The psychedelic drugs market is emerging as a strategic investment opportunity in healthcare, with forecasts generally placing its value around US$6.4 billion in 2025.
This burgeoning sector is set for robust, double-digit compound annual growth, significantly driven by North America, which is anticipated to account for approximately 45–50 percent of this market.
The first half of 2025 was characterized by clinical advancements and softening policy stances, furthering momentum and contributing to growing market interest.
Clinical progress and policy shifts drive market interest
Interest in the space continued in H1 as drug candidates advanced into pivotal trials, particularly in the treatment of depression, anxiety and PTSD. Cybin (NYSEAMERICAN:CYBN) reported meaningful progress, citing investor and regulatory confidence in the therapeutic potential of psilocybin, LSD analogs and DMT derivatives.
Cybin’s 2025 financial results, released on June 30, highlighted significant progress in its lead programs, as well as its strong financial position, with C$135 million in cash reported.
CEO Doug Drysdale emphasized the company’s progress in building a strong foundation for anticipated clinical and regulatory milestones.
Key highlights include strengthened intellectual property with new patents for CYB003 and CYB004, strategic partnerships with Osmind and Thermo Fisher Scientific, and promising Phase 2 efficacy data for CYB003 in MDD, showing 100 percent responder rates and 71 percent remission with two 16 mg doses. The Phase 2 study for CYB004 in GAD is underway and expected to be completed around mid-2025.
Likewise, COMPASS Pathways (NASDAQ:CMPS) announced that its COMP360 psilocybin treatment successfully met its primary goal in a Phase 3 trial for treatment-resistant depression on June 23.
A single 25mg dose of COMP360 significantly reduced depression symptoms compared to a placebo at six weeks, showing a clinically meaningful difference and strong statistical significance. This marks the first Phase 3 efficacy data reported for a classic psychedelic, and Compass Pathways said it plans to discuss these positive results with the FDA.
Policy signals were equally consequential. Notably, the Texas House and Senate passed SB 2308 in May, which will provide up to US$100 million in state funds for ibogaine trials.
The results of the trials will be presented to the US Food and Drug Administration (FDA) for potential approval of ibogaine for opioid use disorder, co-occurring substance use disorder and other neurological or mental health conditions. Governor Abbott signed the bill into law on June 11, representing a notable and progressive shift in the Republicans’ approach to drug policy.
However, the sector continues to face real challenges, such as costly clinical access and inconsistent regulatory frameworks that have resulted in a patchwork of state-level regulations. Despite these challenges, there are ongoing efforts towards federal reform and standardized guidelines.
Health Secretary Robert F. Kennedy Jr. recently told members of Congress that new therapeutics using psychedelic substances could revolutionize treatment for mental health challenges.
“This line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months,” he said during a House subcommittee meeting regarding the Trump administration’s proposed budget for the US Department of Health and Human Services (HHS).
FDA head Marty Makary has likewise labeled the assessment of MDMA and other psychedelics as a “top priority,” announcing initiatives aimed at potentially expediting their approval.
One new program in particular aims to accelerate drug approval, potentially cutting review times from six months to one month.
This initiative might relax requirements for some drugs, possibly waiving placebo-controlled studies, which have been a hurdle for psychedelic research because patients often know if they’ve received the drug.
Looking ahead
The National Psychedelic Landscape Assessment (NPLA) identifies 11 states with a high likelihood of future movement based on legislative viability, advocacy strength, public support, legislative momentum and strategic impact: New Mexico, Nevada, Texas, Illinois, Missouri, California, Massachusetts, Connecticut, Indiana, New York and Arizona.
The report also points to several key trends and persistent challenges in the current psychedelic market.
Decriminalization at the state level has seen an enactment rate of just two percent, despite being a frequently introduced legislative concept, with 67 bills introduced since 2020. Movements have been hampered by public health and safety concerns, although local efforts are gaining momentum.
However, adult-use access has seen no legislative enactments through state legislatures, with existing programs in Oregon and Colorado being implemented predominantly via citizen-led ballot initiatives.
When it comes to medical access programs, New Mexico stands out as the sole state to successfully enact a licensed and regulated psilocybin therapy program through SB 219, battling hurdles such as regulatory complexity, affordability and securing sufficient provider participation.
The report also found that clinical trials have been gaining traction, particularly when state-funded and focused on vulnerable populations like veterans and first responders, with Indiana emerging as a leader in this area.
The state established a therapeutic psilocybin research fund in 2024 that compares psilocybin against existing treatments, and ensures transparent fund administration and research application processing.
A more moderate approach is seen in pilot programs, which offer a controlled environment for access and data collection. The crucial step of implementing legislation, necessary to operationalize enacted policies, shows a 50 percent success rate, according to the report’s findings.
The report also points to corporate influence and the strategic efforts by corporate entities to gain commercial advantage through state trigger laws and compound-specific legislation favoring patented compounds like COMP360.
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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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