Projected Shortage of Non-Human Primates May Impact Drug Development

Over the past few weeks, the pharmaceutical industry — drug development in particular — has faced a new issue regarding drug development and the animal models typically used to model therapeutic effects.

On November 16, 2022, the United States Attorney’s office in the southern district of Florida announced an eight-count indictment on officials of the Cambodian Forestry Administration, the Ministry of Agriculture, and more for smuggling and conspiracy. Officials have been accused of illegally exporting cynomolgus macaques, a non-human primate, to the US for research despite the endangered species classification.

According to an article in STAT News, Cambodia is now halting all export of non-human primates to the US. This action will likely significantly impact US pharmaceutical research and drug development.

Inotiv, a company that provides resources, including non-human primates, to pharmaceutical and medical companies, has recently released a statement regarding recent indictments, which implicate two of its clients, and the availability of non-human primates moving forward.

In the press release from December 12, 2022, the company revealed that approximately 60% of nonhuman primates imported to the US are from Cambodia. The recent crackdown on exports from the country will leave the US unable to obtain more than half of its non-human primates, used by the pharmaceutical industry to test safety and efficacy.

According to the company, approximately $140 million of its $547.7 million revenue from the 2022 fiscal year was due to non-human primates. However, the company temporarily halted nonhuman primates' sales while evaluating the allegations.

After its clients were implicated in the recent indictment, Inotiv also noted that it “strongly condemns any and all unauthorized trading and importation of any endangered species. With respect to legal trading and importation, we believe there is a pressing need to reduce the number of animals used in drug discovery and research and replace them with non-animal alternatives where possible. The company also recognizes that it will take time to achieve safe methods to do so, and there will still be the need for NHPs in the foreseeable future.”

This issue will have lingering impacts, slowing or even halting domestic drug development. With this in mind, researchers may consider other methods to test the efficacy and safety of new drugs. Some officials have proposed a transition to predictive AI technology and other forms of modeling to replace the current standard of animal testing.