市場調査レポート
商品コード
1345407
先天性心疾患デバイスの世界市場-2023年~2030年Global Congenital Heart Defect Devices Market - 2023-2030 |
● お客様のご希望に応じて、既存データの加工や未掲載情報(例:国別セグメント)の追加などの対応が可能です。 詳細はお問い合わせください。
先天性心疾患デバイスの世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 約2営業日
|
概要
世界の先天性心疾患デバイス市場は、2022年に28億米ドルに達し、2023-2030年の予測期間中にCAGR 6.4%で成長し、2030年には46億米ドルに達すると予測されています。
世界の先天性心疾患デバイス市場は、出生時からの先天性心疾患の有病率の増加、臨床試験や研究活動の活発化など、そのダイナミクスに影響を与えるさまざまな要因によって、長年にわたって著しい成長と変貌を遂げてきました。より良い機器製造への政府投資は、世界市場を引き続き牽引し、押し上げると思われます。世界の先天性心疾患装置産業は、その影響を軽減することにますます重点を置いています。
人工ペースメーカー、植込み型除細動器、カテーテルなどの先天性心疾患デバイスは、徐脈、頻脈などの先天性心疾患の治療に最も一般的に使用されています。予測期間中、カテーテル分野が最大の市場シェアを占めると予想されます。同様に、北米が市場を独占しており、この地域の有利な償還政策、高度な医療インフラ、大手企業の存在によって最大の市場シェアを獲得しています。
先天性心疾患の有病率の増加、先進的デバイスの需要増加、認知度の向上、臨床試験の増加、低侵襲手技の採用増加、技術の歩などが、予測期間にわたって世界市場を牽引すると予想される主な要因です。
ダイナミクス
低侵襲手技の採用増加が先天性心疾患デバイス市場の成長を牽引すると期待される
低侵襲手技の採用が増加していることが、予測期間における市場の成長を促進すると予想されます。カテーテル、心臓閉塞器などの先天性心疾患デバイスは、患者をより良い方法で治療するために低侵襲処置を提供します。多くの先天性心疾患患者は、痛みの軽減、回復時間の短縮、傷跡の小ささなどの利点から、従来の開心術よりも低侵襲処置を好みます。このような嗜好は、特に小児先天性心疾患患者に強いです。
例えば、2023年2月22日、メドトロニック社は、先天性または外科的に修復された右室流出路(RVOT)を持つ先天性心疾患患者に対する開心術に代わる低侵襲手術であるハーモニー経カテーテル肺動脈弁(TPV)システムのリニューアルを発表しました。
さらに、低侵襲手術には感染症、出血、創傷治癒の問題などの合併症が予想されます。これは患者の安全性を向上させ、さらなる合併症を減らすことができます。これらの低侵襲手技は、特に小児患者にとって、多くの先天性心疾患を安全な方法で治療するための、より高い利点を提供します。
例えば、2021年6月15日、世界のヘルスケア企業であるアボット社は、インドでAmplatzer Piccolo Occluderを発売しました。この医療機器は、動脈管開存症(先天性心疾患)やPDAを治療するために、低侵襲手技を用いて最も小さな乳児(体重700g程度)に移植できる世界初の医療機器です。Amplatzer Piccoloは、小豆よりもさらに小さな装置で、現在、矯正治療を必要とする未熟児や新生児に希望を与えており、薬に反応せず、矯正手術を受けるリスクが高い可能性があります。
臨床試験の増加も先天性心疾患デバイス市場の成長を促進すると予想される
先進的な先天性心疾患デバイスの臨床試験の増加も、予測期間中の市場成長を促進すると予想されます。臨床試験は、先天性心疾患の治療用に設計された新しいデバイスの安全性と有効性を試験・検証するためのプラットフォームを提供します。臨床試験の肯定的な結果は、規制当局の承認や市場イントロダクションつながり、成長を促進します。
例えば、2021年7月8日、ゼルティスは合成修復肺動脈弁の史上初のピボタル試験を開始したと発表しました。現在までに、右室流出路(RVOT)再建術を必要とする小児患者が、FDA承認の世界なXplore2/Pivotal試験の一環として移植に成功しています。右室流出路再建術は、特定の先天性心疾患を修正するために必要な処置です。
さらに、臨床試験は、先天性心疾患デバイスの性能に関する科学的証拠も生成します。このエビデンスは、医療提供者が治療を決定する際に極めて重要であり、これらのデバイスの採用拡大につながる可能性があります。臨床試験はまた、装置の安全性と有効性を評価することによって、患者の転帰を改善することも目的としています。肯定的な結果が得られれば、より良い治療法の選択肢につながり、これらの機器を使用することでより良い治療を求める患者が増えることになります。
機器に関連する合併症が市場の成長を妨げると予想される
先天性心疾患デバイスに関連する合併症は、市場の成長を妨げると予想されます。カテーテル、ペースメーカー、ステント、弁、閉塞器など、CHDに使用されるデバイスに関連する誤作動や技術的な不具合は、深刻なリスクをもたらす可能性があります。器具の不具合は、修正するために追加の介入や手術を必要とする場合があり、医療費の増加や患者の不満につながるその他のリスクにつながる可能性があります。
さらに、カテーテルを使用したインターベンションのような侵襲的な処置は、付加物における感染、酸素レベルの低下、小児における不整脈のリスクを伴うことが予想されます。感染症は挿入部位や、場合によっては心臓自体の内部で発生し、さらに深刻な合併症を引き起こすこともあります。感染症は入院期間を引き延ばし、抗生物質による治療を必要とさせ、生命を脅かす敗血症に至る可能性があります。
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.
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.
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.
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.
The global congenital heart defect devices market is segmented based on defect type, device type, end-user, and region.
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.
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.
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.
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.
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.
The global congenital heart defect devices market report would provide approximately 61 tables, 58 figures, and 186 Pages.
LIST NOT EXHAUSTIVE