A report by Kalorama Information (New York), “The Worldwide Market for In Vitro Diagnostic Tests,” concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment.

However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. The function of genes is measured by the presence of tangible products, such as proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post-genomic medicine.

For point-of-care (POC) immunoassays, the future outlook is both good and bad. Since the early 1990s, patient self-testing has grown in popularity. Test kits are now readily available for pregnancy, blood pressure, drugs of abuse, H. pylori, blood glucose, cholesterol, cancer, and HIV. Predictions are that patient self-testing will skyrocket because of rising consumer expectations, technological innovations, and the surge of consumer activism in healthcare. Furthermore, pharmacies, retail outlets, and physician offices are establishing their positions for patient wellness screening. Under these conditions, the expectation is that both patient POC self-testing and professional POC testing will grow at 20-25% per year.

But in the professional setting, outside the hospital, most POC immunoassays do not meet the quality standards offered by lab-based tests. Furthermore, the thought is that new tests and assay technologies are too expensive. Faster, more sensitive, more user-friendly, and less expensive tests may produce better market penetration. Nonetheless, as the cost of POC devices have become more affordable and healthcare organizations have constructed data management infrastructures, POC testing has also become an attractive operational and economical alternative to traditional laboratory-based testing in various situations, including physician office testing, homecare, and in-hospital care.

Editor’s note: IVD Technology’s blog, IVDT Insight is now online at ivdtechnology.com/blog/ivdt-insight. Written and produced by the editors of IVD Technology, IVDT Insight analyzes the latest breaking headlines, offers informed commentary on industry topics, and provides a forum for our readers’ opinions and feedback. You can also stay up-to-date on the latest “Breaking Industry News” that is updated daily by accessing IVD Technology’s homepage at ivdtechnology.com. In addition, IVD Technology launched its online “Ask the Experts” program. If you have a question related to IVD development and manufacturing that you would like to ask our experts, please visit ivdt.canon-experts.com. 

Richard Park

richard.park@cancom.com