IVD Procedure Volume and Pricing Analysis

  • January 2013
  • -
  • Kalorama Information
  • -
  • 210 pages

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



Table Of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

The Global IVD and Lab Tests Market

Scope and Methodology

Size and Growth of the Market

Market Trends



CHAPTER TWO: INTRODUCTION

Types of Tests

Venues for Test Usage

Hospitals

Physicians

Independent Clinical Laboratories



Population and Disease Demographics

World Population

Life Expectancy

Disease Incidence and Prevalence

Cancer

Diabetes



Antimicrobial Drug Resistance



Regional Market Characteristics and Trends

United States

Europe

Japan

BRIC Nations

China



Other Countries



CHAPTER THREE: POINT OF CARE TEST PROCEDURE VOLUMES

Overview

Types of Tests

OTC Tests

Pregnancy/Ovulation Tests



Professional Tests

Glucose Tests

Tests for Infectious Disease

Critical Care Tests

Other Tests





Leading Products and Prices

Global Sales by Test Type

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER FOUR: CORE LABORATORY TEST PROCEDURE VOLUMES

Overview

Types of Tests

Clinical Chemistries

Immunoassays



Leading Products and Prices

Global Sales by Test Type

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER FIVE : MOLECULAR TEST PROCEDURE VOLUMES

Overview

Types of Tests

Infectious Disease

Oncology

Inherited Disease

Other



Leading Products and Prices

Global Sales by Test Type

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER SIX: HEMATOLOGY TEST PROCEDURE VOLUMES

Overview

Types of Tests

Leading Products and Prices

Global Sales

Global Procedure Volume

Pricing Trends

Procedure Volume Trends

CHAPTER SEVEN: COAGULATION TEST PROCEDURE VOLUMES

Overview

Types of Tests

Leading Products and Prices

Global Sales

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER EIGHT: MICROBIOLOGY PROCEDURE VOLUMES

Overview

Types of Tests

Leading Products and Prices

Global Sales by Test Type

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER NINE: BLOOD BANKING TESTS PROCEDURE VOLUMES

Overview

Types of Tests

Leading Products and Prices

Global Sales

Global Procedure Volume

Pricing Trends

Procedure Volume Trends

CHAPTER TEN: HISTOLOGY AND CYTOLOGY PROCEDURE VOLUMES

Overview

Types of Tests

Immunohistochemistry and In Situ Hybridization

Circulating Tumor Cells



Leading Products and Prices

Global Sales by Test Type

Global Procedure Volume by Test Type

Pricing Trends

Procedure Volume Trends

CHAPTER ELEVEN: COMPANY PROFILES AND PROCEDURE VOLUME ANALYSIS

Introduction

Abbott Laboratories

Overview

IVD/Lab Test Market Participation



ALERE


Procedure Volume Share


Financial Snapshot



Arkray

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Beckman Coulter, Inc./Danaher

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Becton, Dickinson andamp; Co

Overview

IVD/Lab Test Market Participation

Procedure Volume Share





BioMerieux, Inc.

Overview

IVD/Lab Test Market Participation



Bio-RAD Laboratories, Inc.

Overview

IVD/Lab Test Market Participation



Bio-Reference Laboratories

Overview

IVD/Lab Test Market Participation



Clarient, Inc./GE Healthcare

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Danaher Corp.

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



DaVita, Inc.

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Genoptix, Inc./Novartis

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Gen-Probe, Inc.

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Hologic, Inc.

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Horiba Medical

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Instrumentation Laboratory

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Laboratory Corporation of America

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Myriad Genetics

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Ortho Clinical Diagnostics

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Qiagen

Overview

IVD/Lab Test Market Participation

Procedure Volume Share





Quest Diagnostics

Procedure Volume Share



Radiometer A/S

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Roche

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Siemens

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Spectra Laboratories

Overview

IVD/Lab Test Market Participation

Financial Snapshot



Sysmex Corp.

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



Thermo Fisher Scientific

Overview

IVD/Lab Test Market Participation

Procedure Volume Share



Financial Snapshot



APPENDIX: COMPANY DIRECTORY

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Global IVD and Clinical Lab Sales, 2012 - 2017

Table 1-2: Global IVD and Clinical Lab Procedure Fees Earned by Market Segment(POC, CoreLab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking,Histology/Cytology) 2012 - 2017

Figure 1-1: Global IVD and Clinical Lab Procedure Fees by Market Segment(thousands)

Table 1-3: Global IVD and Clinical Lab Unit Test Prices by Market Segment (POC, CoreLab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking,Histology/Cytology) in $, 2012 - 2017

Table 1-4: Global IVD and Clinical Lab Procedure Volumes by Market Segment (POC,CoreLab, Molecular, Hematology, Coagulation, Microbiology, Blood Banking,Histology/Cytology), 2012 - 2017

Figure 1-2: Global IVD and Clinical Lab Procedure Volumes by Market Segment2012-2017

CHAPTER TWO: INTRODUCTION

Table 2-1: Types of IVD and Clinical Laboratory Tests

Table 2-2: CLIA-Registered Laboratories by Type of Facility, June 2011

Table 2-3: Global Population, 1980 - 2020

Table 2-4: U.S. Population, 1980 - 2020

Table 2-5: Selected Global Disease Statistics, January 2013

Exhibit 2-1: Global IVD and Clinical Lab Market, 2012

CHAPTER THREE: POINT OF CARE TEST PROCEDURE VOLUMES

Table 3-1: Selected POC Tests and Prices, 2012

Table 3-2: Global POC Test Sales by Test Type in $Million, 2012 - 2017

Table 3-3: 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

CHAPTER FOUR: CORE LABORATORY TEST PROCEDURE VOLUMES

Table 4-1: Selected Core Lab Tests and Prices, 2012

Table 4-2: Global Core Lab Test Sales, 2012 - 2017

Table 4-3: 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

CHAPTER FIVE: MOLECULAR ASSAYS

Table 5-1: Selected Molecular Assay Test Services and Prices, 2012

Table 5-2: Global Molecular Assay Sales in $Million, 2012 - 2017

Table 5-3: Global Molecular Assay Procedure Volume by Test Type

(Infectious Disease, Oncology, Inherited Disease, Other), 2012 - 2017

Table 5-4: Global Infectious Disease Molecular Assay Procedure Volume by Test Type(HIV, Hepatitis, GC/Chlamydia, HAI, Respiratory, Others), 2012 - 2017

CHAPTER SIX: HEMATOLOGY TEST PROCEDURE VOLUMES

Table 6-1: Selected Hematology Analyzers and Prices, 2012

Table 6-2: Global Hematology Analyzer Sales in $Million, 2012 - 2017

Table 6-3: Global Lab-Based Hematology Test Procedure Volume in Millions, 2012 - 2017

CHAPTER SEVEN: COAGULATION TEST PROCEDURE VOLUMES

Table 7-1: Selected Coagulation Analyzers and Prices, 2012

Table 7-2: Global Coagulation Analyzer Sales in $Million, 2012 - 2017

Table 7-3: Global Lab-Based Coagulation Test Procedure Volume by Test Type (PT, PTT) 2012 - 2017

CHAPTER EIGHT: MICROBIOLOGY PROCEDURE VOLUMES

Table 8-1: Selected Lab-Based ID/AST Microbiology Instruments and Prices, 2012

Table 8-2: Global Lab-Based ID/AST Microbiology Instrument Sales, 2012 - 2017

Table 8-3: Global Lab-Based ID/AST Microbiology Procedure Volume by Test Type (Automated Panels, Manual Panels, Blood Culture, Chromogenic Media) in Millions, 2012 - 2017

CHAPTER NINE: BLOOD BANKING TESTS PROCEDURE VOLUMES

Table 9-1: Selected Blood Grouping Products and Prices, 2012

Table 9-2: Global Blood Grouping Product Sales, 2012 - 2017

Table 9-3: Global Blood Grouping Procedure Volume in $Million, 2012 - 2017

CHAPTER TEN: HISTOLOGY AND CYTOLOGY PROCEDURE VOLUMES 109

Table 10-1: Selected Histology/Cytology Products and Prices, 2012

Table 10-2: Global Histology/Cytology Sales, 2012 - 2017

Table 10-3: Global Histology/Cytology Procedure Volume by Test Type (Pap, Non-Pap, Image Cytometry, Flow Cytometry, ISH, IHC, CTCs) 2012 - 2017

CHAPTER ELEVEN: PROFILES OF KEY PLAYERS

Table 11-1: Global Sales and Procedure Volumes of the Leading Manufacturers of

IVD and Clinical Lab Products and Equipment, 2012

Figure 11-1: Global Sales and Procedure Volume Share of the Leading Manufacturers of IVD and Clinical Lab Products and Equipment, 2012

Table 11-2: Global Procedure Fees of the Leading Clinical Laboratories, 2012

Figure 11-2: Procedure Fee Share of the Leading Clinical Laboratories, 2012

Table 11-3: Abbott Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-4: Abbott Laboratories Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-5: Alere Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-6: Alere Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-7: Arkray Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-8: Arkray Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-9: Beckman Coulter Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-10: Beckman Coulter Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-11: Becton Dickinson Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-12: Becton Dickinson Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-13: BioMerieux Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-14: BioMerieux Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-15: Bio-Rad Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-16: Bio-Rad Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-17: Bio-Reference Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-18: Bio-Reference Laboratories Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-19: Clarient Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-20: Clarient Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-21: Danaher Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-22: Danaher Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-23: DaVita Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-24: DaVita Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-25: Genoptix Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-26: Genoptix Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-27: Gen-Probe Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-28: Gen-Probe Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-29: Hologic Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-30: Hologic Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-31: Horiba Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-32:: Horiba Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-33: Instrumentation Laboratory Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-34: Instrumentation Laboratory Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-35: Labcorp Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-36: Labcorp Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-37: Myriad Genetics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-38: Myriad Genetics Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-39: Ortho Clinical Diagnostics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-40: Ortho Clinical Diagnostics Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-41: Qiagen Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-42: Qiagen Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-43: Quest Diagnostics Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-44: Quest Diagnostics Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-45: Radiometer A/S Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-46: Radiometer A/S Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-47: Roche Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-48: Roche Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-49: Siemens Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-50: Roche Estimated Global IVD and Clinical Lab Sales by Market Segment , 2012

Table 11-51: Spectra Laboratories Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-52: Spectra Laboratories Estimated Global IVD and Clinical Lab Procedure Fees by Market Segment, 2012

Table 11-53: Sysmex Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-54: Sysmex Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

Table 11-55: Thermo Fisher Scientific Estimated Global IVD and Clinical Lab Procedure Volume by Market Segment, 2012

Table 11-56: Thermo Fisher Scientific Estimated Global IVD and Clinical Lab Sales by Market Segment, 2012

COMPANY DIRECTORY


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