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U.S. Autism Spectrum Disorder Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug Therapy (Antipsychotic Drugs, SSRIs/Antidepressants, Stimulants, Sleep Medications, and Others), By Disease (Autistic Disorder, Asperger Syndrome, Pervasive Developmental Disorder, and Others), By Age Group (Children and Adults), By Distribution Channel (Hospital Pharmacies, Drugs Stores & Retail Pharmacies, and Online Pharmacies), and Country Forecast, 2023-2030

Last Updated: June 24, 2024 | Format: PDF | Report ID: FBI108931



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The U.S. autism spectrum disorder therapeutics market size was worth USD 1.04 billion in 2022 and is projected to grow at a CAGR of 8.7% during the forecast period. 

Autism Spectrum Disorder (ASD) is a developmental disability that causes significant problems in social communication and interaction that involve restricted or repetitive behaviors or interests. The prevalence of autism is substantially increasing across the U.S. which is surging the need for effective screening processes and special education interventions.

  • According to the 2022 Data of Center for Disease Control and Prevention (CDC), the prevalence of autism in the U.S. was 1 in 150 in 2000, which went up to 1 in 100 in 2022.

In order to reduce this rate, the U.S. government is focusing on forming foundations and sanctioning funds for increasing awareness about autism spectrum disorder among the general population. These initiatives are anticipated to increase the early diagnosis rate for this disease nationwide. Moreover, the growing investments or funds approvals are encouraging market players to upscale their clinical research to introduce effective autism spectrum disorder therapeutics with an aim to improve patient outcomes and serve greater accuracy in treating these conditions.

The COVID-19 pandemic impacted the market growth positively. This was due to a gradual shift of the patient population to telehealth for consultation and an increase in the procurement of medication through online pharmacies.

U.S. Autism Spectrum Disorder Therapeutics Market Trends

Increased Clinical Research of Enzyme Replacement Therapy

One of the prevailing market trends observed in the U.S. for autism spectrum disorder therapeutics is the clinical efficiency of enzyme therapy for the treatment of autism-related conditions. Clinical researchers specifically are trying to understand how digestive, nervous, and immune systems lead to food intolerances and digestive problems in autistic children. It has been observed that many autistic patients have additional medical conditions, such as gastrointestinal distress, which includes protein indigestion. To provide a solution to this problem, researchers, as well as market players in the U.S. are focusing on introducing novel therapies. One of the emerging therapies is enzyme replacement therapy, which can help resolve digestive problems, especially protein-associated diseases among autistic patients.

  • Based on this trend, a company named Curemark developed a drug CM-AT for children with autism who have unusually low levels of chymotrypsin, an enzyme that is essential for the breakdown of dietary protein into amino acids that the body cannot make on its own.

U.S. Autism Spectrum Disorder Therapeutics Market Growth Factors

Government Initiatives for Increasing Awareness for Autism Spectrum Disorder to Drive Market Growth

The U.S. government is actively investing to introduce policies and programs to increase awareness about early diagnosis of the disease. They are also sanctioning funds to support and advance the clinical research studies of autism-related work. For instance, under the Consolidated Appropriations Act 2023, a bill was submitted that includes a significant call by Congress to the National Institutes of Health (NIH) to invest a part of its overall USD 2.5 billion funding. The investment will be utilized in autism research and address critical research gaps, including issues across the lifespan, aging and autism, and health disparities.

Such initiatives are anticipated to increase awareness and accessibility toward autism treatment and care among the patient population. These initiatives are likely to surge the demand for effective treatment measures to cater to the growing population's need, subsequently augmenting the U.S. market growth.

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According to an article published by Cross River Therapy in 2022, Rhode Island, Maryland, and Florida are the states with the highest prevalence of autism rate.


Lack of Approved Drugs May Limit Market Growth

One of the critical factors impeding the market growth rate in the U.S. is the lack of drugs approved for managing symptoms associated with autism spectrum disorder in the U.S. There is no cure for this disease; however there are two approved drugs by the U.S. Food and Drug Administration (FDA), Risperidone (Risperdal) and Aripiprazole (Abilify) which are indicated to treat irritability associated with autism spectrum disorder.

Moreover, these limited drugs also have some significant side effects on autistic patients, which have been a pivotal reason for limited adherence to treatment, hence limiting the market growth.

  • According to Autism Speaks, increased appetite and weight gain are well-known side effects of risperidone (Risperdal) and aripiprazole (Abilify). If continued for a longer duration, the weight gain can increase the risk of developing type 2 diabetes and cholesterol problems among autism patients.

Stringent guidelines released by the regulatory authorities regarding drug development for this disease may influence the interest of biopharmaceutical companies in investing and diverting their R&D focus to develop and commercialize novel drugs in this market in the U.S., which is anticipated to restrict market growth.  

U.S. Autism Spectrum Disorder Therapeutics Market Segmentation Analysis

By Drug Therapy Analysis

On the basis of drug therapy, the market is segmented into antipsychotic drugs, SSRIs/antidepressants, stimulants, sleep medications, and others.

The stimulants segment dominated the U.S. autism spectrum disorder therapeutics market share in 2022. Certain factors driving the growth of this segment include the increased focus of market players to introduce novel solutions to decrease hyperactivity in autism patients.

  • According to an article published by the Discover Camp Worth in February 2022, stimulants can improve autism symptoms by 80% if administered in the correct dosages. They can substantially improve core autism symptoms that affect concentration, help in task completion on time, and reduce impulsive behavior.

By Disease Analysis

By disease, the market is segmented into autistic disorder, Asperger syndrome, pervasive developmental disorder (PDD), and others.

The autistic disorder segment held a major share of the U.S. autism spectrum disorder therapeutics market in 2022. Some of the factors responsible for the segment’s growth are the increasing patient pool of this disease coupled with rising awareness about the condition and available options for treatment, which are driving the demand for effective autism spectrum disorder therapeutics measures.

  • In 2023, the Centers for Disease Control and Prevention reported that around 1 in 36 children in the U.S. were diagnosed with autism.

By Age Group Analysis

By age group, the market is segmented into children and adults.

The adults segment accounted for the largest share of the autism spectrum disorder therapeutics market in the U.S. in 2022. The dominance of this segment is attributed to the increase in the diagnosis of autism among the adult population across the country. This is surging the patient population to seek treatment for the disease, further driving the demand for autism spectrum disorder therapeutics, and is leading to the segment’s growth.

  • According to the Centers for Disease Control and Prevention 2023 data, over 5.4 million U.S. adults were diagnosed with an autism spectrum disorder in 2022.

By Distribution Channel Analysis

Based on distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.

The hospital pharmacies segment dominated the market in the U.S. in 2022. The dominance of this segment is attributed to the need for the procurement of prescription drugs from hospital pharmacies, as most of the medications can only be prescribed after a thorough examination by a trained medical professional. Moreover, the availability of autism therapy and medications at the hospitals makes it a more preferred clinical setting by the patient population.

  • According to a study published by the National Autistic Society in February 2021, in New York, 5.9 million individuals with 9.1 million emergency department visits. Of those, 31,682 had autism spectrum disorder (0.5%), accounting for 66,053 (0.7%) emergency department visits. These findings emphasize patient preference toward hospital settings for the treatment related to autism.

List of Key U.S. Autism Spectrum Disorder Therapeutics Market Companies

In terms of the competitive landscape, this market is highly fragmented in the U.S. as no single organization or key player dominates the market. Tier 1 consists of players with approved products and has a strong emphasis on upscaling R&D activities. These players are Otsuka Pharmaceutical Co., Ltd., Janssen Pharmaceuticals, Inc., and H. Lundbeck A/S.

Some other prominent or emerging players in this market are Alembic Pharmaceuticals Limited, Teva Pharmaceutical Industries Ltd, and Sanofi, among others. These companies are major manufacturers of generic versions of autism drugs and are actively focused on expanding their product portfolio for this market in the U.S.


  • Curemark, LLC (U.S.)

  • Alembic Pharmaceuticals Limited (India)

  • Yamo Pharmaceuticals (U.S.)

  • PaxMedica (U.S.)

  • F. Hoffmann-La Roche Ltd (Switzerland)

  • Aurobindo Pharma Ltd. (India)

  • Otsuka Holdings Co. Ltd. (Japan)

  • Janssen Pharmaceuticals, Inc. (U.S.)

  • Teva Pharmaceutical Industries Ltd. (Israel)

  • H. Lundbeck A/S (Denmark)


  • September 2022 – The National Institute of Health awarded USD 100 million to support nine Autism Centers of Excellence (ACEs) over the next five years. The ACE program supports research on diagnosis, causes of, and interventions for autism spectrum disorder.

  • May 2022 – The Autism Impact Fund (AIF) entered into a strategic partnership with Arsenal Capital Partners, a private equity firm. AIF received investment from Arsenal to provide access to best-in-class services, diagnostics, and therapeutics for autism.

  • August 2021 – Janssen Pharmaceuticals, Inc., R&D introduced a new learning system called Janssen Autism Knowledge Engine (JAKE). The company also developed its own smart clinical rating scale called the autism behavior inventory (ABI), administered through the JAKE portal to measure the symptoms of autism.


An Infographic Representation of U.S. Autism Spectrum Disorder Therapeutics Market

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The U.S. autism spectrum disorder therapeutics market report provides a detailed analysis of the industry. It focuses on key aspects such as the prevalence of autism in the U.S., and pipeline analysis. Additionally, it includes an overview of economic cost burden of autism treatment, key industry developments, and the impact of COVID-19 on the market. Besides this, the report offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation



Study Period


Base Year


Estimated Year


Forecast Period


Historical Period


Growth Rate

CAGR of 8.7% from 2023 to 2030


Value (USD Billion)



By Drug Therapy

  • Antipsychotic Drugs

  • SSRIs/Antidepressants

  • Stimulants

  • Sleep Medications

  • Others

By Disease

  • Autistic Disorder

  • Asperger Syndrome

  • Pervasive Developmental Disorder (PDD)

  • Others

By Age Group

  • Children

  • Adults

By Distribution Channel

  • Hospital Pharmacies

  • Drug Stores & Retail Pharmacies

  • Online Pharmacies

Frequently Asked Questions

Fortune Business Insights says that the U.S. market was worth USD 1.04 billion in 2022.

The market is expected to exhibit a CAGR of 8.7% during the forecast period (2023-2030).

By disease, autistic disorder accounts for the leading share in the market.

Otsuka Holdings Co. Ltd. and Janssen Pharmaceuticals, Inc. are the top players in the market.

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