Rising Prevalence of Chronic and Infectious Diseases Driving Clinical Reference Laboratory Market
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. According to the WHO data released in September 2023, noncommunicable diseases (NCDs), including heart disease, cancer, stroke, diabetes, and chronic lung disease, kill 41 million people each year. According to the United Health Foundation, more than 29 million US adults reported having three or more chronic conditions in 2022. 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 disease.
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. Thus, the rising prevalence of infectious and chronic diseases is driving the growth of the clinical reference laboratory market.
Clinical Reference Laboratory Market: Regional Overview
Based on geography, the clinical reference laboratory market is segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2023, North America held the largest market share. The market growth in North America can be mainly associated with the increasing number of clinical trials. 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.
The clinical reference laboratory market in Asia Pacific is expected to register the highest CAGR during the forecast period. The governments of these countries are increasing clinical trials. Also, the rising incidence of infectious diseases and the growing awareness regarding clinical trials are likely to offer growth opportunities to the market players in the coming years. Moreover, in recent decades, the emergence of a number of infectious illnesses, including COVID-19 and monkeypox, has posed a new risk to human health. China has experienced a rapid epidemiological change, with notable advances in infectious disease control. According to the provincial-level administrative divisions (PLADs), 5,770 malaria cases were recorded between 2014 and 2021, with 99.05% of malaria samples submitted to provincial malaria diagnosis reference laboratories. Provincial malaria diagnosis reference laboratories have played a critical role in guaranteeing the accuracy and reliability of Plasmodium diagnosis in healthcare facilities.
Clinical Reference Laboratory Market: Competitive Landscape and Key Developments
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. Market players focus on expanding and diversifying their businesses and acquiring novel customer bases, allowing them to explore attractive business opportunities in the market. As per company press releases, a few recent developments are as follows:
• In February 2024, Myriad Genetics, Inc. completed the acquisition from Intermountain Health of select assets from its Intermountain Precision Genomics (IPG) laboratory business, including the Precise Tumor Test, the Precise Liquid Test, and IPG’s CLIA-certified laboratory in St. George, Utah.
• In January 2024, Quest Diagnostics acquired select assets of Steward Health Care System’s outreach laboratory services business, which serves patients and physicians in Pennsylvania and Ohio. The relationship aims to broaden access to innovative, quality, and cost-effective laboratory services. Quest’s full-service laboratory in Pittsburgh, PA, will provide testing for physicians and patients previously serviced by outreach laboratories operated by Steward Health Care System in parts of Pennsylvania and Ohio.
• In November 2023, Universal DX, a biotech company on a mission to transform cancer into a curable disease, collaborated with Quest Diagnostics to improve colorectal cancer screening in the US, for which more than 110 million people may be eligible. Under the commercial agreement between UDX and Quest, Quest plans to perform and provide clinical laboratory services to providers and patients in the United States based on UDX’s Signal-C, an advanced colorectal cancer screening blood test, assuming premarket approval of the test in the United States.
• In May 2023, Proteomics International Laboratories Ltd signed an exclusive license agreement with Sonic Healthcare USA, a Division of Sonic Healthcare Ltd, for the use and commercialization of the Company’s PromarkerD test for diabetic kidney disease in the US. Under the agreement, Sonic Healthcare USA will be offering PromarkerD to physicians and healthcare systems through its client engagement teams across the US.
• In November 2022, Myriad Genetics, Inc. acquired Gateway Genomics, LLC, a personal genomics company and developer of consumer genetic tests, including the No. 1 selling SneakPeek Early Gender DNA Test.
• In January 2022, SYNLAB acquired Valencia-based Sistemas Genómicos of the Ascires Group—a laboratory specialized in genetics and bioinformatics in Spain—further strengthening its European leadership in genetics. The acquisition will reinforce and complement SYNLAB’s expertise and capabilities in genetics and accelerate the digital transformation of its diagnostic service offering.