Clinical Laboratory Services Market, 7th Edition


Attention: There is an updated edition available for this report.

Clinical Laboratory Services Market, 7th Edition

Clinical Laboratory Services Market, 7th Edition provides an overview of the clinical laboratory industry and the trends driving growth. Included in the report are statistics influencing the industry, incidence of diseases in the U.S. and worldwide demographics, life expectancy, and company strategies. Information is presented as a global focused market report, with key regions discussed 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)
The laboratory service market is also covered by specialty, including:
  • 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
A global market analysis by laboratory type is also displayed, including:
  • Independent and Reference Laboratories
  • Hospital-based Laboratories
  • Clinic-based Laboratories
Also included is a competitive analysis of leading clinical laboratory providers.

All market data pertains to the world market at the manufacturers’ level. The base year for data is 2021. Historical data is provided for the years 2011 through 2020, with forecast data provided for 2022 through 2026. Compound annual growth rates (CAGRs) are provided for the 2021-2026 periods for each segment covered. A U.S. competitive analysis is provided for the year 2021. The forecasted market analysis through 2026 was largely based on demographic trends, disease trends, new developments, company performance trends, merger and acquisitions, and national expansion.


  • Executive Summary
    • Industry at a Glance
    • Scope and Methodology
    • Global Market Overview
      • Table Global Clinical Laboratory Market Analysis, 2011-2026 (in millions of dollars at the manufacturer’s level)
    • Key Issues and Trends Affecting the Market
    • Leading Market Participants
  • Industry Overview
    • Clinical Laboratory Description
    • Number of Laboratory Health Workers by Country
    • 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 Certificates Issued by Type (non-exempt laboratories only), as of May 2022
        • Table CLIA Exempt States, Number of Laboratories, as of May 2022
    • Laboratory Developed Test Regulations
      • FDA
      • Directive 98/79/EC
      • Health Canada Changes and Forecasted Action
    • Payers and Reimbursement
      • Laboratory Service Payer Types
        • Table U.S. Clinical Laboratory Revenues by Client and Payer Type (%), 2021
      • Trends in Medicare Reimbursement
      • Health Care Reform
      • Protecting Access to Medicare Act (PAMA) of 2014
        • Table Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
      • Advanced Laboratory Tests (ADLT)
        • Table List of Approved ADLTs, March 2022
      • 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, 2021
    • Transparency in Pricing
    • Direct-to-Consumer Testing
      • Table Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Labcorp On Demand) 2022* (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
      • 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
    • The Role of Information Technology
      • Table Selected Laboratory Information Management System Providers, 2020 Vendor List
    • Industry Drivers
      • Global Demographics
        • Table The Global Population, 1980-2050
        • Table World Population by Major Geographic Region, 2010 – 2050
        • Table Global Population Trends Age 65+, 2000-2050
      • Chronic Diseases and Conditions
      • Economic Performance
  • Testing Services by Specialty
    • Test and Services Overview
      • Table Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2011-2026 (in millions of dollars at the manufacturers’ level)
    • Clinical Chemistry - Routine and Essential Testing
      • Table Market Overview - Routine and Essential Testing, 2021
      • 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 Market Overview - Immunology & Microbiology Testing, 2021
      • Allergy and Food Intolerance
      • Tumor Markers
      • Cardiac Markers
      • HIV Testing
        • Table Number of Reported HIV Tests Performed by Country, 2018
    • Cytology and Histology Testing
      • Table Market Overview - Cytology & Histology Testing, 2021
    • Genetic Testing
      • Table Market Overview - Genetic Testing, 2021
    • Toxicology Testing
      • Table Substance Detection Periods by Test Method
    • COVID-19 Virus Testing
  • Global Clinical Laboratory Market by Provider Group
    • Clinical Laboratory Market: Provider Overview
      • Table Global Clinical Laboratory Market Analysis by Provider Segment, 2021, 2026 (Hospitals, Physician Offices/Outpatient Clinics, Independent)
    • Hospitals and Acute Care Providers
      • Table Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
    • Physicians and Outpatient Care Providers
      • Table Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
      • Physician Offices
      • Global Nursing Establishments and Assisted Living Facilities
      • Global Dialysis Clinics
    • Independent Laboratory Providers
      • Table Revenues for Selected U.S.-based Reference Labs 2016-2021 ($million, estimated)
      • Table Estimated Clinical Test Volume by Select Independent Laboratory, 2021 (millions of units)
      • Table Estimated COVID-19 Test Volume by Select Independent Laboratory, 2021 (millions of units)
      • Table Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
  • North America Market
    • Overview
      • Table North America Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
    • United States
      • Table The United States Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
      • U.S. Market by Test Type
        • Table The United States Clinical Laboratory Service Market by Testing Services, Estimates and Forecast 2021 and 2026 ($millions)
      • U.S. Market by Laboratory Provider Type
        • Table The United States Clinical Laboratory Service Market by Laboratory Type, Estimates and Forecast 2021 and 2026 ($millions)
      • U.S. Clinical Laboratory Industry Structure
        • Table CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) May 2022
      • Independent Clinical Laboratories
      • Hospital-based Laboratories
        • Table U.S. Hospital Types
        • Table AHA Statistics - U.S. Registered Hospitals by Type, 2010 through 2021
        • Table AHA Statistics for U.S. Hospitals, 2013-2021
      • Physician-Office and Clinic Laboratories
      • Nursing Facility and Home Health
      • Pharmacy-based Laboratories
      • Dialysis Clinics
    • Canada
      • Table Canada Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
  • EMEA Market
    • Overview
      • Table EMEA Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
    • Germany
      • Table Germany Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • France
      • Table France Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • Italy
      • Table Italy Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • Spain
      • Table Spain Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • United Kingdom
      • Table United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • Switzerland
      • Table Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
  • Asia Pacific Market
    • Overview
      • Table Asia Pacific Clinical Laboratory Service Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
    • Japan
      • Table Japan Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
      • Japan Clinical Laboratory Industry Structure
    • China
      • Table China Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
      • China Clinical Laboratory Industry Structure
    • India
      • Table India Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • South Korea
      • Table South Korea Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • Australia
      • Table Australia Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
  • Latin America Market
    • Overview
      • Table Latin America Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
    • Brazil
      • Table Brazil Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
    • Mexico
      • Table Mexico Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
  • Leading Market Participants
    • Global Competitor Summary
    • U.S. Competitive Analysis
      • Table Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2021
    • Quest Diagnostics, Inc.
      • Company Overview
        • Table Quest Diagnostics Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Laboratory Corporation of America
      • Company Overview
        • Table Laboratory Corporation of America Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Sonic Healthcare Limited
      • Company Overview
        • Table Sonic Healthcare Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • SYNLAB International GmbH (SYNLAB Bondco PLC)
      • Company Overview
        • Table SYNLAB Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Eurofins Scientific SE
      • Company Overview
        • Table Eurofins Scientific Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
      • COVID-19 Events and Impact
    • Exact Sciences Corp.
      • Company Overview
        • Table Exact Sciences Corporate Details
      • Performance Review
      • 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
      • Products and Services
    • Miraca Holdings, Inc. –H.U. Group Holdings
      • Company Overview
        • Table Miraca - H.U. Group Holdings, Inc. Corporate Details
      • Performance Review
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Siemens Healthineers
      • Company Overview
        • Table Siemens Healthineers Corporate Details
      • Performance Review
      • 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
      • Products and Services
  • Market Trends and Summary
    • Global Market Overview
      • Table Global Clinical Laboratory Market Analysis, 2011-2026 (in millions of dollars at the manufacturer’s level)
    • Regional Overview
      • Table Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2021
      • 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
  • Accreditation Organizations Under CLIA
    • AABB
    • American Association for Laboratory Accreditation
    • Accreditation Commission for Health Care, Inc. (ACHC)
    • American Society for Histocompatibility and Immunogenetics
    • COLA
    • College of American Pathologists
    • Joint Commission

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings