미국 임상 검사 서비스 시장의 성장 기회와 예측(-2030년)

Fueled by Specialty Testing Expansion, Digital Workflow Innovation, and Value-Based Healthcare Demands

The clinical laboratory testing industry will continue to experience growth in testing volumes due to the aging of the US population, patient awareness of the benefits of laboratory testing, test cost reductions, the development of advanced and specialized tests for disease detection and management, the growing awareness of early detection and prevention as a way to lower healthcare costs, and continued research and development in genetics, genomics, and personalized medicine.

The United States spends approximately 18% of its GDP on healthcare. Healthcare value chain participants face dynamic environments that several trends impact, including the rise in the aging population, chronic disease burden, regulatory challenges, integration across the care continuum, migration to value-based and accountable care models, payer and provider consolidation, new and increased access to data, innovation, and technology, and increasing levels of consumer engagement and expectations.

As a result of post-pandemic test normalization, increased outpatient volume, and the integration of advanced molecular and genomic assays into routine care, growth momentum continues to accelerate through 2024 and 2025. From 2026 onward, growth moderates toward 4 to 5%, in line with the updated forecast trajectory, as the industry settles around payer-driven usage restrictions and high-throughput efficiency. Although the Protecting Access to Medicare Act (PAMA) continues to exert price pressure, payer reimbursements are increasingly linked to clinical utility and test value. To preserve profits, this forces labs-especially those affiliated with hospitals and mid-tier regional players-to focus on operational scalability, test menu optimization, and digital workflow efficiency to run profitably.

Report Summary: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market was valued at USD 130.88 billion in 2024 and is projected to reach USD 175.13 billion by 2030, growing at a CAGR of 5.0% from 2024 to 2030. Market growth is driven by rising test volumes associated with an aging population, increasing prevalence of chronic diseases, and the expanding role of laboratory diagnostics in preventive and value-based care models.

Key Market Trends & Insights

• Independent and reference laboratories account for a significant share of testing volumes in the clinical laboratory services market, supported by national logistics networks and broad test menus.
• In the US Clinical Laboratory Services Market, demand for molecular diagnostics, oncology testing, and genetic assays is increasing alongside routine diagnostic testing.
• Automation, LIS-EHR integration, and AI-enabled workflow optimization are improving turnaround times and operational efficiency across large and mid-sized laboratories.
• The US Clinical Laboratory Service Market is experiencing continued consolidation as large national laboratories expand through acquisitions and hospital outreach partnerships.
• Retail clinics, mobile diagnostics, and home-based sample collection models are expanding patient access and convenience, supporting incremental test utilization.

Market Size & Forecast

• 2024 Market Size: USD 130.88 Billion
• 2030 Projected Market Size: USD 175.13 Billion
• CAGR (2024-2030): 5.0%
• United States: Single-country market with nationwide laboratory coverage

The continued reliance of the U.S. healthcare system on diagnostic testing, combined with technology adoption and service model innovation, is expected to support sustained growth in the U.S. Medical and Diagnostic Laboratory Services Market through the forecast period.

Market Overview & Trends: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market underpins nearly every clinical decision across the healthcare continuum. Laboratory testing supports screening, diagnosis, therapy selection, and disease monitoring, making the clinical laboratory services market indispensable to modern medicine. Demand continues to rise due to population aging, increasing chronic disease burden, and expanded utilization of diagnostic testing in value-based care models.

A major structural trend shaping the US Clinical Laboratory Services Market is the shift toward specialized and high-complexity testing. Molecular diagnostics, genomics, oncology assays, and companion diagnostics are increasingly used to guide personalized treatment strategies. While routine testing continues to provide volume stability, specialty diagnostics are driving incremental growth and clinical relevance.

Automation and digitalization are transforming laboratory operations. Advanced robotics, laboratory information systems (LIS), and artificial intelligence-enabled workflow tools are improving turnaround times and reducing labor dependency. These investments are particularly critical as workforce shortages persist across the U.S. Medical and Diagnostic Laboratory Services Market.

Another important trend is the centralization of testing. Independent and reference laboratories are capturing a growing share of outsourced testing volumes due to economies of scale and broad test menus. Consolidation enables cost efficiency but also intensifies competition within the US Clinical Laboratory Service Market.

Consumerization of healthcare is also influencing demand. Retail clinics, mobile diagnostics, and home-based sample collection are expanding access to routine testing and preventive care. These models complement traditional hospital-based services and reshape patient engagement across the clinical laboratory services market.

Overall, the market is evolving toward a more automated, data-driven, and patient-centric diagnostic ecosystem.

Scope of Analysis: U.S. Medical and Diagnostic Laboratory Services Market

This analysis examines the U.S. Medical and Diagnostic Laboratory Services Market, focusing on laboratory-based testing services delivered within the United States. The study evaluates diagnostic testing performed on blood, tissue, urine, and other biological specimens to support clinical decision-making across preventive, diagnostic, and therapeutic applications.

The scope includes hospital-based laboratories, independent and reference laboratories, physician office laboratories, and emerging retail and home-testing models. Both routine and specialized testing services are covered within the US Clinical Laboratory Services Market, while laboratory equipment manufacturing and reagent sales are excluded.

The study period spans recent historical years through 2030, with 2024 as the base year and 2030 as the forecast endpoint. Market sizing and forecasts are presented in U.S. dollars.

Methodologically, the analysis integrates secondary research, healthcare utilization data, regulatory review, and expert insights. Market forecasts reflect testing volume trends, reimbursement dynamics, and structural changes across the clinical laboratory services market. Segmentation-level revenue estimates are intentionally excluded to maintain analytical consistency.

Market Segmentation Analysis: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market is segmented by service provider type and testing service category, reflecting the diverse operational models and clinical roles within the broader clinical laboratory services market.

Segmentation by Service Providers

By provider type, the US Clinical Laboratory Services Market comprises hospital-based laboratories, physician-owned laboratories (POLs), independent and reference laboratories, specialized laboratories, and other laboratory settings.

Hospital-based laboratories perform the highest volume of tests and are directly integrated into hospital systems, supporting inpatient care, emergency diagnostics, and complex clinical workflows. These laboratories are typically attached to large healthcare institutions and academic medical centers, enabling rapid turnaround times and close coordination with clinical teams.

Physician-owned laboratories (POLs) operate within physician offices and specialty practices such as urology, gynecology, and endocrinology. POLs represent the most common laboratory type by number, although they account for less than 10% of total test volumes. These facilities focus on low-volume, routine, and point-of-care tests that deliver immediate results. Larger POL networks often forward samples to centralized laboratories for advanced testing.

Independent, reference, and specialized laboratories operate across wide geographic regions and manage multiple laboratory facilities. Reference laboratories provide comprehensive test menus and handle high-throughput volumes, while specialized laboratories focus on advanced diagnostics such as oncology, genetics, and molecular testing. These providers play a central role in the US Clinical Laboratory Service Market, supporting outsourced testing for hospitals and POLs.

Other laboratories include retail clinics, mobile diagnostic centers, nursing homes, and home health agencies. These settings primarily support routine and preventive testing. Many services in this category are paid out-of-pocket and are not fully reimbursed under Medicare, contributing modestly to overall healthcare revenue.

Segmentation by Testing Services

By service type, the clinical laboratory services market is divided into routine testing services and specialized testing services.

Routine testing services include commonly performed diagnostic procedures such as blood chemistry panels, complete blood counts, and urine analysis. These tests form the backbone of diagnostic volume across the U.S. Medical and Diagnostic Laboratory Services Market.

Specialized testing services encompass high-end diagnostics such as cytogenetics, molecular diagnostics, next-generation sequencing (NGS), and whole-exome sequencing (WES). Semi-specialized services, including coagulation studies, autoimmune testing, and cancer biomarker assays, also fall within this segment. Growth in specialized testing reflects increasing demand for precision medicine and advanced clinical decision support.

Revenue & Spending Forecast: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market continues to evolve as automation, consolidation, and the shift toward value-based care reshape industry economics. According to the revenue forecast, the market generated USD 130.88 billion in 2024 and is projected to reach USD 175.13 billion by 2030, reflecting a compound annual growth rate (CAGR) of 5.0% during 2024-2030. This steady expansion underscores the essential role of laboratory testing in clinical decision-making across the U.S. healthcare system.

Revenue growth in the US Clinical Laboratory Services Market is supported by rising test volumes driven by an aging population, increasing prevalence of chronic diseases, and expanded utilization of diagnostic testing in preventive and longitudinal care. At the same time, the market is undergoing structural change as laboratories adapt to margin pressures resulting from PAMA-driven reimbursement reductions, rising labor costs, and tighter regulatory oversight of laboratory-developed tests (LDTs).

Large national and hospital-affiliated laboratories are increasingly expanding through mergers, digital integration, and AI-enabled process automation to improve operational efficiency and scale. Investments in automation, LIS-EHR integration, and advanced analytics are enabling providers to manage higher volumes while controlling costs. Additionally, new access channels-such as home-based diagnostics and consumer-oriented testing-are contributing to incremental revenue growth.

Overall, while the clinical laboratory services market remains high-volume in nature, revenue expansion is increasingly linked to payer alignment, operational scale, and technology adoption, positioning the US Clinical Laboratory Service Market for sustained growth through the end of the forecast period.

Growth Drivers: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market is supported by multiple structural growth drivers that are expected to sustain demand through the forecast period. One of the most significant drivers is the rapid expansion of clinical informatics and healthcare data generation across early-stage research, clinical development, and commercial diagnostics. Growing data volumes are increasing the value of integrated diagnostics, predictive analytics, decision-support tools, and companion diagnostics (CDx), strengthening the role of laboratories in drug development and clinical trials.

Technology adoption within the clinical laboratory services market is accelerating as physician-owned laboratories (POLs) expand point-of-care testing (POCT) capabilities. At the same time, rising consumer interest in health IT solutions-such as telemedicine platforms, mobile health applications, and connected diagnostic devices-is driving demand for convenient, faster, and cost-effective testing services.

Another major growth driver is the continued expansion of next-generation sequencing (NGS)-based panels across infectious disease, oncology, and genetic testing. Improvements in payer coverage and declining test costs are enabling broader adoption of molecular pathology services at double-digit growth rates.

Operational investments are also reshaping the US Clinical Laboratory Services Market. Increased spending on robotics, LIS-EHR integration, and AI-driven automation is improving laboratory throughput while reducing turnaround times and workforce dependency. End-to-end digital workflows are becoming a priority for both hospital-based and reference laboratories.

Finally, ongoing reimbursement pressure under PAMA and bundled payment models is pushing laboratories toward higher-value, outcome-based service models. Industry consolidation and vertical integration, combined with the growth of at-home phlebotomy, mobile diagnostics, and retail testing partnerships, are further expanding access and driving sustained growth across the US Clinical Laboratory Service Market.

Growth Restraints: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market faces several structural restraints that may moderate growth through the forecast period. One of the most significant challenges is the implementation of the FDA's Final Rule on Laboratory Developed Tests (LDTs) in 2024. The regulation has increased compliance, validation, and documentation costs, disproportionately impacting small and specialized laboratories. While large reference laboratories may gain a relative advantage, academic and hospital-based labs face longer innovation cycles and delayed test adoption.

Workforce constraints remain a persistent restraint across the clinical laboratory services market. The United States continues to experience a shortage of qualified medical technologists due to underfunded training programs, high retirement rates, and limited new workforce entry. Rising burnout, overtime expenses, and staffing costs are restricting growth, particularly for hospital-based laboratories. Although automation and outsourcing provide partial relief, they do not fully offset labor shortages.

Capital intensity represents another key challenge. Clinical laboratories must continuously invest in analyzers, automation platforms, and IT infrastructure. Smaller and mid-tier laboratories face low margins, extended return-on-investment periods, and limited access to funding, pressures that are amplified by inflation and declining reimbursement rates.

In addition, slow adoption of advanced analytics and automation persists despite mandatory EHR integration. Interoperability issues, fragmented middleware systems, data silos, and cybersecurity risks continue to limit operational efficiency. The absence of standardized test ordering and data exchange protocols further increases administrative burdens, leading to billing delays, claim rejections, and compliance penalties across multi-payer and multi-state laboratory networks.

Competitive Environment: U.S. Medical and Diagnostic Laboratory Services Market

The U.S. Medical and Diagnostic Laboratory Services Market is characterized by a highly fragmented yet consolidating competitive environment, comprising approximately 1,500 CLIA-certified laboratories nationwide. These include regional and national independent laboratories, hospital outreach programs, reference laboratories, and specialty testing providers. Competition within the US Clinical Laboratory Services Market is driven by scale, regulatory compliance, service breadth, and operational efficiency.

Key competitive factors shaping differentiation across the clinical laboratory services market include compliance with CLIA and CAP standards, payer reimbursement rates, test accuracy, turnaround time, cost effectiveness, and the breadth of test menus. Integration with electronic health record (EHR) systems and the ability to realize consolidation synergies through acquisitions also play a critical role in competitive positioning, particularly for large national providers.

End-user verticals span hospital-based laboratories, physician-owned laboratories (POLs), independent and reference laboratories, and specialized testing providers. Additional demand is generated by retail clinics, mobile diagnostic centers, nursing homes, and home health agencies, all of which are increasingly integrated into care delivery models across the US Clinical Laboratory Service Market.

The competitive landscape is led by large national and specialty players, including Labcorp, Quest Diagnostics, Exact Sciences, Natera, Sonic Healthcare USA, Myriad Genetics, Guardant Health, Mayo Clinic Laboratories, and ARUP Laboratories. Collectively, the top five independent reference laboratories (IRLs) accounted for an estimated 46.3% of total U.S. clinical laboratory services revenue in 2024, highlighting increasing concentration at the top end of the market.

Other notable participants include BioReference Laboratories, Northwell Health Labs, PathGroup, Aegis Sciences, as well as academic hospital networks such as Cleveland Clinic and Johns Hopkins.

Distribution across the U.S. Medical and Diagnostic Laboratory Services Market combines hospital-based networks, centralized reference laboratories, and expanding courier and digital logistics infrastructure for specimen collection. In 2024, Quest Diagnostics acquired select laboratory assets from Allina Health, enhancing access to laboratory services across Minnesota and western Wisconsin and underscoring ongoing consolidation trends within the market.

Table of Contents

Growth Opportunities: Research Scope

• Scope of Analysis
• Segmentation
• The Role of Clinical Laboratory Services in Healthcare
• Holistic Business Model-Laboratories as 1-Stop-Shop Service Providers
• Innovations Enhancing Clinical Laboratory Services

Growth Environment: Transformation in United States Clinical Laboratory Services Industry

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the United States Clinical Laboratory Services Industry

Ecosystem in United States Clinical Laboratory Services Industry

• Competitive Environment

Growth Generator in United States Clinical Laboratory Services Industry

• Growth Metrics
• Growth Drivers
• Growth Restraints
• Forecast Considerations
• Revenue Forecast
• Revenue Forecast Analysis
• Revenue Forecast by Service Providers
• Revenue Forecast Analysis by Service Providers
• Revenue Forecast by Services
• Revenue Forecast Analysis by Services
• US Clinical Laboratory Services Pricing Analysis
• US Clinical Laboratory Services Pricing Analysis by Application, 2024
• US Breakdown of Application Shares in Laboratory Services
• United States Key Regulatory and Reimbursement Environment Developments 2020-2025
• United States Regulatory Landscape Analysis-2024 Onwards
• US Health Insurance Landscape-2024 Overview
• Medicare and Medicaid Spending on Hospital Care
• Revenue Share
• Revenue Share Analysis-Competitor
• Revenue Share by Type of Payer in IRLs
• Competitive Landscape, Top Players Offering Parameters
• Notable Activities

Growth Opportunity Universe in United States Clinical Laboratory Services

• Growth Opportunity 1: Specialized and Advanced Testing Beyond Acute and Oncology Testing
• Growth Opportunity 2: Decentralized and Home-Based Diagnostics Ecosystem for Enhanced Access and Speed
• Growth Opportunity 3: AI-Driven Digital Pathology and Workflow Automation for High-Volume Diagnostics

Appendix & Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• List of Exhibits
• Legal Disclaimer