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 third installment of a weekly preview of Kalorama Information’s upcoming publication -The US Market for In Vitro Diagnostic Tests- for March 2014. 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)


This IVD market segment as organized by Kalorama Information includes molecular assays used to detect bacterial and viral pathogens and infections as well as viral load tests. The U.S. market for molecular infectious disease testing originated in the 1990s with the introduction of tests for sexually transmitted diseases (STDs) such as gonorrhea and Chlamydia; viral hepatitis forms; and HIV.  These tests still represent the majority of the U.S. molecular microbiology market, with moderate to little current sales growth owing to a mature or saturated clinical market. Market growth for U.S. HPV tests has similarly cooled in the last two years; longtime industry leader QIAGEN now faces competition from several other companies’ recently introduced non-FISH HPV assays for use on molecular analyzers. The availability of HPV assays on multiple mainstream molecular platforms and high screening volumes has affected price erosion and accelerated U.S. market saturation.

 Projected market growth in molecular microbiology is predicated upon product introductions and increased testing for the following infections and pathogens:

  • Hospital- or healthcare-acquired infections (HAIs)
  • Respiratory viruses
  • Emerging infectious diseases
  • Urinary tract infections
  • Fungi
  • Vaginitis

The above infections and pathogens are expected to show annual sales growth of above 10% on average in the U.S. market through 2018. HAI and respiratory disease tests represent the largest volume markets; remaining high-growth product areas have individually small market volumes, though collectively are capable of driving molecular microbiology market growth.

One of the major market developments for U.S. molecular microbiology has been an industry- and government-led campaign to mitigate the incidence and prevalence of healthcare-acquired infections. HAIs are major contributors to rates of sepsis, one of the top ten leading causes of death for most age groups. Companies such as Cepheid have introduced molecular platforms allowing hospitals and other care providers to identify HAI pathogens and inform effective patient treatment. Previous estimates of HAI testing market growth of up to 18% annually have been dampened by the success of aggressive HAI control practices undertaken by hospitals, which has reduced demand for rapid, specific HAI identification capabilities. The molecular HAI testing market is still expected to grow by at least 10% annually.

Respiratory infections are a target for IVD industry test development due to their universal prevalence and the high demand for accurate and rapid diagnosis, particularly as new infectious diseases and strains re-emerge or enter North America. Differentiating between respiratory infections with similar symptoms, particularly at onset, is an outstanding need that is leading the development of multiplex assays capable of testing for multiple pathogens at once. Market penetration for such assays remains low; successful product innovation with relative platform ease-of-use and low test pricing is expected to drive the near-term future U.S. market for molecular respiratory disease testing.