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全球先天性心臟缺陷设备市场 - 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个工作天内

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简介目录

概述

全球先天性心臟缺陷设备市场在 2022 年达到 28 亿美元，预计到 2030 年将达到 46 亿美元，2023-2030 年预测期间复合年增长率为 6.4%。

多年来，全球先天性心脏病设备市场经历了显着的增长和转变，影响其动态的因素有多种，例如出生后先天性心脏病患病率不断增加、临床试验和研究活动不断增加等。政府对更好的设备製造的投资将继续推动和提振全球市场。全球先天性心脏病设备行业越来越重视减少其影响。

先天性心臟缺陷装置，例如人工起搏器、植入式心臟復律除颤器、导管等最常用于治疗先天性心臟缺陷，例如心动过缓、心动过速等。预计导管细分市场将在预测期内占据最大的市场份额。同样，北美在市场上占据主导地位，由于该地区有利的报销政策、先进的医疗基础设施和主要参与者的存在，占据了最大的市场份额。

由于先天性心臟缺陷的患病率不断增加，对先进设备的需求不断增加，意识不断增强，临床试验不断增加，微创手术的采用不断增加以及技术进步是预计在预测期内推动全球市场的主要因素。

动力学

越来越多地采用微创手术预计将推动先天性心臟缺陷设备市场的增长

微创手术的日益普及预计将在预测期内推动市场的增长。先天性心脏病装置，如导管、心臟封堵器和其他装置，提供微创手术，以更好的方式治疗患者。与传统的心臟直视手术相比，许多患有先天性心脏病的患者更喜欢微创手术，因为微创手术具有疼痛减轻时间短、恢復时间更快和疤痕更小的优点。对于患有先天性心脏病的儿科患者来说，这种偏好尤其强烈。

例如，2023 年2 月22 日，美敦力宣布重新推出Harmony 经导管肺动脉瓣(TPV) 系统，这是一种微创心臟直视手术替代方案，适用于患有天然或手术修復右心室流出道(RVOT ) 的先天性心脏病患者。

此外，微创手术预计会出现感染、出血和伤口癒合问题等并发症。这可以提高患者的安全并减少进一步的并发症。这些微创手术提供了更大的好处，特别是对于儿科患者来说，可以安全地治疗许多先天性心臟缺陷。

例如，2021 年6 月15 日，全球医疗保健公司雅培(Abbott) 在印度推出了Amplatzer Piccolo 封堵器，这是世界上第一个可以通过微创手术植入最小婴儿（体重仅700 克）体内的医疗设备治疗动脉导管未闭（先天性心脏病）或 PDA。 Amplatzer Piccolo 是一种比小豌豆还小的装置，现在为需要矫正治疗、可能对药物无反应且面临接受矫正手术高风险的早产儿和新生儿带来了希望。

临床试验的增加预计也将推动先天性心臟缺陷设备市场的增长

先进先天性心脏病设备的临床试验的增加预计也将在预测期内推动市场的增长。临床试验提供了一个平台来测试和验证用于治疗先天性心臟缺陷的新兴设备的安全性和有效性。积极的试验结果可以导致监管部门的批准和市场的引入，从而推动增长。

例如，2021 年 7 月 8 日，Xeltis 宣布已开始首次合成修復性肺动脉瓣关键试验。迄今为止，作为 FDA 批准的全球 Xplore2/Pivotal 研究的一部分，需要右心室流出道 (RVOT) 重建的儿科患者已成功植入。 RVOT 重建是纠正某些先天性心臟缺陷所需的手术。

此外，临床试验还产生了有关先天性心脏病设备性能的科学证据。这些证据对于医疗保健提供者在做出治疗决策时至关重要，这可能会导致这些设备的采用增加。临床试验还旨在通过评估设备的安全性和有效性来改善患者的治疗结果。积极的结果可以带来更好的治疗选择，吸引更多的患者通过使用这些设备来寻求更好的治疗。

与设备相关的并发症预计将阻碍市场的增长

与先天性心臟缺陷设备相关的并发症预计将阻碍市场的增长。与先心病中使用的设备（例如导管、起搏器、支架、瓣膜或封堵器）相关的故障或技术故障可能会带来严重风险。设备故障可能需要额外的干预或手术来纠正，这可能会导致医疗成本增加和其他导致患者不满意的风险。

此外，任何侵入性手术（例如基于导管的干预措施）预计都会带来导管感染、氧气水平降低以及儿童心律不齐的风险。感染可能发生在插入部位，或者在某些情况下发生在心臟本身，进一步导致严重的并发症。感染会延长住院时间，需要抗生素治疗，并可能导致败血症（一种危及生命的疾病）。

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