Top United States In Vitro Diagnostics Companies Driving Innovation in 2025
27 May, 2025

The size of the United States In Vitro Diagnostics Market is projected to grow to $65.01 billion by 2033. By 2024, the market is expected to be worth US$ 42.71 billion, and it is expected to increase at a compound yearly growth rate of 4.78% until 2030.

A growing aging population, rising illness prevalence, and technology improvements are driving the growth of the in vitro diagnostics (IVD) market in the United States. Molecular diagnostics, immunoassays, and point-of-care testing are important segments with applications in infectious illnesses, chronic disorders, and cancer. Although they may have an effect on market dynamics, regulatory improvements like the FDA's supervision of laboratory-developed tests are intended to improve test accuracy and safety. The market also has to deal with issues like complicated reimbursement procedures and expensive product prices. Notwithstanding these challenges, the IVD industry is expected to develop further because to advancements in AI, home diagnostics, and customized medicine. The United States' healthcare delivery system is changing as a result of these changes.

Companies that provide cutting-edge testing methods in molecular, genetic, and point-of-care diagnostics dominate the U.S. in vitro diagnostics industry. In order to facilitate early identification and individualized treatment, major players prioritize quick, precise findings. These companies are at the forefront of developing home testing kits, integrated lab automation systems, and AI-based diagnostics.

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Leading US In Vitro Diagnostics Companies

Roche Diagnostics

Establishment: 1896

Headquarters: Switzerland

Website: www.roche.ch/en/sites/rotkreuz/about-roche-diagnostics-international

Clinics, labs, and physician offices can obtain diagnostic system solutions from Roche Diagnostics International Ltd (Roche Diagnostics), a division of F. Hoffmann-La Roche Ltd. The business creates, manufactures, and maintains software and equipment systems for in-vitro diagnostics and bioanalytical research. Additionally, it provides molecular diagnostic reagents, test systems, workflow solutions, and diagnostic analysis systems. Blood glucose meters and point-of-care testing equipment are among its main offerings. Hospitals, commercial diagnostic labs, medical professionals, researchers, and pharmacists are among the clients the firm serves with its goods and services. The headquarters of Roche Diagnostics are located in Rotkreuz, Switzerland.

Danaher Corporation

Establishment: 1984

Headquarters: United States of America

Website: www.danaher.com

Revenue: $23.9B in 2023

The scientific and technology firm Danaher Corp (Danaher) works in the fields of biotechnology, life sciences, and diagnostics. Testing equipment, medical diagnostics, life science research tools, reagents and mass spectrometry, professional microscopes, genomic consumables, filtration and flow cytometry, lab automation, centrifugation, particle counting, and characterization businesses are all offered by the company. Through independent distributors throughout the Americas, Europe, the Middle East, Africa, and Asia-Pacific, Danaher provides its goods and services to pharmaceutical and biotechnology firms, healthcare providers, and research institutes. Its production plants are located in the Americas, Asia, Australia, and Europe. The US city of Washington, DC, is home to Danaher's headquarters.

Thermo Fisher Scientific Inc.

Establishment: 1956

Headquarters: United States of America

Website: www.thermofisher.com

Revenue: $42.9B in 2023

Thermo Fisher Scientific Inc. (Thermo Fisher) provides laboratory, pharmaceutical, biotechnology, and specialty diagnostic services in addition to analytical tools and life sciences solutions. Chemicals, cell culture materials, tools for analyzing proteins and cells, clinical and diagnostic tools, chromatography and mass spectrometry devices, laboratory supplies, equipment, instruments, and goods for molecular biology and nucleic acid analysis are among its offerings. Through the Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD brands, the corporation distributes its goods to pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research organizations, and government agencies. It uses a direct sales force, customer care agents, online sales, and independent distributors to sell its goods. The US city of Waltham, Massachusetts, is home to Thermo Fisher's headquarters.

Bio–Rad Laboratories, Inc.

Establishment: 1952

Headquarters: United States of America

Website: www.bio-rad.com

Revenue: $2.6B in 2023

Instruments, software, consumables, and reagents are developed, produced, and marketed by Bio-Rad Laboratories Inc. (Bio-Rad) for use in clinical diagnostics and life science research. Among its products are digital PCR, blood type and antibody detection systems, antibodies, autoimmune testing kits, and equipment for cell isolation and analysis. Among other fields, the company's products are used in immunology, gene expression analysis, cell research, bioprocess analytics, and mutation detection. It provides services to hospitals, public health and commercial laboratories, universities and research organizations, diagnostic manufacturers, and businesses in the food, chemical, pharmaceutical, and biotechnology sectors. Bio-Rad distributes its goods via distributors, agencies, brokers, resellers, and direct sales channels. Among other places, the business operates in the US, Germany, France, China, and Singapore. The US city of Hercules, California, is home to Bio-Rad's headquarters.

Biomerieux

Establishment: 1963

Headquarters: France

Website: www.biomerieux.fr

Revenue: $4.3B in 2023

A division of Institut Merieux SA, bioMerieux SA (bioMerieux) creates, produces, and sells in vitro diagnostic products for use in private and medical labs. In addition to detecting microorganisms in medications, cosmetics, and agri-food items, the firm provides diagnostic solutions, including systems, reagents, and software, for the detection of infectious illnesses, cardiovascular disorders, and malignancies. It provides industrial microbiological control solutions for the food, pharmaceuticals, and cosmetic sectors; veterinary diagnostic labs; blood banks; and immunoassays, microbiology products, molecular biology tests, and other solutions for clinical applications. Additionally, bioMerieux offers systems for counting the bacterial flora, which reveal the quality of food items. The business sells its goods both directly and via a global network of distributors. The headquarters of bioMerieux are located in Marcy l'Etoile, France.

Abbott Laboratories

Establishment: 1888

Headquarters: United States of America

Website: www.abbott.com

Revenue: $42.0B in 2023

Abbott Laboratories (Abbott) is a health care and medical device corporation that develops, creates, produces, and markets goods. Products related to gastroenterology, women's health, cardiovascular and metabolic, pain and central nervous system, respiratory drugs and vaccines, biosimilars, core laboratory and transfusion medicine systems, point-of-care systems, rapid diagnostics lateral flow testing, informatics and automation solutions, nutritional products, rhythm management products, electrophysiology products, heart failure related products, vascular products, structural heart products, and neuromodulation products are among its primary offerings. The business sells its goods to consumers in North America, Latin America, the Middle East, Europe, Asia-Pacific, and Africa through distributors, wholesalers, government organizations, hospitals, pharmacies, and independent merchants. The US headquarters of Abbott are located in Abbott Park, Illinois.

Sysmex Corporation

Establishment: 1968

Headquarters: Japan

Website: www.sysmex.co.jp

Revenue: $3.2B in 2023

Medical device manufacturer Sysmex Corp (Sysmex) conducts research, develops, manufactures, and markets tools, reagents, and software applications that help with disease management, treatment, and health examinations. It provides clinical laboratories with laboratory information systems, reagents, and diagnostic equipment for testing. Haematology, hemostasis, and urinalysis analyzers are among the products that the firm sells. Medical facilities make use of its products. At its locations in Germany, France, New Zealand, Japan, and the US, it carries out research and development. In the Americas, Europe, the Middle East, Africa, and Asia Pacific, the corporation and its subsidiaries conduct business. The headquarters of Sysmex are located in Hyogo, Japan.