Clinical Reference Laboratory Service Market Report 2025

The clinical reference laboratory service market size has grown strongly in recent years. It will grow from $17.28 billion in 2024 to $18.98 billion in 2025 at a compound annual growth rate (CAGR) of 9.9%. The growth in the historic period can be attributed to rising demand for diagnostic testing, increasing prevalence of chronic diseases, growing adoption of personalized medicine, heightened awareness of health and wellness, and the expanding trend of outsourcing diagnostic services.

The clinical reference laboratory service market size is expected to see strong growth in the next few years. It will grow to $27.32 billion in 2029 at a compound annual growth rate (CAGR) of 9.5%. The growth in the forecast period can be attributed to the rising prevalence of infectious diseases, increasing adoption of point-of-care testing, expanding preventive healthcare initiatives, growth in telemedicine and home-based testing, and higher demand for genomic testing. Major trends during this period include advancements in laboratory testing technologies, innovations in molecular diagnostics, integration of artificial intelligence in laboratory workflows, development of novel diagnostic tools, and progress in next-generation sequencing technologies.

The increasing demand for personalized medicine is expected to propel the growth of the clinical reference laboratory service market going forward. Personalized medicine is a healthcare approach that tailors treatments based on an individual’s genetic profile, lifestyle, and environmental factors, ensuring more precise and effective care. The rise in personalized medicine is driven by the growing preference for treatments customized to patients’ unique biological characteristics. Clinical reference laboratory services facilitate personalized medicine by providing precise genetic testing, pharmacogenomic analysis, and other specialized diagnostics that guide individualized treatment strategies. For instance, in February 2023, the Personalized Medicine Coalition, a US-based professional membership organization, reported that 12 new personalized medicines approved in 2022 accounted for approximately 34% of all newly approved therapies, reflecting a substantial increase from prior years. Therefore, the growing demand for personalized medicine is driving the expansion of the clinical reference laboratory service market.

Key companies in the market are focusing on innovations in laboratory automation, such as fully automated next-generation reference labs, to enhance accuracy, efficiency, and turnaround time. Next-generation laboratory automation integrates robotics, artificial intelligence (AI), machine learning, and data analytics to streamline laboratory workflows and improve operational performance. For example, in May 2025, Apollo Diagnostics, an India-based diagnostic service provider, launched the fully automated Digi-Smart central reference laboratory in Chennai. Spanning 45,000 square feet, the facility reduces sample turnaround time by 60% and incorporates AI-powered diagnostic tools, real-time data tracking, and end-to-end digital workflow management. It also supports high-throughput testing with minimal human intervention while maintaining stringent quality standards.

In April 2024, Eurofins Scientific SE, a Luxembourg-based testing laboratory company, acquired Ascend Clinical LLC, a US-based clinical reference laboratory, to expand its U.S. renal and transplant diagnostics services. This acquisition strengthens Eurofins’ presence in the renal and transplant diagnostics market by integrating Ascend Clinical’s highly automated laboratory services for kidney dialysis and related testing.

Major players in the clinical reference laboratory service market are Laboratory Corporation of America Holdings, Mayo Clinic Laboratories, Quest Diagnostics Incorporated, Eurofins Scientific S.E., Sonic Healthcare Limited, Charles River Laboratories International Inc., Acıbadem Healthcare Group, SYNLAB International GmbH, OPKO Health Inc., Unilabs AB, LifeLabs Medical Laboratory Services, ARUP Laboratories, Dr. Lal PathLabs Limited, PathGroup Inc., Clinical Reference Laboratory Inc., ACCU Reference Medical Lab LLC, ACM Global Laboratories, Genova Diagnostics Inc., Cerba HealthCare Group, and MedLabs Diagnostics.

North America was the largest region in the clinical reference laboratory service market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in clinical reference laboratory service market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the clinical reference laboratory service market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Clinical reference laboratory services refer to specialized laboratory services that provide diagnostic testing and analytical support to healthcare providers, hospitals, clinics, and other laboratories. These services are typically offered by large, centralized laboratories that perform high-complexity and specialty tests often unavailable in smaller or on-site hospital labs.

The primary types of clinical reference laboratory services include clinical chemistry, hematology, microbiology, cytology, genetic testing, and others. Clinical chemistry involves analyzing bodily fluids, primarily blood and urine, to diagnose and monitor diseases. Various sample types, such as blood, urine, tissue, and saliva, are processed using technologies like laboratory information systems (LIS), automated lab equipment, and point-of-care testing. Applications span disease diagnosis, drug development, and precision medicine, serving end users including hospitals, diagnostic laboratories, academic institutions, and pharmaceutical companies.

The clinical reference laboratory service market research report is one of a series of new reports that provides clinical reference laboratory service market statistics, including clinical reference laboratory service industry global market size, regional shares, competitors with a clinical reference laboratory service market share, clinical reference laboratory service market segments, market trends and opportunities, and any further data you may need to thrive in the clinical reference laboratory service industry. This clinical reference laboratory service market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The clinical reference laboratory service market consists of revenues earned by entities by providing services such as routine clinical testing, microbiology and infectious disease testing, molecular diagnostics, immunology and serology, and toxicology and drug testing. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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