Researchers recommend US diversify antibiotic imports to reduce shortages

The United States tends to source finished dosage forms (FDFs) of antibiotic products from many different countries while relying on China for a majority of imported active pharmaceutical ingredients (APIs), according to recent research published in JAMA Health Forum.

The researchers said improving domestic production and diversifying antibiotic supply sources “are critical steps that depend on a detailed understanding of antibiotic supply chains and global sources.”

“Antibiotics are essential medicines for clinical practice, emergency preparedness, and national security, making it imperative to understand the origins of the antibiotic supply to safeguard, promote, and improve health in the US,” Mariana P. Socal, MD, PhD, of the department of health policy and management at Johns Hopkins Bloomberg School of Public Health, and colleagues wrote in their study.

In a cross-sectional study, researchers analyzed the importation records of FDFs and APIs from the USA Trade Online platform between 1992 and 2024, recording the originating country, import volume, and cost adjusted for inflation. They identified any trends in import volumes and changes in market concentration for FDFs and APIs over that time with the Herfindahl-Hirschman Index (HHI).

Overall, the researchers sourced antibiotic import data from the 50 FDF-originating countries and 52 API-originating countries including India and China, and countries in the Americas, Europe, Africa, Asia, and Oceania. Between 1992 and 2024, imports of antibiotic FDFs increased by 2,595% in annual volume, and spending increased from $1.5 billion to $4.1 billion between 1992 and 2019 before plateauing and then declining in 2024. In contrast, import volume of APIs remained steady between 1992 and 2024, with spending remaining under an average of $1 billion per year after 2015.

Researchers noted that for both FDFs and APIs, average importation prices significantly declined after adjusting for inflation. In 1992, mean importation prices for FDFs adjusted for inflation started at $1,836.03 per kg, and decreased to $177.44 per kg in 2024, while API importation prices adjusted for inflation decreased from a mean of $351.74 in 2003 to $65.69 per kg in 2024.

While the US imported FDFs and APIs from Belgium, Canada, China, Germany, Ireland, Italy, Japan, Switzerland, and the United Kingdom for every year during the study period, there were 44 countries in FDF and API records overall. For FDFs, there was an increase from 21 countries in 1992 to 37 countries in 2024, and APIs also saw an increase from 32 in 1992 to 43 countries in 2008 before decreasing to 34 countries in 2024.

Countries that were key sources for antibiotic FDF and API imports changed over time, the researchers said. For instance, Europe comprised a majority of FDF imports by volume in 1992 (64.4%), but decreased to 39.3% of imports in 2024. Countries in the Americas such as Mexico and Canada made up 58.9% of FDF imports in 2005 before declining to 8.9% in 2024. At the same time, India had no FDF import record in 2002, but has increased to 28.1% of imports by 2024. For API imports, there was a shift in the sourcing of antibiotic APIs from Europe in 1992 (95.7%) to China (70.1%), other countries in Asia (13.1%), and India (1.9%) in 2024.

The researchers also found there was a shift in FDF and API imports within the last 5 years. The largest proportion of imports for PDFs from originating countries by imported volume between 2020 and 2024 were India (31.9%) and Italy (13.4%), while API imports were mostly sourced from China (62.6%) and Bulgaria (16.1%). When calculating HHI values for FDF and API importation markets, the researchers noted an unconcentrated market for FDF importation as of 2020, and a highly concentrated market for API imports.

Socal and colleagues attributed the unconcentrated market for FDF imports to “decades of incentives for pharmaceutical production in these countries, such as the availability of public sector investment, private sector entrepreneurs, and a strong technological base,” while the highly concentrated API market was attributed to “public subsidies as well as the lower costs of labor and lower environmental regulation.”

To improve antibiotic supply resilience in the US, Socal and colleagues said a good understanding is needed of how FDF-originating countries use supply chains, how the US can increase antibiotic production domestically, and whether prices of products produced in the US compares with imported antibiotic products.

“Policymakers should consider key FDF and API origin countries when imposing tariffs, revising trade agreements, or implementing manufacturing incentives to avoid supply disruptions,” the researchers said. “Specific drugs of critical interest should warrant targeted supply chain analysis and tailored strategies.”

JAMA Health Forum Socal et al.

Researchers recommend US diversify antibiotic imports to reduce shortages

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