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

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

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 compound annual growth rate (CAGR) through 2018. The segments will be released weekly, beginning with histology:

  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)


Including histopathology and cytology, this IVD market segment as outlined by Kalorama Information includes various technologies used to characterize cells and biopsied tissues and distinguish tumor attributes. Market growth in this IVD segment is fueled by the increasingly common application of complex molecular techniques. From the most recent Molecular Diagnostics Market Update:

The most common advanced molecular technique is in situ hybridization and more specifically fluorescent in situ hybridization (FISH) that uses DNA probes to detect pathogens and molecular structures in cells. More recently flow cytometry techniques allow professionals to select targeted cells that can be further analyzed with PCR, sequencing and mass spectrometry.

The result so far has been gene patterns that help distinguish cell and tumor attributes that demonstrate their virulence for disease progression and sensitivity to specific therapeutics. FISH along with a growing population of cancer patients have increased the number of histology analyses performed.

Further, developments in cytology and cervical cancer diagnosis fuel a continuous stream of innovation. For at least the past twenty years molecular analysis of tissue biopsies involves some form of in situ hybridization.

Bit by bit, PCR, microarrays and sequencing techniques are making their way into routine tissue analysis, especially for difficult to manage cases."

The arsenal of molecular diagnostic technology available to histopathologists is ever increasing in response to an aging population and rising burden of cancer in the United States. Medicare payments for histology procedures rose rapidly over the past decade and prompted recent (2012-2013) reform in associated billing codes and reimbursement rates. With newly priced rates below test and procedure costs, market shock was evident in 2013 on the part of pathology groups, reference laboratories, and specialized IVD companies. Market difficulties are expected to be temporary, however, as labs and manufacturers prioritize and innovate lower cost tests and reasonable schedule adjustments are made by CMS.