Psilocybin Assisted Therapy Market Trends

Growth Drivers

• Increasing clinical evidence: Numerous clinical trials have showcased the promising results for psilocybin in treating mental health disorders, encouraging more players to make investments in this field. For instance, in February 2024, Incannex reported the results from its Phase 2 Psi-GAD1 trial, which showcased that psilocybin-assisted therapy significantly reduced anxiety in patients with generalised anxiety disorder. The psilocybin group saw a 12.8-point drop in HAM-A scores, with 44% of patients responding and 27% achieving remission.
• Regulatory changes & legalization trends: Most of the jurisdictions are legalizing or easing regulations for therapeutic use, which is readily propelling growth in the psilocybin assisted therapy market. In April 2025, the Reason Foundation report stated that multiple U.S. states continued advancing psychedelic reform, particularly around psilocybin therapy. It also stated that a growing number of state legislatures are moving toward facilitated access models, regulated systems allowing supervised psilocybin use for medical or therapeutic purposes, modeled after Oregon’s program, thereby positively influencing market growth.
• Reduced social stigma: The ever-increasing public awareness of mental health and reduced stigma around psychedelics are fostering a profitable business environment in this field. MoHFW in August 2025 reported that the government of India has successfully expanded tele-mental health services through 53 Tele MANAS cells in 36 states/UTs, which handled more than 2.3 million helpline calls.  The scheme productively upgraded over 177,000 Sub Health Centres and PHCs to Ayushman Arogya Mandirs, integrating mental health into primary care, thereby denoting a positive market outlook.

Share of Population with Mental Health Disorders by Income Group

Source: OWID

Key Psilocybin Therapy Clinical Trials and Programs in 2025

Source: Company Official Press Releases

Challenges

• Policy & regulatory barriers: This is one of the most important and considerable challenges for the market, which hinders expansion in almost all nations. There has been a presence of evidence-based results for the therapeutic use of psilocybin, but it remains classified as a Schedule I substance in many countries. Therefore, this classification implies a high potential for abuse and no accepted medical use, which further causes limitations in research, commercialization, and clinical accessibility.
• High cost and accessibility of therapy: This is yet another factor skewing the expansion of the psilocybin assisted therapy market. Psilocybin therapy typically involves lengthy, clinician-guided sessions before, during, and after administration of the compound, which adds to the exacerbated costs on manufacturers.  This, in turn, can be unaffordable for many patients, particularly in countries where such therapy is not covered by insurance or public health systems.