Labcorp Holdings Inc. (Labcorp) is a global leader of innovative and comprehensive laboratory services that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions.
By leveraging its unparalleled diagnostics and drug development capabilities, the company provides insights and accelerates innovations to improve health and enhance lives. The company serves clients in approximately 100 countries, provided support...
Labcorp Holdings Inc. (Labcorp) is a global leader of innovative and comprehensive laboratory services that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions.
By leveraging its unparalleled diagnostics and drug development capabilities, the company provides insights and accelerates innovations to improve health and enhance lives. The company serves clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and performed more than 700 million tests annually for patients around the world.
Strategy
The company, through leadership in science, technology, and innovation, provides vital information and services to help its customers make clear and confident health decisions and helps millions of people improve health and lives.
The company is expanding its role in the rapidly evolving healthcare market by strengthening its positions across its portfolio of capabilities, growing strategic opportunities that drive new business, and differentiating its unique offerings, capabilities, and financial performance. The company is focused on two near-term strategic opportunities for growth across both Dx and BLS: be the partner of choice for health systems and local and regional laboratories; and lead in the development, licensing, and scaling of specialty testing.
Longer-term, the company is focused on three enterprise-wide strategic priorities to drive growth: establish leadership and partnership capabilities in cell and gene therapy; expand consumer-centric capabilities; and expand global reach, including through companion diagnostics.
Segments
The company operates through two segments, consisting of Diagnostics Laboratories (Dx), which includes routine testing and specialty/esoteric testing; and Biopharma Laboratory Services (BLS), consisting of Early Development Research Laboratories (ED) and Central Laboratory Services.
Dx segment
Dx segment offers a comprehensive menu of frequently requested core testing and specialty testing through an integrated network of primary and specialty laboratories across the U.S. and Canada. This network is supported by a sophisticated information technology system, with more than 80,000 electronic interfaces to deliver test results, nimble and efficient logistics, and local labs offering rapid response testing.
Dx also provides patient access points that are strategically and conveniently located throughout the U.S., including more than 2,200 patient service centers (PSCs) and more than 6,800 in-office phlebotomists located in customer offices and facilities. Although testing for healthcare purposes and customers who provide healthcare services represents the most significant portion of the clinical laboratory industry, clinical laboratories also perform testing for other purposes and customers, including employment and occupational testing, deoxyribonucleic acid testing to determine parentage and to assist in immigration eligibility determinations, environmental testing, wellness testing, toxicology testing, pain management testing, and medical drug monitoring. Dx offers a test menu that includes a wide range of clinical, anatomic pathology, genetic, and genomic tests; and regularly adds new tests and improves the methodology of existing tests to enhance patient care. Dx also offers more than 75 consumer-initiated wellness tests available online through its Labcorp OnDemand platform.
As part of an ongoing commitment to be an efficient and high-value provider of laboratory services, Dx implemented and has maintained a comprehensive business process improvement initiative known as LaunchPad. The initiative was designed to reengineer the company's systems and processes to create a sustainable and more efficient business model, and to improve the experience of all stakeholders.
Dx offers a range of health and wellness services to employers and MCOs, including health fairs, on-site and at-home testing, vaccinations, and health screenings.
Biopharma Laboratory Services Segment
BLS provides drug development, medical device, and CDx development solutions from early-stage research to clinical development, along with support for crop protection and chemical testing, through its ED and Central Laboratory Services businesses. Its customers consist of pharmaceutical, biotechnology, medical device, and diagnostic companies across the world. With a global network of operations, BLS offers deep expertise in early development and clinical trials in each therapeutic area. BLS has provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, including 86% of those specific to oncology, 74% of those submitted by biotechnology companies, and 80% of those submitted by leading and large pharmaceutical companies. Through its industry-leading central laboratory business, it supports clinical trial activity in approximately 100 countries.
Customers
The company provides its services to a broad range of customers across Dx and BLS. The primary customer groups serviced by the company include:
Payers - Health Plans: The company serves many health plans, including MCOs, employer plans, and other health insurance providers, each of which operates on a national, regional, or local basis. In certain locations, health plans may delegate to independent physician associations (IPAs) or other alternative delivery systems (e.g., ACOs) the ability to negotiate for services on behalf of certain members.
Pharmaceutical, Biotechnology, Medical Device, and Diagnostics Companies and Contract Research Organizations (CROs): The company provides services to hundreds of pharmaceutical, biotechnology, medical device, and diagnostics companies and CROs ranging from the world’s largest multi-nationals to emerging, small, and mid-market companies.
Physicians, Large Provider Organizations, and Other Healthcare Providers: Physicians and other healthcare providers who are authorized to order clinical laboratory testing for their patients are a primary source of requests for Dx’s testing services. These physicians and other providers may practice in a range of settings, including small medical practices, community-based clinics, and large, multidisciplinary organizations.
Hospitals and Health Systems: The company provides hospitals and health systems with services ranging from core and specialty testing to supply chain and technical support services, and the opportunity to be a research partner for participation in studies and clinical trials with BLS. In some cases, a hospital’s on-site laboratory may be operated or managed by an outside contractor or independent laboratory, including the company.
Other Customers: The company serves a broad range of other customers, including but not limited to, governmental agencies, employers, patients and consumers, crop protection and chemical companies, academic institutions, independent clinical laboratories, and retailers.
Sales, Marketing, and Customer Service
The company offers its services through a sales force focused on serving the specific needs of customers in different market segments. The company’s sales force is responsible for both new sales and for customer retention and relationship building.
For Dx, these market segments have different representatives focused on each segment in order to better understand and respond to the unique needs of each segment. These include clinical areas, such as primary care, oncology, women’s health, autoimmune diseases, neurology, infectious diseases, endocrinology, gastroenterology, rheumatology, and other specialties; payers, such as ACOs, MCOs, and employers; and customers, such as physicians and physician organizations, and hospitals and health systems. The BLS global sales organization provides customer coverage across the pharmaceutical, biotechnology, and medical device industries for services, including lead optimization, preclinical safety assessment, analytical services, clinical trial enablement through data insights, central laboratory services, biomarker testing, companion diagnostics (CDx), and technology solutions.
As part of the company’s ongoing strategic priority to maximize the value of its unique leadership in both diagnostics and biopharma laboratory services, sales representatives from each business segment work together on outreach to potential customers of both businesses, including hospitals and health systems that may purchase testing and participate in clinical trials, or pharmaceutical, biotechnology, or medical device companies whose studies may benefit from the use of Dx’s specialty testing, companion diagnostics, and network of PSCs.
Seasonality
The company experiences seasonality across its business. For example, testing volume generally declines during the year-end holiday period and other major holidays. In 2024, approximately 13.7% of the company’s revenues were billed in currencies other than the U.S. dollar, with the Swiss franc, British pound, Canadian dollar, and the euro representing the largest components of its currency exposure.
Spin-off of Fortrea Holdings Inc.
On June 30, 2023, the company completed the previously announced separation (spin-off) of its former clinical development and commercialization services (CDCS) business, Fortrea Holdings Inc. (Fortrea).
Regulation
All major and many smaller company facilities hold CLIA certificates to perform high-complexity testing. The company’s remaining smaller testing sites hold CLIA certificates to perform moderate complexity testing or a certificate of waiver.
Various regulatory agencies, including CMS and the FDA in the U.S., regulate the development, testing, manufacturing, labeling, advertising, marketing, distribution, storage, import, export, performance, and surveillance of diagnostic and therapeutic offerings, including certain offerings provided by the company and the development of therapeutic products that comprise the majority of BLS’s business.
BLS’s laboratory facilities and Dx’s clinical laboratory facilities that perform testing services in the support of preclinical studies and clinical trials must conform to a range of standards and regulations, including good laboratory practice (GLP) and good clinical practice (GCP), current good manufacturing practice (cGMP), human subject protection and investigational product exemption regulations, and quality system regulation (QSR) requirements, as applicable. The preclinical and clinical testing intended to support applications for research or marketing, and the studies that the company conducts, are subject to periodic inspections by the FDA, as well as other pharmaceutical and medical device regulators in the jurisdictions outside the U.S. in which the company operates, which may include, without limitation, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.), the European Union, the European Medicines Agency, the National Medical Products Administration in China, and the Pharmaceuticals and Medical Devices Agency in Japan, to determine compliance with GLP, GCP, and cGMP, as well as other applicable standards and regulations.
The company is in compliance in all material respects with each of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules.
The company has established processes and frameworks to manage compliance with the European Union General Data Protection Regulation (GDPR) and other global privacy and data protection requirements, and to manage preparation for future enacted regulations.
The company continues to work through its trade association to address the scope of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA).
To the extent that the company's laboratories perform such testing, each must be certified as meeting the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services (HHS) (SAMHSA) standards. The company's laboratories in Research Triangle Park, North Carolina; Raritan, New Jersey; Houston, Texas; Southaven, Mississippi; and St. Paul, Minnesota are all SAMHSA certified.
History
Labcorp Holdings Inc. was founded in 1995. The company was incorporated in 2024.