The schizophrenia market is poised for substantial growth, driven by the introduction of innovative therapies and a rising number of diagnosed cases. A recent report highlights that the schizophrenia market across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK, and the US) is projected to grow at a compound annual growth rate (CAGR) of 7.4%, from $8.4 billion in 2021 to $17 billion in 2031. This growth is primarily attributed to the anticipated launches of 11 late-stage pipeline products during the forecast period.
Emerging Therapies and Market Dynamics
These 11 new products are expected to capture a significant portion of the schizophrenia market, accounting for 33.4% of global sales in 2031, even as atypical antipsychotics retain the largest patient share. The higher annual cost of therapy (ACOT) associated with these pipeline products suggests they are unlikely to replace first-line treatment options but will offer valuable alternatives.
Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), approved by the US FDA in September 2024, represents a significant advancement as the first treatment in seven decades that does not modulate dopaminergic or serotonergic transmission. According to key opinion leaders, Cobenfy is likely to be reserved for later lines of treatment after generic antipsychotics fail. However, positive results from its ongoing Phase III trial, ARISE (NCT05145413), could lead to its approval as an adjunctive therapy, potentially introducing it in earlier lines of treatment. 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. These adjunctive therapies could greatly help establish themselves within the highly competitive and genericized schizophrenia market, as patients would not need to switch from their current therapies.
Long-Acting Injectables and Oral Options
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. The anticipated launches of Otsuka’s once-weekly oral brexpiprazole fumarate in Japan in 2027 and Lyndra Therapeutics’ once-weekly oral risperidone, LYN-005, in the US could provide additional options for patients who want a longer-acting antipsychotic without the need for an injectable.
Regional Market Analysis
The US represents the largest market for schizophrenia, accounting for 82.6% of the 7MM sales in 2021. This dominance is due to the large prevalent population of patients with schizophrenia, the high cost of branded drugs, and the number of drugs marketed exclusively in the US compared to other countries in the 7MM. US sales are estimated to increase to $15.1 billion in 2031, at a CAGR of 8.1% over the 10-year timeframe.
Challenges and Opportunities
Despite the projected growth, the schizophrenia market faces challenges, including the loss of exclusivity for multiple antipsychotic LAIs such as Abilify Maintena, Aristada, and Invega Sustenna, leading to significant generic erosion. Nonetheless, the launches of pipeline therapies are expected to fuel overall market growth in the schizophrenia space.
In 2023, the total diagnosed cases of schizophrenia in the seven major markets (7MM) was approximately 3.8 million. Of these, 2.1 million were male, reflecting the higher prevalence of the disorder in men, a pattern consistently observed worldwide. The severity of schizophrenia varies significantly, with 37% of diagnosed cases classified as mild, 33% as moderate, and 29% as severe.
Several companies are actively involved in the treatment of schizophrenia, including Novartis Pharmaceuticals, Zhejiang Jingxin Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., Neurocrine Biosciences, Spinogenix, Cerevel Therapeutics, LLC, LB Pharmaceuticals Inc., and Merck Sharp & Dohme LLC.
