Engineered living therapeutics are advanced probiotic systems – such as microbes, cells and fungi associated with human health – that are being developed to produce therapeutic substances like drugs, enzymes and hormones in a controlled and sustainable manner. To enable this, the genetic code containing instructions for producing therapeutics is introduced into the systems. An important feature of this approach is the ability to include biological control mechanisms that regulate therapeutic production – either through patient-managed triggers or in response to specific, clinically recognized disease signals – ensuring precise and safe activation.46 Production within the patient promises to overcome crucial shortcomings of conventional medications, especially for high-cost biopharmaceuticals. These drugs are currently produced in laboratory settings using modified cell lines, followed by extensive purification, processing and formulation. Producing therapeutics directly in the body avoids the need for these downstream steps, which typically account for 70% of production costs.47 Further, for drugs requiring frequent administration through injections, sustained production within the patient would ensure prolonged and stable drug supply and increased patient adherence to treatment, where crucial, as in the treatment of diabetes. These developments are made possible by advances in synthetic biology and genetic engineering, with ongoing research receiving attention in the US, Europe and China. Several companies are now developing this technology for commercial use. For example, Chariot Bioscience in the US is exploring microbial platforms that release therapeutics into the bloodstream following a single dose, significantly reducing the need for repeated injections.48 Finnish company Aurealis Therapeutics is conducting phase II clinical trials using modified probiotic lactic acid bacteria to simultaneously produce three therapeutic proteins in the treatment of diabetic foot ulcers.49 NEC is conducting clinical phase I/II trials using a weakened strain of Salmonella bacteria to facilitate activation of the patient’s immune system to fight cancer cells.50Importantly, safety is a central focus. Developers are actively addressing concerns such as unintended genetic transfer, immune responses and environmental release.51 Promising approaches currently in the research phase are metabolic and genetic programmes that prevent growth or kill bacteria on command, or the safe encapsulation into polymer-based containers.52 Beyond scientific and technological advancements, regulatory frameworks – such as the Advanced Therapy Medicinal Products in Europe – need to be developed to enable health authorities to evaluate efficacy and safety and ultimately grant market approval.Thomas Hartung Professor, Doerenkamp Zbinden Chair for Evidence-based Toxicology, Johns Hopkins Bloomberg School of Public Health Sang-Yup Lee Senior Vice-President, Research; Distinguished Professor, Korea Advanced Institute of Science and Technology (KAIST)Wilfried Weber Scientific Director and Professor for New Materials, Leibniz Institute for New Materials Create regulatory sandboxes – Establish specialized regulatory frameworks that allow for controlled testing of engineered living therapeutics while developing permanent safety guidelines.Ecosystem readiness map Boxed Icons Launch patient-centred communication initiatives – Develop clear, accessible information resources that explain the science, benefits and safeguards of genetically modified therapeutics to patients and healthcare providers.KEY ACTIONS TO ACHIEVE SCALE TechnologicalSocial Economic EnvironmentalPolicy Image: Engineered living therapeutics use programmed microbes to produce drugs inside the body, reducing costs and improving treatment. Credit: Midjourney and Studio Miko. Prompt (abbreviated): “Web-like structure, growing fungi and living organisms.” Read more: For more expert analysis, visit the engineered living therapeutics transformation map. Authored by: Jean Marie François. Top 10 Emerging Technologies of 2025 19