IVD Test Volumes and Pricing Analysis: 2017

Mar 28, 2017
360 Pages - Pub ID: KLI15299873
Share this report
 
Online Download $4,500
Departmental Site License (one location, up to 10 users) $6,750
Global Site License $9,000

How Many IVD Test Procedures are Completed Each Year?

What is the Volume of IVD Tests by Country?

What is the Size of the IVD Market?

How Fast will the IVD Market Grow?


These are among the questions that are answered in Kalorama Information's  latest study on the in vitro diagnostic (IVD test) industry, According to that study, Worldwide In Vitro Diagnostics Market 2017: IVD Test Volume and Pricing Analysis, the global volume of IVD test procedures is forecast to increase 2.7 percent annually to over 24 billion in 2021. (This is excluding the over-the counter, point-of-care (POC) market and glucose monitoring activities in the professional POC market).  This presages growth in the IVD market.  

This report, Worldwide In Vitro Diagnostic Market 2017: IVD Test Volume and Pricing Analysis examines global trends in the volume of IVD procedures conducted in clinical laboratories and at point-of-care sites.  Aging population trends and a rising level of diseases and disorders will boost the volume of patient testing conducted in most countries. The adaptation of molecular and other advanced life science technologies to new and improved reagents and instruments will broaden IVD capabilities in detecting medical conditions. Medical providers throughout the world will rely increasingly on point-of-care (POC) and clinical laboratory tests to identify patient health problems in early stages and prescribe appropriate therapies.

Worldwide In Vitro Diagnostics Market 2017: Test Procedure Volume and Pricing Analysis  includes the following data points
  • Point-of-Care Test Volume, 2016-2021
  • Point-of-Care Average Pricing
  • Clinical Chemistry Test Volume, 2016-2021
  • Clinical Chemistry Average Pricing
  • Molecular Test Volume by type, 2016-2021
  • Molecular Test Average Pricing
  • Hematology Test Volume, 2016-2021
  • Hematology Test Procedure Average Pricing
  • Coagulation Test Volume, 2016-2021
  • Coagulation Test Average Pricing
  • Microbiology Test Volume, 2016-2021
  • Microbiology Test Average Pricing
  • Blood Screening Test Volume, 2016-2021
  • Blood Screening Average Pricing
  • Histology/Cytology Test Volume, 2016-2021
  • Histology/Cytology Average Pricing
  • Overall IVD Test Volume By Country: U.S., Europe, Brazil, Italy, Spain, India, China, Eastern Europe, Russia, Japan, Western Europe, Eastern Europe
  • Worldwide IVD Market, 2016-2021

The analysis covers commercially sold and distributed tests only. Laboratory developed tests (LDTs) and tests used for research purposes are excluded from the discussion. Global sales of IVD products are expressed in current United States dollars and reflect estimates for the year 2016 and forecasts for each year in the 2017 to 2021 period. Global volumes of various IVD procedures are presented in millions and correlate to the evaluation of a single analyte, marker, or other variable of interest. It should be noted that some IVD tests involve more than one procedure and provide analysis of multiple variables.

Unique Data: IVD Test Volume Share,  by IVD Company 


The global in vitro diagnostic (IVD) industry includes approximately 500 participants, ranging in size from small, narrowly focused firms to large diversified multinational companies.  Since IVD products serve healthcare applications, producers are subject to strict government regulations and serve highly price-sensitive markets.  Overall success in the industry requires an effective balancing of research and development, productivity, manufacturing efficiencies, effective marketing and distribution, and responsive customer service. In general, the competitive structure of the global IVD industry is relatively concentrated at the top tier.  

Ten large, multinational corporations, controlled almost 70 percent of the global market in 2016.  Except for Alere which specializes in products for point-of-care (POC) markets, all of other industry leaders -- Roche, Abbott Laboratories, Siemens, Danaher, Thermo Fisher Scientific, Becton Dickinson, Sysmex, Ortho Clinical Diagnostics, and bioMerieux -- compete in multiple product segments and achieved their strong competitive positions by supplementing internal research and development activities with acquisitions and external collaborative agreements. 

Because it is not possible in a report of this scope to include all market participants, the following profiles include the top producers and companies with extensive global IVD operations. These manufacturers profiled accounted for total world IVD product sales of almost $45 billion in 2014 and their products and systems are utilized in about three-fourths of all global IVD and clinical lab procedures.  In addition to the top producers, profiles of selected clinical laboratory service companies are also presented in this report.  

  • Roche
  • Abbott Laboratories  
  • Siemens AG  
  • Danaher  
  • Thermo Fisher Scientific  
  • Alere  
  • Becton, Dickinson And Company  
  • Sysmex  
  • Biomérieux  
  • Bio-Rad Laboratories  
  • Ortho Clinical Diagnostics  
  • Hologic  
  • Qiagen N.V.  
The selection of IVD procedures by medical providers depends on a number of factors.  Among the key influences are the nature of the healthcare activity involved, the presence or absence of obvious patient symptoms, patient characteristics and history, and, increasingly, cost and third-party reimbursement eligibility.  Based on broad detection capabilities, core laboratories generate the largest share of global IVD procedure volume, or 62 percent in 2016.  These establishments apply clinical chemistry and immunoassays to the high throughput analysis of blood samples.  Both techniques are able to detect or measure several target markers simultaneously.  As a result, a single clinical chemistry or immunoassay test can involve multiple IVD procedures.

Increasing applications in the testing of hospital patients, patients undergoing physical examinations and periodic healthcare checkups, and patients suspected of ingesting toxic substances will boost the volume of core laboratory procedures implemented worldwide.  However, growth in this activity will slow from historical levels as many countries see shorter hospital stays and tighter health insurance restrictions on outpatient testing.  Moreover, increasing competition from point-of-care (POC), molecular, and histology/cytology diagnostics will eliminate the need for some core laboratory tests.


IVD Market Growth


Growth estimates in the IVD market range from 3 to 4%, but this number depends on the segment covered.   Some segments will grow at half the rate, others at double or triple average.  Most areas of the IVD market are competitive.  New companies enter the IVD market on a consistent basis, and IVD market revenue growth exceeds device or average pharmaceutical markets.It is difficult to keep up with fast moving trends in the in vitro diagnostic market space, thus Kalorama Information has several reports addressing the IVD market. This report focuses on procedure volumes.

Through 2021, the fastest global growth in IVD procedure volume will emerge in molecular assays followed by histology/cytology processes, and non-glucose POC tests.  Reflecting further advances in amplification technologies and the discovery of new genetic and protein markers, molecular assays will expand applications in cancer and infectious disease detection and characterization, transplant matching, donated blood screening, and pharmacodiagnostics.  The increasing use of in situ hybridization in the diagnosis, analysis, and monitoring of hematopoietic neoplasms and solid tumors, along with the widening adaptation of immunohistochemistry techniques to the identification of cancerous cell- and tissue-based antigens, will underlie fast-paced growth in the combined worldwide volume of histology and cytology procedures.  The continuing diversification of hospital ambulatory and emergency departments, outpatient clinics, and physicians’ offices into onsite patient testing will promote strong growth in the number of non-glucose POC procedures conducted on lower volume, desktop immunoassay systems.

Demand patterns and growth prospects for IVD procedures will vary widely by country and region.  The fastest growth in volume will occur in developing countries that leverage increasing economic prosperity to achieve significant improvements in medical delivery systems and resident healthcare accessibility.  By contrast, the impoverished nations of Africa, Asia, and Central and South America, are not expected to achieve a significant upgrading of diagnostic testing capabilities in the near term and will remain dependent on philanthropic organizations to detect and control epidemic threats such as HIV, Ebola, and Zika.

Due to maturing markets, the volume of IVD procedures implemented in the developed world will increase more slowly than the average pace of the developing economies.  Moreover, in most developed countries, the strengthening of healthcare cost containment initiatives and price controls will result in tighter restrictions being imposed on patient services.  This trend will increase pressure on medical providers to avoid prescribing or implementing unnecessary tests, which, in turn, will hold down growth in the volume of IVD procedures.
In spite of tighter cost containment measures and slower overall growth in the volume of IVD procedures, the developed countries will provide the best revenue opportunities for high value-added esoteric patient tests.  By enabling the earlier detection and more definitive diagnosis of complex diseases and disorders, these tests hold significant potential to improve the quality and reduce the overall cost of patient care.  Accordingly, they are expected to build up applications in the U.S. and other developed countries pursuing value-based healthcare strategies.
IVD Testing Venues

The performance of global IVD procedures is divided among hospitals, independent clinical laboratories, physicians’ offices, and other medical establishments.  Through onsite clinical and satellite laboratories, hospitals account for the largest share of volume, or approximately 60 percent in 2016.  Generally, these laboratories conduct routine IVD testing on samples extracted from institutionalized patients and patients who are treated by institutional ambulatory departments.

Independent clinical laboratories perform approximately one-third of the worldwide volume of IVD tests.  These establishments dominate the implementation of esoteric procedures outsourced from hospitals.  They also provide routine IVD testing for physicians’ offices, outpatient facilities, and various ancillary medical providers.  An estimated 20,000 independent clinical laboratories are in operation globally.
Laboratories operated by physicians’ offices and other medical establishments conduct the remaining seven percent of the volume of world IVD procedures.  This segment primarily performs POC tests for detecting or monitoring disease markers, such as glucose, electrolytes, infectious agents, and cardiac-related parameters.  Physicians’ offices make up approximately half of the estimated 500,000 other IVD laboratories operating worldwide.  The remaining half is divided among a broad assortment of medical concerns, including ambulatory surgery centers, community clinics, home healthcare agencies, nursing homes, and paramedic organizations.

Global Market Environment

The global volume of IVD procedures will rise with aging demographic patterns, an increasing incidence of acute medical conditions, an increasing prevalence of chronic health problems, and changing patient care approaches emphasizing disease prevention and early detection.  Other factors contributing to growth will include the widening availability of medical providers, ongoing improvements in medical delivery systems, an expanding volume of patient activity, and heightened attention on reducing the incidence of healthcare-associated infections (HAI) in hospitals and other healthcare facilities.  Technological advances will exert a mixed impact on the level of IVD procedures conducted worldwide.  The development of new and upgraded detection capabilities, especially in the areas of molecular assays and cellular analysis, will broaden the availability of high value-added esoteric tests.  Conversely, advances in automation and reagent sensitivity will reduce the number of procedures required to obtain definitive diagnostic results for many diseases and disorders.

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





In this report, {{keyword[keywordTextProperty]}} appears {{keyword[keywordCountProperty]}} times. {{searchResults.STATRESULT.SUMMARY.KW[keywordTextProperty]}} appears {{searchResults.STATRESULT.SUMMARY.KW[keywordCountProperty]}} times.

We were unable to search inside this report.

Search for an exact word or phrase by placing the word or phrase in quotation marks ("market trend"). Search for different versions or tenses of a word by placing an asterisk at the end of the word (pharma*).

Please note that your term must be at least three characters long and numbers will be blocked by the # sign.