BDO’s 2025 Pharmaceutical Tariffs Update

Amid rising R&D costs, strict regulatory requirements, and intense pricing pressures, pharmaceutical companies face yet another challenge: tariff uncertainty.

In September 2025, President Trump threatened triple-digit tariffs on branded pharmaceutical imports. The administration then paused these plans to negotiate agreements with large pharmaceutical companies for exemptions on their name-brand products. Questions remained over tariffs on generic drugs before a spokesperson clarified that the administration was not actively considering tariffs on generics. 

In response to these proposed tariffs, pharmaceutical companies are exploring several tariff mitigation strategies. However, many companies are wary about executing any long-term strategy based on tariffs that may change.


Tariff Mitigation Strategies: Stockpiling vs. Building U.S. Manufacturing Capacity

There are two common strategies that many pharmaceutical companies consider to manage tariff challenges: stockpiling and building U.S. manufacturing capacity.

Stockpiling refers to relocating finished products and APIs to the U.S., rather than storing them in other countries. For this strategy to be effective, pharmaceutical companies need to move materials to the U.S. before the tariffs go into effect.

Building manufacturing facilities in the U.S., on the other hand, makes it possible for pharmaceutical companies to manufacture products domestically, simplifying supply chains and regulatory compliance while avoiding tariffs. Given the extensive resources required to execute this strategy, it is only cost-effective if domestic manufacturing can provide value beyond simply tariff avoidance. 

The table below outlines the benefits and challenges of each strategy in greater detail.


Stockpiling vs. Building Manufacturing Capacity

Strategy
Benefits
Challenges

Stockpiling

  • Allows companies to mitigate costs and risks more quickly, as opposed to more time-intensive strategies (e.g,. reshoring)
  • Makes it easier to quickly respond to a sudden spike in demand 
  • Reduces the risk of supply chain disruption, especially in periods of high demand
  • Presents a cash flow risk, as companies invest in inventory they cannot immediately sell
  • Stockpiling costs have to be capitalized and no deduction can be taken until the products are sold
  • Demand decreases may require companies to discount products, which can result in losses
  • Product quality and safety may degrade over time. If products expire and can no longer be sold, companies will need to write-off their inventory.
  • Regional regulatory requirements can make it difficult to ship products to another country experiencing a spike in demand
  • Can cause strain across the entire pharmaceutical supply chain (e.g., shortages in APIs and finished products) if multiple companies are stockpiling at the same time

Building U.S. Manufacturing Capacity

  • Allows pharmaceutical companies to gain direct control over their drug production and supply chain
  • Simplifies supply chains by avoiding complex customs regulations and high shipping costs
  • Mitigates compliance risk as manufacturers have greater oversight into operations and direct access to regulators
  • Building new factories is expensive, as construction and labor costs are generally higher in the U.S. than elsewhere
    • Tariffs could be overturned by courts or in future administrations, which is why building domestic manufacturing should provide value beyond tariff avoidance. 
  • There is a scarcity of viable manufacturing locations, given the need for a skilled workforce in the surrounding geography
  • Timelines to build new facilities take several years at a minimum due to building permits and regulatory requirements
  • After the facility has been built, obtaining licensing for production can take six months to over a year
  • Facilities with no FDA inspection history tend to have longer timelines for inspection and approval

While both stockpiling and building manufacturing capacity can provide substantial benefits to pharmaceutical companies, they also come with clear risks and costs that may outweigh any savings. To understand whether these strategies are viable options, pharmaceutical companies need to turn to scenario modeling.


Understanding Potential Impacts with Scenario Modeling 

Scenario modeling allows companies to assess the implications of different tariff environments, as well as how a variety of strategies — like stockpiling and building domestic manufacturing capacity — could affect finances and operations. This exercise helps companies forecast not only immediate impacts, but also downstream effects to manufacturing timelines and costs.

Consider a company that produces a branded cardiovascular medication and achieves $2.5 billion in annual revenue. This company currently sources all of its active pharmaceutical ingredients (APIs) from India and China, with final manufacturing split between facilities in Mexico (50%), Ireland (40%), and the U.S (10%). 

As soon as the Trump administration announced the possibility of 100% tariffs on imported branded pharmaceuticals, the company took to scenario modeling to understand how their costs would change. Based on the above information, the model identifies how much of their finished product would be subject to tariffs (90%), as well as how much they would pay in tariffs on the imported APIs from China and India for the 10% of product that the U.S. manufactures domestically.

Once the company understands their expected cost increases, they can analyze the impact of possible tariff mitigation strategies. For example, if the company decides to stockpile the finished product as well as APIs before tariffs go into effect, the model can determine:

  • The potential impact on costs, both in terms of savings from tariff avoidance as well as additional costs associated with moving and storing the finished product and material
  • The risks the company is most likely to face, including potential impacts to cash flow based on demand forecasts, expiration date timelines, and new accounting and tax requirements
  • Short- and long-term changes the company would need to implement to mitigate potential challenges and the feasibility of these changes
  • Overall impacts to EBITDA and COGS over the next one, three, and five years.

Based on this information, the company could determine whether stockpiling would be an appropriate response to the proposed tariffs.

Scenario modeling requires significant investment, not only in terms of technology, but also in the time and effort required to use it effectively. Companies that do not possess the right skills internally may consider working with a supply chain advisor who can conduct a comprehensive supply chain analysis using advanced modeling


Looking Ahead

Tariff uncertainty is driving pharmaceutical companies to focus on risk mitigation, redirecting resources from research and development, supply chain improvements, and innovation. As a result, we expect to see upward pressure on drug prices and greater hesitation from potential investors

The pharmaceutical industry is proactively raising this issue with policymakers, which has resulted in some adjustments to planned tariffs. For example, the industry’s concerns around the financial infeasibility of manufacturing generics in the U.S. resulted in lawmakers instituting a tariff exemption. Further tariff adjustments are likely, as the industry continues to address these challenges with policymakers. Pharmaceutical companies should not assume that tariff policies will remain static when conducting their scenario planning. 

The Trump administration may also be interested in negotiating lower drug prices with pharmaceutical companies in exchange for tariff protection. The administration recently announced a deal to afford tariff protections to a drug developer in exchange for aligning drug prices with the lowest prices paid in other developed nations. The agreement primarily applies to state Medicaid programs and through a new direct-to-consumer website. 

How BDO Can Help

BDO can help pharmaceutical companies create scenario planning models to understand how tariffs impact their business, as well as the regulatory complexities and financial implications of supply chain decisions. We support businesses in evaluating potential tariff risk, as well as the customs and trade implications of manufacturing or sourcing in alternate geographies. We also provide regulatory support services, chemistry manufacturing and control (CMC) services, and manufacturing strategy and operational consulting. 

Need to rethink your pharmaceutical supply chain and manufacturing process? Contact us today to get the support you need.