Autism spectrum disorder (ASD) is a group of multifaceted neurodevelopment disabilities characterized by social, behavioral and communication challenges. This condition is characterized by communication difficulties, social impairment and repetitive and stereotyped behavioral patterns. It is a spectrum condition because while all people affected with autism share some similar difficulties, the level of medical condition affects them in different ways. Symptoms of ASD vary widely and it may sometimes go unrecognized especially in mildly affected children. Early indicators include loss of language or social skills, lack of response, poor eye contact, no single words or two-word phrases by the age of 2 years. If left unrecognized by the age of 3 years, one may recognize later through impaired ability to make friends, stereotyped or unusual use of language, inability to initiate or withstand a conversation with others; varying specific routines or rituals and impairment or absence of imaginative and social interactions.

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Presently, there are no medications that can treat ASD or its core symptoms. It is an underserved market with only two FDA approved drugs Abilify (aripiprazole) and risperidone. These drugs belong to the anti-psychotics therapeutic class, but are approved for the treatment of irritability associated with autistic disorder. Besides, certain other classes of drugs such as antidepressants, anticonvulsants and stimulants are prescribed off-label for reducing autism related neurological challenges.

Patent expiration of Abilify will lead to decline in the market growth which is expected to offset by new introductions which may improve the therapeutic benefits. The growth of this market is primarily attributed to the increasing prevalence of ASD. According to CDC, average prevalence of ASD in Asia, Europe and North America is 1%. Further, the estimates state that the prevalence rate has risen form 1 in 150 children in 2000 to 1 in 68 children in 2010.

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Abilify is a product of Bristol-Myers Squibb and Otsuka Holdings Co., Ltd. While, risperidone is a generic market with many key players such as Janssen Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Actavis, Inc., Mylan Pharmaceuticals, Inc., Ranbaxy Laboratories Limited and Sun Pharmaceutical Industries Limited.

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