Big Pharma’s Dirty Secret: How Outsourcing to China Threatens Global Security

Reclaiming Molecular Sovereignty

Molecules are the lifeblood of critical industries such as drug discovery and agriculture, just as microchips are for any computing device. For a single medicine, including potential pandemic cures, hundreds to thousands of molecules must be produced and tested for biological potency.

Unfortunately, our ability to produce molecules, much like the case with microchips, has been severely handicapped by offshoring. Seventy percent of big pharma companies outsource their synthesis needs, at least partially, to China. Over time, we have short-sightedly shifted expensive labor overseas to cut costs, but at what long-term risk?

Why Domestic Molecule Production Is Strategically Crucial

BGI Group, a Chinese genomics company, exemplifies the risks of relying on offshore research capabilities. A Reuters investigation revealed that BGI has been collecting genetic data from over 8 million women worldwide through its non-invasive prenatal tests (NIPT) branded as NIFTY. These tests not only detect fetal abnormalities but also gather extensive genetic information about the mothers, which is stored in China’s government-funded China National GeneBank. This accumulation of data provides China with strategic advantages in pharmaceuticals and potential military applications, raising significant national security concerns.

Moreover, over 70% of big pharma companies currently outsource their synthesis needs, a trend driven by high labor costs and the manual, time-intensive nature of chemical synthesis. This reliance on offshore synthesis, particularly in regions where adversaries like China are actively building their capabilities, poses long-term risks to national sovereignty and security.

Adding to these concerns, another Reuters investigation exposed that China’s Wuxi AppTec, one of the largest contract research organizations (CROs), has been sharing sensitive data of U.S. pharmaceutical clients with Beijing-based intelligence officials[^5]. This breach underscores the tangible security threats posed by offshoring critical synthesis operations to Chinese firms. Wuxi AppTec’s actions demonstrate how outsourced synthesis can lead to intellectual property leakage and potential misuse of proprietary data, further endangering national and economic security.

A survey by the Biotechnology Innovation Organization (BIO) revealed that a significant percentage of biomanufacturing in the U.S. remains dependent on Chinese facilities. This dependency not only compromises the integrity of pharmaceutical supply chains but also makes the U.S. vulnerable to geopolitical tensions and supply disruptions.

Legislative Action: The BIO Secure Act and Its Impact

In response to these mounting threats, U.S. lawmakers have taken significant steps to curb the risks associated with Chinese biopharma companies. The passage of the BIOSECURE Act is a landmark move aimed at tightening regulations around foreign investments and collaborations in the biotechnology sector. The Act specifically targets companies like Wuxi AppTec, imposing stricter oversight and compliance requirements to prevent the unauthorized sharing of sensitive data with foreign adversaries.

According to PharmaVoice, the BIOSECURE Act seeks to enhance national security by ensuring that critical biopharma operations remain under stringent control. Companies targeted by the Act have voiced concerns over the potential impact on their global operations and competitiveness, highlighting the delicate balance between security and international collaboration. Similarly, Fierce Pharma reports that targeted companies are navigating the new regulatory landscape by reinforcing their data protection measures and reassessing their outsourcing strategies to comply with the Act’s provisions.

The BIOSECURE Act not only addresses immediate security threats but also paves the way for a more resilient and secure domestic biopharma industry. By limiting the extent of data sharing with foreign entities and enhancing the oversight of critical operations, the Act aims to mitigate the risks of intellectual property theft and safeguard national security interests.

We Can't Afford to Miss Out on State-of-the-Art Molecule Production

Severing the molecule synthesis lifeblood will have dire consequences. Biology is poised to become the next major revolution after AI. Advances in fields such as artificial intelligence and translational models are likely to lead to dramatic progress in curing diseases and extending life expectancy. On the flip side, biology can also become a powerful weapon; the recent pandemic opened our eyes to the risks associated with biological threats. We must therefore be able to produce molecules rapidly and cheaply to remain fully sovereign.

The decision to move synthesis outside the Western world was driven by high labor costs. Now that wages are rising, bringing this work back is not feasible unless we fundamentally change how chemistry is done.

Automation: The Key to Reshoring Molecule Production

Automating chemistry has been a dream for decades. Recent advances in robotics have made that dream possible: the hardware exists to execute many of the operations routinely involved in chemistry. Yet this has not happened, mainly because chemical synthesis is highly unpredictable; each synthesis has its own challenges that are solved “on the go.” In Breaking Bad, the protagonist was a brilliant chemist who invented a new way to synthesize a very illegal molecule, then carried out the synthesis manually. This is still how many instances of synthesis work today. In one study, half of the Buchwald-Hartwig couplings (an important class of experiments) at Merck failed—even when performed by highly skilled synthetic chemists.

AI Offers an Opportunity to Reshore Molecule Production - We Must Seize It

The recent rise of AI, coupled with commoditizing advances in automation, creates a unique opportunity for AI-first automation of chemistry. By integrating AI with automation, we can build dark laboratories in which synthesis is carried out fully autonomously. AI can reliably plan all the steps necessary to produce a given molecule, and then these steps can be executed in the lab. By leveraging agentic AI, higher-level projects that require new molecules can be undertaken with the help of an AI-controlled dark laboratory.

Solving Data Availability: The Key to AI-Driven Molecule Synthesis

Where do we begin? Any AI-related matter must be viewed through the lens of data availability. We have abundant data on the internet about the English language, software engineering, and mathematics. Experts predict that in two years, AI will reach near-human levels in software development, acting like a true co-worker. Progress will be fastest in domains rich with data. So do we have enough public data to learn how to produce molecules? Unfortunately, no. Published reactivity data is heavily biased toward reactions that successfully produced the desired product since negative or failed experiments seldom see the light of day. Thus, one critical step in creating dark laboratories is to build sufficiently large datasets to train the AI. Fortunately, advances in miniaturization and automation of chemistry make this feasible.

Building Dark Laboratories: The Future of Autonomous Chemistry

AI-first automation of chemistry is a thrilling opportunity. It will not only boost strategic resilience but also significantly accelerate the discovery of new medicines, cutting both cost and timelines by at least half. Early research in this domain is already promising. By investing in dark laboratories, we can ensure that molecule production remains domestic, secure, and scalable to meet future biological and medical challenges.

Therefore, AI-first automation of chemistry is a space ripe for investment, and the time to act is now.

Piotr Byrski is the Co-Founder and CEO of molecule.one: Warsaw-based company building an AI Chemist and their dark lab.

Piotr Byrski

Founder & CEO - Molecule.one