The schizophrenia market across the seven major markets (7MM*) is poised to grow at a compound annual growth rate (CAGR) of 7.4 per cent from $8.4 billion in 2021 to $17.0 billion in 2031, driven by the anticipated introduction of 11 late-stage pipeline products during the forecast period, according to GlobalData.
GlobalData’s latest report, “Schizophrenia: Seven-Market Drug Forecast and Market Analysis – Update”, reveals that the late-stage pipeline products are expected to capture a significant portion of the schizophrenia market, accounting for 33.4 per cent of global sales in 2031, despite the atypical antipsychotics retaining the largest portion of patient shares.
Christie Wong, Managing Neurology Analyst at GlobalData, comments, “The pipeline products are all expected to have a significantly higher annual cost of therapy (ACOT) when compared with the cheap generic atypical antipsychotics that are predominantly used. Due to the higher ACOT, the pipeline products are unlikely to replace current antipsychotics as first-line treatment options. However, adjunctive therapies that can be used in combination with antipsychotics could be introduced in earlier lines of therapy.”
The pipeline consists of four adjunctive agents: Newron Pharmaceuticals’ evenamide, Neurocrine Biosciences’ Ingrezza (valbenazine tosylate), and Boehringer Ingelheim’s iclepertin. Furthermore, Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) is also being developed as an adjunctive therapy in patients who have an inadequate response to atypical antipsychotic monotherapy in the ARISE trial.
Wong notes, “Should evenamide, Cobenfy, Ingrezza, and iclepertin receive FDA approval for the adjunctive treatment of schizophrenia, patients will not need to switch from their current therapies. This could greatly help these products establish themselves within the highly competitive and genericized schizophrenia market.”
Cobenfy received FDA approval in September 2024 and is the first treatment for schizophrenia that does not modulate dopaminergic or serotonergic transmission in seven decades. GlobalData expects Cobenfy to become the top-selling drug in the schizophrenia market with sales of $2.2 billion across the 7MM in 2031.
While the schizophrenia market is projected to grow during the forecast period across the 7MM, it may face some challenges that will slow its growth. Potential barriers to growth include the loss of exclusivity of multiple antipsychotic long-acting injectables (LAIs).
Wong concludes, “Although implementation of LAIs as the standard of care is low due to their considerably higher ACOT and patient and/or physician preference for oral antipsychotics, LAI sales accounted for over half of the total atypical antipsychotic sales in 2021. The patent expiry of LAIs including Abilify Maintena, Aristada, and Invega Sustenna will result in significant generic erosion. Nonetheless, the launches of the pipeline therapies will fuel overall market growth in the schizophrenia space.”
*7MM = US, France, Germany, Italy, Spain, the UK, and Japan