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市場調査レポート
商品コード
1374809
心臓植込み型電子デバイスの世界市場 - 2023年~2030年Global Cardiac Implantable Electronic Devices Market -2023-2030 |
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カスタマイズ可能
適宜更新あり
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心臓植込み型電子デバイスの世界市場 - 2023年~2030年 |
出版日: 2023年11月01日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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不整脈とは、心拍の速さやリズムに異常があることをいいます。心臓の拍動は速すぎたり遅すぎたり、あるいは奇妙なリズムをとったりします。運動時には心拍数が上がり、リラックスしている時や休息時には心拍数が下がるのが一般的です。心臓植込み型電子デバイス(CIED)は、さまざまな心臓疾患の治療に使用されるバッテリー駆動の医療機器であり、永久ペースメーカー(PPM)、自動植込み型除細動器(AICD)、心臓再同期療法機器(CRT)などがあります。
CIEDは不整脈の監視と管理(PPM、AICD、CRT)、収縮機能の強化(CRT)に利用されています。現在、世界中で年間140万台の心臓植込み型電子デバイス(CIED)が植え込まれていると評価されています。米国心臓病学会によると、米国では年間約20万個のペースメーカーが徐脈患者に植え込まれています。
不整脈を含む心血管系疾患の症例の増加、製品認可の増加、研究活動による好結果、M&Aを含む市場開拓、製品導入、その他の要因の中でも特に意識の高まりが、予測期間中の世界の心臓植込み型電子デバイス市場の成長を後押しすると予想されます。さらに、新製品の発売や技術の進歩も、予測期間における世界市場の成長に貢献すると期待されています。
明確な規制機関からの心臓植込み型電子デバイス認可の増加は、予測期間中の世界市場の成長を後押しすると予想されます。例えば、2023年5月、世界の心臓血管バイオメディカル研究・技術企業であるBiotronik社は、左束ペーシング用に認可された世界最先端のペースメーカーおよび(心臓再同期療法ペースメーカー)CRT-P心臓植込み型電子デバイスラインのCE(Conformite Europeenne)認可を取得しました。
さらに、2022年1月には、医療機器の設計、心臓植込み型電子デバイスの開発、販売、商業化を行う医療技術企業であるメドトロニックが、マイクラAV経カテーテルペーシングシステム(TPS)の商業化および払い戻しに関する厚生労働省の認可を取得しました。今回の承認により、世界で最も小型のペースメーカーであるマイクラTPSを装着できる患者が、世界で最も広い市場の一つである日本で拡大することになります。マイクラAVは、心臓の部屋(心房と心室)間の電気信号が変形した状態である房室ブロックの患者の治療に提案されます。
不整脈を含む心血管疾患の症例が増加していることから、予測期間中に心臓植込み型電子デバイスの需要が高まると予想されます。例えば、2020年に発表されたNIHの研究によると、心房細動の世界の優勢は約375億7,400万症例(世界人口の0.51%)であり、過去20年間に再び33%増加しました。心房細動の負荷が最も高いのは社会人口統計指数の高い国であるが、現在の増加は社会人口統計指数の中間の国で起こっています。
心房細動は非常に典型的な不整脈です。米国では2050年までに600万~1,200万人、欧州では2060年までに1,790万人が心房細動に罹患すると予測されています。心房細動は虚血性脳卒中の重大な脅威であり、相当な罹患率と死亡率とともに重大な経済的負担を引き起こします。
ここでもNIHによれば、不整脈の大部分は広く人口に占める割合は1.5%から5%と予想されており、中でも心房細動は非常に期待されています。さらに、British Heart Foundation UK Factsheet 2023によれば、英国では150万人以上が心房細動と診断されているが、そのうちの相当数は効果的な治療を受けていないです。英国では、65歳以上の未診断(または無症候性)の心房細動患者が少なくとも27万人いると評価されています。
患者の健康安全への懸念から、心臓植込み型電子デバイスの市場からのリコールは、予測期間中の世界市場の成長を妨げると予想されます。例えば、2021年4月、米国食品医薬品局(FDA)は、Medtronic社が、必要なときに高電圧治療を提供する能力に持続的な問題があるため、約35万個の植込み型心臓デバイスをリコールしたと宣言しました。
FDAの発表によれば、エネルギーが低下したショック、あるいは全くショックを与えないショックは、生命を脅かす不整脈を修正できない可能性があり、心停止、その他の重傷、死につながる可能性があります。さらに、これらのデバイスを装着した人が、デバイスの取り外しや交換のために追加の外科的プロセスを必要とする場合、傷害の他の脅威があります。リコールの対象となった心臓植込み型電子デバイスは、Cobalt XT、Cobalt、Crome ICDおよびCRT-D、Claria MRI、Amplia MRI、Compia MRI、Viva、Brava CRT-D、Visia AF、Visia AF MRI、Evera、Evera MRI、Primo MRI、Mirro MRI ICDです。
デバイスやインプラント手術のコストが高いことが、予測期間中の世界市場の成長を妨げると予想されます。例えば、ペースメーカーのコストは通常1万9,000米ドルから9万6,000米ドルです。この費用には、植え込み費用、X線検査、または処置の前後に必要となる可能性のあるその他の画像検査費用、フォローアップのための訪問、および完了する必要のある調整も含まれると予想されます。
さらに、保険が適用されない場合、その費用はおよそ2万米ドルから10万米ドルにもなります。保険が適用されない場合、ペースメーカーと心臓補助装置の埋め込みには、ペースメーカーの種類、部位、入院期間にもよるが、約1万9,000米ドルから9万6,000米ドル以上の費用がかかります。したがって、高額な費用のために、低所得者の大半はインプラント手術を受けることができず、予測期間の市場成長を鈍化させています。
An arrhythmia, or uneven heartbeat, is a trouble with the rate or rhythm of the heartbeat. The heart may beat too fast, too slow, or with an odd rhythm. It is typical for the heart rate to race up in physical exercise and to slow down while relaxing or resting. Cardiac implantable electronic devices (CIEDs) are battery-powered medical devices employed for the treatment of a variety of cardiac conditions these devices include permanent pacemakers (PPMs), automated implantable cardioverter defibrillators (AICDs), and cardiac resynchronization therapy devices (CRTs).
CIEDs are utilized to monitor and manage arrhythmias (PPMs, AICDs, CRTs) and enhance systolic function (CRTs). Presently, it is assessed that up to 1.4 million cardiac implantable electronic devices (CIED) are implanted worldwide annually. According to the American College of Cardiology, roughly 200,000 pacemakers are implanted in the United States in individuals with bradycardic annually.
The growing cases of cardiovascular diseases including arrhythmias, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global cardiac implantable electronic devices market growth in the forecast period. Further, the new product launches and technological advancements also expected to contribute to the global market growth in the forecast period.
The increasing cardiac implantable electronic devices authorizations from distinct regulatory bodies are expected to boost the global market growth during the forecast period. For instance, in May 2023, Biotronik, a global cardiovascular biomedical research and technology corporation, obtained CE (Conformite Europeenne) clearance for the World's foremost pacemaker and (cardiac resynchronization therapy-pacemaker) CRT-P Cardiac Implantable Electronic Devices line authorized for left bundle branch pacing.
Moreover, in January 2022, Medtronic, a medical technology corporation involved in the designing, cardiac implantable electronic devicesion, distribution, and commercialization of device-based medical treatments, obtained Japan's Ministry of Health, Labor, and Welfare authorization for the commercialization and repayment of the Micra AV Transcatheter Pacing System (TPS). This authorization extends the number of patients in Japan, one of the most extensive markets in the globe, who are suitable to obtain the Micra TPS, the globe's tiniest pacemaker. The Micra AV is suggested to treat patients with AV block, a state in which the electrical signals between the chambers of the heart (the atria and the ventricle) are deformed.
The growing cases of cardiovascular diseases including cardiac arrhythmias are expected to boost the demand for cardiac implantable electronic devices in the forecast period. For instnace, according to the NIH study published in 2020, the global preponderance of atrial fibrillation was around 37,574 million cases (0.51% of the global inhabitants), which grew again by 33% in the last two decades. The most elevated load is witnessed in nations with high socio-demographic index, though the most extensive current gain transpired in middle socio-demographic index nations.
Atrial fibrillation is a highly typical cardiac arrhythmia. It has been assessed that around 6-12 million individuals globally are expected to suffer from this disorder in the US by 2050 and 17.9 million individuals in Europe by 2060. Atrial fibrillation is a significant threat element for ischemic stroke and evokes a critical economic load along with substantial morbidity and mortality.
Again, according to the NIH, the preponderance of arrhythmias is anticipated to be 1.5% to 5% in the widespread population, with atrial fibrillation being highly expected. Further, according to the British Heart Foundation UK Factsheet 2023, over 1.5 million people in the UK have been diagnosed with atrial fibrillation, but a substantial number of them are not treated effectively. It is assessed that there are at the minimum 270,000 individuals aged above 65 with undiagnosed (or silent) atrial fibrillation in the UK.
The cardiac implantable electronic devices recalls from the market owing to patient health safety concerns are expected to hamper the global market growth during the forecast period. For instance, in April 2021, the U.S. Food and Drug Administration (FDA) declared that Medtronic recalled almost 350,000 implantable cardiac devices owing to persistent problems with their capability to deliver high-voltage therapy when required.
According to the FDA declaration, a reduced-energy shock, or no shock at all, may fail to fix a life-threatening arrhythmia, which can lead to cardiac arrest, other severe injury, or death. Moreover, there are other threats of injury if an individual with one of these devices requires additional surgical processes to remove and replace the device. Specific cardiac implantable electronic devices included in the recall were the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.
The high cost of devices and implant procedures is expected to hamper the global market growth during the forecast period. For instance, the pacemaker's costs typically range from $19,000 to $96,000. The expense is also expected to include implantation costs, X-rays, or other imaging tests expenses that might be required before and post the procedure, and the follow-up visit and any adjustments that are required to be completed.
Moreover, the cost can differ anywhere from approximately $20,000 and $100,000, without insurance. For individuals without any insurance coverage, a pacemaker and heart-assist implant can cost around $19,000-$96,000 or above, depending on the kind of pacemaker, the site, and the span of the hospital stay. Thus, owing to the high costs majority of low earning population is unable to undergo implant procedure slowing the market growth in the forecast period.
The global cardiac implantable electronic devices market is segmented based on product, indication, end-user and region.
Owing to the increase in cardiac implantable electronic devices launches and approvals the Implantable cardioverter-defibrillators (ICDs) segment is estimated to hold the majority of the global market share in the forecast period. For instance, in October 2020, Abbott introduced its unique ICD and CRT-D in India, thus expanding its cardiac implantable electronic devices line in the nation. The corporation even obtained CE Mark clearance for its Gallant ICD and CRT-D devices in February 2020.
Moreover, in August 2022, Medtronic plc introduced an investigational extravascular implantable cardioverter defibrillator (EV ICD) system defibrillator with the tip positioned under the breastbone, beyond the heart and veins attained a defibrillation success rate of 98.7%, and satisfied its safety endpoints in global clinical investigations.
Further, in February 2023, Medtronic plc, obtained CE (Conformite Europeenne) Mark for its Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for the treatment of dangerously rapid cardiac beats that can direct to premature cardiac arrest. The Aurora EV-ICD system delivers the life-saving advantages of conventional ICDs while dodging specific threats as its lead (thin wire) is positioned outside the heart and veins.
Owing to the increasing cases of cardiovascular disease in North America the region is estimated to dominate the global market during the forecast period. For instance, according to the Centers for Disease Control and Prevention, in the US, approximately 805,000 individuals have heart attacks, and one individual dies every 33 seconds from cardiovascular disease yearly. Moreover, according to the Arrhythmia Alliance Atrial fibrillation impacts nearly 1 out of 50 Americans under the age of 65 and about 1 out of 10 Americans over age 65. The prevalence of ventricular arrhythmias differs widely.
Furthermore, the increase in initiatives to support better practices and awareness in individuals with atrial fibrillation is expected to boost the regional market growth in the forecast period. For instance, the North American Thrombosis Forum's Atrial Fibrillation Action Initiative recognizes multidisciplinary most promising approaches for stroke precluding atrial fibrillation (Afib). The task is to deliver a comprehensive yet straightforward consensus record concentrated on stroke and bleeding threat examination in individuals with Afib and anticoagulation choices and management. The organization intends for this practical record to function as a reference for the whole medical society concerned with the care of individuals with Afib: primary care, emergency medicine, pharmacy, and cardiovascular medicine.
The COVID-19 pandemic inflicted challenges to the standard management of access and delivery of health care worldwide. It promoted the adoption of telemedicine and digital health, establishing a fresh epoch in the management of CIED patients. Patient results could be enhanced with device-based intensive monitoring corresponding with standard in-clinic follow-up at periodic intervals.
The pandemic background encouraged the quest for alternative solutions for practical patient follow-up, like validation of digital technologies, data management techniques, implementation of predictive analytics, cybersecurity, growth of restricted forms of remote CIED programming, and reimbursement. However, the pandemic disturbed the planned implant procedures which were rescheduled or cancelled negatively influencing the global market during the pandemic.
The major global players in the market include: Abbott, Medtronic plc, Boston Scientific Corporation, Biotronic AG, Stryker, Microport Scientific Corporation, Koninklijke Philips N.V., Lepu Medical Technology (Beijing)Co.,Ltd., MEDICO S.R.L., and Vitatron among others.
The global cardiac implantable electronic devices market report would provide approximately 61 tables, 58 figures and 186 Pages.
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