The Worldwide Market for In Vitro Diagnostic Tests

6th Edition [with 2009 Economy Preface]

Product Code KAL00065
Publication Date July 2010
Publisher Kalorama Information
Product Type Report
Pages 900
ISBN Number not applicable

The Worldwide Market for In Vitro Diagnostic Tests

6th Edition [with 2009 Economy Preface]

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. A discovery of the trends that are impacting the industry now, and 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 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 a geographic share 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.

Kalorama Information's Report - '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 800+ page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on:

  • The Impact of US Health Care Reform
    • The Spread of Wireless Diagnostics
    • New Screening Guidelines and Market Impact
    • Chronic vs. Infectious Disease
  • Strange Bedfellows? An Update on the IVD Industry Consolidation
  • The Continued Molecularization of Devices
  • The Current Economic Situation: Recession: Post-Recession?
  • Non-Invasive Sampling
  • PGx and SNP Testing
    • The Dynamic Core Lab
  • IVD and the Promise of Personalized Medicine
  • Update on Regulation of Novel Devices
  • Focus on the Continued Fight against Nosocomial Infections
  • Where Molecular Diagnostics Stands Today
  • Innovations in Blood Banking
  • Companies on the Move, and Those in Decline
  • Histology/Cytology innovations; the role of FISH testing.

In addition, there are now profiles of established and emerging players in IVD, more than 200 companies, from the top tier to the dominant middle, to the companies to watch.

Contents

  • 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
    • Abbot 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