This document provides a summary of a 900-page report on the worldwide in vitro diagnostic (IVD) test market. The report covers all areas of IVD testing and provides market statistics, analysis, and projections through 2012. It discusses trends in technology, regulations, reimbursement, and more. The document summarizes sections of the report on point-of-care testing, core lab testing, immunoassays, and molecular assays. It also profiles over 276 companies in the IVD industry.

1.
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The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 6th Edition [with 2009
economy preface]
December 1, 2008
This edition of Kalorama’s comprehensive and indispensable report covers the breadth
of traditional IVD testing. The report contains complete market statistics and analysis for
all areas of IVD, including:
• Point-of-Care
• Core Lab
• Immunoassays
• Molecular Assays
• Hematology
• Coagulation
• Microbiology and Virology
• Blood Banking
• Histology and Cytology
Market size, growth, share, and geographic distribution, as well as trends in technology
development, regulatory and reimbursement issues, clinical care, and business
environments are discussed. Projections are made through 2012.
Six Times Kalorama Has Examined the IVD Market in Full
This 900-page edition greatly expands coverage of the field and tracks the most
important developments. Expanded or added in this edition are sections on:
• The status of POC and decentralization in lab medicine
• Miniaturization and molecularization of devices
• Geo-economic and demographic influences on markets
• Non-invasive sampling
• Greatly expanded market data on PGx and SNP testing
• Revamped segmentation for clinical chemistry to include workstations and
immunoanalyzers
• More information about more immunoassays

2. • Focus on the renewed interest in microbiology/virology based on
resistance and the re-emergence of serious hospital- and community-
based organisms
• World blood banking developments
• Expanded sections on histology/cytology developments including
emerging areas such as tissue microarrays, circulating tumor cells, and
genomics-fueled innovation.
In addition, there are now profiles of established and emerging players in IVD, more
than 276 companies, from the top tier to emerging and niche competitors to watch.
As part of its coverage, the report breaks down the 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 sixth 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 since the first edition was published in 1997. At
that time, molecular testing was a small emerging discipline that related to chlamydia,
gonorrhea, TB, and some inherited diseases.
That first edition didn’t even have a chapter for molecular diagnostics; it was a
miscellaneous. Now, molecular tests are common in several segments - infectious
diseases, bacterial identification, coagulopathologies, blood unit screening, histology
and soon as POC devices. Therefore the molecular chapter in this report presents
technology and market issues that are common to all segments and concentrates on
purely molecular tests for inherited diseases. Molecular tests used in other segments
are included in the appropriate chapter. In 1997, POC testing meant glucose testing.
Similar to molecular testing, rapid and POC tests are becoming an important part of
testing on all fronts. Here too the POC chapter presents technology and market issues
that are common to all segments and concentrates on blood glucose monitoring.
A Note About The Economy in 2009 and our Forecasts
This report was completed in 2008 before the economic meltdown of 2008/2009 was
fully apparent. The report estimates the world market for IVD products. Kalorama
Information anticipates that this estimate holds true in spite of the current
financial situation. There are many reasons for this rationale. In vitro diagnostics were

3. the first products targeted for cutbacks in the major markets, the IVD industry did not
experience the explosive growth seen in some medical devices, purchases are through
group purchasing organization, new healthcare initiatives proposed by the new U.S.
administration under the guidance of President Barack Obama further bolster the use of
IVDs, and demand for healthcare and thus diagnostic tests in all the major markets. A
special appendix to this report is included to address the economy
Table of Contents
Chapter one: Executive Summary
• Overview
• Size and Growth of the Market
o Important Changes in the IVD Market
o IVD Growth in Developed Countries
o Privatization of Healthcare
o Newly Aggressive Foundations and Initiatives
• Positive and Negative Market Trends
o Human Genome Project Applications
o Remote Patient Monitoring
o Demand for Data
o The Informed Medical Consumer
o Price Point of New Products
o Focus On Home Care Raises Questions
• Top Suppliers and Niche Players
• Scope and Methodology
o Exchange Rates
o Scope
o Methodology
Chapter two: Introduction
• New Report Design
• Lab Medicine Disciplines and Applications
o Core Lab
• Market Analysis of IVD Market Segments
• Age of the Giants and Smaller Colossuses

4. • Licenses and Distribution Agreements
• Top Suppliers and Niche Players
• Point of View
Chapter three: Overview of Global In Vitro Diagnostic Markets
• The Boomers and Aging Worldwide
• Healthcare Spending Worldwide
• World Segments of the IVD Market and IVD Market Evolution
o The United States
o Japan—Just Barely Holding Its Own
o Europe
o China
o India
o Africa
CHAPTER FOUR: TRENDS AND INNOVATIONS:
• Background
• Diabetes innovation
• Miniaturization And Chip Progress
• Non-Invasive Techniques And Alternative Samples
• Commercialization Issues : Patents and market innovation
• Direct to Consumer marketing
• Patient Management and Outcomes-Based Medicine
• Economics of New Tests and Technologies - the old don't disappear
• Post Genomics and Pharmacogenomics - reality check
• Growing Globalization of Public Health Crises - SARS, West Nile, Biowar impact
• Regulatory and Reimbursement Issues And Novel Devices
CHAPTER FIVE: Point-of-Care Tests
• Overview
• Special Topics
o POC in world market
o The pros and cons of POC testing
o Telemedicine Goes Wireless
• Market Analysis
o Blood Glucose Monitoring
• The Commercial Outlook for POC Tests

5. • Companies to Watch
chapter six: The Core Lab
• Core Lab Overview
• Overview of Chemistry Tests
• Special Topics
o Competing for Customer Loyalty
o Client Side
o Vendor Side
o Managed Service Plans
• Market Analysis
o Lab-based Chemistries
o Critical Care Chemistries
o Responses to Cost Pressures
• The Commercial Outlook for Chemistry Tests
• Companies to Watch
• Abaxis, Inc.
o Recent Revenue History
o Key Comment
o Details
• Abbott Diagnostics
o Recent Revenue History
o Key Comment
o Details
• Beckman Coulter Inc.
• Beckman Coulter Inc.
o Recent Revenue History
o Key Comment
o Details
• Instrumentation Laboratory (IL)

6. o Recent Revenue History
o Key Comment
o Details
• IRIS International, Inc.
• IRIS International, Inc.
o Recent Revenue History
o Key Comment
o Details
• Maxmat S.A.
• Maxmat S.A.
o Recent Revenue History
o Key Comment
o Details
• Nova Biomedical
o Recent Revenue History
o Key Comment
o Details
• Olympus America Inc.
o Recent Revenue History
o Key Comment
o Details
• OPTI Medical Systems, Inc.
• OPTI Medical Systems, Inc.
o Recent Revenue History
o Key Comment
o Details
• Ortho Clinical Diagnostics (OCD)
o Recent Revenue History

7. o Key Comment
o Details
• Probe Scientific
o Recent Revenue History
o Key Comment
o Details
• Radiometer A/S
o Recent Revenue History
o Key Comment
o Details
• Randox Laboratories
o Recent Revenue History
o Key Comment
o Details
• Roche Diagnostics
o Recent Revenue History
o Key Comment
o Details
• Siemens Medical Solutions Diagnostics
o Recent Revenue History
o Key Comment
• Sphere Medical Ltd.
o Recent Revenue History
o Key Comment
o Details
chapter seven: Immunoassays

8. • Overview of Immunoassays
o New Immunoassays
o Changes in the Immunoassay Market
• Special Topics
o Proteins: How Low Can You Go
o New Platforms
o immunoPCR
o FACTT
o NADIA
o ELISA
o Role of Immunoassays in Disease Management
• Market Analysis: Leading Suppliers and Growth Potential
o Regional Breakdown
o Abbott
o Roche
o Beckman Coulter
o Siemens/Bayer
o bioMerieux
o Seimens/Dade Behring
• Immunoassay Test Segments— Mature, Maturing and Emerging
o Thyroid Function
o Therapeutic drug tests
o IMx Sirolimus
o Tacrolimus
o Mature Immunoassays
o Anemia
o Fertility
o Tox/DAU
o Allergy
o Maturing Immunoassays
o Proteins
o Growth Immunoassays
o Tumor Markers
o Cardiac Markers
o Autoimmune
o Sepsis
o Diabetes

9. o Miscellaneous
• Point-of-care OTC and Professional Use
o Patient Self-tests (OTC)
o Pregnancy
o Fecal Occult Blood
o Breath Tests
o Professional POC
o Cholesterol
o Cardiac Markers
o Cancer Markers
• The Commercial Outlook for Immunoassays
• Companies to Watch
• Aesku Diagnostics
o Recent Revenue History
o Key Comment
o Details
• AspenBio Pharma, Inc.
o Recent Revenue History
o Key Comment
o Details
• Axela Biosensors, Inc.
o Recent Revenue History
o Key Comment
o Details
• Axis-Shield plc
o Recent Revenue History
o Key Comment
o Details

10. • BG Medicine Inc.
o Recent Revenue History
o Key Comment
o Details
• The Binding Site
o Recent Revenue History
o Key Comment
o Details
• Biocheck Inc.
o Recent Revenue History
o Key Comment
o Details
• BioCurex, Inc.
o Recent Revenue History
o Key Comment
o Details
• BioMarker Group
o Recent Revenue History
o Key Comment
o Details
• BioMedical Diagnostics SA (BMD)
o Recent Revenue History
o Key Comment
o Details
• Biosite Incorporated
o Key Comment
o Details

11. • BioSystems International
o Recent Revenue History
o Key Comment
o Details
• Bio-Rad Laboratories Inc.
o Recent Revenue History
o Key Comment
o Details
• Chimera Biotec GmbH
o Recent Revenue History
o Key Comment
o Details
• China Medical Technologies, Inc.
o Key Comment
o Details
• Concateno Plc
o Recent Revenue History
o Key Comment
o Details
• Conceivex, Inc.
o Recent Revenue History
o Key Comment
o Details
• Corgenix Medical Corporation
o Recent Revenue History
o Key Comment

12. o Details
• Crescent Diagnostics Ltd.
o Recent Revenue History
o Key Comment
o Details
• Critical Therapeutics, Inc.
o Recent Revenue History
o Key Comment
o Details
• Cylex Incorporated
o Recent Revenue History
o Key Comment
o Details
• CytoCore, Inc.
o Recent Revenue History
o Key Comment
o Details
• Diazyme Laboratories
o Recent Revenue History
o Key Comment
o Details
• Early Detect, Inc.
o Recent Revenue History
o Key Comment
o Details

13. • ESA Biosciences Inc.
o Recent Revenue History
o Key Comment
o Details
• Euroimmun AG
o Recent Revenue History
o Key Comment
o Details
• Fujirebio Diagnostics. Inc. (FDI)
o Recent Revenue History
o Key Comment
o Details
• Genosis Inc.
o Recent Revenue History
o Key Comment
o Details
• Grifols, S.A.
o Key Comment
o Details
• Guava Technologies, Inc.
o Recent Revenue History
o Key Comment
o Details
• INOVA Diagnostics Inc.
o Recent Revenue History
o Key Comment
o Details

14. • LifeAssays AB
o Recent Revenue History
o Key Comment
o Details
• Matritech
o Recent Revenue History
o Key Comment
o Details
• Medical Services International Inc.
o Recent Revenue History
o Key Comment
o Details
• Meridian Bioscience, Inc.
o Recent Revenue History
o Key Comment
o Details
• Miraculins Inc.
o Recent Revenue History
o Key Comment
o Details
• Nanobac Pharmaceuticals Inc.
o Recent Revenue History
o Key Comment
o Details
• Nanogen
o Recent Revenue History

15. o Key Comment
o Details
• Onconome, Inc.
• Onconome, Inc.
o Recent Revenue History
o Key Comment
o Details
• Panacea Pharmaceuticals, Inc.
o Recent Revenue History
o Key Comment
o Details
• Phadia AB
o Recent Revenue History
o Key Comment
o Details
• Pria Diagnostics LLC
o Recent Revenue History
o Key Comment
o Details
• Pronostics Ltd.
o Recent Revenue History
o Key Comment
o Details
• Qualigen, Inc.
o Recent Revenue History
o Key Comment
o Details

16. • Quidel Corporation
o Recent Revenue History
o Key Comment
o Details
• Reagena Ltd.
o Recent Revenue History
o Key Comment
o Details
• Response Biomedical Corporation
o Recent Revenue History
o Key Comment
o Details
• Serion Immundiagnostica GmbH
o Recent Revenue History
o Key Comment
o Details
• Singulex Inc.
o Recent Revenue History
o Key Comment
o Details
• Spectral Diagnostics Inc.
o Recent Revenue History
o Key Comment
o Details
• Synova Healthcare, Inc.
o Recent Revenue History

17. o Key Comment
o Details
• TOSOH Corporation
o Recent Revenue History
o Key Comment
o Details
chapter eight: Molecular Assays
• Overview
• Special Topics
o The Special Case of Regulating Molecular Tests
• The promise of personalized medicine
• PCR Patent Update
• Molecular Testing Innovation: Technology and Players
• Market Analysis
o Nucleic Acid Tests
o Prenatal Chromosome Analysis
o Tissue Typing
• The Commercial Outlook for Molecular Tests
• Companies to Watch
• 23andMe, Inc.
o Recent Revenue History:
o Key comment:
o Details
• 454 Life Sciences Corporation
• 454 Life Sciences Corporation
o Recent Revenue History:
o Key Comment:
o Details
o Affymetrix

18. o Recent Revenue History:
o Key Comment:
o Details
• Almac Diagnostics
o Recent Revenue History:
o Key Comment:
o Details
• Althea Technologies, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Arcxis Biotechnologies
o Recent Revenue History:
o Key Comment:
o Details
• Asuragen, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• AutoGenomics, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• BioNanomatrix
o Recent Revenue History:
o Key Comment:
o Details

19. • Bruker BioSciences Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Celera
o Recent Revenue History:
o Key Comment:
o Details
• CeMines, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Clinical Data, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• CombiMatrix Molecular Diagnostics (CMDX)
o Recent Revenue History:
o Key Comment:
o Details
• Consumer Genetics
o Recent Revenue History:
o Key Comment:
o Details
• Curidium Medica Plc
o Recent Revenue History:

20. o Key Comment:
o Details
• Sekisui Medical Co., Ltd
o Recent Revenue History:
o Key Comment:
o Details
• deCode Genetics Inc.
o Recent Revenue History:
o Key Comment:
o Details
• diaDexus Inc.
o Recent Revenue History:
o Key Comment:
o Details
• DiagnoCure
o Recent Revenue History
o Key Comment:
o Details
• DxS
o Recent Revenue history:
o Key Comment:
o Details
• eGene Inc.
o Recent Revenue History:
o Key Comment:
o Details

21. • Eiken Chemical Co., Ltd
o Recent Revenue History:
o Key Comment:
o Details
• Epigenomics AG
o Recent Revenue History:
o Key Comment:
o Details
• EXACT Sciences Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Exiqon A/S
o Recent Revenue History:
o Key Comment:
o Details
• Fluidigm Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Gen-Probe Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Genomic Health
o Recent Revenue History:
o Key Comment:
o Details

22. • Genzyme Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Greiner Bio-One International AG
o Recent Revenue History:
o Key Comment:
o Details
• Ipsogen
o Recent Revenue History:
o Key Comment:
o Details
• Laboratory Corporation of America Holdings (LabCorp)
o Recent Revenue History:
o Key Comment:
o Details
• Luminex Corporation
o Recent Revenue History:
o Key Comment:
o Details
• MacroArray Technologies, LLC
o Recent Revenue History:
o Key Comment:
o Details
• Med BioGene, Inc. (MBI)
o Recent Revenue History:

23. o Key Comment:
o Details
• Modern Technology Corp.
o Recent Revenue History:
o Key comment:
o Details
• Myriad Genetics, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Nanosphere, Inc.
o Recent Revenue History:
o Key Comment:
• Navigenics
o Recent revenue History:
o Key Comment:
o Details
• NeuroMark
o Recent Revenue History:
o Key Comment:
o Details
• NorDiag ASA
o Recent Revenue History:
o Key Comment:
o Details

24. • Novartis Vaccines and Diagnostics/Chiron
o Recent Revenue History:
o Key Comment:
o Details
• Nuvera Biosciences
o Recent Revenue History:
o Key Comment:
o Details
• Orion Genomics
o Recent Revenue History:
o Key Comment:
o Details
• Osmetech plc
o Recent Revenue History
o Key Comment:
o Details
• ParagonDx LLC
o Recent Revenue History:
o Key Comment:
o Details
• PerkinElmer, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Power3 Medical Products, Inc.
o Recent Revenue History:
o Key Comment:
o Details

25. • Progenika Biopharma
o Recent Revenue History:
o Key Comment:
o Details
• Provista Diagnostics
o Recent Revenue History:
o Key Comment:
o Details
• Psynomics Incorporated
o Recent Revenue History:
o Key Comment:
o Details
• Q Chip Ltd.
o Recent Revenue History:
o Key Comment:
o Details
• Qiagen N.V.
o Recent Revenue History:
o Key Comment:
o Details
• Quest Diagnostics Incorporated
o Recent Revenue History:
o Key Comment
o Details
• Rosetta Genomics Ltd.
o Recent Revenue History:

26. o Key Comment:
o Details
• Seegene, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• SensiGen LLC
o Recent Revenue History:
o Key Comment:
o Details
• Sequenom, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Source MDx
o Recent Revenue History:
o Key Comment:
o Details
• Tepnel Diagnostics Ltd.
o Recent Revenue History:
o Key Comment
o Details
• Third Wave Technologies Inc.
o Recent Revenue History:
o Key Comment:
o Details

27. • Whatman plc
o Recent Revenue History:
o Key Comment
o Details
• Xenomics, Inc.
o Recent Revenue History:
o Key Comment:
o Details
chapter nine: Hematology
• Overview
• Decentralized Hematology Testing
• Market Analysis: Leading Suppliers
• The Commercial Outlook for Hematology Tests
• Companies to Watch
• Alifax S.p.a.
o Recent Revenue History
o Key Comment
o Details
• CellaVision AB
o Recent Revenue History
o Key Comment
o Details
• Chempaq A/S
o Recent Revenue History
o Key Comment
o Details
• Diesse Diagnostica Senese S.p.A.
o Recent Revenue History
o Key Comment
o Details

28. • ELITech Group
o Recent Revenue History
o Key Comment
o Details
• Horiba ABX S.A.
o Recent Revenue History
o Key Comment
o Details
• QBC Diagnostics, Inc.
o Recent Revenue History
o Key Comment
o Details
• Sysmex Corporation
o Recent Revenue History
o Key Comment
o Details
chapter TEN: Coagulation
• Overview of Coagulation and Immunohematology Tests
• Market Analysis
o Lab-Based Testing
o D-dimer
o Aspirin Insensitivity
o Genetic Markers of Hypercoagulopathies
o Factor V
o Warfarin
o Decentralized Coagulation Testing - Professional Use
o Decentralized Coagulation Testing - OTC
o Leading Suppliers
• The Commercial Market for Coagulation Tests
• Companies to Watch
• HemoSense, Inc.
o Recent Revenue History: 2007 $31.9 million (est)

29. o Key Comment
o Details
• International Technidyne Corp (ITC)
o Recent Revenue History
o Key Comment
o Details
• Diagnostica Stago
o Recent Revenue History
o Key Comment
o Details
• Trinity Biotech plc
o Revenues
• Revenues
o Key Comment
o Details
• ZyCare, Inc.
o Recent Revenue History
o Key Comment
o Details
chapter eleven: Microbiology and Virology
• Overview
• Special Topics
o Hospital Acquired Infections (HAIs)
o MRSA
o HIV, a 25-year Phenomenon
o Rapid Tests for HIV
o Tuberculosis
o Cellestis
o MDR-TB

30. o Emerging Organisms and the Globalization of Infectious Diseases
o SARS
o Viral Hemorrhagic Fever
o Dengue
o MPV
o Globalization Brings New Threats
o Yaws
o Andenovirus type 14
o Non-Traditional Systems
o FISH
o Cell Counting by Flow Cytometry
o Laser Based Microbial Detection
• Market Analysis
o Supplies
o Microbial Identification and Antimicrobial Sensitivity Tests
o Blood Culture
o Rapid Tests
o Immunoassays - Lab based
o STDs
o Flu
o Immunoassays - Rapid
o Molecular Tests
• The Commercial Outlook for Microbiology / Virology Tests
• Companies to Watch
• 3M Medical Diagnostics
o Recent Revenue History
o Key Comment
o Details
• Accelr8 Technology Corporation
o Recent Revenue History
o Key Comment
o Details
• AdvanDx, Inc.
o Recent Revenue History

31. o Key Comment
o Details
• Becton, Dickinson and Company (BD)
o Recent Revenue History
o Key Comment
o Details
• bioMérieux Inc.
o Recent Revenue History
o Key Comment
o Details
• bioLytical Laboratories
o Recent Revenue History
o Key Comment
o Details
o Recent Revenue History
o Key Comment
o Details
• The BioPen Company
o Recent Revenue History
o Key Comment
o Details
• Calypte Biomedical Corporation
o Recent Revenue History
o Key Comment
o Details
• Cellestis Ltd
o Recent Revenue History
o Key Comment

32. o Details
• Cepheid
o Recent Revenue History
o Key Comment
o Details
• Chembio Diagnostics, Inc.
o Recent Revenue History
o Key Comment
o Details
• Common Sense Ltd.
o Recent Revenue History
o Key Comment
o Details
• Diagnostic HYBRIDS, Inc. (DHI)
o Recent Revenue History
o Key Comment
o Details
• Dynacon Inc.
o Recent Revenue History
o Ket Comment:
o Details
• Enigma Diagnostics Limited
o Recent Revenue History
o Key Comment
o Details

33. • GenPrime, Inc.
o Recent Revenue History
o Key Comment
o Details
• Hain Lifescience GmbH
o Recent Revenue History
o Key Comment
o Details
• HIVmirror LLC
o Recent Revenue History
o Key Comment
o Details
o Recent Revenue History
o Key Comment
o Details
• MedMira, Inc.
o Recent Revenue History
o Key Comment
o Details
• Microbionetics/IME, Inc.
o Recent Revenue History
o Key Comment
o Details
• Micro Imaging Technology, Inc. (MIT)
o Recent Revenue History
o Key Comment
o Details
• Microgen Bioproducts Ltd.

34. o Recent Revenue History
o Key Comment
o Details
• Mobidiag Oy
o Recent Revenue History
o Key Comment
o Details
• Molzym GmbH & Co. KG
o Recent Revenue History
o Key Comment
o Details
• Monogram Biosciences, Inc.
o Recent Revenue History
o Key Comment
o Details
• Myconostica, Ltd.
o Recent Revenue History
o Key Comment
o Details
• OraSure Technologies, Inc.
o Recent Revenue History
o Key Comment
o Details
• Oxoid
o Recent Revenue History
o Key Comment
o Details

35. • Pathway Diagnostics Corporation
o Recent Revenue History
o Key Comment
o Details
• Pocared Diagnostics Ltd
o Recent Revenue History
o Key Comment
o Details
• SIRS-Lab
o Recent Revenue History
o Key Comment
o Details
• StatSure Diagnostic Systems, Inc.
o Recent Revenue History
o Key Comment
o Details
• TREK Diagnostic Systems
o Recent Revenue History
o Key Comment
o Details
chapter twelve: Blood Banking Services
• Overview
o Donor Pools, Costs, Safety, Blood Supply
• The Safety Imperative
o Chagas
o West Nile
o Hepatitis and HIV

36. o Platelets
• Market Analysis
o Blood Grouping
o Immunoassays
o Nucleic Acid Testing (NAT) Continues to Grow
• The Commercial Outlook for Blood Banking
• Companies to Watch
• Cerus Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Navigant Biotechnologies, LLC
o Recent Revenue History:
o Key Comment:
o Details
• Haemonetics Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Immucor, Inc.
o Recent Revenue History:
o Key Comment:
o Details
• Medion Diagnostics AG
o Recent Revenue History: Private
o Key Comment:
o Details

37. • Pall Corporation
o Recent Revenue History:
o Key Comment:
o Details
• Sanquin Reagents
o Key Comment
o Verax Biomedica Inc.
Recent Revenue History
Private
Key Comment
Details
chapter thirteen: Histology and Cytology
• Overview
• Special Topics
o Cancer Drives Histology/Cytology Development
o The Future of the Pap Smear & HPV testing
• Market Analysis
o Histology/Cytology
o Traditional Stains
o In situ Hybridization Products: ISH, CISH and FISH
o Immunohistochemistry and in situ Hybridization
o Flow Cytometry
• The Commercial Outlook for Histology and Cytology Tests
• Companies to Watch
• Agendia B.V.
o Recent Revenue History:
o Key Comment
o Details
• Aperio Technologies, Inc.
o Recent Revenue History

38. o Private
o Key Comment
o Details
• Applied Imaging Corp./Genetix
o Recent Revenue History
o Key Comment
o Details
• AviaraDx (formerly Arcturus Biosciences)
o Recent Revenue History
o Key Comment
o Details
• BioImagene, Inc.
o Recent Revenue History
o Key Comment
o Details
• BIOVIEW, Inc.
o Recent Revenue History
o Key Comment
o Details
• Celerus Diagnostics
o Recent Revenue History
o Key Comment
o Details
• Clarient Inc. (formerly ChromaVision)
o Recent Revenue History
o Key Comment
o Details

39. • Compucyte Corporation
o Recent Revenue History
o Key Comment
o Details
• Cytyc Corporation
o Recent Revenue History
o Key Comment
o Details
• Dako A/S
o Recent Revenue History
o Key Comment
o Details
• Diamics, Inc.
o Recent Revenue History
o Key Comment
o Details
• Digene Corporation
o Recent Revenue History
o Key Comment
o Details
• eXagen Diagnostics, Inc.
o Recent Revenue History
o Key Comment
o Details
• HistoRx, Inc.
o Recent Revenue History

40. o Key Comment
o Details
• Ikonisys Inc.
o Recent Revenue History
o Key Comment
o Details
• Immunicon Corporation
o Recent Revenue History
o Key Comment
o Details
• InterGenetics, Inc.
o Recent Revenue History
o Key Comment
o Details
• MDS/Molecular Devices Corporation
o Recent Revenue History
o Key Comment
o Details
• MonoGen
o Recent Revenue History
o Key Comment
o Details
• mtm laboratories AG
o Recent Revenue History
o Key Comment
o Details

41. • Pathwork Diagnostics (formerly Predicant Biosciences)
o Recent Revenue History
o Key Comment
o Details
• Perceptronix Medical Inc.
o Recent Revenue History:
o Key Comments
o Details
• Rational Therapeutics
o Recent Revenue History
o Key Comments
o Details
• Tripath Imaging, Inc.
o Recent Revenue History:
o Key Comments
o Details
• Ventana Medical Systems. Inc.
o Recent Revenue History
o Key Comment
o Details
• Veridex, LLC
o Recent Revenue History
o Key Comment
o Details
• Vision BioSystems Ltd/Danaher Corp.
o Recent Revenue History:
o Key Comment
o Details

42. Table of Exhibits
CHAPTER ONE: Executive Summary
• Figure 1-1: World In Vitro Diagnostics Market 2007-2012 ($millions)
• Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Country/Region
2007-2012
• Figure 1-2: Regional Market Share of In Vitro Diagnostics Market, 2007 (North
America, EU, Japan, Latin America, Eastern Europe, India, China, ROW)
• Table 1-3: Top Tier IVD Companies, 2007 (Company, Country)
• Figure 1-3 Share of Top Tier Companies, 2007 vs. 2005
• Table 1-1: Exchange Rate Fluctuations, 2003-2007
CHAPTER TWO: Introduction
• Figure 2-1: Worldwide IVD Market Share by Segment
• Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market 2007-2012, $
million
• Table 2-2: Selected Diagnostics Industry Acquisitions, 2006-2007
• Table 2-3: Selected Diagnostics Industry Distribution Agreements 2006-2007
• Table 2-4: Selected Diagnostics Industry Collaborations and Licensing
Agreements, 2006-2007
• Table 2-5: Revenues of Selected IVD Companies, 2005-2007
CHAPTER THREE: OVERVIEW OF WORLD IVD MARKETS
• Table 3-1: Number of People Who Get Chronic Diseases Every Year Worldwide
by Disease
• Table 3-2: WHO Health Spending Statistics
• Figure 3-1: Health Expenditure as a Share of GDP, Developing Countries
• Figure 3-2 Health Expenditure per Capita: Private and Public
• Table 3-3: Worldwide In Vitro Diagnostics Sales by Country/Region 2007-2012
• Table 3-4: European Union IVD Sales by Country 2006
• Figure 3-3: Chinese Market for IVD Reagents 2007-2012
• Figure 3-4: Indian Market for IVD Reagents 2007-2012
CHAPTER FIVE: Point-of-Care Tests
• Table 5-1: POC Sales by Test Category, worldwide 2007-2012
• Table 5-2: World Glucose Monitoring Sales, by Company, 2005 - 2007
• Table 5-3: Selected Blood Glucose Test Devices Innovations, 2006-2007
• Table 5-4: Selected Blood Glucose Test Devices Innovations, 2006-2007
CHAPTER SIX: THE CORE LAB
• Table 6-1: Clinical Chemistry/Immunoassay Sales, 2007-2012

43. • Table 6-2: Chemistry/Immunochemistry Sales of Top Five Manufacturers, 2003-
2005
• Table 6-3: Selected Workstation Innovations, 2006-2007
• Table 6-4: Worldwide Clinical Chemistry Sales by Test Category 2007-2012
(General Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Figure 6-1: Worldwide Clinical Chemistry Sales by Test Category (General
Chem, Blood Gases, Urinalysis, Critical Care, POC)
• Table 6-5: Selected Small Lab Workstations, 2006-2007 (Company, Location,
Details, Status)
CHAPTER SEVEN: IMMUNOASSAYS
• Table 7-1: Selected New Immunoassay Platforms, 2007
• Table 7-2: Selected Small Footprint Immunoassay Systems
• Table 7-3: Worldwide Lab-Based Immunoassay Sales by Analyte Type 2007-
2012 (ID, Tumor Markers, Cardiac Markers, Diabetes/HbA1c, Thyroid, Proteins,
Autoimmune, Anemia, Therapeutic Drugs, Fertility, Allergy, Drugs of Abuse)
• Table 7-4: Revenue History of Leading Immunoassay Vendors, $ million 2005-
2007
• Table 7-5: Selected Tumor Marker Innovations, 2006-2007
• Table 7-6: Selected Cardiac Marker Innovations, 2006-2007
• Table 7-7: Selected Autoimmune Immunoassay Innovations, 2006-2007
• Table 7-8: Selected Sepsis Marker Innovations, 2006-2007
• Table 7-9: Selected Immunoassay Innovations, 2006-2007
• Table 7-10: Regional Breakdown of POC Immunoassay Market
• Figure 7-1 Regional Breakdown of POC Immunoassay Market
• Figure 7-2: Growth Rate of Immunoassays (All Immunoassays, POC OTC
Immunoassays and Professional POC)
• Table 7-10: POC OTC Immunoassay Test Sales by Test Category 2007-2012
(Pregnancy/Ovulation, Fecal Occult Blood, Drugs of Abuse, Cholesterol)
• Table 7-11: Selected OTC Test Devices, 2007
• Table 7-12: Professional POC Testing 2005-2010 (Pregnancy, Cardiac Markers,
Cholesterol/Lipids, HbA1, Fecal occult blood, Cancer Markers, Drugs of Abuse,
Other)
• Table 7-13: Selected Professional POC Tests on the Market and in
Development, 2006-2007
CHAPTER EIGHT: Molecular Assays
• Table 8-1: Selected Molecular Test Innovations, 2006/07
• Table 8-2: Selected Nucleic Acid Testing Platforms, 2006-2007
• Table 8-3: Selected Molecular Test Services, 2007
• Table 8-4: Worldwide Molecular Test Sales by Type, $million 2007-2012
• Table 8-5: Molecular Test Revenues of Selected IVD Vendors, 2005-2007
• Table 8-6: Selected Molecular Sample Preparation Products
• Table 8-7: Worldwide Molecular Test Sales, 2005-2010 (Sales in millions)

44. • Table 8-8: Most Frequently Requested Genetic Tests
CHAPTER NINE: Hematology
• Table 9-1: Selected New Hematology Analyzer Tests 1990s - 2007
• Table 9-2: Selected New Hematology Research Projects
• Figure 9-1: Estimated Market for Manual and Automated Sed Rates 2007-2012
• Table 9-3: Selected Automated ESR Systems, 2007
• Figure 9-2: Estimated Share of Hematology Market by Setting (Central vs
Decentralized) 2007
• Table 9-4: Selected POC Hematology Systems, 2007
• Figure 9-3: Estimated Distribution of Hemoglobin Testing Volume by Region
(U.S., Europe, ROW)
• Table 9-5: Revenue History of the Major Hematology Vendors by Company
2001-2007
• Figure 9-4: Market Share of Hematology Vendors 2007
• Figure 9-5: World Market for Hematology 2007-2012
• Figure 9-6: Estimated Distribution of Hematology Revenues by Region (U.S.,
Europe, Japan, ROW) 2007
• Table 9-6: Selected Hematology Innovations (Company, Location, Segment,
Details, Market Status) 2006-2007
CHAPTER TEN: Coagulation
• Table 10-1: Worldwide Coagulation Sales by Segment 2007-2012
• Figure 10-1: Regional Share of Coagulation Market, 2007
• Figure 10-2: Lab-Based Coagulation Testing 2007-2012
• Table 10-2: Selected Coagulation Automation Innovations
• Figure 10-3: Growth Rate in Coagulation Testing Segments (Genetic Markers
compared to Lab-Based, POC Self Test, and POC Professional)
• Table 10-3: Selected New Warfarin Sensitivity Tests, 2006-2007 (Company,
Location, Test, Status)
• Figure 10-4 Decentralized (POC) Coagulation Testing, Professional: 2007 and
2012 ($millions)
• Figure 10-5: Coagulation POC Testing by Region (US, Europe, ROW)
• Table 10-4: CLIA Waived PT Devices
• Figure 10-6: Decentralized (POC) Coagulation Testing, Over the Counter: 2007
and 2012
• Table 10-5: Top Coagulation Company Revenues 2005 - 2007
• Table 10-6: Selected Coagulation Test Innovations 2006-2007
chapter eleven: Microbiology and Virology
• Table 11-1: Percent of Staph infections Among U.S. Intensive Care Patients
That Are Infected with MRSA
• Table 11-2: CLIA waved Tests for HIV Market

45. • Table 11-3: Selected HIV Test Innovation, 2007
• Table 11-4: PCR, FISH, Flow and Cell Imaging Systems for Bacteria / Virus
Detection, 2007 and 2012 ($million)
• Table 11-5: Worldwide Microbiology/Virology Sales by Type 2007-2012
• Table 11-4: Selected Chromogenic Growth Media
• Table 11-6: Revenue of Selected ID/AST Product Companies, 2007
• Table 11-7: Selected Microbiology/Virology Innovations, 2006-2007 (Company,
Location, Details, Status)
• Table 11-8: Selected Immunoassays for Sepsis (Company, Location, Details,
Status)
• Table 11-9: Selected Syphilis Immunoassays, 2007
• Table 11-10: Selected Infectious Disease Immunoassay Innovations, 2006-2007
• Table 11-11: Selected POC Tests for Infectious Diseases, 2006-2007
• Figure 11-1: Molecular Tests vs. Traditional Lab-Based Immunoassays 2005-
2012 ($millions)
• Table 11-12: Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits,
GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory,
Others), 2007-2012 ($ Millions)
• Figure 11-2: Molecular Test Sales, Infectious Diseases by Type (HIV, Hepatits,
GC/Chlamydia, Organism ID, MRSA et. al, Mycobacteria, TB, Respiratory,
Others), 2007-2012
• Figure 11-3 Molecular Testing Emerging Infectious Disease vs. First Wave
• Table 11-13: Selected Infectious Disease Molecular Test Innovations, 2006-2007
CHAPTER TWELVE: Blood Banking Services
• Table 12-1: Selected Blood Treatment Systems, 2007
• Table 12-2: Worldwide Blood Bank Sales, 2007-2012 (ABO Grouping,
Immunoassay Screen, NAT Screen)
• Table 12-2: Worldwide Blood Bank Sales, 2007 and 2012 ($ millions)
• Figure 12-1: ABO Grouping Revenues by Region (North America, EU, Japan,
ROW)
• Table 12-3: Selected Blood Grouping Innovations, 2006-2007
• Table 12-4: Selected Blood Screen Immunoassay Innovations, 2006-2007
• Table 12-5: Selected Blood Bank Innovations, 2006-2007
chapter thirteen: Histology and Cytology
• Table 13-1: Selected IVD Cancer Markers
• Table 13-2: Selected Microscopy and Image Analysis Product Companies
• Figure 13-1: The Future of Pap Smear Testing, 2005 and 2012
• Table 13-3: Selected Advanced HPV Tests, 2006-2007
• Table 13-4: Worldwide Histology/Cytology Sales by Type 2007-2012 ($million)
• Figure 13-2: Worldwide Histology/Cytology Sales by Type 2007-2012 ($million)
• Table 13-5: Worldwide Flow Cytometry Sales 2007-2012 ($million)
• Table 13-6:Worldwide CTCs and Tissue Microarray Sales 2007-2012

46. • Table 13-7: Selected Vendors of Traditional Histology Stains
• Table 13-8: Revenues of the Major Automated Histology Companies $ million,
2003-2007
• Figure 13-3: Revenues of the Major Automated Histology Companies, 2003-2007
($millions)
• Table 13-9: Selected Pap Test Entrants, 2006-2007
• Figure 13-4 in situ Hybridization Market, 2007 and 2012
• Table 13-10: Selected IHC and ISH Reagent Companies
• Table 13-11: Selected molecular HPV tests, 2006-2007
• Table 13-12: Revenue History of the Cytometry Imaging Market, 2006 ($ million)
• Table 13-13: Selected Histology/Cytology Innovations, 2005
• Table 13-14: Revenue History of Flow Cytometry by Company, 2005-2007
• Figure 13-5: Market Share of Flow Cytometry by Company, 2005 and 2007
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