Autism Spectrum Disorder Therapeutics Market Size in the 7MM is anticipated to increase at a significant CAGR by 2034, estimates DelveInsight

DelveInsight's "Autism Spectrum Disorder Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of the Autism Spectrum Disorder, historical and forecasted epidemiology as well as the Autism Spectrum Disorder market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Autism Spectrum Disorder Market Report

• In Feb 2025, DeFloria, Inc. announced that the FDA completed its review of the Investigational New Drug (IND) application for AJA001, an orally delivered, multi- botanical drug for treating symptoms of autism spectrum disorder (ASD). The company plans to proceed with its Phase 2 clinical trial, set to begin by mid-2025.
• In January 2025, the FDA granted Orphan Drug Designation (ODD) to Capsida Biotherapeutics for CAP-002, a first-in-class gene therapy for STXBP1 disorder, developed in collaboration with Dr. Mingshan Xue at Texas Children's Duncan Neurological Research Institute.
• As per the analysis, about 1 in 44 children, aged 8 years, have been identified with autism spectrum disorder in the US. Boys were found to be four times more likely to be identified with autism spectrum disorder than girls.
• Various sources estimate that around 700,000 people in the UK have a diagnosis of autism, with one in 100 children in the UK having autism spectrum disorder.
• As per analysis, in Germany, children from 6 to 11 years of age showed the highest prevalence, estimated at around 6.0 per 1000.
• According to the analysis, in Japan, the adjusted autism spectrum disorder prevalence was around 3%, with a male-to-female ratio of 2.2:1. Sex differences in behavior, or the presentation of autistic symptoms and co-morbid intellectual disability may contribute to the male bias in diagnoses.
• In 2022, the United States held a significant share of the overall 7MM Autism Spectrum Disorder market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments.
• The leading Autism Spectrum Disorder Companies such as Aardvark Therapeutics, Inc., Otsuka Pharmaceutical, H. Lundbeck A/S, Jazz Pharmaceuticals, MapLight Therapeutics, Vanda Pharmaceuticals, ACADIA Pharmaceuticals Inc., AbbVie, Axial Therapeutics, Inc., Hoffmann-La Roche, Yamo Pharmaceuticals LLC, Janssen Pharmaceuticals, Neurim Pharmaceuticals, Flynn Pharma, and others.
• Promising Autism Spectrum Disorder Therapies such as ML-004, RG7816 (alogabat/RO7017773), AB-2004, L1-79, AJA001, BA-102, CAP-002, radiprodil, and others.

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Autism Spectrum Disorder Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Autism Spectrum Disorder
• Gender-specific Diagnosed Prevalent Cases of Autism Spectrum Disorder
• Age-specific Diagnosed Prevalent Cases of Autism Spectrum Disorder
• Total Treated Cases of Autism Spectrum Disorder

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Marketed Autism Spectrum Disorder Therapies

• RISPERDAL (risperidone): Janssen Pharmaceuticals RISPERDAL (risperidone) is the first US FDA-approved medication for the treatment of symptoms associated with autism spectrum disorder in children and adolescents, including aggressive behavior, deliberate self-injury, and temper tantrums. Risperidone is available in various formulations, including oral tablets and oral solutions. In October 2006, it was approved by the US FDA for the symptomatic treatment of irritability in autistic children and adolescents.
• ABILIFY (aripiprazole): Otsuka Pharmaceutical ABILIFY (aripiprazole) is US FDA-approved for the treatment of irritability in children and adolescents with autism spectrum disorder. The medication helps manage behavioral symptoms and improve daily functioning in patients with ASD.
• SLENYTO (melatonin): Neurim Pharmaceuticals/Flynn Pharma SLENYTO is the first and only pharmacotherapy that is approved for the treatment of insomnia in children with autism spectrum disorder. SLENYTO is a prolonged-release melatonin minitablet developed specifically for the treatment of insomnia in these children, addressing their specific needs. The active ingredient in SLENYTO is melatonin which is a hormone produced by the body. SLENYTO is available in two dosage forms, 1 mg and 5 mg prolonged-release tablets. The activity of melatonin at the melatonin receptors (MT1, MT2, and MT3) is believed to contribute to its sleep-promoting properties.

Emerging Autism Spectrum Disorder Therapies

• ML-004: MapLight Therapeutics ML-004 is MapLight's lead clinical compound. Its selective pharmacological properties make it a highly specific therapy with limited side effects. It is a 5-HT1B receptor agonist. The company is developing ML-004 for multiple indications, including sociability and irritability in autism spectrum disorder and agitation and aggression in Alzheimer's disease. Currently, the drug is being evaluated in a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety profile of ML-004 in up to 150 adults and adolescents with autism spectrum disorder.
• RG7816 (alogabat/RO7017773): Hoffmann-La Roche RO7017773 is a small molecule highly selective positive allosteric modulator of the GABAA α5 receptor, which is expressed in key brain regions for autism spectrum disorder. Currently, the drug is being evaluated in a Phase II, multicenter, randomized, double-blind, study to investigate the efficacy, safety, and tolerability of RO7017773 in participants aged 15-45 years with autism spectrum disorder.
• AB-2004: Axial Therapeutics AB-2004 is an investigational therapy that targets the microbiome-gut-brain axis and its role in co-occurring conditions associated with autism spectrum disorder. AB-2004 is a gut-targeted, molecular therapeutic, which means it is designed to work in the gut only and does not enter other bodily tissues. Currently, the drug is being evaluated in a Phase IIb, randomized, double-blind, placebo-controlled study in a 13 to 17-year-old autism spectrum disorder population.

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Autism Spectrum Disorder Therapies and Companies

• ML-004: MapLight Therapeutics
• RG7816 (alogabat/RO7017773): Hoffmann-La Roche
• AB-2004: Axial Therapeutics, Inc.
• L1-79: Yamo Pharmaceuticals LLC
• AJA001: DeFloria, Inc.
• BA-102: NeuroNOS/Beyond Air
• CAP-002: Capsida Biotherapeutics
• radiprodil: GRIN Therapeutics, Inc.
• RISPERDAL (risperidone): Janssen Pharmaceuticals
• ABILIFY (aripiprazole): Otsuka Pharmaceutical
• SLENYTO (melatonin): Neurim Pharmaceuticals/Flynn Pharma

Autism Spectrum Disorder Market Dynamics

The Autism Spectrum Disorder market dynamics have undergone significant changes over the years. Firstly, the aging population and increasing prevalence is a significant driver. The rising global prevalence of Autism Spectrum Disorder is a major factor driving market growth, leading to higher demand for diagnostic services, therapies, and long-term care solutions. Additionally, growing awareness among parents, educators, and healthcare professionals has improved early screening and diagnosis, enabling timely intervention and expanding the patient population seeking treatment and support services. Advancements in medical research and development have brought new behavioral therapies, digital therapeutics, and pharmacological treatments to the market, improving symptom management. Government support through various programs and funding initiatives focused on developmental disorders are enhancing access to early intervention programs, specialized education, and healthcare services. This, in turn, affects the demand for therapeutic treatments. Pharmaceutical and biotechnology companies are actively investing in clinical research to develop novel therapies targeting core and associated symptoms of autism, strengthening the overall market landscape.

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Scope of the Autism Spectrum Disorder Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Forecast Period - 2024-2034
• Autism Spectrum Disorder Companies- Aardvark Therapeutics, Inc., Otsuka Pharmaceutical, H. Lundbeck A/S, Jazz Pharmaceuticals, MapLight Therapeutics, Vanda Pharmaceuticals, ACADIA Pharmaceuticals Inc., AbbVie, Axial Therapeutics, Inc., Hoffmann-La Roche, Yamo Pharmaceuticals LLC, Janssen Pharmaceuticals, Neurim Pharmaceuticals, Flynn Pharma, and others
• Autism Spectrum Disorder Therapies- ML-004, RG7816 (alogabat/RO7017773), AB-2004, L1-79, AJA001, BA-102, CAP-002, radiprodil, RISPERDAL (risperidone), ABILIFY (aripiprazole), SLENYTO (melatonin), and others
• Autism Spectrum Disorder Unmet Needs, KOL's views, Analyst's views, Autism Spectrum Disorder Market Access and Reimbursement

Table of Content

1. Key Insights
2. Report Introduction
3. Autism Spectrum Disorder Market Overview at a Glance
4. Autism Spectrum Disorder Epidemiology and Market Methodology
5. Autism Spectrum Disorder Executive Summary
6. Key Events
7. Autism Spectrum Disorder Disease Background and Overview
8. Autism Spectrum Disorder Epidemiology and Patient Population
9. Autism Spectrum Disorder Patient Journey
10. Autism Spectrum Disorder Marketed Products
11. Autism Spectrum Disorder Emerging Treatment and Management
12. Autism Spectrum Disorder: 7 Major Market Analysis
13. Autism Spectrum Disorder SWOT Analysis
14. Autism Spectrum Disorder KOL Views
15. Autism Spectrum Disorder Unmet Needs
16. Autism Spectrum Disorder Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

Company Name: DelveInsight Business Research LLP
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About Us

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