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 second 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 cancer markers in blood; for neonatal and prenatal screening; hereditary disease screening; tissue typing for transplantation (organ and marrow); pharmacodiagnostics; and circulating tumor cell (CTC) testing.

Recent segment growth has come largely in conjunction with the development of cancer therapies. Hereditary disease screening includes molecular testing for genetic risk factors, notably the BRCA gene that raises a patient’s risk of breast cancer. Blood-based cancer markers and CTC tests are seeing use in the early detection of cancers, including recurrence, and to monitor remission. Current pharmacodiagnostics (PGx) testing includes EGR and associated gene mutations, HER, and BCR/ABL. Further innovation in PGx is being driven by sequencing - patients at top-tier cancer centers are already benefiting from lab-developed tests (LDTs), while more genetic markers are under development through sequencing and trials to become commercialized assays.

Recent difficulties for advanced lab testing, including molecular assays and histology, have tempered Kalorama’s short-term market outlook. From the upcoming US Market for In Vitro Diagnostic Tests:

The past year was particularly wrenching for the[U.S.] IVD industry, accustomed to leading growth in the molecular segment, that saw flat molecular sales or struggling growth as client labs faced eliminated or reduced test reimbursements. Analysis of U.S. market performance by several leading molecular IVD players leads Kalorama Information to estimate segment growth in 2013 at 3.8%."

Despite headwinds, the U.S. molecular assays market is expected to exhibit stronger growth past 2014 as the long queue of PGx, cancer marker, and genetic risk factor screening tests in development reach the market in response to clinical demand. Many test developers have also escaped the queue and avoided the costs and time investments necessary for FDA approval by reaching the market as a LDT, which remain reimbursed equally with FDA-approved test kits. Shorting traditional regulatory channels represents one clear indicator of the strong organic demand awaiting successful molecular assays in the U.S. market. The principal challenge for this IVD segment - and the source of its recent lackluster growth - in the eyes of many industry stakeholders remains uneven and disjointed regulatory reform. Looking past 2014, Kalorama Information expects significant improvement on the regulatory front and the freeing of U.S. molecular market potential.