U.S. IVD Market at $54 Billion, Growth in POC Seen

Per our latest report on the United States In Vitro Diagnostics Market, the U.S. market dominates the IVD industry by region.  In 2022, the U.S. occupies 42% and about $54 billion of the global market for IVD products.  This major IVD market is in a state of flux, trying to manage a myriad of issues, all of which collide with a huge system that costs more than any other in the world.

The leading growth rates for molecular diagnostics and histology out of all segments in the U.S. IVD market are products of their roles in rapid and sensitive pathogen detection, accurate viral load monitoring, and, in oncology, from risk assessment through tumor monitoring. Cancer represents one of the most burdensome diseases on the U.S. healthcare system. Demographic aging in the United States will continue to increase nationwide cancer incidence.

The POC diagnostics market represents the largest IVD segment in the United States; consisting of both the POC diabetes segment ($8,617 million, 2022) and POC non-diabetes segment ($11,996 million, 2022), which includes infectious disease (including COVID-19). The large market segment reflects the diversity of diagnostic technologies that migrated to near-patient settings and the importance of POC testing for preventative care; not to mention the strong demand for COVID-19 POC tests over the past two years.

More dynamic IVD segments in the U.S. market include microbiology, molecular diagnostics, and histology.

United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition https://kaloramainformation.com/product/united-states-market-for-in-vitro-diagnostic-ivd-tests-2022/

The third- and fourth-largest U.S. IVD segments, immunoassay infectious disease and molecular microbiology, were certainly buoyed by the need for COVID-19 testing. The majority of immunoassay testing volume in the United States is run on core lab immunoassay analyzers or combined immunochemistry instruments.

Molecular diagnostics are uniquely responsive to infectious disease threats in the United States. Market growth for molecular infectious disease tests in the United States exploded in 2020 and has carried through to 2022 due to the pandemic.

Rising analytical speeds in sequencing allows for the rapid development of new probe and primer reagents for use in molecular test kits. Future clinical molecular assays for infectious disease may directly incorporate sequencing due to the technology’s ability to openly read pathogenic genomes for new resistance genes and other traits significant in therapy decisions.

Market performance between U.S. IVD segments has been inconsistent due to the pandemic. Core lab market segments in the United States are projected to grow by a little more than 1.1% through 2027.

In wider context, the United States remains the core geographical IVD market in the world at over $54 billion in sales or approximately 42% of the global market. Market growth in some segments in the United States has been accelerated due to the pandemic and the need for testing for COVID-19. The U.S. IVD market is projected by Kalorama Information to reach over $59 billion in 2027.