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市場調査レポート
商品コード
1384882
リードレスペースメーカーの世界市場規模、シェア、産業動向分析レポート:タイプ別、最終用途別、地域別展望と予測、2023年~2030年Global Leadless Pacemakers Market Size, Share & Industry Trends Analysis Report By Type (Micra Transcatheter Pacing System, and Others), By End-use (Hospitals, and Outpatient Facilities), By Regional Outlook and Forecast, 2023 - 2030 |
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リードレスペースメーカーの世界市場規模、シェア、産業動向分析レポート:タイプ別、最終用途別、地域別展望と予測、2023年~2030年 |
出版日: 2023年10月31日
発行: KBV Research
ページ情報: 英文 199 Pages
納期: 即納可能
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リードレスペースメーカー市場規模は2030年までに8億2,770万米ドルに達すると予測され、予測期間中のCAGRは15.2%の市場成長率で上昇する見込みです。
KBV Cardinalのマトリックスに掲載された分析によると、Medtronic PLCとAbbott Laboratoriesが同市場の先行企業です。ボストン・サイエンティフィック・コーポレーション、インテガー・ホールディングス・コーポレーション、テルモ・コーポレーションなどの企業は、同市場における主要なイノベーターです。2023年9月、ボストン・サイエンティフィック・コーポレーションは、脊椎性疼痛治療に特化した非上場の医療機器会社であるリリーバント・メドシステムズ社の買収を発表しました。この買収により、Relievant Medsystemsの臨床的裏付けのある技術とボストン・サイエンティフィックの戦略が統合され、個別化医療を必要とする個人の治療選択肢が拡大します。
COVID-19の影響
パンデミックの間、多くの病院やヘルスケア施設は、リソースを確保し、ウイルス感染のリスクを減らすために、選択的処置を延期または中止しました。このため、リードレスペースメーカーの植え込みは、多くの場合、選択的で緊急性のない処置とみなされるため、減少しました。リードレスペースメーカーを含む医療機器の世界サプライチェーンは、製造や輸送のロックダウンや制限により混乱に見舞われました。このため、医療機器の供給が遅れ、患者がこれらの先端技術を利用することができなくなる可能性があっています。ヘルスケア・プロバイダーは、COVID-19症例の急増に対応するため、リソースとスタッフを振り向けた。このようにCOVID以外の医療サービスから注目と資源が転用されたことは、リードレスペースメーカーの普及と植え込みに影響を与えました。
市場成長要因
低侵襲手術への需要の高まり
低侵襲手術の開発により、リードの留置や外科的切開の必要性が減少し、手術リスクが低下し、患者の快適性が向上しました。この侵襲性の低減は、患者の安全性の向上だけでなく、回復時間の短縮にもつながっています。リードレスペースメーカー植え込み術を受けた患者は、より短い入院期間と術後の不快感の軽減を経験しています。この迅速な回復により、患者は日常生活や活動に迅速に戻ることができます。これらの処置は、医療施設へのアクセスが制限されているような遠隔地や地方のヘルスケア環境に新たな可能性をもたらしています。その結果、低侵襲手技に対する需要が急速に高まっており、市場の拡大を後押ししています。
心臓不整脈の有病率の上昇
心不整脈の有病率の上昇は、人口動態の変化からライフスタイルの選択、ヘルスケアの進歩に至るまで、複数の要因が複雑に絡み合っています。高血圧は不整脈の確立された危険因子です。高血圧は心臓の構造や電気的シグナル伝達に変化をもたらし、不整脈の可能性を高める。同様に、糖尿病は不整脈、特に心房細動のリスクの増加と関連しています。さらに、不整脈の有病率は特定の年齢層に限定されるものではなく、さまざまな層の個人に影響を及ぼします。高齢者から若年者まで、不整脈を経験するすべての年齢層の患者がこれらの装置の恩恵を受けることができます。したがって、不整脈の有病率の増加がリードレスペースメーカーの需要を押し上げています。
市場抑制要因
規制と償還の課題
医療機器の複雑で長い承認プロセスなどの規制上の課題は、リードレスペースメーカーのイントロダクションを大幅に遅らせる可能性があります。規制機関は安全性と有効性の徹底的な評価を要求するため、製品認可までの期間が長期化します。規制当局の承認が遅れると、患者が先進的な医療ソリューションを利用できなくなるだけでなく、メーカーにとっては市場投入までの時間が長くなり、最先端機器を提供する能力に影響を与えることになります。これらのデバイスの経済的負担は、その潜在的な利点にもかかわらず、ヘルスケアプロバイダーと患者の両方がペーシングソリューションとしてリードレスペースメーカーを選択することを躊躇させる可能性があります。このような経済的負担は、特に、より費用対効果の高い代替医療が利用可能である場合には、これらの機器を選択することを躊躇させる可能性があります。これらすべての要因が市場の成長を妨げる可能性があります。
タイプ別展望
タイプ別に見ると、市場はマイクラ経カテーテルペーシングシステムとその他に二分されます。その他のセグメントは、2022年の市場でかなりの成長率を確保しました。ナノスティムやWiSE CRTシステムなどのデバイスを含むリードレスペースメーカーは、従来のリード付きペースメーカーと比較していくつかの利点があります。Nanostimは非常にコンパクトで、大きめのビタミン・カプセルに近いサイズです。この小ささにより、侵襲の少ない処置が可能となり、より控えめで快適な植え込みが実現します。WiSE CRTシステムは、心不全の治療法である心臓再同期療法用に設計されています。従来のペーシングリードを必要とせず、心臓再同期の利点を提供します。ナノスティムとWiSE CRTシステムはいずれも、低侵襲の植え込み、コンパクトな設計、感染リスクの低減、美容上の利点、長持ちするバッテリー寿命などの大きな利点を提供します。
最終用途の展望
最終用途別では、市場は病院と外来患者に分けられます。病院セグメントは2022年に市場で最大の収益シェアを獲得しました。病院では、ペースメーカー移植専用の手術室や手術チームが必要ないため、リソースを効率的に割り当てることができます。これはコスト削減につながり、他の重要な医療処置にリソースを振り向けることができます。体外に出るリード線がないため、リード線挿入部位に関連する感染症のリスクは事実上排除されます。病院は、機器に関連した感染率の低下から利益を得ることができます。
地域別展望
地域別に見ると、市場は北米、欧州、アジア太平洋、LAMEAで分析されます。北米セグメントが2022年の市場で最大の収益シェアを占めています。北米では、リードレスペースメーカーの需要が着実に増加しています。これらの要因は、心臓ペーシング技術の進化と、心臓不整脈治療のための、より患者中心の、低侵襲で技術的に先進的な選択肢へのシフトを強調しています。リードレスペースメーカーは、感染症にかかりやすいリードを必要としないです。北米のように感染対策が優先される地域では、この機能が高く評価されています。
The Global Leadless Pacemakers Market size is expected to reach $827.7 million by 2030, rising at a market growth of 15.2% CAGR during the forecast period.
European patients and healthcare providers are increasingly valuing minimally invasive procedures. Thus, the European region would register nearly 28% share of the market by 2030. The catheter-based implantation of leadless pacemakers eliminates the need for surgical pockets and leads, reducing pain, scarring, and recovery time. Europe possesses a well-developed healthcare infrastructure with advanced medical facilities and resources. Many outpatient facilities as well as hospitals in this region are equipped to perform leadless pacemaker implantations and provide necessary follow-up care.
The major strategies followed by the market participants are Mergers & Acquisitionas the key developmental strategy to keep pace with the changing demands of end users. For instance, In August, 2022, Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution. Moreover, In April, 2023, Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.
Based on the Analysis presented in the KBV Cardinal matrix; Medtronic PLC and Abbott Laboratories are the forerunners in the Market. Companies such as Boston Scientific Corporation, Integer Holdings Corporation and Terumo Corporation are some of the key innovators in the Market. In September, 2023, Boston Scientific Corporation announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.
COVID-19 Impact
During the pandemic, many hospitals and healthcare facilities postponed or canceled elective procedures to free up resources and reduce the risk of virus transmission. This led to a decrease in leadless pacemaker implantations, as these procedures are often considered elective and non-urgent. The global supply chain for medical devices, including leadless pacemakers, experienced disruptions due to lockdowns and restrictions on manufacturing and transportation. This led to delays in the availability of devices and potentially impacted patients' access to these advanced technologies. Hospitals and healthcare providers redirected resources and staff to handle the surge of COVID-19 cases. This diversion of attention and resources from non-COVID medical services affected the promotion and implantation of leadless pacemakers.
Market Growth Factors
Growing demand for minimally invasive procedures
The development of minimally invasive procedures has decreased the need for lead placement and surgical incisions, lowering surgical risks and enhancing patient comfort. This reduction in invasiveness has not only translated into enhanced patient safety but also quicker recovery times. Patients undergoing leadless pacemaker implantation experience shorter hospital stays and reduced post-operative discomfort. This quick recovery benefits patients by allowing them to return to their daily routines and activities more swiftly. These procedures have opened up new possibilities for remote and rural healthcare settings, where access to healthcare facilities may be limited. As a result, the rapidly increasing demand for minimally invasive procedures will aid in the expansion of the market.
Rising prevalence of cardiac arrhythmias
The rising prevalence of cardiac arrhythmias is a complex interplay of multiple factors, from demographic changes to lifestyle choices and advances in healthcare. High blood pressure is a well-established risk factor for arrhythmias. It can lead to changes in the heart's structure and electrical signaling, increasing the likelihood of arrhythmias. Similarly, diabetes is associated with an increased risk of arrhythmias, particularly atrial fibrillation. Furthermore, the prevalence of arrhythmias is not limited to specific age groups; it affects individuals across various demographics. Patients of all ages who experience cardiac arrhythmias, from the elderly to younger individuals, can benefit from these devices. Therefore, the rising prevalence of arrhythmias is boosting the demand for leadless pacemakers.
Market Restraining Factors
Regulatory and reimbursement challenges
Regulatory challenges, such as the complex and lengthy approval process for medical devices, can significantly delay the introduction of leadless pacemakers. Regulatory agencies require thorough evaluations of safety and efficacy, leading to prolonged timeframes for product clearance. Delays in regulatory approval not only hinder patients' access to advanced medical solutions but also increase the time-to-market for manufacturers, impacting their ability to offer cutting-edge devices. The economic burden of these devices can deter both healthcare providers and patients from choosing leadless pacemakers as a pacing solution despite their potential benefits. Such financial burdens may discourage some individuals from opting for these devices, especially if more cost-effective alternatives are available. All these factors may hamper the growth of the market.
Type Outlook
Based on type, the market is bifurcated into micra transcatheter pacing system and others. The other segment procured a considerable growth rate in the market in 2022. Leadless pacemakers, including devices like Nanostim and WiSE CRT System, offer several benefits compared to traditional pacemakers with leads. Nanostim is remarkably compact, similar in size to a large vitamin capsule. This small size allows for a less invasive procedure and results in a more unobtrusive and comfortable implantation. The WiSE CRT System is designed for cardiac resynchronization therapy, a treatment for heart failure. It offers the benefits of cardiac resynchronization without the need for traditional pacing leads. Both Nanostim and the WiSE CRT System provide significant advantages, such as minimally invasive implantation, compact designs, reduced infection risk, cosmetic benefits, and long-lasting battery life.
End-use Outlook
On the basis of end-use, the market is divided into hospitals and outpatient facilities. The hospitals segment acquired the largest revenue share in the market in 2022. Hospitals can efficiently allocate resources, as there is no need for specialized surgical suites or surgical teams dedicated to pacemaker implantations. This can lead to cost savings and the reallocation of resources to other critical medical procedures. With no leads that exit the body, the risk of infections related to lead entry sites is virtually eliminated. Hospitals can benefit from reduced rates of device-related infections.
Regional Outlook
Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment witnessed the maximum revenue share in the market in 2022. The demand for leadless pacemakers is steadily increasing in North America due to several factors contributing to their growing adoption in the region. These factors highlight the evolving landscape of cardiac pacing technology and the shift towards more patient-centric, minimally invasive, and technologically advanced options for treating cardiac arrhythmias. Leadless pacemakers eliminate the need for leads that can be susceptible to infection. In regions like North America, where infection control is a priority, this feature is highly valued.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Medtronic PLC, Abbott Laboratories, Boston Scientific Corporation, Biotronik SE & Co. KG, Lepu Medical Technology Co., Ltd, Integer Holdings Corporation, MicroPort Scientific Corporation, Osypka AG, Terumo Corporation, and EBR Systems, Inc.
Strategies Deployed in Leadless Pacemakers Market
Partnerships, Collaborations, and Agreements:
Jul-2022: Medtronic plc has formed a strategic partnership with CathWorks, a privately held company headquartered in Kefar Sava, Israel, investing up to $75 million and co-promoting the FFRangio System globally. The agreement included an option for Medtronic to acquire CathWorks based on milestones, with CathWorks having the right to compel the acquisition if Medtronic opts out.
Sep-2021: Terumo Cardiovascular partnered with Etiometry to provide enhanced monitoring insights for adult cardiac surgery patients. This collaboration expanded technologies and enabled the utilization of clinical-decision support tools throughout a patient's hospital stay, offering a more comprehensive view of critical data for improved and informed bedside decisions during the transition from the operating room to the ICU.
Product Launches and Product Expansions:
Feb-2022: Abbott Laboratories has revealed the world's first patient implants of a dual-chamber leadless pacemaker system in its AVEIR DR i2i™ pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker marks a notable technological milestone in leadless pacing, representing the first such occurrence globally within the pivotal trial.
Jan-2022: Medtronic received regulatory approval and launched the Micra AV Transcatheter Pacing System in Japan. This pacemaker was designed to treat patients with AV block, addressing impaired electrical signals between the heart's chambers. The Micra TPS is the world's first leadless pacemaker, with the initial version (Micra VR) approved in Japan in 2017 for patients requiring single-chamber pacing.
Jun-2021: Medtronic PLC has introduced the MICRA AV, a pacemaker smaller than conventional ones, offering a leadless and minimally invasive solution for patients with complete heart block. This innovation, following Medtronic's legacy of inventing and disrupting, provides a cosmetically invisible option for those in need.
Acquisition and Mergers:
Sep-2023: Boston Scientific Corporation has announced the acquisition of Relievant Medsystems, Inc., a privately held medical device company specializing in vertebrogenic pain treatment. This acquisition enables the integration of Relievant Medsystems' clinically backed technology with Boston Scientific's strategies, expanding treatment options for individuals in need of personalized care.
Apr-2023: Abbott Laboratories completed the acquisition of Cardiovascular Systems, Inc. (CSI), a medical device company known for its innovative atherectomy system in the treatment of peripheral and coronary artery disease. This acquisition enhances Abbott's offerings for vascular disease treatment, incorporating CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow.
Aug-2022: Medtronic plc completed the acquisition of Affera, Inc., expanding its cardiac ablation portfolio with the addition of a groundbreaking cardiac mapping and navigation platform, featuring a fully integrated diagnostic, focal pulsed field, and radiofrequency ablation solution.
May-2022: Medtronic PLC completed the acquisition of Intersect ENT, integrating PROPEL and SINUVA into its portfolio. PROPEL implants, maintaining sinus patency and delivering steroids, and SINUVA implants, treating nasal polyps in ethmoid sinus surgery patients, are now part of Medtronic's offerings.
Feb-2022: Boston Scientific has completed the acquisition of Baylis Medical Company Inc. This integration enables Boston Scientific to incorporate Baylis platforms into its existing electrophysiology and structural heart offerings, reinforcing its position in the rapidly growing cardiology markets.
Sep-2021: Boston Scientific Corporation completed the acquisition of Devoro Medical, Inc., a developer of a medical device intended to restore blood flow. Through this acquisition, the WOLF Thrombectomy Platform was integrated into Boston Scientific's products. Additionally, this acquisition provided the physicians with the necessary tools needed for the treatment.
Trials and Approval:
Dec-2022: Biotronik SE & Co. KG has initiated the first patient enrollment in BIO-CONDUCT, an FDA-approved investigational device exemption (IDE) trial. The study examines the use of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area, a location not currently approved for the Solia S lead.
Dec2021: Boston Scientific Corporation has started the MODULAR ATP clinical trial to assess the mCRM Modular Therapy System, which includes the EMBLEM™ MRI S-ICD System and the EMPOWER™ MPS, aiming to be the first leadless pacemaker capable of delivering bradycardia pacing support and antitachycardia pacing (ATP).
Market Segments covered in the Report:
By Type
By End-use
By Geography
Companies Profiled
Unique Offerings from KBV Research