U.S. Clinical Laboratory Services Market Size, Share & Trends Analysis Report By Test Type (Genetic Testing, Cytology Testing, Clinical Chemistry), By Service Provider (Hospital-Based Laboratories, Stand-Alone Laboratories), By Application, And Segment Forecasts, 2025 - 2033

Market Size & Trends

The U.S. clinical laboratory services market size was estimated at USD 9.42 billion in 2024 and is projected to register a CAGR of 5.07% from 2025 to 2033. The market is primarily driven by the increasing burden of chronic diseases, which has intensified the demand for routine and specialized diagnostic testing across care settings. Rising emphasis on early diagnosis and preventive screening has further accelerated the use of clinical laboratory services, particularly for conditions such as diabetes, cardiovascular disorders, and cancer.

In addition, the growing volume of sample testing has led to notable improvements in data management and sample preparation, supporting more efficient laboratory workflows and broader test availability. These enhancements are helping laboratories reduce turnaround times, improve diagnostic accuracy, and handle rising demand across various healthcare settings. Integration of automated systems and digitized reporting tools is also strengthening operational capacity, enabling faster delivery of results and better coordination between clinicians and lab professionals.

The market is also witnessing growing interest from new entrants aiming to capitalize on the sector’s strong potential. Driven by the sector’s lucrative prospects, new entrants are actively investing in the U.S. For instance, in February 2023, Dutch biotech firm Detact Diagnostics established a new laboratory at Keene State College under a two-year rental agreement. Similarly, in May 2021, Neuberg Diagnostics launched a U.S. lab focused on next-generation sequencing (NGS) and molecular diagnostics-key areas for precision medicine and early disease detection. These investments reflect the expanding scope of specialized testing and the increasing role of innovation in shaping future clinical laboratory services.

Moreover, the evolving regulatory environment and focus on value-based care are further influencing the development of clinical laboratory services in the U.S. Laboratories are increasingly aligning with quality standards set by organizations such as CLIA and CAP to maintain compliance and enhance credibility. At the same time, payers' emphasis on cost-effectiveness and clinical utility encourages labs to adopt more targeted testing strategies. This shift reinforces the need for evidence-backed diagnostics that support clinical decision-making and contribute to improved patient outcomes and optimized healthcare spending.

Prior to the COVID-19 pandemic, over 13 billion clinical tests were conducted annually across more than 200,000 CLIA-certified laboratories, highlighting the essential role of diagnostics in the healthcare system. This infrastructure plays a key role in managing chronic conditions, with nearly 60% of the U.S. population living with at least one chronic disease as of 2022, according to the National Association of Chronic Disease Directors. The clinical demand for routine and specialized testing continues to rise with the country’s aging population and the shift toward preventive care.

The pandemic further underscored the critical role of diagnostics, with over 1.17 billion COVID-19 tests performed in the U.S. by March 2023. This surge in testing capacity has strengthened public health preparedness and accelerated investment in lab infrastructure. New entrants are actively tapping into the market’s potential, such as Detact Diagnostics, which established a laboratory at Keene State College in February 2023, and Neuberg Diagnostics, which launched a U.S. lab for next-generation sequencing and molecular diagnostics in May 2021. In addition, ProPhase Labs introduced DNA Complete, Inc. in November 2024, a direct-to-consumer DNA testing platform reflecting the market's growing orientation toward personalized diagnostics. Rising cancer incidence-projected to exceed 2 million new cases in 2024-further reinforces the ongoing demand for advanced laboratory services, particularly in oncology-focused testing.

Challenges & Opportunities

• Challenges:

  • Reimbursement Pressures: Ongoing pricing adjustments under the Protecting Access to Medicare Act (PAMA) and changes in CPT coding continue to create financial uncertainty, especially for independent and smaller labs.

  • Workforce Shortages: A limited supply of qualified laboratory professionals, particularly in rural and high-demand regions, is straining lab operations and affecting turnaround times.

  • Regulatory Complexity: Navigating federal (CLIA, HIPAA) and state-specific regulations poses compliance challenges, especially as testing services diversify into areas like genetic testing and direct-to-consumer diagnostics.

• Opportunities:

  • Growth in Precision Medicine: Rising demand for personalized diagnostics is driving investment in molecular testing, genetic profiling, and companion diagnostics, opening new service avenues for laboratories.

  • Digital Transformation: Adoption of automation, AI-driven analysis, and integrated lab information systems is enhancing efficiency, accuracy, and scalability across service lines.

  • Expansion Beyond Hospital Settings: Increasing use of stand-alone labs, retail-based testing, and home collection services is broadening access and creating new revenue streams outside traditional care settings.

Market Concentration & Characteristics

The U.S. clinical laboratory service market is marked by continuous innovation across core segments such as genetic testing, clinical chemistry, and bioanalytical services. Advancements in automation, next-generation sequencing, and AI-driven diagnostics are enhancing accuracy and efficiency. Emerging areas like cell & gene therapy-related services, toxicology testing, and drug development support are also benefiting from improved assay sensitivity and digital integration. These innovations are expanding the clinical value of laboratory services and aligning them more closely with precision medicine goals.

Mergers and acquisitions in the U.S. clinical laboratory service market are active, with a focus on consolidation, service diversification, and geographic expansion. Larger entities are acquiring regional and specialized labs to strengthen capabilities in genetic testing, toxicology, and bioanalytical services. Strategic acquisitions are also targeting emerging areas such as cell & gene therapy-related diagnostics and clinical trial support. While the market remains competitive, M&A activity is largely driven by the need to scale operations, expand service portfolios, and improve access to advanced diagnostic technologies.

Regulatory oversight is a foundational aspect of the U.S. clinical laboratory service market, primarily guided by frameworks such as the Clinical Laboratory Improvement Amendments (CLIA) and enforced by the Centers for Medicare & Medicaid Services (CMS). These standards govern lab quality, personnel qualifications, and testing accuracy across all service categories. Additional certification from bodies like the College of American Pathologists (CAP) enhances compliance and credibility. Evolving policies under the Protecting Access to Medicare Act (PAMA) impact reimbursement rates, especially for genetic testing and clinical chemistry services. While regulations promote reliability and patient safety, ongoing changes in coding, pricing, and reporting requirements can present operational challenges for both large and mid-sized labs.

The U.S. clinical laboratory service market is experiencing steady service expansion across specialized and high demand testing areas. Laboratories are broadening offerings in genetic testing, toxicology, and bioanalytical services to meet evolving clinical needs. Services related to cell & gene therapy, preclinical trials, and drug development are also being integrated to support personalized medicine and biopharma research. In addition, labs are incorporating comprehensive panels, multiplex assays, and companion diagnostics to address complex disease profiles. This expansion enhances clinical utility and allows providers to serve a wider range of patient populations and research applications.

Regional expansion in the U.S. clinical laboratory service market is focused on increasing access in underserved and rural areas through satellite labs, mobile units, and digital platforms. While urban centers continue to offer advanced services in genetic testing, clinical chemistry, and molecular diagnostics, smaller markets are seeing investments aimed at decentralizing testing capabilities. Collaborations with regional healthcare systems and retail clinics are also supporting a broader service reach. These efforts help reduce geographic disparities in diagnostic access and support more timely and localized care delivery across the country.

Test Type Insights

The clinical chemistry segment dominated the U.S. clinical laboratory service market with the largest revenue share of 44.82% in 2024. This leadership is driven by the segment’s foundational role in routine diagnostics, covering a wide range of tests such as blood glucose, lipid panels, liver enzymes, and kidney function. The high testing volume, supported by chronic disease management and regular health screenings, continues to sustain demand. In addition, advancements in automated analyzers and integration with laboratory information systems have enhanced workflow efficiency and result accuracy, reinforcing the segment’s prominence across hospital labs, independent facilities, and physician offices.

The cytology testing segment is projected to grow at the fastest rate over the forecast period. This growth is supported by the rising need for early detection of cancers and other cellular abnormalities, particularly in cervical, lung, and thyroid cancer screening. The adoption of liquid-based cytology and automated screening technologies has improved diagnostic accuracy and efficiency, making cytology testing a critical component of preventive care. In addition, increasing awareness of routine screening and expanded insurance coverage are driving higher test volumes, supporting a strong outlook for segment growth.

Application Insights

The bioanalytical & lab chemistry services segment dominated the U.S. clinical laboratory service market with a revenue share of 41.63% in 2024. These laboratories apply advanced techniques such as ELISA, chromatography, immunochemistry, mass spectrometry, and molecular biology to meet complex diagnostic and research needs. Bioanalytical services play a critical role in drug discovery and development by quantifying drugs, metabolites, and biomarkers with high sensitivity and specificity. The segment’s leading position is reinforced by rising demand for pharmacokinetic and toxicological assessments in clinical trials and ongoing collaborations with pharmaceutical and biotechnology firms seeking reliable laboratory support for regulated studies.

The toxicology testing services segment is expected to register the highest CAGR over the forecast period. These services play a critical role in identifying and monitoring the presence of drugs, chemicals, and other toxic substances in biological samples such as urine, blood, hair, and saliva. Toxicology testing supports clinical decision-making by confirming diagnoses, guiding treatment plans, and detecting substance exposure in both acute and chronic care settings. Market growth is being supported by strategic moves from key players. For example, in January 2023, Aegis Sciences Corporation acquired HealthTrackRx’s toxicology business unit, enhancing its clinical toxicology offerings.

Service Provider Insights

The hospital-based laboratories segment held the largest revenue share in 2024, driven by high-volume testing for complex, acute, and inpatient conditions. These labs benefit from integrated systems within hospital settings, enabling rapid diagnostics and streamlined clinical workflows. A prime example is Intermountain Health’s Central Laboratory in Utah, which nearly doubled its capacity in May 2024, from 40,542 sq ft to 85,728 sq ft, and processed over 15 million tests annually.

The expansion added specialty testing previously sent out of state, such as organ donation compatibility assays, significantly cutting costs and turnaround time. In addition, White Plains Hospital in New York opened a new lab in March 2023 featuring automated Atellica platforms and point-of-care analyzers, which enhanced throughput, reduced manual interventions, and supported over 4 million tests annually. These investments illustrate hospitals’ commitment to in-house diagnostic capabilities to improve patient outcomes and operational efficiency.

The stand-alone laboratories segment is expected to grow fastest over the forecast period. This growth is driven by increasing demand for accessible, high-throughput diagnostic services outside traditional hospital settings. Stand-alone labs offer the ability to process large volumes of tests quickly and cost-effectively, which appeals to healthcare providers and patients.

Their presence at the retail and community level enhances convenience and supports faster turnaround times. Since the COVID-19 pandemic, the segment has gained momentum, with several emerging players expanding footprints and offering specialized services such as molecular diagnostics and genetic testing. These developments are expected to sustain the segment’s strong growth trajectory.

Key U.S. Clinical Laboratory Services Company Insights

Some key players operating in the market are Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, QIAGEN NV, Eurofins Scientific SE, Siemens Medical Solutions USA, Inc., and NeoGenomics Laboratories. These key players adopt various strategies to compete with their peers and drive growth. Companies are involved in expanding their market presence by entering into partnerships, collaborations and agreements with other players to expand their product portfolio and geographic reach.

OPKO Health, Inc., ARUP Laboratories,and Sonic Healthcare are some emerging market participants in the U.S. Clinical laboratory services market. Emerging companies are employing various strategies to expand their footprint and grow at a fast pace. Customer acquisition strategies are being adopted by partnering with hospitals and clinics. 

Recent Developments

• In February 2025, Labcorp unveiled a major 110,000 sq. ft. laboratory expansion in Raritan, New Jersey, which will support increased capacity for diagnostic testing and scientific innovation, including pathology and genomic testing.

• In April 2024, Labcorp expanded its molecular bioanalytical laboratory in Greenfield, Indiana, to support accelerated development of cell and gene therapies, enhancing its capabilities in bioanalytical and molecular testing.

• In February 2024, Quest launched a comprehensive 88-compound test panel for detecting novel psychoactive substances (NPS), including synthetic cannabinoids and designer drugs, to support clinical toxicology and forensic investigations.

U.S. Clinical Laboratory Services Market Report Scope

U.S. Clinical Laboratory Services Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the U.S. clinical laboratory services market report based on test type,application, and service provider:

• Test Type Outlook (Revenue in USD Million, 2021 - 2033)

  • Genetic Testing

  • Clinical Chemistry

    • Routine Chemistry Testing

    • Therapeutic Drug Monitoring Testing

    • Endocrinology Chemistry Testing

    • Specialized Chemistry Testing

    • Other Clinical Chemistry Testing

  • Medical Microbiology Testing

    • Infectious Disease Testing

    • Transplant Diagnostic Testing

    • Other Microbiology Testing

  • Hematology Testing

  • Immunology Testing

  • Cytology Testing

  • Drug of Abuse Testing

  • Other Esoteric Tests

• Service Provider Outlook (Revenue in USD Million, 2021 - 2033)

  • Hospital-Based Laboratories

  • Stand-Alone Laboratories

  • Clinic-Based Laboratories

• Application Outlook (Revenue in USD Million, 2021 - 2033)

  • Bioanalytical & Lab Chemistry Services

  • Toxicology Testing Services

  • Cell & Gene Therapy Related Services

  • Preclinical & Clinical Trial Related Services

  • Drug Discovery & Development Related Services

  • Other Clinical Laboratory Services