At first glance, the immunoassay market would seem to offer little to healthcare marketers or investors seeking high revenue growth opportunities. Immunoassays are, frankly, an older category of tests. The first tests were launched in the 1960s. Some of the companies of that era still operate, though under different names. Yet there are hundreds of companies making immunoassays, and new companies enter the field all the time. This activity may seem surprising. But one must consider that many of these companies are pursuing high growth immunoassay categories that are obscured by the relatively sluggish overall growth.
Immunoassays are tests that are based on the binding of antibodies to antigens to identify the presence of a substance (an analyte). Many kinds of immunoassays are used to measure analytes such as proteins (including antibodies), hormones, and drugs. Overall, these tests make up a market that has lackluster prospects. According to Kalorama Information, this market, which is characterized by established competitors and nearly commoditized and volume-discounted tests, can expect growth rates of just 2 to 3%. If this kind of growth is sustained, the $17 billion in sales the industry earned in 2012 should top $20 billion in 2017.
Although the immunoassay market seems lacking in vitality, some portions of this multibillion-dollar market are expected to post growth rates as large as those in the much-publicized molecular products market. Moreover, the promising areas of the immunoassay market are large enough to matter to a small company or a creative division of a large diagnostic firm.
Of course, the immunoassay areas that promise high growth contrast with the traditional immunoassay areas, such as blood screening, metabolic and hormone tests, tumor markers, pregnancy test, tests for illicit drugs, and autoimmune assays. For example, in the blood screening market, slow or even flat revenue growth is expected.
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 screened. Additional growth could occur in developing world markets as more of the blood supply is screened.
Another traditional immunoassay area consists of tests used to diagnose or monitor metabolic disorders. Such tests, which make up about 45% of the overall market, include measurements of HbA1c levels (to assess diabetes) and immunoassays that detect thyroid or autoimmune disorders. They have led to successful products. These products, however, tend to come from well-established market leaders. Moreover, new products may be unwelcome. For these reasons, Kalorama Information sees this market segment posting annual revenue increases below 2%.