Autism spectrum disorder (ASD) is a heterogeneous, neurodevelopmental disorder with core symptoms including deficits in social interaction, difficulties in communication, and restricted, repetitive behaviors. Behavioral and developmental therapies are the cornerstone of ASD treatment, regardless of severity, and many patients also receive drug therapy to help manage specific symptoms or comorbidities, such as attention deficit, hyperactivity, irritability, and aggression. The only FDA-approved treatments for ASD are risperidone and aripiprazole, which are indicated for irritability associated with ASD. Other drug classes that may be used in the treatment of ASD include antidepressants, stimulants, and antiepileptics. Significant unmet need remains for pharmacological therapies to treat the core symptoms of ASD, but it is unclear if any pipeline agent can capitalize on this significant commercial opportunity.

QUESTIONS ANSWERED

  •  How large is the diagnosed prevalent ASD population in the United States and EU5 and how will it change through 2027?
  • What is the current treatment landscape for ASD patients and how will it change in the next 10 years? What clinical needs remain unfulfilled?
  •  Which emerging therapies do ASD specialists consider the most promising and which are likely to launch by 2027? What is the commercial impact of these new ASD therapies?

PRODUCT DESCRIPTION
Niche & Rare Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Autism Spectrum Disorder - Landscape & Forecast - Disease Landscape & Forecast
    • Commercial Outlook
      • Key Findings
        • Regional Sales of Key Therapies to Treat Autism Spectrum Disorder: 2027
        • Autism Spectrum Disorder SWOT Analysis
      • Drivers and Constraints
        • What Factors Are Driving Sales in Autism Spectrum Disorder?
        • What Factors Are Constraining Sales in Autism Spectrum Disorder?
      • Drug-Class-Specific Trends
        • Pituitary Neuropeptides
        • Sodium Potassium Chloride Co-Transporters
      • Alternative Market Scenario
        • Alternative Scenario for the Autism Spectrum Disorder Market Through 2027
    • Forecast
      • Sales of Key Therapies in Autism Spectrum Disorder
    • Etiology and Pathophysiology
      • Disease Overview
        • Symptoms
          • Key Pathways and Drug Targets
          • Epidemiology
            • Key Findings
              • Epidemiology Populations
                • Disease Definition (DSM-IV)
                • Methods (DSM-IV)
                • Sources Used for Autism Spectrum Disorder (DSM-IV)
                • Number of Total Prevalent Cases of Autism Spectrum Disorder (DSM-IV) in the Major Pharmaceutical Markets: 2017-2027 (thousands)
                • Disease Definition (DSM-5)
                • Methods (DSM-5)
                • Sources Used for Autism Spectrum Disorder (DSM-5)
                • Number of Total Prevalent Cases of Autism Spectrum Disorder (DSM-5) in the Major Pharmaceutical Markets: 2017-2027 (thousands)
                • Diagnosed Prevalent Cases of Autism Spectrum Disorder (DSM-5): 2017-2027 (thousands)
                • Drug-Treated Prevalent Cases of Autism Spectrum Disorder (DSM-5): 2017-2027 (thousands)
                • Methods
                • Sources Used for Autism Spectrum Disorder Subtypes
                • Number of Total Prevalent Cases of Autism Spectrum Disorder by Subtype in the Major Pharmaceutical Markets: 2017-2027 (thousands)
            • Current Treatment
              • Key Findings
                • Diagnosis
                  • Autism Spectrum Disorder Categorization: DSM-IV versus DSM-5
                  • DSM-5 Autism Spectrum Disorder Diagnostic Criteria
                  • Diagnostic Tests
                  • Screening Tools Used to Assess Risk for Autism Spectrum Disorder
                  • Diagnosis Tests for Autism Spectrum Disorder
                  • Treatment Providers
                  • Expert Insight: Diagnosis and Management of Autism Spectrum Disorder
                • Treatment Goals
                  • Key End Points Used in Clinical Trials for Autism Spectrum Disorder
                  • Expert Insight: Key End Points Used in Clinical Trials for Autism Spectrum Disorder
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drugs Classes Used for Autism Spectrum Disorder
                  • Current Treatments Used for Autism Spectrum Disorder
                  • Expert Insight: Behavioral and Developmental Therapies
                  • Clinical Trial Outcomes for Risperidone
                  • Advantages and Disadvantages of Risperidone
                  • Key Results from Select Clinical Trials Investigating Risperidone for the Treatment of Autism Spectrum Disorder
                  • Expert Insight: Risperidone
                  • Clinical Trial Outcomes for Aripiprazole
                  • Advantages and Disadvantages of Aripiprazole
                  • Key Results from Select Clinical Trials Investigating Aripiprazole for the Treatment of Autism Spectrum Disorder
                  • Expert Insight: Aripiprazole
                  • Clinical Trial Outcomes for Melatonin
                  • Key Results from Select Clinical Trials Investigating Melatonin for the Treatment of Autism Spectrum Disorder
                  • Expert Insight: Anti-Insomnia Therapies
                  • Expert Insight: Antidepressants
                  • Expert Insight: Stimulants and Nonstimulants for Autism Spectrum Disorder/ADHD
                • Medical Practice
                  • Treatment Guidelines
                  • Autism Spectrum Disorder Treatment Guidelines by Country
                  • Generalized Treatment Decision Tree for Autism Spectrum Disorder
              • Unmet Need Overview
                • Current and Future Attainment of Unmet Needs in Autism Spectrum Disorder
                • Top Unmet Needs in Autism Spectrum Disorder: Current and Future Attainment
                • Expert Insight: Unmet Need in Autism Spectrum Disorder
              • Emerging Therapies
                • Key Findings
                  • Pipeline Trends for Autism Spectrum Disorders
                • Key Emerging Therapies
                  • Notable Developments Among Key Emerging Therapies for Autism Spectrum Disorder
                  • Key Therapies in Development for Autism Spectrum Disorder
                  • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Autism Spectrum Disorder
                  • Key Results from Select Clinical Trials Investigating CM-AT for the Treatment of Autism Spectrum Disorder
                  • Analysis of the Clinical Development Program for CM-AT
                  • Expert Insight: CM-AT
                  • Expectations for Launch and Sales Opportunity of CM-AT in Autism Spectrum Disorder
                  • Key Results from Select Clinical Trials Investigating Oxytocin for the Treatment of Autism Spectrum Disorder
                  • Analysis of the Clinical Development Program for Oxytocin
                  • Expert Insight: Oxytocin
                  • Expectations for Launch and Sales Opportunity of Oxytocin in Autism Spectrum Disorder
                  • Key Results from Select Clinical Trials Investigating Balovaptan for the Treatment of Autism Spectrum Disorder
                  • Key Ongoing Clinical Trials of Balovaptan in the Treatment of Autism Spectrum Disorder
                  • Analysis of the Clinical Development Program for Balovaptan
                  • Expert Insight: Balovaptan
                  • Expectations for Launch and Sales Opportunity of Balovaptan in Autism Spectrum Disorder
                  • Key Results from Select Clinical Trials Investigating Bumetanide for the Treatment of Autism Spectrum Disorder
                  • Key Ongoing Clinical Trials of Bumetanide in the Treatment of Autism Spectrum Disorder
                  • Analysis of the Clinical Development Program for Bumetanide
                  • Expert Insight: Bumetanide
                  • Expectations for Launch and Sales Opportunity of Bumetanide in Autism Spectrum Disorder
                • Early-Phase Pipeline Analysis
                  • Notable Developments in the Early-Phase Pipeline for Autism Spectrum Disorder
                  • Select Compounds in Early-Phase Development for Autism Spectrum Disorder
                • Key Discontinuations and Failures in Autism Spectrum Disorder
                  • Patient Registries
                    • Patient Registries for Autism Spectrum Disorder
                    • Prominent Autism Spectrum Disorder Patient Organizations
                  • Orphan Drug Designation
                  • Access & Reimbursement Overview
                    • Looking for More?
                    • Region-Specific Reimbursement Practices
                      • Key Market Access Considerations in Autism Spectrum Disorder: United States
                      • General Reimbursement Environment: United States
                      • Key Market Access Considerations in Autism Spectrum Disorder: EU5
                      • General Reimbursement Environment: EU5
                  • Methodology
                    • Bottom-Up Forecasting Overview
                      • Patient Populations
                      • Drug-Specific Assumptions
                    • Bottom-Up Forecast Assumptions
                      • General Sources of Data
                      • Drug-Treatment Rate Assumptions in Autism Spectrum Disorder
                      • Patient-Share Assumptions in Autism Spectrum Disorder
                      • General Statements About Pricing
                      • Sources for Drug Prices
                      • 2017 Exchange Rates
                      • Price per Treated Day: 2027
                      • Dosing, Days of Therapy, and Compliance
                      • Out-Year Forecasting
                      • Emerging Therapy Prices
                    • Primary Market Research
                      • Experts Interviewed
                  • Appendix
                    • Key Abbreviations Related to Autism Spectrum Disorder
                    • Brands, Marketers, and Generic Availability of Key Therapies for Autism Spectrum Disorder, by Market
                    • Autism Spectrum Disorder Bibliography

                Author(s): Tamara Blutstein, PhD; Alison Isherwood, MSc, MRes, PhD

                Tamara Blutstein is a Senior Business Insights Analyst on the Central Nervous System, Pain, and Ophthalmology team. She is responsible for analyzing and forecasting pharmaceutical markets, primarily in Neurology indications, with specific expertise in Alzheimer’s disease, Parkinson’s disease, and ischemic stroke.

                Prior to joining the company, Tamara was a postdoctoral fellow at Tufts University School of Medicine, where she studied the role of gliotransmission in the regulation of sleep and sleep homeostasis. She earned a Ph.D. in neuroscience from the University of Maryland School of Medicine where she conducted research on the role of gonadal hormones in modulating neuronal-glial communication. She holds a B.A. in neuroscience from Drew University.

                Alison Isherwood, B.Sc., M.Res., M.Sc., Ph.D. joined Decision Resources Group in 2008, as an Epidemiologist. Alison holds a B.Sc. in Medical Microbiology, Masters by Research in the Life Sciences and a M.Sc. in Epidemiology all from the University of Edinburgh. Prior to joining Decision Resources Inc., she was working on her Ph.D. in Molecular Virology, specializing on the severe acute respiratory syndrome (SARS) coronavirus, at the University of Reading. In her role at Decision Resources Group, Alison is currently an Epidemiology team lead as well as project managing custom epidemiology work in multiple therapy areas. Alison’s area of specialization at DRG is cancer, particularly breast cancer.