Description
Clinical laboratories are an essential part of the health industry. It is estimated that between 70% – 80% of physicians’ diagnoses are a result of laboratory tests. In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons. Clinical Laboratory Services Market 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, including the following market data:
- Global Clinical Laboratory Market Analysis, 2010-2023 (in millions of dollars at the manufacturer’s level)
- Global Clinical Laboratory Service Market Analysis, Revenues by Region, 2018 ($millions) (Northern America; Europe, Middle East, Africa; Asia Pacific; Latin America; Total)
- Global Clinical Laboratory Market Analysis, Revenues by Region, 2018 (%) (Northern America, EMEA, Asia Pacific, Latin America)
- Global Clinical Laboratory Market Analysis: Regional Growth Forecast, CAGR 2018-2023 (Northern America, EMEA, Asia Pacific, Latin America)
Assessment of Markets by Specialty
The report also covers the laboratory service market by specialty, including essential and routine testing (clinical chemistry, hematology, coagulation, endocrinology), immunology and microbiology testing, cytology and histology testing, genetic testing, and toxicology testing (drugs of abuse). The following data points are provided:
- Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential, Immunology & Microbiology, Cytology & Histology, Genetic, Toxicology), 2010-2023 (in millions of dollars at the manufacturers’ level)
- Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2018-2023 (Clinical Chemistry – Routine & Essential Testing, Immunology & Microbiology Testing, Cytology & Histology Testing, Genetic Testing, Toxicology Testing)
- Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2018 (%) (Clinical Chemistry – Routine & Essential Testing, Immunology & Microbiology Testing, Cytology & Histology Testing, Genetic Testing, Toxicology Testing)
- Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2010-2023
- Market Overview – Routine and Essential Testing, 2018 (Clinical Chemistry, Hematology, Coagulation, Endocrinology, Others, Total)
- Global Clinical Laboratory Market Analysis: Immunology & Microbiology Testing Service Market Trend, 2010-2023
- Market Overview – Immunology & Microbiology Testing, 2018 (Infectious disease, Immunology, Total)
- Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2010-2023
- Market Overview – Cytology & Histology Testing, 2018 (HPV Testing [Routine/DNA], Tumor Pathology, Total)
- Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2010-2023
- Market Overview – Genetic Testing, 2018 (Prenatal/Newborn Screening, Other Genetic Screening, Total)
- Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2010-2023
The Market by Provider Group
Generally, laboratory service providers can be segmented into three broad groups: hospitals/acute care, physician offices/outpatient clinics, and independent. Clinical Laboratory Services Market presents a provider overview of the market, presenting the following information:
- Global Clinical Laboratory Market Analysis by Provider Segment (Hospitals and Acute Care, Physician Offices/Outpatient Clinics, Independent), 2010-2023 (in millions of dollars at the manufacturers’ level)
- Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2018-2023 (Hospital and Acute Laboratory Service Providers, Physician and Outpatient Clinic Laboratory Service Providers, Independent Laboratory Service Providers)
- Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2018 (%) (Hospital and Acute Laboratory Service Providers, Physician and Outpatient Clinic Laboratory Service Providers, Independent Laboratory Service Providers)
- Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market Trend, 2010-2023
- Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market Trend, 2010-2023
- Global Clinical Laboratory Market Analysis: Independent Laboratory Testing Market Trend, 2010-2023
The Market by Region
The report examines the market in terms of key regions, covering Northern 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); and Latin America (Brazil, Mexico):
- Northern America Market Value by Country, 2018 (in millions of dollars at the manufacturers’ level) (Canada, United States, Rest of Northern America)
- Development of the United States’ Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of the U.S. Clinical Laboratory Market by Testing Service, Estimates and Forecast 2010-2023 ($millions) (Essential & Routine, Immunology & Microbiology, Cytology & Pathology, Genetic, Toxicology)
- U.S. Clinical Laboratory Market Analysis: Testing Service Revenues by Type (%), 2018 (Essential & Routine, Immunology & Microbiology, Cytology & Pathology, Genetic, Toxicology)
- Development of the U.S. Clinical Laboratory Market by Laboratory Type, Estimates and Forecast 2010-2023 ($millions) (Hospital-based, Independent, Physician-based)
- Clinical Laboratory Market Share by Laboratory Type (%), 2018 (Hospital-based, Independent, Physician-based)
- Growth in Clinical Laboratories, 1997-2018 (total number of laboratories)
- EMEA Market Value by Country, 2018 (in millions of dollars at the manufacturers’ level) (Germany, France, Italy, Spain, United Kingdom, Switzerland, Rest of EMEA, Total)
- EMEA Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2018-2023 (Germany, France, Italy, Spain, United Kingdom, Switzerland, Rest of EMEA)
- Development of Germany’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of France’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of Italy’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of Spain’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of United Kingdom’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of Switzerland’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Asia Pacific Clinical Laboratory Service Market Value by Country, 2018 (in millions of dollars at the manufacturers’ level) (China; Japan; India; Korea, S.; Australia; Rest of Asia Pacific; Total)
- Asia Pacific Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2018-2023 (China, Japan, India, South Korea, Australia, Rest of Asia Pacific)
- Development of Japan’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Japan Clinical Laboratory Industry by Type, 2018 (%) (Hospital, Independent/Reference, University)
- Japan Clinical Laboratory Industry by Test Classification, 2018 (%) (Basic [essential/routine], Non-Basic, Pathology, Other Test Services)
- Japan Clinical Laboratory Industry, Number of Laboratories by Major City, 2018 (%) (Tokyo, Osaka, Fukuoka, Saitama, Kyoto, Yokohama, Nagoya, Sendai, Sapporo, Hiroshima, Kawasaki, Kobe, Others)
- Development of China’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of India’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of South Korea’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of Australia’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Latin America Market Value by Country, 2018 (in millions of dollars at the manufacturers’ level) (Brazil, Mexico, Rest of Latin America, Total)
- Latin America Clinical Laboratory Service Market, Growth Projections by Country, CAGR 2018-2023 (Brazil, Mexico, Rest of Latin America)
- Development of Brazil’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
- Development of Mexico’s Clinical Laboratory Service Market, Estimates and Forecast 2010-2023 ($millions)
Competitive Analysis, Featuring Profiles of Leading Market Participants
The clinical laboratory market is highly competitive in terms of prices, locations, and services offered. There are several hundred participants in the market with intense competition at the national, regional and local level for most labs. Clinical Laboratory Services Market provides analysis of market leaders, including:
- Leading Market Participants, Global Service Revenues, 2016, 2017 and 2018 ($millions)
- Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2018
- Estimated U.S. Laboratory Services, Market Share of Leading Clinical Laboratory Providers, 2018 (%)
Further, the report presents profiles of some of the leading market participants that include company overviews; performance reviews; key acquisitions, alliances, and partnerships; products and services; and company growth strategies. The companies covered include the following:
- Alere (Abbott)
- ARUP Labs
- BioReference Laboratories, Inc. (OPKO)
- DaVita, Inc.
- Genomic Health, Inc.
- Laboratory Corporation of America (LabCorp)
- Miraca (SRL)
- Myriad Genetics
- NeoGenomics
- Quest Diagnostics
- Siemens
- Sonic Healthcare
- Spectra Laboratories (Fresenius)
- SYNLAB (Labco Group)
A Review of Market Trends
Clinical Laboratory Services Market concludes with a brief discussion of some of the trends influencing the global market, including:
- Increasing disease burden
- Economic growth in developing regions
- Stabilizing economies in developed regions
- Pricing pressures
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, 2010-2023 (in millions of dollars at the manufacturer’s level)
- Figure 1-1: Global Clinical Laboratory Market Analysis: 2010-2023
- Market Conclusions
- Key Issues and Trends Affecting the Market
- Leading Market Participants
Chapter Two: Industry Overview
- Clinical Laboratory Description
- Number of Laboratory Health Workers by Country
- Figure 2-1: Laboratory Health Workers by Country, 2010-2017 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 2-2: Clinical Laboratory Certificate of Accreditation Issued by Organization (non-exempt laboratories only), July 2018
- Table 2-3: Clinical Laboratory Certificates Issued by State, by Type (non-exempt laboratories only), July 2018
- Figure 2-3: Laboratory Certificate Trends by Application Type, 2010-2018
- Table 2-4: CLIA Exempt States, Number of Laboratories, July 2018
- Laboratory Developed Test Regulations
- Payers and Reimbursement
- Laboratory Service Payer Types
- Table 2-5: U.S. Clinical Laboratory Revenues by Client and Payer Type (%), 2018
- Figure 2-4: Clinical Laboratory Revenues by Client and Payer Type, 2018 Estimates (%) (Managed Care, Medicare and Medicaid, Commercial Insurance, Private Patient)
- Trends in Medicare Reimbursement
- Figure 2-5: Medicare Reimbursement Trends, Average Reimbursement for Clinical Laboratory Services, 2009 through 2019
- Health Care Reform
- Protecting Access to Medicare Act (PAMA) of 2014
- Bundled Insurance Payments for ESRD Patients
- Table 2-6: Laboratory Tests Subject to ESRD Consolidated Billing (CY 2018)
- Table 2-7: Comparison between New Bundled and Composite Medicare Reimbursement Program (1983-2010 and 2011+)
- Commercial Insurance Providers
- Table 2-8: National Commercial Insurance Provider List, 2017
- Figure 2-6: National Commercial Insurance Providers by Membership and Total Revenues, 2017
- Transparency in Pricing
- Figure 2-7: Revenue and Test Volume Trends, Quest Diagnostics, 2010-2018
- Making Tests Affordable – Targeting the Out-of-Pocket Costs
- Direct-to-Consumer Testing
- DTC in Genetic Testing
- Expanding Cancer Test Utilization and Technologies
- Foundation Medicine signs $111M contract with Department of Veterans Affairs
- Quest Diagnostics Attention to Oncology
- The Role of Information Technology
- Industry Drivers
- Global Demographics
- Table 2-9: The Global Population, 1980-2050
- Figure 2-8: The Global Population, 1980-2050 (in millions)
- Table 2-10: World Population by Major Geographic Region, 2010 – 2050 (Asia Pacific, Europe, Northern America, Latin America, Rest of World, World)
- Figure 2-9: World Population by Major Geographic Region, 2010–2050 (Asia Pacific, Europe, Northern America, Latin America, Rest of World)
- Table 2-11: Global Population Trends Age 65+, 2000-2050
- Figure 2-10: Global Population Trends Age 65+, 2000-2050 (Millions)
- Chronic Diseases and Conditions
- Figure 2-11: Global Prevalence of Disease, 2000, 2015 and Projected 2030 (Hypertension, Diabetes Mellitus, Depression, Asthma, Coronary Heart Disease / Ischemic Heart Disease, COPD, Epilepsy, Alzheimer’s Disease, HIV/AIDS, Stroke Survivors, Cancer, Tuberculosis, Parkinson’s Disease, ESRD)
- Figure 2-12: Global Causes of Death, 2000, 2010 and 2016 (Cancers [all types], Ischemic Heart Disease, Stroke, Influenza/Pneumonia, COPD, Alzheimer disease / dementia, Diabetes Mellitus, Road Injuries, Diarrheal Diseases, Tuberculosis, Cirrhosis of the Liver, Kidney disease, HIV/AIDS, Hypertensive Heart Disease, All other causes)
- Figure 2-13: Change in Mortality Over 2000-2016 Period
- Surgical Procedure Volumes
- Table 2-12: Global Surgical Procedure Volume Forecast by Region, 2015-2030 (procedures in thousands) (Northern America, Europe, Asia Pacific, Latin America, Rest of World, Total)
- Economic Performance
- Table 2-13: U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, National Health Expenditure Projects 2017-2026: Fact Sheet
- Figure 2-14: Global Health Spending as a Percentage of GDP, by Country, 2018 estimates (%) (Australia, Canada, Chile, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States)
Chapter Three: Testing Services by Specialty
- Test and Services Overview
- Table 3-1: Global Clinical Laboratory Market Analysis by Test Segment (Clinical Chemistry: Routine & Essential, Immunology & Microbiology, Cytology & Histology, Genetic, Toxicology), 2010-2023 (in millions of dollars at the manufacturers’ level)
- Figure 3-1: Global Clinical Laboratory Market Analysis: Service Revenue Trend, 2010-2023
- Figure 3-2: Global Clinical Laboratory Market Analysis: Segment Growth Forecast, CAGR 2018-2023 (Clinical Chemistry – Routine & Essential Testing, Immunology & Microbiology Testing, Cytology & Histology Testing, Genetic Testing, Toxicology Testing)
- Figure 3-3: Global Clinical Laboratory Market Analysis by Testing Service, Distribution of Revenues 2018 (%) (Clinical Chemistry – Routine & Essential Testing, Immunology & Microbiology Testing, Cytology & Histology Testing, Genetic Testing, Toxicology Testing)
- Clinical Chemistry – Routine and Essential Testing
- Figure 3-4: Global Clinical Laboratory Market Analysis: Clinical Chemistry: Routine & Essential Testing Service Market Trend, 2010-2023
- Table 3-2: Market Overview – Routine and Essential Testing, 2018 (Clinical Chemistry, Hematology, Coagulation, Endocrinology, Others, Total)
- Routine Clinical Chemistry
- Cholesterol Level Testing
- Table 3-3: High Cholesterol Risk Categories (Desirable levels, Borderline high, High risk)
- Table 3-4: Raised or At-Risk Total Cholesterol (> = 190 mg/dL) age standardized estimates, 2008 data (Iceland, Germany, Denmark, United Kingdom, Ireland, Italy, France, Netherlands, Switzerland, United Arab Emirates, Singapore, Japan, Poland, Thailand, Australia, United States, Israel, Canada, Mexico, Russian Federation, Argentina, Brazil, Philippines, Republic of Korea, Turkey, Saudi Arabia, Venezuela, China, India)
- Table 3-5: Normal Reference Levels in a Medical Urinalysis
- Hematology
- Table 3-6: Laboratory Reference Parameters for CBC
- Coagulation
- Endocrinology
- Table 3-7: 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, 2010-2023
- Table 3-8: Market Overview – Immunology & Microbiology Testing, 2018 (Infectious disease, Immunology, Total)
- Allergy and Food Intolerance
- Tumor Markers
- Cardiac Markers
- HIV Testing
- Table 3-9: Number of Reported HIV Testing and Counseling Services by Country, 2014 (India, Ethiopia, Uganda, Kenya, Nigeria, Mozambique, South Africa, Rwanda, United Republic of Tanzania, Zambia, Mexico, Kazakhstan, Malawi, Viet Nam, Côte d’Ivoire, Democratic Republic of the Congo, Zimbabwe, Malaysia, Thailand, Haiti, Peru, Belarus, Indonesia, Burundi, Cuba)
- 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) (Argentina, Bangladesh, Bolivia, Botswana, Brazil, Bulgaria, Chile, Egypt, India, Indonesia, Malaysia, Nicaragua, Peru, South Africa, Zambia, Zimbabwe)
- Cytology and Histology Testing
- Figure 3-7: Global Clinical Laboratory Market Analysis: Cytology & Histology Testing Service Market Trend, 2010-2023
- Table 3-10: Market Overview – Cytology & Histology Testing, 2018 (HPV Testing [Routine/DNA], Tumor Pathology, Total)
- Figure 3-8: Percent of Females Aged 20-69 Screened for Cervical Cancer (all screening methods), by Select Country 2016/2017 Estimates (Canada, France, Germany, Hungary, Israel, Italy, Japan, South Korea, Netherlands, Poland, Spain, Switzerland, Turkey, United Kingdom, United States)
- Table 3-11: Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2017 (Afghanistan, Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Hungary, India, Indonesia, Iran [Islamic Republic of], Iraq, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Venezuela [Bolivarian Republic of], Viet Nam, Afghanistan)
- Genetic Testing
- Figure 3-9: Global Clinical Laboratory Market Analysis: Genetic Testing Service Market Trend, 2010-2023
- Table 3-12: Market Overview – Genetic Testing, 2018 (Prenatal/Newborn Screening, Other Genetic Screening, Total)
- Toxicology Testing
- Figure 3-10: Global Clinical Laboratory Market Analysis: Toxicology Testing Service Market Trend, 2010-2023
- Table 3-13: Substance Detection Periods by Test Method (Urine, Blood, Hair)
- Table 3-14: Screening and Brief Interventions for Substance Abuse by Select Country, 2014 data (Argentina, Australia, Austria, Bangladesh, Brazil, Chile, China, Egypt, Finland, Iraq, Ireland, Israel, Italy, Malaysia, Mexico, New Zealand, Peru, Philippines, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom, United States of America, Viet Nam)
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 (Hospitals and Acute Care, Physician Offices/Outpatient Clinics, Independent), 2010-2023 (in millions of dollars at the manufacturers’ level)
- Figure 4-1: Global Clinical Laboratory Market Analysis: Provider Segment Growth Forecast, CAGR 2018-2023 (Hospital and Acute Laboratory Service Providers, Physician and Outpatient Clinic Laboratory Service Providers, Independent Laboratory Service Providers)
- Figure 4-2: Global Clinical Laboratory Market Analysis by Provider Group, Distribution of Revenues 2018 (%) (Hospital and Acute Laboratory Service Providers, Physician and Outpatient Clinic Laboratory Service Providers, Independent Laboratory Service Providers)
- Hospitals and Acute Care Providers
- Figure 4-3: Global Clinical Laboratory Market Analysis: Hospital and Acute Care Laboratory Testing Market Trend, 2010-2023
- Table 4-2: Hospital Density per 100,000 Population by Country, 2013 (Afghanistan; Brazil; Canada; China; France; Finland; Germany; Iceland; Indonesia; Iraq; Israel; Italy; Japan; Korea, Republic of; Malaysia; Mexico; Netherlands; Pakistan; Philippines; Poland; Saudi Arabia; Singapore; South Africa; Thailand; Turkey; United Kingdom; United States)
- Figure 4-4: Hospitals per 100,000 Population by Country, 2013 (Afghanistan; Brazil; Canada; China; France; Finland; Germany; Iceland; Indonesia; Iraq; Israel; Italy; Japan; Korea, Republic of; Malaysia; Mexico; Netherlands; Pakistan; Philippines; Poland; Saudi Arabia; Singapore; South Africa; Thailand; Turkey; United Kingdom; United States)
- Physicians and Outpatient Care Providers
- Figure 4-5: Global Clinical Laboratory Market Analysis: Physician and Outpatient Care Laboratory Testing Market Trend, 2010-2023
- Physician Offices
- Table 4-3: Medical Doctors per 1,000 Population by Country, 2016 (Afghanistan; Argentina; Australia; Brazil; Canada; China; France; Germany; India; Ireland; Israel; Italy; Japan; Korea, Republic of; Mexico; Netherlands; Poland; Romania; Russian Federation; Saudi Arabia; Singapore; South Africa; Spain; Sweden; Switzerland; Turkey; United Kingdom; United States; Vietnam)
- Figure 4-6: Medical Doctors per 1,000 Population by Country, 2016 (Afghanistan; Argentina; Australia; Brazil; Canada; China; France; Germany; India; Ireland; Israel; Italy; Japan; Korea, Republic of; Mexico; Netherlands; Poland; Romania; Russian Federation; Saudi Arabia; Singapore; South Africa; Spain; Sweden; Switzerland; Turkey; United Kingdom; United States; Vietnam)
- Global Nursing Establishments and Assisted Living Facilities
- Table 4-4: Estimated Nursing Service Establishments and Care Centers by Country, 2017 (Australia, Canada, China, France, Germany, Italy, Japan, Netherlands, Sweden, Switzerland, United Kingdom, United States)
- Figure 4-7: Estimated Nursing Service Establishments and Care Centers by Country, 2017 (Australia, Canada, China, France, Germany, Italy, Japan, Netherlands, Sweden, Switzerland, United Kingdom, United States)
- Global Dialysis Clinics
