Clinical Laboratory Tests Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Clinical Laboratory Tests Market is projected to expand from USD 127.24 Billion in 2025 to USD 214.45 Billion by 2031, registering a CAGR of 9.09%. These specialized medical assessments involve the analysis of biological specimens, such as urine, blood, and tissue, to identify, diagnose, and track disease progression. Market growth is primarily fueled by the increasing global prevalence of chronic disorders, such as diabetes and cardiovascular conditions, which require frequent and precise monitoring. Additionally, the growing geriatric population drives demand for diagnostic services, as older adults typically necessitate more intensive healthcare management. These demographic and epidemiological factors establish a solid foundation for testing volumes, ensuring sustained growth independent of specific technological trends.

However, a significant obstacle to market expansion is the acute shortage of qualified laboratory professionals, which restricts operational scalability and testing capacity. This workforce gap creates bottlenecks that hinder the ability of laboratories to efficiently process rising sample volumes. Data from the American Society for Clinical Pathology indicates that in 2025, the vacancy rate for anatomic pathology departments stood at 28.5 percent. Such staffing deficiencies threaten to delay diagnostic results and impede the broader growth of the global clinical laboratory tests market by limiting the availability of essential services.

Market Drivers

Technological progress in diagnostic automation and the integration of artificial intelligence is refining workflow efficiency and diagnostic accuracy. Laboratories are increasingly adopting AI to manage complex biological data and automate routine tasks, a crucial step for handling higher testing volumes with less manual intervention. This technological momentum is reflected in the regulatory landscape; the U.S. Food and Drug Administration reported in August 2024 that 950 AI/ML-enabled medical devices had been authorized. These innovations help alleviate workforce shortages while enabling the deployment of sophisticated diagnostic algorithms, ensuring labs can meet modern throughput demands.

The proliferation of private and independent clinical laboratory networks is further driving growth through strategic consolidation. Major commercial diagnostic entities are acquiring hospital outreach programs and smaller regional labs to centralize testing operations and optimize supply chain costs. This trend toward large-scale network expansion involves significant capital investment; for instance, Quest Diagnostics announced in a July 2024 press release a definitive agreement to acquire the Canadian provider LifeLabs for approximately CAN $1.35 billion. Such consolidation ensures the continued scalability of the global market, sustaining substantial revenue volumes, as evidenced by Roche’s Diagnostics Division reporting half-year sales of CHF 7.2 billion in 2024.

Market Challenges

The severe shortage of qualified laboratory professionals places a hard ceiling on operational capacity, significantly hampering the Global Clinical Laboratory Tests Market. While the prevalence of chronic diseases drives up demand for diagnostic testing, laboratories cannot scale their services without sufficient certified personnel to validate results and manage complex workflows. Although automation enhances efficiency, it does not eliminate the need for skilled oversight during pre-analytical and post-analytical phases. Consequently, workforce deficits directly result in processing bottlenecks and extended turnaround times, which restricts the overall volume of monetizable tests and erodes potential revenue gains from rising market demand.

This operational strain is intensified by a shrinking workforce demographic that threatens the long-term sustainability of testing services. As experienced personnel leave the field, the capacity to train new recruits and maintain service continuity diminishes. According to the American Society for Clinical Pathology in 2025, 10 out of 17 laboratory departments reported rising retirement rates compared to previous cycles. This trend of accelerating retirements without adequate replacement deepens the staffing crisis, ensuring that service availability remains a primary constraint on market expansion.

Market Trends

The increasing utilization of at-home self-collection and sampling kits is fundamentally transforming patient access by decentralizing diagnostic workflows and empowering consumers to proactively manage their health. This trend shifts routine screening away from traditional phlebotomy centers, allowing patients to perform non-invasive sample collection for conditions ranging from wellness markers to chronic disease monitoring in private settings. Diagnostic providers are aggressively capitalizing on this shift by expanding their direct-to-consumer portfolios to include high-demand assays, creating new revenue channels that bypass traditional physician referrals. For example, Quest Diagnostics reported full-year revenues of $9.87 billion in its January 2025 financial results, a performance supported by the strategic expansion of its consumer-initiated test platform to include approximately 135 distinct health and wellness tests.

Concurrently, the growth of personalized medicine and companion diagnostics is altering laboratory service menus as providers integrate advanced genomic and molecular testing to guide targeted therapeutic interventions. Pharmaceutical and diagnostic developers are synchronizing their pipelines to ensure specific biomarkers can be identified to match patients with oncology and immunology treatments, thereby making high-complexity assays a standard component of clinical care. This synergy between therapeutic development and diagnostic precision sustains revenue streams for major industry players even as pandemic-related testing volumes decline. As reported in its 2024 full-year results released in January 2025, Roche’s Diagnostics Division generated sales of CHF 14.3 billion, with the base business growing 8% largely due to strong demand for immunodiagnostic and molecular solutions supporting advanced clinical decision-making.

Key Players Profiled in the Clinical Laboratory Tests Market

• Quest Diagnostics Incorporated
• Abbott Laboratories Inc.
• Cinven Group
• Laboratory Corporation of America Holdings
• Arup Laboratories Inc.
• Opko Health, Inc.
• Unilabs Diagnostics AB
• Clinical Reference Laboratory, Inc.
• Synnovis Group Llp
• Sonic Healthcare Limited

Report Scope

In this report, the Global Clinical Laboratory Tests Market has been segmented into the following categories:

Clinical Laboratory Tests Market, by Type:

• Complete Blood Count
• HGB/HCT Testing
• Basic Metabolic Panel Testing
• BUN Creatinine Testing
• Electrolytes Testing
• HbA1c Testing
• Comprehensive Metabolic Panel Testing
• Liver Panel Testing
• Lipid Panel Testing
• Renal Panel Testing
• Cardiovascular Panel Tests

Clinical Laboratory Tests Market, by End User:

• Central Laboratories
• Primary Clinics

Clinical Laboratory Tests Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Clinical Laboratory Tests Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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