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Gut Instincts: How Microbiome Science Can Reshape Addiction Medicine

Miriam Saif •
#cell therapy#market access#pharmaceutical

The Addiction Crisis: A Growing Public Health Emergency

Addiction continues to be a major global health challenge: each year, alcohol use contributes to around 2.6 million deaths per year while psychoactive drugs account for 600,000 deaths 1. The COVID-19 pandemic intensified substance use disorders (SUDs), and the U.S. continues to face a worsening opioid crisis driven by fentanyl, methamphetamine, and cocaine 2, 3.

In response, governments, especially in the U.S., are increasing funding for rehabilitation clinics and SUD treatment programmes, with initiatives like Medicaid grants playing a central role 2.

This growing crisis presents a clear gap in the market for scalable, innovative therapies - and microbiome science appears to emerge as a solution.

Scientific Foundation: The Gut-Brain Axis in Addiction

The gut-brain axis is the communication system between the digestive tract and the brain. Gut bacteria help produce chemicals like serotonin and dopamine, which influence mood, stress, and reward — all central to addiction 4 . Disruption of this microbial balance, known as gut dysbiosis, has been linked to increased vulnerability to addiction and cognitive issues. Alcohol and other drugs can damage the gut lining, trigger inflammation, and alter brain function via the dopamine-reward system 5 .

For example, alcohol can damage the gut lining, allowing harmful bacteria to enter the bloodstream and trigger inflammation, which in turn affects brain function 6 .

While factors like age, diet, and gender also play a role, animal studies consistently show the gut microbiome influences addiction-related behaviours. This has led researchers to explore microbiome-targeted treatments, as a new class of therapies that could reduce cravings 7 .

Potential Pipelines

Microbiome-based therapies are being explored for a range of substance use disorders:

  1. Biomarkers - preclinical studies have identified specific gut microbiome bacteria that can act as biomarkers to predict a person’s vulnerability to developing opioid addictive behaviours 8 .
  2. Fecal Microbiota Transplants (FMT) - transfers healthy gut bacteria donated by one person to another to restore microbial imbalances caused by substance abuse 8, 9 .
  3. Short-chain fatty acids - natural compounds shown to reverse the effects of cocaine-seeking behaviour 10.
  4. Probiotics - bacterial strains such as Bfidobacteria and Lactobacillus, can extend the pain-relieving effects of medications like morphine, offering potential treatment for opioid addictions 7 .

Market Growth & Opportunity

The microbiome therapuetics market size is expected to grow from $212.1 million in 2024 to $3.2 billion by 2034 2 . Addiction treatment is a high-impact application area with strong commercial potential. Key drivers include:

Current Landscape

While the connection between the gut microbiome and addiction is scientifically promising, more research is needed to fully understand its therapeutic potential 5 . That said, the field is advancing rapidly, and several biotech companies are already developing microbiome-based solutions for other conditions such as mental health and neurological conditions.

Key innovators in the space:

Strategic Takeaways

Microbiome science represents a unique opportunity to support therapies that could address one of the most urgent areas in public health with:

References

  1. World Health Organization. Over 3 million annual deaths due to alcohol and drug use, majority among men. Who.int. Published June 25, 2024. Accessed October 30, 2025. https://www.who.int/news/item/25-06-2024-over-3-million-annual-deaths-due-to-alcohol-and-drug-use-majority-among-men/

  2. Fine T. Drug & Alcohol Rehabilitation Clinics in the US. Ibisworld.com. Published 2025. Accessed October 30, 2025. https://my.ibisworld.com/us/en/industry-specialized/OD4619/products-and-markets

  3. Kim S, Lee H, Woo S, et al. Global, regional, and national trends in drug use disorder mortality rates across 73 countries from 1990 to 2021, with projections up to 2040: a global time-series analysis and modelling study. EClinicalMedicine. 2024;79:102985-102985. doi:https://doi.org/10.1016/j.eclinm.2024.102985

  4. Barron M. The Gut Microbiome and Drug Addiction: An Emerging Link. ASM.org. Published March 28, 2023. Accessed October 30, 2025. https://asm.org/Articles/2023/April/The-Gut-Microbiome-and-Drug-Addiction-An-Emerging

  5. You X, Niu L, Fu J, et al. Bidirectional regulation of the brain–gut–microbiota axis following traumatic brain injury. Neural Regeneration Research. 2024;20(8):2153-2168. doi:https://doi.org/10.4103/nrr.nrr-d-24-00088

  6. Skosnik PD, Cortes-Briones JA. Targeting the ecology within: The role of the gut–brain axis and human microbiota in drug addiction. Medical Hypotheses. 2016;93:77-80. doi:https://doi.org/10.1016/j.mehy.2016.05.021

  7. Fu X, Chen T, Cai J, Liu B, Zeng Y, Zhang X. The Microbiome–Gut–Brain Axis, a Potential Therapeutic Target for Substance-Related Disorders. Frontiers in Microbiology. 2021;12. doi:https://doi.org/10.3389/fmicb.2021.738401

  8. Barkus A, Baltrūnienė V, Baušienė J, et al. The Gut-Brain Axis in Opioid Use Disorder: Exploring the Bidirectional Influence of Opioids and the Gut Microbiome—A Comprehensive Review. Life. 2024;14(10):1227. doi:https://doi.org/10.3390/life14101227

  9. Wang SC, Chen YC, Chen SJ, Lee CH, Cheng CM. Alcohol addiction, gut microbiota, and alcoholism treatment: A review. International Journal of Molecular Sciences. 2020;21(17):1-11. doi:https://doi.org/10.3390/ijms21176413

  10. https://newatlas.com/author/paul-mcclure. Gut microbiome discovery could lead to new drug addiction treatments. New Atlas. Published August 4, 2023. Accessed October 30, 2025. https://newatlas.com/health-wellbeing/gut-microbiome-study-cocaine-drug-addiction-treatments/

  11. Wani G, Faizullabhoy M. Microbiome Therapeutics Market Size - By Type, By Application- Global Forecast, 2025 - 2034. Global Market Insights Inc. Published April 2025. Accessed October 30, 2025. https://www.gminsights.com/industry-analysis/microbiome-therapeutics-market

  12. Wilson O. Exploring the Human Microbiome: Unveiling the Top 20 Companies Leading Microbiome Research in the US |. Scispot.com. Published 2025. Accessed October 30, 2025. https://www.scispot.com/blog/top-20-microbiome-companies-in-the-us

  13. Seres Therapeutics. Establishing a Better Microbiome for Better Health. Seres Therapeutics. Published 2025. Accessed October 30, 2025. https://www.serestherapeutics.com/

  14. Vedanta Biosciences. Home - Vedanta Biosciences, Inc. Vedanta Biosciences, Inc. Published August 13, 2025. Accessed October 30, 2025. https://www.vedantabio.com/

  15. Reid R. MedTech regulatory reform and the importance of partnerships – MedRegs. Blog.gov.uk. Published April 15, 2025. Accessed October 30, 2025. https://medregs.blog.gov.uk/how-microbiome-science-can-reshape-medicine2025/04/15/medtech-regulatory-reform-and-the-importance-of-partnerships/

  16. Combs K, Tsang L, Wang K, et al. Life Sciences Regulatory Outlook 2025: Areas to Watch in the U.S., EU, UK, and Asia. Ropesgray.com. Published February 6, 2025. Accessed October 30, 2025. https://www.ropesgray.com/en/insights/viewpoints/102jzc4/life-sciences-regulatory-outlook-2025-areas-to-watch-in-the-u-s-eu-uk-and-as

  17. Rodriguez J, Cordaillat-Simmons M, Pot B, Druart C. The regulatory framework for microbiome-based therapies: insights into European regulatory developments. npj Biofilms and Microbiomes. 2025;11(1). doi:https://doi.org/10.1038/s41522-025-00683-0

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