Autism Spectrum Disorder Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug Therapy (Antipsychotic Drugs, Selective Serotonin Reuptake Inhibitors, 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 Regional Forecast, 2023-2030

The autism spectrum disorder therapeutics market size was valued at USD 1.93 billion in 2022 and is projected to grow USD 2.01 billion in 2023 to USD 3.42 billion by 2030, exhibiting a CAGR of 7.9% during 2023-2030. North America dominated the global market with a share of 58.03% in 2022.  

Autism spectrum disorder, also known as ASD, refers to a group of neurological disorders characterized by persistent deficits in social interaction and social communication and a repetitive/restricted pattern of behavior or activities. Autistic disorder, Aspergers syndrome, and Pervasive Development Disorder (PDD) are the three main types of the disorder, which affect millions of people globally. 

According to a 2020 report by the Centers for Disease Control & Prevention (CDC), an estimated 1 out of 54 children has been diagnosed with autism disorder in the U.S. There are a number of factors that are anticipated to contribute to the market’s growth prospects. The growing prevalence of the disease globally, coupled with rising awareness about the condition & the available options for various treatment type of different diseases are the key factors expected to drive the autism spectrum disorder therapeutics market size during the forecast period. Moreover, growing investments by key players in R&D initiatives for the launch of effective drugs to treat autistic disorders are expected to fuel the global market growth.

COVID-19 IMPACT

Robust Demand for Drugs During COVID-19 Backed by Growing Adoption of Telehealth Pushed Market Growth

The unprecedented pandemic at the initial stages resulted in the shutdown of a number of companies in the healthcare industry, leading to a slowdown of manufacturing processes. Additionally, the closure of therapy centers and autistic disorder-related services resulted in the halt/postponement of therapy sessions for autistic children. However, growing anxiety levels in autistic patients and the risk of contracting COVID-19 as these patients fall under vulnerable groups led to the strong adoption of telehealth systems by the patient caregivers/family. This factor also increased the demand for therapeutics and other off-label prescription drugs such as antipsychotics, SSRI, and sleep medications. Furthermore, the increased usage of online channels to procure autism medications also contributed to the growth of the market during COVID-19.

Also, various companies such as Otsuka Pharmaceutical Co., Ltd, and Johnson & Johnson witnessed strong sales trends for the drugs for treatment of the condition.

• For instance, Otsuka recorded a 14.0% increase in sales for Abilify Maintena, over the FY 2019. Therefore, COVID-19 has had a positive impact on the growth of the market.

In 2022, the market exhibited steady growth due to resumption of research and development activities of key market players. The market is anticipated to grow at steady rate during the forecast period, owing to expected launches of pipeline candidates. This is expected to foster the demand for autism spectrum disorder therapeutics.

LATEST TRENDS

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Increased Exploration into Enzyme Replacement Therapy (ERT) as a Novel Therapy for ASD 

Autism Spectrum Disorder is a lifelong disorder that affects the patient and the caregivers, family, and communities. Every child or adult with autism has different set of challenges and many people diagnosed with autism, have additional medical conditions such as gastrointestinal (GI) distress. In the 1980s and 1990s, it was first suggested that autistic patients could not digest food proteins very well, specifically the protein casein (found in milk) and gluten (found in wheat). Many therapies were developed based on this idea, however, due to some difficulties, the therapies were discontinued, and then the enzyme replacement therapy was introduced, which is one of the most important trends witnessed in autism spectrum disorder therapeutics.

Researchers around the globe believe that autism is caused by excess opioid activity in the brain, which leads to the digestive problem associated with particular proteins in food.

• For instance, Curemark developed a drug CM-AT that received a “Fast Track” designation from the U.S. FDA for children with autism, who have an unusually low level of chymotrypsin. This enzyme is essential for breaking down dietary protein into amino acids that the body cannot make on its own. Due to the various positive avenues, enzyme replacement therapy is proving to be a positive novel therapy for treating this disorder.

AUTISM SPECTRUM DISORDER THERAPEUTICS MARKET GROWTH FACTORS

Rising Prevalence of ASD to Propel Market Growth

An increase in the prevalence of autism spectrum disorder (ASD) is positively impacting the growth of the market globally, which has led to increasing demand for clinical research for effective treatment. This can improve patient outcomes and help achieve greater accuracy for the treatment of these conditions.

• For instance, according to a compiled report on worldwide autism rates by Global Health Data Exchange, countries such as France and Portugal have the lowest autism rate of 0.69% and 0.71%, respectively. In contrast, most Middle Eastern countries like Qatar, United Arab Emirates, Oman, Bahrain, and Saudi Arabia have been reported to have the highest prevalence of the disease.


• For instance, in 2021, the prevalence of autism in Qatar is estimated to be 1.6% and 1.0% in Saudi Arabia.

This growing prevalence rate in emerging countries is also anticipated to be one of the key reasons for the market growth, due to the increased demand for effective drugs. Launches of effective drugs are further anticipated to lead to improved patient outcomes, contributing to autism spectrum disorder therapeutics market growth prospects.

Government Initiatives to Increase Awareness Regarding ASD to Boost Market Growth

An increasing number of government initiatives like forming various foundations and sanctioning different funding for the awareness of autism in several countries is driving the market growth. Some of the government initiatives for increasing the awareness of autism across the globe include the initiatives conducted by the Saskatchewan Government.

• In July 2021, the Saskatchewan Government announced that families with children diagnosed with the condition will benefit from expanded funding. From 27th July 2021, Autism Individualized funding is available for children aged 11. Children born on or before March 31, 2021, were eligible to apply for the final payment. Furthermore, in 2021-2022, USD 10.3 million was assigned to provide USD 6,000.0 annually to children who have ASD between the ages of 6 to 11 years.

Such an increasing number of initiatives for patients with the condition would eventually lead to early diagnosis of the symptoms and boost the market growth. Furthermore, demand for autism treatment drugs after diagnoses is expected to contribute to the market growth.

RESTRAINING FACTORS

Lack of Approved Drugs to Hamper Market Growth

Currently, no drug can cure autism spectrum disorder or any of its associated core symptoms despite the increase in the need for effective drugs and clinical trials for autism. Concerned with the stalling of ASD therapeutics, the International Society of CNS Clinical Trials and Methodology and the European College of Neuropsychopharmacology created an ASD working group to review and identify the challenges related to drug development.

It has been witnessed that there is a fundamental weakness in methods, knowledge gaps, and conceptual models in clinical translation research. The agencies and the key companies are currently working on many molecules like Vasopressin 1A antagonist, bumetanide, and oxytocin receptor agonist, which have diverse mechanisms. In the era of targeted treatments, there has been no conclusive evidence supporting any drug's efficacy for the treatment of the condition core symptoms despite multiple attempts. Therefore, posing a challenge for treatment development, thus hampering the demand for autism spectrum disorder therapeutics.

SEGMENTATION

By Drug Therapy Analysis

Stimulants to Emerge as the Dominant Segment Due to Decrease of Hyperactivity In People With Autism

Based on drug therapy, the global market is segmented into antipsychotic drugs, SSRIs/antidepressants, stimulants, sleep medications, and others.

The stimulants segment held a dominant market share in 2022 due to the need for increased focus and decreased hyperactivity in people with autism. The segment is expected to expand at a considerably high CAGR during the forecast period as stimulants substantially contribute to the maintenance of certain symptoms associated with autism.

The SSRIs/antidepressants segment held the second dominant global autism spectrum disorder therapeutics market share, as it is the most commonly prescribed class of drug to autistic people. SSRIs like fluoxetine and sertraline help reduce the intensity and frequency of autism-related behaviors like repetitive actions, anxiety, irritability, tantrums, and aggressive actions. This segment is expected to expand at a considerably high CAGR during the forecast period.

The antipsychotic drugs segment is expected to strongly dominate the market during the forecast period as currently, the only two FDA approval (risperidone and aripiprazole) available to treat the irritability associated with the disorder belong to this segment.

The sleep medications segment is expected to account for a substantial proportion of the market as many patients on the autism spectrum suffer from sleep disturbances. The others segment are expected to account for limited share of the market during the forecast period.

By Disease Analysis

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Increased Prevalence of Autistic Disorder to Lead to Segment’s Dominance

Based on disease, the global market is segmented into autistic disorder, Asperger syndrome, pervasive developmental disorder, and others.

The autistic disorder segment held a dominant market share in the year 2022 owing to the high prevalence of this disease type. The segment held a 54.5% market share in 2022 and is projected to expand at a considerably high CAGR during the forecast period.

According to Pfizer’s report, 1 of every 6 to 8-year-old children are affected by autistic disorder. Therefore, the demand for effective treatment availability is the need of the hour. Hence, pharmaceutical companies are striving to get approvals for products for the management of the disorder and reducing the disease burden on the industry.

The pervasive developmental disorder (PDD) registered a substantial share in 2022 and is expected to exhibit a swift growth rate during the studied period. As autism includes a diverse group of medical conditions, one includes difficulty in socialization and communication skills. These symptoms have been found common in patients as early as infancy. Therefore, product sales for PDD are anticipated to increase during the forecast period. The Asperger syndrome segment is expected to be account as the third largest segment during the forecast period.

By Age Group Analysis

Children Segment to Grow at Faster Pace during the forecast period With Growing Number Of Service Providers 

The global market can be segmented into children and adults based on the age group.

The adult segment held a significant market share in the global market of 2022, owing to the growing number of service providers offering a wide range of cost-effective therapies. Furthermore, an augmented prevalence of autism in adult patients is projected to favor segmental growth.

During the forecast period compared to the adult segment, the children segment is estimated to expand at a relatively higher CAGR in the forecast period owing to the rise in the diagnosis of the condition at an early age. For instance, according to an article published in HealthLine Media, most children with autism are diagnosed after three. In contrast, it can be diagnosed as early as 18 months of age in some cases.

By Distribution Channel Analysis

Higher Procurement of Therapeutics through Hospital Pharmacies Enables Dominance of Segment

Based on the distribution channel, the global market can be segmented into hospital pharmacies, drugs stores & retail pharmacies, and online pharmacies.

The hospital pharmacies segment held the dominant share of the global market in 2022. Majority of the therapeutics can only be prescribed after thorough examinations by trained medical professionals at hospitals, and hence is expected to favor the segmental growth.

The drugs stores & retail pharmacies segment held the second-largest dominant market stake in 2022 and is expected to expand during the forecast period due to the increase in settings usage for procurement of drug refills.

The online pharmacies segment is projected to expand comparatively higher CAGR during the forecast period as most developed countries like the U.S. have well-established digital platforms. Furthermore, during COVID-19, these institutions increased the adoption to obtain prescription medications.

REGIONAL INSIGHTS

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Based on the region, the market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

The North America market size stood at USD 1.12 billion in 2022. The increasing prevalence of autism disorder across the U.S., coupled with the growing adoption and uptake of autism spectrum disorder therapeutics are attributable to the region’s dominance. For instance, according to the John Hopkins report published in 2020, the autism prevalence in the U.S. has been tripled since 2000 from 0.67 to 1.85%. Moreover, the launch of several products by companies across the U.S. & Canada and strong government support contribute to the region's growth. For instance, in April 2019, the Government of Canada announced funding for a community-based project through Autism Spectrum Disorder Strategic Fund. This project has been initiated to provide opportunities for Canadians living with autism disorder. These factors have contributed to the region’s dominance.

Increasing awareness and screening, access to aid, and broadened diagnostic criteria have made Europe the second largest region in the market. Further, higher product sales are anticipated to boost the market in the region during the forecast period.

Asia Pacific is projected to grow with the highest CAGR owing to the rising demand for effective treatment. The development of healthcare infrastructure to fulfill the need for well-equipped healthcare institutions such as hospitals for patients is also contributing to the growth of this region.

In regions such as Latin America and the Middle East & Africa, a lower rate of reported autism disorders and lack of product approvals has resulted in a slower growth rate than other regions.

KEY INDUSTRY PLAYERS

Continuous R&D Initiatives and Strategic Acquisitions by Key Players to Surge Sales Growth 

The competitive landscape reflects a competitive scenario with the presence of a number of companies with diverse product portfolio. Key players in developed countries and growing investments in the research sector to develop innovative therapeutics are likely to dominate the competition scenario during the forecast period.

Players engaged in drug therapy in the global market with considerable market share include Otsuka Holdings Co. Ltd., H. Lundbeck A/S, Janssen Pharmaceuticals, Inc., and Sanofi. Some of the other key players include Alembic Pharmaceuticals Limited, Teva Pharmaceutical Industries Ltd., and Aurobindo Pharma. These players specialize in the manufacturing of generic versions of the various drugs to treat the condition.

LIST OF KEY COMPANIES IN AUTISM SPECTRUM DISORDER THERAPEUTICS MARKET:

• 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)

KEY INDUSTRY DEVELOPMENTS:

• December 2021: F. Hoffmann-La Roche Ltd drug pipeline candidate of RO7017773 was in an ongoing trial phase 2 trial to investigate the efficacy, safety, and tolerability in participants aged 15-45 years with autism spectrum disorder (ASD). The company plans for a regulatory filing in 2024.


• November 2021: Yamo Pharmaceuticals, LLC, received investment from The Autism Impact Fund to support its Phase 2 candidate study of L1-79 in adolescents and adults with autism spectrum disorder.


• October 2021: Axial Therapeutics announced that the company received clearance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for their lead candidate named AB-2004, which is a gut-targeted, molecular therapeutic being studied for the treatment of irritability associated with ASD.


• February 2021: PaxMedica announced positive results from Phase 2 Trial of PAX-101 (IV Suramin) in children with autism.


• May 2020: HARMAN International entered into a multi-year global partnership with F. Hoffmann-La Roche Ltd to develop a digital therapeutic platform for individuals suffering from autism spectrum disorder.

REPORT COVERAGE

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The global market report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, product type, and leading segments of the type and treatment. Furthermore, it offers insights into the market trends and highlights key industry developments, pipeline analysis of therapeutics, impact of the COVID-19 on the market, regulatory and reimbursement scenario, and prevalence of autism spectrum disorder in key countries. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the developed market in recent years.

Report Scope & Segmentation