Autism Spectrum Disorder Market Size and Trend Report including Epidemiology, Disease Management, Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021 - 2031

Autism Spectrum Disorder Market Size and Trend Report including Epidemiology, Disease Management, Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021 - 2031

Summary

Autism spectrum disorder (ASD), also known as autism, is a highly heterogenous disorder characterized by varying social and communication impairments and pervasive repetitive behaviors, in addition to a wide range of associated non-core symptoms.

The ASD market is chronically underserved, with no approved treatments for the core symptoms or for most of the associated non-core symptoms. The only two treatments for ASD that are approved by the FDA are Johnson & Johnson’s Risperdal (risperidone) and Otsuka Pharmaceutical’s Abilify (aripiprazole). These atypical antipsychotics are both indicated for the treatment of irritability associated with ASD in children and adolescents. In Japan, only Abilify is approved for ASD, and there are no approved treatments in the 5EU. A wide variety of other drug classes are used off-label in the management of various symptoms associated with ASD.

Key Highlights

  • Strong growth is expected in the ASD market from 2020 to 2030.
  • GlobalData anticipates that ten late stage pipeline drugs will launch over the forecast period. These are expected to be the main driver of growth in the ASD market across the 7MM.
  • GlobalData expects Johnson and Johnson’s JNJ-5279 to become the top-selling drug in the ASD market with sales of $655.9 Million in 2031.
  • Since most drugs used for ASD are used off-label, there are very few companies with a strong presence in the ASD market. Historically, Otsuka and Johnson & Johnson have been the major players, as these companies marketed the only two products approved for the treatment of ASD. Seven new companies are expected to launch products in the ASD market during the forecast period.
  • Opportunities remain for pharmaceutical companies to develop drugs for the core symptoms of ASD, improved options for irritability associated with ASD, and drugs for other non-core symptoms.
Key Questions Answered
  • What are the key ASD treatments in 2021?
  • When will the late stage pipeline products launch, and how will it affect drug sales and the overall ASD market in the 7MM?
  • Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?
Scope
  • Overview of ASD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized ASD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (children, adolescents, and adults) forecast from 2021 to 2031.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the ASD therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for ASD therapy. The most promising candidates in Phase III and IIb development are profiled.
  • Analysis of the current and future market competition in the global ASD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to Buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global ASD therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ASD therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


1 Autism Spectrum Disorder: Executive Summary
1.1 Strong growth expected in the ASD market during 2021-31
1.2 Targeting core symptoms is a key R&D strategy for ASD
1.3 Opportunities to fulfil key unmet needs will remain, particularly outside of the US
1.4 Novel late-stage pipeline drugs will be a key driver of growth
1.5 What do physicians think?
2 Introduction
2.1 Catalyst
2.2 Related reports
2.3 Upcoming reports
3 Disease Overview
3.1 Etiology and pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
4 Epidemiology
4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 Forecast methodology
4.4.1 Sources
4.4.2 Forecast assumptions and methods
4.4.3 Forecast assumptions and methods: total prevalent cases of ASD
4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of ASD - 7MM
4.5 Epidemiological Forecast for Autism Spectrum Disorder (2021-31)
4.5.1 Total prevalent cases of ASD
4.5.2 Age-specific total prevalent cases of ASD
4.5.3 Sex-specific total prevalent cases of ASD
4.5.4 Diagnosed prevalent cases of ASD
4.5.5 Age-specific diagnosed prevalent cases of ASD
4.5.6 Sex-specific diagnosed prevalent cases of ASD
4.6 Discussion
4.6.1 Epidemiological forecast insight
4.6.2 COVID-19 impact
4.6.3 Limitations of the analysis
4.6.4 Strengths of the analysis
5 Disease Management
5.1 Diagnosis and treatment overview
5.2 Additional key opinion leader insights on disease management
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Effective treatment options for the core symptoms of ASD
7.3 Improved treatment options for treating irritability associated with ASD
7.4 Treatment options for other symptoms associated with ASD
7.5 Increased numbers of physicians able to diagnose and treat ASD
8 R&D Strategies
8.1 Overview
8.1.1 Targeting the core symptoms
8.1.2 Targeting the microbiome
8.1.3 Label expansion of atypical antipsychotics
8.2 Clinical Trials Design
8.2.1 Endpoints
8.2.2 Inclusion/exclusion criteria
9 Pipeline Assessment
9.1 Overview
9.2 Promising drugs in clinical development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive assessment
11 Current and Future Players
11.1 Overview
11.2 Deal-making trends
12 Market Outlook
13 Appendix
List of Tables
Table 1: ASD: key metrics in the 7MM
Table 2: Risk factors and comorbidities for ASD
Table 3: DSM-5 criteria for ASD
Table 4: Non-Pharmacological Treatments for Autism Spectrum Disorder
Table 5: Treatment Guidelines for Autism Spectrum Disorder
Table 6: ASD market - global drivers and barriers, 2021-2031
Table 7: Key events impacting sales for ASD in the US, 2021-31
Table 8: ASD market - drivers and barriers in the US, 2021-2031
Table 9: Key events impacting sales for ASD in the 5EU, 2021-31
Table 10: ASD market - drivers and barriers in the 5EU, 2021-2031
Table 11: Key events impacting sales for ASD in Japan, 2021-31
Table 12: ASD market - drivers and barriers in Japan, 2021-2031
Table 13: High-prescribing physicians (non-KOLs) surveyed, by country
List of Figures
Figure 1: Global sales forecast by country for ASD in 2021 and 2031
Figure 2: Analysis of the company portfolio gap in ASD during the forecast period
Figure 3: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of ASD during the forecast period
Figure 4: 7MM, diagnosed prevalence of ASD, both sexes, %, all ages, 2021
Figure 5: 7MM, sources used and not used to forecast the total prevalent cases of ASD
Figure 6: 7MM, sources used and not used to forecast the diagnosed prevalent cases of ASD
Figure 7: 7MM, total prevalent cases of ASD, N, men and women, all ages, 2021
Figure 8: 7MM age-specific total prevalent cases of ASD, N, men and women, 2021
Figure 9: 7MM total prevalent cases of ASD by sex, N, all ages, 2021
Figure 10: 7MM diagnosed prevalent cases of ASD, N, men and women, all ages, 2021
Figure 11: 7MM age-specific diagnosed prevalent cases of ASD, N, men and women, all ages, 2021
Figure 12: 7MM diagnosed prevalent cases of ASD by sex, N, all ages, 2021
Figure 13: Unmet needs and opportunities in ASD
Figure 14: Overview of the development pipeline in ASD
Figure 15: Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for ASD in the 7MM during the forecast period
Figure 16: Competitive assessment of the marketed and pipeline drugs benchmarked against the SOC, Abilify (aripiprazole)
Figure 17: Analysis of the company portfolio gap in ASD during the forecast period
Figure 18: Global (7MM) sales forecast by country for ASD in 2021 and 2031
Figure 19: Global (7MM) sales forecast by class for ASD in 2021 and 2031
Figure 20: Sales forecast by class for ASD in the US in 2021 and 2031
Figure 21: Sales forecast by class for ASD in the 5EU in 2021 and 2031
Figure 22: Sales forecast by class for ASD in Japan in 2021 and 2031

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