The post-traumatic stress disorder (PTSD) market is expected to grow at a high compound annual growth rate of 16.1% from $1.2bn in 2024 to $5.5bn by 2034 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Australia), according to leading data and analytics company GlobalData’s recent report, Post-Traumatic Stress Disorder: Opportunity Assessment and Forecast. The major driving factors of this growth include an increase in prevalent cases, the entry of eight novel late-stage pipeline products that are all anticipated to be significantly more expensive than the widely used generic drugs currently dominating the market, and an increasing awareness and reduced stigma surrounding PTSD in the general population, leading to higher rates of healthcare presentation and increased diagnosis and treatment rates.
A major focus of research and development (R&D) in the PTSD therapeutic space is the development of new therapeutic options with improved efficacy. As no medications have been approved by the US Food and Drug Administration (FDA) for the treatment of PTSD since 2001, antidepressants of the selective-serotonin reuptake inhibitors (SSRIs) class, of which Zoloft and Paxil are the only approved drugs for PTSD, have been relied upon by physicians worldwide and the consensus is that this strategy is unsuitable for many patients. While SSRIs can result in symptom reduction for PTSD patients, less than 30% of patients achieve remission. The PTSD pipeline is diverse with novel mechanisms of action that developers hope can provide greater efficacy than the SSRIs.
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One significant area of research is into psychedelic therapeutics. Key opinion leaders (KOLs) interviewed by GlobalData consistently highlighted midomafetamine hydrochloride (MDMA) as the most promising psychedelic therapeutic for PTSD, with Lykos Therapeutics’ MDMA-assisted psychotherapy expected to achieve blockbuster status by the end of the forecast period. Despite a challenging path towards the market, having been initially rejected by the FDA in August 2024 and KOLs noting some concerns surrounding trial design and company practice, as the first psychedelic to reach the market for PTSD, GlobalData forecasts Lykos’ drug will generate $1.1 billion in sales across the 7MM by 2034.
Despite their promise, many regulatory challenges exist for psychedelic therapeutics, particularly those that are being developed in conjunction with psychotherapy, including how to attribute benefits between the drug component and the psychotherapy component in a trial, especially as the FDA does not regulate psychotherapy. Furthermore, the known effects of psychedelics make double-blind placebo control, the gold standard for clinical trials, difficult to achieve, as patients can identify when they have received the active compound. This leads to concerns of expectation bias in participants, which can affect the evaluation of the true efficacy of a drug. The other psychedelic therapeutics in the late-stage PTSD pipeline are Compass Pathways’ psilocybin and Seelos Therapeutics’ ketamine.
In addition to the three psychedelic therapeutics, there are five non-psychedelic pipeline products in the late-stage PTSD pipeline that GlobalData expects to launch during the forecast period (2024-2034). These are Otsuka’s Rexulti, which is currently in preregistration in the US, Neuphoria Therapeutics’ BNC-210, Idorsia Pharmaceuticals’ Quviviq, Ananda Scientific’s Nantheia ATL5, and Transcend Therapeutics’ TSND-20. Many of these products have safety profiles favourable to the current treatment options, helping to meet another key unmet need in the PTSD market as the problem of side effects with existing treatments leads to low patient compliance rates. GlobalData expects that the five non-psychedelic pipeline products will generate $2.3bn in sales in the 7MM by 2034.
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By GlobalData
