OPINION – Offshoring and outsourcing antibiotic production to China and India is putting America’s access to lifesaving medicines at risk. It’s time to implement antibiotic security measures before a supply crisis occurs. The first step is rebuilding onshore fermentation manufacturing capacity.
Antibiotics have significantly improved life expectancy and overall public health for over 80 years. Penicillin alone has saved approximately 200 million lives. Its discovery paved the way for further advancements in antibiotics that have saved hundreds of millions more.
From the 1940s to the late 1980s, the United States led global antibiotic manufacturing. The volume of fermentation capacity required to produce antibiotics in the U.S. was a key measure of this. However, over time, pharmaceutical companies steadily outsourced and shifted antibiotic manufacturing to other countries, largely driven by opportunities to reduce costs and avoid capital investment.
Today, the production of antibiotic active pharmaceutical ingredients (APIs) is concentrated in a handful of countries; nearly 70% of the manufacturing sites for a representative shortlist of 40 antibiotic APIs are in India and China (with the majority in China). More concerning, the United States no longer has any significant fermentation manufacturing capabilities to produce antibiotic APIs onshore (see Table 1).
Fermentation capacity for manufacture of antibiotics in USA
Year | Fermentation Capacity (Liters) |
1944 | 400,000 |
1984 | 18,000,000 |
2024 | Less than 400,000 |
This reality creates risks to health security and equitable access to key medicines, especially since antibiotics are such an essential tool for combating infections. In 2024, there were 256 million prescriptions for antibiotics distributed in the U.S. alone. Yet, the amount of antibiotics manufactured in the United States has dwindled to a concerningly low level; 92% of the 111 most-prescribed antibiotics have no U.S. source as of 2021. Worse, antibiotics are 42% more likely to be in short supply than other drug products.
Save your virtual seat now for The Cyber Initiatives Group Winter Summit on December 10 from 12p – 3p ET for more conversations on cyber, AI and the future of national security.
During the COVID-19 pandemic, India limited exports of two common antibiotics, tinidazole and erythromycin (among other drugs), due to dwindling supply of APIs resulting from the temporary closure of Chinese manufacturing facilities. And, in 2017, there was a global shortage of two other antibiotics, piperacillin-tazobactam and benzathine penicillin, because a single factory in China shut down. Just three API manufacturers for these products remain, all in China.
Other countries are already steps ahead of the U.S. in securing their own antibiotic supply. India’s Production Linked Incentive (PLI) scheme, for example, enhances antibiotic security by promoting domestic manufacturing of APIs, key starting materials (KSMs), and drug intermediates. This reduces India’s reliance on imports, and plays a crucial role in protecting Indian public health.
For its national security, the United States must bring antibiotics manufacturing back home. Key is maintaining a level of fermentation manufacturing capacity. This would enhance domestic ability to respond to public health emergencies and minimize the impacts of global supply chain disruptions and geopolitical tensions. Beyond improving antibiotic security, increasing capacity in the U.S. would create net new jobs and enable the implementation of improved and lower cost technologies.
Collaboration between the government and the private sector, particularly via government funding, is crucial to catalyze change in the production landscape. It would also drive innovation in manufacturing processes. To bring fermentation capacity back onshore, something the U.S. has already done to ensure access to other key products, there will have to be incentives.
The CHIPS and Science Act, for example, reduces U.S. dependence on foreign semiconductor manufacturing, particularly from geopolitical rivals like China. The Act provides $52.7 billion in funding to boost domestic semiconductor production, research, and workforce development, ensuring that the United States maintains a secure and resilient supply of critical microchips used in defense, infrastructure, and consumer technology. Antibiotics should receive the same treatment.
Given that higher costs to produce antibiotics onshore drove antibiotic production overseas in the first place, further economic incentives, such as tax credits and subsidies, are also needed. These could motivate pharmaceutical companies to invest in manufacturing capacity domestically. Contract manufacturing organizations (CMOs) and generic drug suppliers should also be targets of these incentives since generics represent over 80% of antibiotic market share by revenue.
Finally, guaranteed purchasing agreements from the government or public entities can provide financial stability for antibiotic manufacturers and make investing in fermentation or manufacturing capabilities a more attractive, lower risk opportunity.
Need a daily dose of reality on national and global security issues? Subscriber to The Cipher Brief’s Nightcap newsletter, delivering expert insights on today’s events – right to your inbox. Sign up for free today.
These opportunities are not without challenges. Pharmaceutical companies have historically prioritized more profitable, chronic disease treatments; antibiotics are prescribed for short durations and generate significantly less revenue compared to other drugs. Any new economic incentives need to be meaningful enough to bridge this gap significantly.
In the meantime, the government should continue stockpiling antibiotics to insure against future shortages. Currently, the U.S. maintains an undisclosed amount of antibiotics through the Center for the Strategic National Stockpile (SNS), but a longer term manufacturing strategy is required to improve safety and reduce risk of shortage.
Access to antibiotics is too critical to simply let cost dictate where production occurs. At the end of the day, this is about protecting our ability to combat infection.
The Cipher Brief is committed to publishing a range of perspectives on national security issues submitted by deeply experienced national security professionals. Opinions expressed are those of the author and do not represent the views or opinions of The Cipher Brief.
Have a perspective to share based on your experience in the national security field? Send it to Editor@thecipherbrief.com for publication consideration.
Read more expert-driven national security insights, perspective and analysis in The Cipher Brief because National Security is Everyone’s Business.
