• by esalazar@marketresearch.com
  • April 7 2014
  • U.S. IVD

Targeting Growth in the U.S. IVD Market: Projected Test Segment Metrics through 2018

Targeting Growth in the U.S. IVD Market: Projected Test Segment Metrics through 2018

An IVD company looking to expand or establish its presence in the U.S. market is advised to pick its spots; many IVD segments are highly competitive or feature clear-cut market leaders. Yet in other segments, unmet clinical demand and responsive innovation will create billions of dollars in added market revenue over the next five years. Derived from market segmentation and projections in TheU.S. Market for In Vitro Diagnostic Tests, Kalorama Information introduces the following relative market opportunity metric to assess the projected performance of U.S. IVD market segments relative to their current value.

The metric uses a ratio of shares for any given IVD market segment or group of segments: the segment’s share of U.S. IVD market volume (in $) added between 2013 and 2018 over the segment’s current share of the U.S. IVD market. Baseline performance for a segment would equate to a metric value of 1.00. Otherwise, a metric value above 1.00 indicates that a segment or group of segments is projected to outperform the overall IVD market and a metric below 1.00 indicates projected below-average market development:

  • Core Lab (Clinical Chemistry, Core Lab Immunodiagnostics, Urinalysis, Hematology) - 0.63
  • Other (Blood Testing and Typing and Coagulation) - 0.72
  • Point-of-Care (Professional and Over-the-Counter POC, inclusive of glucose self-testing) - 0.79
  • Microbiology (Traditional Microbiology [ID/AST], Rapid Tests, Molecular Microbiology Tests, Immunoassays for Infectious Disease) - 1.42
  • Advanced (Molecular Assays, Histology, Cytology, Flow Cytometry) - 2.21

The metric values conform to major trends observed and projected by Kalorama in U.S. clinical testing and IVD sales to laboratories. Core lab IVD segments (metric value 0.63) represent a relatively poor market opportunity for new players. Nearly all clinical labs are already outfitted with core lab instrumentation and market penetration is high among by core lab leaders (Roche, Siemens, Abbott, Beckman Coulter, Ortho Clinical). Market drivers for the core lab are largely limited to demographic aging (gradual increase in per capita lab testing) and client investment in core lab upgrades. The latter driver refers to IVD vendors’ development and labs’ subsequent purchasing of systems with additional panel analytes or test parameters, enhanced automation, and other value-added features. Vested core lab players are the most qualified to introduce upgrades to technologically mature core lab platforms and also offer continuity in support.

Point-of-care diagnostics encompass a wide range of tests in terms of complexity, care settings, and analytes. While the POC diagnostics market is invigorated by the innovation of ease-of-use IVD tests and increasing availability of CLIA-waived test products, the majority of POC sales are from established products with high market penetration and low growth in demand. Emerging product markets such as molecular POC testing will do little to budge overall POC diagnostics market growth through 2018, a test group dominated by a monolithic blood glucose self-testing segment experiencing price erosion in the United States.

Market growth remains robust for U.S. microbiology diagnostics, a group of IVD segments including traditional microbiology (culturing for ID/AST), rapid tests, molecular infectious disease tests, and immunoassay infectious disease tests. Several market drivers exist for microbiology in the United States: hospital investment in microbiology for health-acquired infection (HAI) testing, investment in automated microbiology systems, rising rates of incidence for several sexually transmitted diseases (STDs), and market penetration by higher-priced molecular infectious disease tests.

Advanced IVD tests in this study include molecular assays for non-infectious disease testing, histology, cytology, and flow cytometry. Molecular assays and histology are projected to be the two-fastest growing IVD market segments in the United States through 2018. Tissue analysis or histology in support of cancer diagnosis and treatment is increasingly reliant on immunohistochemical (IHC) reagents and molecular hybridization (ISH/FISH) techniques and represents a fast rising market in the aging United States. The United States is also ground zero for an influx of advanced molecular assays for blood-based cancer testing, circulating tumor cell (CTC) testing, pharmacodiagnostics, and other sequencing-developed tests.