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市場調査レポート
商品コード
1634190
構造心臓デバイスの世界市場 - 2025年~2033年Global Structural Heart Devices Market - 2025 - 2033 |
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カスタマイズ可能
適宜更新あり
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構造心臓デバイスの世界市場 - 2025年~2033年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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構造心臓デバイスの世界市場は2024年に147億9,000万米ドルに達し、2033年には288億4,000万米ドルに達すると予測され、予測期間2025年~2033年のCAGRは8.0%で成長する見込みです。
構造心臓デバイスは、弁、壁、部屋など心臓の構造に影響を及ぼすさまざまな問題を治療するために使用される特殊な医療機器です。これらの疾患は、先天性のもの(出生時に存在するもの)、あるいは加齢、高血圧、その他の心血管疾患などの要因によって経時的に発症するものがあります。最も一般的な心臓の構造的疾患は、大動脈弁疾患、僧帽弁疾患、心房中隔欠損症(ASD)、心室中隔欠損症(VSD)です。これらの異常は、放置しておくと深刻な健康問題を引き起こす可能性があり、通常は外科的介入やデバイスの装着が必要となります。
構造心臓デバイスに対する需要の増加は、予測期間中の市場を牽引する要因です。需要の急増は、主にライフスタイルの変化と人口の高齢化に伴って一般的になりつつある心血管疾患の頻度の増加によるものです。多くの個人が大動脈弁狭窄症などの問題を治療するために構造心臓デバイスを必要としており、新規の機器に対する需要が高まっています。ヘルスケア技術が進歩し、より低侵襲な処置が可能になるにつれて、構造心臓デバイスの市場は大きく成長すると予想されます。
促進要因と抑制要因
構造心臓デバイス需要の増加
構造心臓デバイスに対する需要の増加は、構造心臓デバイスの世界市場成長の重要な要因になると予測されます。構造心臓デバイスの需要は、心血管疾患の有病率の上昇、技術の進歩、構造心臓デバイスに関する意識の高まり、最近の発売や承認によって増加しています。
個人が高齢になり、肥満や座りがちな行動などのライフスタイルに関連した危険因子がより頻繁になるにつれて、心臓弁膜症の有病率が上昇します。心血管障害の有病率の上昇に伴い、新たな解決策が必要とされ、正常な心臓機能を回復させ、患者の予後を改善できる構造心臓デバイスへの需要が高まっています。例えば、米国疾病予防管理センターによると、心臓病は米国の男性、女性、そしてほとんどの人種や民族の人々の主な死因となっています。米国では33秒に1人が心血管疾患で死亡しています。米国では約695,000人が心臓病で死亡しており、これは死亡者5人に1人の割合です。
さらに、器具の設計や材料の進歩により、より頑丈で生体適合性の高い心臓弁や閉塞器が開発されています。このような改良は、装置の機能性を高めるだけでなく、以前のモデルに関連する問題を軽減しています。したがって、洗練された材料で作られた新しい心臓弁は、人間の弁の自然な機能をよりよく模倣することができ、その結果、血流が促進され、弁逆流の症例が減少します。さらに、研究や臨床試験の拡大により、心臓弁の用途は広がり続けており、より広範な患者に使用できるようになっています。
最近では、最新技術で製造された製品も発売されています。例えば、2024年1月、Occlutech社は、米国食品医薬品局(FDA)が心房中隔欠損症(ASD)の治療にOcclutech ASD OccluderとOcclutech Pistol Pusherを承認したと発表しました。さらに2024年6月、ヘルスケア技術の世界的リーダーであるメドトロニックplcは、心臓手術における最新のイノベーションであるアバラス・ウルトラ弁の発売を発表しました。この次世代手術用大動脈組織弁は、留置時の使いやすさと患者の生涯管理を容易にするよう設計されています。心臓外科医とその患者にとって、最初から将来に適合できる大動脈弁ソリューションを求める優れた選択肢です。
手技や機器にかかる高額な費用
処置やデバイスのコストが高いといった要因が、世界の構造心臓デバイス市場を阻害すると予想されます。特に経カテーテル大動脈弁置換術(TAVR)のような最新技術による心臓構造機器の処置に伴う価格負担が大きいことが主な問題の一つです。これらの治療には、デバイス自体の費用だけでなく、術前画像診断、入院、術後ケアなどの追加費用が頻繁に含まれます。
例えば、米国国立衛生研究所によると、機械弁および生体弁を用いた弁置換術の自己負担額の中央値は、それぞれINR107,800(US$1684)およびINR154,000(US$2406)と推定され、バルーン弁切開術の場合はINR14,456(US$367)と推定されました。機械的弁置換術と生体弁置換術、バルーン弁切開術の1回あたりの全体費用は、それぞれINR127,919(US$1999)、INR148,919(US$2372)、INR14,456(US$226)と推定されました。このように高額な費用がかかるため、多くの患者、特に低・中所得地域の患者や十分な保険が適用されない患者は、必要な治療を受けることが難しくなります。その結果、経済的な負担が患者の迅速な治療への意欲を削ぎ、市場の総需要を減少させる可能性があります。
The global structural heart devices market reached US$ 14.79 billion in 2024 and is expected to reach US$ 28.84 billion by 2033, growing at a CAGR of 8.0% during the forecast period 2025-2033.
Structural heart devices are specialized medical devices used to treat a variety of problems affecting the heart's structure, such as its valves, walls, or chambers. These disorders might be congenital (existing at birth) or develop over time as a result of factors such as age, high blood pressure, or other cardiovascular diseases. The most prevalent structural heart conditions are aortic valve disease, mitral valve disease, atrial septal defects (ASD), and ventricular septal defects (VSD). These anomalies can cause serious health problems if left untreated, typically demanding surgical intervention or device placement.
The increasing demand for structural heart devices is the driving factor that drives the market over the forecast period. The surge in the demand is due to this surge is primarily due to an increase in the frequency of cardiovascular diseases, which are becoming more common as lifestyles change and populations age. Many individuals require structural heart devices to treat problems such as aortic stenosis, creating a greater demand for novel devices. As healthcare technology progresses and more minimally invasive procedures become available, the market for structural heart devices is expected to grow significantly.
Market Dynamics: Drivers & Restraints
Increasing demand for structural heart devices
The increasing demand for structural heart devices is expected to be a significant factor in the growth of the global structural heart devices market. The demand for structural heart devices is increasing owing to the rising prevalence of cardiovascular diseases, technological advancements, growing awareness regarding structural heart devices, and recent launches and approvals.
As individuals grow older and lifestyle-related risk factors such as obesity and sedentary behavior become more frequent, the prevalence of heart valve problems rises. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for structural heart devices that can restore normal heart function and improve patient outcomes. For instance, according to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. One person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease, that's 1 in every 5 deaths.
Furthermore, advances in device design and materials have resulted in the development of more robust and biocompatible cardiac valves and occluders. These enhancements not only increase the devices' functionality but also reduce the problems associated with previous models. Thus, newer heart valves constructed of sophisticated materials can better imitate the natural function of human valves, resulting in enhanced blood flow and fewer cases of valve regurgitation. Furthermore, extending research and clinical trials continues to broaden the applications for these devices, allowing them to be used in a larger range of patient scenarios.
There are recent product launches that are manufactured using the latest technologies. For instance, in January 2024, Occlutech announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD). Moreover, in June 2024, Medtronic plc, a global leader in healthcare technology, announced the launch of its latest innovation in cardiac surgery, the Avalus Ultra valve. This next-generation surgical aortic tissue valve is designed to facilitate ease of use at implant and lifetime patient management. It's an excellent choice for cardiac surgeons and their patients seeking an aortic valve solution that can be fit for the future, right from the start.
High costs of procedures and devices
Factors such as high costs of procedures and devices are expected to hamper the global structural heart devices market. One of the primary issues is the significant price burden involved with structural heart device procedures, particularly modern technology like transcatheter aortic valve replacement (TAVR). These treatments frequently include not only the cost of the devices themselves, but also additional costs such as preoperative imaging, hospital stays, and postoperative care.
For instance, according to the National Institute of Health, The median out-of-pocket expenditure for valve replacement surgery using mechanical and bio-prosthetic valves was estimated to be INR107,800 (US$1684) and INR154,000 (US$2406), respectively, and for balloon valvotomy was estimated to be INR14,456 (US$367). Overall package cost per mechanical and bio-prosthetic single valve replacement surgery and balloon valvotomy procedure was estimated as INR127,919 (US$1999), INR148,919 (US$2372) and INR14,456 (US$226), respectively. These high costs can make it difficult for many patients, particularly those in low- and middle-income areas or without adequate insurance coverage, to get the therapies they need. As a result, the financial implications may discourage patients from obtaining prompt treatment, reducing total market demand.
The global structural heart devices market is segmented based on repair devices, replacement devices, application, end-user, and region.
TMVR (Transcatheter Mitral Valve Replacement) segment is expected to dominate the global structural heart devices market share
The TMVR (Transcatheter Mitral Valve Replacement) segment is anticipated to dominate the global structural heart devices market owing to its growing importance in treating mitral valve disorders, technological advancements, recent launches and approvals, and increase in the number of mitral regurgitations. As people live longer, the prevalence of age-related heart diseases, including MR, increases, needing better treatment options. TMVR provides a less intrusive alternative to standard surgical techniques, making it especially appealing to patients who are at high risk of complications from open-heart surgery. This shift toward less intrusive procedures is consistent with general trends in healthcare, which show an increasing preference for interventions that shorten recovery time and hospital stays. For instance, with a global prevalence of over 2%, mitral regurgitation is a common valvular abnormality with various causes, including congenital conditions, rheumatic fever, and degenerative changes in the valve.
Technological advances in TMVR devices have also led to their projected market dominance. Recent advances have resulted in the creation of more complex and dependable equipment that improves procedural success rates and patient outcomes. These developments include improved valve designs that provide greater hemodynamic performance and biocompatibility, as well as upgraded delivery systems that make implantation easier. As these technologies advance, they are projected to gain broader acceptability among healthcare practitioners and patients, increasing demand for TMVR solutions.
For instance, in May 2024, 4C Medical Technologies, a Minnesota-based medical device company focused on structural heart disease, received the FDA's breakthrough device designation for its AltaValve System for transcatheter mitral valve replacement (TMVR). The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation (MR) patients. It is implanted via transseptal access and positioned above the native mitral valve when implanted.
North America is expected to hold a significant position in the global structural heart devices market share
North America will likely account for a significant share of the global structural heart devices market, owing to its advanced healthcare infrastructure, a high prevalence of cardiovascular disorders, technological advancements, and recent launches and approvals. The rising prevalence of cardiovascular disorders needs novel solutions, fueling demand for structural heart devices that can restore normal heart function and improve patient outcomes.
For instance, according to the National Institute of Health, approximately 82.6 million people in the United States currently have one or more forms of cardiovascular disease (CVD), making it a leading cause of death for both men and women. Common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent. The prevalence for men is 8.3 percent and for women is 6.1 percent. About 7 million Americans aged 20 or older have had a stroke. Each year approximately 610,000 experience their first stroke and another 185,000 experience a recurrence. Approximately 87 percent of all strokes are ischemic of which 10 percent result from intracerebral hemorrhage and 3 percent result from subarachnoid hemorrhage.
The region has established itself as a pioneer in the use of advanced medical technologies, particularly in cardiovascular care. One of the most significant developments is the invention and execution of transcatheter heart valve replacement (TAVR) operations, which have transformed the therapeutic landscape for patients with aortic stenosis and other valvular disorders. TAVR is a minimally invasive alternative to standard open-heart surgery that allows for faster recovery and shorter hospital stays, which is especially useful for older patients or those with complications.
For instance, in December 2024, Heart valve developer Anteris Technologies made its U.S. stock market debut one of the few initial public offerings by a MedTech company. The successful funding from this IPO is projected to considerably boost Anteris' capabilities in creating minimally invasive cardiac solutions, aligning with the increasing demand for cardiac surgery in aging populations.
Asia Pacific is growing at the fastest pace in the global structural heart devices market
The Asia Pacific region is emerging as the fastest-growing market for structural heart devices, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of cardiovascular disorders. Cardiovascular diseases (CVDs) continue to be a prominent cause of morbidity and mortality globally, and their prevalence is significantly increasing in the Asia Pacific area. Inactive lifestyles, poor dietary habits, smoking, and increased stress are all contributing factors to this growth.
For instance, according to the National Institute of Health, annual number of deaths from CVD in India is projected to rise from 2.26 million (1990) to 4.77 million (2020). Coronary heart disease prevalence rates in India have been estimated over the past several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations.
The major global players in the global structural heart devices market include Medtronic, Abbott, JenaValve, Artivion, Inc., Boston Scientific Corporation, Micro Interventional Devices, Biomerics, TORAY INDUSTRIES, INC., Occlutech LLC, Shanghai MicroPort Medical (Group) Co.Ltd. among others.
Emerging Players
Capstan Medical, Vesalius Cardiovascula, and Orchestra BioMed among others.
The global structural heart devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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