GxP Insights: 2025 in Review: The Surge in US-Based Life Sciences Manufacturing

Welcome to our monthly industry insights newsletter, tailored for professionals in Medical Devices, Biologics, Cell & Gene Therapy, and Sterile/Aseptic Manufacturing. Each edition delves into a key industry theme, offering expert perspectives and career insights to help you stay ahead.

This month, as we close out 2025, we turn our attention to one trend that emerged as particularly defining amid a year of rapid technological, regulatory and operational change: the scale and pace of investment in US domestic life sciences manufacturing, and the reshoring movement, reshaping how and where critical medicines and technologies are made.

Why It Matters: $370B+ Committed to US Life Sciences Manufacturing

2025 marked a clear turning point: across pharma, biotech and medtech, companies announced hundreds of billions of dollars in new or expanded US facilities, with major drugmakers alone pledging $370B+ toward US projects over the next five years, much of it manufacturing-led.

In this edition, we unpack the drivers behind the surge, the companies leading it, and what it means as investment turns into execution in 2026.

Why 2025 Became the Year of “Build It Here”

A series of compounding factors made 2025 a tipping point for US life sciences manufacturing:

• Geopolitical uncertainty and the Trump administration’s threat of steep tariffs (up to 100%) on imported branded and patented drugs made offshore production riskier and more expensive.
  
  
• The Covid-19 pandemic legacy of drug shortages exposed deep reliance on overseas APIs and intermediates.
  
  
• Concerns around national security and pharmaceutical resilience sharpened the focus on domestic capacity for critical medicines.
  
  
• These pressures were reinforced by policy tailwinds, including more proactive FDA engagement on new facilities (the FDA’s new “PreCheck” program) and signals of streamlined permitting.
  
  
• And lastly, a demand shock for complex therapies, from biologics and GLP-1s to cell, gene and sterile injectables, where manufacturing capacity, rather than R&D, has become the primary constraint.

Who’s Leading: Major US Manufacturing Commitments in 2025

Several top pharma and biotech players have announced multi-billion-dollar US programs aimed squarely at manufacturing and supply-chain resilience.

Headline commitments include:

Eli Lilly – $27B, four US “mega-sites” 

Lilly has more than doubled US manufacturing investment since 2020 to over $50B, announcing four new domestic sites in 2025. The build-out strengthens domestic medicine production across therapeutic areas, with a focus on manufacturing active pharmaceutical ingredients (API), reshoring critical capabilities of small molecule chemical synthesis, further strengthening their supply chain, and extending the company's global parenteral manufacturing network for future injectable therapies.

AstraZeneca – $50B US manufacturing & R&D expansion 

AstraZeneca plans to invest $50 billion in the US by 2030, underpinning its ambition to reach $80B in global revenue, with 50% generated in the US. The cornerstone is a new multi-billion-dollar drug-substance facility in Virginia, producing small molecules, peptides and oligonucleotides to support the company’s weight management and metabolic portfolio, including oral GLP-1. The investment also expands cell-therapy manufacturing, continuous manufacturing, specialty production, and US R&D hubs, and is expected to create tens of thousands of highly-skilled direct and indirect jobs across the US.

Johnson & Johnson – $55B+, $2B+ biologics site in NC

Johnson & Johnson plans to invest over $55 billion in US manufacturing, R&D and technology over the next four years, including four new advanced manufacturing facilities. The programme begins with a $2B+ biologics site in Wilson, North Carolina, a 500,000-sq-ft facility expanding capacity for next-generation oncology, immunology and neuroscience medicines, supporting ~5,000 construction jobs and 500+ direct roles. The wider investment aims to strengthen domestic production across Innovative Medicine and MedTech, expand R&D infrastructure for lifesaving therapies, and advance technology, creating high-paying, high-technology jobs.

Novartis - $23B, 100% end-to-end US production

Novartis plans to invest $23 billion over five years to expand its US manufacturing and R&D footprint across 10 sites, including seven new facilities. The programme will enable end-to-end US production of 100% of Novartis’ key medicines, spanning API, biologics drug substance, secondary production and packaging, and extending manufacturing across small molecules, biologics, radioligand therapies, and siRNA. The investment includes a $1.1B biomedical research hub in San Diego, new and expanded manufacturing sites across multiple states, and supports growth across oncology, immunology, neuroscience and cardiovascular, renal and metabolic diseases, creating ~1,000 direct jobs and ~4,000 additional US jobs.

Roche – $50B US pharmaceuticals & diagnostics expansion 

Roche plans to invest over $50 billion in US pharmaceuticals and diagnostics over the next five years, expanding manufacturing and R&D across multiple states. The programme aims to strengthen domestic production across diagnostics, gene therapy, weight-management medicines and continuous glucose monitoring, including a state-of-the-art gene therapy manufacturing facility in Pennsylvania and a 900,000-sq-ft centre for next-generation weight-loss medicines. The investment also includes a new Massachusetts R&D hub conducting cutting-edge AI research and serving as the centre for Roche’s cardiovascular, renal and metabolism portfolio, creating 12,000+ jobs (including ~1,000 roles at Roche) and positioning the US as a net export base for Roche medicines.

Bristol Myers Squibb – $40B, increased investment in AI & ML

Bristol Myers Squibb plans to invest $40 billion in the US over the next five years to expand its research, technology and domestic manufacturing footprint, strengthening control over highly complex supply chains and aligning manufacturing more closely with US-based R&D. The programme includes ramping up radiopharmaceutical manufacturing, following the $4.1B acquisition of RayzeBio, and increased investment in AI and machine learning to accelerate innovation. The expansion builds on BMS’s already significant US presence and is positioned to enhance resilience and speed across its development and manufacturing network.

Gilead Sciences – $32B, 3 new state-of-the-art facilities

Gilead plans to invest $32 billion in US manufacturing and R&D through 2030, strengthening domestic research, development and production capabilities while generating an estimated $43 billion in US economic value over the next five years. The programme includes three new state-of-the-art facilities, upgrades to three existing sites, and significant investment in new technology and advanced engineering, supporting ~800 new direct jobs and 2,200+ indirect jobs by 2028.

Sanofi, GSK, Takeda & others – scaling US biologics, vaccine and sterile manufacturing capacity 

Sanofi (≈$20B), GSK (≈$30B), Takeda (≈$30B), Biogen (≈$2B), along with Amgen (≈$650M), AbbVie (≈$195M) and others, have each announced major US expansion programmes focused on biologics, vaccines, sterile injectables and advanced manufacturing capabilities. Collectively, these investments span new facilities, site expansions and technology upgrades, aimed at strengthening domestic supply resilience, supporting pipeline growth, and reducing reliance on overseas production for critical medicines.

The Challenges: Capacity, Costs and the Talent Crunch

The surge in US manufacturing investment represents a major step forward for supply-chain resilience, but it also introduces a set of structural challenges that companies must address in parallel with growth.

1. Talent as the primary constraint: workforce availability is the most immediate and persistent challenge. New and expanded facilities demand far more than traditional manufacturing operators; they require automation engineers, bioprocess and MSAT specialists, validation engineers, QA/QC professionals, digital and data specialists, and experienced operations leaders. These capabilities are already in short supply nationally and are particularly difficult to source outside established life sciences hubs, making recruitment, relocation, and long-term workforce development critical to project success.
   
   
2. Time-to-build, permitting and workforce readiness: bringing a new pharmaceutical manufacturing site online remains a long-term undertaking. Even with modular designs and repeatable templates, planning, permitting, construction, utility upgrades and qualification can take years. In parallel, organisations must build or import a suitably skilled workforce, often into regions without an existing life sciences ecosystem, meaning infrastructure readiness and talent availability can be as limiting as capital.
   
   
3. Cost, competitiveness and global balance: US-based facilities must ultimately compete with long-established international plants on cost and efficiency. Automation, continuous manufacturing and digitalisation help narrow that gap, but they also raise upfront capital requirements and significantly increase expectations for technical skill, digital maturity and operational capability across the workforce. At the same time, reshoring does not eliminate the need for global manufacturing networks. The challenge lies in targeted localisation, bringing critical medicines, APIs and advanced modalities onshore while maintaining diversified international supply to preserve flexibility, manage cost and ensure long-term security.

2026 Outlook: From Commitments to Execution

In 2026, US manufacturing investment moves decisively from commitment to execution, and for some companies, like Gilead and AstraZeneca, that transition is already underway, supported by more structured regulatory engagement as early-stage FDA programmes such as PreCheck gain traction.

Talent availability will remain the critical constraint, forcing companies to treat workforce strategy with the same urgency as capital planning. As investment concentrates, established hubs such as Greater Boston, New Jersey, Pennsylvania, Maryland, North Carolina, plus emerging sites like Alabama and Ohio, will compete not just on incentives, but on workforce depth, utilities, permitting speed, and quality of life.

Closing Thought: the 2025 reshoring wave is not a PR exercise but a structural reset of where, and how, therapies and devices for the US market are made. Whether these investments deliver will depend less on headline capex and more on execution, talent and long-term policy stability, making 2026 the year those bets start to become real.

i-Pharm GxP

At i-Pharm GxP, we work alongside the Life Sciences organizations responding to this shift in manufacturing, regulation and supply-chain strategy, helping them scope, staff, and deliver the GxP talent they need to succeed in a changing landscape.

If you’re exploring your next step, we’d love to connect.

Found these insights helpful? Be sure to share them with your network and subscribe here for monthly updates and exclusive industry insights straight to your Inbox.