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心血管・軟部組織修復パッチ市場の2030年までの予測:製品タイプ、材料タイプ、用途、エンドユーザー、地域別の世界分析Cardiovascular & Soft Tissue Repair Patch Market Forecasts to 2030 - Global Analysis By Product Type, Material Type, Application, End User and By Geography |
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心血管・軟部組織修復パッチ市場の2030年までの予測:製品タイプ、材料タイプ、用途、エンドユーザー、地域別の世界分析 |
出版日: 2024年06月06日
発行: Stratistics Market Research Consulting
ページ情報: 英文 200+ Pages
納期: 2~3営業日
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Stratistics MRCによると、心血管・軟部組織修復パッチの世界市場は2024年に50億米ドルを占め、予測期間中にCAGR 10.1%で成長し、2030年には90億米ドルに達する見込みです。
心血管系および軟部組織修復パッチは、心血管系や体内の軟部組織の損傷や弱化した組織を修復するための外科手術に使用される医療機器です。これらのパッチは通常、合成ポリマーや生体組織など、身体の自然治癒プロセスに適合する生体適合性材料から作られています。心臓血管の手術では、これらのパッチは中隔欠損や先天性心欠損のような心臓の壁の欠陥の修復や、動脈瘤や動脈切開のような血管の弱くなった部分の補強によく使われます。
2021年8月にPubMed Centralが発表した論文によると、サウジアラビアの500人の参加者を対象に横断研究が行われ、腹部ヘルニアの有病率は38.8%で、18~25歳の参加者は21.2%と少なかった。
心血管疾患と軟部組織損傷の有病率の上昇
心臓発作や先天性心疾患を含む心血管疾患は、高齢化、ライフスタイルの変化、遺伝的素因などの要因によりますます一般的になっており、効果的な外科的介入に対する需要が高まっています。同様に、運動量の増加や外傷などの要因により、ヘルニアや腹壁欠損などの軟部組織損傷の発生率も増加傾向にあります。外科的修復を必要とするこのような病状の急増は、高度な修復パッチの需要を押し上げています。これらのパッチは、損傷した組織を補強または置換するための信頼性の高いソリューションを提供し、手術結果と患者の回復を高め、市場の成長を牽引しています。
手術費用の高騰
高度医療機器は、その開発や製造に関わる高度な材料や技術により、多額の費用がかかることが多いです。その結果、これらのパッチを使用した外科手術の総費用は、多くの患者、特に十分な医療保険が適用されない患者や、ヘルスケア資金が限られている地域の患者にとって法外なものとなる可能性があります。したがって、これらの処置に関連する経済的課題は、心血管・軟部組織修復パッチ市場の広範な採用と成長を妨げています。
材料科学と技術の進歩
生体工学的組織、合成ポリマー、ナノ材料などの生体適合性材料の革新は、より効果的で耐久性があり、汎用性のある修復パッチの開発につながった。これらの最先端素材は、パッチが天然組織と一体化する能力を向上させ、拒絶反応のリスクを減らし、治癒プロセス全体を強化します。さらに技術の進歩は、感染を予防し治癒を促進するために修復部位に直接薬剤を供給できる薬剤溶出特性などの特殊な機能を備えたパッチの創出を可能にし、心血管・軟部組織修復パッチの普及と使用の拡大につながった。
厳しい規制要件
FDAやEMAなどの規制機関は、安全性、有効性、品質について厳格な基準を課しており、広範な臨床試験と文書化を要求しています。このため、製造業者にとっては開発期間が長期化し、コストが増大します。製造業者はこれらの厳しい基準を満たすために多大な資源を投入しなければならないです。その結果、厳しい規制要件により、新しく改良された心血管・軟部組織修復パッチの入手が制限され、市場の成長が妨げられ、最先端治療への患者のアクセスが遅れる可能性があります。
COVID-19の影響
当初、COVID-19の症例に対するロックダウンと資源配分は、修復パッチを必要とするものを含む選択的手術の減少につながった。そのため、市場の成長は一時的に落ち込んだ。しかし、ヘルスケアシステムが適応するにつれて手術が再開され、市場は回復しました。衛生面への注目も無菌パッチの採用を後押ししたのかもしれないです。全体として、一時的な後退の後、心血管疾患の有病率の上昇とパッチ技術の進歩に後押しされ、市場はパンデミック前の成長軌道に戻ると予想されます。
予測期間中、心臓パッチ分野が最大になる見込み
心臓パッチは低侵襲の心臓手術でよく使用されるため、予測期間中、心臓パッチが最大になると予測されています。この低侵襲アプローチは心臓血管治療の大きな動向であり、心臓パッチはそれを促進する上で重要な役割を果たしています。低侵襲処置が普及するにつれて、心臓パッチの需要は増加すると予想されます。さらに、効果的な心臓パッチは組織再生を促進し、心臓機能を改善し、合併症を減らすことができます。これは患者の予後改善につながるため、外科医による採用率が高まり、これらのパッチの需要が増加します。
血管修復・再建分野は予測期間中に最も高いCAGRが見込まれる
血管修復・再建分野では、血流の圧力に耐えることができる、強靭で耐久性があり生体適合性のあるパッチが必要とされるため、予測期間中に最も高いCAGRが見込まれます。このため、血管用途に特化した機能性に焦点を当てたパッチ材料の技術革新が推進されます。さらに、動脈瘤の治療から末梢動脈疾患まで、さまざまな手技が含まれます。特定の用途に応じて異なるタイプのパッチが必要とされるため、様々なパッチ技術の多様な市場が形成されています。
北米は、心疾患の有病率の上昇、多数の製薬会社の存在、研究開発費の増加、ヘルニア疾患の発生率の増加により、予測期間中に最大の市場シェアを占めると予測されています。例えば、2022年7月の米国疾病予防管理センターのデータによると、心臓病は米国における主要な死因の1つです。すべての心臓病の中で冠状動脈性心臓病は最も一般的な心臓病であり、米国では20歳以上の成人約2,010万人が冠状動脈性心臓病を患っており、この地域の市場成長を牽引しています。
医療インフラの急速な発展、低侵襲手術の動向の高まり、心疾患の罹患率の上昇、医療ツーリズムの増加、中国やインドなど数カ国の急速な経済拡大、高齢者人口の増加、慢性疾患の負担の増加により、アジア太平洋地域は予測期間中に最も高いCAGRを維持すると予測され、今後数年間で最も速い成長率を記録すると予想されます。さらに、先天性心疾患の早期診断と発見、迅速な治療の重要性に対する意識の高まりが、市場を後押ししています。
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
According to Stratistics MRC, the Global Cardiovascular & Soft Tissue Repair Patch Market is accounted for $5.0 billion in 2024 and is expected to reach $9.0 billion by 2030 growing at a CAGR of 10.1% during the forecast period. Cardiovascular and Soft Tissue Repair Patches are medical devices used in surgical procedures to repair damaged or weakened tissues in the cardiovascular system or soft tissues elsewhere in the body. These patches are typically made from biocompatible materials, such as synthetic polymers or biological tissues, that are compatible with the body's natural healing processes. In cardiovascular surgeries, these patches are commonly used to repair defects in the heart's walls, such as septal defects or congenital heart defects, or to reinforce weakened areas of blood vessels, such as aneurysms or arteriotomies.
According to the article published by PubMed Central in August 2021, a cross-sectional study was performed on 500 participants in Saudi Arabia, which showed that the prevalence of abdominal hernia was 38.8 percent and the participants in 18-25 years had less prevalence of 21.2 percent.
Rising prevalence of cardiovascular disease and soft tissue injuries
Cardiovascular diseases, including heart attacks and congenital heart defects, becoming increasingly common due to factors like aging populations, lifestyle changes, and genetic predispositions, there is a growing demand for effective surgical interventions. Similarly, the incidence of soft tissue injuries, such as hernias and abdominal wall defects, is on the rise due to factors like increased physical activity and trauma. This surge in medical conditions requiring surgical repair boosts the demand for advanced repair patches. These patches offer reliable solutions for reinforcing or replacing damaged tissues, enhancing surgical outcomes and patient recovery driving the markets growth.
High cost of procedures
Advanced medical devices often come with substantial costs due to the sophisticated materials and technologies involved in their development and manufacturing. Consequently, the overall expense of surgical procedures using these patches can be prohibitive for many patients, particularly those without adequate health insurance coverage or in regions with limited healthcare funding. Therefore, the financial challenges associated with these procedures hinder the widespread adoption and growth of the cardiovascular and soft tissue repair patch market.
Advancements in material science and technology
Innovations in biocompatible materials, such as bioengineered tissues, synthetic polymers, and nanomaterials, have led to the development of more effective, durable, and versatile repair patches. These cutting-edge materials improve the patches' ability to integrate with natural tissues, reduce the risk of rejection, and enhance the overall healing process. In addition technological advancements have also enabled the creation of patches with specialized features, such as drug-eluting properties, which can deliver medications directly to the repair site to prevent infection and promote healing leading to increased adoption and expanded use of cardiovascular and soft tissue repair patches.
Stringent regulatory requirements
Regulatory agencies, such as the FDA and EMA, impose rigorous standards for safety, efficacy, and quality, requiring extensive clinical testing and documentation. This leads to prolonged development timelines and increased costs for manufacturers, who must invest significant resources to meet these stringent criteria. As a result, stringent regulatory requirements can limit the availability of new and improved cardiovascular and soft tissue repair patches, hindering market growth and delaying patient access to cutting-edge treatments.
Covid-19 Impact
Initially, lockdowns and resource allocation towards COVID-19 cases led to a decline in elective surgeries, including those requiring repair patches. This caused a temporary dip in market growth. However, as healthcare systems adapted, procedures resumed, and the market recovered. The focus on hygiene might have also driven aseptic patch adoption. Overall, after a temporary setback, the market is expected to return to its pre-pandemic growth trajectory, fueled by the rising prevalence of cardiovascular diseases and advancements in patch technology.
The cardiac patches segment is expected to be the largest during the forecast period
The cardiac patches is expected to be the largest during the forecast period as cardiac patches are often used in minimally invasive heart surgeries. This minimally invasive approach is a major trend in cardiovascular treatments, and cardiac patches play a key role in facilitating it. As minimally invasive procedures become more prevalent, the demand for cardiac patches is expected to rise. Moreover, effective cardiac patches can promote tissue regeneration, improve heart function, and reduce complications. This translates to better patient outcomes, leading to a higher adoption rate by surgeons and increased demand for these patches.
The vascular repair & reconstruction segment is expected to have the highest CAGR during the forecast period
The vascular repair & reconstruction segment is expected to have the highest CAGR during the forecast period because these procedures necessitate strong, durable, and biocompatible patches that can withstand the pressure of blood flow. This drives innovation in patch materials, with a focus on functionalities specifically suited for vascular applications. Further it also encompasses various procedures, from treating aneurysms to peripheral artery disease. The need for different patch types based on the specific application creates a diversified market for various patch technologies.
North America is projected to hold the largest market share during the forecast period due to the rising prevalence of cardiac diseases, the presence of a large number of pharmaceutical companies, growing research and development expenditure, and increasing incidences of hernia disorders. For instance, according to data from the Centers for Disease Control and Prevention in July 2022, heart disease is one of the leading causes of death in the United States. Among all the heart diseases coronary heart disease is the most common type of heart disease and about 20.1 million adults age 20 and older have coronary heart disease in the United States drives the growth of the market in this region.
Asia Pacific is projected to hold the highest CAGR over the forecast period owing to rapid developments in healthcare infrastructure, growing trends of minimally invasive surgical procedures, rising incidence of cardiac disease, increasing medical tourism, rapid economic expansion in several countries such as China and India, rising geriatric population, and increasing burden of chronic disorders, Asia Pacific is expected to register the fastest growing rate in the coming years. Additionally raising awareness about the importance of early diagnosis and detection of congenital cardiac disorders, as well as quick treatment propels the market.
Key players in the market
Some of the key players in Cardiovascular & Soft Tissue Repair Patch market include Abbott, Admedus, Atriummed, B.Braun, Bard Peripheral Vascular Inc., Baxter, CorMatrix, Cryolife, Inc., Edwards Life Sciences Corporation, Glycar SA Pty Ltd., Integra LifeSciences Corporation, LabCor, LeMaitre Vascular Inc., Maverick Bioscience, Neovasc, Novomedics, Southern Lights Biomaterials, TEI Biosciences Inc., Terumo Medical Corporation and W.L. Gore & Associates, Inc.
In April 2024, Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit(TM) BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
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