Pharma Reshoring and the New Category of Execution Risk

Pharma’s manufacturing reshoring ambitions have outpaced the industry’s ability to execute them. Companies are launching multiple, concurrent capital programs on a scale and timeline the industry has never experienced — without a proven playbook. The result is a growing tension between aggressive growth targets and the realities of regulatory complexity, supply-chain constraints, and limited experienced talent.

A wave of pharmaceutical manufacturing is returning to the U.S. after decades of offshoring practices born from cost-cutting measures and tax incentives. While the U.S. labor market remains costly, policy pressure, tariff exposure, geopolitical risk, and hard lessons about supply-chain fragility have converged into a single strategic conclusion across the drug industry: Critical medicines production needs to sit on or near U.S. soil. The scale of announced domestic investment is striking — the White House’s public investment tracker now puts total announced U.S. pharmaceutical investment at roughly $428 billion, though not all of that figure is construction or infrastructure capital.^[1]

That is the headline. The harder truth sits underneath it: the organizations making these commitments are executing capital programs that are bigger, faster, and more complex than anything their delivery models were designed to handle. This is not another build cycle. Across the sector, programs are launching at a pace dictated by urgency rather than readiness — and the early signals are familiar: cost increases, schedule pressure, scope that continues to evolve well into execution, and an incredibly complex regulatory compliance environment layered across federal, state, and local governments comprised of agencies who also are also adapting to these conditions in real time

Why Now — And Why Is It Different?

Reshoring is not being driven by a single policy lever. It is the compound effect of several at once: trade and tariff measures that penalize import dependence; national-security attention on the sourcing and supply of essential medicines and active pharmaceutical ingredient; investor pressure for resilient supply; and a desire to limit the risk of counterfeit and diverted components and finished goods. The result is that decisions, which once took years, are being made in quarters. Demand is being reshaped as well by breakout therapeutic categories — the surge in GLP-1 medicines chief among them — which is pulling forward decisions on how much capacity, and what kind, needs to sit onshore.

What makes this distinct from anything before is the combination of four forces operating simultaneously:

• Size — Individual programs now routinely reach projected costs into the multiple billions. With that scale comes a level of capital exposure, delivery complexity, and organizational demand that stretches even the most experienced project teams. A single multi-billion-dollar pharmaceutical manufacturing program is, on its own, among the most demanding capital endeavors any organization can undertake.
• Overlap — What elevates this beyond any prior build cycle is that these programs are not happening one at a time. Across the industry, and within individual companies, multiple multi-billion-dollar programs are running simultaneously, competing for the same engineering firms, the same qualified contractors, the same craft labor, the same regulatory bandwidth, and the same manufacturing expertise. Increasing the challenge is the geographic clustering where several sponsors are building flagship programs in the same region. The overlap and geographic clustering are what turn manageable complexity into systemic risk, and it is what makes this reshoring wave genuinely unprecedented.
• Speed — Tariff and competitive pressure is compressing timelines to the point where companies launch before scope, cost, and execution plans are fully defined. At that pace, aligning the full spectrum of internal stakeholders — finance, technology, operations, regulatory, procurement, project delivery, and the board — becomes its own execution challenge — and misalignment at the front-end compounds cost and schedule risk throughout delivery.
• Complexity — Many of these programs involve advanced modalities — biologics, prefilled syringes and autoinjectors, sterile fill-finish, and cell and gene therapy — where validation requirements, regulatory oversight, and technical start-up demands add layers of technical risk. These are highly specialized environments where every aspect of every process is prescriptively controlled by regulatory requirements, and the consequences of a design or construction misstep extend well beyond cost and schedule. 

Each of these may be manageable individually. Together, they compound and create significant potential headwind. We call it the 10x problem: Ten times the capital at risk, a fraction of the time to plan, and a level of interdependence that makes a delay in one workstream a delay in all of them.

5 Early-Stage Failure Points in Pharma Manufacturing Capital Programs

The 10x problem does not distribute its risk evenly. Across large pharma capital programs, it concentrates at five recurring points — and none of them announce themselves at groundbreaking. Risk is seeded early and surfaces late, and each of these failure points should be treated as a design constraint, not a surprise:

1. Scope ambiguity at launch. Speed forces commitment before definition. Capital is approved against an investment thesis that has not yet been translated into a defined, costed, executable scope — and the gap is filled later, expensively, through change orders and rework.
2. Compressed timelines. Scheduling is treated as the constraint to beat rather than the risk to manage. Validation, commissioning, and regulatory readiness — the activities that actually gate production — get compressed last and hardest.
3. Lack of alignment among stakeholders. There are often misalignments within the organization with the executive, operations, technology, procurement, finance, and project delivery each having different drivers and priorities. Add to that any misalignments with the engineering, procurement, and construction management (EPCM) firms and associated subcontractors and advisors, schedule and cost can both balloon.
4. Labor and materials constraints. Specialized construction labor is finite, and when several mega-programs cluster in one geography, the workforce becomes the binding constraint on every schedule in the region. Materials compound the pressure: heavy dependence on imported goods — including steel and large, custom, highly specialized manufacturing equipment (mixers, bioreactors, and the like) can strain supply well before installation and belongs in planning and scoping from the outset.
5. Regulatory misalignment or inflexible design. If compliance is treated as a downstream checkpoint instead of a design input, design decisions can create regulatory exposure that is only discovered when it is most expensive to fix. The Food and Drug Administration has committed to streamline regulatory requirements and is working to achieve efficiencies through the Pre-Check Pilot Program, leaving the environment in some flux. Manufacturers will need to remain somewhat nimble in response to regulatory changes that could emerge from this program — whether they are directly participating or not.

The pattern across all four is the same: programs that are funded to build but not structured to deliver. Execution readiness is the discipline designed to change that.

The Foundations of Execution Readiness

At the scale and pace of today’s programs, having strong engineering partners, EPCM firms, and procurement infrastructure is necessary but no longer sufficient. What this moment demands, and what most capital delivery models were not structured to provide, is a dedicated manufacturer-side capability that holds the full program accountable to outcomes: not just construction milestones, but cost certainty, regulatory alignment, workforce readiness, stakeholder engagement and alignment, and, ultimately, product release.

Execution readiness is the discipline that connects those dimensions. It means the business case, the capital delivery and project execution strategy, regulatory strategy, stakeholder engagement, and workforce plan are aligned into a single coordinated model — so decisions are made with full visibility into cost, schedule, and risk across the entire program lifecycle and all stakeholders. It is not a single-function role. Vendors and delivery partners are structured to optimize their own scope; execution readiness sits at the manufacturer’s side, ensuring that the sum of those parts actually delivers the investment thesis.

This is, by design, a cross-functional discipline — spanning capital projects, regulatory strategy, labor economics, finance, and risk. And as programs grow larger, run in parallel, and carry higher technical complexity, the absence of that coordination becomes the single greatest source of preventable loss on a capital program.

6 Questions Every Board of Directors and Senior Executive Should Be Asking

If you are accountable for one of these programs, the test is not whether you have a builder. It is whether you can answer these questions with confidence:

1. Who on our team — not our EPCM, not our contractor — owns the realization of the investment thesis, and do they have real-time visibility into cost, schedule, and risk across every workstream and buy in from all internal stakeholders?
2. Is our scope defined well enough to support the capital we have already committed — and if not, how are we managing that gap deliberately rather than absorbing it into the schedule?
3. Are we managing our portfolio of programs as a single portfolio — with visibility into how shared labor, contractors, and regulatory resources are allocated across concurrent builds — or are we running parallel programs as if each exists in isolation?
4. Are our timelines aspirational or achievable given the complexity of our projects and the ecosystem in which we are pursuing them — and do we have a clear, coordinated approach to regulatory requirements and potential downstream hurdles?
5. Are all our key stakeholders — internal departments, executive team, board, EPCM, external advisors — operating in concert toward a shared aim?
6. Have we planned for the distance between “construction complete” and “product released,” or are we assuming it away?

The market does not lack ambition. It lacks the specialized depth to deliver programs of this scale on the aggressive timelines expected by policymakers.  The gap between capital committed and investment realized is exactly where independent advisory changes the result.

How Ankura Can Help

Successful pharmaceutical capital programs require more than engineering and construction expertise; they demand alignment across operations, workforce strategy, regulatory compliance, governance, finance, stakeholder engagement, policy and communications, and execution planning. Ankura combines industry-leading professionals from across these disciplines into a single integrated team, enabling clients to navigate complexity, mitigate execution risk, and deliver transformative capital programs with greater confidence and certainty.

Notes

[1]The $428 billion figure is the sum of 26 announced Pharmaceuticals & Biotech commitments in the White House’s public investment tracker (Investments — The White House), which total $428.4 billion. The figure spans research, development, and capital — of which construction and infrastructure capital is a subset. See White House Investment Tracker. Available online at: https://www.whitehouse.gov/investments/.

^{© Copyright 2026. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC, its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.}