Five Factors Boosting Immunoassays

Five Factors Boosting Immunoassays

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 now used to measure proteins (including antibodies), hormones, drugs, and other analytes.  Fully automated immunoassay systems are now found in clinical laboratories.  Kalorama Information’s report, Immunoassay Markets, can be found at:

Kalorama Information's new report says that mature assays will show only moderate growth, while some segments will outpace the overall market.  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 report notes five drivers of immunoassay markets:

  1. A major driver of the IVD market as a whole, including the immunoassay market, is patients with chronic diseases. Major diseases for which immunoassays are available are discussed in the report.
  2.  In addition, the Patient Protection and Affordable Care Act increased the number of Americans with health insurance. According to the U.S. Census Bureau, 47.951 million people in the United States (or 15.4% of the total population) did not have health insurance in 2012.   With repeal attempts stalled in Congress, the system is in place, for now.
  3. Increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes detected by immunoassays. The function of genes is measured by the presence of gene products, proteins. Thus, immunoassays (in addition to molecular assays) will have an important role in post genomic medicine.
  4.  Development of new immunoassays for novel biomarkers is an important driver of the immunoassay.  Additional information about companies developing these new assays can be found in the profiles in Chapter 8.  In addition to the development of new tests based on novel biomarkers, many of factors are affecting the immunoassay market.
  5.  One market driver in healthcare for many years has been the growing population, and the growing number of older people in need of healthcare.  Each month, 870,000 people turn 65. By 2021, 2.0 million people will celebrate their 65th birthdays each month. This is important because an aging population will push up pension and healthcare costs, forcing major increases in public spending that could slow economic growth in rich and poor countries. While aging population is generally thought to be an issue in developed countries, the report suggests that aging is affecting every country in every part of the world. While developed nations have relatively high proportions of people aged 65 and older, the most rapid increases in the older population are in the developing world.

The overall immunoassay market will continue to grow slowly. Many of the tests available in this market are mature and have been available for several years or decades. The immunoassay market is also a highly competitive market, as demonstrated by the many companies profiled in this report. However, not all segments of the immunoassay market are as bleak as this overall outlook would portray.

Prospects for growth in the immunoassay market are good in certain geographical regions of the world (developing countries). Several factors are driving the growth of diagnostic testing, including testing with lateral flow devices, in these markets. One major factor is economics. There is a growing middle class population that is increasingly insured in many countries in South East Asia and Latin America, and these patients are better able to pay for services. In addition, increased availability of health insurance in emerging companies such as China and India is helping to fuel this growth. These and other factors will make these regions promising segments of the immunoassay market. Many companies are targeting these markets, including major worldwide diagnostic companies and smaller companies established in those 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).

The other significant opportunity for growth in the immunoassay market consists of new opportunities that are made possible by innovations. This includes both innovative new platforms and development of novel biomarkers. Platform innovations are discussed in in the report and new/emerging immunoassay innovations are discussed in the report as well. The attractive opportunities that these innovations may make possible have attracted many companies.