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

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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

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