Increased Monkeypox virus surveillance drives new IVD device development, says GlobalData

Heightened disease control protocols left over from the COVID-19 pandemic are paving the way for new Monkeypox in vitro diagnostic (IVD) devices as medical professionals and world leaders are eager to contain the potential monkeypox outbreak, observes GlobalData, the leading data and analytics company.

According to the World Health Organization, over 2,000 individuals have been infected with Monkeypox in 42 non-endemic countries since January 2022.

Selena Yu, Medical Analyst at GlobalData, comments: “Although it has been reported that Monkeypox is not as infectious as COVID-19, the general public is wary of taking a more reserved approach in containing the outbreaks. Many regions are vaccinating individuals who have come in close contact with infected patients and are asking those exposed to quarantine.”

Some of the major market shareholders for nucleic acid amplification tests (NAATs), outside of COVID-19 tests, are Qiagen, Roche, Abbot, Danaher, and Hologic. Roche has already launched three research-only tests in May and Eurobio released a CE-mark monkeypox screening test that is available to use in hospitals in June. With over 1,700 Roche cobas 6800/8800 systems installed in 2021, GlobalData predicts that if Roche develops a medical-use monkeypox test on this system, it will hold a larger market share as many hospitals already have the cobas 6800/8800 for COVID-19 diagnosis.

Additionally, on June 27, Cepheid, a subsidiary of Danaher, and BioGX announced they are developing a monkeypox PCR test on the Cepheid GeneXpert system. Since there are more than 40,000 GeneXpert systems globally, GlobalData expects Cepheid to quickly become a leader in monkeypox IVDs.

Yu concludes: “Researchers have said that serological test methods, like antigen and antibody detection, cannot distinguish between orthopox viruses. Therefore, companies with the facilities and research abilities to produce large volumes and develop highly sensitive and specific NAATs will gain large market shares as the Monkeypox IVD market expands.”

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