Table of Contents
Chapter One: Executive Summary
Industry at a Glance
Scope and Methodology
Global Market Overview
- Table 1-1: Global Clinical Laboratory Market Analysis, 2011-2026 (in millions of dollars at the manufacturer’s level)
- Figure 1-1: Global Clinical Laboratory Market Analysis: 2011-2026
Key Issues and Trends Affecting the Market
Leading Market Participants
Chapter Two: Industry Overview
Clinical Laboratory Description
- Figure 2-1: Hospital Length of Stay in Days (2018-2019 Average)
Number of Laboratory Health Workers by Country
- Figure 2-2: Laboratory Health Workers by Country, 2010-2019 Average
The Largest Clinical Laboratory Market: The United States
Structure and Regulation in the U.S.
Certificate of Waiver
- Table 2-1: Selected CLIA Waived Laboratory Tests
Certificate of Provider-Performed Microscopy Procedures (PPMP)
- Table 2-2: Provider-Performed Microscopy Procedures
Certificate of Compliance and Certificate of Accreditation
- Figure 2-3: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), May 2022
- Table 2-3: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), as of May 2022
- Figure 2-4: Laboratory Certificate Trends by Application Type, July 2010- May 2022
States Exempt from Federal Clinical Laboratory Improvements Amendments (CLIA) of 1988
- Table 2-4: 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 2-5: U.S. Clinical Laboratory Revenues by Client and Payer Type (%), 2021
- Figure 2-5: Clinical Laboratory Revenues by Client and Payer Type, 2021 Estimates
Trends in Medicare Reimbursement
- Figure 2-6: Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009 through 2021
Health Care Reform
Protecting Access to Medicare Act (PAMA) of 2014
- Table 2-6: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
Impact of CARES Act on PAMA
Advanced Laboratory Tests (ADLT)
- Table 2-7: List of Approved ADLTs, March 2022
Bundled Insurance Payments for ESRD Patients
- Table 2-8: Laboratory Tests Subject to ESRD Consolidated Billing (CY 2022)
Commercial Insurance Providers
- Table 2-9: National Commercial Insurance Provider List, 2021
- Figure 2-7: National Commercial Insurance Providers by Membership and Total Revenues, 2021
Transparency in Pricing
- Figure 2-8: Revenue and Test Volume Trends, Quest Diagnostics
Direct-to-Consumer Testing
- Table 2-10: Select DTC Tests and Prices by Laboratory Service Provider (Quest Direct and Labcorp On Demand) 2022* (in US $)
DTC in Genetic Testing
Expanding Cancer Test Utilization and Technologies
Labcorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy
Labcorp Launches New Test for NSCLC
Labcorp Offers First FDA Test for Monitoring Residual Blood Cancer Cells
Labcorp Launches New Test for Skin Cancer
Quest Diagnostics Attention to Oncology
Quest Collaborates with GRAIL on Oncology
Quest Releases Companion Diagnostic
Quest Offers Biocept’s Liquid Biopsy Test for Lung Cancer
The Role of Information Technology
- Table 2-11: Selected Laboratory Information Management System Providers, 2020 Vendor List
Industry Drivers
Global Demographics
- Table 2-12: The Global Population, 1980-2050
- Figure 2-9: The Global Population, 1980-2050 (in millions)
Regional Population Overview
- Table 2-13: World Population by Major Geographic Region, 2010 – 2050
- Figure 2-10: World Population by Major Geographic Region, 2010–2050
Aging Populations
- Table 2-14: Global Population Trends Age 65+, 2000-2050
- Figure 2-11: Global Population Trends Age 65+, 2000-2050 (Millions)
Chronic Diseases and Conditions
- Figure 2-12: Global Prevalence of Disease, 2000, 2015 and Projected 2030
- Figure 2-13: Global Causes of Death, 2000, 2010 and 2020
- Figure 2-14: Change in Mortality Over 2000-2020 Period
Economic Performance
Health Expenditures
- Figure 2-15: Global Health Spending as a Percentage of GDP, by Country, 2019 estimates (%)
Chapter Three: Testing Services by Specialty
Test and Services Overview
- Figure 3-1: Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2011-2026 ($millions)
- Table 3-1: 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)
- Figure 3-2: Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2021-2026
- Figure 3-3: Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2021, %
Clinical Chemistry – Routine and Essential Testing
- Figure 3-4: Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2011-2026 ($ millions)
- Table 3-2: Market Overview – Routine and Essential Testing, 2021
Routine Clinical Chemistry
Cholesterol Level Testing
- Table 3-3: High Cholesterol Risk Categories
Urinalysis
- Table 3-4: Normal Reference Levels in a Medical Urinalysis
Hematology
Blood Cell Count
- Table 3-5: Laboratory Reference Parameters for CBC
Coagulation
Endocrinology
Thyroid Function Tests
Pregnancy Testing
- Table 3-6: HCG Levels in Pregnant Women by Days Past Ovulation
Immunology and Microbiology
- Figure 3-5: Global Clinical Laboratory Market Analysis: Immunology & Microbiology Testing Service Market Trend, 2011-2026 ($ millions)
- Table 3-7: Market Overview – Immunology & Microbiology Testing, 2021
Allergy and Food Intolerance
Tumor Markers
Cardiac Markers
HIV Testing
- Table 3-8: Number of Reported HIV Tests Performed by Country, 2018
- Figure 3-6: 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
- Figure 3-7: Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2011-2026 ($ millions)
- Table 3-9: Market Overview – Cytology & Histology Testing, 2021
Pap Test
- Figure 3-8: Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country 2019 Estimates
Genetic Testing
- Figure 3-9: Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2011-2026 ($ millions)
- Table 3-10: Market Overview – Genetic Testing, 2021
Toxicology Testing
- Figure 3-10: Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2011-2026 ($ millions)
- Table 3-11: Substance Detection Periods by Test Method
COVID-19 Virus Testing
- Figure 3-11: Global Distribution of COVID-19 Test Services: Volume, Cumulative through December 31, 2021
- Figure 3-12: Factors Affecting COVID-19 Clinical Testing Market, 2022 and Beyond
Chapter Four: Global Clinical Laboratory Market by Provider Group
Clinical Laboratory Market: Provider Overview
- Table 4-1: Global Clinical Laboratory Market Analysis by Provider Segment, 2021, 2026 (Hospitals, Physician Offices/Outpatient Clinics, Independent)
- Figure 4-1: Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2021-2026
- Figure 4-2: Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2021 (%)
Hospitals and Acute Care Providers
- Figure 4-3: COVID-19 Impact on Hospital-based Laboratory Testing Markets, $millions
- Table 4-2: Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
- Figure 4-4: Hospital Beds per 1,000 Population by Country, 2020
Physicians and Outpatient Care Providers
- Figure 4-5: COVID-19 Impact on Physician-based Laboratory Testing Markets, $millions
- Table 4-3: Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
Physician Offices
- Figure 4-6: Medical Doctors per 1,000 Population by Country, 2019/2020
Global Nursing Establishments and Assisted Living Facilities
Global Dialysis Clinics
Independent Laboratory Providers
- Figure 4-7: COVID-19 Impact on Independent Laboratory Testing Markets, $millions
- Table 4-4: Revenues for Selected U.S.-based Reference Labs 2016-2021 ($million, estimated)
- Table 4-5: Estimated Clinical Test Volume by Select Independent Laboratory, 2021 (millions of units)
- Table 4-6: Estimated COVID-19 Test Volume by Select Independent Laboratory, 2021 (millions of units)
- Table 4-7: Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market 2021 and 2026 (U.S./International Estimates)
Chapter Five: North America Market
Overview
- Table 5-1: North America Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
United States
- Table 5-2: The United States Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
- Figure 5-1: The United States Clinical Laboratory Service Market, Performance 2011-2026 ($millions)
U.S. Market by Test Type
- Table 5-3: The United States Clinical Laboratory Service Market by Testing Services, Estimates and Forecast 2021 and 2026 ($millions)
- Figure 5-2: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues by Type, 2021
- Figure 5-3: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Type, 2011-2026 ($millions)
U.S. Market by Laboratory Provider Type
- Table 5-4: The United States Clinical Laboratory Service Market by Laboratory Type, Estimates and Forecast 2021 and 2026 ($millions)
- Figure 5-4: U.S. Clinical Laboratory Market Share by Laboratory Type, 2021
- Figure 5-5: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Laboratory Type, 2011-2026 ($millions)
U.S. Clinical Laboratory Industry Structure
- Figure 5-6: Growth in Clinical Laboratories, 1997-2022
CLIA Laboratory Registration, Laboratories by Type
- Figure 5-7: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: May 2022
- Table 5-5: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) May 2022
- Figure 5-8: Growth Trends in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2019 and May 2022
- Figure 5-9: Change in CLIA Registered Laboratories by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2019-2022
Independent Clinical Laboratories
- Figure 5-10: Leading U.S. Independent Laboratory Groups, Distribution of Centers, 2021
Growth in Independent Clinical Laboratories
- Figure 5-11: Growth in U.S. Independent Laboratory Facilities, June 2011 through May 2022
Hospital-based Laboratories
U.S. Hospital Data
- Figure 5-12: Number of Hospitals in the U.S., 1975-2020
- Table 5-6: U.S. Hospital Types
- Table 5-7: AHA Statistics – U.S. Registered Hospitals by Type, 2010 through 2021
- Table 5-8: AHA Statistics for U.S. Hospitals, 2013-2021
U.S. Hospital Stay Stats
- Figure 5-13: U.S. Hospital Length of Stay, Average by Broad Age Group, 2018
Growth in Hospital Clinical Laboratories
- Figure 5-14: Growth in U.S. Hospital Laboratory Locations, June 2011 through May 2022
Physician-Office and Clinic Laboratories
Number of U.S. Physicians
- Figure 5-15: Number of Physician Offices, United States, 2000-2020
Growth in Clinical Laboratories in the Physician Office
- Figure 5-16: Growth in U.S. Physician Office Laboratory Locations, June 2011 through May 2022
Nursing Facility and Home Health
U.S. Nursing Home Establishments
- Figure 5-17: Number of Nursing Homes (United States), 2000-2020
U.S. Home Health Facilities
Growth in Clinical Laboratories in the Nursing Facility and Home Health Segment
- Figure 5-18: Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through May 2022
Pharmacy-based Laboratories
Growth in Pharmacy-Based Clinical Laboratories
- Figure 5-19: Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through May 2022
Dialysis Clinics
Growth in U.S. Dialysis Clinics and Affiliated Laboratories
- Figure 5-20: Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through May 2022
Canada
- Table 5-9: Canada Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
- Figure 5-21: Canada Clinical Laboratory Service Market, Performance 2011-2026 ($millions)
Chapter Six: EMEA Market
Overview
- Table 6-1: EMEA Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
- Figure 6-1: EMEA Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2021-2026
Germany
- Table 6-2: Germany Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
- Figure 6-2: Leading Laboratory Service Suppliers by Estimated Distribution of Revenues, Germany, 2021
France
- Table 6-3: France Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Italy
- Table 6-4: Italy Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Spain
- Table 6-5: Spain Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
United Kingdom
- Table 6-6: United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Switzerland
- Table 6-7: Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Chapter Seven: Asia Pacific Market
Overview
- Table 7-1: Asia Pacific Clinical Laboratory Service Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
- Figure 7-1: Asia Pacific Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2021-2026
Japan
- Table 7-2: Japan Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Japan Clinical Laboratory Industry Structure
- Figure 7-2: Japan Clinical Laboratory Industry by Type, 2021
- Figure 7-3: Japan Clinical Laboratory Industry by Test Classification, 2021
- Figure 7-4: Japan Clinical Laboratory Industry, Number of Laboratories by Prefecture, 2021
China
- Table 7-3: China Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
China Clinical Laboratory Industry Structure
- Figure 7-5: China Clinical Laboratory Industry by Type, 2021
India
- Table 7-4: India Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
South Korea
- Table 7-5: South Korea Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Australia
- Table 7-6: Australia Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Chapter Eight: Latin America Market
Overview
- Table 8-1: Latin America Market Value by Country, 2021 (in millions of dollars at the manufacturers’ level)
- Figure 8-1: Latin America Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2021-2026
Brazil
- Table 8-2: Brazil Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Mexico
- Table 8-3: Mexico Clinical Laboratory Service Market, Estimates and Forecast 2021 and 2026 ($millions)
Chapter Nine: Leading Market Participants
Global Competitor Summary
- Figure 9-1: Top 10 Market Participants, Global Service Revenues, Estimated 2019 and 2020 ($millions)
U.S. Competitive Analysis
- Table 9-1: Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2021
- Figure 9-2: Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2021
#1: Quest Diagnostics, Inc.
Company Overview
- Table 9-2: Quest Diagnostics Corporate Details
Performance Review
- Figure 9-3: Quest Diagnostics Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#2: Laboratory Corporation of America
Company Overview
- Table 9-3: Laboratory Corporation of America Corporate Details
Performance Review
- Figure 9-4: Laboratory Corporation of America Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#3: Sonic Healthcare Limited
Company Overview
- Table 9-4: Sonic Healthcare Corporate Details
Performance Review
- Figure 9-5: Sonic Healthcare Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#4: SYNLAB International GmbH (SYNLAB Bondco PLC)
Company Overview
- Table 9-5: SYNLAB Corporate Details
Performance Review
- Figure 9-6: SYNLAB Revenue Summary, 2016-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#5: Eurofins Scientific SE
Company Overview
- Table 9-6: Eurofins Scientific Corporate Details
Performance Review
- Figure 9-7: Eurofins Scientific Revenue Summary, 2010-2021($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#6: Exact Sciences Corp.
Company Overview
- Table 9-7: Exact Sciences Corporate Details
Performance Review
- Figure 9-8: Exact Sciences Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#7: BioReference Laboratories – An OPKO Health Subsidiary
Company Overview
- Table 9-8: BioReference Laboratories Corporate Details
Key Acquisitions, Alliances, and Partnerships
Performance Review
- Figure 9-9: BioReference Laboratories Revenue Summary, 2010-2021 ($millions)
Products and Services
COVID-19 Events and Impact
#8: Miraca Holdings, Inc. – H.U. Group Holdings
Company Overview
- Table 9-9: Miraca – H.U. Group Holdings, Inc. Corporate Details
Performance Review
- Figure 9-10: Miraca Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#9: Siemens Healthineers
Company Overview
- Table 9-10: Siemens Healthineers Corporate Details
Performance Review
- Figure 9-11: Siemens Healthineers’ Revenue Summary, 2010-2021 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
COVID-19 Events and Impact
#10: Unilabs
Company Overview
- Table 9-11: Unilabs Corporate Details
Performance Review
Products and Services
COVID-19 Events and Impact
#11: Medicover AB
Company Overview
- Table 9-12: Medicover Corporate Details
Key Acquisitions, Alliances, and Partnerships
Performance Review
- Figure 9-12: Medicover Revenue Summary, 2010-2021 ($millions)
Products and Services
Chapter Ten: Market Trends and Summary
Global Market Overview
- Table 10-1: Global Clinical Laboratory Market Analysis, 2011-2026 (in millions of dollars at the manufacturer’s level)
- Figure 10-1: Global Clinical Laboratory Market Analysis: 2011-2026
Regional Overview
- Table 10-2: Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2021
- Figure 10-2: Global Clinical Laboratory Market Analysis, Revenues by Region, 2021
- Figure 10-3: Global Clinical Laboratory Market Analysis: Regional Growth Forecast, CAGR 2021-2026
- Figure 10-4: Estimated COVID-19 Market Performance 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
Appendix I: 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
