Towards Healthcare

U.S. Immunoassay Companies and Leadership Alignment with Trends

Date : 06 October 2025

Top Companies in the U.S. Immunoassay Market

U.S. Immunoassay Market Companies

Market Forecast

The U.S. immunoassay market size is calculated at US$ 8.99 billion in 2024, grew to US$ 9.43 billion in 2025, and is projected to reach around US$ 14.22 billion by 2034. The market is expanding at a CAGR of 4.93% between 2025 and 2034.

  • Protein research is an integral part of diagnostics and therapeutics to find novel healthcare solutions. For instance, in July 2024, Spear Bio secured $45 million in oversubscribed series A financing to boost product launch for protein research and diagnostics.
  • The leading biopharmaceutical companies are committed to supplying essential biological raw material products to the in vitro diagnostics industry. For instance, in September 2024, DevCo completed a €616 million capital raise for investment in Medix Biochemica.

U.S. Immunoassay Market Value Chain Analysis

R&D

The R&D process for immunoassays in the U.S. involves feasibility, concept assessment, assay development, optimization, validation, performance testing, manufacturing, standardization, regulatory approval, and commercialization.

Key Players: Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., QuidelOrtho Corporation, Siemens Healthineers.

Clinical Trials and Regulatory Approvals

The significant regulatory approvals are seen for neurology, Alzheimer's disease, oncology, cardiology, and infectious diseases. Phase 1 study for an mRNA vaccine candidate for the H5N1 virus is one of the examples of ongoing clinical trials that utilize immunoassays.

Key Players: Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc.

Patient Support and Services

The key players and healthcare service providers include pharmaceutical and biotech companies, diagnostic laboratory networks, hospitals, clinics, and independent organizations. The services include point-of-care testing, home-based testing, patient support programs, etc.

Key Players: Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific Inc.

Latest Announcements by Industry Leaders

In February 2025, Marc N. Casper, chairman, president, and CEO of Thermo Fisher Scientific Inc., announced that the company feels delighted to introduce Sanofi’s Ridgefield site to its network and involve more than 200 highly experienced professionals at Thermo Fisher Scientific Inc. He also proclaimed that these efforts will bring a team and world-class facility into the company’s network to strengthen U.S. manufacturing capabilities. This will support biotech and pharmaceutical customers while raising the company’s future expansion.

Recent Developments in the U.S. Immunoassay Market

  • In August 2025, Abbott Laboratories announced the establishment of a new cardiovascular device manufacturing facility in Georgia, which is predicted to be completed in 2028 and increase organic sales growth for its cardiovascular business, heart failure, and structural heart.
  • In February 2025, Thermo Fisher Scientific Inc. announced the completion of its acquisition of the state-of-the-art sterile fill-finish and packaging site of Sanofi in Ridgefield, New Jersey.

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