Biomanufacturing capacity is expanding steadily—globally, as well as in the U.S.—in the wake of a pandemic that illuminated cracks in the industry’s manufacturing strategies, according to BDO’s bioTRAK database. That doesn’t mean U.S. biopharma corporations are bringing manufacturing home, though.
Instead, they are near-shoring or “friend-shoring” to regions that are friendly to U.S. policy or, minimally, are exempt from zealous COVID-19 restrictions that have kept many Chinese facilities shuttered.
The rationale behind site decisions is nuanced, Dawn Ecker, managing director of bioTRAK database services at BDO USA’s life science industry group, tells GEN, and varies by product. For example, recombinant microbial fermentation is driving most of the U.S. capacity growth. “One company not headquartered in the U.S. said publicly it is looking to diversify/de-risk its manufacturing options by having a U.S.-based site,” Ecker says. The U.S. growth rate is expected to grow 6.4% between 2022 and 2027 (up from 2% between 2017 and 2022), compared to global growth of 2.3% and North American growth of 4.7%.
Mammalian products, in contrast, are less likely to be nearshored. Manufacturing capacity for these products grew 1.9% in the U.S. between 2017 and 2022 but is expected to reach 3.2% between 2022 and 2027. Global growth is projected at 5.2%. “For contract manufacturing organizations (CMO), the U.S. build appears more related to the number of clients in the U.S,” Ecker adds.
China’s hold on biomanufacturing may be wavering, though. A poll by the American Chamber of Commerce in Shanghai during July and August indicated a record low of 55% of respondents were optimistic about the business environment in China for the next five years. That was down 23 points from 2021.
In October, a briefing on the Chamber’s China Business Report cited “stifled” recovery from lockdowns, “deteriorating U.S.-China relations” and macroeconomic pressures. More specifically, “only 18% of respondents ranked China as number one in their company’s global investment plans, down from 27% in 2021.” The survey also showed that 19% of respondents are decreasing their investments in China this year. The reasons all related to China’s zero-COVID-19 policy, according to the Chamber.
As 67% of the global biopharmaceutical industry loses that faith China, India, and Brazil can meet international quality standards for biologics—according to a BioPlan Associates report—other parts of the world see opportunity. Canada, Japan, and many European nations are poised to benefit from high-tech friend-shoring.