The Sage Group

THE SAGE GROUP Reports that the Acute Limb Ischemia (ALI) Market is Approximately $800 Million to $1.2 Billion

ATLANTA, September 21, 2005 (BUSINESS WIRE)— Research published by THE SAGE GROUP concludes that the Acute Limb Ischemia market represents a substantial opportunity for new pharmaceutical and interventional therapies.

“Although the number of patients presenting with an acute occlusion in the lower limbs is under 200,000, the U.S. market value is surprisingly large, approximately $800 million to $1.2 billion,” stated Mary L. Yost, President of THE SAGE GROUP. “This reflects the fact that each patient typically requires multiple therapies to clear the primary obstruction followed by several more to repair the underlying lesion.”

“Frail, elderly ALI patients represent a very difficult to treat group,” continued Yost. Treatment decisions are further complicated by the presence of severe coexisting diseases including heart disease, diabetes, peripheral arterial disease and cancer.

Treatment includes primary amputation, surgical and endovascular revascularization, as well as clot dissolution with drug therapy. Although surgery can achieve excellent technical results, it is associated with a high rate of complications and significant mortality.

“This is a very vibrant area of research with considerable activity focused on developing improved thrombolytic drugs and new endovascular approaches,” stated Ms Yost. “Our research indicates that there is a sizeable market opportunity for safer, faster-acting clot dissolving drugs. Alfimeprase, currently in Phase III ALI trials, is the new thrombolytic drug that is in the most advanced clinical stage. In addition, GPIIb/IIIa inhibitors combined with currently approved thrombolytics have considerable potential to speed clot dissolution while reducing complications,” explained Yost.

“Among the many new less-invasive therapies being developed, ultrasound and the excimer laser represent two intriguing endovascular approaches to treat acute occlusions in the lower limbs. Ultrasound-mediated microbubble destruction also appears to be a very promising new technology,” commented Yost.

About Acute Limb Ischemia

Acute Limb Ischemia (ALI) also known as acute Peripheral Arterial Occlusion (PAO), is a life- and limb-threatening condition caused by the sudden closure of an artery by thrombus (blood clot) or embolism (a clot that forms in one location and travels to another). Another common term for this condition is ‘leg attack.”

Over three-quarters of ALI/PAO cases are caused by thrombosis as a consequence of generalized atherosclerosis. Thrombi typically form at the sites of atherosclerotic lesions, bypass grafts and in association with popliteal aneurysms. Atherosclerosis is the progressive hardening and thickening of the walls of the arteries due to the build-up of plaque (fatty deposits) on the inner lining.

According to Yost, “Within the continuum of severity, acute limb ischemia is the most severe and deadly form of peripheral arterial disease.” Four-year event-free survival for ALI is only 21% compared with a 50% rate for intermittent claudication (the milder form of the disease.).

Compared with survivors of other clot-caused events, first heart attack and stroke, patients with acute limb ischemia have higher mortality rates. The 30-day mortality rate for ALI is 12% to 15%, which is higher than ischemic stroke mortality of 8% to 12% and over twice as high as the 5% to 6% mortality associated with heart attack.

Acute Limb Ischemia—A Market of Multiple Therapies and Multiple Procedures

The report analyzes the disease, causes, morbidity and mortality. Treatments explored include surgery, thromboembolectomy, thrombolysis, percutaneous mechanical thrombectomy (PMT), excimer laser, ultrasonic thrombectomy and ultrasound-mediated microbubble destruction. Currently approved, as well as investigational drugs and devices are evaluated.

Detailed estimates of the number of patients presenting with acute limb ischemia are provided, as well as projected for 2000 through 2020.

The ALI market is analyzed by number of primary and revision procedures, by cause and by clinical classification. Market estimates are projected for each of these for the years 2000 through 2020. The 2000-2020 market potential for thrombolytics, PMT devices, new endovascular devices, GP IIb/IIIa inhibitors and thromboembolectomy is analyzed and projected.

The Peripheral Arterial Disease (PAD) Research Study

Acute Limb Ischemia represents the latest publication in a series of reports analyzing the market opportunity for treatment of diseases in the lower limbs.

The multi-volume PAD Research Study provides a comprehensive analysis of the disease, including current and pipeline drug and interventional therapies, as well as an evaluation of the market opportunities. For each therapy, the market is estimated in terms of number of patients and number of procedures and projected by disease severity for the years 2000 to 2020.


THE SAGE GROUP, an independent research and consulting company, specializes in atherosclerotic disease in the lower limbs, specifically PAD (Peripheral Arterial Disease), CLI (Critical Limb Ischemia) and ALI (Acute Limb Ischemia).

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