In Vitro Diagnostics Market Research Bundle: IVD Procedure Volumes & Pricing Report PLUS Top 25 IVD Companies Report

Best Price Guarantee	Publisher	Published Date	SKU
from $5,995	Kalorama Information	October, 2017	KLI15505338

Best Price Guarantee
Price	from $5,995
Publisher	Kalorama Information
Published Date	October, 2017
SKU	KLI15505338

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ONE: EXECUTIVE SUMMARY

The Global In Vitro Diagnostics Market Outlook

Scope And Methodology

Size And Growth of The Market

IVD Product Sales

Table 1-1: Global IVD Product (Reagent, Instruments, Other Supplies) Sales by Test Type In $ Millions, 2016-2021

IVD Procedure Volume

Figure 1-1: IVD Procedure Volumes by Type, 2016

Table 1-2: Global IVD Procedural Volume by Test Type In Millions, 2016-2021

Figure 1-2: IVD Procedures by Type, 2016-2021

Figure 1-3: IVD Procedures by Type, percentage

Figure 1-4: IVD Product Sales by Type, percentage

Unit Test Prices

Table 1-3: Global IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021

TWO: INTRODUCTION

IVD Testing Trends

IVD Testing Venues

Global Market Environment

Demographic Patterns

World Healthcare Trends

THREE: REGIONAL MARKET TEST PROCEDURE VOLUME ANALYSIS

Global Overview

Table 3-1: Global IVD Procedural Volume by Country/Region In Millions, 2016-2021

United States

Canada

Healthcare Environment

Mexico

Healthcare Environment

Western Europe

Healthcare Environment

France

Germany

Italy

Spain

United Kingdom

Other Western Europe

Asia/Pacific

Healthcare Environment

Australia

China

India

Japan

Other Asia/Pacific

Brazil

Healthcare Environment

Other Central & South America

Healthcare Environment

Russia

Healthcare Environment

Other Eastern Europe

Healthcare Environment

Africa/Mideast

Healthcare Environment

FOUR: POINT OF CARE TEST VOLUME AND PRICING ANALYSIS

Global POC Procedure Volume by Test Type

Glucose

Pregnancy/Ovulation

Colorectal Cancer Screening

Coagulation

Drugs of Abuse

Cholesterol

HIV

H. Pylori

OTC POC

Professional POC

Table 4-1: Global Point-of-Care (Poc) IVD Procedural Volume In Millions, 2016-2021

Types of Tests

Otc Poc Tests

Table 4-2: Global Over-The-Counter (Otc) Procedural Volume by Test Type In Millions, 2016-2012

FIVE: CORE LABORATORY TEST VOLUME AND PRICING ANALYSIS

Types of Tests

Blood Gas Analysis

Urinalysis

Cardiac Markers

Allergy

Tumor Markers

Proteins

Vitamin D

Autoimmune

Diabetes/HbA1c

Thyroid

Anemia

Drugs of Abuse

Therapeutic Drug Monitoring

Fertility

Table 5-1: Global Core Laboratory Procedural Volume by Test Type In Millions, 2016-2021

Clinical Chemistry Procedures

Immunoassay Procedures

Applications

Core Laboratory IVD Product Sales

Table 5-2: Global Core Laboratory IVD Product Sales by Test Type In $ Million, 2016-2021

Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis

Cost & Pricing Trends

Table 5-3: Global Core Laboratory - IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021

SIX: MOLECULAR ASSAYS

Table 6-1: Molecular Assay Procedural Volume by Test Type In Millions, 2016-2021

Types of Test

Testing Technologies

Infectious Diseases

Table 6-2: Global Molecular Infectious Disease Assay Procedural Volume by Test Type In Millions, 2016-2021

Healthcare-Associated Infections

Hepatitis

HIV

Sexually Transmitted Diseases

Respiratory Infections

Other

NAT Blood Screening

Cancer

Transplant Matching

Inherited Diseases

Other Molecular Assays

Global Sales by Test Type & Market

Table 6-3: Global Molecular Assay IVD Product Sales by Test Type In $ Million, 2016-2021

Pricing Trends

Table 6-4: Global Molecular Assays - IVD Product Sales per Procedure In Dollars, 2016-2019

SEVEN: HEMATOLOGY TEST VOLUME AND PRICING ANALYSIS

Complete Blood Count (CBCs)

Other Hematology Tests

Table 7-1: Global Hematology Procedural Volume by Test Type In Millions, 2016-2021

Types of Tests

Global Sales of Hematology Products

Table 7-2: Global Hematology IVD Product Sales by Test Type In $ Million, 2016-2021

Pricing Trends

Table 7-3: Global Hematology IVD Product Sales per Procedure In Dollars, 2016-2021

EIGHT: COAGULATION TEST VOLUME AND PRICING ANALYSIS

Table 8-1: Global Coagulation Procedural Volume by Test Type In Millions, 2016-2021

Types of Tests

Prothrombin Time (PT/INR)

Other Coagulation Tests

Global Sales of Coagulation Products

Table 8-2: Global Coagulation IVD Products by Test Type In $ Million, 2016-2021

Pricing Trends

Table 8-3: Global Coagulation Procedures - IVD Product Sales per Procedure In Dollars, 2016-2021

NINE: MICROBIOLOGY TEST VOLUME AND PRICING ANALYSIS

Table 9-1: Global Microbiology Procedural Volume by Test Type In Millions, 2016-2021

Types of Tests

Chromogenic Media

Automated Panels & Reagents

Manual Panels & Reagents

Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis

Blood Culture

Rapid Microbiological Tests

Global Sales of IVD Microbiology Products

Table 9-2: Global Microbiology Procedures IVD Product Sales by Test Type In $ Million, 2016-2021

Pricing Trends

Table 9-3: Global Microbiology Procedures - IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021

TEN: BLOOD TYPING / GROUPING TEST VOLUME AND PRICING ANALYSIS

Type of Tests

Table 10-1: Global Blood Grouping Procedural Volume In Millions, 2016-2021

Global Abo Blood Grouping Product Sales

Table 10-2: Global IVD Blood Grouping Sales In $ Million, 2016-2021

Pricing Trends

Table 10-3: Blood Grouping Procedures - IVD Products per Procedure, 2016-2021

ELEVEN: HISTOLOGY AND CYTOLOGY TEST VOLUME AND PRICING ANALYSIS

Table 11-1: Global Histology/Cytology Procedural Volume by Test Type In Millions, 2016-2021

Types of Tests

Pap Tests

Immunohistochemistry Tests

In Situ Hybridization

Other Histology/Cytology Tests

Histology/Cytology IVD Product Sales

Table 11-2: Global Histology/Cytology IVD Product Sales by Test Type In $ Millions, 2016-2021

Pricing Trends

Table 11-3: Global Histology/Cytology - IVD Sales per Procedure by Test Type In Dollars, 2016-2021

TWELVE: CORPORATE PROFILES AND COMPANY TEST PROCEDURE VOLUME SHARES

Introduction

Table 12-1 Global Sales And Procedural Volumes of Leading IVD Manufacturers, 2016

ROche

Overview

Diabetes Care

Molecular Diagnostics

Tissue Diagnostics

Table 12-2: Roche Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-3: Roche Estimated Global IVD Procedural Volume by Product Group In Millions, 2016

Centralized and Point of Care Solutions

Abbott Laboratories

Overview

Core Laboratory Products

Molecular Products

Point of Care Products

Diabetes Care Products

Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis

Table 12-4: Abbott Laboratories Estimated Global IVD Product Sales by Product Group In $ Million, 2016 183

Table 12-5: Abbott Laboratories Estimated Global IVD Procedural Volume by Product Group In Millions

Siemens AG

Overview

Clinical Chemistry

Drug Testing Immunoassays

Hematology

Hemostasis

Urinanalysis

Molecular Diagnostics

Point-of-Care Testing

Table 12-6: Siemens Healthineers Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-7: Siemens Healthineers Estimated Global Share of IVD Procedural Volume by Product Group In Millions, 2016

Danaher

Beckman Coulter

Cepheid

Leica Biosystems

Radiometer

Table 12-8: Danaher Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-9: Danaher Estimated Global IVD Procedural Volume by Product Group In Millions, 2016

Thermo Fisher Scientific

Clinical Diagnostics

Immunodiagnostics

Microbiology

Anatomical Pathology

Transplant Diagnostics

Table 12-10: Thermo Fisher Scientific Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-11 Thermo Fisher Scientific Estimated IVD Procedural Volume by Product Group In Millions, 2016

Alere

Table 12-12: Alere Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-13: Alere Estimated Global IVD Procedural Volume by Product Group In Millions, 2016

Professional Diagnostics

Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis

Consumer Diagnostics

BD Becton, Dickinson and Company

Table 12-14: Becton Dickinson Estimated Global IVD Product Sales by Product Group In $ Million, 2016 . 217

Table 12-15: Becton Dickinson Estimated Global IVD Procedural Volume by Product Group In Millions, 2016

Bd Diagnostic Systems

Bd Biosciences

Sysmex

Table 12-16: Sysmex Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Table 12-17 Sysmex Estimated Global IVD Procedural Volume by Product Segment In Millions, 2016

Hematology

Coagulation

Other IVD Products & Services

Biomerieux

Table 12-18: Biomérieux Estimated Global IVD Product Sales

by Product Group In $ Million, 2016

Table 12-19: Biomérieux Estimated Global IVD Procedural Volume by Product Segment In Millions, 2016

Blood Culture

Immunoassay

Rapid Tests

Mass Spectrometry

Molecular

Bio-Rad Laboratories

Blood Virus

Diabetes Testing

Hemaglobinopathies

Immunohematology

Microbiology

Newborn Screening

Other Clinical Diagnostic Products

Table 12-20: Bio-Rad Laboratories Estimated Global IVD Product Sales

by Product Group In $ Million, 2016

Table 12-21: Bio-Rad Laboratories Estimated Global IVD Procedural

Volume by Product Group In $ Million, 2016

Autoimmune

Bioplex 2200 Multiplex Testing

Ortho Clinical Diagnostics

Clinical Chemistry/Immunoassay

Transfusion Medicine

Table 12-22: Ortho Clinical Diagnostics Estimated Global IVD Product Sales

by Product Group In $ Million, 2016

Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis

Table 12-23: Ortho Clinical Diagnostics Estimated Global IVD Procedural Volume by Product Group, 2016

Hologic

Table 12-24: Hologic Estimated Global IVD Product Sales by Product Group In $ Million, 2016

Hologic Procedure Share

Table 12-25: Hologic Estimated Global IVD Procedural Volume by Product Group In Millions, 2016

Molecular Assays And Instruments

Thinprep System

Qiagen

Molecular Infectious Disease

Cancer Diagnostics

Transplant Diagnostics

Next-Generation Sequencing

Circulating Tumor Cells

Table 12-26: Qiagen Estimated IVD Product Sales by Product Segment In $ Million, 2016

Table 12-27: Qiagen Estimated IVD Procedural Volume by Product Segment In Millions, 2016

THIRTEEN: OTHER IVD COMPETITORS

Agilent Technologies

Eiken Chemical Company

Erba Diagnostics

Diasorin

Fujirebio Diagnostics

Molecular

Illumina

Sequencing

Sequencing Kits

Sample Prep

IVD Business

Oncology

HLA Typing

Information Technology

CRISPR

Forensics

CLIA Lab Service

Sample to Insight

Labcorp, Laboratory Corporation of America

Luminex Corporation

Menarini Diagnostics

Mindray Medical

Core Lab

Hematology

Coagulation

Myriad Genetics

Molecular Product News

Perkin Elmer

Newborn Testing

Prenatal Testing

Histology

Information Technology

India

China

Quest Diagnostics

Oncology

Infectious Diseases

Prenatal And Women’s Health

Quest Partners for Market Accessibility

Information Technology

Quidel Corporation

Immunoassays

Randox Laboratories

Royal Philips

Tosoh Corporation

Immunoassays

Trinity Biotech

Wako Pure Chemical Industries

1: EXECUTIVE SUMMARY

Table 1-1: Exchange Rate Fluctuations, 2012–2016

MARKET TRENDS

Gene Editing

Liquid Biopsy

Table 1-2: Selected Liquid Biopsy Innovations

Microbiome

Patient Service Center Revival

IVD Companies Mix and Match

Table 1-3: Selected Menu Expansion by Partnering and Acquisitions

Direct to the Consumer Genomics

Looking to the East

2: TOP 25 IVD COMPANIES - CORPORATE PROFILES

ABBOTT DIAGNOSTICS

Table 2-1: Abbott Recent Revenue History, 2013-2017 ($ million)

Table 2-2: Abbott's Revenue in Selected Test Segments, 2013-2017 ($ million) (Histology (Vysis), Chem/Immuno, Hematology,

Molecular, Point of Care, Diabetes)
2016/2017 Business Highlights

Alere Acquisition Update

Core Lab

Coagulation

Infectious Diseases - Molecular

Diabetes

iSTAT Business

Companion Testing

Zika

ALERE INC.
Table 2-3: Alere Recent Revenue History, 2013-2017 (total Dx, $ million)

Table 2-4: Alere Revenue by IVD Test Segment, 2013-2017 ($ million) (Cardiac Markers, Infectious Diseases, Toxicology, Diabetes- Arriva, Other)
Innovation Milestones

Abbott Acquisition Update

Diabetes

HIV

Alere Reader

Coagulation

Molecular POC

Market Expansion

ARKRAY

Recent Revenue History

Molecular

Immunoassays

Urinalysis

Diabetes

BECKMAN COULTER, INC. / DANAHER
Table 2-5: Beckman Coulter, Inc. / Danaher Recent Revenue History, 2011-2017 ($ million, estimated)

Table 2-6: Beckman Coulter's Revenue in Selected Test Segments ($ million, estimated), 2011-2016 (Routine Chemistry, Immunoassays, Hematology, Microbiology)
Hematology

Clinical Chemistry

Immunoassays

Coagulation

Lab Management

Flow Cytometry

Research

BECTON, DICKINSON AND COMPANY (BD)
Table 2-7: Becton, Dickinson and Company (BD) Recent Revenue History, 2013-2017 (diagnostic systems, $ million)

Table 2-8: BD's Revenue in Selected IVD Test Segments ($ million, estimated), 2013 (Molecular, Microbiology ID/AST, Microbiology media, Rapid Tests, Blood Culture)

Table 2-9: BD's Flow Cytometry Revenue ($ million, estimated), 2012-2015
Cytology

BD Max Molecular

ID/AST

POC Veritor

Mass Spectrometry

Blood Collection

Flow Cytometry

Licensing

BIO-RAD LABORATORIES, INC
Table 2-10: Bio-Rad Laboratories Recent Revenue History, 2013-2017 (all diagnostics, $ million, estimated)

Table 2-11: Bio-Rad's Revenue in Selected Product Segments ($ million, estimated), 2012-2016 (Quality Control, Immunoassays, Microbiology (all), Blood Bank)
Quality Control

Blood Bank

Infectious Diseases - Molecular

Immunoassays

Liquid Biopsy

Microbiome

Droplet Digital PCR

Sequencing

BIOMÉRIEUX INC.
Table 2-12: bioMérieux Recent Revenue History, 2013-2017 (Total IVDs, $ million)

Table 2-13: bioMérieux's Revenue in Selected IVD Test Segments ($ million), 2013-2017 (Microbiology, Immunoassays, Molecular, FilmArray)
Traditional Microbiology

Blood Culture

Immunoassays

Mass Spectrometry

Platelet Safety

Sequencing

Sequencing – Sample Preparation, Molecular

Data Analysis

BioFire Diagnostics Business

CEPHEID / DANAHER
Table 2-14: Cepheid Recent Revenue History, 2013-2017 (clinical product sales, $ million)
Tuberculosis

Microbiology

Influenza

POC HIV

Cancer

DANAHER CORPORATION
Table 2-15: Danaher Corp. Recent Revenue History, 2014-2017 ($ million – diagnostics – most recent years for which data is available, estimated)

Table 2-16: Danaher’s Revenue in Selected Business Segments, 2013-2017 ($ million, estimated)
For 2016 vs 2015, Danaher Reported . . .
Beckman Coulter

Radiometer

Leica Biosystems

Cepheid

Radiometer A/S Profile
Table 2-17: Radiometer Recent Revenue History, 2012-2016 (estimated, core products, $ million)
Radiometer, POC

Radiometer, Critical Care

Radiometer, Immunoassays

GRIFOLS

Recent Revenue History
Table 2-18: Grifols Diagnostic Product Revenues, 2012-2017 ($ million, estimated) (Core, Blood Screen, Total)
2016 Summary as Reported by Grifols

Blood Transfusion Business

Blood Bank CLIA Lab

Coagulation

Acquisitions and Collaborations

HOLOGIC, INC.
Table 2-19: Hologic Recent Revenue History, 2013-2017 (total Dx; $ million)

Table 2-20: Hologic's Revenue in Selected Segments ($ million), 2013-2017 (HPV (legacy), ThinPrep/cytology, Molecular, Blood Bank)
Panther Molecular System

Panther Fusion

Blood Bank - Zika Virus

Collaboration

ILLUMINA
Table 2-21: Illumina Recent Revenue History, 2013-2017 ($ million – not all revenues are for clinical products and services [estimated])
Reported 2016 Summary

Sequencing

Microarrays

Project Firefly

Grail Liquid Biopsy

Forensic Medicine

Prenatal Testing Business

INSTRUMENTATION LABORATORY (IL) / WERFEN
Table 2-22: Instrumentation Laboratory (IL) Recent Revenue History, 2012-2016 ($ million)

Table 2-23: IL’s Revenue in Selected Product Segments ($ million), 2012-2016 (Coagulation, Critical Care)
Expansion

Coagulation

Critical Care

Information Technology

LABCORP, LABORATORY CORPORATION OF AMERICA
Table 2-24: LabCorp Recent Revenue History, 2013-2017 ($ millions)
LabCorp Buys Sequenom
Diagnostics Services
Prenatal
Retail Outlets

LUMINEX CORPORATION
Table 2-25: Luminex Recent Revenue History, 2013-2016 ($ million)
Assay Development

Verigene Business

Business Expansion

ORTHO CLINICAL DIAGNOSTICS (OCD)
Table 2-26: Ortho Clinical Diagnostics (OCD) Recent Revenue History, 2012-2016 ($ million, estimated) .. 122

Table 2-27: OCD's Revenue in Selected Test Segments ($ million), 2015 (Immunoassays, Chemistry, Blood Grouping)
Blood Bank

Core Lab / Immunoassays

Lab Automation

Connectivity

PERKINELMER, INC. (PE)
Table 2-28: PerkinElmer Recent Revenue History, 2014-2017 ($ million, estimated)
Diagnostics

Sequencing

Histology

Prenatal Business

Lab Services

Expansion

QIAGEN N.V.
Table 2-29: QIAGEN Recent Revenue History, 2013-2017 ($ million)

Table 2-30: QIAGEN Molecular IVD Product Revenues ($ million), 2013-2017 (HPV, TB, Other Molecular, Total IVD)
Tuberculosis

Companion Diagnostics

Digital Sequencing

Bioinformatics

Liquid Biopsy

Cervical Cancer

Transplant medicine

Forensic

Expansion

QUEST DIAGNOSTICS
Table 2-31: Quest Diagnostics Recent Revenue History, 2010-2016 ($ million)
Highlights from 2016

Diagnostic Services

Oncology

Infectious Diseases

Prenatal and Women’s Health

Neurology

Retail / Direct to Consumer

QUIDEL CORPORATION
Table 2-32: Quidel Recent Revenue History, 2013-2016 ($ million)
Immunoassays

The Solana Business

ROCHE DIAGNOSTICS
Table 2-33: Roche Diagnostics Recent Revenue History, 2011-2017 ($ millions)

Table 2-34: Roche's Revenue in Selected Test Segments, 2013-2016 ($ millions, estimated) (Chemistry/Immuno, Diabetes, Molecular, Histology)
Hematology

Immunoassays

Global Access Program for HIV

Molecular Expansion

Core Molecular

Diabetes

Coagulation

cobas Liat System - POC

HPV

Blood Bank

Transplant Medicine

Cancer Companion Testing

Prenatal

Liquid Biopsy

Roche’s Ventana Medical Systems Inc.
Table 2-35: Ventana Recent Revenue History, 2013-2017 ($ million)
PHILIPS

Histology

Cancer Genomics

Patient Monitoring

Point of Care

Wearable Self Monitor

SIEMENS HEALTHINEERS
Table 2-36: Siemens Recent Revenue History, 2012-2015 (total IVD; $ million)

Table 2-37: Siemens’ IVD Product Sales in Selected Test Segments, 2012-2015 ($ million) (Chemistry/Immunoassays, Coagulation,
Hematology, Molecular, Urinalysis, Blood Gases)
Business Expansion

Lab Automation

Coagulation

Immunoassays

Molecular

POC Connectivity

SYSMEX CORPORATION
Table 2-38: Sysmex Recent Revenue History, 2012-2017 ($ million)

Table 2-39: Sysmex's Product Sales in Selected Test Segments, 2013-2016 ($ million) (Hematology, Coagulation, Urinalysis)
Business Expansion

Hematology

Coagulation

Urinalysis

Forging New Markets

Sysmex Inostics

THERMO FISHER SCIENTIFIC INC.
Table 2-40: Thermo Fisher Recent Revenue History, 2013-2016 (clinical diagnostics, $ million)

Table 2-41: Thermo Fisher Product Sales in Selected Test Segments, 2015-2016 ($ million) (Clinical products, Immunoassays, Microbiology, Histology)
Immunoassays

Microbiology

Molecular Test Business

Oncology Companion Diagnostics

Zika

Transplant Medicine

Quality Control IT

Point of Care

Mass Spectrometry

Forensic

Expansion

Research

3: OTHER IVD COMPANY NOTABLE
EVENTS
Table 3-1: Selected New Products