As a result of new therapies being introduced to the schizophrenia market and an increase in the prevalent patient population, its value is expected to increase from $9.0 billion in 2021 to $13.0 billion in 2031 across the seven major markets (7MM*) at a compound annual growth rate (CAGR) of 3.7%, according to GlobalData.

Christie Wong, Pharma Analyst at GlobalData, explains: “The schizophrenia market is crowded with inexpensive generic antipsychotics, which are unlikely to be replaced as first-line treatment options. However, the prospect of adjunctive therapies will be welcomed as they target significant unmet needs. In addition, they have novel mechanisms of action (MOAs) that can be used in combination with marketed antipsychotics, rather than having to compete with them.

The leading data and analytics company’s latest report, ‘Schizophrenia Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2031’, reveals that the entry of four adjunctive therapies will be one of the biggest factors driving overall growth in the schizophrenia market and are expected to represent 24.0% of the schizophrenia market in 2031, equivalent to about $3.1 billion.

In addition, there are four pipeline atypical antipsychotic reformulations highlighted in GlobalData’s report that are anticipated to launch during the forecast period. These include Otsuka’s oral brexpiprazole fumarate and three long-acting injectables (LAIs): Otsuka/Lundbeck’s two month aripiprazole formulation, Teva/MedinCell’s mdc-IRM (risperidone), and Luye Pharma LY03010 (paliperidone). They are being investigated as monotherapies to manage the positive and negative symptoms of schizophrenia. Together, these four reformulations are expected to represent 4.1% of the schizophrenia market in 2031, equivalent to about $532.5 million.

Wong notes: “Although some growth in the LAI space is expected, this will be limited by strong competition, with many paliperidone, aripiprazole, and risperidone reformulations already available. Key opinion leaders interviewed by GlobalData were unanimous in their preference to prescribe established LAIs over new pipeline products, particularly if the pipeline agents are anticipated to have premium pricing. As such, the reformulations may have limited market potential.”

While the schizophrenia market is projected to grow steadily during the forecast period, potential barriers to growth include the loss of exclusivity of multiple antipsychotic LAIs. For example, Otsuka/Lundbeck’s Abilify Maintena (aripiprazole ER) is set to lose market exclusivity in the US, France, Germany, Spain, and the UK in 2024, in Italy in 2028, and in Japan in 2029, leading to the anticipated entry of generics.

Wong adds: “In addition to generic once-monthly aripiprazole ER, additional LAIs—generic once-monthly aripiprazole lauroxil, generic once-monthly paliperidone palmitate, and generic once-monthly risperidone—are all set to enter the schizophrenia market during the forecast period, which will undoubtedly impact branded sales negatively. However, the launch of pipeline therapies that target significant unmet needs and/or have novel MOAs will prove a stronger driving force for market growth within the schizophrenia space, leading to an overall upward trend.”

*7MM = US, France, Germany, Italy, Spain, the UK, and Japan.