Biopharma Firms Shift FDA-Approved Drug Manufacturing to Europe Despite US Tariffs, Widening Outsourcing Gap to Historic Levels
核心洞察
In 2025, Europe recorded more than triple the contract manufacturing deal volume of the US for FDA-approved drugs, the widest gap in five years despite a 15% US tariff on EU pharmaceutical imports.
Nine of 14 US-based pharma companies, including Johnson & Johnson and Vertex Pharmaceuticals, signed 13 Europe-based manufacturing deals in 2025 compared to just eight domestic contracts.
Germany emerged as Europe's leading hub, accounting for 12 contract manufacturing deals for US-market drugs in 2025, while Ireland's share of dose manufacturing contracts doubled from 6% to 13%.
US contract manufacturing deals for FDA-approved drugs recorded their steepest decline in five years during 2025, even as record tariffs on EU pharmaceuticals came into force, according to new data from intelligence platform GlobalData (搜索). Despite a 15% US tariff on European pharmaceutical imports, biopharma companies are increasingly outsourcing US-market drug manufacturing to European contract development and manufacturing organisations (CDMOs) rather than domestic providers.
In 2025, Europe recorded more than triple the contract manufacturing deal volume of the US — the widest gap in the five-year period analysed. The first half of 2026 is continuing that trend, with 50% of new drugs having dose manufacturing contracts with European-based facilities, almost doubling their share since 2023. By contrast, the proportion for US-based facilities has remained a static 18% since 2024.
Post-Pandemic Recovery Gives Way to Divergence
Katia Djebbar, Pharma Analyst at GlobalData (搜索), explained that the post-pandemic recovery initially lifted deal volumes on both sides of the Atlantic. "Between 2023 and 2024, deal volume increased in both the US and Europe as the industry recovered post-pandemic," she noted. The steep US decline seen in 2025 therefore represents a sharp reversal of that trajectory.
The gradual decline in both US-based and Europe-based contract manufacturing deals for FDA-approved drugs between 2020 and 2023 was largely attributed to the rise and subsequent fall of Covid-19 vaccine emergency demand over that period. However, the 2025 data marks a decisive break from historical patterns.
Germany and Ireland Lead European Manufacturing Growth
Germany is emerging as the focal point of Europe's growing appeal. According to GlobalData (搜索)'s Drugs by Manufacturer database, Germany accounted for 12 contract manufacturing deals for US-market drugs in 2025 alone, averaging nine per year during the 2020–25 period, consolidating its position as Europe's leading pharmaceutical manufacturing hub. Germany contributed just over a fifth of European dose outsourcing for new drugs in 2025.
Ireland has also seen substantial growth, with Irish facilities accounting for 13% of the region's dose manufacturing contracts in 2025, up from approximately 6% in 2024. This increase coincides with Ireland's enhancement of its Research and Development (R&D) Corporation Tax Credit to 35% in January 2026, building on an earlier increase in 2024 from 25% to 30% — now one of the most competitive rates in Europe. Germany similarly offers a generous R&D tax credit of 25–35%. By comparison, the US offers companies an Alternative Simplified Credit of between 6% and 14%, depending on increases in R&D spending.
US-Based Companies Drive the European Shift
US-headquartered companies are among those driving the trend. Nine of the 14 US-based pharma firms that outsourced manufacturing in 2025 — including Johnson & Johnson and Vertex Pharmaceuticals — signed a combined 13 Europe-based deals. Fewer than half invested in US facilities, completing just eight domestic contracts.
The shift extends beyond outsourcing. Novo Nordisk and Eli Lilly announced investments of $501 million and $3 billion, respectively, to expand their European manufacturing sites. Novo Nordisk is planning to scale up its tablet facility in Ireland to support US demand for Wegovy in pill form — the first and only oral GLP-1 receptor agonist (搜索) approved in the Western market following recent FDA approval.
Biosimilars and Specialised Manufacturing
Biosimilars, in particular, tend to require scalable commercial manufacturing and specialised production technology. Celltrion Inc., which specialises in generic and biosimilar drug development, outsourced nine dose manufacturing contracts to European facilities in 2025, up from seven in 2024, reflecting its reliance on specialised European manufacturing partners.
Policies such as R&D tax credits represent one lever for countries to encourage CDMOs to develop manufacturing techniques and technologies, and support the expansion of specialised facilities on European soil.
A Structural Rather Than Temporary Shift
Djebbar warned that the data signals a structural rather than temporary shift. "The region, with Germany in particular, is increasingly becoming an attractive and well-established hub for pharma manufacturing for the US market," she said. "Such a shift may hinder the current US administration's plans to reshore domestic contract manufacturing."
For biopharma supply chain and CDMO professionals, the data underscores the growing strategic importance of European manufacturing capacity and raises significant questions about the efficacy of tariffs as a tool for reshoring pharmaceutical production. A diversified global supply chain, particularly amid the current unpredictability of the US political climate, allows biopharma companies to minimise the associated risks of sudden, catastrophic disruptions to production.