ImmunoassayImmunoassay tests are performed in laboratories for clinical indications such as screening, diagnosis, and/or monitoring patients. Fully automated immunoassay analyzers available in the market make these processes easy and efficient. According to a report from Kalorama Information, a division of, the top 5 companies that lead the market for immunoassays are Roche, Abbott, Siemens Healthineers, Beckman Coulter and Alere. These five companies are found to earn over 40% of the market.

Here are more details about these top companies –

  1. Roche Diagnostics – This manufacturer in the first position has displaced Abbott as the immunoassay leader. Roche has excelled in infectious diseases and tests for women’s health, sepsis, Vitamin D and a number of cancer markers.
  2. Abbott – Abbott Diagnostics that secured the second market share position of the total market has dominated the market since the 1980s. Though 74% of Abbott’s IVD sales were generated outside the U.S in 2016, the company is slowly regaining ground in its home country through an effort to issue more and more FDA-cleared immunoassays. Abbott’s strength lies in:
    • a broad menu of tests and assay systems
    • successful capture of at least 50% of the world infectious diseases market, primarily hepatitis and HIV tests, outside the United States
  3. Alere – With its participation in nearly all immunoassay POC test segments, this manufacturer has a leading position in rapid cardiac markers, drugs of abuse, infectious disease, pregnancy and fertility testing. The firm is announced to be merged with Abbott, and when that merging is completed, it’s likely that the combined company will gain immunoassay market leadership.
  4. Siemens Healthineers – Immulite from Siemens Healthineers’ is a dedicated system and even though Siemens has automated the analyzer, the company has focused on its chemiluminescence test menu on the line of ADVIA Centaur Immunoassay Systems, originally from Bayer Diagnostics. However, due to its defective results generated by system software, the ADVIA Centaur XPT system was recalled by the FDA in July 2016.
  5. Beckman Coulter – This Company’s Access and Synchron systems provide a wide menu that is continuously enhanced by new tests. Its immunoassay menu consists of more than 60 tests for cancer detection, cardiac disease, thyroid function, reproductive endocrinology and women’s health. Beckman Coulter continues to add novel and proprietary tests from different sources including tests for: inhibin A, High Mobility Group Box 1 (septic shock), erythropoetin, and more.

The report also provides details about other manufacturers and their market shares, and details more than 100 companies participating in the market.