Clinical Reference Laboratory Market Overview, Growth, Trends, Analysis, Research Report (2021-2031)

The clinical reference laboratory market size is projected to reach US$ 74.08 billion by 2031 from US$ 45.35 billion in 2023. The market is expected to register a CAGR of 6.3% during 2023–2031. The use of artificial intelligence in clinical reference laboratories is likely to remain a key trend in the market.

Clinical Reference Laboratory Market Analysis

The increasing prevalence of chronic diseases and the emergence and outbreak of various infectious diseases have fueled the demand for novel treatment options and newer therapeutic categories and created the need for better treatment options in existing therapeutic categories. Accurate diagnostics are critical for identifying disease biomarkers and detecting organisms, particularly in cancer and tuberculosis. Clinical reference laboratories play an important role in modern healthcare. The reference laboratories provide services for the quick diagnosis of infectious diseases that require specialized laboratory testing equipment and expertise, such as swine flu and hepatitis A and B. These laboratories also offer low-cost diagnostic testing for common chronic conditions such as cancer, diabetes, and cardiovascular diseases. Thus, the rising prevalence of infectious and chronic diseases is driving the growth of the clinical reference laboratory market

 Strategic initiatives by the laboratory service providers, such as acquisition and alliance with reference labs, are among the most cost-effective ways to obtain the benefits of better patient care and cost efficiency is expected to offer significant opportunities for the market growth.

Clinical Reference Laboratory Market Overview

Clinical reference laboratories play an important role in the healthcare system by providing essential diagnostic and testing services that help doctors make decisions. As technology advances and the healthcare landscape evolves, the clinical reference laboratory services market observes important trends that will shape the future of precision medicine. Moreover, during the COVID-19 pandemic, it became evident that medical reference labs are critical for rapid testing, establishing novel techniques, generating and analyzing data, and serving as knowledge hubs. Reference labs are more than just high-volume testing facilities; they are the hubs of expertise and data.

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Clinical Reference Laboratory Market: Strategic Insights

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Clinical Reference Laboratory Market Drivers and Opportunities

Increasing Number of Clinical Trials to Favor Market

Clinical trials assist in evaluating whether a new treatment or prevention method, such as a new medicine, diet, or medical technology, is safe and effective. The trials are primarily conducted during the drug development phase. In January 2023, the National Library of Medicine (NLM) reported that there were 38,837 active clinical studies in the US and 105,172 active trials globally. According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are approved annually, with the pharmaceutical industry accounting for roughly 60%. Due to the growing prevalence of chronic diseases, the number of clinical trials is increasing to develop various effective treatments.

Thus, the increasing number of clinical trials is driving the clinical reference laboratory market growth.

Strategic Initiatives with Reference Laboratories

Strategic initiatives by the laboratory service providers, such as acquisition and alliance with reference labs, are among the most cost-effective ways to obtain the benefits of better patient care and cost efficiency.

On April 3, 2024, Eurofins Scientific, a testing laboratories company, acquired Ascend Clinical LLC, a clinical reference laboratory specializing in testing services for kidney diseases in the US. The acquisition further strengthens Eurofins network's footprint in transplant testing and associated renal care, broadening its clinical client base. Ascend has gained access to Eurofins' extensive laboratory network and analytical portfolio and has established industry relationships.

In October 2023, Labcorp, a global leader in innovative and comprehensive laboratory services, announced that it would acquire Baystate Health, Inc.'s (Baystate Health) outreach laboratory business and certain operating assets, including laboratory service centers operated by Baystate Health throughout Massachusetts. This strategic alliance will strengthen Labcorp and Baystate Health's existing reference laboratory relationship to improve the efficiency of routine and specialty lab testing. Thus, the increasing number of acquisitions and alliances with reference laboratories is expected to offer significant opportunities for the market growth.

Clinical Reference Laboratory Market Report Segmentation Analysis

Key segments that contributed to the derivation of the clinical reference laboratory market analysis are service provider and application.

• By service provider, the market is segmented into hospital-based, standalone, and clinical-based. In 2023, the hospital-based segment held the largest share of the market. The standalone segment is anticipated to register the highest CAGR during 2023–2031.
• Based on application, the clinical reference laboratory market is divided into laboratory medicine, clinical trials, and others. In 2023, the laboratory medicine segment held the largest share of the market. The clinical trials segment is estimated to register the highest CAGR during the forecast period.

Clinical Reference Laboratory Market Share Analysis by Geography

The geographic scope of the clinical reference laboratory market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.

North America dominated the clinical reference laboratory market. The market growth in this region can be attributed to an increase in the number of clinical trials and the presence of key players in the region. The US holds the largest share of the clinical reference laboratory market in North America. 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).

Clinical Reference Laboratory Market Regional Insights

The regional trends and factors influencing the Clinical Reference Laboratory Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses Clinical Reference Laboratory Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Clinical Reference Laboratory Market Report Scope

Clinical Reference Laboratory Market Players Density: Understanding Its Impact on Business Dynamics

The Clinical Reference Laboratory Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the Clinical Reference Laboratory Market are:

1. Sonic HealthCare Limited,
2. Unilabs,
3. Quest Diagnostics,
4. Arup Laboratories,
5. Clinical Reference Laboratories,
6. Synlab International GmbH,

Disclaimer: The companies listed above are not ranked in any particular order.

Clinical Reference Laboratory Market News and Recent Developments

The clinical reference laboratory market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market:

• SYNLAB launched a revolutionary test for the diagnosis of bipolar disorder in France. myEDIT-B is the first clinically validated test for the differential diagnosis between bipolar disorder and unipolar depression, signaling a paradigm shift in the identification of this mental health disorder and thus increasing the effectiveness of the treatment approach. (April 2024, SYNLAB International GmbH, Press Release)
• Quest Diagnostics, a leading provider of diagnostic information services, launched MelaNodal Predict, a highly advanced predictive gene expression test to help personalize treatment decisions for patients with melanoma, the deadliest form of skin cancer and one of the most common cancers in the US. (March 2023, Quest Diagnostics, Press Release)
• Proteomics International Laboratories Ltd signed an exclusive license agreement with Sonic Healthcare USA, a Division of Sonic Healthcare Ltd (OTCMKTS: SKHHY), for the use and commercialization of the Company's PromarkerD test for diabetic kidney disease in the US. As per the agreement, Sonic Healthcare USA will be offering PromarkerD to physicians and healthcare systems through its client engagement teams across the US. (May 2023, Sonic Healthcare USA, Press Release)
• Unilabs, the leading European diagnostic services provider, acquired Saltro one of the largest and most innovative diagnostics companies in the Netherlands. The acquisition significantly expands Unilabs' presence in the Netherlands, where its Medlon team currently provides laboratory diagnostics services in the eastern part of the country. With the addition of Saltro, Unilabs become one of the Netherlands' largest and most complete diagnostics providers. (September 2020, UNILABS, Press Release)

Clinical Reference Laboratory Market Report Coverage and Deliverables

The "Clinical Reference Laboratory Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering the following areas:

• Clinical reference laboratory market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
• Clinical reference laboratory market trends as well as market dynamics such as drivers, restraints, and key opportunities
• Detailed PEST/Porter's Five Forces and SWOT analysis
• Clinical reference laboratory market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the clinical reference laboratory market
• Detailed company profiles