U.S. pharma’s sourcing outlook: Is your supply chain ready for potential shifts?

Like the pharmaceutical industry worldwide, the U.S. pharma sector depends on global suppliers to manufacture essential medications, with a significant share of active pharmaceutical ingredients (APIs) and raw materials coming from China. Shifting geopolitics, trade policies, and recent public health challenges have heightened concerns about this reliance, prompting companies to explore alternative options.

In this article, we’ll explore U.S. pharma’s dependence on global suppliers, potential supply chain disruptions, and the importance of diversifying sources. You’ll also discover alternative sourcing options and insights to help your organization enhance stability and resilience.

The geopolitical landscape and its impact on U.S. pharma supply chains

Global supply chains rarely evolve in isolation; they develop within the context of international politics and economic policies. For the pharmaceutical industry, the geopolitical environment can significantly influence raw material sourcing, production timelines, cost-effectiveness, and overall market stability. 

In recent years, tensions between major economies and shifts in trade policies have exposed vulnerabilities in pharma’s reliance on certain regions. For instance, China’s recent revisions to its State Secrets and Data Security laws triggered significant concerns within the global pharmaceutical sector, but especially within the German market.

The U.S.-China relationship, in particular, has been under the spotlight due to various trade disputes. These disputes have, at times, resulted in tariffs, policy changes, or constraints on exports, affecting pharma supply chains for critical ingredients. 

At the same time, public health crises have forced the pharmaceutical sector to re-evaluate its dependencies. The COVID-19 pandemic, for example, revealed bottlenecks in global logistics, leading to delayed shipments of APIs and finished products. 

Although the worst disruptions have eased, the lessons learned remain: disruptions in any single node of a complex supply chain can result in widespread consequences.

How potential changes may disrupt U.S. supply chains

Looking ahead, several changes could further disrupt supply chains in the U.S. pharma sector.

1. Ongoing U.S.-China tensions
Continued economic and political friction between the United States and China could lead to stricter regulations, reducing the predictability of trade. If regulations on API exports tighten or if tariffs become prohibitive, manufacturers might experience higher production costs and longer lead times.

2. Potential domestic legislation
The U.S. government has considered various measures to strengthen domestic production capabilities and reduce reliance on foreign sources. For instance, President Trump had proposed or supported legislative efforts such as the Biosecure Act, designed to encourage onshore production of critical medical supplies and pharmaceuticals. Should any version of the Biosecure Act or similar legislation gain traction, it would likely provide incentives, grants, or mandates for U.S.-based pharmaceutical manufacturing.

The Biosecure Act or comparable bills could be passed within the next 1-3 years. If enacted, these regulations could mandate domestic production of certain pharmaceuticals or medical supplies, signaling a move away from China-centric supply chains. This shift would necessitate diversifying suppliers across other regions or expanding local production capacity, potentially requiring substantial short-term investments.

3. Environmental regulations
China has tightened its environmental regulations on chemical production in recent years. While these policies aim to reduce pollution, they can also constrain output from certain factories, decreasing supply and increasing prices of key materials. If further regulations are introduced, pharma manufacturers that depend on a small set of Chinese factories may find themselves facing sudden shortages or production delays.

The extent of U.S. pharma’s dependence on Chinese suppliers

A substantial portion of APIs used in U.S. pharma (over half in certain categories) comes from China, according to Qualifyze’s extensive database and other sources like FDA reports.

This dependence extends beyond APIs to include raw materials, excipients, and even finished formulations. The scale of this reliance is not limited to small or mid-sized pharmaceutical companies. Even multinational giants rely on Chinese factories for chemicals, intermediates, and APIs, as these components are essential to producing various prescription drugs, over-the-counter medications, and dietary supplements.

China’s pharmaceutical sector thrives on cost-efficiency, large-scale production, and government support. Over time, these advantages have attracted global companies looking to lower production expenses and enhance competitiveness, but this dependence comes with some risks.

Concerns associated with U.S. pharma’s dependence on Chinese suppliers

Relying heavily on a single country (regardless of which one) for a critical component of the supply chain can present risks. The U.S. pharma industry is currently evaluating the implications of its dependence on Chinese suppliers, with key concerns including:

1. Geopolitical tensions: Heightened trade disputes between the U.S. and China can lead to immediate disruptions, tariffs, or export restrictions, impacting supplies of APIs and raw materials.
2. Regulatory constraints: Changes in regulations, such as tighter environmental rules in China, can unexpectedly limit production capacity, leading to shortages or cost increases.
   
3. Quality control: While many Chinese manufacturers adhere to international standards, lapses in quality control or compliance can still occur, resulting in recalls or reputational damage.
4. Single-source vulnerability: When numerous companies rely on the same factories for essential inputs, a shutdown or delay in one facility can have a ripple effect across the industry.

By understanding these risks, pharmaceutical companies are proactively taking steps to mitigate potential disruptions and ensure patient care remains uncompromised.

Resilience in pharma supply chains often begins with diversification. 

Building resilient and diversified supply chains with Qualifyze

At Qualifyze, we believe that organizations must strategically partner with multiple manufacturers to reduce risk rather than sourcing APIs and raw materials from a single country or supplier.

For instance, splitting large orders or relying on multiple regions for the same ingredient can help mitigate the impact of unforeseen events or regulatory changes.

As the industry explores alternatives beyond China, several regions, including the United States, are already recognized as potential suppliers of pharmaceutical raw materials and APIs, providing a more stable geopolitical environment. Here’s a look at other key sourcing regions:

1. United States: The U.S. boasts a well-established pharmaceutical manufacturing industry, known for its cutting-edge technology, strict regulatory oversight, and reliable infrastructure. While production costs can be higher, the assurance of compliance and quality makes it a trusted choice for pharmaceutical sourcing.
2. India: India is often cited as a major alternative for API and generic drug manufacturing. The country has a large, well-established pharmaceutical industry with a history of exporting globally. However, like China, India also relies on external suppliers for certain raw materials, so a diversified approach within India is key.
3. Europe: Countries like Germany, Italy, and Switzerland maintain high-quality pharmaceutical manufacturing sectors, backed by stringent regulatory standards. While costs may be higher, this region offers reliable production, advanced infrastructure, and strong compliance records. 
4. Latin America: Some Latin American nations, including Brazil and Mexico, have developed robust pharmaceutical sectors. As these markets grow, companies there are expanding capacity for both regional and global supply. 
   
5. Southeast Asia: Vietnam, Malaysia, and Singapore are increasingly investing in biotech and pharmaceutical manufacturing. Government incentives and improving quality standards make these locations attractive, though smaller production capacity may mean limited volume output.
   

Key products sourced from China and stable alternatives

Leveraging insights from Qualifyze’s extensive database, we’ve compiled a list of highly demanded Chinese products by U.S. pharma companies. The charts below categorize these products and highlight alternative suppliers available in other regions, including the U.S.