市場調查報告書
商品編碼
1498570
北美心臟標記市場規模和預測、全球和區域佔有率、趨勢和成長機會分析報告範圍:按產品類型、生物標記類型、適應症、最終用戶和國家/地區North America Cardiac Markers Market Size and Forecast, Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Product Type, Biomarker Type, Indication, End User, and Country |
全球北美心臟標記市場預計將從 2023 年的 11.7 億美元增至 2031 年的 28.7 億美元。
本報告中提出的北美心臟標記市場預測可以幫助該市場的利害關係人規劃其成長策略。心血管疾病盛行率的上升和對即時心臟檢測試劑盒需求的激增是推動北美心臟標記市場成長的關鍵因素。
使用外泌體作為 CVD 生物標記的持續研究
缺氧顯著影響外泌體貨物並產生各種蛋白質和 miRNA,這些蛋白質和 miRNA 透過不同的訊號路徑指示 CVD 的血管生成、生長和進展。外泌體引起了研究人員的關注,因為它們與生理和病理條件下的細胞間通訊有關。上調的外泌體 miRNA miR-133a、miR-208a、miR-1、miR-499-5p 和 miR-30a 已被指定用於急性心肌梗塞 (AMI) 的及時診斷。此外,衍生的外泌體,即 miR-192、miR-146a、miR-194 和 miR-92b-5p 被認為是 HF 的潛在生物標記。
生物標記疾病功能
miRNA-126、miRNA-223 和 miRNA-320b 急性心肌梗塞 血小板活化和血栓形成、內皮損傷、心肌細胞凋亡和纖維母細胞增殖
miRNA-1、miRNA-21a/b 和 miRNA-29b 急性心肌梗塞 心肌細胞凋亡、纖維母細胞增生和心臟肥大
miRNA-208a 急性心肌梗塞 心臟肥大與電傳導
miRNA-499 急性心肌梗塞 心肌細胞凋亡
miRNA-486 急性心肌梗塞 心肌細胞凋亡(保護性)
miRNA-223-5p 急性心肌梗塞、動脈粥狀硬化和心臟衰竭 細胞增殖、遷移、凋亡和極化;心肌細胞肥大;和電傳導
miRNA-941 急性冠狀動脈綜合症 細胞增生和炎症
miRNA-216a 和 miRNA-451 冠狀動脈疾病 內皮損傷和單核細胞募集
miRNA-223-3p、miRNA-122-5p 和 miRNA-93-5p 冠狀動脈疾病 發炎、遷移和凋亡、心肌細胞肥大、電傳導和心肌細胞凋亡
miRNA-142-3p、miRNA-17-5p 和 miRNA-126 急性心肌梗塞和冠狀動脈疾病發炎;心肌細胞肥大;以及細胞增殖、遷移和凋亡
miRNA-133a 冠狀動脈疾病 細胞增生和分化、心臟肥大和電傳導(心律不整)
Serpin G1、Serpin F2 和 Cystatin C CD14 心臟衰竭和急性冠狀動脈症候群 發炎、腎功能下降、纖溶下降和血栓形成過程
資料來源:艾倫出版社
在冠狀動脈疾病(CAD)患者中,上調的外泌體蛋白(包括纖維蛋白原BETA/γ鏈、α-1-抗胰凝乳蛋白酶和間α-胰蛋白酶抑制劑重鏈)被評估為推定的蛋白質生物標記。外泌體透過多種細胞間通訊機制在 CVD 發病機制中的功能正在獲得顯著認知。近年來進行的幾項研究提供的證據支持外泌體與正常生理(心臟發育、網狀紅血球成熟和心肌血管生成)和病理生理過程(包括缺血/再灌注(IR)損傷、動脈粥樣硬化和心臟重塑)之間的關聯。缺氧和發炎等壓力條件可以調節生物外泌體含量和目標細胞,有助於改善或損害心臟功能。基於外泌體的 miRNA 和蛋白質在體液中的整合能夠全面分析這些成分在心血管疾病中的潛在生物標記作用。因此,外泌體生物標記的使用正在成為診斷CVD的新方法。
阻礙北美心臟標記市場的因素
公司可以針對特定應用向 FDA 生物標記資格計畫提交心臟標記監管資格申請。只有合格的標記物才可以用於多個藥物開發項目,而不需要藥物評估與研究中心(CDER)的批准來重新確認標記物的適用性。
心臟標記廣泛應用於流行病學研究,以完成 CVD 多個階段的調查。該過程需要更仔細地處理和儲存有價值的生物樣本以獲得詳細資訊。需要精確的品質控制措施來確保這些樣本在適當的儲存條件下處理,以避免資料遺失。心臟標記研究取決於樣本的完整性以及收集、處理和儲存的方式,因為這些研究中使用存檔樣本。處理、標籤、加工、等分、儲存和運輸可能會影響研究結果。樣品必須放置在乾冰上並在當天出貨。如果該過程執行不當,可能會影響樣品的質量,從而影響結果。因此,美國 FDA 制定的嚴格驗證協議以及與樣本採集和儲存相關的技術問題阻礙了北美心臟標記市場的成長。
根據疾病,北美心臟標記市場分為HIV檢測、流感檢測、性傳染病檢測、C型肝炎病毒檢測、熱帶疾病檢測、呼吸道感染檢測、院內感染、鏈球菌等。根據分子診斷,市場進一步分為聚合酶連鎖反應(PCR)、等溫核酸擴增技術(INAAT)等。 2023 年,呼吸道感染檢測領域佔據最大的市場。
根據產品類型,北美心臟標記市場分為試劑和試劑盒以及分析儀。分析儀細分市場在 2023 年佔據更大佔有率。
根據生物標記類型,北美心臟標記市場分為肌鈣蛋白、肌酸激酶-MB、肌紅蛋白、B型利尿鈉肽等。肌鈣蛋白細分市場在 2023 年佔據最大的市場佔有率,預計 2023-2031 年市場複合年成長率最高。
依適應症,市場分為充血性心臟衰竭、心肌梗塞、急性冠狀動脈綜合症等。充血性心臟衰竭細分市場在 2023 年佔據最大市場佔有率。
就最終用戶而言,北美心臟標記市場分為醫院、診斷實驗室、即時檢測設施等。 2023 年,醫院細分市場佔據最大的市場佔有率。
北美傳染病床邊分子檢測市場:區域概覽
發達的醫療保健系統以及用於診斷和預測疾病的心臟標記的高度接受度。不斷成長的老年人口需要生物標記測試來檢測急性心肌梗塞等疾病,從而推動了對測試產品的需求。該地區 Quidel 公司和丹納赫公司等主要參與者的存在是促進該市場成長的另一個因素。根據世界衛生組織(WHO) 統計,約7,700 萬18 歲以上成年人患有2 型糖尿病,其中2,500 萬人處於糖尿病前期,增加了心血管疾病(CVD) 的可能性,並給醫療保健系統帶來了額外壓力。此外,該地區市場參與者採取越來越多的策略來開發創新的心臟生物標記測試,預計將有助於該地區的市場成長。
在準備北美心臟標記市場報告時提到的一些主要一手和二手來源包括世界銀行數據、國家衛生服務部 (NHS)、美國衛生與公眾服務部 (HHS) 和世界衛生組織 (世界銀行) 數據。衛生組織)。
The global North America cardiac marker market is expected to reach US$ 2.87 billion by 2031 from US$ 1.17 billion in 2023. The market is estimated to grow with a CAGR of 11.8% from 2023 to 2031.
The North America cardiac marker market forecast presented in this report can help stakeholders in this marketplace plan their growth strategies. The rising prevalence of cardiovascular diseases and a surge in the demand for point-of-care cardiac testing kits are the key factors propelling the North America cardiac marker market growth.
Ongoing Research in Use of Exosomes as CVD Biomarkers
Hypoxia significantly affects exosome cargo and produces various proteins and miRNAs that indicate angiogenesis, growth, and progression for CVD through different signaling pathways. Exosomes has gathered the attention of researchers because they are relevant to intercellular communication under both physiological and pathological conditions. The upregulated exosome miRNAs miR-133a, miR-208a, miR-1, miR-499-5p, and miR-30a have been designated for the timely diagnosis of acute myocardial infarction (AMI). Further, derived exosomes namely, miR-192, miR-146a, miR-194, and miR-92b-5p are considered as potential biomarkers for HF.
Biomarker Disease Function
miRNA-126, miRNA-223, and miRNA-320b Acute myocardial infarction Platelet activation and thrombus formation, endothelial damage, myocardial apoptosis, and fibroblast proliferation
miRNA-1, miRNA-21a/b, and miRNA-29b Acute myocardial infraction Myocardial apoptosis, fibroblast proliferation, and cardiac hypertrophy
miRNA-208a Acute myocardial infarction Cardiac hypertrophy and electrical conduction
miRNA-499 Acute myocardial infarction Myocardial apoptosis
miRNA-486 Acute myocardial infarction Myocardial apoptosis (protective)
miRNA-223-5p Acute myocardial infarction, atherosclerosis, and heart failure Cell proliferation, migration, apoptosis, and polarization; cardiomyocyte hypertrophy; and electrical conduction
miRNA-941 Acute coronary syndrome Cell proliferation and inflammation
miRNA-216a and miRNA-451 Coronary artery disease Endothelial damage and monocyte recruitment
miRNA-223-3p, miRNA-122-5p, and miRNA-93-5p Coronary artery disease Inflammation, migration and apoptosis, cardiomyocyte hypertrophy, electrical conduction, and cardiomyocyte apoptosis
miRNA-142-3p, miRNA-17-5p, and miRNA-126 Acute myocardial infarction and coronary artery disease Inflammation; cardiomyocyte hypertrophy; and cell proliferation, migration, and apoptosis
miRNA-133a Coronary artery disease Cell proliferation and differentiation, cardiac hypertrophy, and electrical conduction (arrhythmia)
Serpin G1, Serpin F2, and Cystatin C CD14 Heart failure and acute coronary syndrome Inflammation, decrease in kidney function, decrease in fibrinolysis, and thrombotic process
Source: Allen Press
In coronary artery disease (CAD) patients, upregulated exosome proteins-including fibrinogen beta/gamma chain, alpha-1-antichymotrypsin, and inter-alpha-trypsin inhibitor heavy chain-were evaluated as putative protein biomarkers. The function of exosomes in CVD pathogenesis through diverse intercellular communication mechanisms is gaining significant recognition. Several studies conducted in recent years have generated evidence supporting the association of exosomes with normal physiology (cardiac development, reticulocyte maturation, and myocardial angiogenesis) and pathophysiological processes, including ischemia/reperfusion (IR) injury, atherosclerosis, and cardiac remodeling. Stressful conditions such as hypoxia and inflammation can modulate biological exosome content and target cells, thereby contributing to improving or impairing cardiac function. The integration of exosome-based miRNAs and proteins in body fluids enables a comprehensive analysis of the potential biomarker role of these components in cardiovascular diseases. Therefore, the use of exosome biomarkers is emerging as a new approach for the diagnosis of CVDs.
Factor Hampering North American Cardiac Marker Market
Companies can submit an application for regulatory qualification for a cardiac marker to the FDA Biomarker Qualification Program for a specific application. Only the qualified marker can be used in multiple drug development programs without the need for the Center for Drug Evaluation and Research (CDER) approval to reconfirm the suitability of the markers.
Cardiac markers are widely used in epidemiological studies for completing the investigation of numerous stages of CVD. The process requires more careful handling and storage of valuable biological samples to obtain detailed information. Precise quality control measures are required to ensure that these samples are handled in appropriate storage conditions to avoid data loss. Cardiac marker studies depend on the integrity of samples and the manner of collection, processing, and storage, as archived samples are used in these studies. Handling, labeling, processing, aliquoting, storage, and transportation may affect study results. The sample must be placed on dry ice and shipped the same day. If the process is not carried out properly, it can impact the quality of the sample, subsequently hampering the outcomes. Therefore, strict validation protocols established by the US FDA and technical issues associated with sample collection and storage hamper the growth of the North America cardiac markers market.
Based on disease, the North America cardiac marker market is divided into HIV testing, influenza testing, sexually transmitted diseases testing, hepatitis C virus testing, tropical diseases testing, respiratory infection testing, hospital-acquired infections, strep, and others. The market is further divided on the basis of molecular diagnostics into polymerase chain reactions (PCR), isothermal nucleic acid amplification technology (INAAT), and others. The respiratory infection testing segment held the largest market share in 2023.
Based on product type, the North America cardiac markers market is segmented into reagents and kits, and analyzers. The analyzers segment held a larger share in 2023. The reagents and kits segment is expected to register a higher CAGR during 2023-2031.
Based on biomarker type, the North America cardiac markers market is divided into troponin, creatine kinase-MB, myoglobin, B-type natriuretic peptide, and others. The troponin segment held the largest market share in 2023 and is estimated to register the highest CAGR in the market during 2023-2031.
By indication, the market is segmented into congestive heart failure, myocardial infraction, acute coronary syndrome, and others. The congestive heart failure segment held the largest share of the market in 2023. The acute coronary syndrome segment is estimated to register the highest CAGR during 2023-2031.
In terms of end user, the North America cardiac markers market is divided into hospitals, diagnostic laboratories, point-of-care testing facilities, and others. The hospitals segment held the largest market share in 2023. The diagnostic laboratories segment is estimated to register the highest CAGR in the market during 2023-2031.
North America Point-Of-Care Molecular Testing for Infectious Diseases Market: Regional Overview
The the developed healthcare system and the high acceptance of cardiac markers for diagnosing and predicting diseases. The growing geriatric population needs biomarker testing for detecting conditions such as acute myocardial infarction, thereby driving demand for testing products. The existence of key players such as Quidel Corporation and Danaher Corporation in the region is another factor contributing to the growth of this market. According to the World Health Organization (WHO), ~77 million adults over the age of 18 have type 2 diabetes, including 25 million prediabetes, which increases the possibility of cardiovascular diseases (CVDs) and puts additional pressure on the healthcare system. Furthermore, increasing strategies adopted by market players in this region to develop innovative cardiac biomarker tests are expected to contribute to the market growth in this region.
A few of the major primary and secondary sources referred to while preparing the report on the North America cardiac marker market are the World Bank Data, National Health Service (NHS), US Department of Health and Human Services (HHS), and WHO (World Health Organization).