Report

The Clinical Laboratory Services Market size is estimated at USD 296.00 billion in 2025, and is expected to reach USD 405.35 billion by 2030, at a CAGR of 6.49% during the forecast period (2025-2030).

The burden of infectious diseases and chronic disorders is increasing globally, and clinical diagnostic tests represent one of the most accurate methods for identifying and characterizing various biomarkers of chronic diseases. This bolsters their adoption in the detection of various infectious and chronic diseases. For instance, as per the Global Tuberculosis Report 2023, published by the World Health Organization, an estimated 10.6 million people had tuberculosis in 2022, with an incidence rate of 133 cases per 1,000 people. Among those cases, most were from Southeast Asia and Africa. Thus, due to the high burden of infectious diseases, the demand for clinical laboratory services is expected to increase, thereby driving market growth.

The growing burden of cancer is also expected to boost the adoption of clinical diagnostics, thereby fostering the demand for clinical lab services offering cancer testing. For instance, as per the Australian Institute of Health and Welfare estimates, the country recorded 14,800 lung cancer cases in 2023, compared to 14,529 lung cancer cases in 2022. Thus, such an escalating burden of chronic diseases pushed manufacturers and service providers to commercialize disease testing services to bolster their business avenues. For instance, in July 2023, Quest Diagnostics, a provider of diagnostic information services, introduced prostate cancer biomarker tests in collaboration with Envision Sciences. This tissue-based test service was designed to address the clinical needs of patients with aggressive prostate cancer. Thus, the increased burden of target diseases and various testing services commercialized by manufacturers are expected to drive market expansion over the coming years.

Due to the increasing burden of target diseases, market players are developing advanced tests to gain a competitive advantage over their competitors. For instance, in July 2022, SRL Diagnostics launched the Fatty Liver Index for the diagnosis of non-alcoholic fatty liver disease. SRL Diagnostics (Agilus) is one of the providers of laboratory testing services in India. In September 2022, Bionano Genomics Inc. announced the launch of Bionano Laboratories. This new organization combined Bionano's optical genome mapping (OGM) data services with the clinical testing services previously offered by Lineagen. Bionano Laboratories launched its first OGM-based laboratory-developed test (LDT). Thus, the launch of technologically advanced products, coupled with increasing awareness about the early diagnosis of diseases, is anticipated to drive growth in the clinical laboratory services market.

Thus, the above-mentioned factors, including the increasing burden of infectious and chronic diseases and several clinical laboratory services offered by key market players, are expected to support market growth over the forecast period. However, stringent regulatory issues in various countries and the lack of skilled professionals are expected to restrain the market growth during the forecast period.

Clinical Laboratory Services Market Trends

The Independent Laboratories Segment is Expected to Register Healthy Growth Over the Forecast Period

In highly populated and developing countries like India and China, where a significant share of the population does not have access to proper medical diagnostic facilities, independent laboratories have a huge opportunity to thrive, as they can fill the deficit of clinical service providers in these regions.

The increasing number of independent laboratories in developing countries is expected to propel the segment's growth over the coming years. For instance, according to the January 2023 report by the National Accreditation Board for Testing and Calibration Laboratories (NABL) of India, around 8,199 NABL-accredited medical labs were present in India in January 2023, compared to 6,975 in March 2022. Thus, the increasing number of independent labs is projected to support segment expansion over the forecast period.

The independent laboratories segment is projected to experience growth owing to various collaborative efforts undertaken by laboratories to strengthen their business avenues. In November 2022, GC Labs signed a new contract with Medlab Asia, a global partner in Thailand, marking its ongoing commitment to building a strong diagnostics network in Southeast Asia. With this partnership, GC Labs planned to expand its operations across Southeast Asia. In November 2022, PreciseDx collaborated with the pathology laboratory at Dordrecht Hospital, Netherlands. With this collaboration, PreciseDx leveraged its AI-driven Cancer Risk Stratification platform. Therefore, all these developments are anticipated to fuel the segment expansion over the forecast period.

The high burden of chronic and infectious diseases facilitates market players to establish independent/reference laboratories to accelerate diagnostic testing, which is further expected to propel segmental growth. For instance, in August 2023, the American Institute of Pathology and Laboratory Sciences Pvt Ltd established a reference laboratory in India to cater to the increased burden of infectious diseases in the country. Thus, increasing efforts by market participants to establish independent lab services are anticipated to propel segmental growth over the forecast period.

North America is Expected to Hold a Significant Market Share Over the Forecast Period

The key factors driving the growth of the North American clinical laboratory services market include the presence of key players and government organizations in the country, which creates awareness among the general population and allows them to access services conveniently. For instance, the American Clinical Laboratory Association is a not-for-profit organization that offers members the benefits of representation, education, information, and research.

The high burden of the target and chronic diseases in the region and increasing demand for early diagnosis are the other major factors that are driving the growth of the market in North America. For instance, according to the American Cancer Society 2023 update, about 1.93 million new cancer cases were estimated to be reported in 2023 in the United States, compared to 1.9 million cases in 2022. In addition, according to a report by the Canadian government published in September 2023, about 28,600 Canadian women were diagnosed with breast cancer in 2022, representing 25% of all new cancer cases in women that year. The high burden of chronic diseases in the region is likely to create a high demand for robust diagnostics, fueling the demand for clinical laboratory services in the region.

A favorable reimbursement framework for clinical laboratory services in the region is expected to support regional market growth. For instance, as per the January 2024 update from the American Clinical Laboratory Association, various clinical labs across the United States were reimbursed for their services to Medicare beneficiaries using the clinical laboratory fee schedule or the physician fee schedule based on the nature of the service. In addition, in November 2023, the American Clinical Laboratory Association commended the inclusion of clinical laboratory services in the short-term spending package passed by Congress. Thus, such favorable reimbursement policies for clinical lab services are pushing service providers to extend their offerings in the region.

The presence of key market players in the country, acquisitions, partnerships, and new launches are further expected to complement the growth of the clinical laboratory services market in the country. For instance, in August 2023, Labcorp signed an agreement with Tufts Medicine to acquire Tufts Medicine's outreach laboratory business. This agreement helped Labcorp expand its diagnostic testing laboratory services across the United States.

In August 2022, Labcorp announced that it had closed the acquisition of RWJBarnabas Health's outreach laboratory business and selected related assets. RWJBarnabas Health is New Jersey's largest academic health system. Due to the above-mentioned factors, North America is expected to hold a major market share during the forecast period.

Clinical Laboratory Services Industry Overview

The market for clinical laboratory services is highly competitive, and various global and local companies are present in the market. Global players hold a major share of the market. Local companies are also focusing on delivering innovative services to the people, which allows these companies to establish their position in the market. With the rising need for technology, it is expected that few new entrants will be seen in the market in the future, and these players are expected to gain a substantial share. Some of the major players in the market include LabCorp and Quest Diagnostics, OPKO Health Inc., Labcorp, NeoGenomics Laboratories, and Myriad Genetics Inc.

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