Clinical Laboratory Tests Market Size, Share & Trends Analysis Report By Type (Complete Blood Count, HGB/HCT Testing), By End-use (Central Laboratories, Primary Clinics), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global clinical laboratory tests market size was estimated at USD 103.67 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 9.4% from 2023 to 2030. The clinical laboratory tests market is witnessing growth due to factors such as the rising geriatric population, the growing prevalence of target diseases, and the introduction of innovative solutions to meet the growing demand of the market for clinical tests. The healthcare and diagnostics industry has been largely impacted by the spread of COVID-19. The clinical laboratory tests market has witnessed adverse effects of the pandemic. For instance, LabCorp experienced a decline in overall sales of 8.9% in 2020. This can also be attributed to the overall decline in the number of routine health checkups during the pandemic, leading to a decrease in the number of clinical chemistry tests conducted. However, the number of tests conducted has rebounded to normal, which implies that COVID-19 pandemic has had no long-term adverse impact on the market.

According to the WHO, life expectancy is now exceeding 80 years in most developed economies. Aging is influenced by the interaction of several environmental and genetic factors that affect immunity and metabolism, affecting the function of organs, and is characterized as a substantial risk factor for infectious disease development. Thus, screening and diagnostics can play an important role in the management of overall health. Thus, with an increase in the geriatric population, the need for acute and long-term healthcare is also rising, thereby driving the growth of the global market.

Moreover, the introduction of innovative solutions for maximizing efficiency and minimizing errors is expected to serve this market as a high-impact rendering driver. Integrated workflow management systems, database management tools, and patient test records are gaining importance in the healthcare industry, with companies processing as many as 100 to 150 billion samples per year. Implementation and development of data management and informatics solutions for facilitating smooth operations are expected to drive the growth of this market.

However, the market growth is restrained by the ambiguous regulatory framework associated with clinical laboratory tests. The healthcare industry is largely dependent on regulatory frameworks established by organizations such as the U.S. FDA and EMA. There are no clear regulatory guidelines for the diagnostic sector in developing countries such as China and India. The FDA has the authority to regulate laboratory-developed tests that refer to delivering efficient and rapid results and in-house clinical laboratories developing tests. Risks associated with LDTs may have a negative effect on profit margins and may lead to delays in commercialization of newly developed tests.

Type Insights

The HbA1c tests segment held the largest share of market in 2022. The rise in the patient population with diabetes and cholesterol abnormalities is anticipated to propel segment growth, as patients with fluctuations in HbA1c face an increased risk of complications related to diabetes. Moreover, the launch of newer laboratory tests is expected to further propel the market growth. For instance, in May 2022, OmegaQuant launched the HbA1c Test, for the measurement of the amount of blood sugar in the blood. In addition, in May 2022, LabCorp launched LabCorp on demand, an at-home collection device for diabetes risk testing. Such novel launches enable better access to a wide range of laboratory tests for evaluating blood sugar levels.

The HGB/HCT tests segment is expected to show the fastest growth rate over the forecast period. The growth of the segment is attributed to the occurrence of blood-related diseases among the population. The test is used to diagnose the presence of anemia or polycythemia. HGB/HCT test is also performed to monitor drug responses and make decisions pertaining to blood transfusions or evaluation of dehydration. The increasing incidence rate of anemia & other blood disorders and the introduction of non-invasive & technologically advanced products are expected to drive market growth during the forecast period.

End-use Insights

The primary clinics segment held the largest share of the clinical laboratory tests market in 2022. Primary clinics include standalone laboratories, laboratories in physician clinics & primary healthcare centers receiving samples directly from physicians, clinical research centers, and insurance companies. The test is made available to patients immediately with ease and the result is obtained quickly by the care team, physician, and patients, enabling them to take clinical management decisions spontaneously. They provide a smaller test portfolio than hospital-based or standalone laboratories. These laboratories cater to the needs of a few specialties, and hence, have a small share of the market revenue. Though these are smaller contributors, they are expected to make consistent contributions to market growth.

The central laboratories segment is expected to show the fastest growth over the forecast period. The growth of the segment is attributed to the procedure volumes and high market penetration. An increasing number of initiatives carried out by governments to provide various services, such as reimbursement for clinical laboratory tests, is another major factor anticipated to drive the market. Many healthcare institutions are working with laboratories to integrate different tests such as microbiology testing. Moreover, a large number of laboratories in emerging and underdeveloped markets account for a substantial share. Furthermore, regulatory authorities are undertaking initiatives to improve laboratory services and ease the process of diagnosis.

Regional Insights

North America held the largest share of the market in 2022 and is expected to maintain its dominant position, in terms of share, throughout the forecast period. This can be attributed to the increasing geriatric population, rising prevalence of chronic diseases such as cancer, and high market penetration of technologically advanced diagnostic techniques in the region. According to the American Cancer Society, cancer is one of the leading causes of death in North America. The most commonly diagnosed cancers are prostate cancer in men and breast cancer in women. Increasing preference for novel approaches and a rise in patient awareness are factors expected to drive the regional market.

Moreover, market players are now focusing on improvised and software-enabled automated diagnostic systems that help in managing and processing hundreds of samples at a time and obtaining accurate results. Moreover, clinical laboratory tests save costs, lives, and time by enabling early detection and prevention of disease, with the U.S. performing more than 7 billion clinical lab tests per year.

Asia Pacific is estimated to show the fastest growth in the clinical laboratory tests market over the forecast period. The growth of the market in the region is due to the presence of huge untapped opportunities in the form of unmet medical needs, increasing avenues of scientific research, and positive economic growth. Asia Pacific region comprises over one-third of the global population and has been affected the most by the COVID-19 pandemic. Due to this, clinical laboratories have gained importance owing to their crucial role in conducting tests. China and India have conducted the highest number of tests for SARS-CoV-2. However, the testing capacity needs to increase to fulfill the unmet needs in the clinical laboratory segment.

Key Companies & Market Share Insights

The key players operating in the field of clinical laboratory tests are constantly focusing on introducing and changing existing technologies that enhance patient outcomes and significantly increase the effectiveness and efficiency of healthcare. For instance, in December 2022, Omega Laboratories launched Urine Drugs of Abuse testing services that will start offering urine tests, complimenting its molecular testing in Canada. Some of the key players in the global clinical laboratory tests market include:

• Quest Diagnostics Incorporated.

• Abbott

• Cinven

• Laboratory Corporation of America Holdings

• ARUP Laboratories

• OPKO Health, Inc.

• UNILABS

• Clinical Reference Laboratory, Inc.

• Synnovis Group LLP

• Sonic Healthcare Limited.

Recent Developments

• In July 2023, Quest Diagnostics Inc. launched a novel prostate cancer test that is aimed for the improvement of grading and diagnosis. This test caters to clinical demands for tests to identify and differentiate cases of prostate cancer in men

• In July 2023, Laboratory Corporation of America Holdings announced its collaboration with Jefferson Health for the expansion of laboratory services for healthcare providers, and patients. This collaboration will also enhance the access to comprehensive tests for improving affordability, and benefiting the communities in and around Philadelphia

• In June 2023, Abbott collaborated with the American Diabetes Association to understand the effectiveness of diabetes technology like continuous glucose monitoring (CGM) systems in assisting diabetic patients for taking decisions about their food, and regular activities. The CGM system is a clinical test for gathering tools and data to manage glucose levels

• In April 2023, ARUP Laboratories announced its collaboration with Gestalt Diagnostics Inc. for implementing Gestalt’s PathFlow® digital platform for supporting the comprehensive vision of digital pathology. The purpose is to make advancements in research and clinical diagnostic tests in patient care by leveraging the AI-powered software technology

• In March 2023, OPKO Health Inc. entered into a collaborative and licensed agreement with Merck for developing MDX-2201, a pre-clinical nanoparticle vaccine targeting the Epstein-Barr virus (EBV). This collaboration will bring in clinical development, especially in the development of vaccine candidate for protection against the EBV infection

• In February 2023, UNILABS declared an agreement with Siemens Heathineers for the launch of the latest diagnostic testing infrastructure to improve patients care. Siemens will provide clinical chemistry analyzers, haemostasis analyzers, automation solutions for improving the laboratory operation and testing network of UNILABS

Clinical Laboratory Tests Market Report Scope

Global Clinical Laboratory Tests Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on the latest industry trends in each of the sub-segments from 2018 to 2030.  For this study, Grand View Research has segmented the global clinical laboratory tests market report based on type, end-use, and region:

• Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • Complete Blood Count

  • HGB/ HCT testing

  • Basic Metabolic Panel Testing

  • BUN Creatinine Testing

  • Electrolytes Testing

  • HbA1c Testing

  • Comprehensive Metabolic Panel Testing

  • Liver Panel Testing

    • Hepatitis

    • Bile Duct Obstruction

    • Liver Cirrhosis

    • Liver Cancer

    • Bone Disease

    • Autoimmune Disorders

    • Others

  • Renal Panel Testing

  • Lipid Panel Testing

  • Cardiovascular Panel Tests

• End-use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Central Laboratories

    • Complete Blood Count

    • HGB/ HCT testing

    • Basic Metabolic Panel Testing

    • BUN Creatinine Testing

    • Electrolytes Testing

    • HbA1c Testing

    • Comprehensive Metabolic Panel Testing

    • Liver Panel Testing

    • Renal Panel Testing

    • Lipid Panel Testing

    • Cardiovascular Panel Tests

  • Primary Clinics

    • Complete Blood Count

    • HGB/ HCT testing

    • Basic Metabolic Panel Testing

    • BUN Creatinine Testing

    • Electrolytes Testing

    • HbA1c Testing

    • Comprehensive Metabolic Panel Testing

    • Liver Panel Testing

    • Renal Panel Testing

    • Lipid Panel Testing

    • Cardiovascular Panel Tests

• Regional Outlook (Revenue, USD Billion, 2018- 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait