation Recent Revenue History ($ million) Key Comment Magellan Biosciences Recent Revenue History Key Comment A. Menarini Diagnostics Recent Revenue History Key Comment Mindray Bio-Medical Electronics Co., Ltd Recent Revenue History ($ million, estimated) Key Comment Monogram Biosciences, Inc. (formerly ViroLogic) Recent Revenue History ($ million) Key Comment Myriad Genetics, Inc

Recent Revenue History ($ million) Key Comment Nanosphere, Inc Recent Revenue History Key Comment Immunoassays Nova Biomedical Recent Revenue History Key Comment PerkinElmer, Inc Recent Revenue History ($ million) Key Comment Prenatal and Neonatal Screening Phadia AB Recent Revenue History ($ million) Key Comment Autoimmune Quest Diagnostics Recent Revenue History ($ million) Key Comment HIV Oncology Pharmacodiagnostics Neonatal Quidel Corporation Recent Revenue History ($ million) Key Comment Randox Laboratories Ltd Recent Revenue History Key Comment Quality Control Rosetta Genomics Ltd Recent Revenue History Key Comment Sequenom Recent Revenue History ($ million) Key Comment Third Wave Technologies Inc Recent Revenue History ($ million) Key Comment TOSOH Corporation Recent Revenue History ($ million, estimated) Key Comment Trinity Biotech plc Recent Revenue History ($ million, estimated) Key Comment

Immunoassays HIV Coagulation Veridex, LLC Recent Revenue History Key Comment Werfen Group S.A Key Comment

CHAPTER SIXTEEN: COMPANY PROFILES - THE THIRD TIER 3M Medical Diagnostics AcroMetrix Advanced Liquid Logic, Inc AltheaDx Technologies, Inc AMDL Diagnostics, Inc. (ADI) Arrayit Diagnostics Inc AviaraDx (formerly Arcturus Biosciences) Biocare Medical LLC Biotage AB (formerly Pyrosequencing Technologies) bioTheranostics BioTrove, Inc China Medical Technologies, Inc DxS Ltd Envision ALR Epigenomics AG Exosome Diagnostics Inc Grifols, S.A Idaho Technology Inc iKaryos Diagnostics Interleukin Genetics, Inc Intrinsic Bioprobes Inc Ionian Technologies, Inc Linkage Biosciences, Inc Millipore Corporation Nanogen Inc OncoMethylome Sciences S.A OPTI Medical Systems OptiGene Ltd Polymedco, Inc Saladax Biomedical, Inc. (SBI) SensiGen LLC Source MDx Spartan Bioscience Inc SQI Diagnostics Inc TessArae, LLC Transgenomic Inc

TrimGen Corporation TrovaGene, Inc Vermillion Inc Wako Pure Chemical Industries, Ltd

CHAPTER SEVENTEEN: COMPANY PROFILES - BLOOD BANK SPECIALISTS AbSorber AB Arteriocyte, Inc Biotest AG CaridianBCT Inc. (formerly Gambro BCT) Cerus Corporation Daxor Corporation Fenwal Inc Immucor, Inc IntelliDOT Corp Novartis Vaccines and Diagnostics/Chiron Progenika Inc Quotient Biodiagnostics Inc Verax Biomedical Inc

CHAPTER EIGHTEEN: COMPANY PROFILES - COAGULATION SPECIALISTS Accumetrics Corgenix Medical Corporation Diagnostica Stago

CHAPTER NINETEEN: COMPANY PROFILES - DIABETES SPECIALISTS AgaMetrix, Inc Bayer Diabetes Care Animas Corporation Bionime Corporation BodyTel Scientific, Inc DexCom, Inc Diabetech, LP Diagnostic Devices, Inc Entra Health Systems Fora Care Home Diagnostics, Inc Insulet Corporation Lifescan Inc Medtronic Inc OrSense Ltd Smiths Medical MD, Inc. (formerly Deltec, Inc.) Solianis Monitoring AG

CHAPTER TWENTY COMPANY PROFILES - HEMATOLOGY SPECIALISTS Burnet Institute CellaVision AB Chempaq A/S Guava Technologies, Inc Horiba Medical Partec GmbH PointCare Technologies QBC Diagnostics, Inc Zyomyx Inc

CHAPTER TWENTY-ONE: COMPANY PROFILES - HISTOLOGY SPECIALISTS Aperio Technologies, Inc BioImagene Celerus Diagnostics Compucyte Corporation CytoCore, Inc Dako A/S Expression Pathology Inc Genetix Applied Imaging HistoRx, Inc Ikonisys, Inc InterGenetics Inc mtm laboratories AG Pathwork Diagnostics Vision BioSystems Ltd

CHAPTER TWENTY-TWO: COMPANY PROFILES - IMMUNOASSAY SPECIALISTS Adlyfe, Inc Akers Biosciences, Inc Amorfix Life Sciences Ltd Atherotech Avioq, Inc Axela Biosensors, Inc BG Medicine Inc Biomerica Inc BioPorto A/S BioSystems International (BSI) B·R·A·H·M·S Aktiengesellschaft CeMines, Inc Concateno Plc Cylex Incorporated Decision Biomarkers Inc Immunodiagnostic Systems Ltd Innotrac Diagnostics Oy

Inova Diagnostics Inc IVAX Diagnostics, Inc LifeAssays AB Meridian Bioscience, Inc Miraculins Inc Ridge Diagnostics, Inc Shanghai Kehua Bio-engineering SpectraCell Laboratories, Inc

CHAPTER TWENTY-THREE: COMPANY PROFILES - MICROBIOLOGY SPECIALISTS

3QBD Accelr8 Technology Corporation Advanced Analytical Technologies Inc AdvanDx, Inc Arbor Vita Corporation bioLytical Laboratories BioVei Incorporated Cellestis Ltd Chembio Diagnostic Systems, Inc Copan Diagnostics Inc Diagnostic HYBRIDS, Inc. (DHI) Dynacon Inc eGenomics, Inc Enigma Diagnostics Limited Focus Diagnostics, Inc GlysBy Hain Lifescience GmbH Innovotech Inc Liofilchem s.r.l MicroPhage, Inc Mobidiag Oy

CHAPTER TWENTY-FOUR: COMPANY PROFILES - MOLECULAR TEST SPECIALISTS

Arrayit Diagnostics Inc Advanced Analytical Technologies, Inc. (AATI) Arcxis Biotechnologies AutoGenomics, Inc BioHelix Corporation CyGene Laboratories Inc DioGenix, Inc DNage GeneNews Limited Ipsogen

KREATECH Biotechnology B.V Med BioGene, Inc. (MBI) Microchip Biotechnologies, Inc. (MBI) OncoMethylome Sciences S.A Orchid Cellmark Orion Genomics Psynomics Incorporated Rubicon Genomics, Inc Seegene, Inc Tepnel Life Sciences TwistDx, Ltd WaferGen Biosystems, Inc

CHAPTER TWENTY-FIVE: COMPANY PROFILES - POINT-OF-CARE SPECIALISTS 77 Elektronika Kft A/C Diagnostics Acon Laboratories, Inc Acrongenomics Inc Amic AB BioIQ ContraVac, Inc HemoCue AB Identa Corporation Philips Electronics NV QuantRx Biomedical Corporation Screening Devices Canada, Inc Sphere Medical Ltd Soar BioDynamics, Ltd VeriChip Corporation Vital Diagnostics

LIST OF EXHIBITS

LIST OF TABLES CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Exchange Rate Fluctuations, 2006-2009 Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Country/Region

2009-2014 (N. America, Western Eruope, Eastern Europe, ROW, India, L. America, Japan, China)

Figure 1-1: Worldwide IVD Market, 2009 and 2014 ($million) Figure 1-2: Regional Breakout of World IVD Market, 2009 Figure 1-3: Regional Breakout of World IVD Market, 2014 Table 1-3: Top IVD Companies

CHAPTER TWO: INTRODUCTION

Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market (Clinical Chemistry, Immunoassays, Hematology, Microbiology, Microbiology Molecular, Radioimmunoassays, Coagulation, Histology/Cytology, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, POC) 2009-2014 ($million)

Figure 2-1: Breakout of IVD Market by Segment Figure 2-2: Consolidation in IVD as of 2009 Table 2-2: Selected Diagnostics Industry Acquisitions, 2008-2009 (Company,

Location, Details) Table 2-2 (cont.): Selected Diagnostics Industry Acquisitions, 2008-2009 Table 2-3: Selected Diagnostics Industry Distribution Agreements, 2008-2009 Table 2-3 (cont.): Selected Diagnostics Industry Distribution Agreements, 2008-

2009 Table 2-4: Selected Diagnostics Industry Collaborations and Licensing

Agreements, 2008-2009 (Company, Location, Action, Details) Table 2-5: Selected Test Services, sales 2008-2009 (Company, Location, Area,

2008 Revenues, 2009 Revenues, CAGR) Figure 2-3: Growth Rate of Testing Companies vs. Industry Table 2-6: Selected CLIA-certified labs established in 2008 & 2009 (Company,

Location, Details) Table 2-7: Revenues of Selected IVD Companies 2007-2009 Figure 2-4 Top Tier IVD Companies, 2007 and 2009 Table 2-8: Selected IVD Market Laggards, 2008-2009

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

Table 3-1: Selected Disease Statistics, Worldwide, 2008 Table 3-2: Worldwide In Vitro Diagnostics Sales by Country/Region 2009-2014,

(N. America, EU 15/W. Europe, Japan, China, L. America, India, EU 14/ E.Europe, ROW)

Figure 3-1: Chinese IVD Sales, 2009 and 2014 Figure 3-2: Indian IVD Sales, 2009 and 2014 Figure 3-3: Latin American IVD Sales, 2009 and 2014 Table 3-3: Infrastructure Data for Major Markets, 2005-2006 * (India, China ,

U.S.) Table 3-4: Percent Change in Industrial Productivity, December 2007 to

December 2008 Table 3-5: OECD Country Healthcare Statistics for US, Germany, Sweden,

Canada, Italy, Spain, Australia, Netherlands, UK and France Figure 3-4: Healthcare Costs as a Percent of GDP for US, Germany, Sweden,

Canada, Italy, Spain, Australia, Netherlands, UK and France Table 3-6: IVD Expenditure per person, 2009 for US, Italy, France, Japan,

Germany, Spain, UK, Russia, Brazil, China, India Table 3-7: Number of Hospitals and Hospitals with Labs: US & Canada, Europe,

Asia, Latin America, Africa, Oceana Table 3-7: Medical Cost Increases in 18 Countries, Worldwide, 2006-2008

Figure 3-5: North American IVD Market (US and Canada), 2009 and 2014 Table 3-8: U.S. Lab Service Market, 2009 (Type[Hospital/Independent/POL],

Market Share, Revenue) Figure 3-6: Japanese IVD Market Table 3-9: European Union IVD Sales by Country (Germany, Italy, France,

Spain, UK, Belgium, Netherlands, Portugal, Greece, Sweden, Austria, Denmark, Finland, Ireland, Eastern Europe, Other), 2008

CHAPTER FOUR: TRENDS AND INNOVATION

Table 4-1: Average Unemployment Rates, 2009 Table 4-2: Selected POC Wireless Innovations, 2008-2009 (Company, Location,

Details, Status) Table 4-3: RALS connected POC systems, 2009 Table 4-4: Selected biochip and biosensor innovations, 2009 (Organization,

Location, Target, Details) Table 4-5: Selected Innovations in Non-invasive Testing, 2008/09 Table 4-6: Selected Disease Markers in Exhaled Breath Table 4-7: Selected Novel Biomarkers Under Investigation

CHAPTER FIVE: POINT-OF-CARE TESTS

Figure 5-1: POC Test Market , 2009 and 2014 ( ) Table 5-1: POC Sales by Test Category, worldwide 2009-2014 Figure 5-1: Breakout of POC Self Test Market (excluding Glucose) Table 5-2: POC Test Revenues of Selected IVD Companies, , estimated Table 5-3: World Glucose Monitoring Sales, by Company, 2007 - 2009 ( ,

estimated) Table 5-4: Selected Glucose Meter Innovations, 2008-2009 Table 5-5: Selected Data Management Enabled BGMs, 2009 Table 5-6: Selected Continuous BGM Sales, 2009 Table 5-7: Selected Continuous Blood Glucose Systems, 2009 Table 5-8: Selected POC HbA1c Devices, 2009

CHAPTER SIX: THE CORE LAB

Table 6-1: Clinical Chemistry/Immunoassay Sales, 2009-2014 (General Chemistries, Immunos on Workstations, Immunos on Immunoanalyzers)

Figure 6-1: Immunoassay on Workstation Revenues Table 6-2: Core Lab Sales of the Top Five Manufacturers, 2007-2009, * Table 6-3: Lab Automation Summary, Number of Installations, Worldwide, 2009*

(Pre Analytical, Track Connection) Table 6-4: Selected Core Lab Automation Innovations, 2008-2009 Table 6-5: Worldwide Clinical Chemistry Sales by Test Category 2009-2014

(General Chem, Blood Gases, Urinalysis, Critical Care POC) Table 6-6: Selected Critical Care Analysis Innovations, 2008-2009

Table 6-8: Selected Urinalysis Innovations, 2008-2009

CHAPTER SEVEN: IMMUNOASSAYS

Table 7-1: Selected Immunoassays on Core Lab Instruments, 2008-2009 Table 7-2: Selected New Immunoassay Platforms, 2009 Table 7-3: Worldwide Lab-Based Immunoassay Sales by Analyte Type

(Infectious Disease, Cardiac Marker, Tumor Marker, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Therapetuic Drugs, Drugs of Abuse, Fertilty), 2009-2014

Figure 7-1 Selected Immunoassays on Core Lab Instruments, 2008-2009 Figure7-2: Immunoassay Sales by Type Table 7-4: Revenue History of Leading Immunoassay Vendors, 2007-2009 Table 7-5: Selected Tumor Marker Innovations, 2008-2009 Table 7-6: Selected Cardiac Marker Innovations, 2008-2009 Table 7-7: Selected Autoimmune Immunoassay Innovations, 2008-2009 Table 7-8: Selected Immunoassay Innovations, 2008-2009 Table 7-9: POC Immunoassay Test Sales by Test Category

(Pregnancy/Ovulation, Drugs of Abuse, H. pylori, HIV, HbA1c, Cardiac Markers, Other) 2009-2014,

Table 7-10: Selected Professional POC Test Innovations 2008-2009

CHAPTER EIGHT: MOLECULAR ASSAYS

Table 8-1: Selected Drug/Test Pharmacodiagnostic Combinatios Table 8-2 Selected Test Innovations Table 8-3: Selected Nucleic Acid Testing Platforms, 2008-2009 Table 8-4: Selected Pre-Analytical Sample Preparation Products, 2008-2009 Table 8-5: Selected Molecular QC Products, 2008-2009 Table 8-6: Worldwide Molecular Test Sales by Type, 2009-2014 (Infectious

Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)

Figure 8-1: Molecular Assay Sales, 2009 and 2014 Table 8-7: Molecular Test Revenues of Selected IVD Vendors, 2007-2009 Table 8-8: Worldwide Molecular Test Sales for Inherited Disease, Oncology and

Pharmacodiagnostics, 2009-2014 Table 8-9: Selected Blood-based Molecular Tests Table 8-10: Selected Molecular Tests for Prenatal Analysis, 2008-2009 Table 8-11: Selected HLA Typing Tests, 2008-2009

CHAPTER NINE: HEMATOLOGY

Table 9-1: Selected Hematology Innovations, 2008-2009 Table 9-2: Selected POC Hematology Systems, 2008-2009 Figure 9-1: Hematoogy Diagnostics Market, 2009 and 2014 Table 9-3: Revenue History of the Major Hematology Vendors 2007-2009

CHAPTER TEN: COAGULATION

Table 10-1: Selected Warfarin Sensitivity Tests, 2009 Table 10-2: Worldwide Coagulation Sales by Segment ( ) 2009-2014 Table 10-3: Selected Coagulation Innovations, 2008-2009 Table 10-4: World POC Coagulation Sales, 2009 ( ) Table 10-5: Selected CLIA Waived PT Devices Table 10-6: Top Coagulation Company Revenues 2007 - 2009, estimated Table 10-7: Selected Coagulation Test Innovations, 2008-2009

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY

Table 11-1: Selected Advanced Microbiology Platforms Table 11-2: Worldwide Microbiology/Virology Sales by Type (Infectious Disease

Immuno and Rapid, ID/AST, Molecular Infectious Disease Testing) 2009-2014, Table 11-3: Selected Chromogenic Growth Media Figure 11-1: ID/AST Systems Market, 2009 and 2014 Table 11-4: Revenue of Selected ID/AST Product Companies, 2009 (estimated) Table 11-5: Selected ID/AST Innovations, 2008-2009 Table 11-6: Lab-Based Infectious Disease Immunoassays, by Test, 2009

(Hepatitis, HIV, Sepsism Respiratory, STDs, TORCH, Parasitology, Mycology, Others)

Table 11-7: Selected Infectious Disease Immunoassay Innovations, 2008-2009 Table 11-8: Selected Professional-use POC Tests for Infectious Diseases, 2008-

2009 Table 11-9: Molecular Test Sales, Infectious Diseases, 2009-2014, (HAI, HIV,

Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, others) Figure 11-3: Molecular Test Sales, Infectious Diseases by Disease Figure 11-4: Growth of Hospital Acquired Infections Diagnostics: Table 11-10: Selected Infectious Disease Molecular Test Innovations, 2008-2009

CHAPTER TWELVE: BLOOD BANKING SERVICES

Table 12-1: Blood Component Usage Table 12-2: Worldwide Blood Bank Sales, 2009-2014 Table 12-3: Selected Blood Screen Immunoassay Innovations, 2008-2009 Table 12-4 Selected Blood Bank Innovations

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY

Table 13-1: Worldwide Histology/Cytology Sales by Type, 2009-2014 Table 13-2: Selected vendors of traditional histology stains Figure 13-1:Pap Smear Market Growth, 2009 and 2014 Table 13-3: Revenues of the Major Automated Histology Companies, 2007-2009 Table 13-4: Selected HPV test innovations, 2009 Figure 13-2: ISH Testing Market, 2009 and 2014

Table 13-5: Selected Digital Imaging Innovations, 2008-2009 Table 13-6: Selected tissue microarray products, 2008-2009 Figure 13-3: Flow Cytometry Market, 2009 and 2014 Table 13-7: Revenue History of Flow Cytometry by Company, 2007-2009 Table 13-8: Selected CD4 Test Innovations, 2008-2009

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