Report: In Vitro Diagnostic Companies Analysis TOC

Foreword
Introduction
What are in vitro diagnostics?
Market sectors
- Clinical chemistry
- Immunochemistry
- Haematology
- Haemostasis
- Microbiology
- Molecular diagnostics
- Point-of-Care
Geographic trends
- Established markets
- Key emerging markets
Regulatory environment
- US
  - The Clinical Laboratory Improvement Amendments (CLIA)
    - CLIA waivers
    - CLIA categorisation
- European Union
Company Profiles
Abbott Diagnostics
- Overview
- Products/Technologies
  - Technologies
    - AbbottLink and EQC
    - ABBOTT PRISM
    - ACCELERATOR Automated Processing Systems (APS)
    - AEROSET
    - The ARCHITECT Family
    - AxSYM/AxSYM Plus
    - The CELL DYN Family
    - IMx
    - i-STAT
    - TDx/TDxFLx
  - Tests/Reagents
    - Cancer
    - Cardiology
    - General/Special chemistry
    - Infectious disease tests
    - Metabolic
    - Retrovirus
    - Signify products
    - Specific proteins
    - Thyroid
- Major Developments
  - Agreements
    - Novation
    - Celera
    - Axis-Shield
- Financials
Acolyte Biomedica
- Overview
- Products/Technologies
  - Technology
    - BacLite flex
  - Tests
    - BacLite Rapid MRSA
Adaltis
- Overview
- Products/Technologies
  - Instruments
    - ALLERgen Systems
    - Eclectica
  - Tests/Reagents
    - ALLERgen
    - EasyLine
    - Immunoassay
    - Clinical Chemistry
    - Microplate Assays
    - Radioimmunoassay
    - Turbidimetry
- Major Developments
  - Mergers and Acquisitions
    - Shanghai Hua Tai Biotechnology
- Agreements
  - bioMérieux
- Financials
ARKRAY
- Overview
- Products/Technologies
  - Instruments/technologies
    - Blood Ammonia
    - Clinical Chemistry
    - Electrolyte analysis
    - Urinalysis
- Major Developments
  - Mergers and Acquisitions
    - HypoGuard
Axis-Shield
- Overview
- Products/Technologies
  - Technologies
    - Point-of-Care analysers
  - Tests/reagents
    - AxSYM xtra
    - Cardiovascular
    - Point-of-care
    - Rheumatoid arthritis
    - Vitamin B12 deficiency
    - Other tests
- Major Developments
  - Agreements
    - Abbott
    - Bio-Rad Laboratories
  - Financials
Beckman Coulter
- Overview
- Products/Technologies
  - Technologies
    - Access/Access 2
    - ACL systems
    - Array/IMMAGE
    - Cell Lab Quanta/Cytomics
    - Command Central
    - COULTER haematology systems
    - DL2000 Data Manager
    - Paragon/Appraise
    - Power Processor
    - SYNCHRON
    - UniCel
    - Vidiera
  - Tests/Reagents
    - Anaemia
    - Blood virus
    - Bone metabolism
    - Cancer
    - Cardiology
    - Drugs of abuse
    - General/Special chemistry
    - Haemostasis
    - ICON/rapid tests
    - Infectious disease
    - Reproductive
    - Specific proteins
    - Thyroid
    - Others
- Major Developments
  - Mergers, Acquisitions & Divestitures
    - Lumigen
    - Agencourt Personal Genomics
  - Agreements
- Financials
BD Diagnostics
- Overview
- Products/Technologies
  - Technologies
    - BACTEC 9000 Family
    - BBL CHROMagar Orientation//TSA II I Plate
    - BBL Crystal Identification Systems
    - BD Free Flow Electrophoresis System
    - BD Phoenix Automated Microbiology System
    - BD ProbeTec
    - BD Viper
  - Tests/reagents
    - BD Affirm VP III
    - BD BACTEC/F blood culture media
    - BD Directigen tests
    - Infectious disease
    - Febrile diseases
- Major Developments
  - Mergers, Acquisitions & Divestitures
    - GeneOhm
    - BD.id patient identification system
  - Agreements
    - Foundation for Innovative New Diagnostics
    - Roche
- Financials
BioMedica Diagnostics
- Overview
- Products/Technologies
  - Instruments/technologies
    - Clinical chemistry analysers
    - Haemostasis systems
    - Haematology Systems
    - Immunochemistry systems
  - Tests/reagents
    - Rapid Cassette Tests
    - Urinalysis Test Strips
- Major Developments
  - Agreements
    - Medex Laboratories
bioMérieux
- Overview
- Products/Technologies
  - Technologies
    - BacT/ALERT 3D
    - DAVINCI
    - FlexTek 2
    - Informatics
    - NucliSENS EasyQ
    - Reader 250
    - VIDAS Immunoanalysers
    - VIDIA
    - VITEK
  - Tests/reagents
    - Cancer
    - Cardiology
    - Infectious Disease
- Major Developments
  - Mergers and Acquisitions
    - Biomedics
  - Agreements
    - Sysmex
    - Eiken Chemical
    - NuGEN Technologies
    - AdvanDx
- Financials
Bio-Rad Laboratories
- Overview
- Products/Technologies
  - Technologies
    - Autoimmune Enzyme Immunoassay (EIA) automation
    - BioPlex 2200 system
    - Clinical Chemistry
    - Haematology/Immunohaematology
    - Informatics
    - Microbiology
  - Tests/reagents
    - ANCA complete kits
    - Autoimmune Enzyme Immunoassay (EIA)
    - Genetic disorders
    - Immunohaematology
    - Microbiology
    - Special chemistry
- Major Developments
  - Mergers and Acquisitions
    - Blackhawk BioSystems
  - Agreements
    - Axis-Shield
    - Integrated DNA technologies
- Financials
Biosite
- Overview
- Products/Technologies
  - Technologies
    - Triage system
  - Tests/reagents
    - Cardiology
    - Drugs of abuse
    - Infectious disease
- Major Developments
  - Agreements
    - Beckman Coulter
  - Financials
Cytyc
- Overview
- Products/Technologies
  - Technologies
    - FirstCyte Breast Test
    - ThinPrep System
- Major Developments
  - Mergers and Acquisitions
    - Hologic
    - Adiana
    - Adeza
  - Agreements
    - ThinPrep Products
- Financials
Dade Behring
- Overview
- Products/Technologies
  - Technologies
    - BN series
    - BCS/BCT/BFT/PFA haemostasis systems
    - Dimension systems
    - Informatics systems
    - LOCI
    - Quadriga BeFree system
    - Stratus
    - StreamLAB Analytical Workcell
    - Sysmex
    - V-Twin/Viva
    - WalkAway SI/autoSCAN microbiology systems
  - Tests/reagents
    - Drugs of abuse
    - Microbiology panels
    - Plasma protein tests
- Major Developments
  - Agreements
    - DiaSorin
    - Novation
    - Immunalysis
    - Euro-Diagnostica
- Financials
Dako
- Overview
- Products/Technologies
  - Technologies
    - ACIS III
    - CyAn ADP Flow Cytometer
    - Hybridizer/Pascal pressure chamber
    - MoFlo Cell Sorter
    - Staining Systems
  - Tests/Reagents
    - Clinical Immunochemistry
    - Pharmacodiagnostics
- Major Developments
- Financials
DiagnoCure
- Overview
- Products/Technologies
  - Tests
    - ImmunoCyt/uCyt+
    - PCA3 Test for Prostate Cancer
    - Tests in development
- Major Developments
  - Agreements
- Financials
DiaMed
- Overview
- Products/Technologies
  - Technologies
    - Haemostasis
    - Informatics
    - Microbiology Instruments
  - Tests/Reagents
    - Cytokines
    - Infectious Diseases
    - Fertility
    - Tumour Markers
    - Others
- Major Developments
Fujirebio diagnostics
- Overview
- Products/Technologies
  - Tests/reagents
    - Radio immunoassay (RIA) tests
    - CanAg Enzyme Immunoassay (EIA) kits
    - Other tests
- Major Developments
  - Agreements
    - Sanko Junyaku and Eisai
    - ARUP Laboratories
Genomic Health
- Overview
- Products/Technologies
  - Tests
    - Oncotype DX
- Major Developments
  - Agreements
    - Medical Solutions plc
  - Financials
Gen-Probe
- Overview
- Products/Technologies
  - Technologies
    - DTS Systems
    - LEADER Luminometers
    - Tigris DTS
  - Tests/Reagents
    - AccuProbe Culture Identification
    - Blood Screening
    - Mycobacteriology
    - Sexually Transmitted Diseases
    - Streptococcus
- Major Developments
  - Agreements
    - Millipore
    - 3M
    - DiagnoCure
  - Financials
Genzyme Diagnostics
- Overview
- Products
  - Tests/reagents
    - Cholesterol tests
    - OSOM point-of-care
    - Pancreatitis assays
- Major Developments
  - Mergers and Acquisitions
    - Equal Diagnostics
  - Financials
Hitachi Chemical Diagnostics
- Overview
- Products/Technologies
  - Technologies
    - CLA-1 Luminometer
  - Tests
    - CLA Pette Panels
- Major Developments
  - Agreements
    - Response Genetics
- Financials
Inverness Medical Innovations
- Overview
- Products/Technologies
  - Technologies
    - CLONDIAG
    - Wampole ELISA II
  - Tests/reagents
    - BioStar
    - Binax
    - Clearview
    - Consumer diagnostics
    - Determine
    - InstaCheck II/MEDplus-ER drug screen
    - INVERNESS MEDICAL TestPack +Plus
    - Ischaemia Modified Albumin (IMA)
    - Osteomark NTx
    - SureStep
    - ThyroTest TSH
- Major Developments
  - Mergers and Acquisitions
    - Biosite
    - Quality Assured Services
    - Instant Technologies
    - First Check Diagnostics
    - ACON Laboratories
    - Clondiag Chip Technologies
  - Joint Venture
    - SPD Swiss Precision Diagnostics
- Financials
Luminex
- Overview
- Products/Technologies
  - Technologies
    - Luminex 200 System
    - Luminex 100 IS
    - Luminex HTS System
    - xMAP Technology
    - xPONENT Software
  - Tests/Reagents
    - FlexmiR
    - Microspheres
- Major Developments
  - Mergers and Acquisitions
    - Tm Bioscience Corporation
  - Agreements
    - Johns Hopkins University
    - Fisher HealthCare
- Financials
Microbionix
- Overview
- Products/Technologies
  - Instruments
    - Luminex Instrument
  - Tests
    - Multiplex assays
Mikrogen
- Overview
- Products/Technologies
  - Tests
    - recomBlot
    - recomLine
    - recomWell
Olympus Diagnostic Systems Division
- Overview
- Products/Technologies
  - Technologies
    - AU clinical chemistry/immunochemistry systems
    - Data management
    - Lab automation systems
    - PK7300 blood grouping analyser
  - Tests/reagents
    - Cancer
    - Cardiology
    - Drugs of abuse
    - Liver/Pancreas disorders
    - Metabolites/specific proteins
- Major Developments
  - Mergers and Acquisitions
    - Bacus Laboratories
    - Single molecule detection technology from Evotec
  - Agreements
    - Material Science Europa and Saladax Biomedical
    - VisEn Medical
    - Horiba ABX
- Financials
Orion Diagnostica
- Overview
- Products/Technologies
  - Technologies
    - QuikRead 101
    - Turbox system
  - Tests/reagents
    - Bone and tissue assays
    - Dental diagnostic tests
    - Gastroenterology tests
    - Hormone assays
    - Iron deficiency assays
    - Other bacterial tests
    - Point of care
    - Specific proteins
- Financials
Ortho-Clinical Diagnostics
- Overview
- Products/Technologies
  - Technologies/Instruments
    - Automation
    - Blood Donor Screening
    - Chemistry/Immunodiagnostics
  - Tests/Reagents
    - Blood Donor Screening
    - Clinical Chemistry
    - Immunodiagnostics
- Major Developments
  - Agreements
- Financials
  - Johnson & Johnson financial results, 2002-2006 (US$ millions)
Radiometer
- Overview
- Products/Technologies
  - Technologies
    - ABL/NPT blood gas analysers
    - IT systems
    - Samplers and QC
  - Tests
- Major Developments
  - Acquisition by Danaher
  - Accumetrics
  - SenDx Medical
- Financials
Roche Diagnostics
- Overview
- Products/Technologies
  - Technologies
    - Cardiac Reader
    - Cobas AmpliPrep Instrument
    - Cobas Clinical Chemistry/Immunochemistry
    - Cobas Critical Care Systems
    - Cobas s 201 Blood Screening System
    - Cobas TaqMan Analyser
    - Elecsys Analysers
    - Informatics
    - MODULAR SYSTEMS platform
    - Reflotron Systems
    - Roche 9180 Electrolyte Analyser
    - Roche/Hitachi Clinical Chemistry
    - STAGO Systems
    - Urisys Systems
  - Tests/reagents
    - Accutrend Lactate System
    - AmpliChip Microarray tests
    - Bone Markers
    - Cardiology
    - Combur-Test Urine Test Strips
    - Drugs of Abuse/Therapeutic Drug Monitoring
    - Enzymes/Substrates
    - Specific Proteins
    - Others
- Major Developments
  - Mergers and Acquisitions
- Financials
  - Roche financial results 2002-2006 (CHF millions)
Siemens Medical Solutions Diagnostics
- Overview
- Products/Technologies
  - Technologies
    - Automation/Integration
    - RapidSystems blood gas analysers
    - Clinical chemistry systems
    - DCA diabetes system
    - ADVIA haematology systems
    - Immunodiagnostics
    - Molecular diagnostics
    - Urinalysis analysers
  - Tests/reagents
    - Allergy
    - Autoimmune
    - Cardiovascular
    - Drugs of abuse
    - General chemistry
    - Infectious disease
    - Inflammation markers
    - Other tests
    - Reproductive endocrinology
    - Special chemistry
    - Specific proteins
    - TDM
    - Thyroid
    - Tumour markers
- Major Developments
  - Mergers and Acquisitions
    - Dade Behring
    - Diagnostic Products Corporation
  - Financials
Sysmex
- Overview
- Products/Technologies
  - Instruments/Technologies
    - Haematology
    - Haemostasis
    - Immunochemistry
    - Informatics
    - Point of Care
    - Urinalysis
- Major Developments
  - Agreements
    - Amerinet
    - Bio-Rad Laboratories
    - bioMérieux
    - Premier Purchasing Partners
    - Defence Supply Center Philadelphia
    - Affymetrix
    - CellaVision
- Financials
TREK Diagnostic Systems
- Overview
- Products/Technologies
  - Instruments/technologies
    - onSite Urine Culture Device
    - para-JEM systems
    - Sensititre Microbiology Systems
    - Software solutions
    - VersaTREK
- Major Developments
  - Acquisition by Magellan Biosciences
Veridex, LLC
- Overview
- Products/Technologies
  - Technologies
    - CellSearch System
    - GeneSearch System
- Major Developments
  - Agreements
    - Immunicon
    - LabCorp
    - OncoMethylome Sciences
- Financials
  - Johnson & Johnson financial results, 2002-2006 (US$ millions)
SOURCES
Espicom Sources
Others

List of Tables

Leading companies by sales, 2005-2006 (US$ millions)
Clinical chemistry products
Immumochemistry products
Haematology products
Haemostasis products
Microbiology products
Molecular diagnostics products
Point-of-care products
Notified Bodies, September 2007
Abbott financial results, 2002-2006 (US$ millions)
Adaltis financial results, 2004-2006 (C$ thousands & US$ thousands)
Axis-Shield financial results, 2003-2006 (£ millions & US$ millions)
Beckman Coulter financial results, 2002-2006 (US$ millions)
Becton Dickinson financial results, 2002-2006 (US$ millions)
bioMérieux financial results, 2004-2006 (EUR millions)
Rad financial results, 2004-2006 (US$ millions)
Biosite financial results, 2004-2006 (US$ millions)
Cytyc financial results, 2002-2005 (US$ millions)
Dade Behring financial results 2002-2006 (US$ millions)
Dako financial results 2002-2006 (DKK millions)
DiagnoCure financial results, 2004-2006 (US$ thousands)
Genomic Health financial results, 2002-2006 (US$ thousands)
Gen-Probe financial results, 2002-2006 (US$ millions)
Genzyme financial results, 2002-2006 (US$ millions)
Hitatchi financial results 2003-2007 (¥ millions)
Inverness financial results 2002-2006 (US$ millions)
Luminex financial results, 2002-2006 (US$ thousands)
Olympus financial results, 2002-2007 (¥ millions)
Orion financial results, 2004-2006 (EUR millions & US$ millions)
Danaher financial results, 2004-2006 (US$ millions)
Siemens Medical Solutions financial results, 2001-2006 (EUR millions)
Sysmex financial results, 2002-2007 (¥ millions & US$ millions)

List of Figures

Abbot Diagnostics net sales, 2002-2006 (US$ millions)
Adaltis revenue, 2004-2006 (US$ thousands)
Axis-Shield revenue by business sector, 2003-2006 (US$ millions)
Beckman Coulter net sales, 2000-2006 (US$ millions)
BD Diagnostics revenues, 2000-2006 (US$ millions)
bioMérieux net sales, 2004-2006 (US$ millions)
Bio-Rad net sales for Clinical Diagnostics, 2004-2006 (US$ millions)
Cytyc net sales, 2002-2005 (US$ millions)
Dade Behring revenues 2000-2006 (US$ millions)
Dako net sales 2002-2006 (US$ millions)
DiagnoCure revenues, 2004-2006 (US$ thousands)
Genomic Health total revenues, 2003-2006 (US$ thousands)
Gen-Probe total revenues, 2002-2006 (US$ millions)
Genzyme revenues, 2002-2006 (US$ millions)
Hitachi revenues, 2003-2007 (US$ millions)
Inverness sales, 2002-2006 (US$ millions)
Inverness sales by product group, 2006 (%)
Luminex revenues 2002-2006 (US$ thousands)
Olympus sales by business segment, 2005-2007 (¥ millions)
Sales by geographic location, 2007 (%)
Orion net sales, 2004-2006 (US$ millions)
Orion net sales by business sector, 2006 (%)
Net sales by geographic region, 2006 (%)
J&J Medical Devices & Diagnostics sales by subsidiary, 2006 (US$ millions)
Ortho-Clinical Diagnostics sales, 2004-2006 (US$ millions)
Danaher Medical Technologies sales, 2004-2006 (US$ millions)
Roche sales 2000-2006 (US$ millions)
Diagnostics division sales by business segment, 2006 (%)
Diagnostics division sales by geographical region, 2006 (%)
Siemens net sales 2001-2006 (EUR millions)
Sysmex sales by business segment, 2003-2007 (¥ millions)
J&J Medical Devices & Diagnostics sales by subsidiary, 2006 (US$ millions)

In Vitro Diagnostic Companies Analysis

Table of Contents

List of Tables

List of Figures