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全球先天性心臟缺陷設備市場 - 2023-2030

Global Congenital Heart Defect 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: 最快1-2個工作天內

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簡介目錄

概述

全球先天性心臟缺陷設備市場在 2022 年達到 28 億美元，預計到 2030 年將達到 46 億美元，2023-2030 年預測期間年複合成長率為 6.4%。

多年來，全球先天性心臟病設備市場經歷了顯著的成長和轉變，影響其動態的因素有多種，例如出生後先天性心臟病患病率不斷增加、臨床試驗和研究活動不斷增加等。政府對更好的設備製造的投資將繼續推動和提振全球市場。全球先天性心臟病設備行業越來越重視減少其影響。

先天性心臟缺陷裝置，例如人工起搏器、植入式心臟復律除顫器、導管等最常用於治療先天性心臟缺陷，例如心動過緩、心動過速等。預計導管細分市場將在預測期內佔據最大的市場佔有率。同樣，北美在市場上佔據主導地位，由於該地區有利的報銷政策、先進的醫療基礎設施和主要參與者的存在，佔據了最大的市場佔有率。

由於先天性心臟缺陷的患病率不斷增加，對先進設備的需求不斷增加，意識不斷增強，臨床試驗不斷增加，微創手術的採用不斷增加以及技術進步是預計在預測期內推動全球市場的主要因素。

動力學

擴大採用微創手術預計將推動先天性心臟缺陷設備市場的成長

微創手術的日益普及預計將在預測期內推動市場的成長。先天性心臟病裝置，如導管、心臟封堵器和其他裝置，提供微創手術，以更好的方式治療患者。與傳統的心臟直視手術相比，許多患有先天性心臟病的患者更喜歡微創手術，因為微創手術具有疼痛減輕時間短、恢復時間更快和疤痕更小的優點。對於患有先天性心臟病的兒科患者來說，這種偏好尤其強烈。

例如，2023 年2 月22 日，美敦力宣布重新推出Harmony 經導管肺動脈瓣(TPV) 系統，這是一種微創心臟直視手術替代方案，適用於患有天然或手術修復右心室流出道(RVOT ) 的先天性心臟病患者。

此外，微創手術預計會出現感染、出血和傷口癒合問題等併發症。這可以提高患者的安全並減少進一步的併發症。這些微創手術提供了更大的好處，特別是對於兒科患者來說，可以安全地治療許多先天性心臟缺陷。

例如，2021 年6 月15 日，全球醫療保健公司雅培(Abbott) 在印度推出了Amplatzer Piccolo 封堵器，這是世界上第一個可以通過微創手術植入最小嬰兒（體重僅700 克）體內的醫療設備治療動脈導管未閉（先天性心臟病）或 PDA。 Amplatzer Piccolo 是一種比小豌豆還小的裝置，現在為需要矯正治療、可能對藥物無反應且面臨接受矯正手術高風險的早產兒和新生兒帶來了希望。

臨床試驗的增加預計也將推動先天性心臟缺陷設備市場的成長

先進先天性心臟病設備的臨床試驗的增加預計也將在預測期內推動市場的成長。臨床試驗提供了一個平台來測試和驗證用於治療先天性心臟缺陷的新興設備的安全性和有效性。積極的試驗結果可以導致監管部門的批准和市場的引入，從而推動成長。

例如，2021 年 7 月 8 日，Xeltis 宣布已開始首次合成修復性肺動脈瓣關鍵試驗。迄今為止，作為 FDA 批准的全球 Xplore2/Pivotal 研究的一部分，需要右心室流出道 (RVOT) 重建的兒科患者已成功植入。 RVOT 重建是糾正某些先天性心臟缺陷所需的手術。

此外，臨床試驗還產生了有關先天性心臟病設備性能的科學證據。這些證據對於醫療保健提供者在做出治療決策時至關重要，這可能會導致這些設備的採用增加。臨床試驗還旨在通過評估設備的安全性和有效性來改善患者的治療結果。積極的結果可以帶來更好的治療選擇，吸引更多的患者通過使用這些設備來尋求更好的治療。

與設備相關的併發症預計將阻礙市場的成長

與先天性心臟缺陷設備相關的併發症預計將阻礙市場的成長。與先心病中使用的設備（例如導管、起搏器、支架、瓣膜或封堵器）相關的故障或技術故障可能會帶來嚴重風險。設備故障可能需要額外的干涉或手術來糾正，這可能會導致醫療成本增加和其他導致患者不滿意的風險。

此外，任何侵入性手術（例如基於導管的干涉措施）預計都會帶來導管感染、氧氣水平降低以及兒童心律不齊的風險。感染可能發生在插入部位，或者在某些情況下發生在心臟本身，進一步導致嚴重的併發症。感染會延長住院時間，需要抗生素治療，並可能導致敗血症（一種危及生命的疾病）。

Overview

Global Congenital Heart Defect Devices Market reached US$ 2.8 billion in 2022 and is expected to reach US$ 4.6 billion by 2030, growing with a CAGR of 6.4% during the forecast period 2023-2030.

The global congenital heart defect devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics such as the increasing prevalence of congenital heart defects from birth, rising clinical trials and research activities, and others. Government investments in better device manufacturing will continue to drive and boost the global market. The global congenital heart defect devices industry is placing increasing emphasis on reducing its impact.

Congenital heart defect devices such as artificial pacemakers, implantable cardioverter defibrillators, catheters, and others are most commonly used to treat congenital heart defects such as bradycardia, tachycardia, and others. Catheters segment is expected to hold the largest market share over the forecast period. Similarly, North America dominates the market, capturing the largest market share owing to the region's favorable reimbursement policies, advanced healthcare infrastructure, and presence of major players.

Owing to the increasing prevalence of congenital heart defects, increasing demand for advanced devices, growing awareness, rising clinical trials, increasing adoption of minimally invasive procedures, and technological advancements are the major factors expected to drive the global market over the forecast period.

Dynamics

Increasing Adoption of Minimally Invasive Procedures is Expected to Drive the Growth of the Congenital Heart Defect Devices Market

The increasing adoption of minimally invasive procedures is expected to drive the growth of the market over the forecast period. Congenital heart defect devices such as catheters, cardiac occluders, and other devices offers minimally invasive procedures to treat patients in a better way. Many patients with congenital heart defects mostly prefer minimally invasive procedures over traditional open-heart surgeries due to their benefits like shorter reduced pain, quicker recovery times, and smaller scars. This preference is especially strong for pediatric patients with congenital heart defects.

For instance, on February 22, 2023, Medtronic announced the relaunch of its Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).

Moreover, minimally invasive procedures are expected to have complications such as infections, bleeding, and wound healing issues. This can improve patient safety and reduce further complications. These minimally invasive procedures offers enhanced benefits, especially for pediatric patients to treat many congenital heart defects in safe way.

For instance, on June 15, 2021, Abbott, the global healthcare company, launched its Amplatzer Piccolo Occluder in India, the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700 gms) using a minimally invasive procedure to treat patent ductus arteriosus (a congenital heart defect) or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medicine and are at high risk to undergo corrective surgery.

Increasing Clinical Trials is Also Expected to Drive the Growth of the Congenital Heart Defect Devices Market

The increasing clinical trials for advanced congenital heart defect devices are also expected to drive the growth of the market over the forecast period. Clinical trials provide a platform to test and validate the safety and efficacy of emerging devices designed for the treatment of congenital heart defects. Positive trial outcomes can lead to regulatory approvals and market introductions, driving growth.

For instance, on July 08, 2021, Xeltis announced that it had started the first-ever pivotal trial for a synthetic restorative pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, FDA-approved Xplore2/Pivotal study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects.

Further, the clinical trials also generate scientific evidence regarding the performance of congenital heart defect devices. This evidence is crucial for healthcare providers when making treatment decisions, which can lead to increased adoption of these devices. Clinical trials also aim to improve patient outcomes by assessing the safety and efficacy of devices. Positive results can lead to better treatment options, attracting more patients to seek these better treatment by using these devices.

Complications Associated with the Devices is Expected to Hamper the Market's Growth

The complications associated with congenital heart defect devices are expected to hamper the growth of the market. Malfunctions or technical failures associated with the devices used in CHD, such as catheters, pacemakers, stents, valves, or occluders, can pose serious risks. Device failure may require additional interventions or surgeries to correct, which can lead to increased healthcare costs and other risks that leads to patient dissatisfaction.

Additionally, any invasive procedure like catheter-based interventions is expected to carry a risk of infection in aducts, and decreased oxygen levels, and irregular heart rhythms in children. Infections can occur at the insertion site or, in some cases, within the heart itself further leading to serious complications. Infection can prolong hospital stays, necessitate antibiotic treatments, and potentially lead to sepsis, a life-threatening condition.

Segment Analysis

The global congenital heart defect devices market is segmented based on defect type, device type, end-user, and region.

The Catheters Segment Accounted for Approximately 29.4% of the Congenital Heart Defect Devices Market Share

The catheters segment is expected to hold the largest market share over the forecast period. There are continuous advancements in catheters, including the development of smaller, more flexible catheters and improved imaging techniques, which have expanded the range of congenital heart defects that can be treated using these catheters. These advancements in catheters provide more efficient results within short time.

For instance, on September 8, 2022, Biosense Webster, Inc., part of Johnson & Johnson MedTech, announced the release of the OCTARAY Mapping Catheter with TRUEref Technology powered by the CARTO 3 Version 7 System. The OCTARAY Mapping Catheter was developed for the mapping of cardiac arrhythmias, including atrial fibrillation (AFib). The catheter has eight splines with improved electrode spacing options to provide shorter and more efficient mapping times than PENTARAY NAV ECO Mapping Catheter, which may shorten overall ablation procedure times.

Furthermore, these catheter-based procedures offers minimally invasive procedures compared to other devices. This less invasive approach of catheters reduces trauma, shortens recovery times, and minimizes the risk of complications associated with congenital heart defects. This is especially important for pediatric patients suffering from congenital heart defects. Catheter procedures generally carry fewer surgical risks than other devices. There is no need for a sternotomy (chest incision), which can lead to complications like infection or scarring.

For instance, on February 2, 2023, Abbott announced two approvals as part of its growing suite of electrophysiology products in the global market. The company's TactiFlex Ablation Catheter, Sensor Enabled, the world's only ablation catheter with a flexible tip and contact force sensing, received CE Mark for treating people with abnormal heart rhythms like atrial fibrillation (AFib). Abbott's FlexAbility Ablation Catheter, Sensor Enabled also recently secured an expanded indication for treating patients with a complex heart condition by the U.S. Food and Drug Administration.

Geographical Penetration

North America Accounted for Approximately 39.7% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Advanced Healthcare Infrastructure

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare infrastructure. North America is well-known for the strong presence of major players in the region including many pharmaceutical companies and medical device companies. The presence of major players in the region helps to perform the clinical trials and research activities very actively, which helps for the development of advanced devices for congenital heart defects.

Moreover, the region is also very well-known for its advanced and well-established healthcare infrastructure including hospitals, specialty clinics, research and academic centers, and others. This advanced healthcare infrastructure helps patients seek better treatment by choosing advanced and well-suitable devices. Many hospitals in the region is very well-known for their better implantation techniques.

For instance, on May 18, 2022, Children's Hospital Colorado (Children's Colorado) was the first hospital in the world to implant the newly FDA-approved G-Armor Stent. Although the stent is designed to be used in the smallest of patients, it was first implanted in a Colorado father of two. The stent was developed by interventional cardiologist, Gareth Morgan, MD, who oversees the Interventional Congenital Cardiology program at Children's Colorado in conjunction with NuMed for Children.

Competitive Landscape

The major global players in the congenital heart defect devices market include: Lepu Medical Technology Co., Ltd., Abbott Laboratories, Becton, Dickinson and Company, Medtronic, Boston Scientific Corporation, Biotronik, Edwards Lifesciences Corporation., OSYPKA MEDICAL, ABIOMED., and MEDICO S.R.L. among others.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical industries worldwide, including the global congenital heart defect devices market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic treatment and its related restrictions.

The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular check-ups, appointments, device implantations, and consultations worldwide. Many hospitals are focused on COVID-19 cases, this reduced the device implantation in many patients suffering from congenital heart defects.

Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials and medical devices. Movement restrictions and border closures delayed shipments and caused device transportation delays. Additionally, some countries faced shortages of congenital heart defect devices for treatment due to disruptions in their supply chain networks.

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global congenital heart defect devices market. The conflict has less impact mainly due to the low prevalence and absence of key market players in this region. Moreover, the impact of the import and export of raw materials and medical devices is expected to have little influence over the global congenital heart defect devices market growth over the forecast period.

By Defect Type

Atrial Septal Defect
Ventricular Septal Defect
Atrioventricular Septal Defect
Tricuspid Atresia
Truncus Arteriosus
Others

By Device Type

Catheters
Pacemakers
- Single Chamber Pacemaker
- Dual Chamber Pacemaker
- Biventricular Pacemaker
- Leadless Pacemaker

Implantable Cardioverter Defibrillators
Biventricular Devices
Implanted Cardiac Loop Recorders
Others

By End-User

Hospitals
Specialty Clinics
Academic and Research Institutes
Others

By Region

North America
- U.S.
- Canada
- Mexico

Europe
- Germany
- U.K.
- France
- Spain
- Italy
- 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 May 31, 2023, BrightHeart, a Paris-based medical technology company developing unique artificial intelligence software focused on improving the detection of congenital heart defects in fetuses, announced that it has raised €2 million in seed financing from Sofinnova Partners, a leading European life sciences venture capital firm based in Paris, London, and Milan. The funds are being deployed to bolster the development of the BrightHeart technology devices, prepare its regulatory submission, and facilitate the company's expansion.
On February 28, 2023, Eko, a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease, announced the launch of the SENSORA Cardiac Disease Detection Platform. SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system.
On September 07, 2022, Abbott announced that it launched its Amplatzer Talisman patent foramen ovale (PFO) occlusion system in Europe. PFO is a hole in the heart that doesn't close following birth. The company designed the Amplatzer Talisman to treat people with PFO who experienced a stroke and are at risk of having another.
On March 26, 2021, the U.S. Food and Drug Administration (FDA) approved the Harmony Transcatheter Pulmonary Valve (TPV) as the world's first nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). The device is designed for patients who have severe pulmonary valve regurgitation and is intended to both delay and reduce the number of required lifetime open-heart surgeries by improving blood flow to the lungs.

Why Purchase the Report?

To visualize the global congenital heart defect devices market segmentation based on defect type, device type, 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 congenital heart defect 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 congenital heart defect 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 Defect Type
3.2. Snippet by Device Type
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. Increasing Adoption of Minimally Invasive Procedures
  - 4.1.1.2. Increasing Clinical Trials
- 4.1.2. Restraints
  - 4.1.2.1. Complications Associated with the Devices
- 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 Conflict 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 the Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Defect Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Defect Type
- 7.1.2. Market Attractiveness Index, By Defect Type
7.2. Atrial Septal Defect *
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Ventricular Septal Defect
7.4. Atrioventricular Septal Defect
7.5. Tricuspid Atresia
7.6. Truncus Arteriosus
7.7. Others

8. By Device Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 8.1.2. Market Attractiveness Index, By Device Type
8.2. Catheters *
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Pacemakers
- 8.3.1. Single Chamber Pacemaker
- 8.3.2. Dual Chamber Pacemaker
- 8.3.3. Biventricular Pacemaker
- 8.3.4. Leadless Pacemaker
8.4. Implantable Cardioverter Defibrillators
8.5. Biventricular Devices
8.6. Implanted Cardiac Loop Recorders
8.7. Others

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. Academic and Research Institutes
9.5. 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 Defect Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 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 Defect Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 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. 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 Defect Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 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 Defect Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 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 Defect Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 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. Lepu Medical Technology Co., Ltd.*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Abbott Laboratories
12.3. Becton, Dickinson and Company
12.4. Medtronic
12.5. Boston Scientific Corporation
12.6. Biotronik
12.7. Edwards Lifesciences Corporation.
12.8. OSYPKA MEDICAL
12.9. ABIOMED.
12.10. MEDICO S.R.L.

LIST NOT EXHAUSTIVE