Global firms join rush for test kits

As other countries start rolling out their own diagnostic kits to test for the fast-spreading coronavirus, Korean companies who briefly dominated the market are seeing waning opportunities to push their products overseas.

The U.S. Food and Drug Administration (FDA) on Saturday gave emergency authorization to begin using Sunnyvale, California-based Cepheid’s rapid molecular tests that detect Covid-19 viral infections in 45 minutes.

Shipments for the diagnostic kit will begin Friday. The company plans to make millions of units of the new diagnostic kit during the next few months.

The start of authorization for U.S. firms indicates opportunities are waning for local players like Seegene competing to export their Covid-19 diagnostic kits to other countries heavily affected by the pandemic.

Coronavirus test kits from local diagnostic kit makers including Seegene, SolGent, Kogene Biotech and SD Biosensor have been in high demand for exports to other countries after their products were given emergency production approval from local authorities once the outbreak reached Korean soil. Many of them this month signed export agreements with a number of countries, and some remain in discussions to expand their exports to additional markets.

Seegene, one of the first to jump on the development of Covid-19 test kits, reportedly received inquiries for exports from more than 30 countries. Market expectations are also growing as the Ministry of Food and Drug Safety said it is reviewing approval requests for 40 additional coronavirus detection kits.

But analysts have warned the industry should temper its expectations, as Korea isn’t the only country with companies developing highly-demanded diagnostic kits. When demand is this high, it is also inevitable that the competition is fierce on both the local and global levels.

“Although we could hope for increased exports from [local diagnostic kit makers] earning CE marking or export approvals from the Ministry of Food and Drug Safety, a lot of global companies and research institutions have already launched CE-marked and FDA-approved diagnostic kits,” said Kang Ha-young, an analyst at KTB Investment & Securities, in a report. “It is possible that local players’ Covid-19 diagnostic kits won’t be able to contribute to their balance sheets as much as the market anticipates.”

Among a total of 19 emergency approval requests for Covid-19 tests through the end of February, only four received approval, meaning the approval rate for the other 40 under review could also remain low.

At the same time, at least 15 pharmaceutical companies and institutions outside Korea, including some big names like Roche and Thermo Fisher Scientific, are developing diagnostic solutions on their own.

As of early last week, six coronavirus detection kits had earned emergency use approval from the U.S. regulator, and its counterpart in the European Union approved more than 10.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]