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Autism Spectrum Disorders - High Unmet Needs Create Significant Market Opportunities
Decision Resources, Inc, June 2011
“Oh, this field is going to transform. I think you’re going to actually see new drugs come to market based on novel mechanisms with good preclinical evidence.” So one interviewed thought leader predicts. Although behavioral therapy remains the cornerstone of autism spectrum disorders (ASD) treatment, most thought leaders interviewed by Decision Resources indicate that the majority of ASD patients (including a large number of patients with classic autism) receive some form of drug therapy during the course of their treatment. Only two agents have been FDA approved for the treatment of ASD patients, but these are not the first choice of therapy for many of our interviewed experts. Given the lack of available treatments, substantial opportunity awaits a company that invests in new agents in this market.
Questions answered in this report:
- ASD is much more common in males than females. What is the male to female ratio in prevalence? What is the present prevalent population in the United States and the forecasted number of prevalent cases of ASD over the next ten years? Is the prevalence of ASD increasing?
- Only two agents, both of which are antipsychotics, are currently approved to treat patients with ASD—Janssen’s (Johnson & Johnson’s) Risperdal (risperidone) and Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify (Aripiprazole). What do interviewed thought leaders say about use of these agents? Are these treatments effective in ASD patients? What are the sales of Risperdal and Abilify in this market? What factors influence sales of these two agents? What other drugs are prescribed for ASD patients?
- None of the current treatments for ASD address the core symptoms of the disease. What are the emerging agents in the pipeline? Do any of these address the core symptoms of ASD? Do any of them show promising results from clinical trials? How do interviewed thought leaders perceive emerging therapies?
- The DSM-IV criteria for ASD are being reviewed, and the final approved DSM-V criteria are expected to be published in May 2013. How do the proposed new diagnostic criteria differ from the existing criteria? What do interviewed thought leaders say about the new proposed criteria?
Primary research: Interviews with U.S. thought leaders who work closely with children with ASD. Includes pediatric psychologists, psychiatrists, and neurologists.
Epidemiology: Prevalent U.S. cases over a ten-year forecast period, 2010-2020; trends in prevalence.
Diagnostic criteria: Review of current diagnostic criteria and the proposed DSM-V criteria for ASD.
Emerging therapies: Phase III: 1 drug; Phase II: 3 drugs; Phase I: 1 drug.
Select emerging therapies for fragile X syndrome: The link between autism spectrum disorders and fragile X syndrome and clinical development for fragile X syndrome: Phase III: 1 drug; Phase II/III: 1 drug; Phase II: 2 drugs; Phase I: 1 drug.
U.S. market: 2010 brand sales attributable to use for autism spectrum disorders; market considerations.
Autism Spectrum Disorders: Definitions and Symptoms
Current Diagnostic Criteria for ASD
Proposed DSM-V Diagnostic Criteria for ASD
Genetic Causes of ASD
Other Causes of ASD
Epidemiology and Patient Populations
Treatment Approaches for Autistic Spectrum Disorder
Behavioral and Developmental Therapies
Selective Serotonin Reuptake Inhibitors
Other Drug Treatments
Emerging Treatments for Autism Spectrum Disorders
Seaside Therapeutics’ STX-209
Forest Laboratories/Merz’s Memantine
Emerging Metabotropic Glutamate Receptor Antagonists for Fragile X Syndrome
Market Outlook for Autism Spectrum Disorders
About the Authors
- BioMarin Pharmaceutical
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Cypress Bioscience
- Eli Lilly
- Forest Laboratories
- Johnson & Johnson
- Merz Pharma
- Otsuka Pharmaceutical
- Promius Pharma (Dr Reddy’s Laboratories)
- Seaside Therapeutics