IVD Procedure Volume and Pricing Analysis


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IVD Procedure Volume and Pricing Analysis

This report examines the global procedure volumes for IVD and laboratory tests. It covers only commercialized tests, specifically excluding those that are developmental or used primarily for research purposes.. Point of Care (Glucose, Pregnancy, Other)

  • CoreLab (General Chemistries, Blood Gas Analyzers, Urinalysis, Immunoassays
  • Infectious Disease, Cardiac Markers, Diabetes/HbA1c, Autoimmune)
  • Molecular (Infectious Disease [inc. molecular tests for HIV, Hepatitis, STDs, HAI, Respiratory, Other], Oncology, Inherited Disease, Other)
  • Hematology
  • Coagulation (PT, PTT)
  • Microbiology (Automated Panels, Manual Panels, Blood Culture, Chromogenic Media)
  • Blood Banking
  • Histology/Cytology (Pap, Non-Pap, Image Cytometry, Flow Cytometry, ISH, IHC, CTCs)
For each of these categories., Global procedure volume estimates are provided for the historic 2012 period and forecasts are provided through 2017. Price estimates are offered for leading products, systems and equipment; these represent average list prices but do not take into account variations between countries, discounts or rebates and other fluctuations. Pricing trend analysis is provided for each category. Basic sales estimates for each major market segment are provided. The report also provides
  • Fees earned by test providers across categories, 2012-2017
  • Regional Analysis of IVD market drivers
  • Fees Earned by Largest Clinical Laboratories
  • Cancer, Infectious Disease, Microbial Resistance and Other Import Trends
  • Description of IVD Tests in Clinical Use.
  • CLIA Registered Labs by Facility 2012
Clinical laboratory medicine plays an integral role in healthcare and disease management, as it estimated that approximately 80% of physician’s diagnoses are a result of laboratory tests. In addition to disease diagnosis, clinical lab testing is also performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons. The increase in lab procedure volumes across categories of tests, as well as the corresponding increase in fees earned and instruments and reagents sold, points to the increasing importance of testing to the healthcare system. The global market for in vitro diagnostics (IVD) and clinical lab tests remains strong, with a plethora of new products and rising procedure volumes through 2017. Furthermore, clinical lab testing is poised to increase dramatically in the developing nations and even developed economies like China as the healthcare infrastructure in these countries improves and the standard of care is uniformly raised across their populations. This, combined with the introduction of new tests and technologies in the developed world will drive strong global growth through the foreseeable future. Which company is performing what share of IVD procedures? This unique business planning tool answers this question, allowing readers to obtain procedure volume by company. The following IVD leaders are profiled and their procedure volume is analyzed in this report:
  • Abbott Laboratories
  • ALERE
  • Arkray
  • Beckman Coulter, Inc./Danaher
  • Becton, Dickinson & Co.
  • BioMerieux, Inc.
  • Bio-RAD Laboratories, Inc.
  • Bio-Reference Laboratories
  • Clarient, Inc./GE Healthcare 1
  • Danaher Corp.
  • DaVita, Inc.
  • Genoptix, Inc./Novartis
  • Gen-Probe, Inc.
  • Hologic, Inc.
  • Horiba Medical
  • Instrumentation Laboratory
  • Laboratory Corporation of America
  • Myriad Genetics
  • Ortho Clinical Diagnostics
  • Qiagen
  • Quest Diagnostics
  • Radiometer A/S
  • Roche
  • Siemens
  • Spectra Laboratories
  • Sysmex Corp.
  • Thermo Fisher Scientific
Historical information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives and other experts were conducted to capture the perspectives from industry participants’ point of view and assess trends, and form the basis of the forecasting and competitive analysis.


  • Executive Summary
    • THE GLOBAL IVD AND LAB TESTS MARKET
      • Scope and Methodology
      • Size and Growth of the Market
        • Table Global IVD and Clinical Lab Sales, 2012 - 2017
        • Table Global IVD and Clinical Lab Procedure Fees by Market Segment (POC, CoreLab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking, Histology/Cytology) 2012 - 2017
        • Table Global IVD and Clinical Lab Unit Test Prices by Market Segment (POC, Core Lab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking, Histology/Cytology) in $, 2012 - 2017
        • Table Global IVD and Clinical Lab Procedure Volumes by Market Segment (POC, CoreLab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking, Histology/Cytology), 2012 - 2017
      • Market Trends
  • Introduction
    • TYPES OF TESTS
      • Table Types of IVD and Clinical Laboratory Tests
    • VENUES FOR TEST USAGE
      • Hospitals
        • Table CLIA-Registered Laboratories by Type of Facility, June 2011
      • Physicians
      • Independent Clinical Laboratories
    • POPULATION AND DISEASE DEMOGRAPHICS
      • World Population
        • Table Global Population, 1980 - 2020
        • Table U.S. Population, 1980 - 2020
      • Life Expectancy
      • Disease Incidence and Prevalence
        • Table Selected Global Disease Statistics, January 2013
      • Antimicrobial Drug Resistance
    • REGIONAL MARKET CHARACTERISTICS AND TRENDS
      • United States
      • Europe
      • Japan
      • BRIC Nations
      • Other Countries
  • Point of Care Test Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
      • OTC Tests
      • Professional Tests
    • LEADING PRODUCTS AND PRICES
      • Table Selected POC Tests and Prices, 2012
    • GLOBAL SALES BY TEST TYPE
      • Table Global POC Test Sales by Test Type in $Million, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global POC Test Procedure Volume by Test Type in Millions, (Glucose, Pregnancy/Ovulation, Other OTC, Professional Glucose, Infectious Disease, Critical Care, Other POC) 2012 - 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Core Laboratory Test Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
      • Clinical Chemistries
      • Immunoassays
    • LEADING PRODUCTS AND PRICES
      • Table Selected Core Lab Tests and Prices, 2012
    • GLOBAL SALES BY TEST TYPE
      • Table Global Core Lab Test Sales, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global Core Lab Test Procedure Volume by Test Type (General Chemistries, Blood Gas Analyzers, Urinalysis, Immunoassays Infectious Disease, Cardiac Markers, Diabetes/HbA1c, Autoimmune), 2012 - 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Molecular Assays
    • OVERVIEW
    • TYPES OF TESTS
      • Infectious Disease
      • Oncology
      • Inherited Disease
      • Other
    • LEADING PRODUCTS AND PRICES
      • Table Selected Molecular Assay Test Services and Prices, 2012
    • GLOBAL SALES BY TEST TYPE
      • Table Global Molecular Assay Sales in $Million, 2012 – 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global Molecular Assay Procedure Volume by Test Type (Infectious Disease, Oncology, Inherited Disease, Other), 2012 - 2017
      • Table Global Infectious Disease Molecular Assay Procedure Volume by Test Type (HIV, Hepatitis, GC/Chlamydia, HAI, Respiratory, Others), 2012 - 2017 (millions)
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Hematology Test Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
    • LEADING PRODUCTS AND PRICES
      • Table Selected Hematology Analyzers and Prices, 2012
    • GLOBAL SALES
      • Table Global Hematology Analyzer Sales in $Million, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME
      • Table Global Lab-Based Hematology Test Procedure Volume in Millions, 2012 - 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Coagulation Test Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
    • LEADING PRODUCTS AND PRICES
      • Table Selected Coagulation Analyzers and Prices, 2012
    • GLOBAL SALES
      • Table Global Coagulation Analyzer Sales in $Million, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global Lab-Based Coagulation Test Procedure Volume by Test Type (PT, PTT) 2012 - 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Microbiology Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
    • LEADING PRODUCTS AND PRICES
      • Table Selected Lab-Based ID/AST Microbiology Instruments and Prices, 2012
    • GLOBAL SALES BY TEST TYPE
      • Table Global Lab-Based ID/AST Microbiology Instrument Sales, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global Lab-Based ID/AST Microbiology Procedure Volume by Test Type (Automated Panels, Manual Panels, Blood Culture, Chromogenic Media) in Millions, 2012 - 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Blood Banking Tests Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
    • LEADING PRODUCTS AND PRICES
      • Table Selected Blood Grouping Products and Prices, 2012
    • GLOBAL SALES
      • Table Global Blood Grouping Product Sales, 2012 - 2017
    • GLOBAL PROCEDURE VOLUME
      • Table Global Blood Grouping Procedure Volume in millions, 2012 – 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Histology and Cytology Procedure Volumes
    • OVERVIEW
    • TYPES OF TESTS
      • Immunohistochemistry and In Situ Hybridization
      • Circulating Tumor Cells
    • LEADING PRODUCTS AND PRICES
      • Table Selected Histology/Cytology Products and Prices, 2012
    • GLOBAL SALES BY TEST TYPE
      • Table Global Histology/Cytology Sales, 2012 – 2017
    • GLOBAL PROCEDURE VOLUME BY TEST TYPE
      • Table Global Histology/Cytology Procedure Volume by Test Type (Pap, Non-Pap, Image Cytometry, Flow Cytometry, ISH, IHC, CTCs) 2012 – 2017
    • PRICING TRENDS
    • PROCEDURE VOLUME TRENDS
  • Profiles of Key Players
    • INTRODUCTION
      • Table Global Sales and Procedure Volumes of the Leading Manufacturers of IVD and Clinical Lab Products and Equipment, 2012
      • Table Global Procedure Fees of the Leading Clinical Laboratories, 2012
    • ABBOTT LABORATORIES
      • Overview
      • IVD/Lab Test Market Participation
        • Table Abbott Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Abbott Laboratories Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • ALERE
      • Procedure Volume Share
        • Table Alere Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Alere Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • ARKRAY
      • Overview
      • IVD/Lab Test Market Participation
      • Procedure Volume Share
        • Table Arkray Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Arkray Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • BECKMAN COULTER, INC./DANAHER
      • Overview
      • IVD/Lab Test Market Participation
        • Table Beckman Coulter Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Beckman Coulter Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • BECTON, DICKINSON &CO.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Becton Dickinson Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Becton Dickinson Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • BIOMERIEUX, INC.
      • Overview
      • IVD/Lab Test Market Participation
        • Table BioMerieux Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table BioMerieux Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • BIO-RAD LABORATORIES, INC.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Bio-Rad Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Bio-Rad Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • BIO-REFERENCE LABORATORIES
      • Overview
      • IVD/Lab Test Market Participation
        • Table Bio-Reference Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Bio-Reference Laboratories Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • CLARIENT, INC./GE HEALTHCARE
      • Overview
      • IVD/Lab Test Market Participation
        • Table Clarient Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Clarient Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • DANAHER CORP.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Danaher Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Danaher Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • DAVITA, INC.
      • Overview
      • IVD/Lab Test Market Participation
        • Table DaVita Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table DaVita Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • GENOPTIX, INC./NOVARTIS
      • Overview
      • IVD/Lab Test Market Participation
        • Table Genoptix Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Genoptix Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • GEN-PROBE, INC.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Gen-Probe Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Gen-Probe Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • HOLOGIC, INC.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Hologic Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Hologic Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • HORIBA MEDICAL
      • Overview
      • IVD/Lab Test Market Participation
        • Table Horiba Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Horiba Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • INSTRUMENTATION LABORATORY
      • Overview
      • IVD/Lab Test Market Participation
        • Table Instrumentation Laboratory Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Instrumentation Laboratory Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • LABORATORY CORPORATION OF AMERICA
      • Overview
      • IVD/Lab Test Market Participation
        • Table Labcorp Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Labcorp Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • MYRIAD GENETICS
      • Overview
      • IVD/Lab Test Market Participation
        • Table Myriad Genetics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Myriad Genetics Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • ORTHO CLINICAL DIAGNOSTICS
      • Overview
      • IVD/Lab Test Market Participation
        • Table Ortho Clinical Diagnostics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Ortho Clinical Diagnostics Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • QIAGEN
      • Overview
      • IVD/Lab Test Market Participation
        • Table Qiagen Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Qiagen Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • QUEST DIAGNOSTICS
      • Procedure Volume Share
        • Table Quest Diagnostics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
        • Table Quest Diagnostics Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • RADIOMETER A/S
      • Overview
      • IVD/Lab Test Market Participation
        • Table Radiometer A/S Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Radiometer A/S Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • ROCHE
      • Overview
      • IVD/Lab Test Market Participation
        • Table Roche Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Roche Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • SIEMENS
      • Overview
      • IVD/Lab Test Market Participation
        • Table Siemens Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Roche Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • SPECTRA LABORATORIES
      • Overview
      • IVD/Lab Test Market Participation
        • Table Spectra Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Spectra Laboratories Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment in $Millions, 2012
    • SYSMEX CORP.
      • Overview
      • IVD/Lab Test Market Participation
        • Table Sysmex Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Sysmex Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
    • THERMO FISHER SCIENTIFIC
      • Overview
      • IVD/Lab Test Market Participation
        • Table Thermo Fisher Scientific Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment in Millions, 2012
      • Financial Snapshot
        • Table Thermo Fisher Scientific Estimated Global IVD and Clinical Lab Sales by Market Segment in $Millions, 2012
  • Company Directory

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