Top Five IVD Segments in the United States - Leaders in Forecast Growth

Top Five IVD Segments in the United States - Leaders in Forecast Growth

(This post represents the fifth and final installment of a weekly preview for Kalorama Information’s upcoming publication The US Market for In Vitro Diagnostic Tests. The posts review the projected top-performing IVD segments in the U.S. market through 2018.)

The United States is the most mature and diversified IVD market in the world, with many clinical tests first developed and approved in the country and most core testing segments already at market saturation. Established market segments such as clinical chemistry, hematology, urinalysis and over-the-counter (OTC) test products idle relatively in the U.S. market, at 1-3% growth annually, with sales growth dependent upon economic and demographic growth and laboratory re-tooling. At the other end of the spectrum (segments reaching >4% annual growth) are IVD disciplines still penetrating clinical markets or introducing significant numbers of new assays.

In preparation of an in-depth market report on the U.S. IVD market, Kalorama Information has ranked the top five clinical diagnostics segments in terms of their forecast growth through 2018:

  1. Histology
  2. Molecular Assays (Non-Infectious)
  3. Molecular Assays (Infectious - Microbiology and Virology)
  4. Professional Point-of-Care (POC) and Near-Patient Tests
  5. Microbiology (ID/AST - Identification and Antimicrobial Sensitivity Tests)


The clinical microbiology market leverages several technological platforms including molecular diagnostics, immunodiagnostics, and traditional microbiology (culturing and analysis using specialized media substrates and chemical reagents). Kalorama Information classifies traditional and automated culturing with non-immunodiagnostic, non-molecular microbial testing as microbial identification and antibiotic susceptibility testing (ID/AST). Traditional and automated microbiology ID/AST represents the fifth-fastest growing segment in the U.S. IVD market. Larger labs’ steady adoption of automated ID/AST, culturing and other pre-analytical systems has bolstered the traditional microbiology’s role in clinical testing and driven segment sales. Far from its perception as a moribund segment, traditional microbiology is responsive to and intimately involved with clinical labs’ and U.S. healthcare’s leading challenges.

Growth in the U.S. traditional microbiology market is primarily a product of increased testing for healthcare- and hospital-acquired infections (HAI) testing and ID/AST automation. Clinical samples run on ID/AST systems originate from urine, sputum, the respiratory system, urogenital system, wounds, blood, stool, cerebrospinal fluid (CSF), and post-surgical dressings and sutures. Routine microbiology work is generated by hospitalized and surgical inpatients. Overall, depending on sampling site, 80-99% of microbiology specimens test negative. Microbiology automation is increasingly a necessity, rather than efficiency tool, for hospital labs and other testers handling high patient volumes. Universal and frequent screening is all the more necessary for hospitals combating or actively working to prevent HAIs, which can be disastrous to business; run up significant costs for control; and result in government penalties.

A more significant future source of growth in the microbiology ID/AST segment will be the penetration of automated pre-analytical and ID/AST systems able to streamline and standardize specimen processing across all sample types. One market leader, Copan, has developed such a system - Liquid-Based Microbiology (LBM) - that automates the transferring of different specimen forms to a universal liquid growth medium. Subsequent identification and characterization of cultured samples or their analysis is thus sped up significantly within the lab.

Another product area of high growth in traditional microbiology is chromogenic media used to screen for HAIs, respiratory and gastrointestinal (GI) pathogens. Chromogenic media provides faster and easily interpretable results for identifying and qualifying the presence of pathogens such as salmonella, shigella, E. coli, strep B, staph, candida, and HAIs (MRSA, VRE). Selective and chromogenic media contain substrates that limit or prevent the growth of non-targeted organisms and label target pathogens through metabolized fluorescence or coloring on the culture medium. Even with the success of molecular platforms in infectious disease testing, selective and chromogenic media continue to perform as a cost-competitive alternative.