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全球E型肝炎診斷測試市場 2023-2030Global Hepatitis E Diagnostic Tests Market 2023-2030 |
全球E型肝炎診斷測試市場預計在預測期內(2024-2031年)CAGR為7.40%。市場的成長歸因於對全球健康關注的需求。E型肝炎作為主要公共衛生問題的全球盛行率和重要性推動了診斷測試的不斷成長和接受,以有效管理和盡量減少疾病對公共衛生的影響。根據美國國立衛生研究院(gov.)2023年5月的資料,E型肝炎是由E型肝炎病毒(HEV)引起的肝臟炎症,通常透過受污染的水或食用未煮熟的動物肉(尤其是豬肉)傳染。根據世界衛生組織(WHO)統計,每年約有 2,000 萬例 HEV 感染,導致 330 萬有症狀病例和 44,000 人死亡。這佔病毒性肝炎相關死亡率的 3.3%。而E型肝炎在全球流行。
全球E型肝炎診斷測試市場依產品類型、動物類型、應用和最終用戶進行細分。根據產品類型,市場分為固定式多層 CT 掃描儀和攜帶式 CT 掃描儀。根據動物類型,市場分為伴侶動物、牲畜動物和其他動物。根據應用,市場細分為神經病學、腫瘤學、心臟病學、腎臟病學、胃腸病學等。此外,根據最終用戶,市場細分為獸醫診所和醫院、研究機構等。酶聯免疫吸附測定(ELISA)子類別預計將佔據技術領域的很大一部分市場佔有率。該成長可歸因於醫院廣泛採用診斷肝炎的程序。
在疾病類型中,血清學檢測子細分市場預計將在全球E型肝炎診斷檢測市場中佔據相當大的佔有率。細分市場的成長歸因於血清學檢測的進步。酵素免疫分析(EIA)測試的引進,特別是能夠識別 IgM 和 IgG 抗 HEV 抗體的被動 EIA 技術,強調了E型肝炎診斷血清學測試的技術進步。 IgM 和 IgG 抗體之間的區分有助於識別現代或先前的疾病。據 MDPI 表示,2021年 1月,用於檢測 HEV 感染的血清學檢測包括酵素免疫分析(EIA)檢測。間接 EIA 測定能夠檢測 IgM 和 IgG 抗 HEV 抗體。 IgM 抗 HEV 抗體最早出現,顯示急性或近期感染,而 IgG 抗 HEV 抗體持續數年,顯示近期或先前感染。然而,這些檢測的靈敏度和特異性可能有所不同,並且可能與其他病毒(如 CMV 和 EBV)發生交叉反應。萬泰試驗是最常用的 IgM 檢測商業 ELISA 試驗,在 EIA 試驗中以其高靈敏度和特異性而聞名。
全球E型肝炎診斷測試市場根據地理位置進一步細分,包括北美(美國和加拿大)、歐洲(英國、義大利、西班牙、德國、法國和歐洲其他地區)、亞太地區(印度、中國) 、日本、韓國和亞洲其他地區)以及世界其他地區(中東和非洲以及拉丁美洲)。其中,由於醫療保健設施的不斷成長、適用的製造商數量巨大以及政府參與度和專業社區的增加,預計亞太地區將在全球市場中佔據顯著佔有率。
在所有地區中,北美地區預計在預測期內將以相當大的CAGR成長。區域成長歸因於該地區診斷測試的發展。這些研究的見解推動了診斷測試的發展,這些測試能夠識別E型肝炎感染的多種標記物,例如抗體和病毒RNA,以便提供更完整的診斷圖並幫助了解疾病動態。據 MDPI 表示,2023年 10月,對愛沙尼亞 1002 份供體血清中抗 HEV IgG 和 IgM 抗體以及病毒 RNA 的流行情況進行了分析。其中,48份血清(4.8%)檢測出抗HEV抗體呈陽性,其中40份(4%)含有抗HEV IgG,15份(1.5%)含有抗HEV IgM。此外,7 名捐贈者同時擁有這兩類抗體。然而,在任何血清樣本中均未檢測到 HEV RNA。然而,隨著年齡的成長,抗 HEV IgG 帶因者的發生率較高,統計分析發現感染風險變數與抗 HEV 抗體盛行率之間沒有統計上的顯著關聯。
服務於E型肝炎診斷測試市場的主要公司包括 Bio-Rad Laboratories, Inc.、Danaher Corp.、Diasorin SpA、EKF Diagnostics Holdings plc、ELITech Group 等。市場參與者透過各種策略(包括併購、夥伴關係、合作、融資和新產品發布),為市場成長做出了巨大貢獻,以保持市場競爭力。例如,2022年9月,Gilead Sciences, Inc.與Brigham婦女醫院、Harvard醫學院和Beth Israel Deaconess醫療中心合作。這項多年計畫包括一項分階段的方法,目的是解決越南和菲律賓這兩個乙型肝炎和丙型肝炎流行率很高的國家的基礎醫療機構的病毒性肝炎診斷和管理障礙。
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.