The Worldwide Market for Clinical Laboratory Services, 9th Edition

The Worldwide Market for Clinical Laboratory Services, 9th Edition


Discover Comprehensive Insights with Kalorama’s Clinical Laboratory Services Report


Understanding the clinical laboratory market is crucial for effective business planning. The Worldwide Market for Clinical Laboratory Services, 9th Edition answers essential questions such as the size of the service market for clinical testing, the types of tests that are in demand, and the future trajectory of this market 2023-2028. It also identifies the companies poised to earn the most revenue and examines their strategies post-COVID-19 as the virus becomes endemic.

Why This Report is Essential for IVD Manufacturers


Kalorama Information’s annual review of the clinical labs market is a must-have resource for IVD manufacturers. Clinical laboratories are fundamental to the diagnostic services within the IVD market, providing critical analysis for a myriad of disorders and diseases, including pathology, immunology, cholesterol testing, allergy testing, urinalysis, and genetic testing. These laboratories are indispensable to the healthcare industry.

Market Opportunity in Lab Services: Now in its 9th Edition


The Worldwide Market for Clinical Laboratory Services, 9th Edition offers a detailed overview of the clinical laboratory industry, highlighting key trends and growth drivers.

Key Features of the Report
  • Industry Overview: Gain a comprehensive understanding of the clinical laboratory industry and the trends propelling its growth.
  • Influential Statistics: Examine data on disease incidence in the U.S. and globally, demographic trends, life expectancy, and company strategies.
  • Global Focus: The report covers key regions including:
  • North America (United States, Canada)
  • Europe, Middle East, and Africa - EMEA (Germany, France, Italy, Spain, United Kingdom, Switzerland)
  • Asia Pacific (Japan, China, India, South Korea, Australia)
  • Latin America (Brazil, Mexico)
  • Specialty Segments Covered
  • Essential and Routine Testing: Clinical chemistry, hematology, coagulation, endocrinology
  • Immunology and Microbiology Testing
  • Cytology and Histology Testing
  • Genetic Testing
  • Toxicology Testing: Drugs of abuse
  • COVID-19
Market Segmentation by Laboratory Type
  • Independent and Reference Laboratories
  • Hospital-based Laboratories
  • Clinic-based Laboratories
Competitive Analysis

The report provides a thorough competitive analysis of leading clinical laboratory providers, offering insights into market positioning and strategic initiatives.

Data and Forecasting
  • Market Data: Pertains to the world market at the manufacturers’ level.
  • Base Year: 2023
  • Historical Data: 2018 through 2022
  • Forecast Data: 2024 through 2028
  • CAGRs: Provided for the 2023-2028 period for each segment.
Challenges and Adjustments

This report is part of a regularly updated series. Each new edition reflects the latest findings, adjusting for company performance, pricing pressures, reimbursement challenges, and the ongoing impacts of COVID-19.

Exclusions

The market analysis excludes revenues from clinical trial laboratory testing, environmental testing, veterinary laboratory testing, and other similar industries.

Prepare for Future Market Trends

Stay ahead with insights into demographic trends, disease trends, new developments, company performance, mergers and acquisitions, and national expansions. This report is a critical tool for navigating the evolving clinical laboratory market landscape.


  • Executive Summary
    • Industry at a Glance
      • Table Clinical Laboratory Service Market Overview, 2024
    • Scope and Methodology
    • Global Market Overview
      • Table Factors Driving Demand in Clinical Laboratory Service Market, 2024
      • Table Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions at the manufacturers' level)
      • Table Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions)
    • Key Issues and Trends Affecting the Market
    • Leading Market Participants
  • Industry Overview
    • Clinical Laboratory Description
      • Table Clinical Laboratory Order (Diagnosis, Treatment, Monitoring)
      • Table Global Hospital Length of Stay in Days, by Country, 2021 Average
    • Number of Laboratory Health Workers by Country
      • Table Global Laboratory Health Workers, by Country, 2010-2021 Average
    • The Largest Clinical Laboratory Market: The United States
      • Structure and Regulation in the U.S.
        • Table Selected CLIA Waived Laboratory Tests
        • Table Provider-Performed Microscopy Procedures
        • Table Clinical Laboratory Certificate of Accreditation Issued, by Organization (non-exempt laboratories only), March 2024
        • Table Clinical Laboratory Certificates Issued, by Type (non-exempt laboratories only), as of April 2023
        • Table Laboratory Certificate Trends, by Application Type, July 2010 - March 2024
        • Table CLIA Exempt States, Number of Laboratories, as of March 2024
    • Laboratory Developed Test Regulations
    • Payers and Reimbursement
      • Table Positive Forces and Negative Forces for Payers and Reimbursement
      • Laboratory Service Payer Types
        • Table U.S. Clinical Laboratory Revenues, by Client and Payer Type, 2023 (%)
        • Table Clinical Laboratory Revenues, by Client and Payer Type, 2023 Estimates (%)
      • Trends in Medicare Reimbursement
        • Table Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009-2024
      • Health Care Reform
      • Protecting Access to Medicare Act (PAMA) of 2014
        • Table Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
      • Advanced Laboratory Tests (ADLT)
        • Table List of Approved ADLTs, 2018-March 2024
      • Bundled Insurance Payments for ESRD Patients
        • Table Laboratory Tests Subject to ESRD Consolidated Billing (CY 2022)
      • Commercial Insurance Providers
        • Table National Commercial Insurance Provider List, 2023
        • Table National Commercial Insurance Providers, by Membership and Total Revenues, 2023 ($ billions)
    • Transparency in Pricing
      • Table Revenue and Test Volume Trends, Quest Diagnostics, 2010-2023 ($ millions)
    • Direct-to-Consumer Testing
      • Table Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Labcorp On Demand) 2023 (in US $)
      • DTC in Genetic Testing
    • Expanding Cancer Test Utilization and Technologies
      • Labcorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy
      • Labcorp Launches New Test for NSCLC
      • Labcorp Offers First FDA Test for Monitoring Residual Blood Cancer Cells
      • Labcorp Launches New Test for Skin Cancer
      • Labcorp Acquires Select Assets of Invitae
      • Labcorp Launches Plasma Detect
      • Quest Diagnostics Attention to Oncology
      • Quest Collaborates with GRAIL on Oncology
      • Quest Releases Companion Diagnostic
      • Quest Offers Biocept's Liquid Biopsy Test for Lung Cancer
      • Quest Acquires Haystack Oncology
      • Quest Launches MelaNodal Predict Test
    • The Role of Information Technology
      • Table Selected Laboratory Information Management System Providers, 2023 Vendor List
    • Industry Drivers
      • Global Demographics
        • Table The Global Population, 1980-2050
        • Table The Global Population, 1980-2050 (in millions)
        • Table World Population, by Major Geographic Region, 2010-2050 (in millions)
        • Table World Population, by Major Geographic Region, 2010-2050 (in millions)
        • Table Global Population Trends Age 65+, 2000-2050 (in millions)
        • Table Global Population Trends Age 65+, 2000-2050 (in millions)
      • Chronic Diseases and Conditions
        • Table Global Prevalence of Disease, 2000, 2015, and Projected 2030 (in millions)
        • Table Global Causes of Death, 2000, 2010, and 2020 (in millions)
        • Table Change in Mortality by Disease Type, Over 2000-2020 Period (%)
      • Economic Performance
        • Table Global Health Spending as a Percentage of GDP, by Country, 2022 estimates (%)
  • Testing Services by Specialty
    • Test and Services Overview
      • Table Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2018-2028 ($ millions)
      • Table Global Clinical Laboratory Market Analysis, by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2018-2028 ($ millions at the manufacturers' level)
      • Table Global Clinical Laboratory Market Analysis, Segment Growth Forecast, by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), CAGR 2023-2028 (%)
      • Table Global Clinical Laboratory Market Analysis, by Testing Service (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), Distribution of Revenues, 2023 (%)
    • Clinical Chemistry - Routine and Essential Testing
      • Table Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2018-2028 ($ millions)
      • Table Market Overview - Routine and Essential Testing, 2023 ($ millions)
      • Routine Clinical Chemistry
      • Cholesterol Level Testing
        • Table High Cholesterol Risk Categories
      • Urinalysis
        • Table Normal Reference Levels in a Medical Urinalysis
      • Hematology
        • Table Laboratory Reference Parameters for CBC
      • Coagulation
      • Endocrinology
        • Table HCG Levels in Pregnant Women by Days Past Ovulation
    • Immunology and Microbiology
      • Table Global Clinical Laboratory Market Analysis: Immunology & Microbiology Testing Service Market Trend, 2018-2028 ($ millions)
      • Table Market Overview - Immunology & Microbiology Testing, 2023 ($ millions)
      • Allergy and Food Intolerance
      • Tumor Markers
      • Cardiac Markers
      • HIV Testing
    • Cytology and Histology Testing
      • Table Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2018-2028 ($ millions)
      • Table Market Overview - Cytology & Histology Testing, 2023 ($ millions)
      • Table Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country, 2019 Estimates
    • Genetic Testing
      • Table Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2018-2028 ($ millions)
      • Table Market Overview - Genetic Testing, 2023 ($ millions)
    • Toxicology Testing
      • Table Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2018-2028 ($ millions)
      • Table Substance Detection Periods by Selected Test Method
  • Global Clinical Laboratory Market by Provider Group
    • Clinical Laboratory Market: Provider Overview
      • Table Global Clinical Laboratory Market Analysis, by Provider Segment (Hospitals, Physician Offices/Outpatient Clinics, Independent), 2023-2028 ($ millions at the manufacturers' level)
      • Table Global Clinical Laboratory Market Analysis, Provider Segment Growth Forecast, CAGR 2023- 2028 (%)
      • Table Global Clinical Laboratory Market Analysis, by Provider Group, Distribution of Revenues, 2023 (%)
    • Hospitals and Acute Care Providers
      • Table COVID-19 Impact on Hospital-based Laboratory Testing Markets, 2021-2023 ($ millions)
      • Table Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)
      • Table Hospital Beds per 1,000 Population, by Country, 2021/2022
    • Physicians and Outpatient Care Providers
      • Table COVID-19 Impact on Physician-based Laboratory Testing Markets, 2021-2023 ($ millions)
      • Table Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)
      • Physician Offices
        • Table Medical Doctors per 1,000 Population, by Country, 2021/2022
      • Global Nursing Establishments and Assisted Living Facilities
      • Global Dialysis Clinics
    • Independent Laboratory Providers
      • Table COVID-19 Impact on Independent Laboratory Testing Markets, 2021-2023 ($ millions)
      • Table Revenues for Selected U.S.-based Reference Labs 2018-2023 ($ millions, estimated)
      • Table Estimated Clinical Test Volume by Select Independent Laboratory, 2023 (millions of units)
      • Table Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market, 2023 and 2028 (U.S./International Estimates)
  • North America Market
    • Overview
      • Table North America Market Value, by Country, 2023 ($ millions at the manufacturers' level)
    • United States
      • Table The United States Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Table The United States Clinical Laboratory Service Market, Performance 2018-2028 ($ millions)
      • U.S. Market by Test Type
        • Table The United States Clinical Laboratory Service Market, by Testing Services, Estimates and Forecast 2023 and 2028 ($ millions)
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues, by Type, 2023 (%)
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time, by Type, 2018-2028 ($ millions)
      • U.S. Market by Laboratory Provider Type
        • Table The United States Clinical Laboratory Service Market, by Laboratory Type, Estimates and Forecast 2023 and 2028 ($ millions)
        • Table U.S. Clinical Laboratory Market Share, by Laboratory Type, 2023 (%)
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time, by Laboratory Type, 2018-2028 ($ millions)
      • U.S. Clinical Laboratory Industry Structure
        • Table Growth in Clinical Laboratories, 2000-2023
        • Table U.S. CLIA Clinical Laboratory Registration, by Primary Laboratory Type, April 2024
        • Table CLIA Registered Laboratories, by Type of Facility (Exempt/Non-Exempt Combined), April 2024
        • Table Growth Trends in CLIA Registered Laboratories, by Type of Facility (Exempt/Non-Exempt Combined) June 2020 and April 2024
        • Table Change in CLIA Registered Laboratories, by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2020-2024
      • Independent Clinical Laboratories
        • Table Leading U.S. Independent Laboratory Groups, Distribution of Centers, December 2023 (%)
        • Table Growth in U.S. Independent Laboratory Facilities, June 2011 through April 2024
      • Hospital-based Laboratories
        • Table U.S. Hospital Types
        • Table AHA Statistics - U.S. Registered Hospitals, by Type, 2010-2022
        • Table AHA Statistics for U.S. Hospitals, 2014-2022
        • Table U.S. Hospital Length of Stay, Average by Broad Age Group, 2021
        • Table Growth in U.S. Hospital Laboratory Locations, June 2011 through April 2024
      • Physician-office and Clinic Laboratories
        • Table Growth in U.S. Physician Office Laboratory Locations, June 2011 through April 2024
      • Nursing Facility and Home Health
        • Table Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through April 2024
      • Pharmacy-based Laboratories
        • Table Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through April 2024
      • Dialysis Clinics
        • Table Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through April 2024
    • Canada
      • Table Canada Clinical Laboratory Service Market, Estimates and Forecast 2023-2028 ($ millions)
      • Table Canada Clinical Laboratory Service Market, Performance 2018-2028 ($ millions)
  • EMEA Market
    • Overview
      • Table EMEA Market Value, by Country, 2023 ($ millions at the manufacturers' level)
      • Table EMEA Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028
      • Germany
        • Table Germany Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
        • Table Leading Laboratory Service Suppliers, by Estimated Distribution of Revenues, Germany, 2023 (%)
      • France
        • Table France Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Italy
        • Table Italy Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Spain
        • Table Spain Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • United Kingdom
        • Table United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Switzerland
        • Table Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
  • Asia Pacific Market
    • Overview
      • Table Asia Pacific Clinical Laboratory Service Market Value, by Country, 2023 ($ millions at the manufacturers' level)
      • Table Asia Pacific Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028 (%)
      • Japan
        • Table Japan Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Japan Clinical Laboratory Industry Structure
        • Table Japan Clinical Laboratory Industry, by Type, 2023 (%)
        • Table Japan Clinical Laboratory Industry, by Test Classification, 2022-2023 (%)
        • Table Japan Clinical Laboratory Industry, Number of Laboratories, by Prefecture, 2023 (%)
      • China
        • Table China Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • China Clinical Laboratory Industry Structure
        • Table China Clinical Laboratory Industry, by Type, 2023 (%)
      • India
        • Table India Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • South Korea
        • Table South Korea Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Australia
        • Table Australia Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
  • Latin America Market
    • Overview
      • Table Latin America Market Value, by Country, 2023 ($ millions at the manufacturers' level)
      • Table Latin America Clinical Laboratory Service Market, Growth Projections, by Country, CAGR 2023-2028
      • Brazil
        • Table Brazil Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
      • Mexico
        • Table Mexico Clinical Laboratory Service Market, Estimates and Forecast 2023 and 2028 ($ millions)
  • Leading Market Participants
    • Global Competitor Summary
      • Table Market Participants, Global Service Revenues, Estimated 2022 and 2023 ($ millions)
    • U.S. Competitive Analysis
      • Table Top Ten Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2023 ($ millions)
      • Table Top 10 Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2023 (%)
    • Select Company Profiles
    • Quest Diagnostics, Inc.
      • Company Overview
        • Table Quest Diagnostics Corporate Details
      • Performance Review
        • Table Quest Diagnostics Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Laboratory Corporation of America
      • Company Overview
        • Table Laboratory Corporation of America Corporate Details
      • Performance Review
        • Table Laboratory Corporation of America Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Exact Sciences Corp.
      • Company Overview
        • Table Exact Sciences Corporate Details
      • Performance Review
        • Table Exact Sciences Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Sonic Healthcare Limited
      • Company Overview
        • Table Sonic Healthcare Corporate Details
      • Performance Review
        • Table Sonic Healthcare Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • BioReference Laboratories - An OPKO Health Subsidiary
      • Company Overview
        • Table BioReference Laboratories Corporate Details
      • Key Acquisitions, Alliances, and Partnerships
      • Performance Review
        • Table BioReference Laboratories Revenue Summary, 2010-2023 ($ millions)
      • Products and Services
    • Myriad Genetics, Inc.
      • Company Overview
        • Table Myriad Genetics Corporate Details
      • Key Acquisitions, Alliances, and Partnerships
      • Performance Review
        • Table Myriad Genetics Revenue Summary, 2010-2023 ($ millions)
      • Products and Services
    • SYNLAB International GmbH (SYNLAB Bondco PLC)
      • Company Overview
        • Table SYNLAB Corporate Details
      • Performance Review
        • Table SYNLAB Revenue Summary, 2015-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Eurofins Scientific SE
      • Company Overview
        • Table Eurofins Scientific Corporate Details
      • Performance Review
        • Table Eurofins Scientific Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • H.U. Group Holdings Miraca
      • Company Overview
        • Table H.U. Group Holdings, Inc. Corporate Details
      • Performance Review
        • Table H.U. Holdings Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Siemens Healthineers
      • Company Overview
        • Table Siemens Healthineers Corporate Details
      • Performance Review
        • Table Siemens Healthineers' Revenue Summary, 2010-2023 ($ millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Unilabs
      • Company Overview
        • Table Unilabs Corporate Details
      • Performance Review
      • Products and Services
    • Medicover AB
      • Company Overview
        • Table Medicover Corporate Details
      • Key Acquisitions, Alliances, and Partnerships
      • Performance Review
        • Table Medicover Revenue Summary, 2010-2023 ($ millions)
      • Products and Services
  • Market Trends and Summary
    • Global Market Overview
      • Table Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions at the manufacturers' level)
      • Table Global Clinical Laboratory Market Analysis, 2018-2028 ($ millions)
    • Regional Overview
      • Table Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2023 ($ millions)
      • Table Global Clinical Laboratory Market Analysis, Revenues by Region, 2023 (%)
      • Table Global Clinical Laboratory Market Analysis, Regional Growth Forecast, CAGR 2023-2028 (%)
      • Table Estimated COVID-19 Market Performance, by Region, 2023 ($ millions)
      • Population growth
      • Aging populations
      • Increasing disease burden
      • Economic growth in developing regions
      • Stabilizing economies in developed regions
      • Pricing pressures
      • Focusing on Efficient health systems
      • Overall growth in demand for health care services
      • COVID-19
      • Multiplex Testing
      • AI and Machine Learning Laboratory Trends
      • Molecular Testing and Other Advanced Testing Will Open New Avenues
      • Digital Pathology Trends
      • Staffing Shortages

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