The total post-traumatic stress disorder market was estimated to be worth US$211.4m across the seven major markets (7MM*) in 2018. This is expected to grow at a compound annual growth rate (CAGR) of 18.7% to reach US$1.2bn by 2028, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report: ‘Post-Traumatic Stress Disorder (PTSD): Opportunity Analysis and Forecasts to 2028’ reveals that lack of efficacy is the most pressing unmet need in the PTSD market and there have been no approved products to treat the disorder since 2001. However, two drug candidates in the PTSD pipeline that are expected to launch in the 7MM by 2022 are set to revolutionize the treatment of the disorder, as evidenced by promising results in clinical trials.

Magdalene Crabbe, Pharma Analyst at GlobalData, comments: “Zoloft and Paxil, currently the only two approved products in the 7MM for PTSD, are antidepressants of the selective-serotonin reuptake inhibitors (SSRIs) class. The fact that Zoloft and Paxil work via the same mechanism of action means that they have the same unpleasant side effects as well as boxed warnings for impulsiveness and suicidal behaviors.

“Brexpiprazole, an atypical antipsychotic approved for the treatment of major depressive disorder and schizophrenia, is in the pipeline for PTSD and has shown efficacy when administered as an adjunct to Zoloft. The well-established safety profile and low frequency of adverse effects puts brexpiprazole in good stead to become the highest selling drug in the market, with forecasted annual sales of US$361.7m by 2028.”

MDMA is a stimulant and late-stage pipeline product which was given breakthrough designation by the FDA, despite being a widely abused recreational drug. Its superior efficacy to marketed therapies and low frequency of administration are likely to be viewed favorably by physicians and patients alike.

GlobalData expects that in its first year on the market, MDMA is set to acquire a large patient share in the US as the first new drug for chronic PTSD to be approved in 18 years. Brexpiprazole and MDMA are set to make up 47% of drug sales in 2022 and this figure will climb to 59% in 2028.

Crabbe concludes: “This potential for high sales whilst addressing the longstanding clinical unmet needs for the indication is clear assurance of the increasing efforts to add PTSD to the list of psychiatric disorders that will experience market growth in the coming years and beyond.”

*7MM: The US, France, Germany, Italy, Spain, UK and Japan