Autism Spectrum Disorder Market

• The Autism Spectrum Disorder Market size is expected to experience steady growth during the forecast period (2024–2034). The increase in Autism Spectrum Disorder Market Size is a direct consequence of increased awareness, improved diagnostic practices, and the development of new therapies.
• The current Autism Spectrum Disorder Therapeutics Market is dominated by big pharmaceutical companies like Otsuka, Johnson & Johnson, and Flynn Pharma, offering various approved therapies such as ABILIFY (aripiprazole), RISPERDAL (risperidone), and SLENYTO (prolonged-release melatonin). The market size of these is anticipated to increase in interventions marketed to cure autism in the coming years.
• To further propel the market in the coming years, several Autism Spectrum Disorder Companies like MapLight Therapeutics, Hoffmann-La Roche, Axial Therapeutics, and Yamo Pharmaceuticals are developing their assets like ML-004, RG7816, AB-2004, and L1-79 for autism spectrum disorder. Due to the anticipated approval of a few late-stage emerging therapies, which are under development in the coming years, the overall Autism Spectrum Disorder Therapeutics Market is expected to grow at a significant CAGR over the forecast period (2024–2034).
• 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-cannabinoid 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.

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DelveInsight’s comprehensive report titled “Autism Spectrum Disorder Market Insights, Epidemiology, and Market Forecast – 2034” offers a detailed analysis of Autism Spectrum Disorder. The report presents historical and projected epidemiological data covering total diagnosed prevalent cases of autism spectrum disorders, age-specific cases of autism spectrum disorders, gender-specific cases of autism spectrum disorders, and total treated cases of autism spectrum disorders. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The Autism Spectrum Disorder Therapeutics Market Report analyzes the existing treatment practices and unmet medical requirements in ASD. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Autism Spectrum Disorder Treatment Market

Autism Spectrum Disorder Overview

Autism Spectrum Disorder is a neurodevelopment disorder characterized by difficulties with social communication and social interaction and restricted and repetitive patterns in behaviors, interests, and activities. The symptoms are present early on in development and affect daily functioning. They can differ individually but mainly there are two categories of symptoms; social communication and interaction difficulties, and restricted or repetitive behaviors. The diagnosis of autism spectrum disorder is based on diagnostic evaluations that often involve a team including a physician and a psychologist, and may include other disciplines such as speech and language pathology or occupational therapy. The current treatment options for managing the core symptoms of autism spectrum disorder include psychosocial therapies and some approved pharmacological therapies aripiprazole, risperidone, and SLENYTO.

Autism Spectrum Disorder Diagnosis

The diagnosis of autism spectrum disorder is based on diagnostic evaluations that often involve a team including a physician and a psychologist, and may include other disciplines such as speech and language pathology or occupational therapy. The evaluation should include standardized observations of the individual, assessments of his/her learning and cognitive abilities, and interviews to gather information about behavior across multiple settings and her/his medical and developmental history.

Autism Spectrum Disorder Treatment

Currently, no treatment has been shown to cure autism spectrum disorder, but several interventions have been developed and studied for use with young children. These interventions may reduce symptoms, improve cognitive ability and daily living skills, and maximize the ability of the child to function and participate in the community. There are many types of treatments available. The most effective treatments available today are applied behavioral analysis (ABA), occupational therapy, speech therapy, physical therapy, and pharmacological therapy. Pharmaceutical treatments can help ameliorate some of the behavioral symptoms of autism spectrum disorder, including irritability, aggression, and self-injurious behavior.

Autism Spectrum Disorder Epidemiology

The epidemiology section on the Autism Spectrum Disorder Therapeutics Market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of autism spectrum disorder. Additionally, the Autism Spectrum Disorder epidemiology report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• 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.

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Autism Spectrum Disorder Market Outlook

There is no cure for autism spectrum disorder, but various interventions and treatments have been approved for the treatment of autism spectrum disorder. 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. ABILIFY (aripiprazole) is also US FDA-approved for the treatment of irritability in children and adolescents with autism spectrum disorder. SLENYTO (melatonin) is the first and only pharmacotherapy that is approved for the treatment of insomnia in children with autism spectrum disorder.

SLENYTO (melatonin) is a prolonged-release melatonin minitablet developed specifically for the treatment of insomnia in these children, addressing their specific needs.

Developmental approaches focus on improving specific developmental skills, such as language skills or physical skills, or a broader range of interconnected developmental abilities. Developmental approaches are often combined with behavioral approaches. The most common developmental therapy for people with autism spectrum disorder is speech and language therapy. Psychological approaches can also help people with autism spectrum disorder cope with anxiety, depression, and other mental health issues.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Autism Spectrum Disorder market in the 7MM is expected to change significantly during the study period 2020–2034.

Autism Spectrum Disorder Recent Developments

• In April 2025, NeuroNOS, a subsidiary of Beyond Air, announced that the FDA granted Orphan Drug Designation to its lead investigational therapy, BA-102, for treating Phelan-McDermid Syndrome (PMS), a condition linked to Autism Spectrum Disorder (ASD). The company plans to begin first-in-human clinical trials for ASD in 2026.
• In March 2025, GRIN Therapeutics, Inc. announced that the FDA granted Orphan Drug designation for its investigational drug, radiprodil, for the treatment of GRIN-related neurodevelopmental disorder (NDD).
• 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-cannabinoid 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.

Marketed Autism Spectrum Disorder Drugs

• 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.

• 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.

Note: Detailed marketed therapies assessment will be provided in the final report....

Emerging Autism Spectrum Disorder Drugs

The autism spectrum disorders pipeline is quite robust with several products available in the developmental stage. There are several key players involved in the development of promising products such as MapLight Therapeutics, Hoffmann-La Roche, Axial Therapeutics, Yamo Pharmaceuticals, and others

• 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.

Autism Spectrum Disorder Market Segmentation

DelveInsight’s ‘Autism Spectrum Disorder Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future Autism Spectrum Disorder market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Autism Spectrum Disorder Market Size by Countries

The market size for Autism Spectrum Disorder is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2022, the United States held a significant share of the overall 7MM (Seven Major Markets) Autism Spectrum Disorder market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Autism Spectrum Disorder Market Size by Therapies

Autism Spectrum Disorder market size by therapies is categorized into current and emerging markets for the study period 2020–2034. One of the emerging drugs anticipated to launch during the forecast period is the ML-004 by MapLight Therapeutics.

Note: Detailed market segment assessment will be provided in the final report....

Autism Spectrum Disorder Drugs Uptake

This section focuses on the sales uptake of potential Autism Spectrum Disorder drugs that have recently been launched or are anticipated to be launched in the Autism Spectrum Disorder market between 2020 and 2034. It estimates the market penetration of Autism Spectrum Disorder drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Autism Spectrum Disorder market.

The emerging Autism Spectrum Disorder therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the Autism Spectrum Disorder market.

Autism Spectrum Disorder Market Access and Reimbursement

DelveInsight’s ‘Autism Spectrum Disorder Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of Autism Spectrum Disorder. This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current Autism Spectrum Disorder market trends and fill gaps in secondary findings, we interview KOLs and SMEs working in the Autism Spectrum Disorder domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Autism Spectrum Disorder market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Autism Spectrum Disorder unmet needs.

Autism Spectrum Disorder: KOL Insights

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as the Boston Children’s Hospital in the US, CIBER de Enfermedades Cardiovasculares (CIBERCV) in Spain, Oita University, Yufu in Japan, University Children’s Hospital, Magdeburg, in Germany, and organizations like Autism Spectrum Disorder Research Foundation, International Autism Spectrum Disorder Registry, among others.

“Although Autism Spectrum Disorder can be a lifelong disorder, treatments and services can improve a person’s symptoms and ability to function.”

Note: Detailed assessment of KOL Views will be provided in the full report on Autism Spectrum Disorder...

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the Autism Spectrum Disorder Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Autism Spectrum Disorder Pipeline Development Activities

The Autism Spectrum Disorder Therapeutics Market Report offers an analysis of  Autism Spectrum Disorder clinical trials within Phase II and III stages and examines Autism Spectrum Disorder Companies involved in developing targeted therapeutics for Autism Spectrum Disorder. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The Autism Spectrum Disorder Therapeutics Market Report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging Autism Spectrum Disorder therapies.

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Autism Spectrum Disorder Treatment Market Report Insights

• Patient-based Autism Spectrum Disorder Market Forecasting
• Autism Spectrum Disorder Therapeutic Approaches
• Autism Spectrum Disorder Pipeline Drugs Analysis
• Autism Spectrum Disorder Market Size and Trends
• Autism Spectrum Disorder Therapeutics Market Opportunities
• Impact of Upcoming Autism Spectrum Disorder Therapies

Autism Spectrum Disorder Treatment Market Report Key Strengths

• 11 Years Autism Spectrum Disorder Market Forecast
• The 7MM Coverage
• Autism Spectrum Disorder Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Autism Spectrum Disorder Therapeutics Market
• Autism Spectrum Disorder Drugs Uptake

Autism Spectrum Disorder Treatment Market Report Assessment

• Current Autism Spectrum Disorder Treatment Market Practices
• Autism Spectrum Disorder Unmet Needs
• Autism Spectrum Disorder Pipeline Drugs Analysis Profiles
• Autism Spectrum Disorder Therapeutics Market Attractiveness
• Autism Spectrum Disorder Market Drivers
• Autism Spectrum Disorder Market Barriers

Key Questions Answered In The Autism Spectrum Disorder Market Report:

How common is Autism Spectrum Disorder?

• What are the key findings of Autism Spectrum Disorder epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020–2034)?
• What are the currently available treatments for Autism Spectrum Disorder?
• What are the disease risk, burden, and unmet needs of Autism Spectrum Disorder?
• At what CAGR is the Autism Spectrum Disorder market and its epidemiology is expected to grow in the 7MM during the forecast period (2024–2034)?
• How would the unmet needs impact the Autism Spectrum Disorder market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of Autism Spectrum Disorder in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2020–2034)?
• How many companies are currently developing therapies for the treatment of Autism Spectrum Disorder?

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