U.S. Clinical Laboratory Tests Market- Industry Analysis, Market Size, Share, Trends, Growth and Forecast 2024 - 2030.

Overview

The US clinical laboratory testing market size is estimated to reach USD 102.3 billion by 2030, after growing at a CAGR of 2.4% during the forecast period 2024-2030. Clinical laboratory testing is a process in which a diagnostic test is performed under controlled environmental conditions by a qualified physician or a technician in the laboratory using suitable machines, supplies, and equipment. Typically, the tests are performed on samples acquired from patients. These include blood samples, stool and urine samples, tissue, or other material that may be useful in determining the existence of a specific disease, infection, or health condition. A collective number of medical tests that ought to be performed in a laboratory containing all equipment and medicines ideally for disease diagnosis and treatment are called clinical laboratory tests. The tests have an exhaustive variety like Complete Blood Count (CBC), Basic Metabolic Panel (BMP), Erythrocyte Sedimentation Rate (ESR), and BUN Creatinine testing, to name a few. The growing prevalence of chronic diseases namely cardiovascular disorders, tuberculosis, and diabetes coupled with rising investments in diagnosing and technological advancements like Computer Assisted Tomography, Prothrombin Time (PT) test, and vitro diagnostic tests, among others, are the key factors driving the growth of the market. According to the CDC (Centers for Disease Control and Prevention), 70% of medical decisions depend on laboratory test results, showing the important role of clinical laboratories in today’s healthcare system solutions. Most clinical lab tests in the United States are currently performed on computerized testing machines or with the use of special health kits containing lab testing chemicals of controlled quality in order to produce trustworthy and exact lab test results.

Report Coverage

The report “US Clinical Laboratory Testing Market – Forecast (2024-2030)”, by IndustryARC, covers an in-depth analysis of the following segments of the US clinical laboratory testing market.

By Test Type: Complete Blood Count (CBC), Basic Metabolic Panel (BMP), Erythrocyte Sedimentation Rate (ESR), BUN Creatinine testing, Electrolytes testing, HbA1c testing, Comprehensive metabolic panel testing, Liver panel testing, Renal panel testing, Lipid panel testing and Others

By Lab Type: Hospital Based Laboratories, Clinics Based Laboratories, Central Independent Laboratories, Physician Office Based Laboratories, Retail Clinic and Others.

Key Takeaways

• The Complete Blood Count test type dominates the clinical laboratory market in the United States. Continuing growth in the frequency of chronic diseases, along with a high demand for rapid products for assessing health problems, is likely to provide the market with significant momentum in the future years. For instance, in 2022, a new blood test created by Thermo Fisher Scientific has been approved by the U.S. Food and Drug Administration that can predict imminent preeclampsia, helping pregnant women who are at risk of this severe and sometimes deadly form of high blood pressure.
• The advantages and rules provided by the US government; the number of independent testing labs is growing in the country. In 2023, the Protecting Access to Medicare Act will result in reimbursement reductions of up to 15% for more than 800 laboratory tests. 60% of lab firms provide continuing education in an effort to attract and keep medical laboratory personnel.

By Test Type - Segment Analysis

Complete Blood Count test type dominated the US clinical laboratory testing market in 2023. One of the most frequently ordered tests by doctors is a CBC, which is used to assess a patient's blood levels, ascertain whether an infection is present, and decide whether prompt treatment is required. The United States Food and Drug Administration has approved a complete blood cell count (CBC) test that, based on its classification, can be performed at more medical facilities, such as clinics, hospitals, and other types of healthcare facilities, by a larger range of people (such as support staff). Results will become available faster owing to the expanded test access. According to the Centers for Disease Control, the prevalence of diabetes has grown in recent years, and numerous studies have indicated that it will continue to rise. For instance, the United States population of 37.3 million, or 11.3%, have diabetes in 2022. The number of individuals with diagnosed diabetes was predicted to be 28.7 million, or 28.5% of the population. A diagnosis of diabetes has not been made in almost 8.5 million patients as of 2022. The need for complete blood count testing will rise as a result, aiding in market expansion.

By Lab Type - Segment Analysis

Hospital Based Laboratories dominated the US clinical laboratory testing market in 2023. In the US, Hospital-based laboratories are responsible for conducting most of the tests and generally perform more tests than all the other laboratory types, combined. These medical labs primarily not only serve the inpatient and outpatient testing needs of the linked hospital but also do diagnostic tests for patients who are not admitted to the hospital, a practice known as "outreach testing." Given that some hospitals are responsible for the operation of more than one lab, the number of hospital-based labs in the United States exceeds the number of hospitals.  The presence of numerous government laws is one of the key drivers of rivalry between private labs and hospital-based labs. For example, the CMS (Federal Centers for Medicare and Medicaid Services) pays more for hospital-based laboratory services than independent laboratories. Hospitals are major players in the clinical laboratory services sector because they can offer tests and diagnostics for both inpatient and outpatient needs as well as walk-in clients who want to take advantage of the facility's on-site medical expertise after receiving the results.

Drivers – US Clinical Laboratory Testing Market

• The rising prevalence of diseases is driving the market growth

The growing prevalence of chronic diseases, such as cardiovascular disorders, and diabetes, has led to an increased need for diagnostic testing. Laboratory tests play a crucial role in disease diagnosis, monitoring, and treatment decisions, driving the demand for clinical laboratory testing services. Cardiovascular diseases, such as heart disease and stroke, are the leading causes of death in the US. Diagnostic tests, such as lipid profiles, and cardiac biomarker tests, help in assessing the risk factors, diagnosing heart conditions, and
monitoring disease progression. Early detection and management of cardiovascular disorders through diagnostic testing can lead to better outcomes and improved patient care. Clinical laboratory tests provide valuable insights into disease markers, biomarkers, genetic mutations, and other indicators that aid in disease diagnosis, prognosis, and treatment selection. According to the Centers for Disease Control and Prevention, In the United States, heart disease is the leading cause of mortality for men and women and for members of the majority of racial and ethnic groups. Cardiovascular disease claims one life in the United States every 33 seconds. In the United States, heart disease claimed the lives of almost 695,000 persons in 2021, accounting for 1 in 5 fatalities. In the United States, the prevalence of diabetes is rising alarmingly. In 2022, there are expected to be 37.3 million cases of diabetes, according to the CDC's (Centres for Disease Control) National Diabetes Statistics Report, and this is the major factor driving the market's growth.

 New Innovations are Driving the Market 

Advances in genomes and proteomics are likely to lead to the development of new, more complex, and specialized tests. These advancements are also increasing interest in and demand for precision medicine, which is based on diagnostic and prognostic testing and employs data information services and tactics to provide the most effective
healthcare to individuals. Pharmacogenomic testing is being utilized more and more as criteria to assist speed up drug approval procedures and better target therapy based on patient and tumor-specific genetic markers. Several companies in the US have played a significant role in developing innovative solutions in clinical laboratory testing. For instance, on 23 August 2022, The Digital LightCycler System, Roche's first digital polymerase chain reaction (PCR) system, was unveiled. This next-generation technique identifies disease and is designed to correctly quantify minuscule quantities of particular DNA and RNA targets that current PCR methods cannot detect. Clinical researchers will be able to split DNA and RNA from an already extracted clinical sample into up to 100,000 small individual reactions using the Digital LightCycler System. The machine may then do PCR on the findings and generate extremely complex data analysis. These types of Innovative methods for improving efficiency and minimizing errors are expected to be a major driver in the market.

Challenges – US Clinical Laboratory Testing Market  

Lack of Skilled Labor Throughout the Country Is Likely to Challenge the Market Growth 

According to the US Bureau of Labor Statistics, there will be a 19% increase in demand for clinical laboratory technologists and technicians between 2016 and 2030. There is a shortage of clinical laboratory technicians as a result of a number of causes, including but not limited to a lack of training programs, career development possibilities, and an aging workforce. The field of clinical laboratory testing is rapidly evolving, with the introduction of new technologies and methodologies. Keeping up with these advancements requires ongoing education and training for laboratory professionals. Workforce shortages can impede the adoption and integration of new technologies, limiting the ability of laboratories to offer advanced testing services. Labs are reevaluating their workforce assignments due to rising financial strains and a lack of qualified workers. Today's laboratories run an increasing number of tests, yet there aren't enough lab technicians to handle the increasing volume of samples. According to a Forbes article in 2022, there are over 335,000 laboratory technicians working across the country, and it is predicted that this number will fall in the next years. There is a shortage of around 7% or one technologist for every 1,000 people in the United States

 Market Landscape

Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the US clinical laboratory testing market. in 2022, The major players in the US clinical laboratory testing market are Quest Diagnostics, Laboratory Corporation of America (LabCorp), Opko Health, Inc, Sonic Healthcare USA, Arup Laboratories, Abbott Laboratories, Neogenomics Laboratories, Inc, Siemens Healthineers USA, Eurofins USA, Mayo Clinic Laboratories and Others.

Developments:

• In May 2023, Labcorp made an agreement with Providence Health & Services to expand healthcare access, introduce world-class diagnostic capabilities, and guarantee that services are affordable for both patients and providers.
•  In October 2022, LabCorp made a collaboration with Ascension. The new partnership increases access to LabCorp's clinical laboratory services, analytics, and laboratory network for the Ascension-served areas, enhancing productivity and advancing healthcare.
• In April 2023, Quest Diagnostics has acquired NewYork-Presbyterianthe. The alliance aims to give clinicians and patients access to high-quality, reasonably priced testing. Patients will also profit from having access to Quest's network of around 100 patient care locations throughout the five boroughs.