GlobalData Forecasts Trends in Acute Ischemic Stroke Market to 2015

The industry report, “Acute Ischemic Stroke – Drug Pipeline Analysis and Market Forecasts to 2015” by GlobalData identifies the key trends that are shaping and driving the global Acute Ischemic Stroke (AIS) market.

The global AIS market is valued at an estimated US$2.9 billion in 2008. It is forecast to grow at a Compound Annual Growth Rate (CAGR) of 3.4 percent to reach US$3.6 billion by 2015. This is primarily attributed to a weak pipeline landscape.

The delay in seeking treatment within the three-hour therapeutic window, and the clinical trial failure rate continue to pose significant challenges for prospective market entrants. The ageing population will be a key driver of this market.

The global AIS market is a lucrative market with unmet needs. The fact that the product currently on the market does not serve the unmet need of a larger therapeutic window, better efficacy and safety, and being suitable for a wider patient pool, results in the market continuing to present opportunities for stronger pipeline candidates.

This historically static market offers potential for any drug maker whose drug can meet the needs of the market. At the same time, this market is continuously haunted by high clinical trial failure making it a market with high commercial risk. The clinical trial failure is mainly due to poor clinical trial design, certain methodological defects, and animal model unpredictability.

This is a market with the potential for opportunity for which technologically innovative products will be required for value capture. However, if a company wants to capture this unmet need, it will need to overcome prevailing product weaknesses and major adverse effects such as Intracranial Hemorrhage (ICH). Currently, these are the biggest challenges preventing most pipeline products from capturing the unmet need of this market.

The current market landscape has been found to be weak. There is only one approved product and an older generic, aspirin, serving the entire acute phase of the AIS market. Recombinant tissue Plasminogen Activator (rt-PA) treats the acute phase of ischemic stroke and occupies the major market share for the acute phase. However, generics also occupy a considerable market share as the majority of the patient pool is ineligible to receive this treatment.

The weak point in this landscape is that the only marketed product available has low efficacy and safety. Patient satisfaction remains low and physician satisfaction, in terms of rt-PA, is high only within the three-hour therapeutic window. New entrants into the market will be forced to match or exceed both the efficacy and safety profile of the current marketed product.

The AIS pipeline has been found to be weak. Desmoteplase remains the most promising option for the acute phase of the disease in the late stage of the pipeline. In addition to the compounds that are used for the acute phase of the disease, GlobalData has also covered compounds that are being tried as neuroprotectants for stroke prevention in atrial fibrillation, and certain other anticoagulants and antiplatelets. The key products in the Phase III pipeline are: Desmoteplase, a tissue plasminogen activator; Dabigatran and Rivaroxaban, for stroke prevention in atrial fibrillation; and DP-b99, Citicoline as neuroprotectants. Desmoteplase with features such as a higher therapeutic window, high fibrin selectivity, and a good reperfusion rate remains the most promising product in the pipeline, although the first Phase III program failed. Neuroprotectants are being tried as an alternative intervention but no single neuroprotectant has passed clinical trials. There is only one tissue plasminogen activator in the Phase III stage that has the ability to directly treat the acute phase and the current market will continue to be underserved with low efficacy products.

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