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Global Clinical Medical Laboratory Services Market - Strategy & Trends with Forecasts by Assay Type, by Place, by Product, and by Country. Situation Analysis with Executive & Consultant Guides. 2024 to 2028

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    Report

  • 357 Pages
  • November 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5744889

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.

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. Forecast demand for new testing regimes or technologies. Make research investment decisions.

The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

Table of Contents

1 Market Guides
1.1 Strategic Situation Analysis
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 New Demand for Clinical Testing
2.2 Defining the Opportunity
2.2.1 Revenue Market Size
2.3 Methodology
2.3.1 Methodology
2.3.2 Sources
2.3.3 Authors
2.4 Perspective: Healthcare and the IVD Industry
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 Instrumentation Supplier
3.1.4 Chemical/Reagent Supplier
3.1.5 Pathology Supplier
3.1.6 Independent Clinical Laboratory
3.1.7 Public National/regional Laboratory
3.1.8 Hospital Laboratory
3.1.9 Physicians Office Lab (POLS)
3.1.10 Audit Body
3.1.11 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 Physicians 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 Demographic Impacts on Consumption
4.1.2 COVID Related Impacts
4.1.3 Point of Care Testing Makes a Difference
4.1.4 Alternative Medicine Effect
4.1.5 Esoterics
4.1.6 A New Laboratory Discipline
4.2 Factors at Work to Shrink the Market
4.2.1 Where are Costs Going?
4.2.2 Population Effects
4.2.3 Management Practices
4.2.4 Wellness
4.2.5 Cannabilization
4.2.6 Point of Care
4.3 Automation and Laboratory Trends
4.3.1 Traditional Automation and Centralization
4.3.2 The New Automation, Decentralization and Point Of Care
4.3.3 Instruments Key to Market Share
4.3.4 Bioinformatics Plays a Role
4.3.5 PCR Takes Command
4.3.6 Next Generation Sequencing Fuels a Revolution
4.3.7 NGS Impact on Pricing
4.3.8 Whole Genome Sequencing, A Brave New World
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
4.3.10 Shifting Role of Diagnostics

5 Clinical Laboratory Services 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 Atalan Sees Potential in Hospital Outreach Business
5.3 Challenge Bringing Routine Testing to Point of Care
5.4 Natera Cites Test Volume Growth, Rosy Reimbursement
5.5 Patients Becoming Stakeholders in Infectious Disease Testing
5.6 MedGenome Acquires Prognosis Laboratories
5.7 Brooks Automation Acquires Aim Lab
5.8 Avalon GloboCare Announces Strategic Investment in Laboratory Services MSO
5.9 Mayo Clinic Laboratories and Helix to provide Biopharma Services
5.10 CompuGroup Medical Acquires Medicus Laboratory Information Systems
5.11 Quest Diagnostics acquires Summa Health Outreach lab
5.12 Q² Solutions Launches Self-Collection Safety Lab Panel
5.13 Bionano Genomics Announces Launch of Bionano Laboratories
5.14 Labcorp to Spin Off Clinical Development Business
5.15 Value-Based Care Growing More Profitable for Labs
5.16 Lucid Diagnostics Reports Revenue Growth
5.17 NGS Cancer Testing Decision Appeases Industry
5.18 Clinical Labs Make Strong Showing in 2021
5.19 Seegene to Enter Syndromic MDx Space
5.20 EKF Diagnostics Acquires Advanced Diagnostic Laboratory
5.21 Molecular Health, EDGC Ink Liquid Biopsy Partnership
5.22 ProPhase Labs Acquires Nebula Genomics for $14.6M
5.23 Karius Cell-Free DNA Method to Detect Infection Validated
5.24 EDGC Enters Liquid Biopsy Space With Cf DNA
5.25 TruDiagnostic Receives CLIA Certification for Kentucky Laboratory
5.26 Enzo Biochem Q2 Revenues Up 62 Percent
5.27 Thermo Fisher Gets CE Mark for High-Throughput COVID-19 Assay
5.28 FDA Issues Alert - False Negatives due to SARS-CoV-2 Mutations
5.29 Will Labs Use Expanded Molecular Testing Capacities Post-COVID-19?
5.30 Chinese Infectious Dx Firm Vision Medicals Completes Series B Financing
5.31 Cooperative Aims to Expand Clinical, Commercial NGS Access

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

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
7.3 Global Market by Place - Overview
7.3.1 Table - Global Market by Place
7.3.2 Chart - Global Market by Place - Base/Final Year Comparison
7.3.3 Chart - Global Market by Place - Base Year
7.3.4 Chart - Global Market by Place - End Year
7.3.5 Chart - Global Market by Place - Share by Year
7.3.6 Chart - Global Market by Place - Segments Growth
7.4 Global Market by Product - Overview
7.4.1 Table - Global Market by Product
7.4.2 Chart - Global Market by Product - Base/Final Year Comparison
7.4.3 Chart - Global Market by Product - Base Year
7.4.4 Chart - Global Market by Product - End Year
7.4.5 Chart - Global Market by Product - Share by Year
7.4.6 Chart - Global Market by Product - 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 Molecular Diagnostics
8.5.1 Table Molecular Diagnostics - by Country
8.5.2 Chart - Molecular Diagnostics Growth
8.6 Esoteric
8.6.1 Table Esoteric - by Country
8.6.2 Chart - Esoteric Growth

9 Global Clinical Laboratory Diagnostic Markets - By Place
9.1 In Patient Hospital
9.1.1 Table In Patient Hospital - by Country
9.1.2 Chart - In Patient Hospital Growth
9.2 Out Patient Hospital
9.2.1 Table Out Patient Hospital - by Country
9.2.2 Chart - Out Patient Hospital Growth
9.3 Independent Laboratory
9.3.1 Table Independent Laboratory - by Country
9.3.2 Chart - Independent Laboratory Growth
9.4 Physicians Office Laboratory
9.4.1 Table Physicians Office Laboratory - by Country
9.4.2 Chart - Physicians Office Laboratory Growth
9.5 Other Laboratory
9.5.1 Table Other Laboratory - by Country
9.5.2 Chart - Other Laboratory Growth

10 Global Clinical Laboratory Diagnostic Markets - By Product
10.1 Instruments
10.1.1 Table Instruments - by Country
10.1.2 Chart - Instruments Growth
10.2 Reagents
10.2.1 Table Reagents - by Country
10.2.2 Chart - Reagents Growth
10.3 Labour
10.3.1 Table Labour - by Country
10.3.2 Chart - Labour Growth
10.4 Overhead
10.4.1 Table Overhead - by Country
10.4.2 Chart - Overhead Growth
10.5 Other Product
10.5.1 Table Other Product - by Country
10.5.2 Chart - Other Product Growth

11 The Future of the Clinical Laboratory
12 Appendices
12.1 United States Medicare System: Clinical Laboratory Fees Schedule
12.2 The Most Used IVD Assays
12.3 The Highest Grossing Assays

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 Segments
Table 8 Six Factors Limiting Growth
Table 9 Seven Key Diagnostic Laboratory Technology Trends
Table 10 - Global Market by Region
Table 11 Global Market by Assay Type
Table 12 Global Market by Place
Table 13 Global Market by Product
Table 14 Chemistry by Country
Table 15 Microbiology by Country
Table 16 Hematology by Country
Table 17 Anatomic Pathology by Country
Table 18 Molecular Diagnostics by Country
Table 19 Esoteric by Country
Table 20 In Patient Hospital by Country
Table 21 Out Patient Hospital by Country
Table 22 Independent Laboratory by Country
Table 23 Physicians Office Laboratory by Country
Table 24 Other Laboratory by Country
Table 25 Instruments by Country
Table 26 Reagents by Country
Table 27 Labour by Country
Table 28 Overhead by Country
Table 29 Other Product by Country
Table 30 Clinical Lab Fee Schedule
Table 31 The Most Common Assays
Table 32 Largest Revenue Assays

List of Figures
Figure 1 Global Healthcare Spending
Figure 2 The Road to Diagnostics
Figure 3 The Changing Age of The World’s Population
Figure 4 Health Care Consumption by Age
Figure 5 Cancer Incidence - Age at Diagnosis
Figure 6 Centralized vs. Decentralized Laboratory Service
Figure 7 A Highly Multiplexed Syndromic Testing Unit
Figure 8 The Real Cost to Sequence the Human Genome
Figure 9 The Codevelopment Process
Figure 10 Comparing MDx Diagnostic and Traditional Testing
Figure 11 Global Market Pareto Chart
Figure 12 Global Market by Assay Type - Base vs. Final
Figure 13 Global Market by Assay Type Base Year
Figure 14 Global Market by Assay Type End Year
Figure 15 Assay Type Share by Year
Figure 16 Assay Type Segments Growth
Figure 17 Global Market by Place - Base vs. Final
Figure 18 Global Market by Place Base Year
Figure 19 Global Market by Place End Year
Figure 20 Place Share by Year
Figure 21 Place Segments Growth
Figure 22 Global Market by Product - Base vs. Final
Figure 23 Global Market by Product Base Year
Figure 24 Global Market by Product End Year
Figure 25 Product Share by Year
Figure 26 Product Segments Growth
Figure 27 Chemistry Growth
Figure 28 Microbiology Growth
Figure 29 Hematology Growth
Figure 30 Anatomic Pathology Growth
Figure 31 Molecular Diagnostics Growth
Figure 32 Esoteric Growth
Figure 33 In Patient Hospital Growth
Figure 34 Out Patient Hospital Growth
Figure 35 Independent Laboratory Growth
Figure 36 Physicians Office Laboratory Growth
Figure 37 Other Laboratory Growth
Figure 38 Instruments Growth
Figure 39 Reagents Growth
Figure 40 Labour Growth
Figure 41 Overhead Growth
Figure 42 Other Product Growth

Samples

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Companies Mentioned

  • Acibadem Labmed Laboratory
  • ACM Medical Laboratory
  • Adicon Clinical Laboratories
  • American Bio-Clinical Laboratories, Int'l
  • ARUP Laboratories
  • Ascend Clinical
  • Assurance Scientific Laboratories
  • 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
  • Sophia Genetics
  • Spectra Laboratories
  • Synlab
  • Sysmex Inostics
  • Unilabs
  • Werfen