The autism spectrum disorder (ASD) 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 of 18.7% from $364.9 million in 2024 to $2 billion in 2034, according to GlobalData’s recently published report, Autism Spectrum Disorder: Opportunity Assessment and Forecast. This significant growth 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 characterised by challenges with social communication and repetitive behavioural patterns. These core symptoms of ASD can affect the individual’s ability to function in school, work and other areas of life. But there are currently no approved pharmacological therapies to target the core symptoms, so each of these symptoms individually constitutes an unmet need for therapeutic intervention, warranting targeted drug development. Key opinion leaders interviewed by GlobalData and high prescribing psychiatrists, paediatricians and primary care physicians surveyed by GlobalData identified the lack of treatment options for core symptoms as one of the most significant unmet needs for ASD patients.
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However, 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 its core symptoms, ASD is frequently associated with difficult behaviours, such as irritability, hyperactivity and aggression. There are only two treatments: Johnson & Johnson’s Risperdal (risperidone) and Otsuka Pharmaceutical’s Abilify (aripiprazole) are indicated for the treatment of irritability associated with ASD in children and adolescents in the US. In Japan, only Abilify is approved. There are no approved treatments for irritability associated with ASD in the five major European markets (5EU: France, Germany, Italy, Spain and the UK).
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 to receive supplemental new drug application approval in the US in the third quarter of 2027 and the first quarter of 2029 respectively.
GlobalData forecasts that the five late-stage pipelines 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 the fourth quarter of 2029 and is anticipated to be the highest selling pipeline product.
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By GlobalDataWith 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 and representing 93.3% of the overall market across the 7MM. 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 faces challenges that will curtail its growth. Potential barriers to growth of the global ASD market include the continued use of inexpensive generic products throughout the forecast period, limiting uptake of more expensive branded products such as the newer atypical antipsychotics. Nonetheless, the launches of the pipeline therapies which target the core symptoms of ASD will fuel overall market growth in the ASD space.
