Industry

The laboratory industry is a part of the broader healthcare and health technology industry. Companies exist at various levels, including clinical laboratory services, suppliers of instrumentation equipment and consumable materials, and suppliers and developers of diagnostic tests themselves (often by biotechnology companies). The top ten companies that are leading the Clinical Laboratories market are Quest Diagnostics Inc., Laboratory Corporation of America Holdings, The British United Provident Association Ltd., NHS Blood and Transplant, London Ambulance Services, Fargo Medical Laboratories, Labco Quality Diagnostics, LifeLabs Medical Laboratory Services and others.

Clinical laboratory services includes large multinational corporations such LabCorp, Quest Diagnostics, and Sonic Healthcare but a significant portion of revenue, estimated at 60% in the United States, is generated by hospital labs. In 2018, the total global revenue for these companies was estimated to reach $146 billion by 2024. The Global Medical Laboratories is valued at $78 billion in 2019. Another estimate places the market size at $205 billion, reaching $333 billion by 2023. The American Association for Clinical Chemistry (AACC) represents professionals in the field.

Clinical laboratories are supplied by other multinational companies which focus on materials and equipment, which can be used for both scientific research and medical testing. The largest of these is Thermo Fisher Scientific. In 2016, global life sciences instrumentation sales were around $47 billion, not including consumables, software, and services. In another estimate the life sciences and lab equipment is expected to reach $52.3 billion by 2025. In general, laboratory equipment includes lab centrifuges, transfection solutions, water purification systems, extraction techniques, gas generators, concentrators and evaporators, fume hoods, incubators, biological safety cabinets, bioreactors and fermenters, microwave-assisted chemistry, lab washers, and shakers and stirrers.

As of 2018update, the in-vitro-diagnostics (IVD) market was estimated at a global value of around $61.22 billion, with companies: Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers, Johnson & Johnson Medical Devices and Diagnostics, Beckman Coulter and BioMerieux. Another estimate places the IVD market reaching at $79.20 billion by 2025 with companies: F. Hoffmann-La Roche AG, QIAGEN, Abbott Laboratories, Siemens AG, Thermo Fisher Scientific Inc., Danaher Corporation, Bio-Rad Laboratories Inc., Sysmex Corporation, Quest Diagnostics and Cepheid Inc. Many of the companies sell capital equipment and supply consumables, and the devices are also used for industrial purposes such as food testing. Molecular diagnostics is estimated at 10% of total revenue, and half of that focused on infectious disease testing. Blood transfusion diagnostics has become increasingly important with the prevalence of infectious and chronic diseases, with companies like: Grifols S.A., Bio-Rad Laboratories, Inc., Quotient Limited , and Immucor, Inc.

In August 2020, Carterra Inc., announced availability of a highly accurate assay for simultaneously measuring the concentration and binding of IgG, IgM, and IgA antibodies to the Receptor Binding Domain (RBD) of SARS-CoV-2.

United Statesedit

In the United States, estimated total revenue as of 2016 was $75 billion, about 2% of total healthcare spending. In 2016, an estimated 60% of revenue was done by hospital labs, with 25% done by two independent companies (LabCorp and Quest). North America dominated the Medical Laboratories Market with a share of 39% in 2019. According to the data of Centers for Disease Control and Prevention (CDC), there were 40 million people aged 65 and above in the U.S. accounting for 13% of the total population and CDC projected that around 20% of the population of U.S. would be under this category by 2030. Hospital labs may also outsource their lab, known as outreach, to run tests; however, health insurers may pay the hospitals more than they would pay a laboratory company for the same test, but as of 2016, the markups were questioned by insurers. Rural hospitals, in particular, can bill for lab outreach under the Medicare's 70/30 shell rule.

Laboratory developed tests are designed and developed inside a specific laboratory and do not require FDA approval; due to technological innovations, they have become more common and are estimated at a total value of $11 billion in 2016.

Due to the rise of high-deductible health plans, laboratories have sometimes struggled to collect when billing patients; consequently, some laboratories have shifted to become more "consumer-focused".