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全球戊型肝炎诊断测试市场 2023-2030Global Hepatitis E Diagnostic Tests Market 2023-2030 |
全球戊型肝炎诊断测试市场预计在预测期内(2024-2031年)CAGR为7.40%。市场的成长归因于对全球健康关注的需求。戊型肝炎作为主要公共卫生问题的全球盛行率和重要性推动了诊断测试的不断增长和接受,以有效管理和尽量减少疾病对公共卫生的影响。根据美国国立卫生研究院(gov.) 2023 年5 月的数据,戊型肝炎是由戊型肝炎病毒(HEV) 引起的肝臟炎症,通常透过受污染的水或食用未煮熟的动物肉(尤其是猪肉)传染。根据世界卫生组织 (WHO) 统计,每年约有 2,000 万例 HEV 感染,导致 330 万有症状病例和 44,000 人死亡。这占病毒性肝炎相关死亡率的 3.3%。而戊型肝炎在全球流行。
全球戊型肝炎诊断测试市场按产品类型、动物类型、应用和最终用户进行细分。根据产品类型,市场分为固定式多层 CT 扫描仪和便携式 CT 扫描仪。根据动物类型,市场分为伴侣动物、牲畜动物和其他动物。根据应用,市场细分为神经病学、肿瘤学、心臟病学、肾臟病学、胃肠病学等。此外,根据最终用户,市场细分为兽医诊所和医院、研究机构等。酶联免疫吸附测定 (ELISA) 子类别预计将占据技术领域的很大一部分市场份额。这一增长可归因于医院广泛采用诊断肝炎的程序。
在疾病类型中,血清学检测子细分市场预计将在全球戊型肝炎诊断检测市场中占据相当大的份额。细分市场的成长归因于血清学检测的进步。酵素免疫分析 (EIA) 测试的引入,特别是能够识别 IgM 和 IgG 抗 HEV 抗体的被动 EIA 技术,强调了戊型肝炎诊断血清学测试的技术进步。 IgM 和 IgG 抗体之间的区分有助于识别现代或先前的疾病。据 MDPI 称,2021 年 1 月,用于检测 HEV 感染的血清学检测包括酵素免疫分析(EIA)检测。间接 EIA 测定能够检测 IgM 和 IgG 抗 HEV 抗体。 IgM 抗 HEV 抗体最早出现,显示急性或近期感染,而 IgG 抗 HEV 抗体持续数年,显示近期或先前感染。然而,这些检测的灵敏度和特异性可能有所不同,并且可能与其他病毒(如 CMV 和 EBV)发生交叉反应。万泰试验是最常用的 IgM 检测商业 ELISA 试验,在 EIA 试验中以其高灵敏度和特异性而闻名。
全球戊型肝炎诊断测试市场根据地理位置进一步细分,包括北美(美国和加拿大)、欧洲(英国、义大利、西班牙、德国、法国和欧洲其他地区)、亚太地区(印度、中国) 、日本、韩国和亚洲其他地区)以及世界其他地区(中东和非洲以及拉丁美洲)。其中,由于医疗保健设施的不断增长、适用的製造商数量巨大以及政府参与度和专业社区的增加,预计亚太地区将在全球市场中占据显着份额。
在所有地区中,北美地区预计在预测期内将以相当大的CAGR成长。区域增长归因于该地区诊断测试的发展。这些研究的见解推动了诊断测试的发展,这些测试能够识别戊型肝炎感染的多种标记物,例如抗体和病毒RNA,以便提供更完整的诊断图并帮助了解疾病动态。据 MDPI 称,2023 年 10 月,对爱沙尼亚 1002 份供体血清中抗 HEV IgG 和 IgM 抗体以及病毒 RNA 的流行情况进行了分析。其中,48份血清(4.8%)检测出抗HEV抗体呈阳性,其中40份(4%)含有抗HEV IgG,15份(1.5%)含有抗HEV IgM。此外,7 名捐赠者同时拥有这两类抗体。然而,在任何血清样本中均未检测到 HEV RNA。然而,随着年龄的增长,抗 HEV IgG 带因者的发生率较高,统计分析发现感染风险变数与抗 HEV 抗体盛行率之间没有统计上的显着关联。
服务于戊型肝炎诊断测试市场的主要公司包括 Bio-Rad Laboratories, Inc.、Danaher Corp.、Diasorin SpA、EKF Diagnostics Holdings plc、ELITech Group 等。市场参与者透过各种策略(包括併购、合作、合作、融资和新产品发布),为市场成长做出了巨大贡献,以保持市场竞争力。例如,2022年9月,吉利德科学公司与布莱根妇女医院、哈佛医学院和贝斯以色列女执事医疗中心合作。这项多年计画包括一项分阶段的方法,旨在解决越南和菲律宾这两个乙型肝炎和丙型肝炎流行率很高的国家的基础医疗机构的病毒性肝炎诊断和管理障碍。
Global Hepatitis E Diagnostic Tests Market Size, Share & Trends Analysis Report by Disease Type (Serology Tests, Molecular Tests, Immunoassays, and Point-of-Care Tests), by Technology (Enzyme-Linked Immunosorbent Assay, Rapid Diagnostic Tests, Next-Generation Sequencing, and Nucleic Acid Amplification Tests) and by End User (Hospitals and Clinics, Diagnostic Laboratories, and Public Health Agencies and Research Institutions), Forecast Period (2024-2031)
The global hepatitis e diagnostic tests market is anticipated to grow at a CAGR of 7.40% during the forecast period (2024-2031). The market's growth is attributed to the demand for global health concern. The global prevalence and significance of Hepatitis E as a major public health concern motivate continued growth and acceptance of diagnostic tests to effectively manage and minimize the disease's impact on public health. According to the National Institute of Health (gov.) in May 2023, the hepatitis E is a liver inflammation caused by the hepatitis E virus (HEV), that is commonly transmitted through contaminated water or the consumption of undercooked animal meat, particularly pork. According to the World Health Organization (WHO), there are approximately 20 million HEV infections annually, resulting in 3.3 million symptomatic cases and 44,000 deaths. This accounts for 3.3% of viral hepatitis-related mortalities. While hepatitis E is prevalent globally.
The global hepatitis E diagnostic tests market is segmented on the product type, animal type, application, and end user. Based on the product type, the market is sub-segmented into stationary multi-slice CT scanner, and portable CT scanner. Based on the animal type, the market is sub-segmented into companion animal, livestock animal, others. Based on the application, the market is sub-segmented into neurology, oncology, cardiology, nephrology, gastroenterology, and others. Furthermore, on the basis of end-user, the market is sub-segmented into veterinary clinics and hospitals, research institutes, and others. The enzyme-linked immunosorbent assay (ELISA) subcategory is expected to capture a significant portion of the market share within the technology segment. The growth can be attributed to the widespread adoption of the procedure to diagnose hepatitis in hospitals.
Among the disease type, the serology tests sub-segment is expected to hold a considerable share of the global Hepatitis E Diagnostic Tests market. The segmental growth is attributed to the advancement in serological testing. The introduction of Enzyme Immunoassay (EIA) testing, specifically passive EIA techniques capable of identifying IgM and IgG anti-HEV antibodies, emphasizes technological advances in serology tests for Hepatitis E diagnosis. The division between IgM and IgG antibodies aids in the identification of modern or previous diseases. According to the MDPI, in January 2021, serological tests used to detect HEV infection include enzyme immunoassay (EIA) tests. Indirect EIA assays are capable of detecting IgM and IgG anti-HEV antibodies. IgM anti-HEV antibodies are the first to appear, indicating an acute or recent infection, while IgG anti-HEV antibodies persist for years, suggesting a recent or past infection. However, the sensitivity and specificity of these assays can vary, and there is a potential for cross-reactivity with other viruses such as CMV and EBV. The Wantai test is the most commonly used commercial ELISA test for IgM detection, known for its high sensitivity and specificity among EIA tests.
The global hepatitis E diagnostic tests market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, Asia-Pacific is anticipated to hold a prominent share of the market across the globe, owing to the growing healthcare facilities, a significant amount of applicable manufacturer and rise in government involvement and proficient communities.
Among all regions, the North America regions is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the diagnostic test development across the region. Insights from such studies motivate the development of diagnostic tests capable of identifying numerous markers of Hepatitis E infection, such as antibodies and viral RNA, in order to provide a more complete diagnostic picture and aid in understanding disease dynamics. According to the MDPI, in October 2023, the prevalence of anti-HEV IgG and IgM antibodies, as well as viral RNA, was analyzed in 1002 donor sera in Estonia. Out of these, 48 sera (4.8%) tested positive for anti-HEV antibodies, with 40 (4%) containing anti-HEV IgG and 15 (1.5%) containing anti-HEV IgM. Additionally, 7 donors had antibodies of both classes simultaneously. However, no HEV RNA was detected in any of the blood serum samples. However for a higher incidence of anti-HEV IgG carriers with age, statistical analysis identified no statistically significant associations between infection risk variables and the prevalence of anti-HEV antibodies.
The major companies serving the hepatitis E diagnostic tests market includes Bio-Rad Laboratories, Inc., Danaher Corp., Diasorin S.p.A., EKF Diagnostics Holdings plc, ELITech Group, and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in September 2022,Gilead Sciences, Inc. collaborated with Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year program comprises a staged approach to addressing barriers to viral hepatitis diagnosis and management in basic healthcare authorities in Vietnam and the Philippines, two countries with significant hepatitis B and C prevalence.