Following COVID’s massive disruption to the infectious disease (ID) molecular diagnostics space, total testing volumes in the U.S. have recovered, but recovery behavior varies between ID analytes. ID analytes’ growth patterns, as tracked in our Infectious Disease DxBook, fall into two main categories, and examining each one provides insight into broader U.S. market trends in this new post-pandemic testing landscape.

From 2016 to 2019, the average ID test volume per tracked U.S. lab grew at a modest 5% CAGR. Although ID testing volumes dipped early in the pandemic, 2020’s scramble to ramp up molecular diagnostic capacity accelerated broader ID testing in the long term, as labs quickly purchased and upgraded instruments to meet short-term needs for COVID. By 2021, this increased testing capacity drove average volumes to grow by a substantial ~15% across major analytes, more than compensating for lost growth in 2020. In 2022, volume growth slowed down to 6%, comparable to historical trends.

Growing analytes fall into 2 categories based on where this growth is coming from:

1. Growing Footprint: New labs are adding a given test to their menu

2. Stable Footprint: The number of labs offering a given test remains consistent, but equipped labs are seeing increases in volume demand

Two examples – respiratory panels, a “growing footprint” analyte, and C. difficile, a “stable footprint” analyte – illustrate some implications of each growth pattern for manufacturers’ competitive positioning.

1. Respiratory panels’ growing footprint has created market opportunity

Respiratory panels experienced rapid growth in volume and footprint in the U.S. over the last 5 years, with a 20% CAGR and penetration increasing from ~35% to ~60% of labs. This growth largely occurred during the pandemic, in three distinct phases in as many years.

In 2020, respiratory panels’ lab footprint grew faster than total market volumes could increase, with a ~20% jump in respiratory-equipped labs but only a ~15% jump in total volumes as suppliers struggled to meet new kit demand. By the pandemic’s second year, kit manufacturers ramped up production; while respiratory panels’ footprint remained stable, volumes grew by ~30% as manufacturers better served existing customers. In 2022, many providers shifted their testing preference from standalone COVID-19 assays toward respiratory panels; combined with increased kit supply, volumes and footprint grew further, with a ~25% increase in respiratory-equipped labs and ~55% increase in volumes.

This growing footprint created an opportunity for manufacturers to take market share, and Cepheid capitalized. Pre-pandemic (2018), bioMérieux dominated the U.S. respiratory panel market among surveyed labs (~65% share), and Luminex (~20% share) was the second largest manufacturer. Cepheid and bioMérieux’s swift release of their SARS-CoV-2-inclusive respiratory panels allowed them to capture ~40% and ~50%, respectively, of the pandemic-fueled respiratory panel volume growth; in turn, Cepheid’s overall share doubled (~15% to ~30%) while bioMérieux retained its dominant market position. Meanwhile, Luminex’s slow respiratory panel development missed winter 2020’s COVID-19 surge, and Luminex’s share halved to ~10% by 2022.

While COVID understandably accelerated demand for respiratory panels in particular, 7 other analytes that our Infectious Disease DxBook follows have seen adoption widen among labs flush with new instruments and molecular diagnostics experience.

2. C. difficile’s stable footprint fostered competition to poach market share

C. difficile, one of the most popular ID analytes, has had a stable footprint in the U.S. over the last 5 years, with a steady clinical lab penetration of ~85%. Despite testing volumes slightly contracting (~15%) from 2018 to 2020 among interviewed labs, pandemic-fueled molecular diagnostics growth pushed C. difficile testing volumes upward by ~40% from 2020 to 2022.

C. difficile’s stable footprint and high adoption rates meant that market share had to be captured from existing labs, and two events catalyzed this shift: Meridian’s decline and Cepheid’s new assay. Labs began to move away from the Meridian Alethia (formerly Illumigene) due to its high hands-on time, while Cepheid released a new high-sensitivity, easy-to-use assay in 2019.

The Infectious Disease DxBook shows that labs that shifted C. difficile testing onto a different instrument (N = 15) most commonly moved it to a Cepheid platform, typically a newly acquired instrument. Cepheid’s GeneXpert’s versatility and well-liked sample-to-answer model remain key assets, and when a better-performing assay for a high-penetration analyte such as C. difficile enters the market, labs may be motivated to adopt not only that new test, but also shift or expand other portions of their testing menus. Indeed, ~75% of interviewed labs purchasing a new Cepheid platform expanded their ID testing menus upon doing so. Even high-penetration, stable-footprint analytes offer opportunities to trigger broader market shifts if new assay offerings favor a versatile platform such as Cepheid’s with numerous available tests. Apart from C. difficile, 13 other analytes in our Infectious Disease DxBook have seen a growth in volumes but a stable footprint.  

Finally, the infectious disease market is subject not only to shifts in competitive landscape, but also to legislative and public health forces that can stunt or accelerate an analyte’s growth. For example, the VALID act, if passed, would give the FDA oversight over LDTs and may increase LDT costs prohibitively for smaller labs, possibly reducing some analytes’ lab footprints. Meanwhile, outbreaks such as COVID-19 or, more recently, monkeypox can spur rapid growth in an analyte’s footprint. A growing analyte footprint can highlight a testing market with additional potential, while a stable footprint can nevertheless provide opportunities for disruptive product improvement and synergies. Monitoring shifts in clinical labs’ testing behaviors remains essential to informing strategic decisions in the rapidly changing post-COVID molecular diagnostics landscape.

These insights rely on data from the Infectious Disease DxBook, which captures detailed quantitative and qualitative information about molecular diagnostics testing for 31 targets from 1,000 U.S. clinical labs annually. If you would like to learn more about the DxBooks, please contact us at dxbooks@decibio.com.

Disclaimer: Companies listed above may be DeciBio clients and/or customers.