Abstract
Introduction
Over the past 6 years, three major events have impacted the autism spectrum disorders market. In 2006, Risperdal became the first drug to receive approval from the US FDA for the symptomatic treatment of irritability in children and adolescents with ASDs. Later, in 2009, the FDA approval Abilify for the same indication. In 2008, generic risperidone launched following Risperdal’s US patent expiry.
Features and benefits
• Overview of marketed and pipeline drugs in clinical development for autism spectrum disorders.
• Analysis of the market positioning of each product approved for the treatment of autism spectrum disorders.
• Assessment of the strengths, weaknesses, opportunities and threats for marketed and late-stage pipeline candidates.
• Summary of the clinical and commercial attractiveness for each of the marketed products.
• Insight from key opinion leaders on marketed and pipeline products.
Highlights
Risperdal and Abilify are the only two products approved for the treatment of autism spectrum disorders (ASDs). Both of these atypical antipsychotics are indicated for the management of irritability symptoms associated with ASDs in the US. Due to the failure of these drugs to address the core symptoms of ASDs, many other drugs are used off-label.
Abilify is the most recent entrant to the ASDs market, having received US Food and Drug Administration (FDA) approval in November 2009. The drug' s partial agonism of dopamine receptors unique mechanism of action is considered a key differentiating factor, producing a superior side-effect profile compared to other atypical antipsychotics.
To date, none of the four late-stage pipeline candidates for autism spectrum disorders has publically presented the late-stage Phase II or III trial data necessary for the clinical assessment of these compounds.
Your key questions answered
• What are the key differentiating features of approved therapies for the treatment of autism spectrum disorders?
• How do key opinion leaders perceive available treatments for autism spectrum disorders?
• What opportunities are there for existing players in the autism spectrum disorders market to increase their market share?
• What is the development status of current pipeline candidates development status?
• What clinical trial design are current pipeline canddiates following? What do pipeline candidates need to demonstrate in order to be successful?
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
MARKET DEFINITION AND OVERVIEW
Market definition
Product overview
MARKETED PRODUCT PROFILES
Abilify (aripiprazole; Bristol-Myers Squibb/Otsuka Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Risperdal (risperidone; Johnson & Johnson)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
PIPELINE PRODUCT PROFILES
CM-AT (Curemark)
Drug profile
Development overview
SWOT analysis
Other drugs in clinical development for autism spectrum disorders
STX-209 (arbaclofen; Seaside Therapeutics)
UCB-MNC (umbilical cord blood mononuclear stem cells; Beike Biotech)
CYP-2001 (carbetocin; Cypress Bioscience)
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
