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市場調查報告書

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1352142

全球經導管心臟瓣膜置換設備市場 - 2023-2030

Global Transcatheter Heart Valve Replacement 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: 最快1-2個工作天內

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簡介目錄

概述

經導管心臟瓣膜置換術 (THVR) 設備是用於微創治療以取代失效心臟瓣膜的醫療技術。在這些設備的幫助下，患有主動脈瓣狹窄或逆流等疾病的個體無需進行心臟直視手術即可獲得置換瓣膜的好處。

THVR 裝置經由導管置入動脈，通常置入股動脈或一些類似的接入點。 THVR 裝置由牛、豬或人體組織等材料製成的生物瓣膜所構成。這些瓣膜的性能與正常心臟瓣膜相似。使用 THVR 裝置中常見的框架或支架將置換瓣膜固定在自然瓣膜環內。

自膨脹或氣球膨脹框架都是兩種選擇。當使用 THVR 設備將瓣膜帶到目標位置時，機制允許瓣膜部署在預期位置。根據患者的解剖結構和健康狀況，可以選擇不同的進入路徑，例如經股動脈、經心尖或經主動脈。

市場動態

技術進步

2023 年8 月，美國食品藥物管理局(FDA) 指定Genesis MedTech 的J-Valve 經股動脈(TF) 系統為突破性設備，用於治療嚴重的天然主動脈瓣逆流(AR) 和AR 為主的混合性主動脈瓣疾病。心臟團隊確定有資格使用該設備並且處於開放式主動脈瓣置換術高風險的患者。

這種尖端設備的目標受眾是患有主動脈瓣膜疾病的人。心臟衰竭可能是由稱為主動脈瓣逆流的常見疾病引起的。 J-Valve 經導管主動脈瓣置換治療採用微創經血管技術，無需進行心臟直視手術或體外循環。該技術使用擴張支架框架和錨定機構將裝置固定到失效的瓣膜上。

經導管二尖瓣置換術的益處不斷增加

對於患有二尖瓣疾病，特別是二尖瓣狹窄或逆流的患者，經導管二尖瓣置換術（TMVR）此新型醫療方法具有許多優點。 TMVR 不需要使用大的手術切口，因為它可以透過微小的穿刺或插入血管的導管來完成。與心臟直視手術相比，這可以減少創傷、減少痛苦、加速恢復時間並降低感染機會。

TMVR 患者的住院時間通常比接受標準手術二尖瓣置換術的患者短。因此，患者可以更快地康復並更早恢復正常活動。對於因高齡、脆弱或其他疾病等問題而被認為高風險或無法進行心臟直視手術的患者，TMVR 提供了有益的治療選擇。

FDA 核准

2023年2月，CardioFlow Medtech自主研發的經導管主動脈瓣植入術VitaFlow Liberty經導管主動脈瓣及回收輸送系統（VitaFlow Liberty）及Alwide Plus球囊導管（Alwide Plus）取得泰國食品藥品監督管理局註冊批准（TAVI）解決方案。

新一代TAVI產品VitaFlow Liberty對輸送系統進行了改進，繼承了原經導管主動脈瓣膜和輸送系統（VitaFlow）的獨特設計。其新穎的雙增強螺旋結構是獨一無二的，能夠快速、穩定、準確地釋放和收回，同時保留閥段出色的靈活性、無方向性和 360 度彎曲。

心血管疾病盛行率增加

據世界衛生組織稱，每年有 1790 萬人死亡，心血管疾病 (CVD) 是全球死亡的主要原因。冠心病、腦血管疾病、風濕性心臟病和其他疾病都屬於心臟和血管疾病（CVD）的範疇。每 5 例 CVD 死亡中就有超過 4 例是由心臟病發作和中風造成的，其中三分之一的死亡發生在 70 歲之前。

此外，隨著世界人口老化，心臟病，特別是瓣膜問題的風險也會增加。主動脈瓣狹窄和其他瓣膜疾病在老年人中更為常見，需要適當的治療選擇。

成本高

患者、醫療保健專業人員和醫療保健系統都可能受到醫療程序和干涉措施（包括經導管心臟瓣膜置換術 (THVR)）價格的影響。經導管心臟瓣膜本身就佔了價格的很大一部分。這些瓣膜通常是生物瓣膜，其開發和生產成本高。醫院費用涵蓋一系列費用，例如使用手術室、麻醉、護理和復健室護理等。

經導管心臟瓣膜的製造需要大量的研究、臨床測試、監管許可和持續的進步，所有這些都會增加整體成本。另一個需要考慮的因素是教育醫護人員進行 THVR 治療和管理問題的費用。

設備併發症和缺乏程序專業知識

醫療手術中的兩個關鍵因素，即使是像經導管心臟瓣膜置換術 (THVR) 這樣複雜的手術，也是設備問題和缺乏手術知識。經導管心臟瓣膜是醫療設備的一個例子，有時可能會促使影響患者治療效果和手術效果的問題。

瓣膜可能無法正常運作，這可能會促使滲漏、血流不正確或瓣膜狹窄（變窄）。 THVR 方法非常複雜，需要特定的知識和專業知識。醫療保健提供者缺乏經驗可能會促使不太理想的結果和可能的後果。

Overview

Transcatheter Heart Valve Replacement (THVR) devices are medical technologies used in minimally invasive treatments to replace failing heart valves. With the help of these devices, individuals with diseases like aortic stenosis or regurgitation can receive the benefits of a replacement valve without undergoing open heart surgery.

THVR devices are made to be placed into blood arteries by catheters, frequently in the femoral artery or some similar access point. Bioprosthetic valves made of materials like bovine, porcine, or human tissues make up THVR devices. These valves are made to perform similarly to how normal heart valves do. The replacement valve is fixed in place within the natural valve annulus using frames or stents seen in THVR devices.

Self-expanding or balloon-expandable frames are both options. When a valve is brought to the target location using THVR devices, mechanisms allow the valve to be deployed in the intended location. Depending on the anatomy and health of the patient, different access routes, such as transfemoral, transapical, or transaortic, may be selected.

Market Dynamics

Technological Advancements

In August 2023, the U.S. Food and Drug Administration (FDA) designated Genesis MedTech's J-Valve Transfemoral (TF) System as a Breakthrough Device for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients who are determined by a heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

The target audience for this cutting-edge device is people with aortic valvular disease. Heart failure can result from the common condition known as aortic regurgitation. A minimally invasive transvascular technique is used to accomplish the J-Valve Transcatheter aortic valve replacement treatment, eliminating the requirement for open heart surgery or extracorporeal circulation. The technique uses an expanding stent frame and an anchor mechanism to secure the device to a failing valve.

Increasing Benefits of Transcatheter Mitral Valve Replacement

For patients with mitral valve disease, particularly mitral stenosis or regurgitation, the novel medical treatment known as transcatheter mitral valve replacement (TMVR) has a number of advantages. The use of major surgical incisions is less necessary with TMVR because it can be done through tiny punctures or catheters placed into blood vessels. Compared to open heart surgery, this leads to less trauma, less suffering, quicker recovery times, and a lower chance of infection.

TMVR patients often stay in the hospital for less time than patients who have standard surgical mitral valve replacement. Patients can heal more quickly and resume their regular activities earlier as a result. For patients who are deemed high-risk or inoperable for open-heart surgery due to issues including advanced age, fragility, or the presence of additional medical disorders, TMVR offers a beneficial therapy option.

FDA Approval

In February 2023, the VitaFlow Liberty Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty) and the Alwide Plus Balloon Catheter (Alwide Plus), CardioFlow Medtech received registration approval from the Food and Drug Administration, Thailand for its independently developed Transcatheter aortic valve implantation (TAVI) solutions.

With an improvement to the delivery system, VitaFlow Liberty, a new-generation TAVI product, carries over the original Transcatheter Aortic Valve and Delivery System (VitaFlow)'s distinctive design. Its novel double-reinforced spiral construction is one-of-a-kind and enables quick, stable, and accurate release and retrieval while preserving the valve segment's excellent flexibility, non-directionality, and 360-degree bending.

Increasing Prevalence of Cardiovascular Diseases

According to the World Health Organization, with 17.9 million deaths per year, cardiovascular diseases (CVDs) are the leading cause of death worldwide. Coronary heart disease, cerebrovascular disease, rheumatic heart disease, and other illnesses are among the categories of heart and blood vessel disorders known as CVDs. Heart attacks and strokes account for more than four out of every five CVD deaths, and one-third of these deaths happen before the age of 70.

In addition, the risk of heart disorders, particularly valvular problems, rises as the world's population ages. Aortic stenosis and other valvular disorders are more prevalent in elderly people, need appropriate treatment choices.

High Cost

Patients, healthcare professionals, and healthcare systems may all be impacted by the price of medical procedures and interventions, including transcatheter heart valve replacement (THVR). The transcatheter heart valve itself accounts for a sizable portion of the price. The development and production of these valves, which are often bioprosthetic, is costly. Hospital expenses cover a range of fees, such as the use of operating rooms, anesthesia, nursing care, and recovery room care.

Transcatheter heart valve creation requires a substantial amount of research, clinical testing, regulatory clearances, and continual advancements, all of which add to the overall cost. Another factor to take into account is the price of educating medical staff to carry out THVR treatments and manage problems.

Device Complications and lack of Procedural Expertise

Two crucial factors in the world of medical operations, even sophisticated ones like transcatheter heart valve replacement (THVR), are device issues and a lack of procedural knowledge. Transcatheter heart valves are one example of a medical device that might occasionally result in issues that can affect patient outcomes and the effectiveness of the surgery.

The valve might not work as it should, which could cause leakage, incorrect blood flow, or valve stenosis (narrowing). The THVR method is intricate and necessitates specific knowledge and expertise. Healthcare providers' inexperience can result in less-than-ideal results and possible consequences.

Segment Analysis

The global transcatheter heart valve replacement devices market is segmented based on type, product, indication, end-users and region.

The transcatheter aortic valve replacement segment accounted for approximately 45.3% of the market share

As per the article published in Stat Pearls in 2023, patients with severe symptomatic aortic stenosis (AS) typically have surgical aortic valve replacement. Before, patients who were deemed to be at high risk for surgery could only get palliative treatments like diuretics and balloon valvuloplasty, which had little impact on long-term outcomes. For patients deemed to be inoperable, the discovery of Transcatheter aortic valve replacement (TAVR) has emerged as a lifeline, offering both a reduction in symptoms and a statistically significant mortality benefit.

There are numerous transcatheter aortic valves on the market. However, only the SAPIEN valves from Edwards Lifesciences in Irvine, California, and the CORE valves from Medtronic in Fridley, Minnesota, are now FDA-approved for use in the United States. Bovine pericardial tissue and a chromium-cobalt alloy frame make up the SAPIEN valves. The SAPIEN valves can expand like a balloon. The EVOLUT-R valve is part of Medtronic's most recent iteration. Porcine tissue and a nitinol frame make up its construction.

Geographical Penetration

Presence of Major Players and Increasing Prevalence of Cardiovascular Disease

North America has been a dominant force in the global transcatheter heart valve replacement devices market. For instance, in June 2023, egnite, Inc., a leading digital health company for cardiovascular care, and JenaValve Technology, Inc., a developer and manufacturer of differentiated Transcatheter aortic valve replacement (TAVR) systems, collaborated to understand the treatment model and associated outcomes for patients with aortic regurgitation (AR).

The partnership uses the market-leading database of egnite to measure prevalence and treatment trends. It is conservatively estimated that approximately 500,000 people are diagnosed with moderate or severe AR in the United States. They seek to accelerate change, offer better treatment alternatives, and ultimately save lives by leveraging cutting-edge analytics and JenaValve's inventive Transcatheter treatments. These findings encourage additional focus on enhancing outcomes for patients with AR by offering insightful information to politicians and healthcare professionals.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global transcatheter heart valve replacement devices market. Many hospitals and healthcare facilities delayed elective treatments during the early stages of the pandemic, including THVR, in order to devote resources to COVID-19 patients.

As a result, THVR procedures decreased. Due to concerns about contracting the virus in medical facilities during the pandemic, many people were reluctant to have elective surgeries. As a result, there were fewer patients for THVR surgeries. The traditional patient-provider relationship necessary for THVR evaluations was impacted when more healthcare professionals and patients used telemedicine for consultations and follow-up appointments.

Russia-Ukraine War Impact Analysis

Healthcare systems in the impacted areas may be under stress as a result of armed conflicts, which may take resources and focus away from elective operations like THVR. Hospitals may need to give emergency patients priority over elective procedures. Security concerns, infrastructural damage, and population displacement in conflict zones might restrict patients' access to medical facilities.

This affected a patient's eligibility for THVR procedures. The displacement of medical personnel due to conflict may result in a shortage of skilled workers qualified to carry out difficult treatments like THVR.

By Product

Self-Expandable Transcatheter Aortic Valves
Ballon Expandable Transcatheter Aortic Valves
Mechanically Expandable Transcatheter Aortic Valves

By Procedure Type

Transcatheter Aortic Valve Replacement
Transcatheter Mitral Valve Replacement
Transcatheter Pulmonary Valve Replacement

By Indication

Severe Aortic Valve Stenosis
Aortic Regurgitation
Others

By End-users

Hospitals
Ambulatory Surgical Centers
Cardiac Catheterization Laboratories

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 May 2023, JenaValve Technology, Inc., a developer and manufacturer of differentiated Transcatheter aortic valve replacement (TAVR) systems, the first two Trilogy Heart Valve System implantations in Asia were completed.

Competitive Landscape

The major global players in the market include Abbott, Edwards Lifesciences Corporation, Medtronic plc., Boston Scientific Corporation, JenaValve Technology, Inc., Meril Life Sciences, Sahajanand Medical Technologies Limited, MicroPort Scientific Corporation, Venus Medtech (Hangzhou) Inc., and Peijia Medical Limited.

Why Purchase the Report?

To visualize the global transcatheter heart valve replacement devices market segmentation based on product, procedure 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 heart valve replacement 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 heart valve replacement devices market report would provide approximately 69 tables, 67 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
3.2. Snippet by Procedure Type
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. Technological Advances
  - 4.1.1.2. Increasing Benefits of Transcatheter Mitral Valve Replacement
  - 4.1.1.3. FDA Approval
  - 4.1.1.4. Increasing Prevalence of Cardiovascular Diseases
- 4.1.2. Restraints
  - 4.1.2.1. High Cost
  - 4.1.2.2. Device Complications and Lack of Procedural Expertise
- 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 Product

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
- 7.1.2. Market Attractiveness Index, By Product
7.2. Self-Expandable Transcatheter Aortic Valves
7.3. Self-Expandable Transcatheter Aortic Valves*
- 7.3.1. Introduction
- 7.3.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.4. Ballon Expandable Transcatheter Aortic Valves
7.5. Mechanically Expandable Transcatheter Aortic Valves

8. By Procedure Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 8.1.2. Market Attractiveness Index, By Procedure Type
8.2. Transcatheter Aortic Valve Replacement*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Transcatheter Mitral Valve Replacement
8.4. Transcatheter Pulmonary Valve Replacement

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. Severe Aortic Valve Stenosis*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Aortic Regurgitation
9.4. Others

10. By End-users

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-users
- 10.1.2. Market Attractiveness Index, By End-users
10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Ambulatory Surgical Centers,
10.4. Cardiac Catheterization Laboratories

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
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 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-users
- 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
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 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-users
- 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
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 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-users
- 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
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 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-users
- 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
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Procedure Type
- 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-users

12. Competitive Landscape

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

13. Company Profiles

13.1. Abbott*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Edwards Lifesciences Corporation
13.3. Medtronic plc
13.4. Boston Scientific Corporation
13.5. JenaValve Technology, Inc.
13.6. Meril Life Sciences
13.7. Sahajanand Medical Technologies Limited
13.8. MicroPort Scientific Corporation
13.9. Venus Medtech (Hangzhou) Inc.
13.10. Peijia Medical Limited

LIST NOT EXHAUSTIVE