Japan to draft DNA synthesis rules to prevent bioterror misuse amid AI worries

TOKYO -- Japan's government plans to create regulations for contract DNA synthesis, the process in which specialized firms artificially generate DNA based on third-party orders for research purposes. These rules aim to deter bioterrorism and misuse arising from the potential misuse of artificial intelligence (AI) to design harmful pathogens.

As AI technology progresses, it becomes feasible to create viruses and biological entities not found in nature, prompting discussions in the United States and Europe about enhancing safety measures. In Japan, the Cabinet Office will establish a new expert panel to examine drafting guidelines for scrutinizing hazardous DNA sequences and identifying customers' intended use.

Contract synthesis supports various research fields and industries, such as life sciences research, medicine, drug discovery, agriculture, and livestock. It enables research institutions and pharmaceutical companies to specify necessary DNA sequences and have specialized companies synthesize them for studying gene functions or endowing organisms with new capabilities. The top five companies in the United States and Europe account for 50% to 60% of the global market, with Japan also hosting multiple synthesis companies.

Nevertheless, rapid advancements in AI and DNA synthesis technology have raised concerns about potential misuse. In 2023, a research team from Stanford University and other U.S. institutions successfully synthesized DNA based on AI-designed genetic information, creating a novel virus not found in nature. Another team at the Massachusetts Institute of Technology reported in 2024 that they had divided orders for fragments of the Spanish flu virus genome among multiple synthesis companies, later combining them to recreate the virus.

Screening by synthesis companies acts as a deterrent against misuse. In the United States and Britain, guidelines advise companies to verify whether ordered sequences correspond to pathogens or toxins and to confirm customers' intended usage. In 2025, the U.S. administration under President Donald Trump mandated research institutions receiving government grants to utilize DNA synthesis companies adhering to the guidelines.

The European Union is also pursuing legislative action. Japan has lacked public rules thus far, relying on companies' voluntary efforts.

To tackle this issue, the Cabinet Office will form a new expert panel of biosecurity experts and stakeholders under Japan's bioeconomy strategy body. The panel aims to draft guidelines based on international precedents and expects to finalize its recommendations by January 2027. Japan's Growth Strategy recognizes synthetic biology and biotechnology as 17 critical strategic fields, and officials deem the rulemaking necessary in the near term.

According to a research company in India, the global DNA synthesis market was valued at $5.19 billion (approximately 820 billion yen) in 2025 and is projected to expand about four and a half times over the next decade.