嚴重肢體缺血市場 - 全球及區域 - 分析與預測（2025 年至 2035 年）

Critical Limb Ischemia Market - A Global and Regional Analysis: Focus on Country and Region - Analysis and Forecast, 2025-2035

出版日期: 2025年06月30日 | 出版商:

BIS Research | 英文 100 Pages | 商品交期: 1-5個工作天內

價格

簡介目錄圖表

嚴重肢體缺血是周邊動脈疾病(PAD) 的嚴重晚期階段，其中流向肢體（通常是腳和腿）的血流量嚴重減少。

嚴重肢體缺血是指動脈嚴重狹窄或阻塞，通常由動脈粥狀硬化引起，導致脂肪沉積和斑塊在動脈內積聚，從而限制血流。血液循環減少會導致組織缺氧和必需營養物質，進而引發劇烈疼痛、潰瘍不癒合、壞疽，在某些情況下甚至需要截肢。

嚴重肢體缺血與高死亡和殘疾風險有關，通常診斷於患有慢性靜止痛、傷口不癒合或患肢組織壞死的個體。此病最常見於具有糖尿病、高血壓、吸煙和肥胖等風險因素的個體。治療通常包括藥物治療、微創手術（例如血管成形術和置入術）、外科手術干預，有時還會結合再生療法來改善血流並保留患肢。早期診斷和介入對於避免包括截肢在內的嚴重併發症至關重要。

嚴重肢體缺血市場的主要驅動力之一是糖尿病、高血壓、肥胖和吸煙等風險因素的日益普及。這些疾病大大增加了患有周邊動脈疾病(PAD) 的幾率，如果不及時治療，可能會發展為嚴重肢體缺血。隨著這些風險因素在全球範圍內持續增加，嚴重肢體缺血的發生率也在上升，增加了對有效治療的需求。此外，老化也是市場發展的關鍵驅動力，因為老年人患有嚴重肢體缺血的風險更高。被診斷患有嚴重肢體缺血的患者數量不斷增加，推動了對先進醫療手段的需求，例如微創手術（切除術、支架植入術、動脈粥樣硬化置入術等）和再生療法，以改善血流並防止肢體缺失。嚴重肢體缺血負擔的持續加重正在推動新治療方法的開發並擴大市場。

儘管嚴重肢體缺血市場正在成長，但仍有若干挑戰阻礙其發展，特別是血管成形術、置入術和切除術等微創手術，以及幹細胞療法等再生療法。這些治療方法通常需要大量資金，因此難以獲得，特別是對於中低收入國家和缺乏全面保險的患者而言。此外，嚴重肢體缺血患者需要長期護理，包括後續觀察、藥物治療和持續管理潛在疾病（例如糖尿病和高血壓），進一步增加了醫療保健系統的成本負擔。這種經濟障礙導致治療延遲或不充分，最終影響患者的預後。經濟負擔問題仍是阻礙嚴重肢體缺血治療廣泛應用的關鍵因素之一。

全球嚴重肢體缺血市場競爭激烈，多家主要企業推動創新和市場成長。波士頓科學公司、雅培實驗室、Rexgenero Ltd.、LimFlow SA、心血管系統公司、拜耳股份公司、Cytori Therapeutics公司、阿斯特捷利康、諾華股份公司、Hemostemix 公司和 Lisata Therapeutics 等公司處於開發和商業化嚴重肢體缺血治療方法的前沿。這些公司在推動微創治療、再生療法、藥物療法和創新醫療設備方面取得了重大進展，旨在改善患者預後並減少截肢需求。專注於研發、策略夥伴關係以及擴大新興市場准入，進一步推動了全球嚴重肢體缺血治療市場的成長。

市場區隔

細分一：按地區

北美洲
歐洲
亞太地區

全球嚴重肢體缺血市場正經歷重大變革時期，其驅動力源自於新興趨勢，這些趨勢正在重塑嚴重肢體缺血的診斷、治療和管理方式。諸如血管成形術、置入術和動脈粥狀硬化斑塊切除術等微創手術的應用日益普及，因其相較於傳統手術具有諸多優勢，例如恢復時間更快、併發症發生率更低以及患者預後更佳。此外，人們對幹細胞療法和基因療法等再生醫學的日益關注，有望超越單純的症狀管理，透過促進血管生成和改善患肢血流，提供長期解決方案。

促成這一轉變的另一個趨勢是精準醫療的整合，精準醫療根據每位患者的基因和生物標記數據，量身定做治療方案，從而實現更有效、更個性化的護理。此外，非侵入性影像和高階血管造影術等診斷技術的進步，使得更早發現嚴重不良事件（CLI）成為可能，從而能夠更及時地進行干預，防止病情發展到更嚴重的階段，例如壞疽和截肢。

全球人口老化以及糖尿病、高血壓和肥胖等慢性疾病（這些都是嚴重肢體缺血的風險因素）的增多，正在推動對創新治療方案的需求。這促使製藥和醫療設備公司加大對新治療方法、新藥物和新器材開發的投資，以滿足日益成長的需求。這些趨勢不僅改變了嚴重肢體缺血的臨床管理，也為醫療保健領域的成熟和新興企業參與企業創造了新的市場機會。

本報告研究了全球嚴重肢體缺血市場，並概述了市場以及區域趨勢和公司概況。

關鍵策略和發展
- 合併與收購
- 協同活動
- 業務擴展和資金籌措
- 產品發布和核准
- 其他活動
公司簡介
- Boston Scientific Corporation Inc.
- Abbott Laboratories
- Rexgenero Ltd.
- LimFlow SA
- Cardiovascular Systems, Inc.
- Bayer AG
- Cytori Therapeutics, Inc.
- AstraZeneca
- Novartis AG
- Hemostemix Inc.
- Lisata Therapeutics

第4章調查方法

簡介目錄圖表

Product Code: BHL3068SA

Global Critical Limb Ischemia Market, Analysis and Forecast: 2025-2035

Critical Limb Ischemia is a severe, advanced stage of peripheral artery disease (PAD), a condition in which there is a significant reduction in blood flow to the extremities, typically the legs and feet. critical limb ischemia occurs when the arteries become severely narrowed or blocked, usually due to atherosclerosis, where fatty deposits or plaque accumulate in the arteries, restricting the blood flow. This reduced circulation deprives the tissues of oxygen and essential nutrients, leading to severe pain, non-healing ulcers, gangrene, and, in some cases, the need for amputation.

critical limb ischemia associated with a high risk of mortality and disability, and it is typically diagnosed in individuals who experience chronic rest pain, wounds that do not heal, or tissue death in the affected limb. The condition is most commonly seen in people with risk factors such as diabetes, hypertension, smoking, and obesity. Treatment usually involves a combination of medical management, minimally invasive procedures (like angioplasty and stenting), surgical interventions, and, in some cases, regenerative therapies to improve blood flow and preserve the affected limb. Early diagnosis and intervention are crucial to avoid severe complications, including amputation.

One of the key drivers of the Critical Limb Ischemia market is the rising prevalence of risk factors such as diabetes, hypertension, obesity, and smoking. These conditions significantly increase the likelihood of developing peripheral artery disease (PAD), which can progress to critical limb ischemia if not treated in time. As these risk factors continue to rise globally, the incidence of critical limb ischemia is also increasing, creating a greater demand for effective treatments. Additionally, the aging population is another important factor driving market growth, as older adults are at a higher risk of developing CLI. The growing number of patients diagnosed with critical limb ischemia is fueling the demand for advanced medical treatments, such as minimally invasive procedures (e.g., angioplasty, stenting, atherectomy) and regenerative therapies, to improve blood flow and prevent limb loss. This increasing burden of critical limb ischemia cases is propelling the development of new therapeutic options, thereby expanding the market.

Despite the growth of the Critical Limb Ischemia market, several challenges continue to hinder its progress. One of the primary challenges is the high cost of treatment associated with advanced critical limb ischemia therapies, particularly minimally invasive procedures like angioplasty, stenting, and atherectomy, as well as regenerative therapies such as stem cell treatments. These procedures often require significant financial investment, making them less accessible to patients, especially in low- and middle-income countries or for those without comprehensive insurance coverage. Additionally, the long-term care required for critical limb ischemia patients, including follow-up procedures, medications, and ongoing management of underlying conditions (such as diabetes and hypertension), further increases the cost burden on healthcare systems. This financial barrier can lead to delayed or inadequate treatment, which ultimately affects patient outcomes. The challenge of affordability remains one of the key factors limiting the widespread adoption of advanced critical limb ischemia therapies.

The global Critical Limb Ischemia market is highly competitive, with several leading companies driving innovation and market growth. Companies such as Boston Scientific Corporation Inc., Abbott Laboratories, Rexgenero Ltd., LimFlow SA, Cardiovascular Systems, Inc., Bayer AG, Cytori Therapeutics, Inc., AstraZeneca, Novartis AG, Hemostemix Inc., and Lisata Therapeutics are at the forefront of developing and commercializing treatment options for CLI. These companies are making significant strides in advancing minimally invasive procedures, regenerative therapies, pharmaceutical treatments, and innovative medical devices, aimed at improving patient outcomes and reducing the need for amputation. Their focus on research and development, strategic partnerships, and expanding access to new markets is further propelling the growth of the critical limb ischemia treatment market globally.

Market Segmentation:

Segmentation 1: by Region

North America
Europe
Asia-Pacific

The global Critical Limb Ischemia market is undergoing significant transformation, fueled by emerging trends that are reshaping the way critical limb ischemia is diagnosed, treated, and managed. Key trends such as the increasing use of minimally invasive procedures, including angioplasty, stenting, and atherectomy, are becoming more prevalent due to their advantages in reducing recovery times, lowering complication rates, and improving patient outcomes compared to traditional surgery. Additionally, the growing focus on regenerative medicine, including stem cell therapies and gene therapies, holds promise for not just managing symptoms but potentially offering long-term solutions by promoting angiogenesis and improving blood flow in the affected limbs.

Another trend contributing to this transformation is the integration of precision medicine, where treatments are tailored to individual patient profiles based on genetic and biomarker data, allowing for more effective and personalized care. Furthermore, advancements in diagnostic technologies, such as non-invasive imaging techniques and advanced angiography, are enabling earlier detection of CLI, allowing for more timely interventions that can prevent the progression to more severe stages, such as gangrene and amputation.

The global aging population and the rise in chronic conditions such as diabetes, hypertension, and obesity, all of which are risk factors for CLI, are driving the demand for innovative treatment options. In response, pharmaceutical companies and medical device manufacturers are increasingly investing in the development of new therapies, drugs, and devices to meet the growing need. These trends are not only transforming the clinical management of critical limb ischemia but also creating new market opportunities for both established players and emerging companies in the healthcare sector.

Executive Summary

Scope and Definition

Market/Product Definition

Inclusion and Exclusion

Key Questions Answered

Analysis and Forecast Note

1. Global Critical Limb Ischemia Market: Industry Outlook

1.1 Introduction
1.2 Market Trends
1.3 Regulatory Framework
1.4 Epidemiology Analysis
1.5 Clinical Trial Analysis
1.6 Market Dynamics
- 1.6.1 Impact Analysis
- 1.6.2 Market Drivers
- 1.6.3 Market Challenges
- 1.6.4 Market Opportunities

2. Global Critical Limb Ischemia Market (Region), ($Billion), 2023-2035

2.1 North America
- 2.1.1 Key Findings
- 2.1.2 Market Dynamics
- 2.1.3 Market Sizing and Forecast
  - 2.1.3.1 North America Critical Limb Ischemia Market, by Country
    - 2.1.3.1.1 U.S.
2.2 Europe
- 2.2.1 Key Findings
- 2.2.2 Market Dynamics
- 2.2.3 Market Sizing and Forecast
  - 2.2.3.1 Europe Critical Limb Ischemia Market, by Country
    - 2.2.3.1.1 Germany
    - 2.2.3.1.2 U.K.
    - 2.2.3.1.3 France
    - 2.2.3.1.4 Italy
2.3 Asia Pacific
- 2.3.1 Key Findings
- 2.3.2 Market Dynamics
- 2.3.3 Market Sizing and Forecast
  - 2.3.3.1 Asia Pacific Critical Limb Ischemia Market, by Country
    - 2.3.3.1.1 China
    - 2.3.3.1.2 Japan

3. Global Critical Limb Ischemia Market: Competitive Landscape and Company Profiles

3.1 Key Strategies and Development
- 3.1.1 Mergers and Acquisitions
- 3.1.2 Synergistic Activities
- 3.1.3 Business Expansions and Funding
- 3.1.4 Product Launches and Approvals
- 3.1.5 Other Activities
3.2 Company Profiles
- 3.2.1 Boston Scientific Corporation Inc.
  - 3.2.1.1 Overview
  - 3.2.1.2 Top Products / Product Portfolio
  - 3.2.1.3 Top Competitors
  - 3.2.1.4 Target Customers/End-Users
  - 3.2.1.5 Key Personnel
  - 3.2.1.6 Analyst View
- 3.2.2 Abbott Laboratories
  - 3.2.2.1 Overview
  - 3.2.2.2 Top Products / Product Portfolio
  - 3.2.2.3 Top Competitors
  - 3.2.2.4 Target Customers/End-Users
  - 3.2.2.5 Key Personnel
  - 3.2.2.6 Analyst View
- 3.2.3 Rexgenero Ltd.
  - 3.2.3.1 Overview
  - 3.2.3.2 Top Products / Product Portfolio
  - 3.2.3.3 Top Competitors
  - 3.2.3.4 Target Customers/End-Users
  - 3.2.3.5 Key Personnel
  - 3.2.3.6 Analyst View
- 3.2.4 LimFlow SA
  - 3.2.4.1 Overview
  - 3.2.4.2 Top Products / Product Portfolio
  - 3.2.4.3 Top Competitors
  - 3.2.4.4 Target Customers/End-Users
  - 3.2.4.5 Key Personnel
  - 3.2.4.6 Analyst View
- 3.2.5 Cardiovascular Systems, Inc.
  - 3.2.5.1 Overview
  - 3.2.5.2 Top Products / Product Portfolio
  - 3.2.5.3 Top Competitors
  - 3.2.5.4 Target Customers/End-Users
  - 3.2.5.5 Key Personnel
  - 3.2.5.6 Analyst View
- 3.2.6 Bayer AG
  - 3.2.6.1 Overview
  - 3.2.6.2 Top Products / Product Portfolio
  - 3.2.6.3 Top Competitors
  - 3.2.6.4 Target Customers/End-Users
  - 3.2.6.5 Key Personnel
- 3.2.7 Cytori Therapeutics, Inc.
  - 3.2.7.1 Overview
  - 3.2.7.2 Top Products / Product Portfolio
  - 3.2.7.3 Top Competitors
  - 3.2.7.4 Target Customers/End-Users
  - 3.2.7.5 Key Personnel
  - 3.2.7.6 Analyst View
- 3.2.8 AstraZeneca
  - 3.2.8.1 Overview
  - 3.2.8.2 Top Products / Product Portfolio
  - 3.2.8.3 Top Competitors
  - 3.2.8.4 Target Customers/End-Users
  - 3.2.8.5 Key Personnel
  - 3.2.8.6 Analyst View
- 3.2.9 Novartis AG
  - 3.2.9.1 Overview
  - 3.2.9.2 Top Products / Product Portfolio
  - 3.2.9.3 Top Competitors
  - 3.2.9.4 Target Customers/End-Users
  - 3.2.9.5 Key Personnel
  - 3.2.9.6 Analyst View
- 3.2.10 Hemostemix Inc.
  - 3.2.10.1 Overview
  - 3.2.10.2 Top Products / Product Portfolio
  - 3.2.10.3 Top Competitors
  - 3.2.10.4 Target Customers/End-Users
  - 3.2.10.5 Key Personnel
  - 3.2.10.6 Analyst View
- 3.2.11 Lisata Therapeutics
  - 3.2.11.1 Overview
  - 3.2.11.2 Top Products / Product Portfolio
  - 3.2.11.3 Top Competitors
  - 3.2.11.4 Target Customers/End-Users
  - 3.2.11.5 Key Personnel
  - 3.2.11.6 Analyst View