PUBLISHER: The Business Research Company | PRODUCT CODE: 1829951
PUBLISHER: The Business Research Company | PRODUCT CODE: 1829951
A clinical reference laboratory is a specialized facility that conducts high-complexity diagnostic testing and analysis on biological samples, including blood, urine, and tissue. These labs provide advanced testing services such as molecular diagnostics, toxicology, immunology, and pathology. They are equipped with cutting-edge technology and follow strict regulatory standards to ensure the accuracy, reliability, and compliance of their results with healthcare regulations.
The main types of clinical reference laboratories include clinical chemistry, genetics testing, microbiology, cytology, and others. Clinical chemistry, a branch of clinical pathology, focuses on the quantitative analysis of bodily fluids such as blood and urine to determine the concentration of various chemical substances. This field employs a range of technologies, from traditional laboratory methods to digital technologies, automated testing platforms, and molecular diagnostics, and is utilized by clinics, hospitals, and independent labs.
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 sharp increase in U.S. tariffs and resulting trade tensions in spring 2025 are significantly impacting the medical equipment sector, especially for imported components used in imaging machines, surgical-grade stainless steel, and disposable plastics. With hospitals and clinics pushing back against price increases, manufacturers are facing margin pressure. The situation is further complicated by regulatory challenges, as switching suppliers due to tariffs often necessitates re-certification of medical devices, leading to delays in market entry. In response, companies are mitigating risks by dual-sourcing key components, ramping up domestic production of standardized items, and accelerating research into more cost-effective materials.
The clinical reference laboratory market research report is one of a series of new reports from The Business Research Company that provides clinical reference laboratory market statistics, including clinical reference laboratory industry global market size, regional shares, competitors with a clinical reference laboratory market share, detailed clinical reference laboratory market segments, market trends and opportunities, and any further data you may need to thrive in the clinical reference laboratory industry. This clinical reference laboratory 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 market size has grown strongly in recent years. It will grow from $43.94 billion in 2024 to $47 billion in 2025 at a compound annual growth rate (CAGR) of 7.0%. The growth in the historic period can be attributed to increasing prevalence of chronic diseases, increasing value-based outsourcing from hospitals, growing number of bio reference laboratories, increasing adoption of point-of-care testing, and emergence of various infectious diseases.
The clinical reference laboratory market size is expected to see strong growth in the next few years. It will grow to $61.05 billion in 2029 at a compound annual growth rate (CAGR) of 6.8%. The growth in the forecast period can be attributed to increasing focus on molecular biology, increasing number of clinical trials, increasing development in microbiology, rising popularity for preventive medicine, and increasing awareness on using test kits. Major trends in the forecast period include technological advancements, use of artificial intelligence, advanced automation technology in reference laboratories, use of personalized medicine, and automation and artificial intelligence integration.
The forecast of 6.8% growth over the next five years indicates a slight reduction of 0.2% from the previous estimate for this market.This reduction is primarily due to the impact of tariffs between the US and other countries. This is likely to directly affect the US through tariffs on quality control sera and automated specimen sorting systems, sourced from key regions such as France and Canada, which could lead to compromised test accuracy and higher laboratory operational expenses.The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The growing demand for diagnostic testing is expected to drive the expansion of the clinical reference laboratory market in the future. Diagnostic testing involves analyzing biological samples to detect, diagnose, and monitor diseases, medical conditions, or infections. This surge in demand for diagnostic testing is largely due to advancements in medical technology, which have made tests more accessible, accurate, and efficient. Clinical reference laboratories play a crucial role in diagnostic testing, offering specialized and precise analysis through advanced technologies and standardized protocols. These laboratories ensure reliable test results that are critical for early disease detection, treatment planning, and patient monitoring across a variety of medical fields. For example, in April 2024, a report from the National Health Service (NHS), the UK's publicly funded healthcare system, revealed that 376,200 patients were waiting over six weeks for a key diagnostic test, marking an increase of 21,200 from the previous month. As a result, the growing demand for diagnostic testing is expected to drive the clinical reference laboratory market's growth.
Key players in the clinical reference laboratory market are focusing on developing advanced products, such as automated sample processing platforms, to improve efficiency, accuracy, and scalability. Automated sample processing platforms are high-throughput laboratory systems that use robotics and advanced software to handle, prepare, and analyze biological samples with minimal human intervention, ensuring efficiency, accuracy, and standardization in diagnostic and research workflows. For example, in January 2023, QIAGEN NV, a Germany-based provider of sample and assay technologies for molecular diagnostics, launched the EZ2 Connect MDx platform for diagnostic laboratories. The EZ2 Connect MDx is an IVD platform designed for automated sample processing, allowing laboratories to efficiently purify DNA and RNA from 24 samples simultaneously in as little as 30 minutes. It utilizes magnetic-bead technology for nucleic acid extraction from various sample types, including blood plasma, serum, and stool. The platform is equipped with prefilled, sealed reagent cartridges, integrated cameras for load checking, and UV decontamination features to ensure process safety and reduce contamination risks. Additionally, it includes onboard pipetting, heating, and automated piercing of sealed cartridges for seamless operation. The resulting analyte is compatible with multiple downstream technologies, such as real-time PCR, digital PCR, and next-generation sequencing.
In April 2024, Eurofins Scientific, a Luxembourg-based testing laboratory company, acquired Ascend Clinical LLC for an undisclosed amount. This acquisition enables Eurofins Scientific to enhance its presence in renal and transplant testing by integrating Ascend Clinical's expertise, advanced laboratory services, and established client base with Eurofins' extensive network, technological capabilities, and industry relationships. This merger is expected to improve diagnostic offerings, enhance patient care, and drive growth in the clinical diagnostics sector across the United States. Ascend Clinical LLC is a U.S.-based provider of clinical reference laboratory testing and services.
Major players in the clinical reference laboratory market are Mayo Clinic Laboratories, Eurofins Scientific, Quest Diagnostics, Sonic Healthcare, IDEXX Laboratories, Unilabs, ARUP Laboratories, Lancet Laboratories, Neogenomics Laboratories, Sekisui Diagnostics, Ampath Laboratories, Clinical Reference Laboratory, Al Borg Medical Laboratories, Medsol Diagnostics, Medlabs Group, Cerba International, Enable Biosciences, Lifebrain Group, CRL Diagnostics, Dr. Mufti's Oncopathology.
North America was the largest region in the clinical reference laboratory market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in clinical reference laboratory report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the clinical reference laboratory market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The clinical reference laboratory market consists of revenues earned by entities by providing services such as pathology services, biomarker testing and pharmacogenomics. The market value includes the value of related goods sold by the service provider or included within the service offering. The clinical reference laboratory market also includes sales of diagnostic test kits, blood collection tubes, microbiology culture media and immunoassay reagents. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
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.
Clinical Reference Laboratory Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on clinical reference laboratory market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for clinical reference laboratory ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The clinical reference laboratory market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.