Ischemic stroke (IS) is one of the leading causes of death and neurological disability worldwide. In 2014, we estimate, nearly 1.5 million ischemic strokes occurred in the seven major pharmaceutical markets, and 1.1 million prevalent cases survived a stroke in the previous year. More than 15 years after its approval, recombinant tissue plasminogen activator (rt-PA; alteplase [Genentech’s Activase, Boehringer Ingelheim’s Actilyse, Kyowa Hakko Kirin’s Activacin, Mitsubishi Tanabe Pharma’s Grtpa]) remains the only pharmacological therapy approved for the acute treatment of IS in all markets under study. However, because of strict inclusion criteria and documented safety risks, we estimate the drug was administered to only 7% of diagnosed patients who experienced an IS event in 2014. Given the staggering societal costs of stroke and the historical propensity for pipeline therapeutics to fail in development, there remains a dire need and enormous opportunity for alternative treatments—be they thrombolytic, neuroprotective, or neurorestorative; drugs or devices; acute or recovery—that can safely and effectively prevent permanent neurological damage in a greater percentage of patients during an IS event and help restore lost function for the millions of post-stroke survivors who live with residual impairment.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 23 country-specific interviews with international stroke experts.
Epidemiology: Our epidemiological estimates include total, diagnosed, and drug-treated events of IS (first-ever and recurrent strokes), segmented by diagnosed events that present to a hospital within 3 hours, 3-4.5 hours, 4.5-6 hours, 6-9 hours, 9-12 hours, 12-24 hours, and later than 24 hours or for whom time of symptom onset is unknown; hourly presentation rates also presented for the first 9 hours. These estimates are based on primary data acquired from the U.S. Paul Coverdell National Acute Stroke Registry and other sources. Additional estimates of 12-month diagnosed prevalent cases of IS (i.e., stroke survivors at one year) and total lifetime prevalence of IS.
Emerging therapies: Phase II: 11 drugs; Phase III: 3 drugs; preregistration: 0 drugs; registered: 0 drugs. Coverage of 5 select preclinical and Phase I products.