The Worldwide Market for In Vitro Diagnostic Tests, 4th Edition

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Published Oct 15, 2004 | 425 Pages | Pub ID: KLI993155

This comprehensive report is a thorough overview of the in vitro diagnostics (IVD) industry worldwide, covering the breadth of traditional IVD testing (Kalorama released a report dedicated to the molecular diagnostics segment in the Spring of 2004). The report contains complete market statistics and analysis for all areas of IVD, including:
  • Point-of-Care
  • Clinical Chemistry
  • 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 will be discussed. Projections are made through 2008.

This edition of The Worldwide Market for In Vitro Diagnostic Tests is a completely updated study. Kalorama re-evaluated all segments and competitors and has added several new sections to the report, including

  • New Horizons - a review of diagnostic opportunities in non-clinical areas and how there is a cross over from these - back and forth
  • The impact of bioshield on assays for emerging diseases
  • Strategies for sales outside the United States - a growing trend that cannot be ignored
  • An expanded analysis of geographic-specific markets and global trends in healthcare.
1 Executive Summary
  • Introduction
  • Scope and Methodology
  • Size and Growth of the Market
  • Market Trends
  • The Nature of the Industry - Post Genomics, Informatics, Microfluidics

2 Introduction

  • Background
  • Lab Medicine Disciplines and Applications
  • Market Analysis of IVD Market Segments
  • Top Suppliers and Niche Players
  • Tests, Bioinformatics and Drugs - 21st Century Diagnostics Paradigm
  • Point of View

3 Overview of Global In Vitro Diagnostic Markets

  • Background
  • World Segments of the IVD Market and IVD Market Evolution
  • The United States of America - A free market in disguise
  • Japan - Holding its own
  • Europe - Economic crisis drives reorganizations
  • China - The WTO powerhouse
  • The Lure of Emerging Markets
  • IVD Market Growth - Segments and technologies
  • Traditional IVDs
  • New Horizons in Industrial Diagnostics
  • End-Users of Clinical IVD Products
  • End-Users of IVD Products Outside the Laboratory

4 Trends in Healthcare Delivery and In Vitro Diagnostics

  • Background
  • Outpatient / Inpatient Product Mix
  • 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, Biowarfare impact
  • Regulatory and Reimbursement Issues and Novel Devices

5 Point-of-Care Tests

  • Overview of POC Tests
  • POC Test Segments
  • Market Analysis: Leading Suppliers
  • Cost Pressures and Perceived Barriers for POC Tests
  • Institutional Users of POC Tests
  • The Home Test Segment
  • The Commercial Outlook for POC Tests

6 Clinical Chemistry

  • Overview of Chemistry Tests
  • Market Analysis: Leading Suppliers and Growth Potential
  • Lab Automation and Work Station Consolidation
  • The Commercial Outlook for Chemistry Tests

7 Immunoassays

  • Overview of Immunoassays
  • Market Analysis: Leading Suppliers and Growth Potential
  • Immunoassay Test Segments - Mature and Emerging
  • New Antibodies, Labels, and Homogeneous Assay Designs
  • Proteins in Post Genomic Medicine
  • The Commercial Outlook for Immunoassays

8 Molecular Assays

  • Overview of Molecular Assays
  • Market Analysis: Leading Suppliers and Growth Potential
  • Post Genomic Medicine and the Gene/Protein Mix
  • Molecular Testing Initiatives -- Technology and Players
  • PCR patents and Innovation
  • The Commercial Outlook for Molecular Tests

9 Hematology

  • Overview of Hematology
  • Market Analysis : Leading Suppliers and Growth Potential
  • Rare Event Cell Counting Techniques
  • Decentralized Hematology Testing
  • The Commercial Outlook for Hematology Tests

10 Coagulation

  • Overview of Coagulation / Immunohematology Tests
  • Market Analysis: Leading Suppliers and Growth Potential
  • Hypercoagulopathies and Cardiac Disease
  • POC and self-testing coagulation systems
  • The Commercial Market for Coagulation Tests

11 Microbiology and Virology

  • Overview of Microbiology / Virology Tests
  • Market Analysis: Leading Suppliers and Growth Potential
  • Antimicrobial Resistance - a moving target
  • Tradition is Challenged by Molecular Techniques
  • Emerging Organisms and the Globalization of Infectious Diseases
  • The Commercial Outlook for Microbiology / Virology Tests

12 Blood Banking Services

  • Overview of Blood Banking
  • Market Analysis: Leading Suppliers and Growth Potential
  • Nucleic Acid Testing Continues to Grow
  • Artificial Blood Products Begin to Appear
  • The Commercial Outlook for Blood Banking

13 Histology and Cytology

  • Overview of Histology / Cytology
  • Market Analysis: Leading Suppliers and Growth Potential
  • Genomic Medicine Fuels Automated Techniques and FISH
  • The Commercial Outlook for Histology and Cytology Tests

 

14 Company Profiles

  • Top 15 Competitors
  • Roche Diagnostics
  • Abbott Labs
  • Ortho Clinical Diagnostics & LifeScan
  • Bayer Corporation, Healthcare Division
  • Beckman Coulter Inc.
  • Dade Behring Inc.
  • BD Diagnostics
  • bioMerieux Inc.
  • Bio-Rad Laboratories Inc.
  • ARKRAY (formerly Kyoto Daiichi)
  • Sysmex Corporation
  • Diagnostic Product Corporation (DPC)
  • Olympus America Inc.
  • Chiron Corporation
  • Cytyc Corporation

15 Niche Player Summaries

 

  • Accelr8 Technology Corp.
  • Accumetrics Incorporated
  • Acolyte Biomedica Ltd
  • ADIATEC
  • AdvanDx, Inc.
  • Aerocrine, Inc.
  • Akers Biosciences, Inc.
  • Alpco Diagnostics
  • American Diagnostica Inc. (ADI)
  • Animas Corporation
  • Applied Biosystems Group
  • Applied Imaging Corp.
  • Arcturus Bioscience Inc.
  • Ark Therapeutics Limited
  • artus GmbH
  • Associates of Cape Cod, Inc.
  • AutoGenomics, Inc.
  • Axis-Shield plc
  • Bacterial Barcodes
  • Bender MedSystems GmbH
  • Biotools, B & M Labs, S.A.
  • BMD (Biomedical Diagnostics)
  • BioPredictive S.A.S
  • Biosite Incorporated
  • Cancer Genetics Inc.
  • Celera Diagnostics
  • Cepheid
  • Cholestech
  • ChromaVision Medical Systems, Inc.
  • CLONDIAG chip technologies GmbH
  • co.don Tissue Engineering, Inc.
  • Correlogic Systems, Inc.
  • C.S.F. srl
  • Cylex Inc.
  • diaDexus Inc.
  • Digene Corporation
  • Epoch Biosciences, Inc.
  • Equal Diagnostics
  • Exiqon A/S
  • Focus Technologies (formerly MRL)
  • Gen-Probe Incorporated
  • Generex Biotechnology Corporation
  • Genomic Health, Inc.
  • Genoptix Inc.
  • Healthy Estrogen.com, Inc.
  • Hemosystem S.A.
  • Horiba Medical Diagnostic Instruments & Systems
  • Hypoguard USA, Inc.
  • IBEX Technologies Inc.
  • Ikonisys, Inc.
  • Innogenetics
  • Innotrac Diagnostics Oy
  • Invirion Inc.
  • i-Stat  (acquired by Abbott Diagnostics)
  • LightUp Technologies AB
  • Luminex Corporation
  • MAST GROUP Ltd.
  • MedMira Inc.
  • Medtronic MiniMed
  • A.Menarini Diagnostics
  • Metrika Inc.
  • Micronics, Inc.
  • Nanobac Life Sciences, Inc.
  • N-Dia, Inc.
  • NetImpact Holdings, Inc.
  • OraSure Technologies, Inc.
  • PointCare Technologies, Inc.
  • Sakura Finetek USA Inc.
  • ScheBo-Biotech AG
  • Schleicher & Schuell BioScience, Inc.
  • Sequella Incorporated
  • Signet Laboratories Inc.
  • Smiths Medical MD, Inc. (formerly Deltec, Inc.)
  • SomaLogic, Inc.
  • Sontra Medical Corporation
  • TheraSense, Inc.  (Acquired by Abbott Diagnostics)
  • Third Wave Technologies Inc.
  • Tm Bioscience Corp.
  • Ventana Medical Systems
  • Veridex LLC
  • Virologic, Inc.
  • ZymeQuest, Inc.







List of Exhibits

CHAPTER ONE: Executive Summary

  • Table 1-1: Exchange Rate Fluctuations, 2000-2003
  • Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Country/Region (8 Regions), 2003-2008

CHAPTER TWO: Introduction

  • Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market (14 Segments), 2003-2008
  • Table 2-2: Major Diagnostics Industry Acquisitions (42 Deals), 2002-2004
  • Table 2-3: Major Diagnostics Industry Distribution Agreements (47 Deals), 2002-2004
  • Table 2-4: Revenues of Top IVD Companies (31 Companies), 1999-2003

CHAPTER THREE: Overview of Global In Vitro Diagnostic Markets

  • Table 3-1: Old-Age Dependency Ratios (Eldery as a Percentage of Working-Age Population) Comparative Projections by Country (7 Countries), 2000 vs 2025
  • Table 3-2: Worldwide In Vitro Diagnostics Sales by Country/Region (8 Regions), 2003-2008
  • Table 3-3: European Union IVD Sales by Country (9 Countries + Others), 1996 vs 2003
  • Table 3-4: Estimated IVD Market Growth Rates of Selected European Countries (14 Countries)
  • Table 3-5: Number of Medical Institutions in China by Type
  • Table 3-6: Selected IVD Companies Involved in International Marketing Efforts
  • Table 3-7: Worldwide In Vitro Diagnostic Reagent Sales by Product Market (14 Segments), 2003-2008
  • Table 3-8: Selected Mad Cow Tests on the Market
  • Table 3-9: Selected Food Industry Testing Products on the Market
  • Table 3-10: Selected Biowarfare Agent Tests on the Market

CHAPTER FOUR: Trends in Healthcare Delivery and In Vitro Diagnostics

  • Table 4-1: Selected Biochip Products in Development, 2002-2004
  • Table 4-2: Selected Biochip Products Available, 2002-2004
  • Table 4-3: Selected IVD Manufacturer Collaborations and License Agreements, 2002-2004
  • Table 4-4: Selected IVD Patents Issued 2002-2004
  • Table 4-5: Selected Direct to Consumer Tests
  • Table 4-6: Selected OTC Tests, 2002-2004
  • Table 4-7: Selected States That Allow Direct-to-Consumer Lab Testing
  • Table 4-8: Selected SARS Tests on the Market, 2002-2004
  • Table 4-9: Selected Biowarfare Agent Tests

CHAPTER FIVE: Point-of-Care Tests

  • Table 5-1: Selected Diabetes Management Programs
  • Table 5-2: Selected OTC Test Devices, 2002-2004
  • Table 5-3: Selected Professional POC Tests on the Market and in Development (79 Tests), 2002-2004
  • Table 5-4: POC Test Sales by Test Category (8 Self Test Categories; 10 Professional Test Categories) 2003-2008
  • Table 5-5: Selected Diabetes Test Devices Available 2002-2004
  • Table 5-6: Selected Diabetes Test Devices in Development, 2002-2004

CHAPTER SIX: Clinical Chemistry

  • Table 6-1: General Chemistry Sales of Top Six Manufacturers, 2000-2003
  • Table 6-2: Worldwide Clinical Chemistry Sales by Test Category (6 Categories), 2003-2008
  • Table 6-3: Selected Innovations in Clinical Chemistry, 2002-2004

CHAPTER SEVEN: Immunoassays

  • Table 7-1: Summary of Immunoassay Developments, 2002-2004
  • Table 7-2: Worldwide Lab-Based Immunoassay Sales by Analyte Type (11 Types), 2003-2008
  • Table 7-3: Revenue History of Leading Immunoassay Vendors (7 Vendors), 2001-2003
  • Table 7-4: Selected Proteomics and Protein Pattern Products, 2002-2004
  • Table 7-5: Selected New Commercial Tumor Markers, 2002-2004
  • Table 7-6: Traditional and New Tumor Markers: 7-7: Selected Immunoassay Innovations, 2002-2004

CHAPTER EIGHT: Molecular Assays

  • Table 8-1: Worldwide Molecular Test Sales by Type (6 Categories), 2003-2008
  • Table 8-2: Molecular Test Revenues of Top 24 IVD Vendors, 2002-2003
  • Table 8-3: Selected Infectious Disease Molecular Test Innovations, 2002-2004
  • Table 8-4: Most Frequently Requested Genetic Tests
  • Table 8-5: Selected SNP Test Innovations, 2002-2004
  • Table 8-6: Major Molecular Tests Platforms and Their Manufacturers
  • Table 8-7: Selected PGx Products, 2002-2004

CHAPTER NINE: Hematology

  • Table 9-1: Revenue History of the Five Major Hematology Vendors, 2001-2003

CHAPTER TEN: Coagulation

  • Table 10-1: Worldwide Coagulation Sales by Segment (3 segments), 2003-2008
  • Table 10-2: Top Four Coagulation Company Reagent Revenues, 2003

CHAPTER ELEVEN: Microbiology and Virology

  • Table 11-1: Worldwide Microbiology/Virology Sales by Type (6 Categories) 2003-2008
  • Table 11-2: Selected Biowarfare Agent Tests
  • Table 11-3: Selected SARS Tests on the Market, 2002-2004

CHAPTER TWELVE: Blood Banking Services

  • Table 12-1: Selected Blood Bank Product Innovations

CHAPTER THIRTEEN: Histology and Cytology

  • Table 13-1: Worldwide Histology/Cytology Sales by Type (5 Categories), 2003-2008
  • Table 13-2: Revenues of the Four Major Automated Histology Companies, 1999-2003
  • Table 13-3: Selected IHC and ISH Reagent Companies
  • Table 13-4: Selected Histology/Cytology Innovations, 2002-2004
  • Table 13-5: Revenue History of Flow Cytometry by Company, 2001-2003
  • Table 13-6: Selected Flow Cytometry Innovations, 2002-2004

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