Pillars of U.S. Physician Office Testing - Urinalysis

Pillars of U.S. Physician Office Testing - Urinalysis

A given in near every general practitioner’s office or primary clinic, dipstick urinalysis requires only a disposable collection cup, test strip, and sink. The test is routine, simple, multiplexed and extremely low-cost (strips cost $0.05 or less each) - tested parameters include urine bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrites, pH, protein, specific gravity and urobilinogen. Similar to more complex chemistry panels, dipstick urinalysis can alert clinicians to multiple conditions including liver disease; kidney disease and disfunction; diabetes; diabetic complications; infection; and other potentially acute health problems.

Performing an extensive review of secondary resources and an analysis of healthcare filings, Kalorama Information estimates dipstick urinalysis to lead all tests in terms of volume in the U.S. physician office laboratory (POL) market. The highly established technology behind the test, intense industry competition and low cost of the test product, however, diminish the relative revenue opportunities for IVD companies in POL dipstick urinalysis.

Dipstick Urinalysis Tests

Growth in POL dipstick urinalysis test volume has averaged 1% or less annually in the United States, though higher insurance coverage in the wake of the Affordable Care Act’s (ACA) implementation should provide a marginal boost to market growth, which could reach 2% annually in coming years. With practically zero technical barriers to market entry and the automatic eligibility of urinalysis dipstick products for a CLIA waiver, industry competition and price erosion is a significant challenge to market development. In the past decade, approximately 1,200 CLIA waivers were granted for dipstick urinalysis analytes. In the past three years, 45 CLIA-waived dipstick urinalysis products have been introduced to the U.S. market with the majority of products marketed and sold to POLs.

The remaining market opportunity for dipstick urinalysis is in the placement of benchtop or portable dipstick readers. The instruments eliminate user subjectivity and qualitative reading of dipstick parameters while freeing practices and clinics to run significantly greater urinalysis volumes. POL users also stand to generate revenue by maximizing volume for the low-cost tests. Companies offering dipstick urinalysis readers include ACON Laboratories (U120 models; also OEM-manufactured for other vendors), Siemens Healthcare Diagnostics (CLINITEK Status models), Roche Diagnostics (Urisys 1100), and POL distributors such as McKesson/PSS and Henry Schein (OEM models) among others. Future trends in urinalysis will see these POL market leaders and competitors increase market penetration of automated dipstick urinalysis. Dipstick urinalysis may also be integrated into other POL testing modalities and platforms (lab urinalysis and chemistry) or be granted additional waived analytes.

For more information regarding physician office laboratory (POL) markets, please consult Kalorama Information’s recently published Physician Office Laboratory Markets.