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全球神经血管栓塞设备市场 - 2023-2030

Global Neurovascular Embolization Devices Market - 2023-2030

出版日期: 2023年09月06日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 约2个工作天内

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简介目录

概述

全球神经血管栓塞器械市场在 2022 年达到 37 亿美元，预计到 2030 年将达到 60 亿美元，2023-2030 年预测期间复合年增长率为 6.4%。

神经血管栓塞装置阻断或阻止血液流向不良血管畸形。动脉瘤夹、液体栓塞系统、血流转向支架、栓塞线圈和血管内血流干扰器是神经血管栓塞装置的例子。中风是一种大脑血液供应中断的疾病，导致缺氧、脑损伤和工作能力下降。

最常见的原因是向大脑输送血液的动脉中出现血栓。当血管破裂导致血液滴入大脑时，甚至可能因出血而诱发。中风可引起持久性损伤，例如部分瘫痪以及词彙、认知和记忆障碍。所涉及的大脑区域和血液供应被阻断的时间会影响残疾的类型和严重程度。

脑中风和动脉瘤病例的增加、产品授权的增加、研究活动的积极成果、市场发展（包括合併、收购、产品推出、意识的提高等因素）预计将在预测期内推动全球神经血管栓塞设备市场的增长。此外，不断增长的案例和研究资金预计也将有助于预测期内的全球市场增长。

动力学

脑中风和动脉瘤病例不断增加

脑中风和动脉瘤病例的增加预计将在预测期内推动全球市场的增长。例如，根据世界中风组织的数据，中风已经达到流行率。全球 25 岁以上成年人中，预计有四分之一的人一生中会发生中风，预计今年全球将有超过 1220 万人首次中风，650 万人将因此死亡。

迄今为止，全球已有超过 1.1 亿人遭遇过中风。中风的患病率随着年龄的增长而大幅上升，然而，超过60% 的中风发生在70 岁以下的人身上，约16% 的中风发生在50 岁以下的人身上。此外，根据英国NHS 的数据，大约有1% 的中风发生在50 岁以下的人身上。英国每年有 12,500 人患有脑动脉瘤破裂。

此外，脑动脉瘤影响了大约 3.0% 的英国人，脑动脉瘤基金会评估每年有超过 600 万美国人受到脑动脉瘤的影响。此外，根据NIH的数据，全球脑动脉瘤患病率约为3.2%，标准年龄为50岁，性别比例为1:1。 50 岁后这一比例变化很大，女性比例不断增加，接近 2:1，这被认为是由于循环雌激素减少导致血管组织胶原蛋白范围减少。

不断发展的市场

全球神经血管栓塞器械市场的不断发展预计将推动全球市场的发展。例如，2021年7月，神经和外周血管介入医疗器械公司Zylox-Tonbridge医疗科技有限公司获得3.29亿美元，用于维持其核心开发产品的设计和商业化，包括神经血管栓塞线圈、微导管用于捲绕等。此外，2023年1月，Fluidx Medical Technology, Inc.披露了有关IMPASS栓塞装置在与脑膜中动脉（MMA）栓塞相关的体内研究中取得成功的数据，该栓塞可用于治疗慢性硬膜下血肿（ CSDH ）位于大脑表面。

同样，2021 年3 月，心血管和神经血管市场创新疗法的设计者Shape Memory Medical Inc. 的IMPEDE-FX RapidFill 设备获得了CE 标誌批准，该设备是IMPEDE 可生物降解外周血管栓塞塞产品组合的补充。此外，2023 年 7 月，Shape Memory Medical Inc. 与全球医疗技术市场领导者达成了再许可协议。根据该协议，Shape Memory Medical 打算将其专有的形状记忆聚合物技术转授许可，用于Shape Memory Medical 心血管、血管内和神经血管重点之外的治疗领域的狭窄适应症，以获取预付费用以及未来的地标和特许权使用费。

产品召回

由于安全问题而从市场召回的产品预计将阻碍预测期内全球市场的增长。例如，2021 年 9 月，美敦力召回其 Pipeline Flex 栓塞设备和采用 Shield 技术的 Pipeline Flex 栓塞设备，这些设备是用于堵塞脑动脉瘤的经导管设备。该公司表示，当系统用于定位、恢復或将支架推入患者体内时，输送系统的金属丝和管道存在破裂和折断的风险。

FDA 已将其认定为 I 级召回，即最严重的召回类型。据估计，使用这些设备会导致严重损害或死亡。此次召回涉及 59 起设备故障、10 起严重损坏和 2 起死亡事件。此次召回涉及 2019 年 4 月至 2020 年 8 月期间在美国销售的 8,825 件设备。美敦力是 Micro Therapeutics Inc. ev3 Neuroangio 的母公司，该公司负责製造这些设备。 2021 年 7 月，我们向所有买家邮寄了一封召回信，要求他们停止使用任何受影响的产品，并立即隔离所有未使用的受影响产品。

高昂的设备费用和平均住院费用

神经血管栓塞装置的高成本和平均住院费用预计将在预测期内减缓全球市场的增长。例如，根据《血管外科杂誌》发表的一项研究，儘管市场竞争加剧，用于颅内动脉瘤栓塞的弹簧圈的价格仍在持续上涨。美国市场上的线圈标价从 500 美元到 3000 美元不等。

平均干预费用为 21,687.22 美元，根据动脉瘤部位的不同存在一定差异。此外，主动脉瘤腔内修復术的平均住院费用为 45,304 美元（50% 手术室用品，包括移植物）。与动脉瘤相关的平均再入院和再干预费用分别为 13,119 美元和 22,023 美元。门诊费用平均每人每年 657 美元，其中 72% 来自计算机断层扫描。

Overview

Global Neurovascular Embolization Devices Market reached US$ 3.7 billion in 2022 and is expected to reach US$ 6.0 billion by 2030, growing with a CAGR of 6.4% during the forecast period 2023-2030.

Neurovascular embolization devices block or stop blood flow to undesirable vessel malformations. Aneurysm clips, liquid embolic systems, flow diversion stents, embolization coils, and intravascular flow disruptors are examples of neurovascular embolization devices. Stroke is an ailment where the blood supply to the brain is disrupted, resulting in a lack of oxygen, brain injury, and failure to perform.

It is most often because of a clot in an artery delivering blood to the brain. It can even be induced by hemorrhage when a burst vessel leads blood to drip into the brain. Stroke can induce enduring injury, such as partial paralysis and impairment in vocabulary, cognition, and remembering. The region of the brain involved and the period the blood supply has been blocked affects the sort and severity of disability.

The growing cases of brain stroke and aneurysms, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global neurovascular embolization devices market growth in the forecast period. Further, the growing cases and research fundings are also expected to contribute to the global market growth in the forecast period.

Dynamics

Growing Cases of Brain Stroke and Aneurysms

The growing cases of brain stroke and aneurysms are expected to boost the global market growth during the forecast period. For instance, according to the World Stroke Organization, stroke has already achieved epidemic ratios. Worldwide 1 out of 4 adults above the age of 25 are expected to have a stroke in their lifetime, over 12.2 million individuals globally are anticipated to encounter their first stroke this year and 6.5 million will die as a consequence.

More than 110 million individuals in the globe have encountered a stroke till present in their lives. The prevalence of stroke rises greatly with age, nevertheless, more than 60% of strokes transpire to individuals under the age of 70, and around 16% transpire to those below the age of 50. Moreover, according to the NHS England, about 1 out of 12,500 individuals in England have a ruptured brain aneurysm every year.

Furthermore, brain aneurysm impacts roughly 3.0% of people in the U.K. and the Brain Aneurysm Foundation assesses that over 6.0 million Americans are affected by brain aneurysms annually. In addition, according to the NIH, the global preponderance of cerebral aneurysms is roughly 3.2%, with a standard age of 50 and an altogether 1:1 gender ratio. This ratio varies greatly after age 50, with an increasing female predominance closing 2:1, considered to be owing to reduced circulating estrogen inducing a decrease in the collagen range of the vascular tissue.

Increasing Market Developments

The increasing market developments in the global neurovascular embolization devices market are expected to boost the global market. For instance, in July 2021, Zylox-Tonbridge Medical Technology Co., Ltd., a neuro- and peripheral-vascular interventional medical device corporation secured USD 329 million to sustain the designing and commercialization of its core developments including neurovascular embolization coils, a microcatheter for coiling, among others. Moreover, in January 2023, Fluidx Medical Technology, Inc., disclosed the data concerning the success of the IMPASS Embolic Device in in-vivo research associated with middle meningeal artery (MMA) embolizations which can be utilized for the treatment of chronic subdural hematomas (CSDH) on the surface of the brain.

Similarly, in March 2021, Shape Memory Medical Inc., a designer of innovative treatments for cardiovascular and neurovascular markets, obtained CE Mark Approval for the IMPEDE-FX RapidFill Device, an addition to the IMPEDE portfolio of biodegradable peripheral vascular embolization plugs. Further, in July 2023, Shape Memory Medical Inc. formed a sublicense deal with a global MedTech market leader. Under this, Shape Memory Medical intends to sublicense its proprietary shape memory polymer technology for a narrow indication in a therapeutic area beyond Shape Memory Medical's cardiovascular, endovascular, and neurovascular focus, in retrieval for an upfront license fee, and future landmarks and royalties.

Product Recalls

The product recalls from the market due to safety concerns are expected to hamper the global market growth during the forecast period. For instance, in September 2021, Medtronic recalled its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices utilized to plug brain aneurysms. The corporation expressed a risk of the delivery system's wire and tubes fracturing and breaking off when the system is being utilized to position, recover, or push the stent inside a patient.

The FDA has recognized this as a Class I recall, the most severe type of recall. Usage of these devices is estimated to induce severe damage or death. There have been 59 documented device malfunctions, 10 severe damages, and two deaths linked to this recall. The recall encloses 8,825 devices in the United States that were distributed between April 2019 to August 2020. Medtronic is the parent group of Micro Therapeutics Inc., ev3 Neurovascular, which constructs the devices. A recall letter was mailed to all buyers in July 2021, asking them to stop the use of any impacted product and quarantine all unused impacted products immediately.

High Device and Mean Hospitalization Costs

The high neurovascular embolization devices costs and mean hospitalization costs are expected to slow the global market growth in the forecast period. For instance, according to a study published in the Journal of Vascular Surgery, the price of coils used for intracranial aneurysm embolization has continued to rise despite an increase in competition in the marketplace. Coils on the US market range in list price from $500 to $3000.

The average intervention cost was USD 21,687.22, with some variation according to the aneurysm site. Moreover, the mean hospitalization cost for endovascular aortic aneurysm repair was $45,304 (50% operating room supplies, including graft). The average aneurysm-related readmission and reintervention costs were $13,119 and $22,023, respectively. Outpatient payments averaged $657 per person per year, 72% of which is attributable to computed tomography scans.

Segment Analysis

The global neurovascular embolization devices market is segmented based on product type, treatment, indication, end-user and region.

Flow Diversion Stents Product Type Expected to Dominate Market

Owing to the increasing market developments in the Flow Diversion Stents segment it is expected to dominate the global market. For instance, in October 2022, the Medtronic Neurovascular Co-Lab Platform was designed to sustain the pace of much-required innovation in stroke treatment and sustenance. Their community platform strives to modify opinions and technology into breakthrough multinational treatments by providing entrepreneurs and medics understanding and consideration and, most significantly, ensuring that innovation arrives to as many individuals as imaginable around the globe.

Moreover, in January 2023, Therma Bright Inc. financed Israeli Ischemic Stroke Blood Clot Retriever Technologies Startup Inretio Inc. The PREVA basket "ensnares" the clot, enclosing it and shielding the brain from any sub-clots that break off in the thrombectomy therapy. Again, in February 2022, Perfuze, a company involved in designing next-generation catheter-based aspiration technology, secured a USD 23.94 million Series A financing round.

Geographical Penetration

Growing Cases of Stroke and Aneurysm

The increasing cases of stroke and aneurysms in North America are expected to boost the regional market growth, dominating the global market throughout the forecast period. For instance, according to CDC facts revised in 2022, each year over 795,000 individuals in the United States encounter a stroke, approximately 610,000 of these are first or new strokes. Moreover, in the United States, there is assessed to be at least one stroke every 40 seconds, and every four minutes, an individual dies of a stroke. The same source even noted that roughly 87% of all strokes are ischemic strokes, in which blood flow to the brain gets blocked. An assessed 6.7 million individuals in the United States have an unruptured brain aneurysm or 1 in 50 individuals, the yearly rate of rupture is around 8 - 10 per 100,000 individuals.

Further, almost 30,000 individuals in the United States encounter a brain aneurysm rupture annually, it is estimated that a brain aneurysm ruptures every 18 minutes. Furthermore, the increase in the research funding in this region are also expected to contribute to the regional market growth in the forecast period. For instance, in October 2021, the Udall Center at the University of Minnesota Medical School acquired a new USD 11.3 million funding from the National Institute of Neurological Stroke for research purposes.

COVID-19 Impact Analysis

During the COVID-19 pandemic, elective and routine examinations and operations were postponed or discontinued because of redirecting aids to additional emergent therapy for extremely sick individuals and to avert the spread and contraction of COVID-19. Additionally, the workforce was pulled narrow, and healthcare structures witnessed growing turnover rates for full-time and agreement workers, which pushed the system and decreased the capacity to deliver clinical assistance.

The COVID-19 pandemic induced substantial disruption to specified care pathways, including critical conditions including aneurysmal subarachnoid hemorrhage (SAH) (aSAH). There was a relative decrease in the number of patients with aSAH during the COVID-19 pandemic. In spite of the extremely different states of hospitalization, there was no impairing noteworthy impact on the treatment and consequence of admitted individuals with aSAH. A past COVID-19 infection appeared to be an unrelated determining factor affecting favorable results.

By Product Type

Liquid Embolic Systems
Embolization Coils
Aneurysm Clips
Flow Diversion Stents
Others

By Treatment

Ischemic Stroke Solutions
Hemorrhagic Stroke Solutions

Indication
- Brain aneurysm
- Arteriovenous malformations
- Others

By End-User

Hospitals
Specialty Clinics
Ambulatory Surgical Centers
Academic Research Centers
Others

By Region

North America
- U.S.
- Canada
- Mexico

Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe

South America
- Brazil
- Argentina
- Rest of South America

Asia-Pacific
- China
- India
- Japan
- Australia
- Rest of Asia-Pacific

Middle East and Africa

Key Developments

In February 2023, Shape Memory Medical Inc., designer of shape memory polymer for peripheral and neurovascular markets, reported the first patient treated in Germany as component of the EMBO-Post Market Surveillance Registry, the Company's forthcoming, multicenter, registry investigation of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular embolization.
In 2022, Rapid Medical, a designer of novel neurovascular devices, obtained FDA 510(k) authorization for TIGERTRIEVER 13 for the major vessel occlusions during the 19th Annual Conference of the Society of Neurointerventional Surgery (SNIS) in Toronto.
In June 2022, Medtronic introduced the CE-marked fourth generation flow system, pipeline vantage with Shield technology, for endovascular treatment of brain aneurysms.

Competitive Landscape

The major global players in the market include: Medtronic plc, Stryker Corporation, Johnson & Johnson Inc., Terumo Corporation, B. Braun Melsungen AG., Integra LifeSciences Corporation, Acandis GmBH, Phenox GmBH, Lepu Medical Technology (Beijing)Co., and Shape Memory Medical Inc. among others.

Why Purchase the Report?

To visualize the global neurovascular embolization devices market segmentation based on product type, treatment, indication, end-user and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of neurovascular embolization devices market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as excel consisting of key product of all the major players.

The global neurovascular embolization devices market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Treatment
3.3. Snippet by Indication
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Product Approvals and Positive Research Outcomes
  - 4.1.1.2. Increasing Efforts from Distinct Associations
- 4.1.2. Restraints
  - 4.1.2.1. High Treatment Cost of Neurovascular Embolization Devices
  - 4.1.2.2. Low Prevalence of the Disorder
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Patent Analysis
5.6. Technology Trend
5.7. End-User Trend
5.8. SWOT Analysis
5.9. DMI Opinion

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID
- 6.1.2. Scenario During COVID
- 6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Product Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 7.1.2. Market Attractiveness Index, By Product Type
7.2. Liquid Embolic Systems*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Embolization Coils
7.4. Aneurysm Clips
7.5. Flow Diversion Stents
7.6. Others

8. By Treatment

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 8.1.2. Market Attractiveness Index, By Treatment
8.2. Oral Ischemic Stroke Solutions*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Hemorrhagic Stroke Solutions

9. By Indication

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 9.1.2. Market Attractiveness Index, By Indication
9.2. Infants Brain aneurysm*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Arteriovenous malformations
9.4. Others

10. By End-User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Specialty Clinics
10.4. Ambulatory Surgical Centers
10.5. Academic Research Centers
10.6. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. UK
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.5.7.1. China
  - 11.5.7.2. India
  - 11.5.7.3. Japan
  - 11.5.7.4. Australia
  - 11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. Medtronic plc*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Stryker Corporation
13.3. Johnson & Johnson Inc.
13.4. Terumo Corporation
13.5. B. Braun Melsungen AG.
13.6. Integra LifeSciences Corporation
13.7. Acandis GmBH
13.8. Phenox GmBH
13.9. Lepu Medical Technology (Beijing)Co.
13.10. Shape Memory Medical Inc.

LIST NOT EXHAUSTIVE

14. Appendix

14.1. About Us and Services
14.2. Contact Us

02-2729-4219

+886-2-2729-4219

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