February 15, 2014 (Vol. 34, No. 4)

Growth Prospects—Flecks of Hidden Gold—Still Occur in an Otherwise Mature Market

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%.

Immunoassay Market by Slower and Faster Growth Segments

Segments with High Growth

Contrast the prospects for traditional market segments with those for relatively new market segments, such as immunoassays for cardiac markers. Cardiovascular disease is the leading cause of death, and many diagnostic procedures have been developed to identify people who have some type of cardiovascular disease. These include a number of different laboratory tests: troponin I, troponin T, CK-MB (creatine kinase MB), and myoglobin tests. Such tests, which can identify patients with myocardial necrosis as the result of a heart attack (myocardial infarction), are commonly used on patients who come to emergency rooms with symptoms of a heart attack.

Not only are immunoassays for cardiac markers relatively new, they meet a pressing need. Also, these tests are being adapted for many different immunoassay platforms ranging from large analyzers to point-of-care devices. For all these reasons, brisk revenue growth can be expected. In addition, the likelihood of new test products in this market segment is high.

Allergy is also another area where Kalorama Information predicts relatively high revenue growth. The prevalence of allergies and asthma is increasing in the United States and Europe. Traditional allergy testing has been performed by skin tests. However, more and more patients are being seen by family physicians who have little experience with skin testing for allergies, and who may choose to order immunoassays if they request allergy diagnostic testing. This combination—more patients and inexperienced physicians—is fueling growth in the allergy immunoassay market.

Some of the greatest opportunities are in cancer testing and in the detection of infectious disease. Even though infectious diseases represent the largest segment of the lab-based immunoassay market, it is still the fastest-growing segment, driven by factors such as growth in infectious disease testing in developing countries.

Growth in the Developing World

This market is dominated by tests for hepatitis (especially hepatitis B and hepatitis C) and HIV. Combined, immunoassays for hepatitis and HIV represent 36% of the lab-based immunoassay market. These viral diseases are major problems worldwide, especially in many developing countries.

Infectious disease, allergy, cancer, and cardiac markers make up a majority of the immunoassay market and will see 4 to 5% annual growth in revenues. In some cases, growth rates will be even higher. For example, prospects for growth in the immunoassay market are good in developing countries.

In the developing world, the growth of diagnostic testing is being driven by economic factors. Specifically, there is a growing and increasingly insured middle class population in many countries in China, Southeast Asia, India, and Latin America. In this population, patients are better able to pay for services.

These markets are being targeted by many companies, including major worldwide diagnostic companies and smaller companies that are establishing themselves in developing countries. Much of the growth of testing in these markets in the near future will be with existing technology (including ELISA and lateral flow tests). Another major driver of the immunoassay market—and the diagnostic testing market as a whole—is the growing prevalence of chronic disease.

Opportunities Due to Innovation

The other significant opportunity for growth in the immunoassay market consists of new opportunities that are made possible by innovation. Not only are novel biomarkers becoming available, new platforms are being developed. For example, point-of-care tests will make immunoassays more relevant to patient care.

The cardiac marker segment of the immunoassay market is an attractive market that has caught the attention of many companies. In this market segment, rapid and quantitative results for multiple cardiac markers elicited from the point-of-care generally have a positive effect, reducing the number of misdiagnosed myocardial infarctions, and reducing costs for hospitals, clinics, and patients.

Bruce Carlson ([email protected]) is the publisher of Kalorama Information. To read the Kalorama Information report entitled “The World Market for Immunoassays,” visit www.kaloramainformation.com.

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