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1345458

全球神經血管栓塞設備市場 - 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: 約2個工作天內

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簡介目錄

概述

全球神經血管栓塞器械市場在 2022 年達到 37 億美元，預計到 2030 年將達到 60 億美元，2023-2030 年預測期間年複合成長率為 6.4%。

神經血管栓塞裝置阻斷或阻止血液流向不良血管畸形。動脈瘤夾、液體栓塞系統、血流轉向支架、栓塞線圈和血管內血流乾擾器是神經血管栓塞裝置的例子。中風是一種大腦血液供應中斷的疾病，導致缺氧、腦損傷和工作能力下降。

最常見的原因是向大腦輸送血液的動脈中出現血栓。當血管破裂導致血液滴入大腦時，甚至可能因出血而誘發。中風可引起持久性損傷，例如部分癱瘓以及詞彙、認知和記憶障礙。所涉及的大腦區域和血液供應被阻斷的時間會影響殘疾的類型和嚴重程度。

腦中風和動脈瘤病例的增加、產品授權的增加、研究活動的積極成果、市場發展（包括合併、收購、產品推出、意識的提高等因素）預計將在預測期內推動全球神經血管栓塞設備市場的成長。此外，不斷成長的案例和研究資金預計也將有助於預測期內的全球市場成長。

動力學

腦中風和動脈瘤病例不斷增加

腦中風和動脈瘤病例的增加預計將在預測期內推動全球市場的成長。例如，根據世界中風組織的數據，中風已經達到流行率。全球 25 歲以上成年人中，預計有四分之一的人一生中會發生中風，預計今年全球將有超過 1220 萬人首次中風，650 萬人將因此死亡。

迄今為止，全球已有超過 1.1 億人遭遇過中風。中風的患病率隨著年齡的成長而大幅上升，然而，超過60% 的中風發生在70 歲以下的人身上，約16% 的中風發生在50 歲以下的人身上。此外，根據英國NHS 的數據，大約有1% 的中風發生在50 歲以下的人身上。英國每年有 12,500 人患有腦動脈瘤破裂。

此外，腦動脈瘤影響了大約 3.0% 的英國人，腦動脈瘤基金會評估每年有超過 600 萬美國人受到腦動脈瘤的影響。此外，根據NIH的數據，全球腦動脈瘤患病率約為3.2%，標準年齡為50歲，性別比例為1:1。 50 歲後這一比例變化很大，女性比例不斷增加，接近 2:1，這被認為是由於循環雌激素減少導致血管組織膠原蛋白範圍減少。

不斷發展的市場

全球神經血管栓塞器械市場的不斷發展預計將推動全球市場的發展。例如，2021年7月，神經和周邊血管介入醫療器械公司Zylox-Tonbridge醫療科技有限公司獲得3.29億美元，用於維持其核心開發產品的設計和商業化，包括神經血管栓塞線圈、微導管用於捲繞等。此外，2023年1月，Fluidx Medical Technology, Inc.披露了有關IMPASS栓塞裝置在與腦膜中動脈（MMA）栓塞相關的體內研究中取得成功的數據，該栓塞可用於治療慢性硬膜下血腫（ CSDH ）位於大腦表面。

同樣，2021 年3 月，心血管和神經血管市場創新療法的設計者Shape Memory Medical Inc. 的IMPEDE-FX RapidFill 設備獲得了CE 標誌批准，該設備是IMPEDE 可生物分解周邊血管栓塞塞產品組合的補充。此外，2023 年 7 月，Shape Memory Medical Inc. 與全球醫療技術市場領導者達成了再許可協議。根據該協議，Shape Memory Medical 打算將其專有的形狀記憶聚合物技術轉授許可，用於Shape Memory Medical 心血管、血管內和神經血管重點之外的治療領域的狹窄適應症，以獲取預付費用以及未來的地標和特許權使用費。

產品召回

由於安全問題而從市場召回的產品預計將阻礙預測期內全球市場的成長。例如，2021 年 9 月，美敦力召回其 Pipeline Flex 栓塞設備和採用 Shield 技術的 Pipeline Flex 栓塞設備，這些設備是用於堵塞腦動脈瘤的經導管設備。該公司表示，當系統用於定位、恢復或將支架推入患者體內時，輸送系統的金屬絲和管道存在破裂和折斷的風險。

FDA 已將其認定為 I 級召回，即最嚴重的召回類型。據估計，使用這些設備會導致嚴重損害或死亡。此次召回涉及 59 起設備故障、10 起嚴重損壞和 2 起死亡事件。此次召回涉及 2019 年 4 月至 2020 年 8 月期間在美國銷售的 8,825 件設備。美敦力是 Micro Therapeutics Inc. ev3 Neuroangio 的母公司，該公司負責製造這些設備。 2021 年 7 月，我們向所有買家郵寄了一封召回信，要求他們停止使用任何受影響的產品，並立即隔離所有未使用的受影響產品。

高昂的設備費用和平均住院費用

神經血管栓塞裝置的高成本和平均住院費用預計將在預測期內減緩全球市場的成長。例如，根據《血管外科雜誌》發表的一項研究，儘管市場競爭加劇，用於顱內動脈瘤栓塞的彈簧圈的價格仍在持續上漲。美國市場上的線圈標價從 500 美元到 3000 美元不等。

平均干涉費用為 21,687.22 美元，根據動脈瘤部位的不同存在一定差異。此外，主動脈瘤腔內修復術的平均住院費用為 45,304 美元（50% 手術室用品，包括移植物）。與動脈瘤相關的平均再入院和再干涉費用分別為 13,119 美元和 22,023 美元。門診費用平均每人每年 657 美元，其中 72% 來自電腦斷層掃描。

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