자폐스펙트럼증(ASD) : 신규 요법, 미충족 수요 및 TPP 인사이트 리포트(2026년)

Autism Spectrum Disorder (ASD) Emerging Therapy and TPP Insights

Thelansis's "Autism Spectrum Disorder (ASD) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Autism Spectrum Disorder (ASD) Overview

Autism Spectrum Disorder (ASD) is a complex, heterogeneous neurodevelopmental condition characterized by persistent deficits in social communication and interaction, along with restricted and repetitive patterns of behavior, interests, or activities. The disorder encompasses a broad spectrum of functional abilities, ranging from individuals requiring substantial lifelong support to those with high levels of independence.

The etiology of ASD is multifactorial, with strong genetic contributions alongside environmental risk factors such as advanced parental age and prematurity. It is also associated with certain genetic conditions, including Fragile X Syndrome. Clinical presentation varies widely and may include sensory processing differences (hyper- or hyporeactivity), language delays, and in some cases, developmental regression during early childhood.

Management has evolved toward a neurodiversity-affirming, individualized care model, focusing on early and sustained interventions. Standard approaches include behavioral therapy, speech-language therapy, occupational therapy, and educational support aimed at improving functional independence, communication, and quality of life. There are currently no disease-modifying pharmacological therapies, with available medications primarily targeting associated symptoms (e.g., irritability, anxiety).

Key Highlights

• In the US, total prevalent cases are projected to increase from 4.0M in 2025 to 4.3M by 2035, reflecting steady growth (0.7% CAGR).
• The condition is highly heterogeneous, with varying levels of functional impairment and support needs, contributing to complex and individualized care pathways.
• Absence of disease-modifying therapies and reliance on long-term behavioral and supportive interventions highlight a significant unmet need.

Market Overview

• The Germany ASD market is projected to grow from $35.9M in 2025 to $46.5M by 2035, reflecting moderate growth aligned with increasing diagnosis and service utilization.
• Market expansion is primarily driven by:
• Increased demand for behavioral, developmental, and supportive therapies
• Rising awareness and earlier diagnosis
• The market remains relatively constrained due to limited pharmacological treatment options and a strong reliance on non-drug interventions.
• Future growth will depend on the development of targeted therapies addressing core symptoms, alongside continued expansion of early intervention and support services.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• MapLight Therapeutics
• Bazelet Nehushtan Ltd.
• Aardvark Therapeutics, Inc.
• AbbVie
• Floreo, Inc.
• Jazz Pharmaceuticals
• Astrogen, Inc.
• Definium Therapeutics US, Inc.
• Neuroventi Inc.
• Vertero Therapeutics
• Shanghai Auzone Biological Technology Co., Ltd.
• Hoffmann-La Roche
• Intra-Cellular Therapies, Inc.
• Bristol-Myers Squibb
• ACADIA Pharmaceuticals Inc.
• Otsuka Pharmaceutical Development & Commercialization, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)