Infantile Spasms Therapeutics Market is Forecast to Show Slow Growth until 2019

Monday 12 March 2012, Amsterdam

The report is an essential source of information and analysis on the global Infantile Spasms Therapeutics market. The report identifies the key trends shaping and driving the global Infantile Spasms Therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Infantile Spasms Therapeutics sector.

Infantile Spasms Therapeutics Market is Forecast to Show Slow Growth until 2019

They estimates that the global infantile spasms therapeutics market was worth $93.3m in 2011. It is forecast to grow at a Compound Annual Growth Rate (CAGR) of 2.7% during 2011-2019 to reach $115.4m by 2019. The market is primarily dominated by the US as it accounts for more than 95% of the global market. The US market is dominated by two approved products H.P. Acthar Gel (adrenocorticotropin hormone) and Sabril (vigabatrin). Sabril was the first drug to be approved by the Food and Drug Administration (FDA) in 2009 and H.P. Acthar Gel (adrenocorticotropin hormone) was approved for infantile spasms in 2010. Both have Orphan Drug Exclusivity (ODE) in the US. The global infantile spasms therapeutics market grew at a CAGR of 37.1% during 2006-2011. This striking growth was primarily attributed to the steep increase in the price of H.P. Acthar Gel in the US in 2008.

Unmet Need Remains Unaddressed

The infantile spasms therapeutics market has significant unmet need. Drugs such as Adrenocorticotropin Hormone (ACTH), vigabatrin, prednisone, pyridoxine and valproate are commonly prescribed for the treatment of infantile spasms. However, these drugs only focus on improving the patient’s Quality of Life (QoL) and do not target the underlying cause of the disease. The currently available treatments do not provide complete alleviation from seizures and mental regression. This suggests that there is enormous scope for new market entrants offering superior efficacy and safety and possibly a complete cure for infantile spasms.

The Current Infantile Spasms Therapeutics Market is Weak due to the Lack of Effective Treatment Options

The current infantile spasms competitive landscape comprises products such as ACTH, vigabatrin, prednisone, pyridoxine and valproate. In the US, only H.P Acthar Gel and Sabril are approved for infantile spasms. The European infantile spasms therapeutics market is primarily dominated by generic vigabatrin, ACTH, prednisone and valproate. There is no approved drug in Japan for infantile spasms, meaning that the market is served by off-label usage of drugs such as pyridoxine, ACTH, valproate and other antiepileptic drugs. Currently used therapies have moderate efficacy and low safety profiles, and so the market demands new therapies with novel mechanisms of action which will not only reduce the severity of epileptic syndromes but also improve cognitive outcomes.

Lack of Late Stage Pipeline Products in Clinical Phase Likely to Result in a Stagnant Market for Infantile Spasms

An analysis shows that there are two molecules under development for infantile spasms. The CPP-115 of Catalyst Pharma is currently in Phase I stage of development and P529 of Paloma Pharma is in preclinical stage of development. The lack of late stage pipeline activity could be due to factors such as high drug development cost and the complex etiology and pathophysiology of infantile spasms disorder. A complex pathophysiology represents a challenging clinical development environment and may not promote the development of a single drug able to block pathophysiological pathways and ultimately present a cure for thedisease.