IT’S NOT JUST CLINICAL LABORATORIES seeking ways to repurpose the analyzers and automation they used to perform SARS-CoV-2 testing. As the pandemic continues to ease, some in vitro diagnostics (IVD) companies want to help their lab customers by expanding the types of diagnostic tests than can be run on these instrument systems.
This is true at Thermo Fisher Scientific. Faced with diminishing returns for SARS-CoV-2 testing revenue, the company is working to expand its diagnostic test menu so that clinical laboratory and pathology customers can continue full use of the vendor’s instruments.
Given that other IVD companies must also deal with less demand for COVID-19 testing, the coming months present a good opportunity for lab and pathology leaders to review their vendor contracts and perhaps negotiate more favorable agreements.
Thermo Fisher expects to earn $2.6 billion in testing revenue in 2022, but that amount will fall in 2023, said Marc Casper, CEO, President, and Chairman of the company based in Waltham, Mass. Casper spoke during Morgan Stanley’s 2022 Global Healthcare Conference on Sept. 12.
“We’re assuming an endemic level next year, and about $400 million [in testing revenue],” Casper said. “We’ll know that better as the pandemic plays out.”
Thermo Fisher is the third largest IVD company in the world. Its Laboratory Products Division earned $14.8 billion in 2021 and the company holds an estimated 12.6% of the IVD market. (See TDR, “2021 Rankings of the World’s Top 12 IVD Companies,” Aug. 29, 2022.)
Casper outlined expansion plans for the following three product areas:
- Rapid systems (i.e., generating results within 30 minutes): Thermo Fisher has already added influenza testing to the menu for these systems. This will largely benefit physician’s offices and retail clinics. Other tests will be added.
- Sample preparation: These instruments will support other molecular testing beyond respiratory diagnostics.
- Quantitative polymerase chain reaction (qPCR): The company has already launched new panels for infectious disease testing, primarily with respiratory illnesses. It plans to add panels for sexually-transmitted diseases.
New qPCR Instruments
Casper said qPCR technology found new buyers during the pandemic, which led to more clinical lab customers.
“Pre-pandemic, we were a smaller player in molecular diagnostics,” he noted. “We had all the technologies in sample preparation as well as our qPCR instruments, but they were primarily used in research applications. So, you’d find them in every research lab around the world, every public health lab, but less of a presence in the clinical space.”
In 2019, Thermo Fisher had 5.4% of the IVD market. The company has more than doubled its market share since then.
According to Casper, as COVID-19 spread, Thermo Fisher increased its production of molecular diagnostics tests while also working with regulators to streamline approval processes. “We wound up with a very large share of the qPCR base for COVID testing around the world,” he said. “That led to a huge install base increase of lab-based qPCR instruments and lab-based sample preparation instruments.”