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導管心血管設備

市場調查報告書

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1352130

全球經導管二尖瓣修復裝置市場 - 2023-2030

Global Transcatheter Mitral Valve Repair Devices Market - 2023-2030

出版日期: 2023年09月27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

多年來，全球經導管二尖瓣修復器材市場經歷了顯著的成長和變革，影響其動態的因素有很多。心血管疾病的增加、醫療設備的研發和政府投資是影響全球經導管二尖瓣修復設備的關鍵促進因素。經過充滿課題的2020年，經導管二尖瓣修復器材產業表現出適度的彈性和適應性。

政府對心血管疾病的投資，特別是在發展中經濟體，將繼續推動經導管邊緣修復（TEER）設備並推動全球經導管二尖瓣修復設備市場。全球經導管二尖瓣修復器材產業越來越重視更好地管理二尖瓣逆流。各自的措施包括使用其他設備，例如瓣環成形術設備和經導管腱索修復術來治療二尖瓣逆流。

經導管邊緣修復（TEER）設備類型佔據了一半以上的市場。同樣，北美在經導管二尖瓣修復裝置市場上佔據主導地位，佔據最大市場佔有率，超過 1/3。該地區在醫療保健領域的快速投資以及全球經導管二尖瓣修復設備市場主要參與者的不斷崛起，使其成為最大的市場佔有率持有者。美國擁有最大的製造商和消費者群體。

動力學

研究人員不斷加強研究和開發

在收入水準提高、投資和基礎設施發展的推動下，已開發經濟體的醫療保健產業不斷改善。一些國家對經導管二尖瓣修復裝置的需求量很大，反映出它們的醫療保健產業不斷擴大。不斷增加的研發將是推動市場成長的關鍵因素。

醫療和經導管治療的最新進展大大擴展了治療繼發性二尖瓣逆流 (SMR) 的選擇。一項名為「MitraClip 經皮治療心臟衰竭患者與功能性二尖瓣逆流(COAPT) 試驗的心血管結果評估」的重要研究表明，使用第二版MitraClip 系統的二尖瓣經導管邊對邊修復術(M-TEER) 可增強左心室射血分數 (LVEF) 和 SMR 降低的心臟衰竭患者的預後以及預期壽命品質。

為了進一步最大限度地減少 MR 並改善有問題的二尖瓣 (MV) 解剖結構的手術結果，目前 M-TEER 領域的科學進展專注於改進設備設計和增加設備尺寸。這些進展可能會促使心臟衰竭症狀減輕，並可能為因解剖學課題而不符合 M-TEER 資格的 SMR 患者提供更好的預後。

融資或投資數量不斷增加

全球經導管二尖瓣修復裝置市場的主要驅動力之一是強大的管道，特別是在新興經濟體以及不斷成長的投資和資金。例如，2022 年 11 月 23 日，一家名為 Nyra Medical, Inc. 的醫療器材公司宣布完成 2,000 萬美元的 A 輪融資。該公司正在開發革命性的經導管二尖瓣置換技術。 Epidarex Capital、Broadview Ventures 和 Georgia Research Alliance Venture Fund 是本輪融資的投資者之一，該輪融資由 Vensana Capital 和一家重要的國際醫療設備公司共同領投。

此次融資的收益將用於透過初步的可行性臨床試驗來支持 Nyra 的技術。為了解決可能促使二尖瓣逆流的缺陷，同時保持自然瓣膜形狀，Nyra 正在研究一種名為 CARLEN 的經導管技術，該技術透過專有植入物改變天然二尖瓣小葉。

與設備相關的課題和限制

對於不同病因的MR，應採用不同的方法。對於所有 MR 原因，TEER 擁有最豐富的研究資料和最令人信服的治療成功證據。只有患有繼發性 MR 的個體才能接受瓣環成形術，但小葉修復和更出色的進步可能即將到來。腱索修復治療中央後葉脫垂的有效性僅在低風險個體中進行了研究；需要進一步的研究來支持該手術對高風險患者的有效性、安全性和長期影響。

儘管採用微創經股動脈方法，死亡率低，TMVr 後恢復快，但該策略的一些缺點以及 MV 疾病和解剖的複雜性是不可否認的。 TMVr 的主要缺點是 MR 下降不太可預測，並且可能會持續或復發。具有功能性 MR 的個體的復發率可能更高，因為更多的心臟重塑（包括修復裝置在收縮期間的部分 MV 閉塞）。經導管修復手術通常在技術上也很困難，有時需要一系列設備來確保手術的有效性。

與設備相關的併發症或風險

經導管心臟瓣膜 (THV) 的錨固力是由經導管人工二尖瓣框架與周圍組織之間的摩擦產生的。因此，部署在不好的地點可能會減少這種力量並促使錯位或遷移。在 Cheung TMVR 案例研究中，一名患者因心臟衰竭再次住院，該案例研究了連續 23 名接受二尖瓣 ViV 治療的患者。

超音波心動圖顯示瓣膜向左前房移動 5 毫米，並伴隨明顯的室間隔逆流，需要進行第二次順利的經心尖 (TA) TMVR。 Guerrero 的二尖瓣環內瓣膜鈣化 (ViMAC) 研究顯示，五名經導管瓣膜栓塞 (TVE) 患者需要第二次 THV，六名患者經歷了植入裝置遷移。

Overview

The global transcatheter mitral valve repair devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Rising cardiovascular disorders, research and development and government investments in medical devices are among the key drivers impacting transcatheter mitral valve repair devices globally. After the challenging year of 2020, the transcatheter mitral valve repair devices industry showed moderate resilience and adaptability.

Government investments in cardiovascular disorders, particularly in developing economies, will continue to drive transcatheter edge-to-edge repair (TEER) devices and boost the global transcatheter mitral valve repair devices market. The global transcatheter mitral valve repair devices industry is placing increasing emphasis on better management of mitral regurgitation. The respective initiatives includes the use of other devices, such as annuloplasty devices and transcatheter chordal repair for treatment of mitral regurgitation.

The transcatheter edge-to-edge repair (TEER) device type, accounts for over half of the market share. Similarly, the North America dominates the transcatheter mitral valve repair devices market, capturing the largest market share of over 1/3rd. The region's rapid investments in healthcare and rising major players in the transcatheter mitral valve repair devices market globally, makes it the largest market share holder. United States has the largest pool of manufacturers as well as consumers.

Dynamics

Growing Research and Development by the Researchers

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by rising income levels, investments and infrastructure development. Several countries have experienced substantial demand for transcatheter mitral valve repair devices, reflecting their expanding healthcare industries. Rising research and development will be a crucial factor driving the growth of the market.

Recent improvements in medical and transcatheter therapy have greatly expanded the options for treating secondary mitral regurgitation (SMR). An important study called the Cardiovascular Outcomes Evaluation of the MitraClip Percutaneous Therapy for Cardiac Failure Patients alongside Functional Mitral Regurgitation (COAPT) trial demonstrated that mitral valve transcatheter edge-to-edge repair (M-TEER) using the second version of the MitraClip system enhances prognosis as well as quality life expectancy in heart failure individuals who have reduced LV ejection fraction (LVEF) and SMR.

In order to further minimize MR and improve procedural outcomes in problematic mitral valve (MV) anatomies, current scientific advancement in the area of M-TEER focuses on improving device design and increasing device sizes. These developments might lead to a reduction in symptoms of heart failure and possibly a better prognosis for SMR patients who would not otherwise be eligible for M-TEER because of anatomic challenges.

Rising Number of Funding or Investments

One of the primary drivers of the global Transcatheter Mitral Valve Repair Devices market is robust pipeline, especially in emerging economies and rising investments and funding. For instance, on November 23, 2022, a medical device firm named Nyra Medical, Inc. has announced the completion of a $20 million Series A fundraising. The company is developing a revolutionary transcatheter mitral valve replacement technology. Epidarex Capital, Broadview Ventures, and the Georgia Research Alliance Venture Fund were among investors in the round, which was co-led by Vensana Capital and a significant, international medical equipment firm.

The financing's proceeds will be utilized to support Nyra's technology via preliminary clinical trials of viability. In order to address inadequacies that might otherwise result in mitral regurgitation while maintaining the natural valve shape, Nyra is working on a transcatheter technique called CARLEN that changes the native mitral valve leaflets through a proprietary implant.

Challenges and Limitations Associated with the Devices

For MR with various etiologies, various approaches should be used. For all MR causes, the TEER has the greatest research data and the most convincing proof of therapeutic success. Only individuals with secondary MR can receive an annuloplasty, however leaflet repair and more excellent advancements may be on the horizon. The effectiveness of chordal repair in treating central posterior leaflet prolapse has been examined exclusively in low-risk individuals; further research is required to support the efficacy, safety, and long-term effects of this procedure in high-risk patients.

Despite the minimally invasive transfemoral method, a low death rate, and rapid recovery following TMVr, several drawbacks of this strategy as well as the intricacy of MV illness and anatomy cannot be denied. TMVr's primary drawback is that MR decline is less predictable and could continue or recur. Recurrence rates may be higher in individuals who have functional MR because of more cardiac remodeling including the repair device's partial MV occlusion during systole. Transcatheter repair operations are also frequently technically difficult, and occasionally an array of devices is needed to guarantee the procedure's efficacy.

Complications or Risks Related to the Device

The anchoring force of the transcatheter heart valve (THV) is produced by friction between the transcatheter prosthetic mitral valve's frame and the surrounding tissue. As a result, deployment in a bad spot could reduce this force and cause misposition or migration. One patient was hospitalized again with heart failure in Cheung TMVR case study of 23 consecutive patients who underwent mitral ViV.

Echocardiography revealed 5-mm valve migration to the anterior left atrium with significant intervalvular regurgitation, necessitating a second uneventful transapical (TA) TMVR. Guerrero's valve-in-mitral annular calcification (ViMAC) study revealed that five transcatheter valve embolization (TVE) patients needed a second THV, and six patients experienced implanted device migration.

Segment Analysis

The global transcatheter mitral valve repair devices market is segmented based on device type, indication, end user and region.

High Advantages and Advancements of Transcatheter Edge-to-Edge Repair Devices

A minimally invasive treatment called mitral transcatheter edge-to-edge repair (TEER) is used to treat mitral valve regurgitation, a disease where the valve between the left chambers of the heart doesn't seal completely. Each time the heart beats, healthy heart valves securely open and close to regulate blood flow from the heart and back to the other parts of the body. Blood seeps backward if the mitral valve isn't closing properly, which makes the heart work harder. People may feel exhausted or out of breath as a result of a buildup of pressure in the lungs. In the absence of medical care, the regurgitation (backflow) may develop over time and manifest new symptoms.

In TEER, a tiny device is implanted in the valve to aid in its more complete closure and the restoration of regular blood flow utilizing either the Pascal Precision or Abbott MitraClip systems. These tools function by bringing the flaps of the valve into a more straight-forward alignment. They are put through an artery using a catheter, which is a long, thin tube. As a result, only a little incision is needed for the treatment. Feeling short of breath, chest pain, and other symptoms can be reduced thanks to TEER, which also enhances quality of life.

Geographical Penetration

North America Accounted for Largest Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Due to the rising need for transcatheter mitral valve repair devices in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for transcatheter mitral valve repair devices.

Increasing expenditure on healthcare and rising research studies, advancement of technologies for different devices for mitral regurgitation, and increase in pharmaceutical and medical devices business establishment across the region are also contributing to the growth of transcatheter mitral valve repair devices market share of this region.

The key healthcare organizations' and businesses' joint research initiatives are also expected to contribute to the rising demand, as will new product development, which constantly looks to improve present options. The market in this area is growing as people become more aware of various novel devices such as annuloplasty devices, for treatment purposes. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global transcatheter mitral valve repair devices market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising cardiovascular disorders have fueled the demand for transcatheter mitral valve repair devices in the region. United States have been proactive in executing several initiatives or researches, stimulating transcatheter mitral valve repair devices demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global transcatheter mitral valve repair devices market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the medical device sector, with a significant consumer of transcatheter mitral valve repair devices, was significantly impacted.

Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020. Major pharmaceutical or medical device industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for transcatheter mitral valve repair devices. As a result, many medical device plants either suspended or reduced production to align with the reduced demand.

The COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials to the pharmaceuticals manufacturing plants. Movement limitations and border closures caused production and supply delays. Additionally, some nations experienced a lack of raw resources as a result of supply chain network interruptions.

With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages as workers fell sick or were unable to travel to work due to lockdown restrictions. To curb the spread of the virus, pharmaceutical plants implemented stringent safety measures, reducing the number of workers allowed on-site at a time. However, these measures were vital to safeguard the health of the workforce and maintain essential operations during the pandemic.

Russia-Ukraine War Impact Analysis

The medical device businesses are starting to worry regarding their capacity to continue operating, much like other parts of the world. Russia's invasion of Ukraine has an effect on millions of people not only in this nation in Eastern Europe but also all around the world. Device developers will thus experience delays in the development process, a loss of business consistency, and the possibility of non-compliance for drugs already on the market.

For many years, clinical trials in several therapeutic fields have benefited significantly from the participation of Ukraine, Russia, and other CIS nations. Clinical trial durations can frequently be accelerated by incorporating more patients into studies when there is availability to skilled investigators, high-quality patient populations, and big patient populations. Trials that are delayed in Russia and Ukraine as well as relocation to other regions of Europe for fresh trials are currently viable choices. These factors will impact the global transcatheter mitral valve repair devices market.

By Device Type

Annuloplasty Devices
- Direct Annuloplasty
- Indirect Annuloplasty
  - Transcatheter Edge-to-Edge Repair (TEER) Devices
  - Transcatheter Chordal Repair

By Indication

Mitral regurgitation (MR)

Primary Mitral Regurgitation
Secondary Mitral Regurgitation
- Mitral Stenosis (MS)

By End User

Hospitals
Specialty Clinics
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

On September 17, 2022, results from CLASP IID, a groundbreaking controlled, randomized study that directly contrasts two cutting-edge transcatheter edge-to-edge repair (TEER) procedures, were released by Edwards Lifesciences Corporation. According to the study, TEER is a safe and efficient treatment option for those having degenerative mitral regurgitation (DMR). Findings from the CLASP IID essential trial were concurrently published in JACC: Cardiovascular Interventions and offered as a late-breaking clinical research meeting at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the yearly scientific conference of the Cardiovascular Research Foundation.
On June 8, 2022, MitraClip, the first transcatheter edge-to-edge repair (TEER) device in the world, and TriClip, a pioneering minimally invasive tricuspid heart valve repair technology, both received late-breaking data announcements from Abbott. The statistics support the structural cardiac solutions offered by the company's for mitral as well as tricuspid regurgitation (MR or TR) in a wide spectrum of patient populations struggling with leaky heart valves.

Competitive Landscape

The major global players in the market include Abbott, Edwards Lifesciences Corporation, Cardiac Dimensions, NeoChord, Inc., 4C Medical Technologies, Nyra Medical, Shockwave Medical Inc., Coramaze Technologies, Boston Scientific Corporation and Medtronic among others.

Why Purchase the Report?

To visualize the global transcatheter mitral valve repair devices market segmentation based on device type, 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 transcatheter mitral valve repair 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 products of all the major players

The global transcatheter mitral valve repair 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 Device Type
3.2. Snippet by Indication
3.3. Snippet by End User
3.4. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Growing Research and Development by the Researchers
  - 4.1.1.2. Rising Number of Funding or Investments
- 4.1.2. Restraints
  - 4.1.2.1. Challenges and Limitations Associated with the Devices
  - 4.1.2.2. Complications or Risks Related to the Device
- 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. Russia-Ukraine War Impact Analysis
5.6. 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 Device Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 7.1.2. Market Attractiveness Index, By Device Type
7.2. Annuloplasty Devices*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.2.3. Direct Annuloplasty
- 7.2.4. Indirect Annuloplasty
7.3. Transcatheter Edge-to-Edge Repair (TEER) Devices
7.4. Transcatheter Chordal Repair

8. By Indication

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 8.1.2. Market Attractiveness Index, By Indication
8.2. Mitral regurgitation (MR)*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 8.2.3. Primary Mitral Regurgitation
- 8.2.4. Secondary Mitral Regurgitation
8.3. Mitral Stenosis (MS)

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Specialty Clinics
9.4. Others

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.6.1. U.S.
  - 10.2.6.2. Canada
  - 10.2.6.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.6.1. Germany
  - 10.3.6.2. UK
  - 10.3.6.3. France
  - 10.3.6.4. Italy
  - 10.3.6.5. Spain
  - 10.3.6.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.6.1. Brazil
  - 10.4.6.2. Argentina
  - 10.4.6.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.6.1. China
  - 10.5.6.2. India
  - 10.5.6.3. Japan
  - 10.5.6.4. Australia
  - 10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Abbott*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Edwards Lifesciences Corporation
12.3. Cardiac Dimensions
12.4. NeoChord, Inc.
12.5. 4C Medical Technologies
12.6. Nyra Medical
12.7. Shockwave Medical Inc.
12.8. Coramaze Technologies
12.9. Boston Scientific Corporation
12.10. Medtronic

LIST NOT EXHAUSTIVE