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, stands as 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 segment, the innovations that are occurring, trends that are impacting the segment. Market size, and forecast and market share are provided; and discussion of regional numbers of the segment is provided where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market is provided for 2009; projections are made through 2014.

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.

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

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

The report covers companies that are established leaders in in vitro diagnostics, companies that dominate a specialty area and those that have very innovative or promising approaches. Over two hundred companies are profiled in the The Worldwide Market for In Vitro Diagnostics; among those companies profiled:

• Abbott Diagnostics

• ARKRAY

• Becton, Dickinson and Company (BD)

• Beckman Coulter Inc.

• bioMérieux Inc.

• Bio-Rad Laboratories Inc.

• Gen-Probe Inc.

• Hologic, Inc.

• Instrumentation Laboratory (IL)

• Inverness Medical Innovations

• Ortho Clinical Diagnostics

• QIAGEN N.V.

• Radiometer A/S

• Roche Diagnostics

• Siemens Healthcare Diagnostics

• Sysmex Corporation

• Thermo Fisher Scientific Inc.

• Affymetrix, Inc.

• Agendia BV

• Axis-Shield plc

• Bio-Reference Laboratories, Inc. (BRLI)

• Bruker BioSciences Corporation

• Celera Diagnostics

• Cepheid

• Clarient Inc.

• Clinical Data, Inc.

• Danaher Corporation

• DiaSorin S.p.A.

• Eiken Chemical Co., Ltd

• ELITech Group

• Fujirebio Diagnostics, Inc.

• Genomic Health, Inc.

• Genzyme Genetics

• Innogenetics NV

• International Technidyne Corp (ITC)

• IRIS International, Inc.

• Laboratory Corporation of America Holdings (LabCorp)

• Life Technologies

• Luminex Corporation

• Magellan Biosciences

• A. Menarini Diagnostics

• Mindray Bio-Medical Electronics Co., Ltd

• Monogram Biosciences, Inc.

• Myriad Genetics, Inc.

• Nanosphere, Inc.

• Nova Biomedical

• PerkinElmer, Inc.

• Phadia AB

• Quest Diagnostics

• Quidel Corporation

• Randox Laboratories Ltd.

• Rosetta Genomics Ltd.

• Sequenom

• Third Wave Technologies Inc.

• TOSOH Corporation

• Trinity Biotech plc

• Veridex, LLC

• Werfen Group S.A.

• 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

• 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.

• AbSorber AB

• Arteriocyte, Inc.

• Biotest AG

• CaridianBCT Inc.

• Cerus Corporation

• Daxor Corporation

• Fenwal Inc.

• Immucor, Inc.

• IntelliDOT Corp.

• Novartis Vaccines and Diagnostics/Chiron

• Progenika Inc.

• Quotient Biodiagnostics Inc.

• Verax Biomedical Inc.

• Accumetrics

• Corgenix Medical Corporation

• Diagnostica Stago

• 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.

• Solianis Monitoring AG

• Burnet Institute

• CellaVision AB

• Chempaq A/S

• Guava Technologies, Inc.

• Horiba Medical

• Partec GmbH

• PointCare Technologies

• QBC Diagnostics, Inc.

• Zyomyx Inc.

• 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

• 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

• 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.

• 3QBD

• Accelr8 Technology Corporation

• Advanced Analytical Technologies Inc.

• AdvanDx, Inc.

• bioLytical Laboratories

• BioVei Incorporated

• Cellestis Ltd

• Chembio Diagnostic Systems, Inc.

• Copan Diagnostics Inc.

• Diagnostic HYBRIDS, Inc.

• Dynacon Inc.

• eGenomics, Inc.

• Enigma Diagnostics Limited

• Focus Diagnostics, Inc.

• GlysBy

• Hain Lifescience GmbH

• Innovotech Inc.

• Liofilchem s.r.l.

• MicroPhage, Inc.

• Mobidiag Oy

• Molzym GmbH & Co. KG

• Myconostica, Ltd.

• Oxoid

• Pocared Diagnostics Ltd

• Prodesse Inc.

• SIRS-Lab

• SmartGene GmbH

• TheraDoc

• TREK Diagnostic Systems

• Tyrian Diagnostics Limited

• Veredus Laboratories Pte

• ViraCor Laboratories

• VIRCO BVBA

• Advanced Analytical Technologies, Inc.

• Arcxis Biotechnologies

• AutoGenomics, Inc.

• BioHelix Corporation

• CyGene Laboratories Inc.

• DioGenix, Inc.

• DNage

• GeneNews Limited

• Ipsogen

• KREATECH Biotechnology B.V.

• Med BioGene, Inc.

• Microchip Biotechnologies, Inc.

• OncoMethylome Sciences S.A.

• Orchid Cellmark

• Orion Genomics

• Psynomics Incorporated

• Rubicon Genomics, Inc.

• Tepnel Life Sciences

• TwistDx, Ltd.

• WaferGen Biosystems, Inc.

• Xceed Molecular

• 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

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

• 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