In Vitro Diagnostic Companies Analysis

Date: September 22, 2007
Pages: 166
Price:
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: I3E8C1B21A3EN
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In Vitro Diagnostic Companies Analysis
Evaluation of the products, alliances and performance of over 30 leading global players.

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 sector are covered
  • Clinical Chemistry
  • Immunochemistry
  • Haematology/Haemostasis
  • Microbiology
  • Molecular Diagnostics
  • Point of Care

Leading manufacturers evaluated
  • Abbott Diagnostics
  • Acolyte Biomedica
  • Adaltis
  • Axis-Shield
  • ARKRAY
  • Beckman Coulter
  • Becton Dickinson
  • BioMedica Diagnostics
  • bioMérieux
  • Bio-Rad
  • Biosite
  • Cytyc
  • Dade Behring
  • Dako
  • DiagnoCure
  • DiaMed
  • Fujirebio Diagnostics
  • Genomic Health
  • Gen-Probe
  • Genzyme Diagnostics
  • Hitachi Chemical Diagnostics
  • Inverness Medical Innovations
  • Luminex
  • Microbionix
  • Mikrogen
  • Olympus
  • Orion Diagnostica
  • Ortho-Clinical Diagnostics
  • Radiometer
  • Roche Diagnostics
  • Siemens Medical Solutions
  • Sysmex
  • TREK Diagnostics
  • Veridex

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
EU 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)
Bio-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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