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市場調査レポート
商品コード
1374800
生体吸収性血管スカフォールドの世界市場-2023年~2030年Global Bioresorbable Vascular Scaffolds 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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生体吸収性血管スカフォールドの世界市場-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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生体吸収性血管スカフォールドは、閉塞した動脈を開くために使用される新しいタイプのステントです。このステントは閉塞した動脈内で一時的な足場として機能し、治癒が完了するにつれてゆっくりと溶解します。このため、患者の体内に残留物が残ることはないです。
生体吸収性スキャフォールドは、他の技術を凌駕する潜在的な利点を提供する可能性があります。従来のステントに比べて優れた適合性と柔軟性があるため、組織バイオメカニクスの分布の変化が少なく、血管の形状が維持されます。金属ケージからの血管の解放」は、生理的血管運動、メカノトランスダクション、適応剪断応力、後期内腔獲得(永久ステントによる後期内腔損失とは対照的)、後期拡張性リモデリングの回復に役立ちます。
おそらく、生体吸収性血管スカフォールドの最も大きな利点は、患者の体内に一時的にしか存在しないことであろう。足場は3年かけて溶解し、血管が自然な状態に戻るのを助ける。したがって、生体吸収性血管足場は、これらのデバイスが適していると判断された患者にとって優れた選択肢となります。
生体吸収性血管スカフォールドは、冠動脈疾患(CAD)の治療において従来の金属製ステントに代わる有望な選択肢として浮上しています。CADの治療を希望する患者が増えるにつれ、ヘルスケアプロバイダーは従来の治療に伴うリスクや合併症を最小限に抑えつつ、より良い治療結果を提供できる革新的なソリューションを求めています。BVSの設計と製造工程は、技術の進歩により、これまで以上に信頼性と有効性が高まっています。
冠動脈疾患は、心臓に血液を供給する動脈(冠動脈と呼ばれる)の壁にプラークが蓄積することによって引き起こされます。プラークはコレステロールの沈着でできています。プラークが蓄積すると、時間の経過とともに動脈の内側が狭くなります。この過程はアテローム性動脈硬化と呼ばれます。
例えば、疾病管理予防センターが更新したファクトシート2023によると、冠動脈性心疾患は最も一般的な心臓病のタイプであり、2021年には375,476人が死亡しました。2021年には、CADによる死亡者の約10人に2人が65歳未満の成人です。
さらに、世界の生体吸収性血管足場市場は、新技術の進歩、低侵襲処置の採用の増加、新興市場での新製品発売、老人人口の増加、予測期間中に市場をさらに牽引するであろう規制承認の増加など、他の様々な要因によって牽引されています。
限定的な臨床エビデンス生体吸収性スキャフォールド市場は、限定的な長期臨床エビデンスという課題に直面しています。従来のステントと比較した生体吸収性足場インプラントの治療成績は、その有効性と安全性を決定的に立証するためにさらなる評価が必要です。もう一つの問題は複雑な製造工程であり、生体吸収性スキャフォールドの複雑な製造工程はコスト上昇の一因となっています。
A bioresorbable vascular scaffold is a newer type of stent used to open up a blocked artery. This stent acts as a temporary scaffold in a blocked artery and slowly dissolves over time as healing completes. This way, no residue gets left in the patient's body.
Bioresorbable scaffolds may offer potential advantages over other technologies. Their superior conformability and flexibility compared with conventional stents reduce altered distribution of the tissue biomechanics and preserve vessel geometry. The 'liberation of the vessel from a metallic cage' can help in the restoration of physiological vasomotion, mechanotransduction, adaptive shear stress, late luminal gain (as opposed to late luminal loss with permanent stents), and late expansive remodelling.
Perhaps, the most significant advantage of bioresorbable vascular scaffolds is that their presence in the patient's body is only temporary. They dissolve over three years and help the vessel return to its natural state. Thus, bioresorbable vascular scaffolds are an excellent option for patients deemed fit for these devices.
Bioresorbable vascular scaffolds have emerged as a promising alternative to traditional metallic stents in the treatment of coronary artery disease (CAD). As more patients seek treatment for CAD, healthcare providers look for innovative solutions that can provide better outcomes while minimizing risks and complications associated with traditional treatments. BVS design and manufacturing processes are becoming more reliable and effective than ever before due to advancements in technology.
Coronary artery disease is caused by plaque buildup in the wall of the arteries that supply blood to the heart (called coronary arteries). Plaque is made up of cholesterol deposits. Plaque buildup causes the inside of the arteries to narrow over time. This process is called atherosclerosis
For instance, according to the Centers for Disease Control and Prevention updated factsheet 2023, coronary heart disease is the most common type of heart disease, killing 375,476 people in 2021. About 1 in 20 adults age 20 and older have CAD (about 5%).2 In 2021, about 2 in 10 deaths from CAD happen in adults less than 65 years old.
Furthermore, the global bioresorbable vascular scaffolds market is driven by various other factors like new technological advancements, a rise in the adoption of minimally invasive procedures, the launch of novel products in emerging markets, a rise in the geriatric population, an increase in regulatory approvals that will further drive the market during the forecast period.
Limited clinical evidence the bioresorbable scaffolds market faces a challenge in terms of limited long-term clinical evidence. The outcomes of bioresorbable scaffold implants compared to traditional stents need further evaluation to establish their efficacy and safety conclusively. Another issue is the complex manufacturing process, the intricate manufacturing process of bioresorbable scaffolds contributes to their higher costs.
The global bioresorbable vascular scaffolds is segmented based on device type, application, material type, end user and region.
The everolimus-eluting device from the device type segment accounted for 41.2% and it is expected to be dominated during the forecast period. Everolimus-eluting device refers to a medical device that releases everolimus, a drug that inhibits cell proliferation and reduces the risk of restenosis, into the coronary artery wall to prevent re-narrowing of the blood vessel caused by coronary artery disease.
For instance, in June 2022, Shanghai MicroPort Medical (Group) Co., Ltd released the 2-year clinical follow-up results from the pivotal FUTURE II trial of its self-developed, second-generation, fully bioresorbable vascular scaffolds system - Firesorb Bioresorbable Rapamycin Targeted Eluting Coronary Scaffold System.
The FUTURE II trial is a prospective, multi-centre, non-inferiority designed randomized controlled trial comparing the safety and efficacy of the second-generation thinner-strut bioresorbable eluting scaffolds - Firesorb and that of a market-leading everolimus-eluting metallic stent. The FUTURE II trial was conducted at 28 medical centres in China and enrolled a total of 433 patients with obstructive coronary atherosclerotic heart disease.
Moreover, in September 2020 Abbott stated that it started the LIFE-BTK clinical trial for its Espirit BTK everolimus-eluting resorbable scaffold system. According to a news release, Abbott's Espirit system is the first to begin an investigational device exemption (IDE) trial in the U.S. for a fully resorbable device for treating below-the-knee blocked arteries or critical limb ischemia (CLI) in people battling advanced stages of peripheral artery disease (PAD).
North America is estimated to hold about 38.4% of the total market share throughout the forecast period, owing to the sophisticated healthcare infrastructure, rise in patient awareness about minimally invasive treatments, and high disposable income rising disease burden and changing lifestyle of people. Additionally, the strong foothold of industry players in the region will provide innovative solutions that will increase the adoption rate and are anticipated to drive the bioresorbable vascular scaffold industry in North America.
For instance, in September 2022 REVA Medical, LLC, a leader in bioresorbable polymer technologies for vascular applications, stated that enrollment in the MOTIV pivotal trial has been initiated at clinical centres in both the U.S. and Europe. The study will evaluate the use of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold for treatment in patients suffering from chronic limb-threatening ischemia (CLTI).
During this pandemic of COVID-19, the rising prevalence of cardiovascular diseases and accompanying surgery adoptions is accelerating market growth. Amid this pandemic, the demand for bioresorbable scaffolds is increasing as they provide complete resorption and temporal mechanical support for patients.
Bioresorbable scaffolds are widely used as potential solutions for coronary artery diseases. These scaffolds prevent the adverse reactions caused by permanent metallic devices during percutaneous coronary intervention, which is a safe, effective, and timely preferred treatment for coronary artery diseases.
The major global players in the Bioresorbable Vascular Scaffolds market include: BIOTRONIK, REVA Medical, Arterius, Meril Life Sciences Pvt. Ltd, Zorion Medical, Translumina, Abbott, Boston Scientific Corporation, Nano Therapeutics, Tsuna Med and among others.
The global bioresorbable vascular scaffolds market report would provide approximately 69 tables, 70 figures, and 185 Pages.
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