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Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19

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  • 271 Pages
  • February 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5457760

COVID testing accelerates shift to Molecular Diagnostics. Infectious disease diagnostics becomes a growth industry.

The Clinical Laboratory rose to the COVID challenge, but the end of the pandemic has created a new approach to diagnostics. Point of Care and Self Testing are threatening long term demand for clinical lab services but Molecular Diagnostics is driving runaway growth. Understand the opportunities and the threats in this comprehensive report.

The fundamentals are still here. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations.

Trends like:

  • The genetic blizzard
  • Emerging economies and global prosperity
  • Pharmacogenomics
  • Healthcare expansion in China
  • Climate change
  • Globalization
  • Automation

Exciting technical developments especially in the area of molecular diagnostics and pharmacogenomics hold the promise of a dynamic, growing and evolving world market that is moving out of the national and regional orientation and onto a global stage.

The report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions. Based on extensive primary and secondary research the testing volume data is broken down into price and volumes allowing researchers and investors to quickly create informed and reasonable forecasts of demand. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth.

The report includes detailed breakouts for 15 Countries and 4 Regions.

The report includes five year market forecasts.

Table of Contents

1 Market Guides 
1.1 Clinical Laboratory Services - Strategic Situation Analysis and Covid -19 Impact
1.2 Guide for Executives, Marketing, Sales and Business Development Staff 
1.3 Guide for Management Consultants and Investment Advisors 

2 Introduction and Market Definition 
2.1 The Growing Demand for Clinical Testing 
2.2 Defining the Opportunity 
2.2.1 Volumes
2.2.2 Prices 
2.2.3 Revenue Market Size 
2.3 Methods and Sources 
2.3.1 Authors 
2.3.2 Sources 
2.4 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic 
2.4.1 Global Healthcare Spending 
2.4.2 Spending on Diagnostics 
2.4.3 Important Role of Insurance for Diagnostics 

3 Overview of a Dynamic Market 
3.1 Players in a Dynamic Market
3.1.1 Academic Research Lab 
3.1.2 Diagnostic Test Developer 
3.1.3 Genomic Instrumentation Supplier 
3.1.4 Pharmaceutical/Reagent Supplier 
3.1.5 Independent Testing Lab 
3.1.6 Public National/regional lab 
3.1.7 Hospital lab 
3.1.8 Physician Lab 
3.1.9 Audit Body 
3.1.10 Certification Body
3.2 Segmentation - Different Approaches 
3.2.1 Traditional Market Segmentation
3.2.2 Laboratory Focus and Segmentation 
3.3 Structure of Clinical Testing Industry 
3.3.1 The Hospital Lab - Share of the Pie 
3.3.2 Key Role for Economies of Scale 
3.3.3 Physician Office Lab’s are Still Here 
3.3.4 Physician’s and POCT - Reviving Patient Service in China 
3.4 National and Regional Diversity 

4 Trends Driving a Changing Market 
4.1 Growth Is Pushed from Many Sides 
4.1.1 Understanding the Impact of Aging Population 
4.1.2 COVID Related Testing Growth 
4.1.3 Point of Care Testing can increase demand 
4.1.4 Alternative Medicine Creates Testing Opportunity 
4.1.5 Esoteric Testing Moving Mainstream 
4.1.6 Genetic Based Testing Creates New Department and New Discipline 
4.2 Factors at Work to Shrink the Market 
4.2.1 Lower Unit Costs 
4.2.2 Economic or population contraction 
4.2.3 Testing usage analysis curtailing growth 
4.2.4 Wellness has a downside 
4.2.5 Test Displacement Impacts Important 
4.2.6 Point of Care Testing 
4.3 Automation 
4.3.1 Stranded LIMS Investment 
4.3.2 Software as a Service 
4.3.3 Physician Office and Access Systems 
4.4 Environment and Evolution 
4.5 Diagnostic Technology Development 
4.5.1 Next Generation Sequencing Fuels a Revolution 
4.5.2 Impact of NGS on pricing 
4.5.3 POCT/Self Testing Disruptive Force 
4.5.4 Pharmacogenomics Blurs Diagnosis and Treatment 
4.5.5 CGES Testing, A Brave New World 
4.5.6 Molecular Diagnostics Technologies at The Forefront of Growth 
4.5.7 Biochips/Giant magneto resistance based assay 

5 Laboratory, Molecular Diagnostics and Genomic Testing Recent Developments
5.1 Recent Developments - Importance and How to Use This Section 
5.1.1 Importance of These Developments 
5.1.2 How to Use This Section 
5.2 Seegene to Enter Syndromic MDx Space 
5.3 EKF Diagnostics Acquires Advanced Diagnostic Laboratory 
5.4 Molecular Health, EDGC Ink Liquid Biopsy Partnership 
5.5 ProPhase Labs Acquires Nebula Genomics for $14.6M 
5.6 Karius Cell-Free DNA Method to Detect Infection Validated 
5.7 South Korean Firm EDGC to Expand Into Liquid Biopsy Space With Cf DNA Platform
5.8 TruDiagnostic Receives CLIA Certification for Kentucky Laboratory 
5.9 Enzo Biochem Q2 Revenues Up 62 Percent 
5.10 Thermo Fisher Gets CE Mark for High-Throughput COVID-19 Assay 
5.11 FDA Issues Alert - False Negatives due to SARS-CoV-2 Mutations 
5.12 Will Labs Use Expanded Molecular Testing Capacities Post-COVID-19? 
5.13 Chinese Infectious Dx Firm Vision Medicals Completes Series B Financing 
5.14 Cooperative Aims to Expand Clinical, Commercial NGS Access
5.15 Emerging COVID-19 Sequencing Assays - An Alternative to Existing Diagnostics?
5.16 CDC Ranks Two More Microbes as ‘Urgent Threat’ 
5.17 ACLA Requests $5 billion to keep private labs going 
5.18 Applied Biology to Launch New Laboratory for Hair and Skin Disorders 
5.19 Quest Diagnostics Acquires Outreach Operations 
5.20 Quest Diagnostics Buys Assets of Boston Clinical Laboratory Services 
5.21 CLA Urges FDA to Halt Crackdown on PGx Testing 
5.22 Quest Diagnostics Subsidiary Buys True Health Dx Assets 
5.23 BioReference Laboratories selected by IPA Association 

6 Profiles of Key Companies 
6.1 Acibadem Labmed Laboratory 
6.2 ACM Medical Laboratory 
6.3 Adicon Clinical Laboratories 
6.4 American Bio-Clinical Laboratories, Int'l 
6.5 American Pathology Partners 
6.6 ARUP Laboratories 
6.7 Ascend Clinical 
6.8 Assurance Scientific Laboratories 
6.9 Aurora Diagnostics 
6.10 Bio-Reference Laboratories 
6.11 Bioscientia Institut für Medizinische Diagnostik GmbH 
6.12 BP Healthcare Group 
6.13 Clinical Reference Laboratory 
6.14 Clongen Laboratories 
6.15 CompuNet Clinical Laboratories 
6.16 Diagnósticos da América 
6.17 DIAN Diagnostics Co., Ltd. 
6.18 Enzo Biochem 
6.19 Eone Laboratories 
6.20 Eurofins Scientific 
6.21 Exagen Diagnostics 
6.22 Genzyme Corporation 
6.23 Gribbles Pathology 
6.24 Guangzhou Kingmed Diagnostics Group Co., Ltd. 
6.25 Integrated Regional Laboratories 
6.26 KDL Group 
6.27 Laboratory Corporation of America
6.28 Lifelabs 
6.29 Mayo Clinic Laboratories 
6.30 Mid America Clinical Laboratories 
6.31 MNG Labs 
6.32 Myriad Genetics/Myriad RBM 
6.33 NeoGenomics 
6.34 OncoDNA 
6.35 Pathology, Inc. 
6.36 ProPhase Labs 
6.37 Psychemedics Corporation 
6.38 Quest Diagnostics 
6.39 RDL Reference Laboratory 
6.40 Sonic Healthcare 
6.41 Spectra Laboratories 
6.42 Sysmex Inostics
6.43 Unilabs 

7 The Global Market for Clinical Laboratory Testing 
7.1 Global Market Overview by Country 
7.1.1 Table - Global Market by Country 
7.1.2 Chart - Global Market by Country 
7.2 Global Market by Assay Type - Overview 
7.2.1 Table - Global Market by Assay Type 
7.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
7.2.3 Chart - Global Market by Assay Type - Base Year 
7.2.4 Chart - Global Market by Assay Type - End Year 
7.2.5 Chart - Global Market by Assay Type - Share by Year 
7.2.6 Chart - Global Market by Assay Type - Segments Growth 

8 Global Clinical Laboratory Diagnostic Markets - By Assay Type 
8.1 Chemistry 
8.1.1 Table Chemistry - by Country 
8.1.2 Chart - Chemistry Growth 
8.2 Microbiology
8.2.1 Table Microbiology - by Country 
8.2.2 Chart - Microbiology Growth 
8.3 Hematology 
8.3.1 Table Hematology - by Country 
8.3.2 Chart - Hematology Growth 
8.4 Anatomic Pathology 
8.4.1 Table Anatomic Pathology - by Country 
8.4.2 Chart - Anatomic Pathology Growth 
8.5 Covid-19 
8.5.1 Table Covid-19 - by Country 
8.5.2 Chart - Covid-19Growth 
8.6 Molecular Diagnostics 
8.6.1 Table Molecular Diagnostics - by Country 
8.6.2 Chart - Molecular Diagnostics Growth 

9 Global Clinical Laboratory Diagnostic Markets - Price and Volume Charts 
9.1 Chemistry Price and Volume 
9.1.1 Table Chemistry Price - by Country 
9.1.2 Table Chemistry Volume - by Country 
9.2 Microbiology Price and Volume 
9.2.1 Table Microbiology Price - by Country
9.2.2 Table Microbiology Volume - by Country 
9.3 Hematology Price and Volume 
9.3.1 Table Hematology Price - by Country 
9.3.2 Table Hematology Volume - by Country 
9.4 Anatomic Pathology Price and Volume 
9.4.1 Table Anatomic Pathology Price - by Country 
9.4.2 Table Anatomic Pathology Volume - by Country 
9.5 Covid-19 Price and Volume 
9.5.1 Table Covid-19 Price - by Country
9.5.2 Table Covid-19 Volume - by Country 
9.6 Molecular Diagnostics Price and Volume 
9.6.1 Table Molecular Diagnostics Price - by Country 
9.6.2 Table Molecular Diagnostics Volume - by Country

10 The Future of the Clinical Laboratory 

11 Appendices 
11.1 United States Medicare System: 2021 Clinical Laboratory Fees Schedule 

List of Tables
Table 1 Market Players by Type 
Table 2 Clinical Laboratory Departments and Segments 
Table 3 Laboratory Management Focus - Different Approaches 
Table 4 Key Segmentation Variables Going Forward
Table 5 Factors Affecting Local Clinical Testing Demand 
Table 6 Seven Factors Driving Growth 
Table 7 Alternative Medicine Creates New Clinical Testing Markets 
Table 8 Six Factors Limiting Growth 
Table 9 Key Diagnostic Laboratory Technology Trends 
Table 10 Next Generation Sequencing Technologies - Speed and Cost 
Table 11 Key Point of Care Testing Uses 
Table 12 Clinical Application Areas for Molecular Diagnostics 
Table 13 - Global Market by Region 
Table 14 Global Market by Assay Type 
Table 15 Chemistry by Country 
Table 16 Microbiology by Country 
Table 17 Hematology by Country 
Table 18 Anatomic Pathology by Country 
Table 19 Covid-19 by Country 
Table 20 Molecular Diagnostics by Country 
Table 21 Chemistry Price by Country 
Table 22 Chemistry Volume by Country 
Table 23 Microbiology Price by Country 
Table 24 Microbiology Volume by Country 
Table 25 Hematology Price by Country 
Table 26 Hematology Volume by Country 
Table 27 Anatomic Pathology Price by Country 
Table 28 Anatomic Pathology Volume by Country 
Table 29 Covid-19 Price by Country 
Table 30 Covid-19 Volume by Country 
Table 31 Molecular Diagnostics Price by Country 
Table 32 Molecular Diagnostics Volume by Country
Table 33 2021 Clinical Lab Fee Schedule 

List of Figures
Figure 1 The Lab Test Pie 
Figure 2 Global Market Density Chart 
Figure 3 Global Market by Assay Type - Base vs. Final
Figure 4 Global Market by Assay Type Base Year 
Figure 5 Global Market by Assay Type End Year 
Figure 6 Assay Type Share by Year 
Figure 7 Assay Type Segments Growth 
Figure 8 Chemistry Growth 
Figure 9 Microbiology Growth 
Figure 10 Hematology Growth 
Figure 11 Anatomic Pathology Growth 
Figure 12 Covid-19 Growth 
Figure 13 Molecular Diagnostics Growth 



Companies Mentioned

  • Acibadem Labmed Laboratory 
  • ACM Medical Laboratory 
  • Adicon Clinical Laboratories 
  • American Bio-Clinical Laboratories, Int'l 
  • American Pathology Partners 
  • ARUP Laboratories 
  • Ascend Clinical 
  • Assurance Scientific Laboratories 
  • Aurora Diagnostics 
  • Bio-Reference Laboratories 
  • Bioscientia Institut für Medizinische Diagnostik GmbH 
  • BP Healthcare Group 
  • Clinical Reference Laboratory 
  • Clongen Laboratories 
  • CompuNet Clinical Laboratories 
  • Diagnósticos da América 
  • DIAN Diagnostics Co., Ltd. 
  • Enzo Biochem 
  • Eone Laboratories 
  • Eurofins Scientific 
  • Exagen Diagnostics 
  • Genzyme Corporation 
  • Gribbles Pathology 
  • Guangzhou Kingmed Diagnostics Group Co., Ltd. 
  • Integrated Regional Laboratories 
  • KDL Group 
  • Laboratory Corporation of America
  • Lifelabs 
  • Mayo Clinic Laboratories 
  • Mid America Clinical Laboratories 
  • MNG Labs 
  • Myriad Genetics/Myriad RBM 
  • NeoGenomics 
  • OncoDNA 
  • Pathology, Inc. 
  • ProPhase Labs 
  • Psychemedics Corporation 
  • Quest Diagnostics 
  • RDL Reference Laboratory 
  • Sonic Healthcare 
  • Spectra Laboratories 
  • Sysmex Inostics
  • Unilabs