Abstract
BACKGROUND: In the wake of positive clinical trial outcomes of psychedelic-assisted psychotherapy for the treatment of various psychiatric disorders, there has been an influx of financial investment into psychedelic drug development from the pharmaceutical and biotech sectors. Psychedelics are now a multibillion dollar industry, with hundreds of companies that are seeking to commercialize therapeutic applications of psychedelics formed over the course of just a few years. MATERIALS AND METHODS: This paper aims to provide a broad overview of the psychedelic industry by detailing the history and current state of psychedelic drug commercialization, exploring challenges to commercial viability, highlighting ethical considerations, and incorporating lessons from the analogous ketamine and cannabis industries, which largely preceded the psychedelic industry. RESULTS: We found that although the roots of the psychedelic industry go back decades, financial investment did not take off in earnest until the late 2010s and early 2020s. The main focus of companies in the psychedelic sector can be broadly grouped into: (1) drug discovery and development; (2) novel formulations and routes of administration; (3) manufacturing and synthesis; (4) treatment centers and wellness clinics; (5) consumer packaged goods and adult use; and (6) adjunct technologies. Challenges to commercial viability include regulatory barriers to drug development, treatment costs and logistics of administration, and intellectual property and patent issues. In terms of ethics, the industry must consider the potential adverse effects of psychedelics, cost-cutting inclinations, ensuring therapeutic benefits reach vulnerable and marginalized communities, and indigenous reciprocity. We also underscore the potential benefits commercialization may bring. Lastly, the ketamine and cannabis industries can provide blueprints for regulatory approval, clinical implementation, insurance reimbursement, and federal policy more broadly. CONCLUSION: Altogether, this article provides a wide-spanning overview of the emerging commercialization of psychedelics, acknowledging both the monumental progress and critical challenges that remain for the industry.