PUBLISHED DATE : Jun 2021 | Pages : 178
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U.S. Clinical Laboratory Test Market Size, Share, & Trends Analysis Report by Test Complexity (Routine and Specialty Tests), Providers (Hospital-Based Laboratories, Independent Reference Laboratories, Physician Office Laboratories, and Other Laboratories), and Test Type (Clinical and Immunochemistry, Microbiology and Cytology, Genetics and Cytogenetics (Molecular Diagnostics), Hematology, and Toxicology) Industry Analysis Report, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast 2021–2026
178 Pages
26 Tables
80 Charts
1 Regions
1 Countries
13 Companies
3 Market Segment
| Report Attribute | Details |
|---|---|
| MARKET SIZE (REVENUE) | USD 106.05 BILLION (2026) |
| CAGR | 1.97% (2021-2026) |
| Base Year | 2020 |
| Forecast Year | 2021-2026 |
| Market Segments | Test Complexity (Routine and Specialty Tests), Providers (Hospital Based Laboratories, Independent Reference Laboratories, Physician Office laboratories, and Other Laboratories), and Test Type (Clinical and Immunochemistry, Microbiology and Cytology, Genetics and Cytogenetics (Molecular Diagnostics), Hematology, and Toxicology) |
| Geographic Analysis | US |
| Countries Covered | United States |
The U.S. clinical laboratory test market size to reach around USD 106.05 billion by 2026, growing at a CAGR of approximately 1.97% during the forecast period. 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.
Laboratory Corporation of America and Quest Diagnostics are the dominant vendors in the U.S. clinical laboratory testing market. During the emergence of the COVID-19 pandemic, clinical laboratories shifted their investments into defense mechanisms to tackle the coronavirus by expanding their COVID-19 testing volumes. For instance, LabCorp steadily increased its capacity to perform the tests, and by the end of the year 2020, the company started performing 2,75,000 tests per day.
This research report includes a detailed segmentation by
The routine testing segment in the US clinical laboratory test market accounted for over 42% in 2020.
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.
The rapid increase of various diseases is fueling the growth of specialty tests in clinical laboratories, which will witness huge demand in the US during the forecast period. Biopharma companies are rapidly seeking partners to co-develop the tests for their manufactured drugs. Reimbursements under Medicare and Medicaid services are also favorable factors increasing the adoption of specialty tests among the US population.
Around 55% of hospital-based laboratories perform maximum test volumes in the clinical lab testing setting 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.
The U.S. clinical laboratory test services market by clinical chemistry segment is projected to post an absolute growth of around 14% by 2026.
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.
Laboratory Corporation of America and Quest diagnostics is the dominant vendors in the U.S. clinical laboratory testing market.
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.
New entrants with extensive resources are likely to adopt acquisition as an expanding strategy into traditional operations in the laboratory testing services industry. Siemens Healthineers upgrades its technical operations by incorporating artificial intelligence and consistently improving its core business.
Frequently Asked Questions
How big is the U.S. clinical laboratory test market?
The U.S. clinical laboratory test market size to reach around USD 106.05 billion by 2026.
What is the clinical laboratory test market growth?
The U.S. clinical laboratory tests market to grow at a CAGR of approximately 1.97% during the forecast period.
Which segment accounted for the largest U.S. clinical laboratory test market share?
Around 50% of hospital-based laboratories perform the maximum test volumes in the clinical lab testing in the U.S.
Who are the leading players in the clinical lab testing market?
LabCorp, Quest Diagnostics, Siemens Healthineers, BioReference Laboratories, Sonic Healthcare, Eurofins Scientific, and Mayo Clinic Laboratories are the major players in the market.
What are the factors driving the U.S. clinical laboratory test market?
The acceptance of advanced technologies such as AI and the Internet of Things (IoT) assists in remote monitoring and the management of the devices in the laboratory testing services industry.
The U.S. clinical laboratory test market is expected to grow at a CAGR of approximately 1.97% during 2021-2026.
The following factors are likely to contribute to the growth of the U.S. clinical laboratory test market during the forecast period:
Base Year: 2020
Forecast Year: 2021-2026
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.
Key Vendors
Other Prominent Vendors
Segmented by Test Complexity
Segmented by Providers
Segmented by Test Type
1 Research Methodology
2 Research Objectives
3 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 Healthcare
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
List Of Exhibits
Exhibit 1 Segmentation of Clinical Laboratory Testing Market in US
Exhibit 2 Market Size Calculation Approach 2020
Exhibit 3 Tests Performed in US Clinical Laboratories (Percentage)
Exhibit 4 Volume of Molecular & Serology Tests performed by Quest Diagnostics March 2020-2021 (millions)
Exhibit 5 US Clinical Laboratories facing Shortage of Supplies for Performing Clinical Tests (%)
Exhibit 6 High Penetration of Digital Pathology Testing Solutions
Exhibit 7 Workflow Process Involved in Digital Pathology
Exhibit 8 End-users Increasing Focus on Lab Automation
Exhibit 9 Benefits of Automation in Laboratory Testing
Exhibit 10 Increasing Availability of DTC Diagnostics Services by Clinical Laboratories
Exhibit 11 Growing Prevalence of Chronic & Acute Diseases
Exhibit 12 Estimated Number of Americans with Chronic Conditions 1995–2030 (millions)
Exhibit 13 Prevalence of Multiple Chronic Disorders in Select Regions (%)
Exhibit 14 Number of Infectious Disease Cases in US 1990–2018
Exhibit 15 Rising Popularity of Early Disease Diagnosis & Prevention
Exhibit 16 Advantages of Early Disease Diagnosis & Prevention
Exhibit 17 Periodic Occurrence of Epidemics & Pandemics
Exhibit 18 Pandemic or Epidemic Outbreaks in Last Two Decades
Exhibit 19 Technological Advances in IVD fueling Laboratory Diagnosis Volumes
Exhibit 20 Increase in Popularity & Advances in Point-of-Care (POC) Diagnostics
Exhibit 21 Impact of Presence of Unclear Regulatory Framework
Exhibit 22 Clinical Laboratory Testing Market in US 2020–2026 ($ billion)
Exhibit 23 Clinical Laboratory Testing Market in US by Test Complexity (%)
Exhibit 24 Clinical Laboratory Testing Market in US by Provider (%)
Exhibit 25 Clinical Laboratory Testing Market in US by Test Type (%)
Exhibit 26 Five Forces Analysis 2020
Exhibit 27 Incremental Growth by Test Complexity 2020 & 2026
Exhibit 28 Clinical Laboratory Testing Market in US by Test Complexity
Exhibit 29 Clinical Laboratory Testing Market in US by Test Complexity: Incremental Growth ($ billion)
Exhibit 30 Clinical Laboratory Testing Market in US by Test Complexity: Absolute Growth (%)
Exhibit 31 Clinical Laboratory Testing Market in US by Routine Tests: Incremental Growth & Absolute Growth Comparison
Exhibit 32 Clinical Laboratory Testing Market in US by Routine Tests 2020–2026 ($ billion)
Exhibit 33 Percentage of Disorders/Ailments in US Population
Exhibit 34 Clinical Laboratory Testing Market in US by Specialty Tests: Incremental Growth & Absolute Growth Comparison
Exhibit 35 Clinical Laboratory Testing Market in US by Specialty Tests 2020–2026 ($ billion)
Exhibit 36 Incremental Growth by Providers 2020 & 2026
Exhibit 37 Percentage of Clinical Laboratory Testing Service Providers in US by Test Volume
Exhibit 38 Types of Laboratories in US (in Thousand)
Exhibit 39 Clinical Laboratory Testing Market in US by Providers: Incremental Growth ($ billion)
Exhibit 40 Clinical Laboratory Testing Market in US by Providers: Absolute Growth (%)
Exhibit 41 Clinical Laboratory Testing Market in US by Independent Laboratories: Incremental Growth & Absolute Growth Comparison
Exhibit 42 Clinical Laboratory Testing Market in US by Independent Laboratories 2020–2026 ($ billion)
Exhibit 43 Clinical Laboratory Testing Market in US by Hospital-based Laboratories: Incremental Growth & Absolute Growth Comparison
Exhibit 44 Clinical Laboratory Testing Market in US by Hospital-based laboratories 2020–2026 ($ billion)
Exhibit 45 Types of Tests Performed in POL (%)
Exhibit 46 Clinical Laboratory Testing Market in US by Physician Office Laboratories: Incremental Growth & Absolute Growth Comparison
Exhibit 47 Clinical Laboratory Testing Market in US by POLs 2020–2026 ($ billion)
Exhibit 48 Clinical Laboratory Testing Market in US by Other Laboratories: Incremental Growth & Absolute Growth Comparison
Exhibit 49 Clinical Laboratory Testing Market in US by Other Laboratories 2020–2026 ($ billion)
Exhibit 50 Incremental Growth by Test Type 2020 & 2026
Exhibit 51 Percentage Shares of Tests Different Types of Laboratory s In the US
Exhibit 52 Clinical Laboratory Testing Market in US by Test Type: Incremental Growth ($ billion)
Exhibit 53 Clinical Laboratory Testing Market in US by Test Type: Absolute Growth (%)
Exhibit 54 Clinical Laboratory Testing Market in US by Clinical Chemistry: Incremental Growth & Absolute Growth Comparison
Exhibit 55 Estimated Number of Rheumatoid Arthritis Cases in US (millions) (2010–2030)
Exhibit 56 Clinical Laboratories Testing Market in US by Clinical & Immunochemistry 2020–2026 ($ billion)
Exhibit 57 Clinical Laboratory Testing Market in US by Microbiology & Cytology: Incremental Growth & Absolute Growth Comparison
Exhibit 58 Clinical Laboratory Testing Market in US by Microbiology & Cytology 2020–2026 ($ Billion)
Exhibit 59 Clinical Laboratory Testing Market in US by Hematology: Incremental Growth & Absolute Growth Comparison
Exhibit 60 Clinical Laboratory Testing Market in US by Hematology 2020–2026 ($ Billion)
Exhibit 61 Clinical Laboratory Testing Market in US by Genetics & Cytogenetics: Incremental Growth & Absolute Growth Comparison
Exhibit 62 Clinical Laboratory Testing Market in US by Genetics & Cytogenetics 2020–2026 ($ Billion)
Exhibit 63 Clinical Laboratory Testing Market in US by Toxicology: Incremental Growth & Absolute Growth Comparison
Exhibit 64 Clinical Laboratory Testing Market in US by Toxicology 2020–2026 ($ Billion)
Exhibit 65 Major Factors Considered by Healthcare s to select Clinical Laboratory Testing Service
Exhibit 66 Clinical Laboratory Testing Market in US: Vendors Market Share 2020
Exhibit 67 BioReference Laboratories: Total Revenue 2018–2020 ($ million)
Exhibit 68 Eurofins Scientific Revenue 2018–2020 ($ billion)
Exhibit 69 Eurofins Scientific Revenue Share by Region 2020 (%)
Exhibit 70 Eurofins Scientific: Major Service Offerings
Exhibit 71 Laboratory Corporation of America Revenue 2018–2020 ($ billion)
Exhibit 72 Laboratory Corporation of America Segment-wise Revenues 2019–2020 ($ billion)
Exhibit 73 Quest Diagnostics Revenue 2018–2020 ($ billion)
Exhibit 74 Quest Diagnostics: Revenue by Services 2020 (%)
Exhibit 75 Siemens Healthineers Revenue 2018–2020 ($ billion)
Exhibit 76 Siemens Healthineers Revenue by Segments 2018–2020 ($ billion)
Exhibit 77 Sonic Healthcare: Total Revenue 2018–2020 ($ million)
Exhibit 78 Sonic Healthcare: Laboratory Business Segment Revenue 2019-2020 ($ million)
Exhibit 79 DaVita Revenue 2018–2020 ($ billion)
Exhibit 80 DaVita Revenue Share by Modality 2020
List of Tables
Table 1 Key Caveats
Table 2 Currency Conversion 2013−2020
Table 3 Federal Agencies under CLIA Administration and their Responsibilities
Table 4 Typical Panels of Tests or Complete Profile Tests
Table 5 Most Common Immunology and Serology Tests
Table 6 Microbial Examination Techniques
Table 7 Types of Genetic Tests as per CDC
Table 8 Clinical Laboratory Testing Market in US: Vendors Ranking 2020
Table 9 BioReference Laboratories: Major Services Offerings
Table 10 Laboratory Corporation of America: Major Service Offerings
Table 11 Mayo Clinic Laboratories: Major Service Offerings
Table 12 Quest Diagnostics: Major Service Offerings
Table 13 Siemens Healthineers: Major Service Offerings
Table 14 Sonic Healthcare: Major Services Offerings
Table 15 ARUP Laboratories: Major Service Offerings
Table 16 Clinical Reference Laboratory: Major Services Offerings
Table 17 DaVita: Major Service Offerings
Table 18 Fresenius Medical Care: Major Service Offerings
Table 19 Laboratory of Florida: Major Service Offerings
Table 20 US Specialty Labs: Major Services Offerings
Table 22 Clinical Laboratory Testing Market in US by Test Complexity 2020–2026 (%)
Table 24 Clinical Laboratory Testing Market in US by Providers 2020–2026 (%)
Table 26 Clinical Laboratory Testing Services Market in US by Test Type 2020-2026 (%)
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