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市場調查報告書
商品編碼
1828130
2025年全球免疫診斷市場報告Immunodiagnostics Global Market Report 2025 |
近年來,免疫診斷市場呈現強勁成長勢頭,規模將從2024年的228.8億美元增加到2025年的243.2億美元,複合年成長率為6.3%。預測期內的成長主要受以下因素驅動:感染疾病率上升、自體免疫疾病發生率上升、癌症診斷和監測、感染疾病全球化、公共衛生措施以及篩檢計畫。
預計未來幾年免疫診斷市場規模將強勁成長,2029年將達到328.9億美元,複合年成長率為7.8%。預測期內的成長可歸因於疫情防治、個人化醫療和生物標記發現、新興市場醫療基礎設施的不斷完善、與實驗室資訊系統的整合以及慢性病負擔的日益加重。預測期內的主要趨勢包括多重技術、就地檢驗(POCT)、生物標記發現和個人化醫療、數位免疫診斷的興起以及向液態切片的轉變。
免疫診斷試劑是主要依賴抗原抗體反應檢測血清胰島素的診斷方法。這些檢測已被用於識別抗體和寄生蟲抗原。
免疫診斷部門的主要產品包括試劑和耗材、儀器和軟體以及服務。試劑是用於與其他物質發生化學反應以檢測特定物質存在的物質,而耗材是指用於執行分析技術的可追溯物品。相關技術包括酵素結合免疫吸附檢測法、化學冷光免疫檢測、螢光免疫分析、免疫檢測和快速檢測。這些技術應用於各種醫療保健領域,包括感染疾病、腫瘤學、內分泌學、骨礦疾病、自體免疫疾病、心臟生物標記和藥物監測。研究的最終用戶包括醫院、診所、診斷實驗室和學術研究機構。
2025年春季美國關稅的突然上調及其引發的貿易摩擦對醫療設備行業產生了重大影響,尤其對用於診斷影像設備的進口零件、手術用不銹鋼和一次性塑膠製品產生了重大影響。由於醫院和診所抵制漲價,製造商面臨利潤壓力。監管挑戰使情況更加複雜,因為由於關稅而更換供應商通常需要重新認證醫療設備,導致市場進入延遲。為此,企業正在透過雙重採購關鍵零件、增加標準化產品的國內生產以及加快尋找更具成本效益的材料來降低風險。
本研究報告是商業研究公司 (The Business Research Company) 新報告系列的一部分,該系列提供免疫診斷試劑市場統計數據,例如全球市場規模、區域佔有率、競爭對手的市場佔有率、詳細的免疫診斷試劑市場細分、市場趨勢和商業機會,為您提供在免疫診斷試劑行業取得成功所需的數據。本免疫診斷試劑市場研究報告透過對產業現狀和未來趨勢的詳細分析,全面展望了您所需的一切。
我們對該市場未來五年7.8%的成長率預測與先前的預測一致。下降的主要原因是美國與其他國家之間關稅的影響。這種影響可能會直接影響美國,因為來自瑞典和台灣等主要地區的多重微球陣列和側流硝酸纖維素膜的供應鏈中斷,可能導致自體免疫疾病檢測的延遲和專業檢測成本的增加。這種影響可能會透過互惠關稅以及日益加劇的貿易緊張局勢和限制對全球經濟和貿易的負面影響,更廣泛地體現出來。
預計未來幾年,感染疾病的盛行率將推動免疫診斷市場的成長。感染疾病是由病毒、細菌、真菌、寄生蟲和其他可在人與人之間傳播的微生物引起的疾病。免疫診斷檢測用於檢測血液樣本中是否有病毒。例如,美國政府機構疾病管制與預防中心 (CDC) 在 2024 年 3 月報告稱,結核病病例數將從 2022 年的 8,320 例增加到 2023 年的 9,615 例,增加 1,295 例。因此,預計感染疾病的盛行率將顯著推動免疫診斷市場的發展。
預計不斷成長的醫療保健支出將推動免疫診斷試劑市場的未來成長。醫療保健支出是指醫療保健的總支出,涵蓋特定醫療保健系統或經濟體在醫療保健相關商品和服務上的所有支出。這些支出對於促進免疫診斷解決方案的開發和應用至關重要。例如,2023年11月,總部位於加拿大的非營利組織加拿大衛生資訊研究所預測,2023年醫療保健總支出將達到3,440億美元,較去年同期成長2.8%。因此,醫療保健成本的上漲正在推動免疫診斷試劑市場的擴張。
免疫診斷市場的主要企業正致力於創造創新解決方案,例如肺炎鏈球菌抗原免疫診斷檢測,這有助於診斷肺炎球菌肺炎感染。此檢驗用於檢測體液中是否存在肺炎球菌抗原,有助於診斷肺炎鏈球菌感染。例如,2024 年 9 月,義大利生物技術公司 DiaSorin SpA 推出了 LIAISON 肺炎球菌抗原免疫診斷檢測。此診斷測試專門用於定性檢測疑似患有肺炎球菌肺炎的成人尿液檢體中的肺炎球菌抗原。該測試提供了一種高性能解決方案,使醫療保健提供者能夠快速診斷肺炎球菌肺炎並將其與其他呼吸道感染疾病分開來。與 LIAISON CLIA 分析儀一起使用時,只需 35 分鐘即可獲得結果,從而可以及時、有針對性地進行抗生素治療。此外,識別 91 种血清型的能力增強了臨床決策能力,支持有效的抗生素管理,並且是社區獲得性肺炎免疫診斷領域的重大進步。
免疫診斷市場的主要企業正在擴大建立夥伴關係,以推動收益成長。醫療專家、學術機構和IT公司之間的合作將顯著促進市場擴張,促進創新並加速免疫診斷藥物的臨床應用。例如,2022年10月,澳洲放射性藥物公司Telix Pharmaceuticals Limited與美國醫療科技公司GE Healthcare合作,將Telix的在臨床實驗PET成像放射性示蹤劑與GE Healthcare的免疫診斷產品組合結合。此次合作旨在改善免疫治療測試中的治療方法選擇和患者監測。
2023年5月,美國生技公司Freenome收購了Oncimmune,收購金額未揭露。此次收購旨在整合Oncimmune的創新技術和免疫分析專業知識,並增強Freenome在早期癌症檢測方面的能力。此次收購旨在鞏固Freenome在癌症診斷市場的地位,並擴展其液態切片解決方案組合。 Oncimmune總部位於英國,專注於開發有助於癌症診斷和監測的免疫分析和生物標記發現技術。
免疫診斷市場的主要企業包括:雅培實驗室、Arkray Inc.、bioMerieux Inc.、Immunodiagnostic Systems Holdings Plc (IDS)、Bio-Rad Laboratories Inc.、DiaSorin SpA、F. Hoffmann-La Roche Ltd.、強生服務公司、西門子股份公司、Sysmex Corporation、Sysmex Corporation, 世界飛納赫爾科技公司、Sysmeding ? AG、珀金埃爾默公司、默克集團、Becton Dickinson and Company、Grifols SA、Ortho Clinical Diagnostics、貝克曼庫爾特公司、Bio-Techne Corporation、Creative Diagnostics、Fujire Holdings Inc.、Gold Standard Diagnostics Corp.、Hologic Inc.、Lumin Corporation、Fujire Holdings Inc.、Gold Standard Diagnostics Corp.、Hologic Inc.、Lumin Corporation., Inc., 阿拉伯聯合大公國 Corporation, el開鏡。
2024年免疫診斷試劑市場最大的地區是北美。免疫診斷試劑市場報告涵蓋的地區包括亞太地區、西歐、東歐、北美、南美以及中東和非洲。
免疫診斷試劑市場報告涵蓋的國家:澳洲、巴西、中國、法國、德國、印度、印尼、日本、俄羅斯、韓國、英國、美國、加拿大、義大利、西班牙
免疫診斷市場由提供凝集、比濁法、免疫沉澱和放射免疫擴散檢測服務的營業單位所獲得的收益所構成。市場規模包括服務提供者銷售或包含在其服務產品中的相關產品的價值。免疫診斷市場還包括抗鏈球菌溶血素-O乳膠、傳染性單核球增多症增多症玻片、類風濕因子和梅毒血清試劑的銷售。此市場的價值是指“出廠價”,即商品製造商或生產商向其他營業單位(包括下游製造商、批發商、經銷商和零售商)或直接向最終客戶銷售的商品價值。該市場中的商品價值還包括商品製造商銷售的任何相關服務。
Immunodiagnostics is a diagnostic approach that relies primarily on the antigen-antibody response for detecting serum insulin. These tests are employed to identify antibodies and parasite antigens.
The principal products in the field of immunodiagnostics include reagents and consumables, instruments and software, and services. Reagents are substances used to initiate chemical reactions with other substances to detect the presence of specific substances, while consumables refer to traceable items utilized in the execution of analysis techniques. The technologies involved encompass enzyme-linked immunosorbent assay, chemiluminescence immunoassay, fluorescent immunoassay, radioimmunoassay, rapid tests, and others. These technologies find applications in various medical fields such as infectious diseases, oncology, endocrinology, bone and mineral diseases, autoimmunity disorders, cardiac biomarkers, drug monitoring, and more. The end-users of immunodiagnostics include hospitals, clinics, diagnostic laboratories, academic and research institutes, among others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp increase in U.S. tariffs and resulting trade tensions in spring 2025 are significantly impacting the medical equipment sector, especially for imported components used in imaging machines, surgical-grade stainless steel, and disposable plastics. With hospitals and clinics pushing back against price increases, manufacturers are facing margin pressure. The situation is further complicated by regulatory challenges, as switching suppliers due to tariffs often necessitates re-certification of medical devices, leading to delays in market entry. In response, companies are mitigating risks by dual-sourcing key components, ramping up domestic production of standardized items, and accelerating research into more cost-effective materials.
The immunodiagnostics market research report is one of a series of new reports from The Business Research Company that provides immunodiagnostics market statistics, including immunodiagnostics industry global market size, regional shares, competitors with immunodiagnostics market share, detailed immunodiagnostics market segments, market trends, and opportunities, and any further data you may need to thrive in the immunodiagnostics industry. This immunodiagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The immunodiagnostics market size has grown strongly in recent years. It will grow from $22.88 billion in 2024 to $24.32 billion in 2025 at a compound annual growth rate (CAGR) of 6.3%. The growth in the historic period can be attributed to the increasing incidence of infectious diseases, rise in autoimmune diseases, cancer diagnosis and monitoring, globalization of infectious diseases, public health initiatives, and screening programs.
The immunodiagnostics market size is expected to see strong growth in the next few years. It will grow to $32.89 billion in 2029 at a compound annual growth rate (CAGR) of 7.8%. The growth in the forecast period can be attributed to pandemic preparedness and response, personalized medicine and biomarker discovery, growing healthcare infrastructure in emerging markets, integration with laboratory information systems, rising burden of chronic diseases. Major trends in the forecast period include multiplexing technologies, point-of-care testing (POCT), biomarker discovery and personalized medicine, the rise of digital immunodiagnostics, shift toward liquid biopsy.
The forecast of 7.8% growth over the next five years remains unchanged from the previous projection for this market.This reduction is primarily due to the impact of tariffs between the US and other countries. This is likely to directly affect the US through supply chain disruptions for multiplex bead arrays and lateral flow nitrocellulose membranes, sourced from key regions such as Sweden and Taiwan, which could lead to delayed autoimmune disease detection and increased costs for specialty testing.The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The rising prevalence of infectious diseases is anticipated to drive the growth of the immunodiagnostics market in the coming years. Infectious diseases are illnesses caused by germs such as viruses, bacteria, fungi, or parasites that can be transmitted between individuals. Immunodiagnostic assays are utilized to detect the presence of viruses in blood samples. For example, in March 2024, the Centers for Disease Control and Prevention (CDC), a U.S. government agency, reported that the number of tuberculosis cases increased from 8,320 in 2022 to 9,615 in 2023, representing an increase of 1,295 cases. Therefore, the growing prevalence of infectious diseases is expected to significantly boost the immunodiagnostics market.
The increasing healthcare expenditure is expected to propel the growth of the immunodiagnostics market in the future. Healthcare expenditure refers to the total spending on healthcare costs, encompassing all money spent on healthcare-related goods and services within a specific healthcare system or economy. This expenditure is vital for fostering the development and accessibility of immunodiagnostic solutions. For example, in November 2023, the Canadian Institute for Health Information, a non-profit organization based in Canada, projected that total health expenditure would reach $344 billion in 2023, indicating a modest growth of 2.8% compared to the previous year. Therefore, the rising healthcare expenditure is driving the expansion of the immunodiagnostics market.
Leading companies in the immunodiagnostics market are focused on creating innovative solutions, such as the S. pneumoniae antigen immunodiagnostic assay, to assist in diagnosing pneumococcal pneumonia infections. This assay is used to detect the presence of Streptococcus pneumoniae antigens in bodily fluids, facilitating the diagnosis of pneumococcal infections. For instance, in September 2024, DiaSorin S.p.A., an Italy-based biotechnology company, introduced the LIAISON S. pneumoniae antigen immunodiagnostic assay. This diagnostic test is specifically designed for the qualitative detection of Streptococcus pneumoniae antigens in urine samples from adults suspected of having pneumococcal pneumonia. The assay provides a high-throughput solution, enabling healthcare providers to rapidly diagnose and differentiate pneumococcal pneumonia from other respiratory infections. When utilized with LIAISON CLIA analyzers, the test delivers results in just 35 minutes, promoting timely and targeted antimicrobial therapy. Additionally, its capability to identify 91 serotypes enhances clinical decision-making and supports effective antibiotic stewardship, representing a significant advancement in the immunodiagnostics field for community-acquired pneumonia.
Major companies in the immunodiagnostics market are increasingly forming partnerships to drive revenues. Collaborations involving medical experts, academic entities, and IT firms can significantly contribute to market expansion by fostering innovation and accelerating clinical immunodiagnostics. For example, in October 2022, Telix Pharmaceuticals Limited, an Australia-based radiopharmaceutical company, partnered with GE Healthcare, a US-based medical technology company, to combine Telix's investigational PET imaging radiotracers with GE Healthcare's immuno-diagnostic range. This collaboration aims to improve therapy selection and patient monitoring in immunotherapy trials.
In May 2023, Freenome, a biotechnology company based in the U.S., acquired Oncimmune for an undisclosed amount. This acquisition is intended to enhance Freenome's capabilities in early cancer detection by incorporating Oncimmune's innovative technology and expertise in immune profiling. The move aims to strengthen Freenome's position in the oncology diagnostics market and expand its portfolio of liquid biopsy solutions. Oncimmune, located in the UK, specializes in developing technologies for immune profiling and biomarker discovery to aid in cancer diagnosis and monitoring.
Major companies operating in the immunodiagnostics market include Abbott Laboratories, Arkray Inc., bioMerieux Inc., Immunodiagnostic Systems Holdings Plc (IDS), Bio-Rad Laboratories Inc., DiaSorin S.p.A., F. Hoffmann-La Roche Ltd., Johnson & Johnson Services Inc., Siemens AG, Sysmex Corporation, Thermo Fisher Scientific Inc., Danaher Corporation, Qiagen N.V., Tecan Trading AG, PerkinElmer Inc., Merck KGaA, Becton Dickinson and Company, Grifols S.A., Ortho Clinical Diagnostics, Beckman Coulter Inc., Bio-Techne Corporation, Creative Diagnostics, Fujirebio Holdings Inc., Gold Standard Diagnostics Corp., Hologic Inc., Luminex Corporation, Myriad Genetics Inc., Natera Inc., OraSure Technologies Inc., Quidel Corporation
North America was the largest region in the immunodiagnostics market in 2024. The regions covered in the immunodiagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the immunodiagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The immunodiagnostics market consists of revenues earned by entities by providing agglutination, nephelometry, immunoprecipitation, and radial immunodiffusion test services. The market value includes the value of related goods sold by the service provider or included within the service offering. The immunodiagnostics market also includes sales of anti-streptolysin-O latex, infectious mononucleosis slide, rheumatoid factor, and syphilis serology reagent. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Immunodiagnostics Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on immunodiagnostics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for immunodiagnostics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The immunodiagnostics market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.