Autistic Spectrum Disorder (ASD)

Published Date : Nov 2023
Category : Neurodegenerative Disorders
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Autistic Spectrum Disorder (ASD) - Developmental Disorder

Potential Challenges of Living with Autism

Autism spectrum disorder (ASD) is a neurological and developmental disorder caused by differences in the brain, which initiates early in childhood and lasts throughout one's life. It has an impact on a person's behavior, interactions with others, social communication difficulties, and learning. Children with ASD disorder has complex neurodevelopmental disorders that are characterized by behavioral and psychological issues. Due to their limited adaptive capabilities, these kids are upset when the current surrounding environment changes. The symptoms of autism in infants’ impact daily functioning and are present from early childhood. Compared to the general population, children with ASD autism have co-occurring language problems, intellectual disabilities, and seizures. According to WHO, it is estimated that worldwide about 1 in 100 children has Autism spectrum condition (ASC).

There are five types of ASD which include Autistic Disorder, Asperger’s Disorder, Rett’s Disorder, Childhood Disintegrative Disorder, and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The rare disorders that are considered under ASD are Childhood disintegrative disorder (CDD), also called disintegrative psychosis, and Heller syndrome. In the Fifth Edition (DSM-5) of the Diagnostic and Statistical Manual of ASD Mental Disorders, childhood disintegrative disorder, along with other types of autism, is combined into a single spectrum called autism spectrum disorder. The causes of ASD are not yet known, and it is often seen that children having this disorder have achieved normal developmental milestones before the regression of skills.

The onset age of ASD varies it usually appears three years after achieving regular developmental milestones. A child affected with childhood ASD show normal development, and they normally develop age-appropriate verbal and nonverbal communication, as well as social relationships, motor, play, and self-care skills as compared to other same-aged children. The most prevalent and distinctive characteristic of this disorder is the loss of attained skills. Autism in boys and children assigned male at birth (AMAB) is much more likely than autism in girls and children assigned female at birth (AFAB). It’s more than four times more common in boys and children AMAB than in girls and children AFAB.

NCBI indicates that ASD is becoming more prevalent. It is currently unknown whether this development is the result of overdiagnosis, overawareness, or too broad diagnostic criteria. Its prevalence is reported to be 1 in 68. With just 1.7 instances per 100,000 people, childhood disintegrative disorder is an uncommon disorder with an estimated frequency of 1 to 2 cases per 100,000 people. With an incidence 60 times lower than that of autistic disorder, childhood disintegrative disorder is an uncommon disorder.

Innovation in the diagnostic and treatment field has been considered an essential part of increasing the opportunities on a worldwide scale for the market players. DiseaseLandscape Insights here aids in making educated decisions in the field of medical technology, therapies, and diagnostics, where diverse technologies and spectacular developments will modify the landscape, resulting in greater growth.

Autism spectrum disorder is growing worldwide, causing a drastic shift in individual outcomes and quality of life. Changing the current circumstances of autism spectrum disorder would thus push the companies in the right direction and impart new prospects for a variety of market participants in the domain of DiseaseLandscape.

DiseaseLandscape Insights is ready to facilitate strategic decisions in the diagnostic, treatment, and medical device landscapes.

Diagnostic Analysis:

Diagnosing autism is difficult as there’s no autism testing, such as a laboratory test, to diagnose this condition. However, healthcare providers perform specialized screenings and evaluations. The process of getting an autism spectrum disorder diagnosis includes the following steps.

  • Autism Spectrum Disorder (ASD) Screening

ASD Disease screening is the first step in diagnosing ASD. As there is no cure for ASD, early autism spectrum treatment helps to reduce autism symptoms and improve quality of life. ASD screening is most often used to check signs of autism in newborn children aged 2 and under.

There is no special test for ASD. Screening usually includes a questionnaire for parents that asks for information about a child's development and behavior, observing children's behavior, and interactions with others as well as tests that examine child to perform tasks that check their thinking skills and ability to make decisions. Sometimes a physical problem causes autism-like symptoms. So, screening also includes Blood tests to check for lead poisoning and other disorders and hearing tests when hearing problems cause problems in language skills and social interaction along with genetic tests these tests look for inherited disorders such as Fragile X syndrome. Fragile X causes intellectual disabilities and symptoms like ASD. It most often affects the boys.

  • PTEN Genetic Test

A PTEN genetic test uses a sample of blood or other body tissue to look for changes in a gene called PTEN. Changes in genes are also called gene variants or mutations. Genes are parts of DNA in cells that are inherited from parents. Inherited changes in the PTEN gene are not common. But when they happen, they cause several types of autism disorders. These disorders all include the growth of benign tumors (not cancer). These tumors are called hamartomas. The disorders are grouped and called PTEN hamartoma tumor syndrome (PHTS). Cowden syndrome and Bannayan-Riley-Ruvalcaba syndrome are two types of PHTS disorders.

The PTEN genetic test is used to look for changes in the PTEN gene. It's not a routine test. It is used to find out the change in the PTEN gene involved in cancer and check for inherited changes in the PTEN gene.

  • Developmental Diagnosis

While a quick screening tool test cannot diagnose a child, it suggests whether the child is developing normally or whether further autism spectrum testing by a specialist is necessary. It might be necessary to conduct a formal developmental evaluation if the screening tool reveals a problem area. This official assessment, which takes a closer look at a child's development, is typically completed by a qualified professional like an occupational therapist, developmental pediatrician, child psychologist, speech-language pathologist, or another specialist. The specialist conducts an organized test on the child, observes the child, and questions the parents The outcomes of this official assessment show the child's advantages and disadvantages and help determine whether they meet the criteria for a developmental diagnosis.

Treatment Analysis:

Autism disorder treatment for childhood disintegrative disorder is similar. Early and extensive educational interventions are emphasized. The treatment plan is primarily behavior-based and extremely regimented. A typical component of the overall treatment plan is family counselling, which includes educating the parents, so they adhere to the child's home treatments. Occupational, speech, language, social skills development, and sensory integration therapies all be employed by the requirements of the child. The children affected experience a delirious loss of language, social skills, and self-care abilities. They also face ongoing challenges in specific areas and need long-term care. Children with disintegrative disorder need to be treated with medication, behavior therapy, and environmental therapy.

  • Behavior Therapy

The primary goal of applied behavioral analysis is to systematically teach the patient how to retrain their language, social skills, and self-care abilities. The way these treatment programs are set up, acceptable behavior is reinforced while problematic behaviour is discouraged using rewards. These programs, which other healthcare workers use, are typically developed by certified behavior analysis professionals. Individuals with varying degrees of expertise in various fields, such as occupational therapy, physical therapy, psychology, and speech therapy, benefit from this. It is recommended that caregivers, parents, and teachers utilize these behavior models consistently.

  • Environmental Therapy

Enhancing the sensory experience through sensory enrichment is one way to reduce autism symptoms, many of which are also present in childhood disintegrative disorder.

  • Medications

Since no medication directly cures this disease, medications are used to treat ASD symptoms in infants as they develop. Antipsychotic drugs are used to treat aggressive and recurrent behavioural patterns. Experts use stimulants, other antipsychotics, and selective serotonin reuptake inhibitors (SSRIs) to control problematic behavior, especially aggression. The use of neuroleptic medication carries a significant risk of neuroleptic malignant syndrome. When seizures occur, anticonvulsants are given.

For market participants, DiseaseLandscape Insights assists in the development and setup of commercial ASD services. DLI helps players by offering research and development in drug discovery, clinical trial phases, and market analysis of product launch expansion. DLI helps with resource allocation, risk assessment, medication safety, and insights into the dynamics of disease for long-term planning.

DLI also provides information for papers about medications, clinical and drug safety, and regulatory bodies. To be informed and clear, stakeholders can find out more information about different preventive actions by visiting the websites of major medical organizations, journal articles, publication abstracts, and marketing materials.

Treatment Market Players:



Ajanta Pharma Inc.




Otsuka America Pharmaceutical


Otsuka America Pharmaceutical


Neuracle Lifesciences




Taj Pharma

Risperidone Tablets USP 2mg

Mankind Pharma Pvt Ltd

Nudon (2 mg)

Moxy Laboratories Pvt. Ltd


K.C. Laboratories Pvt. Ltd.


Gentech Healthcare


Invision Medi Sciences Pvt. Ltd. (Marx Remedies)

Krisp (1mg)


Regulatory Framework for Autism Spectrum Disorder:

On 20 May 2020, TGA approved SLENYTO sponsored by RAD Data Australia Pty Ltd, whose active ingredient is melatonin. Designated that SLENYTO (modified release tablet) is now indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism and Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

In a webinar presentation on 1 March 2023, it was stated that changing the classification of MDMA and psilocybin enables prescribing by authorized psychiatrists. This webinar addresses the recent announcement by the Therapeutic Goods Administration (TGA) that medicines containing Psilocybin and MDMA will be classified as Schedule 8 (controlled drug) in the Poisons Standard for specific conditions when prescribed by a psychiatrist under the Authorised Prescriber scheme.

DiseaseLandscape Insights has significantly simplified the regulatory structure for key players who have a presence in ASD Landscape. DLI helps the stakeholders understand the import/export laws, surveillance, and regulatory design of different countries. Key players adequately mitigate, handle, and respond to the epidemics of ASD by considering the well-being of the affected population.

Market Trends Analysis:

The market is expanding because of the development of various drugs for the treatment of ASD; however, the disease cannot be completely cured. In-depth research is required to come up with a complete curative medicine for ASD. Market players have various opportunities in the diagnostic as well as treatment fields. Research on monoclonal antibodies and immunotherapy helps the market player to grow globally.

To promote patients' health researchers, use AI to predict challenging behaviors common in profound autism. Using artificial intelligence tools to analyse years of biomedical data, researchers at Rensselaer discovered a possible connection between sleep, gastrointestinal health, and two potentially harmful behaviors often associated with profound autism: self-injury and aggression. People with profound ASD often need around-the-clock care. Additionally, it is common for them to exhibit self-injurious and aggressive behaviors, which present safety concerns for themselves and their caretakers.

Furthermore, researchers utilized AI to uncover a link between sleep and gastrointestinal health, and the challenging behaviors in individuals with profound autism, such as self-injury and aggression.

However, the usage of AI for the treatment of ASD and rising R&D spending are further factors that are projected to boost the global market. A slew of AI technologies is transforming practically every stage of the new ASD drug process, with significant potential to reshape the industry's pace and cost.

Clinical Data Assessment:

With the increasing emphasis on comparative effectiveness, the government emphasizes the importance of clinical trials in the practice of evidence-based medicine and healthcare reform. Clinical data helps the market players to properly compare medical therapy and achieve one of the primary aims of healthcare reform.

The study titles of the currently active clinical trials, as well as the phases in which they are being conducted, are included in the table below.

Phase 1

Phase 2

Phase 3

Phase 4

Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder

Treatment of Children with Autistic Spectrum Disorder with Autologous Umbilical Cord Blood, a Pilot Study

The Effects of Medical Cannabis in Children with Autistic Spectrum Disorder

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

Oxytocin in Individuals with Spectrum Autism Disorders

Melatonin Dose-effect Relation in Childhood Autism

Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children with Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial

Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach

Phase 1 Study of Intranasal Oxytocin on Parents' Behavioral and Physiological Responses to Children with Autism

A Phase 2 Randomized Three-Arm Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of 16 Weeks of Treatment with Trichuris Suis Ova (TSO) Therapy in Pediatric Patients Ages 6 to 17 With Autism

An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects with Autism Spectrum Disorders

Improving Driving in Young People with Autism Spectrum Disorders

Autologous Bone Marrow Stem Cells for Children with Autism Spectrum Disorders

Autologous Bone Marrow Stem Cells for Children with Autism Spectrum Disorders

Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

An Open-Label Study of Glutathione in Children with Autism Spectrum Disorder

Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders

An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD).

Oxytocin in Adolescents with Autism Spectrum Disorders

A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults with Autism Spectrum Disorders



The industry's leading players create new products and methods for managing and identifying ASD epidemics with the help of DiseaseLandscape Insights. Furthermore, there is an increasing need for clinical assessment, innovative treatments, and diagnostic tools because of a better understanding of the dynamics of disease.

DLI's services make it easier for industry participants to conduct clinical trials for new drugs and treatments. It also helps with other tasks like patient recruitment and regulatory compliance. DLI also gives industry participants comprehensive information about rivals in the market, market expansion, and new laws and regulations worldwide. DLI helps all market players establish a more solid presence in the ASD industry.

Vishal SawantBusiness Development

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