How US-based Manufacturing Could Reshape the Future of Big Pharma
Big Pharma is undergoing a profound shift, moving more of its manufacturing and production facilities back to US soil. Amgen’s recent billion-dollar investment in two new facilities—a biomedicine product assembly site in Ohio and a multiproduct drug manufacturing plant in North Carolina—marks just one of many major industry commitments to US-based production.
Other pharmaceutical giants, like Eli Lilly, BeiGene, and AstraZeneca, have announced similarly large investments in domestic facilities, reflecting a larger movement that could redefine pharmaceutical production standards. At the core of this shift are several intersecting motivations: strengthening the resilience of the pharmaceutical supply chain, reducing dependence on foreign manufacturers, and aligning more closely with US regulatory standards.
The push for US-based pharmaceutical manufacturing
As one of the world’s largest biopharmaceutical companies, Amgen is leading a resurgence in US-based drug manufacturing with investments totaling over a billion dollars in new Ohio and North Carolina facilities. Amgen’s facility in Ohio, a nearly 300,000-square-foot site, is dedicated to final assembly and packaging of biomedicine products, while its North Carolina facility will soon produce multiple drug substances, increasing its manufacturing capacity to meet growing US demand.
This movement isn’t exclusive to Amgen; Eli Lilly has committed $4.5 billion toward a new manufacturing plant in Indiana, and BeiGene is putting $800 million into a flagship biologics facility in New Jersey. AstraZeneca, too, is bolstering its US footprint with a $300 million state-of-the-art manufacturing site in Maryland focused on cancer trials and cell therapy platforms.
This investment wave is largely driven by three core factors. First, recent global disruptions, including the Covid-19 pandemic, highlighted the need for resilient and geographically diverse supply chains. Second, regulatory alignment with US standards offers significant advantages, as it reduces the risk of compliance issues and delays associated with foreign manufacturing. Finally, an overarching goal is to bolster national security by ensuring a reliable domestic supply of essential medicines.
The benefits of enhancing supply chain resilience
The pandemic served as a wake-up call for the global pharmaceutical supply chain, revealing its vulnerabilities and underscoring the need for a more robust and resilient infrastructure. Approximately 72% of active pharmaceutical ingredient (API) facilities supplying the US are located overseas, with 13% based in China and nearly half in India.
The reliance on foreign production not only heightens risks during global disruptions but also raises concerns around quality control and regulatory compliance. For Big Pharma, increasing US-based manufacturing is a strategic move to mitigate these risks. Through the introduction of Executive Order 14017, the US government has made it a priority to fortify domestic supply chains for essential goods, including pharmaceuticals.
The advantages of domestic production extend beyond supply chain resilience. With local facilities, pharmaceutical companies have enhanced oversight of the entire drug production process, from initial API synthesis to final packaging. This end-to-end visibility not only strengthens quality control but also reduces the risks of non-compliance with FDA standards, which can be more challenging to enforce across international borders.
Financial implications and potential cost savings of US-based production
While the initial costs of shifting to US-based manufacturing are considerable, the long-term financial outlook suggests a range of benefits that could offset these upfront expenses. Investments in US facilities are often associated with higher labor costs, stringent regulatory requirements, and significant operational expenses. However, pharmaceutical companies are likely to see several financial advantages over time, including reduced transportation costs, lower import tariffs, and simplified logistics that come with operating domestically.
One key benefit of US-based production is the reduced dependence on complex international logistics networks. Transporting pharmaceuticals internationally involves navigating various customs regulations, high shipping costs, and handling risks for temperature-sensitive products.
Another advantage of US-based manufacturing is the reduction in compliance-related costs associated with cross-border regulations. US manufacturing allows companies to align more closely with FDA standards, which can help prevent regulatory delays, compliance issues, and the costly recalls that often arise from quality discrepancies in international production.
The proximity of manufacturing to the US market could help stabilize or reduce drug prices in the long run. Lowered import tariffs and minimized logistics costs contribute to making local manufacturing a financially viable strategy, despite the higher labor and regulatory costs associated with US operations. While short-term production costs may increase, these savings on logistics, compliance, and tariffs may ultimately benefit consumers by curbing drug price inflation.
Quality control and the advantage of local market proximity
Beyond financial and logistical benefits, US-based manufacturing enables pharmaceutical companies to enhance quality control, particularly for complex or temperature-sensitive medications. Domestic production provides a level of oversight across the entire production lifecycle that is difficult to achieve with overseas facilities.
For products requiring precise cold chain management—such as vaccines and biologics—local manufacturing brings an added layer of security. With the ability to control storage and transport conditions more effectively, companies can ensure that drugs maintain their quality and potency until they reach patients.
With these advantages, US-based production aligns closely with FDA regulatory standards, minimizing the risks of recalls and quality issues that are more common in international manufacturing. Maintaining facilities within the US reduces delays related to import inspections and compliance discrepancies that often arise with international production.
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