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市場調查報告書
商品編碼
1828064
2025年全球免疫檢測市場報告Immunoassay Global Market Report 2025 |
近年來,免疫檢測市場穩定成長,從2024年的358.1億美元成長到2025年的373.2億美元,複合年成長率為4.2%。預測期內的成長主要受疾病流行、人口老化、感染疾病爆發、就地檢驗、研究經費增加等因素所驅動。
預計未來幾年免疫檢測市場規模將強勁成長,到2029年將達到494億美元,複合年成長率為7.3%。預測期內的成長可歸因於個人化醫療、新興市場的擴張、疫情防治、癌症診斷以及向居家檢測的轉變。預測期內的主要趨勢包括監管協調、多用途免疫檢測、客製化檢測服務、與穿戴式裝置的整合以及檢測法的微型化。
免疫檢測是一種生物分析測試,利用抗體與抗原的結合來檢測和定量特定化學物質,在疾病診斷中發揮重要作用。免疫檢測測試結果的資訊可用於制定適當的治療策略。免疫檢測測試依賴高特異性抗分析物抗體上有限數量的受體與大多數標記和未標記樣本分析物之間的競爭性結合反應。
免疫檢測產品的主要類型包括試劑和套件、分析儀和設備以及軟體和服務。試劑是促進反應的物質或產品,常用於各種測試。免疫檢測樣本包括血液、唾液和尿液,檢體包括治療監測、腫瘤學、循環系統、內分泌學、傳染病檢查和自體免疫疾病。免疫檢測產品的最終用戶多種多樣,包括研究和學術實驗室、居家醫療機構、製藥和生物技術公司、委外研發機構(CRO)、血庫、醫院和診所以及臨床實驗室。
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價格上漲,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、加強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,該系列提供免疫檢測市場統計數據,例如免疫檢測行業的全球市場規模、各地區市場佔有率、免疫檢測測定市場佔有率的競爭對手、詳細的免疫檢測市場細分、市場趨勢和機遇,以及您在免疫檢測行業取得成功所需的數據。本免疫檢測市場研究報告對該行業的現狀和未來趨勢進行了詳細分析,為您提供所需的一切觀點。
未來五年7.3%的預測成長率比我們先前對該市場的預測略有下降,下降了0.2%。下降的主要原因是美國與其他國家之間關稅的影響。美國可能會直接感受到這種影響,因為酵素連結抗體和微孔盤洗板機的供應鏈中斷,這些產品來自瑞士和荷蘭等主要地區,這可能導致傳染病檢查延遲和診斷實驗室成本增加。此外,這種影響可能會透過互惠關稅以及貿易緊張局勢和限制加劇對全球經濟和貿易的負面影響,在更廣泛的範圍內顯現。
感染疾病和慢性病的流行預計將在不久的將來推動免疫檢測市場的成長。慢性病通常被定義為持續一年以上、需要持續治療、限制日常活動或兩者兼而有之的疾病。感染疾病是由細菌、病毒、真菌和寄生蟲等生物引起的疾病。許多生物在人體內和人與人之間共存,有些感染疾病可以在人與人之間傳播。免疫檢測用於檢測各種感染疾病和慢性病。例如,根據美國生物醫學研究機構國立衛生研究院 (NIH) 的報告,預計到 2023 年,美國50 歲及以上患有至少一種慢性病的人數將增加 99.5%,從 2020 年的 71,522,000 人增加到 2050 年的 142,660,000 人。此外,患有多種疾病的人數預計將增加 91.16%,從 2020 年的 7,834,000 人增加到 2050 年的 14,968,000 人。因此,感染疾病和慢性病的日益普及正在推動市場的成長。
預計政府主導的醫療保健研究和開發舉措將在未來幾年支持免疫檢測市場的成長。這些措施是指各級政府當局(地方、區域、國家和國際)為解決具體問題、實現具體目標和帶來計劃積極變化而採取的具體行動、計劃、措施和項目。這些舉措旨在改善診斷測試的可近性、提高醫療保健品質和應對公共衛生挑戰,從而推動對免疫測量的需求。例如,2022 年,英國政府機構衛生和社會保障部宣布資助 2.6 億英鎊(2.7065 億美元)加強醫療保健研究和製造。 BEIS 和 DHSC 的這項承諾旨在透過新的隱私保護平台和臨床研究服務支持美國主導的診斷和治療健康研究,並撥款 6,000 萬英鎊(6,360 萬美元)支持英國生命科學製造業的擴張。因此,政府在醫療保健領域的舉措的成長正在推動免疫檢測市場的發展。
產品創新是發展勢頭強勁的關鍵趨勢,領先企業正努力透過提供尖端產品來鞏固其市場地位。例如,中國生物技術公司Getein BIoTech Inc.在2022年德國慕尼黑國際醫學展覽會上推出了MAGICL 6000。這款可攜式化學冷光免疫檢測分析儀專為中高容量工作流程的實驗室設計,提供一步式化學冷光解決方案。該設備以其高效、緊湊、全自動和快速評估頻率而脫穎而出,為診斷實驗室提供了一個技術先進的選擇。
免疫檢測市場包括供應免疫檢測套件、分析儀和試劑的營業單位所獲得的收益。市場規模還包括服務供應商銷售或包含在其服務產品中的相關商品的價值。僅包括營業單位之間交易或銷售給最終消費者的商品和服務。
Immunoassay is a bioanalytical test that utilizes the binding of antibodies to antigens to detect and quantify specific chemicals, playing a crucial role in the diagnosis of diseases. Information derived from immunoassay test results can be used to establish appropriate courses of therapy. This method relies on a competitive binding reaction between a limited number of receptors on a highly specific anti-analyte antibody, labeled versions of an analyte, and a significant portion of an unlabeled sample analyte.
The main types of immunoassay products include reagents and kits, analyzers or instruments, and software and services. Reagents are substances or products that accelerate a reaction and are commonly used in various tests. Immunoassay specimens include blood, saliva, urine, and others, and the technique is applied in therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and more. The end users of immunoassay products are diverse and include research and academic laboratories, home care settings, pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), blood banks, hospitals and clinics, and clinical laboratories.
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 immunoassay market research report is one of a series of new reports from The Business Research Company that provides immunoassay market statistics, including immunoassay industry global market size, regional shares, competitors with a immunoassay market share, detailed immunoassay market segments, market trends and opportunities, and any further data you may need to thrive in the immunoassay industry. This immunoassay market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The immunoassay market size has grown steadily in recent years. It will grow from $35.81 billion in 2024 to $37.32 billion in 2025 at a compound annual growth rate (CAGR) of 4.2%. The growth in the historic period can be attributed to disease prevalence, aging population, infectious disease outbreaks, point-of-care testing, increased research funding.
The immunoassay market size is expected to see strong growth in the next few years. It will grow to $49.4 billion in 2029 at a compound annual growth rate (CAGR) of 7.3%. The growth in the forecast period can be attributed to personalized medicine, expansion in emerging markets, pandemic preparedness, cancer diagnostics, shift to home-based testing. Major trends in the forecast period include regulatory harmonization efforts, multipurpose immunoassays, customized assay services, integration with wearable devices, and miniaturization of assays.
The forecast of 7.3% growth over the next five years indicates a slight reduction of 0.2% from the previous estimate 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 enzyme-conjugated antibodies and microplate washers, sourced from key regions such as Switzerland and the Netherlands, which could lead to slower infectious disease testing and increased diagnostic laboratory costs.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 growing prevalence of infectious and chronic diseases is expected to drive the growth of the immunoassay market in the near future. Chronic illnesses are generally defined as conditions that last for a year or longer, require ongoing medical attention, restrict daily activities, or both. Infectious diseases are illnesses caused by organisms such as bacteria, viruses, fungi, or parasites. Numerous organisms coexist within and on the human body, and several infectious diseases can be transmitted from one person to another. Immunoassays are utilized to detect various infectious and chronic diseases. For example, a report from the National Institutes of Health (NIH), a US-based biomedical research agency, stated that in 2023, the number of individuals aged 50 and older in the United States with at least one chronic illness is projected to increase by 99.5%, from 71.522 million in 2020 to 142.66 million by 2050. Moreover, the number of people with multimorbidity is expected to rise by 91.16%, from 7.8304 million in 2020 to 14.968 million by 2050. Therefore, the increasing incidence of infectious and chronic diseases is driving market growth.
Government-led research and development initiatives in healthcare are anticipated to support the growth of the immunoassay market in the future. These initiatives refer to specific actions, programs, policies, or projects undertaken by government authorities at various levels-local, regional, national, or international-to tackle specific issues, achieve certain objectives, or foster positive changes in society. Such initiatives have aimed at improving access to diagnostic testing, enhancing healthcare quality, and addressing public health challenges, thereby driving demand for immunoassays. For instance, in 2022, the Department of Health and Social Care, a UK government authority, announced £260 million (US$270.65 million) in funding to enhance healthcare research and manufacturing. This commitment, made by BEIS and DHSC, was aimed at supporting NHS-led health research into diagnostics and treatment through new privacy-preserving platforms and clinical research services, along with £60 million (US$63.60 million) to aid in expanding life sciences manufacturing in the UK. Consequently, the growth of government initiatives in healthcare is driving the immunoassay market.
A key trend gaining momentum is product innovation, with major companies striving to strengthen their market position through cutting-edge offerings. For instance, Getein Biotech Inc., a China-based biotechnological company, introduced the MAGICL 6000 at MEDICA 2022. This portable chemiluminescence immunoassay analyzer is designed for labs with mid- to high-workflow requirements, providing a one-step chemiluminescence solution. The instrument stands out for its efficiency, compact size, complete automation, and rapid assessment frequency, offering a technologically advanced option for diagnostic laboratories.
Major players in the immunoassay market are introducing innovative immunoassay analyzers to gain a competitive advantage. These analyzers automate the detection and quantification of biological molecules, such as proteins or hormones, through immunological reactions. Beckman Coulter Diagnostics launched the DxI 9000 Access Immunoassay Analyzer in May 2023, addressing the needs of clinical laboratories for speed, reliability, reproducibility, and expanded menu options. The analyzer incorporates advanced features such as new analyte processing and detection technology, precision sensors, smart algorithms, and remote real-time system monitoring. Its distinctive feature includes no daily maintenance, enhancing its efficiency in diagnostic workflows.
In January 2023, Heska Corporation, a US-based biotechnology firm, acquired MBio Diagnostics, Inc. for an undisclosed sum. This acquisition is intended to strengthen Heska Corporation's research, development, and manufacturing capabilities, primarily by incorporating LightDeck's innovative point-of-care technology. This integration will facilitate the launch of advanced diagnostic platforms, including a product for canine cancer screening. MBio Diagnostics, Inc. is a US-based company that specializes in immunoassays.
Major companies operating in the immunoassay market include Siemens Healthineers GmbH, bioMerieux, Abbott, Beckman Coulter Inc., Quidel Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories Inc., Becton Dickinson and Company, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Merck KGaA, Agilent Technologies Inc., PerkinElmer Inc, WAK-Chemie Medical GmbH, J Mitra & Co Pvt Ltd, Kamiya Biomedical Company, Tosoh Corporation, Gyros Protein Technologies AB, BioCheck Inc., Bio-Techn, DiaSorin S.p.A, Meso Scale Diagnostics LLC, QIAGE, Randox Laboratories Ltd., Shenzhen Mindray Bio-Medical Electronics Co Ltd, Danaher Corporation, Hologic Inc., Tecan Trading AG, Eurofins Scientific, Abcam plc, Enzo Biochem Inc., Luminex Corporation, Quanterix Corporation, Roche Diagnostics, ZEUS Scientific Inc.
North America was the largest region in the immunoassay market in 2024. Asia-Pacific is expected to be the fastest-growing region in the immunoassay market report during the forecast period. The regions covered in the immunoassay market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa
The countries covered in the immunoassay market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The immunoassay market includes revenues earned by entities by supplying immunoassay kits, analyzers, and reagents. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
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.
Immunoassay 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 immunoassay 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 immunoassay ? 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 immunoassay 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.