By: Maureen Kingsley

The market for infectious disease diagnostics in the United States makes up a significant part of the IVD market. In 2005, the total market size for infectious disease diagnostics was more than $6 billion, increasing at a compound annual growth rate of 9% at that time. Molecular testing has seen the most significant rate of growth. In 2008, the market for infectious disease diagnostics was $8.4 billion, and it is expected to increase to $12.4 billion by 2013. These figures were presented in the market report “Infectious Disease Diagnostic Markets,” published by Kalorama Information (New York; www.kaloramainformation.com).

Immunoassays currently are the technology used most often to determine bacterial and viral surface antigens or antibodies produced in response to those antigens; however, this 40-year-old technology is giving way to nucleic-acid-based testing (NAT). NAT is based on the determination of the presence of genetic material in a patient's sample. These assays are more specific and sensitive than immunoassays, and they can pinpoint small differences in a pathogen's genotype that cause major differences in its phenotype. (Examples of these differences include drug resistance and virulence.) NATs also detect the presence of a pathogen much faster than immunoassays.

In diagnosing infectious diseases, NAT is developing an advantage over immunoassays. The cost of molecular assays is expected to drop following the expiration of various PCR patents, and the technology's reach is global. These two factors will result in an increasingly larger market, which will see a sustained average annual growth rate of 15-18% as more NAT products come to market.

Conversely, the market for immunoassays for diagnosing infectious diseases is increasing very slowly. Nothing is driving market growth; the only chance for growth is within the blood-banking sector.

One factor affecting infectious disease diagnosis applications is the eternal influence of bacterial and viral infections on humanity. There is a near-permanent market for diagnostics in this sector.

Another influential factor is the increasing incidence of drug-resistant bacterial and viral infections. Diagnostics will be increasingly used to ensure drugs are used in cases of infection only.

A third influential factor is the “controlled growth” of NAT. Although NAT represents the future of infectious disease testing, it will see growth that is controlled.