Critical limb ischemia (CLI) is a kind of peripheral arterial disease (PAD) in which chronic inflammation associated with atherosclerosis (progressive thickening of arteries lining) causes reduced blood flow to the extremities (legs, feet and hands), leading to severe pain and ulcers or sore. Some major risk factors for critical limb ischemia comprise aging (people aged 60 or over are at high risk of developing this diseased condition), diabetes, obesity, high cholesterol level, sedentary lifestyle, smoking and high blood pressure. Critical limb ischemia is associated with most common symptoms such as severe pain and numbness in the legs and feet when a person is in sedentary stage (rest pain), ulcers or skin sores and tissue necrosis (gangrene).
Critical limb ischemia being severe condition of PAD does not improve on its own and requires comprehensive treatment by a vascular surgeon. Treatment focuses on reducing the number of risk factors, relieving pain, reduction of blood pressure and cholesterol level, and to preserve the limb. However, there is no specific drug approved by the United States Food and Drug Administration (FDA) for treating CLI. There are many companies including Aastrom Biosciences, Biotronik AG, United Therapeutics and Sanofi that are striving to develop drug meant to cure CLI and PAD. Endovascular therapy is one of the common options in the care of CLI. Angioplasty, stents, laser atherectomy and directional atherectomy are some major endovascular procedures that are used to treat critical limb ischemia. Treatment may also involve surgical procedure for removing arterial blockage.
Worldwide increasing geriatric population, rising incidence of CLI and participation of a large number of companies to develop drugs supposed to treat CLI are among the major factors driving the market growth across the globe. Statistics released by the United Nations (UN) suggest that the global share of elderly population (aged 60 years and over) as a proportion of the global population has been increased from 9.2% in 1990 to 11.7% in 2013, and is expected to reach 21.1% by the end of 2050. In 2013, nearly 841 million people were aged 60 years and over which is likely to reach more than 2 billion by 2050.
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As people age they are at high risk of developing CLI, therefore, increasing elderly population is expected to drive the market growth during the forecast period. According to Vascular Disease Management, the prevalence of CLI has been estimated to be 300 per million inhabitants. In the United States, approximately 1 million people are affected with CLI. However, an analysis suggested by the Sage Group indicates that nearly 2 million people in the U.S. are living with CLI and owing to continuous rise in geriatric population the prevalence is expected to reach 3.5 million by 2020. Such high prevalence of people with CLI represents a favorable market for critical limb ischemia treatment market. In terms of geography, North America, Europe, Asia-Pacific and Rest of the World (RoW) are the four major markets for critical limb ischemia. Of these North America represents the largest market, followed by Europe, Asia-Pacific and Rest of the World (RoW).
Some of the major companies and research institution that are actively participating to develop medicines for treating critical limb ischemia include Aastrom Biosciences, Mahidol University, University Hospital Ostrava, MultiGene Vascular Systems Ltd. University of Southern California, Harvest Technologies, Seoul Veterans Hospital, GWT-TUD GmbH, Biotronik AG, United Therapeutics, Sanofi, Asklepios Kliniken Hamburg GmbH, Anesiva, Inc. and medac GmbH.