| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| CAGR | 8.30 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Critical Limb Ischemia Treatment Market Analysis
The Global Critical Limb Ischemia Treatment Market is expected to register a CAGR of 8.3% during the forecast period.
The COVID-19 pandemic had a significant impact on the healthcare systems with significant consequences for not only COVID-19-infected patients but also others, resulting in the cancellation of diagnostic and treatment procedures. For instance, according to an article published by the Internal Journal of Surgery Case Reports in March 2021, hospitals deferred elective procedures, venous surgeries, and the treatment of asymptomatic conditions requiring intervention, thus impacting the market growth. Additionally, according to a study published in the Journal of Vascular Surgery in August 2021, the SARS-CoV-2 infection had been linked to an increased risk of thrombotic complications, including limb ischemia. COVID-related limb ischemia appeared in individuals with a low incidence of comorbidities and was associated with a high death and amputation risk. As a result, the increased risk of limb ischemia associated with COVID-19 infection substantially impacted the market. However, currently, the market is growing at a stable pace owing to a resumption of surgical procedures and it is expected to witness a similar trend over the coming years.
Certain factors that are propelling the market growth are the increasing prevalence of critical limb ischemia and the improvement in healthcare infrastructure.
The significant burden of critical limb ischemia is expected to propel the growth of the market. For instance, according to a June 2022 study published in the Journal of Clinical Medicine, the mean annual incidence of chronic limb-threatening ischemia (CLTI) in New Zealand (NZ) was 36.2 per 100,000 people in 2021. Men had a higher annual incidence of CLTI conditions. Thus, this is expected to rise in demand for its treatment, thereby boosting the market growth.
Additionally, the growing prevalence of the risk factors which increase CLI incidence is expected to boost the growth of the market. For instance, according to an article published by the Korean Circulation Journal in June 2021, it has been observed that the obese and underweight groups are more likely to experience critical limb ischemia and infrapopliteal artery disease. According to the WHO European Regional Obesity report 2022, overweight and obesity have reached epidemic proportions in the WHO European Region, impacting about 60% of individuals. Children are also affected with 7.9% of children under the age of 5 and one out of every three school-aged children being overweight or obese. Alarmingly, there have been consistent increases in the prevalence of overweight and obesity in the WHO European Region and no Member State is on track to reach the target of halting the rise in obesity by 2025. This is expected to increase the demand for critical limb ischemia treatment, thereby fueling the market growth.
Furthermore, various strategies adopted by the market players such as product launches, mergers and acquisitions, and product development are expected to support the market's expansion over the forecast period. For instance, in May 2022, Filterlex Medical Ltd., a cardiovascular medical device firm, announced the positive results of a first-in-human (FIH) trial demonstrating the CAPTIS device's safety, practicality, and performance. CAPTIS is a next-generation, full-body embolic protection device that minimizes the risk of stroke and other complications during left-heart surgery by releasing embolic particles into the bloodstream. Hence, such studies are likely to contribute to the market growth over the forecast period.
However, stringent regulatory guidelines and an increasing number of recalls may restrain the market growth.
Critical Limb Ischemia Treatment Market Trends
Embolic Protection Devices Segment Expects to Register a High CAGR over the Forecast Period
Embolic protection devices (EPDs) are medical devices used to prevent or reduce plaque debris from reaching the distal bed. They are commonly used in saphenous vein graft (SVG) interventions and during carotid artery stenting procedures. The embolic protection devices segment is expected to witness significant growth in the critical limb ischemia treatment market over the forecast period.
The factors propelling the growth of embolic protection devices are the higher adoption of these devices as it prevents distal embolization and lower clinical complications by capturing and removing thrombus/debris while performing surgical procedures. For instance, according to an article published by Cardiovascular Interventional Radiology, in May 2021, it has been found that the Spider FX embolic protection device was safe and effective in capturing embolic debris during femoropopliteal interventions. Thus, the increased safety and efficacy of these devices are expected to increase the usage of these devices in treating critical limb ischemia, thereby boosting the market growth.
Furthermore, the rising company activities for developing bone graft substitute products and the rising adoption of various business strategies such as collaborations, mergers, and acquisitions are all anticipated to increase the market growth over the forecast period. For instance, in May 2021, Emboline raised USD 55 million in a Series D investment transaction. This investment will support a planned US-based pivotal trial for FDA approval as well as investigational studies for new indications, and manufacturing and commercial operations for the Emboliner, a device designed to give total embolic protection by catching and eliminating all debris during transcatheter treatments.
Understand The Key Trends Shaping This Market
Download PDF
North America Dominates the Market and is Expected to do Same over the Forecast Period
North America is expected to dominate the overall critical limb ischemia treatment market throughout the forecast period. The factors that propel the market growth are the high prevalence of critical limb ischemia patients and the presence of key market players.
The rising burden of critical limb ischemia, along with risk factors such as obesity, diabetes, hypertension, and hyperlipidemia among the population, is the key factor driving the demand for the studied market over the forecast period. Patients with diabetes are at increased risk of developing chronic limb-threatening ischemia (CLTI) due to peripheral arterial disease, and an increase in the prevalence of diabetes is expected to boost market growth. For instance, according to 2022 statistics published by the International Diabetes Federation, in the 10th edition of 2021, 32 million people were living with diabetes in the United States, and this number is projected to reach 34 million by 2030 and 36 million by 2050. High blood sugar caused by diabetes can damage the nerves that control the heart and blood vessels, leading to a variety of arterial diseases which can narrow the arteries. This is expected to increase the demand for effective treatment, thereby boosting the market growth.
Moreover, the increasing focus of the company to develop technologically advanced devices and drugs to treat critical limb ischemia is expected to augment the growth of the market. For instance, in May 2022, the US FDA approved Medtronic's IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, a drug-coated balloon (DCB), for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. Additionally, in January 2022, Cook Medical received the Breakthrough Device designation from the US FDA on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI).
Get Analysis on Important Geographic Markets
Download PDF
Critical Limb Ischemia Treatment Industry Overview
The critical limb ischemia treatment market is moderately competitive and consists of several major players. The companies are adopting various business strategies such as product launches, collaborations, funding, and others to withhold their position in the market and enter the critical limb ischemia market. Some of the key players in the studied market are Medtronic plc, Abbott Laboratories, Rexgenero Ltd., LimFlow SA, Cardiovascular Systems, Inc., Eli Lilly and Company, and ThermoGenesis Holdings, Inc
Critical Limb Ischemia Treatment Market Leaders
-
Medtronic plc
-
LimFlow SA
-
Cardiovascular Systems, Inc
-
Eli Lilly and Company
-
Abbott Laboratories
- *Disclaimer: Major Players sorted in no particular order
Need More Details on Market Players and Competiters?
Download PDF
Critical Limb Ischemia Treatment Market News
- In June 2022, Royal Philips announced the most recent results from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular system - Tack (4F) - the first and only device of its kind approved by the US FDA, provides a sustained treatment effect and a positive impact on quality of life for patients with critical limb ischemia (CLI),
- In March 2022, LimFlow completed enrollment in the PROMISE II U.S. pivotal trial of a breakthrough device designed to prevent amputations in patients with chronic limb-threatening ischemia who have no other options.
Critical Limb Ischemia Treatment Industry Segmentation
As per the scope of this report, critical limb ischemia is a chronic disease of peripheral arteries in which chronic inflammation associated with atherosclerosis causes the shortened flow of blood and oxygen to the legs, hands, and feet. It results in excruciating pain, numbness, and sores on the hands, feet, or legs that heal slowly. It is a severe disorder that raises the chance of death, heart complications, and limb amputation.
The Critical Limb Ischemia Treatment Market is segmented by Treatment Type (Devices (Embolic Protection Devices and Peripheral Dilatation Systems), Drug (Antiplatelet Drugs, Antihypertensive Agents, Lipid-lowering Agents, and Others), and Surgery), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.
| By Treatment Type | Devices | Embolic Protection Devices | |
| Peripheral Dilatation Systems | |||
| Drugs | Antiplatelet Drugs | ||
| Antihypertensive Agents | |||
| Lipid-lowering Agents | |||
| Other Drugs | |||
| Surgery | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
Need A Different Region or Segment?
Customize Now
Critical Limb Ischemia Treatment Market Research FAQs
What is the current Global Critical Limb Ischemia Treatment Market size?
The Global Critical Limb Ischemia Treatment Market is projected to register a CAGR of 8.3% during the forecast period (2025-2030)
Who are the key players in Global Critical Limb Ischemia Treatment Market?
Medtronic plc, LimFlow SA, Cardiovascular Systems, Inc, Eli Lilly and Company and Abbott Laboratories are the major companies operating in the Global Critical Limb Ischemia Treatment Market.
Which is the fastest growing region in Global Critical Limb Ischemia Treatment Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global Critical Limb Ischemia Treatment Market?
In 2025, the North America accounts for the largest market share in Global Critical Limb Ischemia Treatment Market.
What years does this Global Critical Limb Ischemia Treatment Market cover?
The report covers the Global Critical Limb Ischemia Treatment Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Critical Limb Ischemia Treatment Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Our Best Selling Reports
Critical Limb Ischemia Industry Report
Statistics for the 2025 Global Critical Limb Ischemia Treatment market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Critical Limb Ischemia Treatment analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
