Press Release

Acute Ischemic Stroke (AIS) Therapeutics - Novel Drugs with Improved Efficacy to Drive the Market


September 20th, 2011

Launch of Drugs with Extended Timeframe of Admission to Lead to High Market Growth in the Forecast Period

Global Information Inc. presents "Acute Ischemic Stroke (AIS) Therapeutics - Pipeline Assessment and Market Forecasts to 2018" by GlobalData.

The expected launch of three drugs: desmoteplase, RG3626 (an extended timeframe formulation of alteplase), and DP-b99, which is a novel molecule also targeting an extended timeframe of administration will facilitate the global acute ischemic stroke therapeutics market to grow at a Compound Annual Growth Rate (CAGR) of 16.7% over the next eight years, to reach approximately $880m by 2018. The market was valued at at $256.5m in 2010.

These drugs, after approval, are expected to be placed at a premium price, which will lead to an increased annual cost of treatment. Thus, the approval of these drugs and the high price associated with them will be the main drivers of the acute ischemic stroke therapeutics market. The current market consists of branded as well as generic drugs.

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Novel Drugs with Better Efficacy Required for Value Capture

The efficacy of the current product offerings in the acute ischemic stroke market is moderate to low. The major marketed products for acute ischemic stroke include drug classes such as fibrinolytics, anti-coagulants and anti-platelets. Any new entrant providing increased benefits such as innovative mechanisms of action and improved efficacy and safety profiles, targeting an increase in the three hour therapeutic window as compared to the current formulation of Activase and thereby reducing the mortality and recurrence rate of stroke in comparison to existing players, may be able to capture market value.

A Weak Market with Only Two Approved Drugs

There are only two approved drugs in the US and Europe in the acute ischemic stroke market, Activase and Plavix (clopidogrel). Activase is for the primary treatment and Plavix is for maintenance therapy, along with other generic anti-platelets such as aspirin. There is high unmet need in the market due to the presence of only two approved drugs (Activase and Plavix) in the US and Europe, and an additional drug (Radicut) only available for treatment in Japan

Anti-coagulants such as heparin and warfarin are also used to a limited extent as maintenance therapy for the acute phase treatment of acute ischemic stroke. Activase treats the acute phase of ischemic stroke and thus occupies a major market share for the acute phase.

As the majority of the patient pool is unable to receive the primary fibrinolytics treatment, generics also play a considerable role in capturing the market share in the acute ischemic stroke market. This indicates that the competitive landscape for the treatment of acute ischemic stroke (acute phase as well as maintenance therapy) is weak. Physician satisfaction in terms of Activase treatment is high; however, it can be given to the patient only within three hours of the onset of the stroke, which leaves a significant unmet need for therapies with an extended timeframe of administration. New entrants with better efficacy and safety profiles as well as extended timeframes of administration will offer tough competition to the currently marketed products.

D-Pharm and H Lundbeck to be the Key Players in the Acute Ischemic Stroke Market Companies like D-Pharm Ltd. and H Lundbeck A/S are going to be the key players in the acute ischemic stroke therapeutics market. Aldagen, Inc., Celgene Corporation, Corrimum Gmbh, Mitsubhishi Tanabe Pharma, Panacea Pharmaceuticals, Pfizer, Inc., Sanofi, Stemedica Cell Technologies and Vernalis PLC also have pipeline drugs in the early stages of development.

The competition in the market is weak as there are only two approved drugs for the treatment of acute ischemic stroke in the market, which is also dominated by other generic anti-platelets and anti-coagulants. The market scenario is expected to change after the launch of new therapies such as Membrane Active Chelator (MAC) and plasminogen activators, with a better efficacy and safety profile as compared to the existing drugs, and they also target a higher therapeutic time window as compared to the existing therapy Activase.

A Strong Pipeline to Aid Robust Growth in the Future

There are 46 molecules in various phases of development in the acute ischemic stroke market. The first-in-class molecules contribute 76% of the total pipeline, of which, three first-in-class molecules are in Phase III. There are six me-too drugs contributing to 15% of the pipeline, three generics constituting 7% of the pipeline, and one product extension which accounts for 2% of the total acute ischemic stroke pipeline.

Two of the Phase III molecules, desmoteplase and DP-b99, and one filed drug, RG3626, are expected to be launched during the forecast period. These molecules primarily target the therapeutic time window of more than three hours, as desmoteplase can be administered within three to nine hours of the stroke onset, while RG3626 can be given within up to 4.5 hours of the onset of stroke, and DP-b99, a novel molecule with an improved mechanism of action, can also be administered at an extended timeframe of more than three hours, thereby having an impact on the market. Hence, the pipeline for the acute ischemic stroke therapeutics market is strong and is expected to have a positive impact on the market during the forecast period.


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