Autism Spectrum Disorder Market: Key Highlights
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Autism Spectrum Disorder Market size projection: As per DelveInsight’s analysis, the total market size of Autism Spectrum Disorder in the 7MM is expected to grow significantly by 2034.
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Autism Spectrum Disorder Market Drivers: Key market drivers of Autism Spectrum Disorder include rising prevalence rates, enhanced screening and diagnostic protocols, expanding pediatric and adult therapy adoption, and burgeoning late‐stage therapeutic pipelines targeting core Autism Spectrum Disorder symptoms.
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Autism Spectrum Disorder Epidemiology: The report provides the total Autism Spectrum Disorder potential pool, revealing approximately 1 in 44 children aged 8 years identified with Autism Spectrum Disorder in the US. Furthermore, 1 in 100 children in the UK has Autism Spectrum Disorder.
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Key Autism Spectrum Disorder companies: Leading Autism Spectrum Disorder companies, such as Otsuka Pharmaceuticals, Johnson & Johnson, Flynn Pharma, MapLight Therapeutics, Roche, Axial Therapeutics, and Yamo Pharmaceuticals, among others.
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Pipeline assets: Some of the key Autism Spectrum Disorder therapies in the pipeline include ML-004 (MapLight Therapeutics), RG7816/RO7017773 (Hoffmann-La Roche), AB-2004 (AcadIA Pharmaceuticals), L1-79 (Yamo Pharmaceuticals), and AJA001 (DeFloria).
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Recent developments:
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In April 2025, NeuroNOS (Beyond Air) received FDA orphan drug designation for BA-102 for Phelan-McDermid Syndrome linked to ASD, with Phase I trials planned for 2026.
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In March 2025, GRIN Therapeutics earned orphan drug designation for radiprodil in GRIN-related neurodevelopmental disorders.
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In February 2025, DeFloria’s AJA001 IND was cleared by FDA, with Phase II trials slated for mid-2025.
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Access DelveInsight’s in-depth epidemiological analysis covering age- and gender-specific prevalence across the US, EU4, and Japan.
Autism Spectrum Disorder Market Analysis
DelveInsight’s comprehensive Autism Spectrum Disorder Market Insight, Epidemiology And Market Forecast report indicates that the Autism Spectrum Disorder market in the 7MM exhibits a steady growth trajectory fueled by improved disease recognition and emerging therapies. The current market is dominated by pharmacotherapies such as aripiprazole (ABILIFY) and risperidone (RISPERDAL), alongside SLENYTO (prolonged‐release melatonin) for insomnia management in Autism Spectrum Disorder (ASD). Furthermore, the geographic analysis shows the US as the largest market contributor due to higher per‐patient treatment costs and prevalence, while EU4 and Japan present significant growth opportunities with growing pediatric screening initiatives. DelveInsight’s epidemiological segmentation details age‐specific, gender‐specific, and total diagnosed prevalent cases across the 7MM, highlighting substantial adult diagnosis expansion over the forecast period.
Explore DelveInsight’s comprehensive Autism Spectrum Disorder Market Forecast to uncover growth trends, key drivers, and 7MM market projections through 2034.
Autism Spectrum Disorder Competitive Landscape
The key Autism Spectrum Disorder players include Otsuka Pharmaceuticals (ABILIFY; aripiprazole), Johnson & Johnson (RISPERDAL; risperidone), Neurim/Flynn Pharma (SLENYTO; melatonin), MapLight Therapeutics (ML-004; 5-HT1B agonist), Hoffmann-La Roche (RG7816; GABAB positive allosteric modulator), Yamo Pharmaceuticals (L1-79; neuroinflammatory modulator), and DeFloria, Inc. (AJA001; botanical multi-cannabinoid), among others.
The current Autism Spectrum Disorder treatment options include applied behavioral analysis, speech and occupational therapies, and adjunctive pharmacological interventions targeting irritability and sleep disorders. Recent development milestones include multiple FDA orphan designations and IND clearances. Strategic collaborations involve licensing deals for ML-004 and co-development partnerships between biotech innovators and large pharma. The robust Autism Spectrum Disorder pipeline underscores a shift toward mechanism-specific interventions addressing sociability, irritability, and core ASD deficits.
Autism Spectrum Disorder Market Drivers and Barriers
According to DelveInsight’s analysis, the unmet medical needs persist in addressing core social communication impairments and repetitive behaviors. Key market drivers include expanding government screening programs, favorable reimbursement landscapes, and patient advocacy group engagement. There are a few Autism Spectrum Disorder Market Barriers as well, which include heterogeneous patient presentations, high R&D costs, and the absence of curative treatments, necessitating personalized therapeutic approaches.
Conclusion
The Autism Spectrum Disorder market is evolving rapidly, fueled by innovation, regulatory support, and growing awareness. As emerging therapies advance toward approval, collaboration between biotech innovators and pharmaceutical giants is expected to transform the treatment landscape, addressing long-standing unmet needs in core ASD symptom management.
Scope of the Autism Spectrum Disorder Market Report
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Seven-major-market analysis: US, EU4 (Germany, France, Italy, Spain), UK, Japan
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Epidemiology insights: total diagnosed prevalent cases, age-specific, gender-specific, treated cases
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Market trends: historical (2020–2023) and forecasted (2024–2034) market size and CAGR
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Treatment landscape: current and emerging therapies, clinical trial pipeline
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Market access and reimbursement: country-wise policies, health technology assessments
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Competitive intelligence: SWOT, market entry strategies, licensing and collaborations
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KOL perspectives: qualitative insights from global Autism Spectrum Disorder experts and clinical thought leaders
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Autism Spectrum Disorder Patient insights: prescription patterns, physician perspectives, unmet needs
Leverage actionable intelligence from DelveInsight’s Autism Spectrum Disorder market report to guide investment, partnership, and portfolio strategies in the neurodevelopmental space.
Table of Contents
1. Key Insights
2. Report Introduction
3. Autism Spectrum Disorder Market Overview at a Glance
4. Epidemiology and Market Forecast Methodology
5. Executive Summary
6. Key Events
7. Disease Background and Overview
8. Autism Spectrum Disorder Epidemiology and Patient Population
9. Autism Spectrum Disorder Patient Journey
10. Autism Spectrum Disorder Marketed Therapies
11. Autism Spectrum Disorder Emerging Therapies
12. Autism Spectrum Disorder: Market Analysis
13. Key Opinion Leaders’ Views
14. SWOT Analysis
15. Autism Spectrum Disorder Unmet Needs
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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