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 fourth 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)


Diagnostic tests performed outside the central laboratory or at decentralized locations testing are generally known as point-of-care (POC). Over the years, the proliferation of transportable, portable and handheld instruments as well as ease-of-use immunoassay and even molecular test kits has supported the migration of POC testing (POCT) from the laboratory environment to a range of medical environments including the physician office; clinics, including convenience clinics; workplace; home; disaster care; and triage care. In the United States, regulatory easing through Clinical Laboratory Improvement Amendments (CLIA) test product waivers has permitted a wide range of personnel to purchase and perform diagnostic tests with minimal certification or training. Professional POC diagnostics products are used by medical and clinical personnel at a CLIA-waived site or moderate complexity lab.

Professional POC diagnostics are aligned with prospective growth areas in post-ACA U.S. health care. Hospital outpatient care, convenience clinics and new care organizations and venues are being emphasized in U.S. health care to reduce costs and increase patient exposure with medical professionals. Such venues are located apart from centralized labs and are prime applications for professional POC diagnostics where operational flexibility, ease-of-use and rapid results are highly valued. Based upon the advantages of POC diagnostic products in peripheral testing venues (outside of hospitals and centralized labs) and steady, continued use in physician offices and hospital care, Kalorama Information expects professional POC diagnostics to marginally exceed overall U.S. IVD market growth.

Professional POC diagnostics are commonly associated with rapid chemical and immunoassay tests; including fecal occult blood tests (FOBTs); lateral flow cardiac marker tests; cholesterol and lipid tests; lateral flow and test strip toxicology and therapeutic drug tests; blood glucose and HbA1c tests for diabetes; and rapid infectious disease tests. Professional POC HbA1c has recently seen strong growth as a powerful and cost-effective tool in routine patient screens and check-ups to detect diabetes or assess pre-diabetes risk. Otherwise, many professional POC assays are established product spaces where sales growth is unlikely to outstrip growth in patient utilization of health care.

Core lab instrumentation is also available for POC and near-patient testing applications, with moderate complexity, benchtop or small footprint clinical chemistry, integrated chemistry, immunoassay and hematology analyzers widely available. Investment in core lab testing capabilities, however, is contingent upon the consistency and volume of testing for a POC user.  A hematology analyzer is a viable, profitable option for an oncology practice or clinic, where blood counts and differentials are routine in monitoring cancer patients. Likewise, a critical care or emergency care department performing routine inpatient screening could reasonably invest in an immunoassay analyzer. On the other hand, there is little incentive for many physician practices and clinics to avoid out-sourcing when test volumes are insufficient to justify instrument investment or generate a profit.

Overall, professional POC diagnostics is an established IVD field in the United States and aberrant growth beyond the overall IVD market is unlikely without major product introductions or disruptive technologies. Mounting pressure on reimbursement schedules used by Medicare and Medicaid, and referenced by private insurers for their own pricing, will deter POC testers from expanding in-house testing as profit opportunities dwindle. Anatomic pathology practice labs have already seen their procedure and test reimbursement rates severely slashed. Private payers will be motivated to seek similar savings from decentralized testing at hospitals when out-sourced testing is an alternative. Profitable use and clinical necessity will continue to define U.S. market opportunities in professional POC diagnostics.

An intriguing subsegment within the U.S. professional POC market is molecular POC diagnostics. Effective patient screening for high-risk pathogens and infections is a strong value proposition in many care settings. Companies such as Cepheid are marketing or developing fully automated, moderate complexity molecular systems and assays that move several high-growth clinical tests - for HAIs, STDs, other infectious diseases - from traditional lab settings to POC settings. Further product development in POC molecular diagnostics - particularly in system test cost reduction - could instill additional growth in the professional POC IVD segment.