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SUMMARY
HUGE POTENTIAL
The global market for in vitro diagnostics (IVD) in 2007 is estimated to be
US$34 billion and we expect growth to be around 9% annually.
Although in vitro diagnostics influence more than 60% of clinical decisions,
IVD sales represent only a small proportion of total healthcare expenditures;
in 2005 IVD sales in Europe totalled less that 2% of total healthcare
expenditure. However, clinicians are under increasing pressure for better
clinical outcomes and to control cost through efficient disease management.
The early detection and treatment of long-term conditions is critical, and
modern, fast and effective diagnostics are essential to meeting these aims.
INNOVATION IS DRIVING CHANGE
For example, molecular diagnostics is the fastest growing segment of clinical
diagnostics with a growth rate of around 10-15% and is estimated to be worth
approximately US$2.4 billion.
By detecting DNA and RNA sequences characteristic of bacteria, viruses or
cells, molecular diagnostics has applications in a wide variety of disorders
including infectious diseases, cancer and cardiovascular. Molecular diagnostic
testing is often complex and usually carried out in a lab environment. The
trend and challenge is to create testing products which provide fast and
accurate results in a clinical setting.
This is a competitively hot area with Beckman Coulter, Becton Dickinson,
Siemens, bioMérieux, Roche and Gen-Probe all involved.
For Each Company
- Overview
- Products/Technologies
- Major Developments Mergers, acquisitions and alliances
- Financial Performance(where available)
All major IVD sectors are covered
- Clinical Chemistry
- Immunochemistry
- Haematology/Haemostasis
- Microbiology
- Molecular Diagnostics
- Point of Care
TABLE OF CONTENTS
- 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
- 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
- Financials
- ARKRAY
- Overview
- Products/Technologies
- Instruments/technologies
- Blood Ammonia
- Clinical Chemistry
- Electrolyte analysis
- Urinalysis
- Major Developments
- Axis-Shield
- Overview
- Products/Technologies
- Technologies
- 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
- 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
- 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
- Agreements
- Axis-Shield
- Integrated DNA technologies
- Financials
- Biosite
- Overview
- Products/Technologies
- Technologies
- Tests/reagents
- Cardiology
- Drugs of abuse
- Infectious disease
- Major Developments
- Cytyc
- Overview
- Products/Technologies
- Technologies
- FirstCyte Breast Test
- ThinPrep System
- Major Developments
- Mergers and Acquisitions
- Agreements
- 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
- 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
- Major Developments
- 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
- Genzyme Diagnostics
- Overview
- Products
- Tests/reagents
- Cholesterol tests
- OSOM point-of-care
- Pancreatitis assays
- Major Developments
- Mergers and Acquisitions
- Financials
- Hitachi Chemical Diagnostics
- Overview
- Products/Technologies
- Major Developments
- 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
- Major Developments
- Mergers and Acquisitions
- Tm Bioscience Corporation
- Agreements
- Johns Hopkins University
- Fisher HealthCare
- Financials
- Microbionix
- Overview
- Products/Technologies
- 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
- 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
- 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)
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