In front of Fujifilm's exhibition booth at the BioUSA event held in the United States on June 16 this year (local time). /Courtesy of Boston=Reporter Heo Ji-yoon

Competition among Korea, China, and Japan corporations is intensifying over the $500 trillion won global contract development and manufacturing organization (CDMO) market. As uncertainty in the market grows amid U.S.-China economic tensions and the Trump administration's policy to impose tariffs on imported medicines, both crisis and opportunity are coming to the fore.

Japan's Fujifilm is taking an aggressive approach by expanding production capacity in the United States. Fujifilm's CDMO subsidiary Fujifilm Diosynth Biotechnologies (hereafter Fujifilm) on the 24th (local time) opened a biopharmaceutical manufacturing facility in Holly Springs, North Carolina.

The plant, into which Fujifilm invested $3.2 billion (about 4.48 trillion won), operates eight 20,000-liter bioreactors (fermentation tanks) that produce antibody drug substances and finished drugs. Fujifilm plans to begin finished goods production next year.

Construction of the site is proceeding in two phases, and what has been completed this time is phase one. The company said it will double the plant's capacity by 2028. In the second-phase expansion, the company said it will add eight bioreactors of the same specification to secure a total production capacity of 320,000 liters. Fujifilm introduced the Springs plant as the largest cell culture biopharmaceutical manufacturing facility in North America.

The company last year expanded large reactors for antibody production in Europe's Denmark and the United States and established production facilities in Japan. Ida Toshihisa, a Fujifilm vice president, said, "Fujifilm's investment of more than $8.0 billion (about 11.2 trillion won) worldwide to expand the CDMO business shows the company's firm commitment to advancing the life sciences field."

Exterior view of the pharmaceutical manufacturing facility of China's WuXi Biologics in New Jersey, USA. /Courtesy of WuXi Biologics website

The global biopharmaceutical CDMO market is currently led by Switzerland's Lonza, Korea's Samsung Biologics, the United States' Catalent and Thermo Fisher Scientific, and China's WuXi Biologics. Behind No. 1 Lonza, corporations ranked Nos. 2–5 are jostling for position in fierce competition.

The global market was shaken as economic tensions between the United States and China intensified earlier. When the U.S. Congress last year introduced a biosecurity bill that would ban transactions with Chinese biotech corporations, it was projected that WuXi Biologics, China's largest biopharmaceutical CDMO corporation, would face a business crisis. Seizing that opening, latecomers newly entered the CDMO business one after another.

In Korea, Lotte Biologics, Celltrion's subsidiary Celltrion BioSolutions, CHA Biotech's subsidiary Matica Bio, Prestige Biologics, ST PHARM, and Binex have entered the biopharmaceutical CDMO business.

Final passage of the U.S. biosecurity bill, which had threatened Chinese corporations, fell through. However, according to foreign media and the industry, key anti-China figures in the Trump second-term administration are pushing to revive the biosecurity bill, and there is speculation it will be included in a revision to the National Defense Authorization Act (NDAA) and go before the Senate by the end of this year.

Lee Ji-won, a research fellow at Heungkuk Securities, said in a report, "If the U.S. biosecurity bill is revived in the second half and passes the Senate, the stock price momentum of domestic CDMOs could strengthen along with a rate-cutting stance, and small and mid-sized CDMOs with stronger contract development (CDO) capabilities than large contract manufacturing (CMO) could benefit."

U.S. tariff policy is also a key variable in the CDMO market. On the 26th, U.S. President Donald Trump said he would impose a 100% tariff starting next month on medicines from pharmaceutical companies that do not build factories in the United States, putting the pharmaceutical and biotech sectors that produce medicines outside the United States and export to the U.S. on high alert. The industry predicted that a shift in the production structure of the pharmaceutical and biotech industries would be unavoidable.

The Trump administration's aggressive tariff policy has also increased the likelihood that global pharmaceutical companies, clients of CDMO firms, will push for local production in the United States. An industry official said, "Given that it is difficult for global pharmaceutical companies to change existing drug manufacturing plants or contract manufacturing partners in the short term, there will be no immediate shock to CDMO business companies," but added, "However, it may become difficult to choose plants outside the United States at the initial stage of new product manufacturing or new drug development."

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