Clinical Laboratory Service Markets, 6th Edition

Clinical Laboratory Services Market, 6th Edition, new from Kalorama Information, 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, as of 2020
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 2020. Historical data is provided for the years 2010 through 2019, with forecast data provided for 2020 through 2025. Compound annual growth rates (CAGRs) are provided for the 2020-2025 periods for each segment covered. A U.S. competitive analysis is provided for the year 2020, based on performance through third quarter reports. The forecasted market analysis through 2025 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, 2010-2025 (in millions of dollars at the manufacturer's level)
      • Table Global Clinical Laboratory Market Analysis: 2010-2025
      • Market Conclusions
    • Key Issues and Trends Affecting the Market
    • Leading Market Participants
  • Industry Overview
    • Clinical Laboratory Description
      • Table Hospital Length of Stay in Days (2018-2019 Average)
    • Number of Laboratory Health Workers by Country
      • Table Laboratory Health Workers by Country, 2010-2019 Average
      • 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 2020
        • Table Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), as of March 2020
        • Table Laboratory Certificate Trends by Application Type, July 2010- March 2020
        • Table CLIA Exempt States, Number of Laboratories, as of March 2020
    • Laboratory Developed Test Regulations
    • Payers and Reimbursement
      • Laboratory Service Payer Types
        • Table U.S. Clinical Laboratory Revenues by Client and Payer Type (%), 2020
        • Table Clinical Laboratory Revenues by Client and Payer Type, 2020 Estimates
      • Trends in Medicare Reimbursement
        • Table Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009 through 2020
      • Health Care Reform
      • Protecting Access to Medicare Act (PAMA) of 2014
        • Table Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2023
      • Advanced Laboratory Tests (ADLT)
        • Table List of Approved ADLTs, March 2021
      • Bundled Insurance Payments for ESRD Patients
        • Table Laboratory Tests Subject to ESRD Consolidated Billing (CY 2019)
      • Commercial Insurance Providers
        • Table National Commercial Insurance Provider List, 2020
        • Table National Commercial Insurance Providers by Membership and Total Revenues, 2020
    • Transparency in Pricing
      • Table Revenue and Test Volume Trends, Quest Diagnostics
    • Direct-to-Consumer Testing
      • Table Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Pixel LabCorp) 2019* (in US $)
      • DTC in Genetic Testing
    • Expanding Cancer Test Utilization and Technologies
      • LabCorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy
      • Foundation Medicine signs $111M contract with Department of Veterans Affairs
      • Quest Diagnostics Attention to Oncology
    • The Role of Information Technology
      • Table Selected Laboratory Information Management System Providers, 2020 Vendor List
    • Industry Drivers
      • Global Demographics
        • Table The Global Population, 1980-2050
        • Table The Global Population, 1980-2050 (in millions)
        • Table World Population by Major Geographic Region, 2010 - 2050
        • Table World Population by Major Geographic Region, 2010–2050
        • Table Global Population Trends Age 65+, 2000-2050
        • Table Global Population Trends Age 65+, 2000-2050 (Millions)
      • Chronic Diseases and Conditions
        • Table Global Prevalence of Disease, 2000, 2015 and Projected 2030
        • Table Global Causes of Death, 2000, 2010 and 2016
        • Table Change in Mortality Over 2000-2016 Period
      • Economic Performance
        • Table Global Health Spending as a Percentage of GDP, by Country, 2019 estimates (%)
  • Testing Services by Specialty
    • Test and Services Overview
      • Table Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2010-2025 ($millions)
      • Table Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2010-2025 (in millions of dollars at the manufacturers' level)
      • Table Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2020-2025 (excluding COVID-19)
      • Table Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2020 (%)
    • Clinical Chemistry - Routine and Essential Testing
      • Table Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2010-2025
      • Table Market Overview - Routine and Essential Testing, 2020
      • Routine Clinical Chemistry
      • Cholesterol Level Testing
        • Table High Cholesterol Risk Categories
        • Table Raised or At-Risk Total Cholesterol (> = 190 mg/dL) age standardized estimates, 2008 data
      • 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, 2010-2025
      • Table Market Overview - Immunology & Microbiology Testing, 2020
      • Allergy and Food Intolerance
      • Tumor Markers
      • Cardiac Markers
      • HIV Testing
        • Table Number of Reported HIV Tests Performed by Country, 2018
        • Table Number of HIV Testing/Counseling Facilities per 100,000 Adult Populations and HIV Positive Population per 1,000 by Select Country (2017)
    • Cytology and Histology Testing
      • Table Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2010-2025
      • Table Market Overview - Cytology & Histology Testing, 2020
      • Table Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country 2016/2017 Estimates
    • Genetic Testing
      • Table Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2010-2025
      • Table Market Overview - Genetic Testing, 2020
    • Toxicology Testing
      • Table Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2010- 2025
      • Table Substance Detection Periods by Test Method
    • COVID-19 Virus Testing
      • Table Global Distribution of COVID-19 Test Services: Volume, 2020
      • Table Factors Affecting COVID-19 Clinical Testing Market, 2021 and Beyond
  • Global Clinical Laboratory Market by Provider Group
    • Clinical Laboratory Market: Provider Overview
      • Table Global Clinical Laboratory Market Analysis by Provider Segment, 2020, 2025 (Hospitals, Physician Offices/Outpatient Clinics, Independent)
      • Table Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2020- 2025
      • Table Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2020 (%)
    • Hospitals and Acute Care Providers
      • Table COVID-19 Impact on Hospital-based Laboratory Testing Markets, $millions
      • Table Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)
      • Table Hospital Beds per 1,000 Population by Country, 2020
    • Physicians and Outpatient Care Providers
      • Table COVID-19 Impact on Physician-based Laboratory Testing Markets, $millions
      • Table Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)
      • Physician Offices
        • Table Medical Doctors per 1,000 Population by Country, 2019/2020
      • Global Nursing Establishments and Assisted Living Facilities
      • Global Dialysis Clinics
    • Independent Laboratory Providers
      • Table COVID-19 Impact on Independent Laboratory Testing Markets, $millions
      • Table Revenues for Selected U.S.-based Reference Labs 2015-2020 ($million, estimated)
      • Table Estimated Clinical Test Volume by Select Independent Laboratory, 2020 (millions of units)
      • Table Estimated COVID-19 Test Volume by Select Independent Laboratory, 2020 (millions of units)
      • Table Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market 2020 and 2025 (U.S./International Estimates)
  • North America Market
    • Overview
      • Table North America Market Value by Country, 2020 (in millions of dollars at the manufacturers' level)
    • United States
      • Table The United States Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
      • Table The United States Clinical Laboratory Service Market, Performance 2010-2025 ($millions)
      • U.S. Market by Test Type
        • Table The United States Clinical Laboratory Service Market by Testing Services, Estimates and Forecast 2020 and 2025 ($millions)
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues by Type, 2020
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Type, 2010- 2025 ($millions)
      • U.S. Market by Laboratory Provider Type
        • Table The United States Clinical Laboratory Service Market by Laboratory Type, Estimates and Forecast 2020 and 2025 ($millions)
        • Table U.S. Clinical Laboratory Market Share by Laboratory Type, 2020
        • Table U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Laborator Type, 2010-2025 ($millions)
      • U.S. Clinical Laboratory Industry Structure
        • Table Growth in Clinical Laboratories, 1997-2020
        • Table U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: March 2020
        • Table CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) March 2020
        • Table Growth Trends in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2011 and March 2020
        • Table Change in CLIA Registered Laboratories by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2011-2020
      • Independent Clinical Laboratories
        • Table Leading U.S. Independent Laboratory Groups, as of March 2020
        • Table Leading U.S. Independent Laboratory Groups, Distribution of Centers, as of March 2020
        • Table Growth in U.S. Independent Laboratory Facilities, June 2011 through March 2020
      • Hospital-based Laboratories
        • Table Number of Hospitals in the U.S., 1975-2019
        • Table U.S. Hospital Types
        • Table AHA Statistics - U.S. Registered Hospitals by Type, 2010 through 2019
        • Table AHA Statistics for U.S. Hospitals, 2012-2019
        • Table U.S. Hospital Length of Stay, Average by Broad Age Group, 2016
        • Table Growth in U.S. Hospital Laboratory Locations, June 2011 through March 2020
      • Physician-office and Clinic Laboratories
        • Table Number of Physician Offices, United States, 2000-2017, Estimated 2018
        • Table Growth in U.S. Physician Office Laboratory Locations, June 2011 through March 2020
      • Nursing Facility and Home Health
        • Table Number of Nursing Homes (United States), 2000-2017, Estimated 2018
        • Table Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through March 2020
      • Pharmacy-based Laboratories
        • Table Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through March 2020
      • Dialysis Clinics
        • Table Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through March 2020
    • Canada
      • Table Canada Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
      • Table Canada Clinical Laboratory Service Market, Performance 2010-2025 ($millions)
  • EMEA Market
    • Overview
      • Table EMEA Market Value by Country, 2020 (in millions of dollars at the manufacturers' level)
      • Table EMEA Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020-2025
    • Germany
      • Table Germany Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
      • Table Leading Laboratory Service Suppliers by Estimated Distribution of Revenues, Germany, 2020
    • France
      • Table France Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Italy
      • Table Italy Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Spain
      • Table Spain Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • United Kingdom
      • Table United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Switzerland
      • Table Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Rest of EMEA
      • Middle East
      • Turkey
  • Asia Pacific Market
    • Overview
      • Table Asia Pacific Clinical Laboratory Service Market Value by Country, 2020 (in millions of dollars at the manufacturers' level)
      • Table Asia Pacific Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020- 2025
    • Japan
      • Table Japan Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
      • Japan Clinical Laboratory Industry Structure
        • Table Japan Clinical Laboratory Industry by Type, 2020
        • Table Japan Clinical Laboratory Industry by Test Classification, 2020
        • Table Japan Clinical Laboratory Industry, Number of Laboratories by Prefecture, 2020
    • China
      • Table China Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
      • China Clinical Laboratory Industry Structure
        • Table China Clinical Laboratory Industry by Type, 2020
    • India
      • Table India Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • South Korea
      • Table South Korea Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025
    • Australia
      • Table Australia Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Rest of Asia Pacific
      • Singapore
      • Indonesia
      • Philippines
      • Taiwan
  • Latin America Market
    • Overview
      • Table Latin America Market Value by Country, 2020 (in millions of dollars at the manufacturers' level)
      • Table Latin America Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2020- 2025
    • Brazil
      • Table Brazil Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Mexico
      • Table Mexico Clinical Laboratory Service Market, Estimates and Forecast 2020 and 2025 ($millions)
    • Rest of Latin America
      • Argentina
      • Chile
        • Table Estimated Clinical Labs in Chile (Average Tests/Year, Number of Labs, Private Sector, Public Sector) – 2019
      • Colombia
        • Table Classification of Laboratories by Test Complexity
      • Peru
      • Venezuela
  • Leading Market Participants
    • Global Competitor Summary
      • Table Top 10 Market Participants, Global Service Revenues, Estimated 2019 and 2020 ($millions)
      • Table Market Contribution by Clinical Laboratory Service Providers, 2020
    • U.S. Competitive Analysis
      • Table Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2020
      • Table Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2020
    • Quest Diagnostics, Inc.
      • Company Overview
        • Table Quest Diagnostics Corporate Details
      • Performance Review
        • Table Quest Diagnostics Revenue Summary, 2010-2020 ($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, 2010-2020 ($millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Sonic Healthcare Limited
      • Company Overview
        • Table Sonic Healthcare Corporate Details
      • Performance Review
        • Table Sonic Healthcare Revenue Summary, 2010-2020 ($millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • SYNLAB International GmbH (SYNLAB Bondco PLC)
      • Company Overview
        • Table SYNLAB Corporate Details
      • Performance Review
        • Table SYNLAB Revenue Summary, 2016-2020 ($millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Exact Sciences Corp.
      • Company Overview
        • Table Exact Sciences Corporate Details
      • Performance Review
        • Table Exact Sciences Revenue Summary, 2010-2020 ($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, 2010-2020 ($millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
    • Miraca Holdings, Inc.
      • Company Overview
        • Table Miraca - H.U. Group Holdings, Inc. Corporate Details
      • Performance Review
        • Table Miraca Revenue Summary, 2010-2020 ($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, 2010-2020 ($millions)
      • Products and Services
    • Unilabs
      • Company Overview
        • Table Unilabs Corporate Details
      • Performance Review
      • Products and Services
    • Siemens Healthineers
      • Company Overview
        • Table Siemens Healthineers Corporate Details
      • Performance Review
        • Table Siemens Healthineers' Revenue Summary, 2010-2020 ($millions)
      • Key Acquisitions, Alliances, and Partnerships
      • Products and Services
  • Market Trends and Summary
    • Global Market Overview
      • Table Global Clinical Laboratory Market Analysis, 2010-2025 (in millions of dollars at the manufacturer's level)
      • Table Global Clinical Laboratory Market Analysis: 2010-2025
    • Regional Overview
      • Table Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2020
      • Table Global Clinical Laboratory Market Analysis, Revenues by Region, 2020
      • Table Global Clinical Laboratory Market Analysis: Regional Growth Forecast, CAGR 2020-2025
      • Table Estimated COVID-19 Market Performance by Region, 2020
      • 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 Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) (formerly known as the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP))
    • American Society for Histocompatibility and Immunogenetics
    • COLA
    • College of American Pathologists

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