Immunoassays are versatile tests, used in detection of many conditions, from allergies to cancer. They are tests that are based on the binding of antibodies to antigens to identify the presence of a substance (an analyte). Immunoassays have been used in clinical laboratory medicine since the 1960s, and are indispensable tools in clinical diagnostics. A wide range of types of immunoassays is used to measure proteins (including antibodies),
hormones, drugs, and other analytes. Kalorama Information has
found that the market for immunoassays, or tests that bind
antibodies to antigens to detect the presence of a substance (an
analyte) in a patient, is over $20 billion. Fully automated
immunoassay systems are now found in clinical laboratories.
Even though the field of immunoassays is now mature,
companies have continued to develop new immunoassays and
immunoassay instrument platforms to improve the sensitivity of
the assays. New developments are designed to make multiplexing
possible, to miniaturize the platforms for point-of-care, and to
identify and develop assays for novel biomarkers; thus, further expanding the potential of immunoassays for the future.
The immunoassay market consists of three major segments:
The central lab-based immunoassays market is by far the largest segment of the total immunoassay market with 70.6% of this market in 2016. Centralized laboratories include reference laboratories (such as Laboratory Corporation of America or LabCorp, Quest Diagnostics, and others), hospital laboratories, laboratories operated by health maintenance organizations (HMOs), and other centralized laboratories. These laboratories range from very high volume labs down to smaller labs, but they typically use the fully automated immunoassay and chemistry/immunoassay analyzers discussed in Chapter 3 for their high volume immunoassay tests. They may also have other platforms
Based on Kalorama Information’s
for tests that are not as high volume, and therefore are not on the fully automated platforms. While the central laboratory segment of the immunoassay market is expected to continue to dominate this market, the market share of this segment is gradually shrinking due to the more rapid growth seen in the point-of-care (POC) or rapid test segment of the market.
- The market for point-of-care (POC) testing consists of two segments, self-testing (also referred to as the over-the-counter or OTC segment), and professional POC testing. However, there are many locations where POC testing can occur within these segments, especially the professional POC market. Professional POC testing is performed in a number of different settings including in hospitals, physicians office laboratories (POLs) and clinics, retail clinics, and many other locations. While the POC/rapid test segment represented only 25.9% of total world immunoassay sales in 2016, this is the fastest growing segment of the immunoassay market. POC/rapid testing is expected to grow to 27% of the total immunoassay market by 2021.
- The smallest growing segment of the immunoassay market is the blood testing (or blood screening) market, which represents only 3.5% of the total immunoassay market. In developed countries, all units of blood and blood products are already screened for several infectious agents. Growth of the blood testing market in these countries is primarily driven by changes in the numbers of units donated and being screened. An exception and potentially significant step increase in the size of this market could occur if it is mandated that a new (additional) immunoassay be used to screen blood for an additional disease. In some developing countries, not all units of blood and blood products are screened for every recommended infectious agent. Additional growth could occur in these markets as more of the blood supply is screened. However, Kalorama expects that the overall, worldwide market for immunoassays used to screen blood will continue to grow slowly.