From a pure business perspective, the pandemic has been a windfall for Abbott, Cepheid, PerkinElmer, Roche, Thermo Fisher Scientific and other COVID-19 testing companies. However, while the COVID-19 revenue windfalls of the past year are already starting to trail off, the long-term market for biomarker-based infectious disease testing is beyond sustainable. A new report from laboratory industry financial consulting firm Kalorama Institute says that the global market for such testing will reach nearly $15 billion in 2021. And that number does not even include COVID-19 testing.
The Biomarker Infectious Disease Test Market
Biomarkers are biological or biochemical molecules, genetic changes and other measurable characteristics that are used for diagnostic, treatment and medical research applications, including identifying diseases, prognosis, evaluating genetic risks for certain conditions, disease monitoring, determining appropriate treatment options, etc. Biomarkers used to detect infectious agents include proteins (antigens), antibodies produced in response to the agents, genomic markers, etc.
Kalorama is one of the best sources of data and analysis profiling different segments of the laboratory testing market. Its new report “World Market for Diagnostic Biomarkers,” predicts that global sales of biomarker-based infectious disease tests, excluding COVID-19 tests, will reach $14.8 billion in 2021. Kalorama also projects compound annual revenue growth of 5.8 percent per year from 2021 to 2027. Of course, those numbers become much bigger when the COVID-19 wildcard is included. These data are based on the three major types of biomarker-based infectious disease tests, in order of how fast they are expected to grow in volume and market share between now and 2027:
- Molecular Tests
The segment of the biomarker infectious disease testing market that Kalorama expects to grow the fastest is molecular testing, including polymerase chain reaction (PCR), microarrays and other assays that detect nucleic acids, DNA, RNA and genes associated with particular pathogens. Rapidity of growth will be driven by the fact that molecular tests are more accurate than antigen and antibody tests, which makes them more likely to be used for more complex infectious disease testing applications and treatment settings requiring a more definitive diagnosis.
While it is not part of the Kalorama growth analysis, this is the same pattern that has played out with COVID-19 testing. In addition to COVID, molecular tests are commonly used to detect HPV, Chlamydia trachomatis/Neisseria gonorrhoea (CT/NG), and tuberculosis. Another growing application of molecular tests is the detection of resistance genes linked to healthcare-associated infections and disease-resistant pathogens.
- Rapid Immunoassays
The Kalorama report predicts moderate growth for rapid immunoassays based on lateral flow immunochromatographic techniques capable of detecting pathogens in both medical treatment home and other point-of-care settings. There are currently rapid immunoassays for bacterial vaginosis (BV), chlamydia, dengue, Ebola, HIV, influenza, Legionnaires’ disease, malaria, rotavirus, respiratory syncytial virus (RSV), group A Streptococcus, Treponema pallidum, and Trichomonas vaginalis.
- Laboratory Immunoassays
Kalorama predicts slower growth for laboratory immunoassays, currently the largest segment of the biomarker infectious disease test market and which is expected to account for over 60 percent of global sales over the long term. The strength of this segment is the capacity of these assays, particularly enzyme-linked immunoassays, to detect antibodies and antigens associated with a wide range of common pathogens, including influenza, pneumonia, Clostridium difficile (C. diff), hepatitis C, HIV, herpes simplex virus (HSV) and Lyme disease.
Infectious disease testing based on biomarkers was on a steady arc well before the pandemic hit. The Kalorama report is useful in re-establishing the larger context without the unpredictable COVID-19 factor. What we do know is that COVID-19 will lift all segments. However, the pattern of growth, at least in the short term, will likely run against the grain of the larger infectious disease market, with laboratory immunoassays growing the fastest due to the need for rapid tests that can be used to screen the asymptomatic at home and other non-treatment settings.