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U.S. Clinical Laboratory Test Market - Industry Outlook & Forecast 2021-2026

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  • 178 Pages
  • June 2021
  • Region: United States
  • Arizton
  • ID: 5336116
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In-depth Analysis and Data-driven Insights on the Impact of COVID-19 Included in this U.S. Clinical Laboratory Test Market Report

The U.S. clinical laboratory test market is expected to grow at a CAGR of approximately 2% during 2021-2026.

The dominant model of clinical laboratory testing remains the centralized model for diagnosing and treating several acute and chronic diseases. The emerging trend in the clinical lab testing market, such as lab automation and the incorporation of AI and machine learning into diagnostic services, is boosting the market's growth rate. Digital pathology solutions have been adopted by most pharmaceutical companies and clinical research institutions. Direct to consumer tests are performed from home, have greater accessibility in giving the samples to the clinical laboratories, and payments are directly collected from the consumers, thereby creating ease in the payments process. Many laboratories in the global market are offering these tests now to consumers. Many vendors ranging from major to emerging clinical laboratories vendors in the U.S. are extending their focus on direct access testing services.

The following factors are likely to contribute to the growth of the U.S. clinical laboratory test market during the forecast period:
  • High Penetration of Digital Pathology Testing Solutions
  • Increasing Availability of DTC Diagnostics Services by Clinical Laboratories
  • Rising of Periodic Occurrence of Epidemics and Pandemics
  • Technological Advancements in IVD Fueling Laboratory Diagnosis Volumes

The report considers the present scenario of the U.S. clinical laboratory test market and its market dynamics for the period 2021-2026. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply sides of the market. It also profiles and analyzes leading companies and several other prominent companies operating in the market.


The U.S. clinical laboratory test market research report includes a detailed segmentation by test complexity, providers, test type. Providers including POLs, hospital-based laboratories, and independent laboratories that perform CLIA-waived tests are gaining popularity in the country. An increasing number of innovative CLIA-waived tests will greatly expand access to beneficial clinical diagnostic testing across the US. From patient presentation to result in availability, the CBC test sets a standard for speed, with more than 16+ tests available in under five minutes, making it the most utilized lab test in the US.

According to the estimations of CMS, there are approximately 9,100 hospital-based laboratories in the country. The hospitals maintain on-site laboratories and perform laboratory tests for in-patient and outpatients with a significant majority. The profitability of the hospital laboratories rose to 85% due to the hospital outreach programs. Approximately 80% of the tests performed in the physician office labs are waived tests, and the provider performed microscopy.

According to the American Academy of Family Physicians, physician office laboratories have a mild positive impact due to COVID-19.

Immunology and serology tests are witnessing increasing demand during the COVID-19 pandemic. The trend of early diagnosis and the disease management awareness among the population in the US are the major factors attributing to the increase in test volumes in the clinical and immunochemistry segment. The U.S. clinical laboratory test market by clinical and immunochemistry is expected to reach around USD 55 billion by 2026. The advancement in technology in the hematology lab testing services is driving the market. Over the past few years, several new products and technologies have emerged in the hematology testing market.

Segmented by Test Complexity
  • Routine Tests
  • Specialty Tests

Segmented by Providers
  • Hospital Based Laboratories
  • Independent Reference Laboratories
  • Physician office laboratories
  • Other laboratories

Segmented by Test Type
  • Clinical and Immunochemistry
  • Microbiology and Cytology
  • Genetics and Cytogenetics (Molecular Diagnostics)
  • Hematology
  • Toxicology


The US is home to many global and international standard clinical reference laboratories. The competition is emerging from new technologies such as digital pathology and growing from non-traditional competitors such as government agencies or employers establishing their clinical laboratory for testing. LabCorp, Quest Diagnostics, Siemens Healthineers, BioReference Laboratories, Sonic Healthcare, Eurofins Scientific, and Mayo Clinic Laboratories are the major players in the market.

Key Vendors
  • BioReference Laboratories
  • Eurofins Scientific
  • Laboratory Corporation of America
  • Mayo Clinic Laboratories
  • Quest Diagnostics
  • Siemens Healthineers
  • Sonic Healthcare

Other Prominent Vendors
  • ARUP Laboratories
  • Clinical Reference Laboratory
  • DaVita
  • Fresenius Medical Care
  • Laboratory of Florida
  • US Speciality Labs


1. How big is the U.S. clinical laboratory test market?
2. What is the clinical laboratory test market growth?
3. Which segment accounted for the largest U.S. clinical laboratory test market share?
4. Who are the leading players in the clinical lab testing market?
5. What are the factors driving the U.S. clinical laboratory test market?
Frequently Asked Questions about the U.S. Clinical Laboratory Test Market

What is the estimated value of the U.S. Clinical Laboratory Test Market?

The U.S. Clinical Laboratory Test Market was estimated to be valued at $94.33 Billion in 2020.

What is the growth rate of the U.S. Clinical Laboratory Test Market?

The growth rate of the U.S. Clinical Laboratory Test Market is 2.0%, with an estimated value of $106.05 Billion by 2026.

What is the forecasted size of the U.S. Clinical Laboratory Test Market?

The U.S. Clinical Laboratory Test Market is estimated to be worth $106.05 Billion by 2026.

Who are the key companies in the U.S. Clinical Laboratory Test Market?

Key companies in the U.S. Clinical Laboratory Test Market include BioReference Laboratories, Eurofins Scientific, Laboratory Corporation of America, Mayo Clinic Laboratories, Quest Diagnostics, Siemens Healthineers, Sonic Healthcare, ARUP Laboratories and DaVita.

Table of Contents

1 Research Methodology2 Research Objectives3 Research Process
4 Scope & Coverage
4.1 Market Definition
4.1.1 Inclusions
4.1.2 Exclusions
4.1.3 Market Estimation Caveats
4.2 Base Year
4.3 Scope Of The Study
4.4 Market Segments
4.4.1 Market By Test Complexity
4.4.2 Markey By Providers
4.4.3 Market By Test Types
5 Report Assumptions & Caveats
5.1 Key Caveats
5.2 Currency Conversion
5.3 Market Derivation
6 Market At A Glance
7 Introduction
7.1 Overview
8 Regulatory & Reimbursement Scenario: Us Clinical Laboratory Testing
8.1 Regulatory Scenario
8.2 Reimbursement Scenario
9 Impact Of Covid-19 On Us Clinical Laboratory Testing
9.1 Overview
9.2 Impact On Supply Chain During The Covid-19 Pandemic
10 Market Opportunities & Trends
10.1 High Penetration Of Digital Pathology Testing Solutions
10.2 End-Users Increasing Focus On Lab Automation
10.3 Increasing Availability Of Dtc Diagnostics Services By Clinical Laboratories
11 Market Growth Enablers
11.1 Growing Prevalence Of Chronic & Acute Diseases
11.2 Rising Popularity Of Early Disease Diagnosis & Prevention
11.3 Periodic Occurance Of Epidemics & Pandemics
11.4 Technological Advances In Ivd Fueling Laboratory Diagnosis Volumes
12 Market Restraints
12.1 Increase In Popularity & Advances In Point-Of-Care (Poc) Diagnostics
12.2 Presence Of Unclear Regulatory Framework
13 Market Landscape
13.1 Market Overview
13.2 Market Size & Forecast
13.3 Five Forces Analysis
13.3.1 Threat Of New Entrants
13.3.2 Bargaining Power Of Suppliers
13.3.3 Bargaining Power Of Buyers
13.3.4 Threat Of Substitutes
13.3.5 Competitive Rivalry
14 Test Complexity
14.1 Market Snapshot & Growth Engine
14.2 Market Overview
14.3 Routine Tests
14.3.1 Market Overview
14.3.2 Market Size & Forecast
14.4 Specialty Tests
14.4.1 Market Overview
14.4.2 Market Size & Forecast
15 Providers
15.1 Market Snapshot & Growth Engine
15.2 Market Overview
15.3 Independent Reference Laboratories
15.3.1 Market Overview
15.3.2 Market Size & Forecast
15.4 Hospital-Based Laboratories
15.4.1 Market Overview
15.4.2 Market Size & Forecast
15.5 Physician Office Laboratories (Pols)
15.5.1 Market Overview
15.5.2 Market Size & Forecast
15.6 Other Laboratories
15.6.1 Market Overview
15.6.2 Market Size & Forecast
16 Test Type
16.1 Market Snapshot & Growth Engine
16.2 Market Overview
16.3 Clinical & Immunochemistry
16.3.1 Market Overview
16.3.2 Market Size & Forecast
16.4 Microbiology & Cytology
16.4.1 Market Overview
16.4.2 Market Size & Forecast
16.5 Hematology
16.5.1 Market Overview
16.5.2 Market Size & Forecast
16.6 Genetics & Cytogenetics
16.6.1 Market Overview
16.6.2 Market Size & Forecast
16.7 Toxicology
16.7.1 Market Overview
16.7.2 Market Size & Forecast
17 Competitive Landscape
17.1 Competition Overview
17.2 Market Share Analysis
17.2.1 Bioreference Laboratories
17.2.2 Eurofins Scientific
17.2.3 Lab Corporation Of America
17.2.4 Mayo Clinic Laboratories
17.2.5 Quest Diagnostics
17.2.6 Siemens Healthineers
17.2.7 Sonic Healthcare
18 Key Company Profiles
18.1 Bioreference Laboratories
18.1.1 Business Overview
18.1.2 Services Offerings
18.1.3 Key Strategies
18.1.4 Key Strengths
18.1.5 Key Opportunities
18.2 Eurofins Scientific
18.2.1 Business Overview
18.2.2 Services Offerings
18.2.3 Key Strategies
18.2.4 Key Strengths
18.2.5 Key Opportunities
18.3 Laboratory Corporation Of America
18.3.1 Business Overview
18.3.2 Service Offerings
18.3.3 Key Strategies
18.3.4 Key Strengths
18.3.5 Key Opportunities
18.4 Mayo Clinic Laboratories
18.4.1 Business Overview
18.4.2 Services Offerings
18.4.3 Key Strategies
18.4.4 Key Strengths
18.4.5 Key Opportunities
18.5 Quest Diagnostics
18.5.1 Business Overview
18.5.2 Service Offerings
18.5.3 Key Strategies
18.5.4 Key Strengths
18.5.5 Key Opportunities
18.6 Siemens Healthineers
18.6.1 Business Overview
18.6.2 Service Offerings
18.6.3 Key Strategies
18.6.4 Key Strengths
18.6.5 Key Opportunities
18.7 Sonic Healtcare
18.7.1 Business Overview
18.7.2 Services Offerings
18.7.3 Key Strategies
18.7.4 Key Strengths
18.7.5 Key Opportunities
19 Other Prominent Vendors
19.1 Arup Laboratories
19.1.1 Business Overview
19.1.2 Service Offerings
19.1.3 Key Strategies
19.1.4 Key Strengths
19.1.5 Key Opportunities
19.2 Clinical Reference Laboratory
19.2.1 Business Overview
19.2.2 Services Offerings
19.2.3 Key Strategies
19.2.4 Key Strengths
19.2.5 Key Opportunities
19.3 Davita
19.3.1 Business Overview
19.3.2 Service Offerings
19.3.3 Key Strategies
19.3.4 Key Strengths
19.3.5 Key Opportunities
19.4 Fresenius Medical Care
19.4.1 Business Overview
19.4.2 Service Offerings
19.4.3 Key Strategies
19.4.4 Key Strengths
19.4.5 Key Opportunities
19.5 Laboratory Of Florida
19.5.1 Business Overview
19.5.2 Service Offerings
19.5.3 Key Strategies
19.5.4 Key Strengths
19.5.5 Key Opportunities
19.6 Us Specialty Labs
19.6.1 Business Overview
19.6.2 Services Offerings
19.6.3 Key Strengths
19.6.4 Key Strategies
20 Report Summary
20.1 Key Takeaways
20.2 Strategic Recommendations
21 Quantitative Summary
21.1 Market By Test Complexity
21.2 Market By Providers
21.3 Market By Test Type
22 Appendix
22.1 Abbreviations

Companies Mentioned

  • BioReference Laboratories
  • Eurofins Scientific
  • Laboratory Corporation of America
  • Mayo Clinic Laboratories
  • Quest Diagnostics
  • Siemens Healthineers
  • Sonic Healthcare
  • ARUP Laboratories
  • Clinical Reference Laboratory
  • DaVita
  • Fresenius Medical Care
  • Laboratory of Florida
  • US Speciality Labs


Our research comprises a mix of primary and secondary research. The secondary research sources that are typically referred to include, but are not limited to, company websites, annual reports, financial reports, company pipeline charts, broker reports, investor presentations and SEC filings, journals and conferences, internal proprietary databases, news articles, press releases, and webcasts specific to the companies operating in any given market.

Primary research involves email interactions with the industry participants across major geographies. The participants who typically take part in such a process include, but are not limited to, CEOs, VPs, business development managers, market intelligence managers, and national sales managers. We primarily rely on internal research work and internal databases that we have populated over the years. We cross-verify our secondary research findings with the primary respondents participating in the study.