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    North America Clinical Laboratory Test Market

    ID: MRFR/LS/1651-CR
    85 Pages
    Rahul Gotadki
    April 2017

    North America Clinical Laboratory Test Market Research Report Information By Type of Laboratory (Hospital based, Central/Independent, Physician Office Laboratory, and Others), By Type of Test (CBC and Routine Blood Test, Anatomic Pathology, Molecular Test, Immunology Test, Drug Test, and Others) And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2032

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    North America Clinical Laboratory Test Market Research Report - Forecast to 2032 Infographic
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    Table of Contents

    North America Clinical Laboratory Test Market Summary

    The North America Clinical Laboratory Test market is projected to grow significantly from 21.0 USD Billion in 2024 to 41.7 USD Billion by 2035.

    Key Market Trends & Highlights

    North America Clinical Laboratory Test Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 6.45 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 41.7 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 21.0 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of advanced diagnostic technologies due to increasing demand for personalized medicine is a major market driver.

    Market Size & Forecast

    2024 Market Size 21.0 (USD Billion)
    2035 Market Size 41.7 (USD Billion)
    CAGR (2025-2035) 6.45%

    Major Players

    Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics

    North America Clinical Laboratory Test Market Trends

      • Growing healthcare expenditure is driving the market growth

    Market CAGR for North American clinical laboratory test market is being grown due to rising healthcare expenditures. Expanding regulatory backing and increased spending in clinical laboratory tests are expected to propel the market. The economies of North America are sophisticated, and there are strict regulations governing the approval of new tests. 

    The FDA has authorized these experiments in accordance with the 510(k) medical device rule. Panel tests conducted on instruments must go through a similar FDA approval procedure in order to be authorized for commercialization. In Canada, these tests must have approval from Health Canada.

    The market is expanding due to the result of favorable regulatory policies and high insurance coverage (almost 100%). If these tests are quickly invoiced to insurance providers, it is simpler for patients to estimate expenses. Urinalysis, blood tests, and screening checks are covered by Medicaid. However, local hospital costs are more expensive than the price of tests.

    Obesity and diabetes, which both raise illness risk and lead to metabolic imbalances, are two diseases for which aging has emerged as a prominent risk factor. The demand for clinical laboratory testing is expected to rise as a result. The majority of affluent countries now have life expectancies above 80 years, according to the World Health Organization. 

    Aging is a vital risk factor for the emergence of infectious diseases because it is driven by the connection of numerous environmental and genetic factors that modify immunity, metabolism, and organ functions. Consequently, diagnostics and screening can be quite important in the overall management of health. The market for clinical laboratory testing is being driven by the increase in the worldwide geriatric population as well as the demand for acute and long-term healthcare. Thus, driving the North America Clinical Laboratory Test market revenue.

    North America Clinical Laboratory Test Market Drivers

    Market Segment Insights

    North America Clinical Laboratory Test Type of Laboratory Insights

    The North America Clinical Laboratory Test market segmentation, based on the type of laboratory includes Hospital-based, Central/Independent, Physician Office Laboratory, and Others. Over the projection period, the segment for central/independent laboratories is anticipated to increase at the quickest rate. The strong market penetration and procedure volumes are credited with the segment's growth. Another significant factor projected to propel the market is the rising number of efforts adopted by governments to offer various services, such as reimbursement for clinical laboratory testing.

    North America Clinical Laboratory Test Type of Test Insights

    The North America Clinical Laboratory Test market segmentation, based on type of test, includes CBC and Routine Blood Test, Anatomic Pathology, Molecular Test, Immunology Test, Drug Test, and Others. The molecular test category had the biggest revenue share and is anticipated to hold onto the top spot for the duration of the forecast. Additional factors driving the growth of the molecular testing market include the increasing prevalence of lifestyle-related disorders, including diabetes, high blood pressure, also growing public awareness of advanced clinical laboratory tests.

    Figure 1 North America Clinical Laboratory Test Market, by Test Type, 2023 & 2032 (USD Billion)

    Source Secondary Research, Primary Research, MRFR Database and Analyst Review

    Get more detailed insights about North America Clinical Laboratory Test Market Research Report - Forecast to 2032

    Regional Insights

    By region, the study provides the market insights into North America. The North American North America Clinical Laboratory Test market area will dominate this market, owing to an increase in the count of geriatric population. In addition, the growing spread of chronic diseases like cancer will boost market growth in this region. US held the fastest growth while Canada is expected to register fastest CAGR over the projected period.

    The FDA and EMA's regulatory frameworks are extremely important to the US’s healthcare sector. Laboratory-designed tests (LDTs), which are tests developed internally by clinical laboratories that deliver accurate and quick findings, are governed by the Food and Drug Administration (FDA). The mentioned factors are expediting the growth of US Clinical Laboratory Test Market.

    The Canada clinical laboratory test Market is expanding as more people become aware of the value of early disease identification and the advantages of early treatment. Some of the government measures that are to blame for the growth of the Canadian clinical diagnostics industry include the federal government's proposed Bill C-17 in the House of Commons, which would grant provinces and territories an additional $2 Bn as a one-time top-up, split evenly by population.

    Further, the major countries studied in the market report are The US, and Canada.

    Figure 2 NORTH AMERICA CLINICAL LABORATORY TEST MARKET SHARE BY REGION 2023 (USD Billion) North America Clinical Laboratory Test Market 

    Source Secondary Research, Primary Research, MRFR Database and Analyst Review 

    Key Players and Competitive Insights

    Leading market players are aggressively adopting new business tactics to extend their product offerings, which will help the North America Clinical Laboratory Test market, grow faster. 

    Market participants are also undergoing a range of strategic activities to expand their  presence, with important market developments including new product developments, contracts & agreements, mergers & acquisitions, increased investments, & collaboration with other similar organizations. To expand and survive in a more competitive and rising market climate, North America Clinical Laboratory Test industry must offer cost-effective items.

    Manufacturing locally to minimize capital requirements is one of the key business tactics used by manufacturers in the North America Clinical Laboratory Test industry to benefit clients and increase the market sector. In recent years, the North America Clinical Laboratory Test industry has offered some of the most significant advantages to medicine. 

    Major players in the North America Clinical Laboratory Test market, including Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics, and others, are attempting to enhance market demand by investing in research and development operations.

    Quest Diagnostics Inc. (Quest Diagnostics) offers diagnostic information services to patients and physicians through a network of laboratories and business-owned patient service centers. It provides a variety of services, including anatomic pathology, clinical trial testing, life insurer services, genetic testing, gene-based testing, and other specialized tests, as well as a range of medical information technology and diagnostic devices. Among others, Quest Diagnostics offers its services to hospitals, clinics, managed care organizations, other health insurance companies, laboratories, and governmental organizations. 

    In February 2023, Cleveland Diagnostics, Inc., a biotechnology business in commercial development that creates next-generation diagnostic tests for the early diagnosis of malignancies, today announced a deal intended to increase patient access to the firm's cutting-edge IsoPSA prostate cancer test. Patients will be able to access IsoPSA through an agreement with Quest Diagnostics (NYSE DGX), the country's top provider of diagnostic information services, and, after receiving a prescription from their doctor, provide a blood sample for testing at one of more than 2,100 Quest Diagnostics patient service centre locations nationwide.

    Laboratory Corp of America Holdings (LabCorp) offers Clinical laboratory services and complete drug development assistance. It is concentrated on the creation and marketing of various diagnostic technologies and testing services. The business provides clinical diagnostics laboratory services, including standard, genomic, and specialized tests. Forensic identity services, clinical trials services, drug testing services, deoxyribonucleic acid (DNA) identification services, paternity testing services, general and specialty laboratory testing, bone marrow and human leukocyte antigen (HLA) testing, patient services, personalized medicine, and hospital services are just a few of the services it offers. 

    Through Covance, it also provides medication development services. Through a network of primary laboratories and patient care facilities, it provides services to managed care organizations, physicians, hospitals, government agencies, and biotechnology and pharmaceutical businesses.

    In May 2022, AtlantiCare, the largest healthcare provider in southern New Jersey, and Labcorp (NYSE LH), a top  life sciences firm, announced today that they have completed a transaction to deepen their long-term strategic partnership. Select assets from AtlantiCare's clinical outreach business, which serves the patients of the AtlantiCare Physician Group and Affiliated Physicians throughout southern New Jersey, will be acquired by Labcorp. The deal is the latest in a string of fresh and expanded partnerships between Labcorp and health systems around the nation, highlighting the value Labcorp contributes to enhancing patient care and laboratory services.

    Key Companies in the North America Clinical Laboratory Test Market market include

    Industry Developments

    May 2021  Neuberg Diagnostics, a company with headquarters in Chennai, stated on Monday that it has begun operating a clinical laboratory in North Carolina, a US state. The NCGM Inc (Neuberg Centre for Genomic Medicine) facility in North Carolina will concentrate on genomic and molecular diagnostics using new generation sequencing technologies.

    Market Segmentation

    North America Clinical Laboratory Test Regional Outlook

    North America
    • US
    • Canada

    North America Clinical Laboratory Test, Type of Test Outlook

    • CBC and Routine Blood Test
    • Anatomic Pathology
    • Molecular Test
    • Immunology Test
    • Drug Test
    • Others

    North America Clinical Laboratory Test, Type of Laboratory Outlook

    • Hospital-based
    • Central/Independent
    • Physician Office Laboratory
    • Others

    Report Scope

    North America Clinical Laboratory Test Report Scope

    Attribute/Metric Details
    Market Size 2023 USD 19.54 Billion
    Market Size 2024 USD 20.98 Billion
    Market Size 2032 USD 34.6 Billion
    Compound Annual Growth Rate (CAGR) 6.45% (2024-2032)
    Base Year 2023
    Market Forecast Period 2024-2032
    Historical Data 2018- 2022
    Market Forecast Units Value (USD Billion)
    Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments Covered Type of Test, Type of Laboratory, and Region
    Geographies Covered North America
    Countries Covered The US, Canada
    Key Companies Profiled Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics
    Key Market Opportunities Growing number of chronic diseases
    Key Market Dynamics Increase in health-related expenditures and government support

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    How much is the North America Clinical Laboratory Test market?

    The North America Clinical Laboratory Test market size was valued at USD 19.54 Billion in 2023.

    What is the growth rate of the North America Clinical Laboratory Test market?

    The market is projected to grow at a CAGR of 6.45% during the forecast period, 2024-2032.

    Which region held the largest market share in the North America Clinical Laboratory Test market?

    North America had the largest share in the market

    Who are the key players in the North America Clinical Laboratory Test market?

    The key players in the market are Aurora Diagnostics, Laboratory Corporation of America, LifeLabs Medical Laboratories, Quest Diagnostics.

    Which type of laboratory led the North America Clinical Laboratory Test market?

    The central/independent category dominated the market in 2022.

    Which type of test had the largest market share in the North America Clinical Laboratory Test market?

    The molecular test had the largest share in the market.

    1. Report Prologue
    2. Market Dynamics
    3. Market Factor Analysis
      1. Value Chain Analysis 12
        1. Inbound planning 12
        2. Specimen Testing 13
        3. Report DEliVERY 13
    4. Marketing and Sales 13
      1. Customer Services 13
      2. Supply
    5. chain analysis 14
      1. Logistic Information 14
        1. Product
    6. Selection 14
      1. Procurement 14
        1. Inventory Management
        2. Serving Customers 15
      2. Porter’s five forces
    7. model 16
      1. Bargaining power of suppliers 17
        1. Bargaining
    8. Power of Buyers 17
      1. Threat of New Entrants 17
        1. Threat
    9. of Substitutes 17
      1. Intensity of Rivalry 18
    10. North America
    11. Clinical Laboratory Test Market, By Type of Laboratory
      1. Introduction 19
    12. North America Clinical Laboratory Test Market, By Type of Test
      1. Introduction
    13. North America Clinical Laboratory Test Market, By Country
    14. Introduction
    15. North America Clinical Laboratory Test Market: Competitive Landscape
    16. Company Profile
      1. AURORA Diagnostics 33
        1. Company Overview
        2. Product/ Business segment overview 33
        3. Financial
    17. Overview: 33
      1. Key Development 34
        1. SWOT Analysis
        2. MRFR Analysis 35
      2. Laboratory Corporation of America
        1. Company Overview 36
        2. Product/ Business segment
    18. overview 36
      1. Financial Overview 36
        1. Key Development
        2. SWOT Analysis 39
        3. MRFR Analysis 39
      2. LifeLabs Medical Laboratories. 40
        1. Company Overview 40
        2. Product/ Business segment overview 40
        3. Financial Overview:
        4. Key Development 41
        5. SWOT Analysis 41
        6. MRFR Analysis 42
      3. Quest Diagnostics 43
        1. Company
    19. Overview 43
      1. Product/Business Segment Overview 43
    20. Financial Overview 43
      1. Key Development 44
        1. SWOT
    21. Analysis 45
      1. MRFR Analysis 45
      2. Sonic Healthcare 46
        1. Company Overview 46
        2. Product/ Business segment overview
        3. Financial Overview 46
        4. Key Development 48
        5. SWOT Analysis 49
        6. MRFR Analysis 49
    22. List of
    23. 2030 (USD MILLION)
    24. BY TYPE OF TEST, 2022-2030 (USD MILLION)
    25. TEST MARKET BY COUNTRY 2022-2030 (USD MILLION)
    26. List of Figures
    27. NORTH AMERICA CLINICAL LABORATORY TEST MARKET, BY TYPE OF LABORATORY
    28. NORTH AMERICA CLINICAL LABORATORY TEST MARKET, BY TYPE OF TEST
    29. AMERICA CLINICAL LABORATORY TEST MARKET, BY COUNTRY
    30. CLINICAL LABORATORY TEST MARKET: COMPANY SHARE ANALYSIS, 2020 (%)

    North America Clinical Laboratory Test Market Segmentation

    North America Clinical Laboratory Test Type of laboratory Outlook (USD Billion, 2018-2032)

    • Hospital based
    • Central/Independent
    • Physician Office Laboratory
    • Others

    North America Clinical Laboratory Test Type of test Outlook (USD Billion, 2018-2032)

    • CBC and Routine Blood Test
    • Anatomic Pathology
    • Molecular Test
    • Immunology Test
    • Drug Test
    • Others
      • US Outlook (USD Billion, 2018-2032)

      • US North America Clinical Laboratory Test by Type of laboratory
        • Hospital based
        • Central/Independent
        • Physician Office Laboratory
        • Others
      • US North America Clinical Laboratory Test by Type of test
        • CBC and Routine Blood Test
        • Anatomic Pathology
        • Molecular Test
        • Immunology Test
        • Drug Test
        • Others
      • CANADA Outlook (USD Billion, 2018-2032)

      • CANADA North America Clinical Laboratory Test by Type of laboratory
        • Hospital based
        • Central/Independent
        • Physician Office Laboratory
        • Others
      • CANADA North America Clinical Laboratory Test by Type of test
        • CBC and Routine Blood Test
        • Anatomic Pathology
        • Molecular Test
        • Immunology Test
        • Drug Test
        • Others
    North America Clinical Laboratory Test Market Research Report - Forecast to 2032 Infographic
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