Clinical Reference Laboratory Market is expected to reach US$ 74.08 Billion by 2031

Hospital-Based Segment to Contribute Significantly to Clinical Reference Laboratory Market Growth During 2023–2031 

According to our latest study on "Clinical Reference Laboratory Market Forecast to 2031 – Global Analysis – Service Provider and Application," the market was valued at US$ 45.35 billion in 2023 and is expected to reach US$ 74.08 billion by 2031. The rising prevalence of chronic and infectious diseases and the increasing number of clinical trials are the key factors contributing to the growing clinical reference laboratory market size. However, complications related to the regulatory framework and the adoption of continuous technological developments impede the market growth.

One of the most significant changes in modern research laboratories is the increasing use of automation. Artificial intelligence (AI) is becoming increasingly important in laboratory medicine. One significant advantage of AI for laboratory professionals is the ability to automate normal and repetitive tasks in the lab. AI can extract data from various sources, including test results and observations from handwritten notes, and populate electronic records, decreasing the need for laboratory personnel to enter data manually. AI effectively provides the opportunity to increase quality, particularly in the pre- and post-analytical phases.

Clinical Reference Laboratory Market, by Geography

AI systems can automatically schedule repairs and maintenance based on past data and usage patterns, preventing equipment breakdowns. Furthermore, AI will accelerate the evolution of personalized medicine. For instance, laboratories can use AI algorithms to analyze genetic sequences and detect disease-causing mutations in patient samples. When paired with patient data such as medical history, lifestyle, and symptoms, this information will enable clinicians to provide more personalized diagnoses and treatment suggestions. AI, machine learning (ML), and data analytics (DA) will soon be integrated into laboratory medicine. Diagnostic laboratories are rapidly digitizing with the installation of laboratory information management systems (LIMS) and research instrument management systems (RIMS). Thus, the advantages related to AI are likely to boost the use of AI and bring new clinical reference laboratory market trends in the coming years.

Market Segmentation:

The clinical reference laboratory market analysis has been carried out by considering the following segments: service provider and application. Based on service provider, the clinical reference laboratory market is segmented into hospital-based, standalone, and clinical-based. The hospital-based segment held the largest market share in 2023. The standalone segment is anticipated to register the highest CAGR during 2023–2031. Most hospitals have a laboratory for testing during emergencies. The tests performed by the hospital-based reference laboratory include troponin markers for heart attacks, where findings are needed quickly for patient care, and some tests are done in large volumes, such as electrolytes managed within hospital facilities. Large hospitals may process hundreds of samples.

The majority of the tests performed in independent reference laboratories are referred by physicians' offices, hospitals, and other healthcare facilities, including nursing homes. While most hospitals strive to perform as many tests in-house as possible, reference labs are employed for specialized tests that are only needed in rare cases or require specialized equipment. LabCorp, Quest Diagnostics, and ARUP are a few examples of standalone reference laboratories. The cost of testing obtained through reference laboratories has risen dramatically over time as a result of novel genetic testing and the emergence of personalized medicine, which is primarily reliant on laboratory testing. New tests in the market and the downsizing of hospital laboratory staff have created a trend toward moving testing away from hospital laboratories to independent and specialty reference laboratories.

By application, the market is segmented into laboratory medicine, clinical trials, and others. The laboratory medicine segment held the largest clinical reference laboratory market share in 2023. The clinical trials segment is anticipated to register the highest CAGR during 2023–2031. Laboratory medicine is essential in healthcare because it provides objective data to help healthcare professionals guide disease prevention, risk assessment, diagnosis, therapy, and patient monitoring, ensuring safe, appropriate, and effective clinical decision-making. The clinical reference laboratory is critical in laboratory medicine management because it provides specialized diagnostic tests and services that normal clinical laboratories are unable to offer. For example, the UC Health Laboratory strives for excellence in laboratory services and offers professional support in laboratory medicine.

Clinical reference labs assist research teams in effectively completing their projects by providing an extensive range of clinical trials and comparative testing that is both cost-effective and efficient. The research-based organizations are outsourcing clinical trials to develop their products to avoid errors due to improper execution. For instance, CRL Corp is one of the largest privately held laboratories in the US, providing central laboratory services for clinical trials to the global pharmaceutical and biotechnology industries. It also has a wholly-owned CAP-accredited European facility in Cambridge, UK, with a proven track record of providing comprehensive central laboratory solutions to over 4,000 clinical trials worldwide.

The scope of the clinical reference laboratory market report entails North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Spain, Italy, and the Rest of Europe), Asia Pacific (China, India, Japan, Australia, and the Rest of APAC), Middle East & Africa (South Africa, Saudi Arabia, the UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America). 

In terms of revenue, North America dominated the clinical reference laboratory market share in 2023. The US is one of the leading clinical research destinations. Nearly half of the total clinical trials are performed in the US. Additionally, most pharmaceutical research companies choose to perform clinical trials in the US owing to fast approval timelines, a favorable regulatory framework, and established medical infrastructure. Moreover, data generated for clinical trials in the US is accepted globally. According to the World Health Organization (WHO) report in 2021, the US registered the highest number of clinical trials (157,618). The expanding access of companies through mergers and acquisitions further boosts the growth of the clinical reference laboratory market in the US. For instance, in December 2020, Clinical Reference Laboratory (CRL)—a privately held clinical testing laboratory in the US—acquired Confirm BioSciences, a leading provider of comprehensive screening tools and solutions. Confirm will continue as a subsidiary under its current name. The acquisition expands Confirm's access to lab testing services and R&D capabilities. NCEZID laboratories, Mayo Clinic Laboratories, and CRL are among the leading reference laboratories for clinical trials. The increasing number of clinical trials in the US favors the clinical reference laboratory market growth in the country.

Europe occupies a significant position in the global clinical reference laboratory market and is expected to record a strong growth rate during the forecast period. The market growth in the region is mainly attributed to the rising number of clinical trial activities for new drug development and the increasing incidence of infectious diseases.

Sonic HealthCare Limited, Unilabs, Quest Diagnostics, Arup Laboratories, Clinical Reference Laboratories, Synlab International GmbH, Laboratory Corporation of America Holdings, Myriad Genetics Inc, TOPLAB, and Boca Biolistic LLC are among the prominent players profiled in the clinical reference laboratory market report.

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