Lewes, DE -- (SBWIRE) -- 03/18/2014 -- According to report in 2012 sales for ASD in patients ages 0–19 was approximately $1.44 billion across the six major pharmaceutical markets covered in this report: the US, France, Germany, Italy, Spain, and the UK. The US contributed the majority of these sales, generating an estimated $238m. By the end of the forecast period in 2018, sales are forecast to decline to $1.41 billion at a negative Compound Annual Growth Rate (CAGR) of (0.4%) over the six-year period. Although only the 5EU markets are forecast to experience sales growth over the forecast period, with a CAGR of 3.1%, the majority of sales will still come from the US, which will represent 98% of the market value in 2018.
Major drivers of the growth of the ASD market over the forecast period include:
>> The approval and expected launch of the atypical anti-psychotic, Latuda, across all of the six major markets (6MM) will stimulate growth at the end of the forecast period. Namenda is also expected to generate increased sales in the US following its approval as an ASD treatment.
>> The introduction of three new first-in-class treatments in the US markets will provide physicians with much-needed new treatments for the numerous core and non-core symptoms of ASD.
>> Increasing social awareness of this disorder can lead to increased and earlier diagnosis rates.
Major barriers for the ASD market over the forecast period include:
>> The unknown etiology and pathophysiology of ASD prevents the development of effective treatments and diagnostic tools.
>> The patent expiries of Abilify (aripiprazole) and Namenda will lead to decreased sales as a result of generic erosion.
>> Some key opinion leaders (KOLs) believe that the drug formulations of some pipeline products may not be well-tolerated by many patients, thereby limiting their target patient pool.
Companies Focusing on Diverse Pharmaceutical Targets in an Attempt to Treat Different ASD Symptoms
The ASD pipeline is very diverse, with companies focusing on different approaches to treating differing core and non-core symptoms of the disorder. There are currently 10 products in various stages of clinical development, including one in pre-registration, two in Phase III, five in Phase II, one in Phase I/II, and in one Phase I. Almost almost all of these compounds have the potential to become a first-in-class treatment.
The exception is Latuda, which is an atypical anti-psychotic and belongs to the same class as the only currently approved drugs, risperidone and Abilify. Many of these pipeline candidates are hoping to become the first drugs available to treat a core ASD symptom.
The enzyme replacement therapy, CM-AT, is positioned to be the first to market, given that it is in pre-registration with the Food and Drug Administration (FDA) and is benefiting from its fast-track status.
High Unmet Need for Efficacious ASD Treatments With Good Safety Profiles
The ASD market remains relatively untapped, with only two approved products being available, risperidone and Abilify, which are both in the same class and are used to treat irritability associated with the disorder. These products have only a moderate side effect profile, with significant associated weight gain as the most commonly reported complaint among physicians. There is a clear need for weight-neutral anti-psychotic medications to be developed and approved for this sensitive patient population, as well as for the development of safe and efficacious drugs to treat the many other core and non-core symptoms of ASD, which can, in some cases, be severe and debilitating. At present, numerous drugs used to treat ASD are administered off-label, with some patients being prescribed several medications that are taken concurrently. Not surprisingly, this can cause many undesired side effects and may also exacerbate other autistic symptoms, making the goal of developing a safe and effective treatment very challenging. This lack of approved and effective products to treat ASD opens an opportunity for many drug companies to develop and expand their central nervous system (CNS) portfolios and attempt to gain approval for this indication, thereby moving into this chronically underserved market and gaining a significant market share.
Lack of Suitable Medications for Young Autistic Children
Many young autistic children often experience severe core and non-core symptoms and require medical treatment to alleviate these symptoms. However, many of the medications that are currently available and are used off-label for older autistic children are not suitable for young autistic children, since they do not provide the low doses that are tolerable by this patient subgroup, and are often available only in incompatible formulations, such as tablets. Drug companies are not targeting this very young population of autistic children and have not considered their specific needs. Therefore, companies that currently benefit from the use of their drugs as off-label treatments for older autistic children could boost their market share by developing low-dose formulations of these drugs as oro-dispersible tablets, dissolvable tablets, or liquid formulations, which would encourage physicians to prescribe to younger autistic patients. Ideally, safety and efficacy studies should also be carried out with these drugs in order to provide prescribing physicians with reliable data on which to base their treatment patterns for this sensitive patient population.
Market Entry of Novel Pipeline Products is Set to Change the ASD Treatment Landscape
During the forecast period of this report (2012–2018), it is expected that four new ASD treatments will enter the US market, and two new treatments will enter the 5EU markets. Of these, three will aim to become first-in class treatments, and one will aim to target the core symptoms of the disorder. Although this would give these drugs a significant clinical advantage, should they reach the market as expected, they will need the help of a larger pharmaceutical company with a strong sales force and marketing capabilities to realize their full market potential. This chronically underserved market will, however, actively embrace any novel treatment that has been shown to be both safe and efficacious. By the end of the forecast period in 2018, research anticipates that there will be a significant change in the ASD market leader across the 6MM, and also in the future potential of newly-launched products.
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