Schizophrenia market expected to reach $17bn across 7MM by 2031

The schizophrenia market across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US) is poised to grow at a compound annual growth rate (CAGR) of 7.4% from $8.4bn in 2021 to $17bn in 2031, according to GlobalData’s recently published report, Schizophrenia: Seven-Market Drug Forecast and Market Analysis – Update . This moderate growth will be driven by the anticipated launches of 11 late-stage pipeline products during the forecast period.

The 11 new products are expected to capture a significant portion of the schizophrenia market, accounting for 33.4% of global sales in 2031, despite atypical antipsychotics retaining the largest patient share. The pipeline products are all expected to have a significantly higher annual cost of therapy (ACOT) than the cheap generic atypical antipsychotics that are predominately used. Due to the higher ACOT, the pipeline products are unlikely to replace first-line treatment options.

Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) received US Food and Drug Administration (FDA) approval in September 2024 and is the first treatment for schizophrenia in seven decades that does not modulate dopaminergic or serotonergic transmission. Key opinion leaders interviewed by GlobalData noted that Cobenfy is likely to be reserved for later lines of treatment, after failure on generic antipsychotics. However, should Cobenfy receive positive results in its ongoing Phase III trial, ARISE (NCT05145413), and obtain approval as an adjunctive therapy, Cobenfy could be introduced in earlier lines of therapy. GlobalData expects Cobenfy to become the top-selling drug in the schizophrenia market with sales of $2.2 billion across the 7MM in 2031.

Other late-stage pipeline products being investigated as adjunctive agents include Newron Pharmaceuticals’ evenamide, Neurocrine Biosciences’ Ingrezza (valbenazine tosylate) and Boehringer Ingelheim’s iclepertin. As patients would not need to switch from their current therapies, it could greatly help these products establish themselves within the highly competitive and genericised schizophrenia market.

The prescription of long-acting injectables (LAIs) has remained low due to their considerably higher ACOT and patient and/or physician preference for oral antipsychotics. However, LAI sales accounted for more than half of the total atypical antipsychotic sales in 2021. In 2027, Otsuka’s once-weekly oral brexpiprazole fumarate is anticipated to launch in Japan and Lyndra Therapeutics’ once-weekly oral risperidone, LYN-005, is anticipated to launch in the US. These products could provide an additional option for patients who want a longer-acting antipsychotic without the need for an injectable.