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全球经导管二尖瓣修復装置市场 - 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: 约2个工作天内

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简介目录

概述

多年来，全球经导管二尖瓣修復器材市场经历了显着的成长和变革，影响其动态的因素有很多。心血管疾病的增加、医疗设备的研发和政府投资是影响全球经导管二尖瓣修復设备的关键驱动因素。经过充满挑战的2020年，经导管二尖瓣修復器材产业表现出适度的弹性和适应性。

政府对心血管疾病的投资，特别是在发展中经济体，将继续推动经导管边缘修復（TEER）设备并推动全球经导管二尖瓣修復设备市场。全球经导管二尖瓣修復器材产业越来越重视更好地管理二尖瓣逆流。各自的措施包括使用其他设备，例如瓣环成形术设备和经导管腱索修復术来治疗二尖瓣逆流。

经导管边缘修復（TEER）设备类型占据了一半以上的市场。同样，北美在经导管二尖瓣修復装置市场上占据主导地位，占据最大市场份额，超过 1/3。该地区在医疗保健领域的快速投资以及全球经导管二尖瓣修復设备市场主要参与者的不断崛起，使其成为最大的市场份额持有者。美国拥有最大的製造商和消费者群体。

动力学

研究人员不断加强研究和开发

在收入水准提高、投资和基础设施发展的推动下，已开发经济体的医疗保健产业不断改善。一些国家对经导管二尖瓣修復装置的需求量很大，反映出它们的医疗保健产业不断扩大。不断增加的研发将是推动市场成长的关键因素。

医疗和经导管治疗的最新进展大大扩展了治疗继发性二尖瓣逆流 (SMR) 的选择。一项名为「MitraClip 经皮治疗心臟衰竭患者与功能性二尖瓣逆流(COAPT) 试验的心血管结果评估」的重要研究表明，使用第二版MitraClip 系统的二尖瓣经导管边对边修復术(M-TEER) 可增强左心室射血分数 (LVEF) 和 SMR 降低的心臟衰竭患者的预后以及预期寿命品质。

为了进一步最大限度地减少 MR 并改善有问题的二尖瓣 (MV) 解剖结构的手术结果，目前 M-TEER 领域的科学进展专注于改进设备设计和增加设备尺寸。这些进展可能会导致心臟衰竭症状减轻，并可能为因解剖学挑战而不符合 M-TEER 资格的 SMR 患者提供更好的预后。

融资或投资数量不断增加

全球经导管二尖瓣修復装置市场的主要驱动力之一是强大的管道，特别是在新兴经济体以及不断增长的投资和资金。例如，2022 年 11 月 23 日，一家名为 Nyra Medical, Inc. 的医疗器材公司宣布完成 2,000 万美元的 A 轮融资。该公司正在开发革命性的经导管二尖瓣置换技术。 Epidarex Capital、Broadview Ventures 和 Georgia Research Alliance Venture Fund 是本轮融资的投资者之一，该轮融资由 Vensana Capital 和一家重要的国际医疗设备公司共同领投。

此次融资的收益将用于透过初步的可行性临床试验来支持 Nyra 的技术。为了解决可能导致二尖瓣逆流的缺陷，同时保持自然瓣膜形状，Nyra 正在研究一种名为 CARLEN 的经导管技术，该技术透过专有植入物改变天然二尖瓣小叶。

与设备相关的挑战和限制

对于不同病因的MR，应采用不同的方法。对于所有 MR 原因，TEER 拥有最丰富的研究资料和最令人信服的治疗成功证据。只有患有继发性 MR 的个体才能接受瓣环成形术，但小叶修復和更出色的进步可能即将到来。腱索修復治疗中央后叶脱垂的有效性仅在低风险个体中进行了研究；需要进一步的研究来支持该手术对高风险患者的有效性、安全性和长期影响。

儘管采用微创经股动脉方法，死亡率低，TMVr 后恢復快，但该策略的一些缺点以及 MV 疾病和解剖的复杂性是不可否认的。 TMVr 的主要缺点是 MR 下降不太可预测，并且可能会持续或復发。具有功能性 MR 的个体的復发率可能更高，因为更多的心臟重塑（包括修復装置在收缩期间的部分 MV 闭塞）。经导管修復手术通常在技术上也很困难，有时需要一系列设备来确保手术的有效性。

与设备相关的併发症或风险

经导管心臟瓣膜 (THV) 的锚固力是由经导管人工二尖瓣框架与周围组织之间的摩擦产生的。因此，部署在不好的地点可能会减少这种力量并导致错位或迁移。在 Cheung TMVR 案例研究中，一名患者因心臟衰竭再次住院，该案例研究了连续 23 名接受二尖瓣 ViV 治疗的患者。

超音波心动图显示瓣膜向左前房移动 5 毫米，并伴随明显的室间隔逆流，需要进行第二次顺利的经心尖 (TA) TMVR。 Guerrero 的二尖瓣环内瓣膜钙化 (ViMAC) 研究显示，五名经导管瓣膜栓塞 (TVE) 患者需要第二次 THV，六名患者经历了植入装置迁移。

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