An example of a large scale biologics production facility.
Germfree
Key Takeaways:
· In return for their investment in U.S. manufacturing, the administration would drop a proposed 100% tariffs on branded and patented drugs imported to the U.S.
· Trump’s push for most-favored-nation aims to lower the price of prescription drugs in the U.S. to be in line with the lowest prices paid by other developed countries.
· Despite the best of intentions from FDA, the Trump administration, and drug makers, onshoring will likely not happen overnight and alone will not solve the drug pricing issue.
Offshore manufacturing has long been a vulnerability in the U.S. pharmaceutical supply chain. As of 2025, 69% of generics and 53% of branded drugs used in the U.S. are made abroad, with only 9% of API producers based domestically, 22% are in China, and 44% are in India. This reliance became painfully clear during the pandemic and geopolitical disruptions, which exposed the fragility of global supply chains.
President Trump has called on the biopharmaceutical sector to find ways that put American patients and workers first. Member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) have responded by promising to deliver $500 billion in new U.S.-based manufacturing and infrastructure investment to build both scale and resilience, injecting an estimated $1.2 trillion into the economy.
“For every $1 invested by the biopharma industry, another $1.60 is spent in other areas of the economy, creating a ripple effect,” says Drew Voytal,senior director, Public Affairs & Strategic Initiatives, PhRMA. “These investments will create more than 100,000 jobs, including 25,000 biopharma facility jobs.”
In some cases, these projects take the form of large facilities that they believe are essential to producing complex biologics and next-generation therapies, others are making their supply chains more agile to ensure flexibility and responsiveness in times of disruption.
In return for their investment in U.S. manufacturing, the administration would drop a proposed 100% tariffs on branded and patented drugs imported to the U.S.
New, large sites could result in old problems
Drug makers have spent the last nine months touting their U.S. manufacturing investments amid tariff threats on imported pharmaceuticals. Historical investments include AbbVie, which started construction of a $70 million expansion at is Bioresearch Center in Worcester, MA, which handles biologics R&D and manufacturing. This builds on the company’s commitment to invest more than $10 billion of capital in the U.S. to support biologics innovation and manufacturing of next-generation oncology and immunology medicines. The company also plans to spend $195 million to build an API production site in North Chicago, set to be fully operational in 2027.
Johnson & Johnson has also promised to invest $55 billion over the next four years; $50 billion from Eli Lilly; and $50 billion from AstraZeneca will help deliver $80 billion in total revenue by 2030, 50% of which is expected to be generated in the U.S. AstraZeneca said in a news release that it will have a three-year exemption from tariffs on their products. AstraZeneca has also reached an agreement with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the company to fully onshore medicines manufacturing so that all of its medicines sold in America are made in America.
A rendering of AstraZeneca's $4.5 billion Virginia manufacturing facility.AstraZenecaAstraZeneca’s commitment includes a $4.5 billion new manufacturing site in Virginia to produce drug substance for the pharma’s weight management and metabolic portfolio. Roche is following suit. Already a net exporter of diagnostic solutions from the U.S. to the rest of the world, Roche is striving to achieve the same for medicines as quickly as possible. An additional pharmaceutical manufacturing site is under construction in North Carolina, further solidifying domestic production capabilities. Roche is also expanding pharmaceutical production at its Oceanside, CA, facility to manufacture additional medicines for U.S. patients.
“We currently have 50% spare capacity at our U.S. production sites,” a Roche Group Media Relations tells Healthcare Packaging. “We have also transferred the technology for manufacturing one of our drugs to the U.S. Unlike competitors with concentrated manufacturing, Roche has one of the industry's broadest global networks, with major sites in the U.S., Switzerland, Germany, Singapore, and Japan. This allows for product registration at multiple sites, ensuring supply security and the flexibility to re-route production as needed. We are therefore confident in our ability to maintain an uninterrupted supply of medicines to patients worldwide.”
A broader network of sites could be a better approach to avoid supply disruptions. “Large-scale facilities may seem like the solution, but they don’t solve the agility and resilience challenges facing U.S. pharma,” says Carol Houts, chief strategy officer of Germfree, makers of cGMP-compliant pharmaceutical isolators. “Companies focused solely on mega-sites risk replicating old vulnerabilities.” Germfree’s strategy centers on modular platforms that support both onshore and decentralized manufacturing models, ensuring flexibility and speed.
Addressing API chokepoints
She goes on to say that the future lies in regionalized, modular, and digital networks: utility-rich API clusters, decentralized fill-finish hubs, and point-of-care micro-facilities. “If APIs and key starting materials remain offshore, domestic finished‑dose plants still depend on fragile inputs. The fastest path to resilience pairs fit‑for‑purpose modular facilities with policy and procurement that reward availability and readiness. So, onshoring is necessary, but not sufficient.”
Hazardous BSL_3 GMP facility with containment isolator.GermfreeAddressing the API chokepoint demands targeted policy and economic incentives, as well as infrastructure. APIs are inexpensive to import from India and China, making U.S. production cost-prohibitive without support, explains Houts.
Support could be in the form of FDA’s Advanced Manufacturing Technologies (AMT) and PreCheck initiatives. These two programs are designed to onshore and modernize U.S. pharma manufacturing. While AMT encourages use of innovative technologies, the voluntary PreCheck program streamlines the review and approval of new production facilities.
“These frameworks may accelerate U.S. facility readiness and speed domestic readiness, while providing earlier, structured interactions (design, construction, pre‑production) through streamlined CMC processes,” says Houts. “Those tools help, but agility will define the next generation of manufacturing leaders.”
Delayed tariffs bring down drug prices
The next generation of pharma leaders may be those who find a way to lower the cost of prescription drugs. Trump’s push for most-favored-nation (MFN) aims to lower the price of prescription drugs in the U.S. to be in line with the lowest prices paid by other developed countries. This initiative was pushed through with executive orders and direct negotiations with pharmaceutical companies.
For example, AstraZeneca will provide Direct-to-Consumer (DTC) sales to eligible patients with prescriptions for chronic diseases at a discount of up to 80% off list prices. AstraZeneca will participate in the TrumpRx.gov direct purchasing platform, which will allow patients to purchase medicines at a reduced cash price from AstraZeneca. AstraZeneca has also reached an agreement with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the company to fully onshore medicines manufacturing so that all of its medicines sold in America are made in America.
Similarly, Pfizer (which also agreed to a three-year grace period during which time its products under a Section 232 investigation won’t face tariffs provided further invest in U.S. manufacturing) has voluntarily agreed to implement measures designed to ensure Americans receive comparable drug prices to those available in other developed countries and pricing newly launched medicines at parity with other key developed markets. Pfizer will also participate in TrumpRx.gov. The large majority of the company’s primary care treatments and some select specialty brands will be offered at savings that will range as high as 85% and on average 50%.
Not everyone is a fan of MFN. “Proposals like most favored nation price controls and tariffs will undermine American leadership of the biopharmaceutical industry and limit treatment availability for patients,” says Voytal of PhRMA.
Generics play a vital role in domestic manufacturing
Making more drugs available and less expensive are the objectives of generics manufacturers. As part of an overall policy goal of the current Administration to increase U.S.-based manufacturing, the FDA recently launched a pilot prioritization program for the review of abbreviated new drug applications (ANDAs) for generic drugs that aims to spur and reward investment in U.S. drug manufacturing and research and development by providing faster reviews for generic-drug companies that test and manufacture their products in the U.S. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the U.S. and whose products are made in the U.S. using exclusively domestic sources for active pharmaceutical ingredients (APIs) are eligible for priority review.
“The Association for Accessible Medicines (AAM) applauds FDA’s leadership in establishing the ANDA Prioritization Pilot Program and appreciates the agency’s recognition that generic medicines play a vital role in strengthening the domestic pharmaceutical manufacturing base,” an AAM spokesperson tells Healthcare Packaging.
Hillsboro, Roche’s primary manufacturing site for U.S. drug products.Roche
AAM also recognizes that it will take time to expand domestic capacity for key elements of the program and to meet the three criteria as currently outlined: bioequivalence (BE) testing, active pharmaceutical ingredient (API) production, and finished dosage form manufacturing. “We are hopeful that the pilot will remain available and adaptable as this capacity grows, and that FDA will continue to refine the program in response to lessons learned during early implementation,” says the spokesperson.
AAM is encouraging FDA to consider a tiered eligibility structure to broaden participation, promote incremental progress toward full onshoring, and generate practical insights to inform the future evolution of the pilot program. AAM also encourages FDA to clarify and maintain flexibility in how it defines “domestic” API manufacturing for the purposes of the pilot. “We recommend that FDA adopt a pragmatic, risk-based approach that recognizes the value of performing substantial manufacturing operations in the U.S.,” says the AAM spokesperson. “Such flexibility would help ensure that the pilot remains inclusive, attainable, and effective in driving meaningful investment in U.S.-based API production, while maintaining the program’s core intent of strengthening supply-chain resilience.”
The spokesperson, does, however, admit that making generics in the U.S. won’t make generics drugs cheaper for U.S. patients. “In fact, production costs will go up for generic manufacturers.”
Onshoring will not happen overnight
Despite the best of intentions from FDA, the Trump administration, and drug makers, the spokesperson says that onshoring will not happen overnight and alone will not solve the drug pricing issue. “It will require sustained collaboration, long-term policy commitment, and an economic environment that supports reliable investment in the production of affordable, high-quality generic medicines in the U.S.,” says the AAM spokesperson.
Houts adds, “The push to onshore drug manufacture is aiming to build strategic resilience, rather than achieving a 100% domestic footprint. Some high-volume products may still be efficiently produced overseas, but critical therapies, sterile injectables, and shortage-prone drugs benefit from proximity to patients and regulators. A hybrid model is emerging; large U.S. hubs for essential generics, modular facilities for urgent needs, and point-of-care sites for advanced therapies.”
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A rendering of AstraZeneca's $4.5 billion Virginia manufacturing facility.AstraZeneca
