The autism spectrum disorder (ASD) market across the seven major markets (7MM*) is projected to grow at a compound annual growth rate (CAGR) of 18.7%, from $364.9 million in 2024 to $2.0 billion in 2034, according to GlobalData, a leading data and analytics company.
GlobalData’s latest report, “Autism Spectrum Disorder: Opportunity Assessment and Forecast” reveals that the significant growth in the market will be driven by the anticipated launches of five late-stage pipeline products during the forecast period.
ASD refers to a broad range of conditions characterized by challenges with social communication and repetitive behavioral patterns. These are the core symptoms of ASD that can affect the individual’s ability to function in school, work, and other areas of life. There are currently no approved pharmacological therapies to target the core symptoms, so each symptom individually constitutes a significant unmet need for therapeutic intervention, warranting targeted drug development.
Christie Wong, Managing Neurology Analyst at GlobalData, comments: “The ASD therapeutics market has entered an exciting phase, with the anticipated launch of pipeline products targeting the core symptoms of ASD by 2034. In order of entry, these will be Curemark’s CM-AT/ LUMINENZ-AT, Yamo Pharmaceuticals’ L1-79 (metyrosine), and MapLight Therapeutics’ ML-004 (zolmitriptan).”
In addition to the core symptoms of ASD, the condition is frequently associated with difficult behaviors such as irritability, hyperactivity, and aggression. There are only two treatments for ASD: Johnson & Johnson’s Risperdal (risperidone) and Otsuka Pharmaceutical’s Abilify (aripiprazole), both indicated for the treatment of irritability associated with ASD in children and adolescents in the US. In Japan, only Abilify is approved for ASD. There are no approved treatments for irritability associated with ASD in the five major European markets (5EU**).
Wong adds: “The repurposing of atypical antipsychotics originally approved for schizophrenia and bipolar disorder is a prevalent strategy in the ASD market, particularly targeting irritability associated with ASD. Johnson and Johnson’s Caplyta (lumateperone) and AbbVie’s Vraylar (cariprazine) are both in Phase III development for ASD leveraging this trend and are anticipated receive sNDA approval in the US in Q3 2027 and Q1 2029, respectively.”
GlobalData forecasts that the five late-stage pipeline products will capture a significant portion of the ASD market and could drive combined sales of approximately $1.7 billion by 2034 in the 7MM, accounting for 83.4% of the ASD market. Curemark’s CM-AT/ LUMINENZ-AT is expected to launch in the US in Q4 2029 and is anticipated to be the highest selling pipeline product.
With an estimated $228.4 million in drug sales, the US dominated the ASD market in 2024, representing 62.6% of 7MM sales. GlobalData expects the US to remain as the leading market throughout the forecast period, generating sales of $1.9 billion in 2034, representing 93.3% of the overall market across the 7MM.
Wong continues: “This dominating position within the 7MM is a result of a high diagnosed prevalence and the launch of pipeline products exclusively in the US. GlobalData forecasts that five pipeline products will launch in the US, whereas only one product is anticipated to launch in the EU, and none in Japan.”
While the ASD market is projected to grow during the forecast period across the 7MM, it will face some challenges that will curtail its growth. Potential barriers to the growth of the global ASD market include the continued use of inexpensive generic products throughout the forecast period.
Wong concludes: “The wide availability cheap generic products could limit the uptake of more expensive branded products such as the newer atypical antipsychotics. Nonetheless, the launches of the pipeline therapies that target the core symptoms of ASD will fuel overall market growth in the ASD space.”
*7MM- US, France, Germany, Italy, Spain, UK, and Japan
**5EU- France, Germany, Italy, Spain, and UK
