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市场调查报告书
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1289774
全球中枢神经系统生物标志物市场 - 2023-2030年Global Central Nervous System Biomarkers Market - 2023-2030 |
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全球中枢神经系统生物标志物市场规模在2022年达到47.908亿美元,预计到2030年将出现有利可图的增长,达到98.527亿美元。在预测期间(2023-2030年),该市场的年复合增长率为9.7%。
生物标志物或生物标记物是定量测量,提供有关生物过程、疾病状态或对治疗的反应的信息。它们有可能更好地了解某一特定疾病的病因和发病机制,为研究人员和临床医生提供对许多衰弱性疾病的诊断、治疗和预后的宝贵见解。
中枢神经系统生物标志物市场受到一些因素的推动,如结合蛋白质组学、基因组学和中枢神经系统组织、CSF或血液的代谢组学询问,以及成像技术和新型生物标志物的开发。
中枢神经系统疾病的新型潜在生物标志物包括tau蛋白、神经丝轻链(NFL)、胶质纤维酸性蛋白(GFAP)和泛素C端水解物-L1(UCH-L1)。tau蛋白是一种神经轴突标志物,主要位于中枢神经系统的白质中,据报道在缺血性中风和心脏骤停中会增加。NFL在心脏骤停后的预后中具有很高的准确性,但也有报道说它在神经退行性疾病(如阿尔茨海默病)中会增加。
GFAP是一种星形细胞标志物,作为神经保护机制的一部分而产生,并与头部创伤、脑内出血、缺血性中风和心脏骤停后的预后有关。UCH-L1是一种神经元细胞体标记,对脑损伤后的神经轴突稳定性和修复至关重要。
技术的进步加快了生物标志物的发现速度,但大多数生物标志物还没有得到验证。将生物标记物纳入临床试验和实践将有助于提高研究效率,并为个性化神经病学的发展提供信息。
随着验证过程的高成本,如样本收集和储存,政府的规则和政策正在改变,因为报销不包括不被认为是标准护理的生物标志物介导的治疗。
即使生物标志物为测试增加了重要的价值,但退款是有限的。例如,拥有5000多万受益人的美国最大的医疗保健保险公司Medicare不资助实验性药品或大多数筛查和生物标志物测试。因此,上述因素预计将在预测期内阻碍市场的增长。
COVID-19大流行病与一系列神经系统并发症有关,包括认知障碍和神经退行性变化。例如,西弗吉尼亚州的马歇尔大学回顾了与COVID-19有关的各种神经退行性变化,并强调了主要循环生物标志物的重要性,与疾病的进展和严重程度有关。
他们的文献调查表明,重要的中枢神经系统蛋白,如GFAP、NfL和pT181-tau,以及各种炎症细胞因子,在COVID-19患者中都有明显改变。目前对与COVID-19有关的神经病理变化以及生物标志物在识别有可能发展为严重疾病的病人方面的潜在用途的理解是有限的。
关于战争对全球科学界的长期影响以及俄罗斯乌克兰战争期间乌克兰学术、医学和科学学科研究机会的错过的风险。根据FDA的临床试验数据库,乌克兰正在测试251种药品和设备。
根据临床试验数据库,2022年,乌克兰正在进行或计划进行1000多项药物临床试验,其中仅在肿瘤学领域就有786项。战争对俄罗斯的临床试验基地产生了负面影响,因为资源和人力没有按照优先次序分配,导致中枢神经系统护理恶化。
The Global Central Nervous System Biomarkers Market size reached US$ 4,790.8 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 9,852.7 million by 2030. The market is exhibiting at a CAGR of 9.7% during the forecast period (2023-2030).
Biomarkers or biological markers are quantitative measurements that provide information about biological processes, a disease state, or a response to treatment. They have the potential to better understand the etiology and pathogenesis of a given disorder, providing researchers and clinicians with valuable insight into diagnosis, treatment, and prognosis for many debilitating disorders and diseases.
The central nervous system biomarkers market is driven by factors such as combining proteomics, genomics, and metabolomic interrogation of CNS tissues, CSF, or blood, and imaging technologies and the development of novel biomarkers.
Novel potential biomarkers for CNS disorders include the tau protein, neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and ubiquitin C-terminal hydrolase-L1 (UCH-L1). The tau protein is a neuroaxonal marker located mainly in the white matter of the central nervous system and is reported to be increased in ischemic stroke and cardiac arrest. The NFL is highly accurate in prognostication after cardiac arrest, but it has also been reported to increase in neurodegenerative disorders such as Alzheimer's disease.
GFAP is an astrocytic marker that is produced as part of a neuroprotective mechanism and has been associated with prognosis after head trauma, intracerebral hemorrhage, ischemic stroke, and cardiac arrest. UCH-L1 is a neuronal cell body marker that is crucial for neuroaxonal stability and repair after brain injury.
Technological advances have increased the pace of biomarker discovery, but most are yet to be validated. Incorporating biomarkers into clinical trials and practice will help improve study efficiency and inform advancements in personalized neurology.
With the high cost of the validation process, such as sample collection & storage, government rules and policies are changing since reimbursements do not cover biomarker-mediated therapies that are not considered standard of care.
Even though biomarkers add significant value to tests, refunds are limited. For instance, Medicare, the nation's largest healthcare insurer with more than 50 million beneficiaries, does not fund experimental medicines or most screening and biomarker tests. Therefore, the above factors are expected to hamper the market growth over the forecast period.
The COVID-19 pandemic has been linked to a range of neurological complications, including cognitive impairment and neurodegenerative changes. For instance, Marshall University, West Virginia, reviewed the diverse neurodegenerative changes associated with COVID-19 and highlighted the importance of major circulating biomarkers, associated with disease progression and severity.
Their literature survey indicated that important CNS proteins, such as GFAP, NfL, and pT181-tau, and various inflammatory cytokines, are altered significantly in COVID-19 patients. The current understanding of the neuropathological changes associated with COVID-19 and the potential use of biomarkers in identifying patients at risk for developing severe forms of the disease is limited.
Risk about the war's long-term impact on the scientific community worldwide and the missed opportunities for research in Ukraine's academic, medical, and scientific disciplines during Russia Ukraine war. Ukraine was testing 251 medicines and devices, according to the FDA's clinical trials database.
According to the clinical trials database, in 2022, over 1,000 medication clinical trials were underway or planned in Ukraine, including 786 in the field of oncology alone. The war has had a negative impact on Russian clinical trial sites, as resources and manpower are not allocated according to priority, leading to worsening CNS care.
The global central nervous system biomarkers market is segmented by type, application, disease, end-user, and by region.
The safety biomarkers segment accounted for the highest market stake accounting for approximately 35.5% of the central nervous system biomarkers market in 2022. Safety biomarkers are expected to dominate the market growth due to increased awareness of health issues such as depression, Parkinson's, and multiple sclerosis. They play a crucial role in preclinical and clinical research trials, with rapid changes in growth measurement, computation, and analysis leading to the explosive growth of the translational research field. For Instance, Donanemab improved cognition and ability to perform activities of daily living in patients with early Alzheimer's disease at 76 weeks.
North America is estimated to hold around 42.7% of the total market share throughout the forecast period due to rising CNS cancer cases and increased R&D expenditure. According to the American Cancer Society, brain malignancy is the second most common cancer in children and adolescents, where CNS biomarkers are commonly used.
The major global players in the market include: Acumen Pharmaceuticals, Biogen, Alseres Pharmaceuticals, Aposense, Avacta Life Sciences Ltd., Banyan Biomarkers Inc., Bio-Rad Laboratories Inc., DiaGenic ASA, G-Biosciences, and Thermo Fisher Scientific.
The global central nervous system biomarkers market report would provide approximately 54 tables, 46 figures, and 195 pages.
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