市场调查报告书
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心臟生物标记的全球市场预测(~2030 年):按产品类型、测试地点、应用、最终用户和区域进行分析Cardiac Biomarkers Market Forecasts to 2030 - Global Analysis By Product Type (B-Type Natriuretic Peptide, Creatine Kinase-Muscle/Brain and Other Product Types), By Location of Testing, Application, End User and By Geography |
2023年,全球心臟生物标记市场规模为187亿美元,预计预测期内复合年增长率为16.6%,到2030年将达到548亿美元。心臟生物标记是由于心臟受伤、损伤或压力而释放到血液中的特定分子或蛋白质。
肌钙蛋白、肌酸激酶 MB (CK-MB) 和 B 型利钠胜肽(BNP) 等生物标记在诊断上用于指示心臟相关疾病。这些检测到的数值和浓度有助于诊断心臟病、心臟衰竭和其他心臟疾病,确定治疗策略并评估心臟健康状况。
根据世界卫生组织 (WHO) 的数据,18 岁以上的成年人中有 7700 万人患有第 2 型糖尿病,其中 2500 万人患有糖尿病前期。这增加了心血管疾病的风险,并给医疗保健系统带来了进一步的压力。
心血管疾病增加
心肌梗塞、心臟衰竭和心肌缺血等心臟相关疾病的全球负担日益增加,增加了对可靠诊断工具的需求。心臟生物标记是心血管疾病早期发现、诊断和预后的重要指标。它准确评估心臟健康、预测风险和指导治疗策略的能力是高效、及时和准确诊断的关键,以应对全球范围内日益增加的心血管疾病发病率。这符合当前的需求。
严格规定
严格的法规阻碍了心臟生物标记的开发和实用化。严格的监管核准流程需要广泛的临床检验,通常会导致新生物标记的上市时间较长。这些严格的指南需要进行全面的研究,以确保检测心臟病的准确性、敏感性和特异性。遵守这些法规需要在研究、临床试验和满足特定性能标准方面进行大量投资,这增加了成本和时间限制。
越来越重视即时侦测
即时检测可实现快速、方便的现场诊断,并立即提供结果,而无需将检体发送到中心实验室。在心臟治疗中,这可以快速检测肌钙蛋白等生物标记,从而快速诊断心臟病等心臟疾病。这项转变将透过加快治疗决策(尤其是在紧急情况下)来改善患者照护,也将透过减少週转时间和提高心臟紧急情况管理的整体效率来支持卫生系统。
替代诊断方法的出现
先进影像技术和即时检测设备等新技术可能会提供更快、非侵入性且可能更具成本效益的心臟健康评估方法。此类替代技术可能会挑战传统生物标记测试的主导地位,并影响市场采用和医疗保健提供者的偏好。
COVID-19 大流行将医疗资源转移到病毒管理上,影响了心臟生物标记测试。非新冠就诊次数减少导致心臟评估减少,进而影响了生物标记测试的频率。此外,一些新冠肺炎患者出现心臟併发症,增加了对生物标记评估的需求。疫情对医疗保健系统造成的压力已经改变了优先事项,影响了心臟生物标记的利用率,并凸显了在健康危机期间采取适应性诊断策略的必要性。
肌钙蛋白部分预计将在预测期内成为最大的部分
肌钙蛋白片段预计将占据主导地位,因为它们被广泛用作诊断心臟相关疾病的敏感和特异性心臟生物标记。肌钙蛋白,尤其是肌钙蛋白 I 和肌钙蛋白 T,在检测心肌损伤方面表现出良好的敏感性,并且在诊断心臟病发作方面特别有用。由于全世界心血管疾病的盛行率不断增加,且肌钙蛋白检测在日常临床实践中的应用越来越多,预计肌钙蛋白检测将在预测期内成为心臟生物标记检测的最大部分。
医院部门预计在预测期内复合年增长率最高
由于患者在医院环境中获得先进医疗服务和诊断设施的机会增加,医院部门预计将大幅成长。医院是急诊护理的主要中心,心臟生物标记检测在心臟相关疾病的诊断中发挥着至关重要的作用。心血管疾病盛行率的上升以及医院环境中及时、准确诊断的需求正在推动这一领域的预期成长。
由于其成熟的医疗基础设施、技术进步和高昂的医疗成本,北美预计将主导心臟生物标记市场。该地区强大的研发活动和主要市场参与者的存在帮助其占领了巨大的市场份额。此外,心血管疾病的高盛行率以及人们对先进诊断技术的认识和采用的提高正在推动市场的成长。
由于心血管疾病盛行率的增加、人口老化的加剧以及医疗基础设施的改善,预计亚太地区心臟生物标记市场将显着增长。该地区的心臟健康意识不断增强,推动了对先进诊断工具的需求。此外,政府和医疗机构加强心臟护理的努力也有助于市场扩张。随着医疗技术的进步,随着中国和印度等国家越来越多地采用心臟生物标记物,亚太地区有望见证显着的市场成长。
According to Stratistics MRC, the Global Cardiac Biomarkers Market is accounted for $18.7 billion in 2023 and is expected to reach $54.8 billion by 2030 growing at a CAGR of 16.6% during the forecast period. Cardiac biomarkers are specific molecules or proteins released into the bloodstream due to heart injury, damage or stress. These biomarkers, such as troponins, creatine kinase-MB (CK-MB), and B-type natriuretic peptide (BNP), are used in diagnostics to indicate heart-related conditions. Their detection and levels aid in diagnosing heart attacks, heart failure or other cardiac diseases, guiding treatment decisions and assessing cardiac health.
According to the World Health Organization (WHO), 77 million adults above 18 years have type 2 diabetes, with 25 million prediabetics. This increases cardiovascular disease risk and puts additional pressure on the health system.
Rising cardiovascular diseases
With an increasing global burden of heart-related conditions like heart attacks, heart failure and cardiac ischemia, there's a growing demand for reliable diagnostic tools. Cardiac biomarkers serve as vital indicators, aiding in the early detection, diagnosis, and prognosis of cardiovascular ailments. Their ability to accurately assess heart health, predict risks, and guide treatment strategies aligns with the pressing need for efficient, timely, and precise diagnostics in combating the rising incidence of cardiovascular diseases worldwide.
Stringent regulations
Stringent regulations pose a restraint on cardiac biomarker development and implementation. The rigorous approval processes set by regulatory bodies demand extensive clinical validation, often prolonging the time-to-market for new biomarkers. These stringent guidelines necessitate comprehensive studies to ensure accuracy, sensitivity and specificity in detecting cardiac conditions. Compliance with these regulations involves significant investment in research, clinical trials, and meeting specific performance criteria, leading to increased costs and time constraints.
Increasing focus on point-of-care testing
Point-of-care tests allow for rapid and convenient on-site diagnostics, offering immediate results without the need for sending samples to a central laboratory. In cardiac care, this facilitates quicker detection of biomarkers like troponins, enabling faster diagnosis of heart conditions such as heart attacks. This shift enhances patient care by expediting treatment decisions, especially in emergency settings and supports healthcare systems by reducing turnaround times and improving overall efficiency in managing cardiac emergencies.
Emergence of alternative diagnostic methods
New technologies, such as advanced imaging techniques or point-of-care testing devices, might offer rapid, non-invasive and possibly more cost-effective ways to assess cardiac health. These alternatives could challenge the dominance of traditional biomarker testing, impacting market adoption and preferences among healthcare providers.
The COVID-19 pandemic influenced cardiac biomarker testing by diverting healthcare resources towards managing the virus. Reduced non-COVID medical visits led to fewer cardiac evaluations, impacting biomarker testing frequency. Additionally, some COVID patients experienced cardiac complications, increasing the demand for biomarker assessments. The pandemic's strain on healthcare systems altered priorities, affecting cardiac biomarker utilisation and emphasising the need for adaptable diagnostic strategies during health crises.
The troponins segment is expected to be the largest during the forecast period
The troponins segment is projected to dominate due to its widespread use as a highly sensitive and specific cardiac biomarker for diagnosing heart-related conditions. Troponins, especially troponin I and troponin T, exhibit superior sensitivity in detecting myocardial injury, notably for diagnosing heart attacks. The growing prevalence of cardiovascular diseases globally and the increasing adoption of troponin testing in routine clinical practice contribute to its anticipated prominence, making it the largest segment in cardiac biomarker testing during the forecast period.
The hospitals segment is expected to have the highest CAGR during the forecast period
The hospitals segment is poised for substantial growth due to increased patient access to advanced healthcare services and diagnostic facilities in hospital settings. Hospitals serve as primary centres for acute care, where cardiac biomarker testing plays a pivotal role in diagnosing heart-related conditions. Rising incidences of cardiovascular diseases and the need for timely and accurate diagnostics within hospital environments contribute to the segment's anticipated growth.
North America's anticipated dominance in the cardiac biomarkers market is attributed to well-established healthcare infrastructure, technological advancements and high healthcare spending. The region's robust research and development activities, along with the presence of key market players, contribute to its significant market share. Additionally, the high prevalence of cardiovascular diseases, coupled with increasing awareness and adoption of advanced diagnostic techniques, drives market growth.
The Asia-Pacific region is poised for substantial growth in the cardiac biomarker market due to the increasing prevalence of cardiovascular diseases, a rising ageing population and improving healthcare infrastructure. The region witnesses a growing awareness of cardiac health, driving demand for advanced diagnostic tools. Additionally, initiatives by governments and healthcare organisations to enhance cardiac care contribute to the market's expansion. The increasing adoption of cardiac biomarkers in countries like China and India, along with advancements in healthcare technologies, positions the Asia-Pacific region for significant market growth.
Key players in the market
Some of the key players in Cardiac Biomarkers Market include Abbott Laboratories, Beckman Coulter, Becton, Dickinson and Company (BD), BG Medicine, Bio-Rad Laboratories, Corgenix , Fujirebio, Hologic, Meso Scale Diagnostics (MSD), Mindray, Ortho Clinical Diagnostics, Pathkind Labs, Qiagen, Randox Laboratories, R-Biopharm AG, Response Biomedical, Roche Diagnostics, Siemens Healthineers, Singulex Inc, SRL Diagnostics, Thermo Fisher Scientific and Trinity Biotech.
In October 2023, Mindray has announced the introduction and global launch of two new high-sensitivity troponin I (hs-cTnI) and NT-proBNP cardiac biomarkers. The additions enhance Mindray's diverse portfolio of cardiac biomarkers for diagnosing and managing cardiovascular diseases (CVDs), according to a written statement issued by the global medical devices and solutions provider.
In January 2023, Pathkind Labs, Roche Diagnostics partner to release cardiac biomarker. This announcement of NTProBNP comes in light of the growing burden of heart failure among T2D patients in India, inciting the need for urgent action. NTProBNP can directly predict adverse outcomes and cardiovascular mortality and can evaluate the overall status of a patient with type 2 diabetes to facilitate the establishment of correct therapy management and follow-up.
In September 2022, SRL Diagnostics launched "Heart Assure," a specialized test that can predict the risk of a cardiac event in an individual. High-sensitivity troponin I is a simple blood test that can precisely predict a cardiac injury by providing a heart health risk score.