Advanced flow cytometry and microbiology tests will provide more opportunity for manufacturers than POC tests or clinical chemistry test products sold in the United States, according to Kalorama Information.  Kalorama made the finding in its new report The United States Market for In Vitro Diagnostic Tests. The healthcare market research publisher used a Relative Opportunity Metric to assess the segments of clinical lab testing in the world’s largest healthcare market.       

“Any IVD company looking to expand or establish its presence in the U.S. market is advised to pick its spots as many IVD segments are highly competitive or feature clear-cut market leaders,” said Emil Salazar, analyst for Kalorama Information and author of the report.  “Yet in other segments, unmet clinical demand and responsive innovation will create billions of dollars in added market revenue over the next five years.”

Kalorama has developed a relative opportunity metric, using a ratio of shares for any given IVD market segment or group of segments: the segment’s share of U.S. IVD market volume (in $) added between 2013 and 2018 over the segment’s current share of the U.S. IVD market. Baseline performance for a segment would equate to a metric value of 1.00. Otherwise, a metric value above 1.00 indicates that a segment or group of segments is projected to outperform the overall IVD market and a metric below 1.00 indicates projected below-average market development:

  • Core Lab (Clinical Chemistry, Core Lab Immunodiagnostics, Urinalysis, Hematology) – 0.63
  • Other (Blood Testing and Typing and Coagulation) – 0.72
  • Point-of-Care (Professional and Over-the-Counter POC, inclusive of glucose self-testing) – 0.79
  • Microbiology (Traditional Microbiology [ID/AST], Rapid Tests, Molecular Microbiology Tests, Immunoassays for Infectious Disease) – 1.42
  • Advanced (Molecular Assays, Histology, Cytology, Flow Cytometry) – 2.21

The metric values conform to major trends observed and projected by Kalorama in U.S. clinical testing and IVD sales to laboratories. Core lab IVD segments (metric value 0.63) represent a relatively poor market opportunity for new players.   

“Nearly all clinical labs are already outfitted with core lab instrumentation and market penetration is high among by core lab leaders like Roche, Siemens, Abbott, Beckman Coulter, Ortho Clinical, said Salazar.  “Point-of-care diagnostics is boosted by ease-of-use IVD tests and increasing availability of CLIA-waived test products, but the majority of POC sales volume is from established products with high market penetration and low growth in demand.”

According to the report, Market growth remains robust for U.S. microbiology diagnostics, a group of IVD segments including traditional microbiology (culturing for ID/AST), rapid tests, molecular infectious disease tests, and immunoassay infectious disease tests. Several market drivers exist for microbiology in the United States: hospital investment in microbiology for health-acquired infection (HAI) testing, investment in automated microbiology systems, rising rates of incidence for several sexually transmitted diseases (STDs), and market penetration by higher-priced molecular infectious disease tests.

The report also indicates that advanced IVD tests in this study, including molecular assays for non-infectious disease testing, histology, cytology, and flow cytometry. Molecular assays and histology are projected to be the two-fastest growing IVD market segments in the United States through 2018. Tissue analysis or histology in support of cancer diagnosis and treatment is increasingly reliant on immunohistochemical (IHC) reagents and molecular hybridization (ISH/FISH) techniques and represents a fast rising market in the aging United States. The United States is also ground zero for an influx of advanced molecular assays for blood-based cancer testing, circulating tumor cell (CTC) testing, pharmacodiagnostics, and other sequencing-developed tests.

The report, The United States Market for In Vitro Diagnostic Tests, contains further detail on the US IVD market including segment markets and forecasts, corporate profiles, and other information.  The report can be found at

For more information, visit Kalorama Information.