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, 2017-2027 (in millions of dollars at the manufacturer’s level)
Figure 1-1: Global Clinical Laboratory Market Analysis: 2017-2027
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, 2010-2021 Average
The Largest Clinical Laboratory Market: The United States
Structure and Regulation in the U.S.
Table 2-1: Selected CLIA Waived Laboratory Tests
Table 2-2: Provider-Performed Microscopy Procedures
Figure 2-3: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), [ACHC, ASHI, AABB, JC, COLA, CAP] by % April 2023
Table 2-3: Clinical Laboratory Certificates Issued by Type (non-exempt laboratories only), as of April 2023
Figure 2-4: Laboratory Certificate Trends by Application Type (Compliance, Waiver, PPM, Accredidation), July 2010 – April 2023
Table 2-4: CLIA Exempt States, Number of Laboratories, as of April 2023
Laboratory Developed Test Regulations
Payers and Reimbursement
Laboratory Service Payer Types
Table 2-5: U.S. Clinical Laboratory Revenues by Client and Payer Type (%), [Medicare and Medicaid, Private Patient, Commercial Insurance, Managed Care], 2022
Figure 2-5: Clinical Laboratory Revenues by Client and Payer Type, 2022 Estimates (Managed Care, Medicare and Medicaid, Private Patient, Commercial Insurance]
Trends in Medicare Reimbursement
Figure 2-6: Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009 through 2023
Health Care Reform
Protecting Access to Medicare Act (PAMA) of 2014
Table 2-6: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2026
Advanced Laboratory Tests (ADLT)
Table 2-7: List of Approved ADLTs, March 2022 (Lab Name, Test Name, Test Descriptor, Approval Date, New ADLT Initial Period, Payment Amount)
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, 2022 (Commercial Insurance Company, Membership, Total Revenues)
Figure 2-7: National Commercial Insurance Providers by Membership and Total Revenues, 2022
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 $)
DTC in Genetic Testing
Expanding Cancer Test Utilization and Technologies
Labcorp and QIAGEN Launch new Companion Diagnostic for Metastatic Breast Cancer Therapy
Labcorp Launches New Test for NSCLC
Labcorp Offers First FDA Test for Monitoring Residual Blood Cancer Cells
Labcorp Launches New Test for Skin Cancer
Quest Diagnostics Attention to Oncology
Quest Collaborates with GRAIL on Oncology
Quest Releases Companion Diagnostic
Quest Offers Biocept’s Liquid Biopsy Test for Lung Cancer
Quest Acquires Haystack Oncology
The Role of Information Technology
Industry Drivers
Global Demographics
Table 2-12: The Global Population, 1980-2050
Figure 2-9: The Global Population, 1980-2050 (in millions)
Table 2-13: World Population by Major Geographic Region, 2010 – 2050
Figure 2-10: World Population by Major Geographic Region, 2010–2050
Table 2-14: Global Population Trends Age 65+, 2000-2050
Figure 2-11: Global Population Trends Age 65+, 2000-2050 (Millions)
Chronic Diseases and Conditions
Figure 2-12: Global Prevalence of Disease, 2000, 2015 and Projected 2030 (Hypertension, Diabetes, Depression, Asthma, CHD, COPD, Epilepsy, Alzheimer’s Disease, HIV/AIDS, Stroke, Cancer, TB, Parkinson’s)
Figure 2-13: Global Causes of Death, 2000, 2010 and 2020
Figure 2-14: Change in Mortality Over 2000-2020 Period
Economic Performance
Figure 2-15: Global Health Spending as a Percentage of GDP, by Country, 2019 estimates (%)
Chapter Three: Testing Services by Specialty
Test and Services Overview
Figure 3-1: Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2017-2027 ($millions)
Table 3-1: Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential; Immunology & Microbiology; Cytology & Histology; Genetic; Toxicology; COVID-19), 2017-2027 (in millions of dollars at the manufacturers’ level)
Figure 3-2: Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2022-2027 (Clinical Chemistry, Immunology & Microbioogy, Cytology & Histology, Genetic Testing, Toxicology, COVID-19)
Figure 3-3: Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2022, % (Clinical Chemistry, Immunology & Microbioogy, Cytology & Histology, Genetic Testing, Toxicology, COVID-19)
Clinical Chemistry – Routine and Essential Testing
Figure 3-4: Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2017-2027 ($ millions)
Table 3-2: Market Overview – Routine and Essential Testing, 2022 (Clinical Chemistry, Hematology, Coagulation, Endrocrinology, Others)
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
Table 3-5: Laboratory Reference Parameters for CBC
Coagulation
Endocrinology
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, 2017-2027 ($ millions)
Table 3-7: Market Overview – Immunology & Microbiology Testing, 2022 [Immunology, Microbiology $ and %]
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, 2017-2027 ($ millions)
Table 3-9: Market Overview – Cytology & Histology Testing, 2022 (HPV, Tumor Pathology)
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, 2017-2027 ($ millions)
Table 3-10: Market Overview – Genetic Testing, 2022 (Prenatal, Other Genetic)
Toxicology Testing
Figure 3-10: Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2017-2027 ($ millions)
Table 3-11: Substance Detection Periods by Selected Test Method
COVID-19 Virus Testing
Figure 3-11: Global Distribution of COVID-19 Test Services: Volume, Cumulative through December 31, 2022
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, 2022, 2027 (Hospitals, Physician Offices/Outpatient Clinics, Independent)
Figure 4-1: Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2022-2027
Figure 4-2: Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2022 (%)
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 2022 and 2027 (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 2022 and 2027 (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, $millions
Table 4-4: Revenues for Selected U.S.-based Reference Labs 2017-2022 ($million, estimated)
Table 4-5: Estimated Clinical Test Volume by Select Independent Laboratory, 2021 (millions of units)
Table 4-7: Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market 2022 and 2027 (U.S./International Estimates)
Chapter Five: North America Market
Overview
Table 5-1: North America Market Value by Country, 2022
(in millions of dollars at the manufacturers’ level)
United States
Table 5-2: The United States Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Figure 5-1: The United States Clinical Laboratory Service Market, Performance 2017-2027 ($millions)
U.S. Market by Test Type
Table 5-3: The United States Clinical Laboratory Service Market by Testing Services (Essential & Routine, Immunology and Microbiology, Cytology and Pathology, Genetic, Toxicology, COVID-19) Estimates and Forecast 2022 and 2027 ($millions)
Figure 5-2: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues by Type, 2022 (Essential & Routine, Immunology and Microbiology, Cytology and Pathology, Genetic, Toxicology, COVID-19) Estimates and Forecast 2022 and 2027 ($millions)
Figure 5-3: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Type, 2017-2027 ($millions) (Essential & Routine, Immunology and Microbiology, Cytology and Pathology, Genetic, Toxicology, COVID-19) Estimates and Forecast 2022 and 2027
U.S. Market by Laboratory Provider Type
Table 5-4: The United States Clinical Laboratory Service Market by Laboratory Type, Estimates and Forecast 2022 and 2027 ($millions)
Figure 5-4: U.S. Clinical Laboratory Market Share by Laboratory Type, 2022
Figure 5-5: U.S. Clinical Laboratory Market Analysis: Testing Service Revenues Over Time by Laboratory Type, 2017-2027 ($millions)
U.S. Clinical Laboratory Industry Structure
Figure 5-6: Growth in Clinical Laboratories, 2000-2023
Figure 5-7: U.S. CLIA Clinical Laboratory Registration by Primary Laboratory Type: April 2023
Table 5-5: CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) April 2023
Figure 5-8: Growth Trends in CLIA Registered Laboratories by Type of Facility (Exempt/Non-Exempt Combined) June 2019 and April 2023
Figure 5-9: Change in CLIA Registered Laboratories by Type of Facility, Highest and Lowest Growth Segments, % Change, Compounded Annually 2019-2023
Independent Clinical Laboratories
Figure 5-10: Leading U.S. Independent Laboratory Groups, Distribution of Centers, December 2022
Figure 5-11: Growth in U.S. Independent Laboratory Facilities, June 2011 through April 2023
Hospital-based Laboratories
Table 5-7: U.S. Hospital Types
Table 5-8: AHA Statistics – U.S. Registered Hospitals by Type, 2010 through 2021
Table 5-9: AHA Statistics for U.S. Hospitals, 2013-2021
Figure 5-12: U.S. Hospital Length of Stay, Average by Broad Age Group, 2018
Figure 5-13: Growth in U.S. Hospital Laboratory Locations, June 2011 through April 2023
Physician-office and Clinic Laboratories
Figure 5-14: Number of Physician Offices, United States, 2000-2020
Figure 5-15: Growth in U.S. Physician Office Laboratory Locations, June 2011 through April 2023
Nursing Facility and Home Health
Figure 5-16: Number of Nursing Homes (United States), 2000-2020
Figure 5-17: Growth in U.S. Nursing Facility/Home Health Laboratory Locations, June 2011 through April 2023
Pharmacy-based Laboratories
Figure 5-18: Growth in U.S. Pharmacy-Based Laboratories, mid-2011 through April 2023
Dialysis Clinics
Figure 5-19: Growth in U.S. Dialysis Clinic-based Laboratories, mid-2011 through April 2023
Canada
Table 5-10: Canada Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Figure 5-20: Canada Clinical Laboratory Service Market, Performance 2017-2027 ($millions)
Chapter Six: EMEA Market
Overview
Table 6-1: EMEA Market Value by Country, 2022 [Germany, France, Italy, Spain, United Kingdom, Switzerland, Rest of EMEA] (in millions of dollars at the manufacturers’ level)
Figure 6-1: EMEA Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2022-2027
Germany
Table 6-2: Germany Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Figure 6-2: Leading Laboratory Service Suppliers by Estimated Distribution of Revenues, Germany, 2022
France
Table 6-3: France Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Italy
Table 6-4: Italy Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Spain
Table 6-5: Spain Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
United Kingdom
Table 6-6: United Kingdom Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Switzerland
Table 6-7: Switzerland Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Chapter Seven: Asia Pacific Market
Overview
Table 7-1: Asia Pacific Clinical Laboratory Service Market Value by Country [China, Japan, India, South Korea, Australia], 2022
(in millions of dollars at the manufacturers’ level)
Figure 7-1: Asia Pacific Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2022-2027
Japan
Table 7-2: Japan Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Japan Clinical Laboratory Industry Structure
Figure 7-2: Japan Clinical Laboratory Industry by Type, 2022
Figure 7-3: Japan Clinical Laboratory Industry by Test Classification, 2022
Figure 7-4: Japan Clinical Laboratory Industry, Number of Laboratories by Prefecture, 2022
China
Table 7-3: China Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
China Clinical Laboratory Industry Structure
Figure 7-5: China Clinical Laboratory Industry by Type, 2022
India
Table 7-4: India Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
South Korea
Table 7-5: South Korea Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Australia
Table 7-6: Australia Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Chapter Eight: Latin America Market
Overview
Table 8-1: Latin America Market Value by Country, 2022 (in millions of dollars at the manufacturers’ level)
Figure 8-1: Latin America Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2022-2027
Brazil
Table 8-2: Brazil Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Mexico
Table 8-3: Mexico Clinical Laboratory Service Market, Estimates and Forecast 2022 and 2027 ($millions)
Chapter Nine: Leading Market Participants
Global Competitor Summary
Figure 9-1: Top 10 Market Participants, Global Service Revenues, Estimated 2021 and 2022 ($millions)
U.S. Competitive Analysis
Table 9-1: Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2022
Figure 9-2: Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2022
Select Company Profiles
Quest Diagnostics, Inc.
Company Overview
Table 9-3: Quest Diagnostics Corporate Details
Performance Review
Figure 9-3: Quest Diagnostics Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Laboratory Corporation of America
Company Overview
Table 9-4: Laboratory Corporation of America Corporate Details
Performance Review
Figure 9-4: Laboratory Corporation of America Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Exact Sciences Corp.
Company Overview
Table 9-7: Exact Sciences Corporate Details
Performance Review
Figure 9-7: Exact Sciences Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Sonic Healthcare Limited
Company Overview
Table 9-5: Sonic Healthcare Corporate Details
Performance Review
Figure 9-5: Sonic Healthcare Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
BioReference Laboratories – An OPKO Health Subsidiary
Company Overview
Table 9-11: BioReference Laboratories Corporate Details
Key Acquisitions, Alliances, and Partnerships
Performance Review
Figure 9-11: BioReference Laboratories Revenue Summary, 2010-2022 ($millions)
Products and Services
Myriad Genetics, Inc.
Company Overview
Table 9-10: Myriad Genetics Corporate Details
Key Acquisitions, Alliances, and Partnerships
Performance Review
Figure 9-10: Myriad Genetics Revenue Summary, 2010-2022 ($millions)
Products and Services
SYNLAB International GmbH (SYNLAB Bondco PLC)
Company Overview
Table 9-6: SYNLAB Corporate Details
Performance Review
Figure 9-6: SYNLAB Revenue Summary, 2015-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Eurofins Scientific SE
Company Overview
Table 9-8: Eurofins Scientific Corporate Details
Performance Review
Figure 9-8: Eurofins Scientific Revenue Summary, 2010-2022($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
H.U. Group Holdings
Company Overview
Table 9-9: H.U. Group Holdings, Inc. Corporate Details
Performance Review
Figure 9-9: H.U. Holdings Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Siemens Healthineers
Company Overview
Table 9-13: Siemens Healthineers Corporate Details
Performance Review
Figure 9-13: Siemens Healthineers’ Revenue Summary, 2010-2022 ($millions)
Key Acquisitions, Alliances, and Partnerships
Products and Services
Unilabs
Company Overview
Table 9-12: Unilabs Corporate Details
Performance Review
Products and Services
Medicover AB
Company Overview
Table 9-10: Medicover Corporate Details
Key Acquisitions, Alliances, and Partnerships
Performance Review
Figure 9-10: Medicover Revenue Summary, 2010-2022 ($millions)
Products and Services
Chapter Ten: Market Trends and Summary
Global Market Overview
Table 10-1: Global Clinical Laboratory Market Analysis, 2017-2027
(in millions of dollars at the manufacturer’s level)
Figure 10-1: Global Clinical Laboratory Market Analysis: 2017-2027
Regional Overview
Table 10-2: Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2022
Figure 10-2: Global Clinical Laboratory Market Analysis, Revenues by Region, 2022
Figure 10-3: Global Clinical Laboratory Market Analysis: Regional Growth Forecast, CAGR 2022-2027
Figure 10-4: Estimated COVID-19 Market Performance by Region, 2022
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