Architecting a New Framework for Supply Resilience
As global volatility exposes the fragility of lean supply models, the industry is pivoting toward regionalized manufacturing and agile optionality to safeguard patient access.
For many years, the bio/pharma supply chain was operated primarily around cost optimization, which resulted in consolidation of API and raw material sourcing into a handful of global hubs (1). However, over recent years a variety of disruptions and a shifting geopolitical landscape have exposed the fragility of such a lean supply chain model and has led the industry to the consensus that resilience can no longer be a secondary consideration.
“We live in a global environment, and no-one can foretell exactly what might happen from one period of time to another,” remarked Kent Payne, PhD, Managing Partner and Board Member for Wilmington PharmaTech (2). “So, it’s always best to make sure there is a redundancy, if you will, within your supply chain, and a focus on a long-term supply chain diversification and geographic diversification in particular.”
The Momentum of Regionalization
One way of improving supply chain resilience in the current environment is to regionalize production. Through selectively using redundancy and nearshoring/reshoring production, companies can simplify logistics and remove some of the complexities inherent with global supply chains (3).
“The industry momentum behind onshoring and domestic manufacturing resilience is dramatic, particularly when compared to previous years,” stated Ryan Lake, CFO, Lifecore Biomedical (4). “The discussions around onshoring and reshoring have surged to levels that I have never seen before, and this is clearly driven by tariffs, geopolitical uncertainty, quality, and supply chain initiatives from customers.”
Lake pointed out that these drivers are all intrinsically tied to long-term supply risk management and enhanced resilience. “Significant investments by CDMOs and large pharma in U.S. capacity reflect this trend. We are seeing a strong movement toward biopharma leaders rebalancing global manufacturing footprints by prioritizing U.S.-based production to strengthen supply chain security,” he added.
“Regional manufacturing is now a must have and not optional,” concured Elliott Berger, Board Director, Orientation Marketing, and an executive consultant to many pharma services companies and their investors (5). Biopharma companies will need a flexible supply strategy to deliver APIs in each region to bypass geopolitical, tariff, and regulatory issues while staying close to the patient, he asserted.
“U.S. for U.S., Europe for Europe, and Asia (China or Korea or Japan) for Asia production is likely to be the case for most medicines in the future,” Berger predicted (5).
Reshoring Complexity
While the push for domestic manufacturing is intense, it is important to also understand that reshoring is a complex and capital-intensive undertaking that should not be approached with a one-size-fits-all mindset. James Hurst, VP Operations & Charnwood Site Head, Almac Pharma Services, explained that re‑shoring can certainly improve resilience, but organizations often underestimate the cost and effort of changing regions, qualifying new suppliers, or recreating established capabilities. “True resilience means ensuring consistent, reliable supply from development through commercialization,” he said (6).
For Professor Tom Moody, Vice President of API Development and Commercialization at Almac Sciences and Arran Chemical Company, a structural move toward regionalization is apparent within industry at the moment — representing a response to rising raw material costs and the risks created by the heavy concentration of API supply in a few specific geographies. “But reshoring is not a one size fits all solution. The right answer is what I call ‘rightshoring’ — placing each stage of development and manufacturing where regulatory agility, technical capability, and long-term resilience are best aligned,” he proposed (6).
“A key consideration is understanding the regulatory burden. Site transfers often require substantial revalidation and dossier updates, which can introduce operational delays and cost exposure — particularly for older products,” added Moody (6). “Companies also need to account for the growing import compliance complexity created by geopolitical shifts and evolving trade rules; waiting for clarity is no longer a viable strategy.”
Structured Risk Management
“The onshoring conversation has evolved from a reactive response to recent disruptions into a more structured approach to long-term risk management,” specified Jeremie Trochu, CEO of Ardena (7). “Rather than fully reshoring supply chains, biopharma companies are prioritizing regional resilience, ensuring critical manufacturing steps can be executed locally where it matters most, while maintaining flexibility and redundancies across regions.”
As a result of this new approach, industry is seeing global manufacturing footprints being re-balanced, Trochu observed. “Investors and regulators increasingly expect credible regional optionality, such as US-for-US and EU-for-EU supply, combined with enterprise-wide standardization of quality systems, processes and data. The objective is not duplication for its own sake, but predictable execution, transparency, and control across a global resilient network,” he said (7).
“At the same time, the focus is shifting away from building sheer capacity toward improving operational productivity and responsiveness,” Trochu confirmed. “New investments are centered on flexible infrastructure, digital oversight, faster tech transfer and more resilient supplier strategies, allowing manufacturers to adapt to volatility without compromising quality or long-term supply commitments.”
References
Rubió. Supply Chain in Pharma in 2026. Biotech Spain, Feb. 5, 2026.
Thomas, F. DCAT Week 2026: Building a Sustainable Supply. The Pharma Navigator, March 18, 2026.
Celen, W.; Walker, G.-C.; Jain, S.; Taupin, A. A Strategic Approach to Cost in Biopharma. BCG, Nov. 22, 2023.
Thomas, F. J.P. Morgan Healthcare Conference 2026: Investing in Domestic Resilience. The Pharma Navigator, Jan. 9, 2026.
Thomas, F. J.P. Morgan Healthcare Conference 2026: From Speculative Hype to Operational High Conviction. The Pharma Navigator, Jan. 5, 2026.
Thomas F. DCAT Week 2026: Aligning Science and Strategy. The Pharma Navigator, March 25, 2026.
Thomas, F. J.P. Morgan Healthcare Conference 2026: Targeting a Competitive Future. The Pharma Navigator, Jan. 8, 2026.
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