全球 ELISpot 和 FluoroSpot 檢測市場規模、份額和趨勢分析報告—產業概覽和 2032 年預測

ELISpot 和 FluoroSpot 偵測市場規模

• 2024 年全球 ELISpot 和 FluoroSpot 檢測市場規模為3.3649 億美元 ，預計 到 2032 年將達到 8.1546 億美元，預測期內 複合年增長率為 11.70%。
• 市場成長主要受到傳染病、癌症和自體免疫疾病日益普及的推動，這推動了對 ELISpot 和 FluoroSpot 等高靈敏度和特異性免疫監測檢測的需求
• 此外，這些檢測方法在疫苗開發、臨床試驗和免疫學研究中的應用日益廣泛，使其成為單細胞分析細胞激素分泌的重要工具。這些因素正在加速 ELISpot 和 FluoroSpot 技術的部署，從而顯著促進該行業的成長。

ELISpot 和 FluoroSpot 偵測市場分析

• ELISpot 和 FluoroSpot 檢測廣泛用於在單細胞層級檢測和量化細胞激素分泌細胞，由於其高靈敏度、多路復用能力和適合低頻細胞分析，正在成為免疫學研究、疫苗開發和臨床診斷中不可或缺的工具
• 對這些檢測的需求不斷增長，主要是由於全球傳染病、癌症和自體免疫疾病的增加，以及對個人化醫療和免疫治療監測的日益重視
• 北美在 ELISpot 和 FluoroSpot 檢測市場佔據主導地位，2024 年其收入份額最大，為 35.9%，其特點是對生物醫學研究的大力投資、先進的醫療保健基礎設施以及大量正在進行的以免疫分析為重點的臨床試驗，尤其是在美國
• 由於研究資金增加、生物技術產業不斷擴大以及中國、印度和韓國等國家對免疫學檢測的認識不斷提高，預計亞太地區將成為預測期內 ELISpot 和 FluoroSpot 檢測市場成長最快的地區
• 檢測試劑盒領域在 ELISpot 和 FluoroSpot 檢測市場佔據主導地位，2024 年的市佔率為 50.1%，這得益於其易於使用、標準化協議以及在檢測細胞因子分泌細胞方面的高靈敏度，在研究和臨床應用中得到廣泛應用

報告範圍以及 ELISpot 和 FluoroSpot 偵測市場細分      

ELISpot 和 FluoroSpot 偵測市場趨勢

“對多路復用和高靈敏度免疫監測的需求增加”

• A significant and accelerating trend in the global ELISpot and FluoroSpot assay market is the growing demand for multiplexing capabilities and ultra-sensitive immune cell analysis, especially in vaccine development, oncology, and infectious disease research. These assays enable the simultaneous detection of multiple cytokines secreted by individual immune cells, providing a more comprehensive picture of immune function and response
  • For instance, FluoroSpot assays have gained prominence due to their ability to detect and quantify multiple analytes from the same cell, such as IFN-γ, IL-2, and TNF-α, enhancing the value of limited biological samples in preclinical and clinical studies. This is particularly useful in cancer immunotherapy trials, where detailed immune profiling is critical
• Advancements in reagent design, detection systems, and imaging software are further improving assay sensitivity and throughput. Technologies such as automated plate readers with high-resolution imaging and software-powered spot analysis are streamlining workflows and enabling large-scale screening efforts in pharmaceutical R&D and academic labs
• The rising interest in personalized medicine and immune monitoring is also pushing researchers and clinicians to adopt ELISpot and FluoroSpot assays for patient stratification, vaccine efficacy studies, and monitoring of T-cell and B-cell responses in real-time
• This trend toward more advanced, data-rich, and multi-analyte capable assays is driving innovation among manufacturers. For instance, companies such as Oxford Immunotec and Mabtech are continually launching enhanced kits with broader cytokine panels, higher specificity, and improved assay reproducibility
• The growing need for detailed immune response evaluation in immunotherapy, autoimmune disease diagnostics, and infectious disease surveillance is propelling the adoption of multiplex-ready ELISpot and FluoroSpot assays across research institutions, clinical settings, and biotech firms worldwide

ELISpot and FluoroSpot Assay Market Dynamics

Driver

“Rising Demand for Immune Monitoring in Vaccine Development and Immunotherapy”

• The growing emphasis on precise immune monitoring in vaccine development, cancer immunotherapy, and infectious disease research is a key driver for the increasing demand for ELISpot and FluoroSpot assays
  • For instance, in March 2024, Oxford Immunotec expanded its T-SPOT Discovery SARS-CoV-2 kit offering to support vaccine response studies in broader population groups, enabling researchers to measure T-cell responses post-vaccination. Such initiatives are significantly driving the adoption of ELISpot and FluoroSpot platforms in both research and clinical settings
• As the global healthcare landscape shifts toward personalized medicine and immunologically driven therapies, these assays offer critical advantages, including single-cell sensitivity, multiplexing capabilities, and quantifiable cytokine detection, allowing for more detailed profiling of immune responses
• In addition, the increasing volume of clinical trials and research studies requiring immune monitoring solutions has led to widespread utilization of ELISpot and FluoroSpot kits by pharmaceutical companies, academic institutions, and diagnostic laboratories
• The surge in infectious disease outbreaks, such as COVID-19 and emerging viral threats, has further highlighted the importance of immune response assays to evaluate both vaccine efficacy and immune memory
• The need for reliable, reproducible, and sensitive immune profiling tools continues to rise, particularly in regions investing in advanced healthcare diagnostics and translational research, positioning ELISpot and FluoroSpot assays as essential instruments in modern immunological workflows

Restraint/Challenge

“High Equipment Costs and Technical Complexity in Implementation”

• The high cost of specialized instruments and consumables required for ELISpot and FluoroSpot assays presents a significant barrier to widespread adoption, particularly among smaller laboratories, academic institutions in developing regions, and budget-constrained research settings. These assays often require high-resolution imaging systems, automated plate readers, and specialized software, all of which add to the initial capital expenditure
  • For instance, while leading manufacturers such as Mabtech and CTL offer sophisticated FluoroSpot analyzers with advanced multiplexing capabilities, the upfront costs associated with acquiring and maintaining such systems can deter smaller research groups from adopting these technologies
• Moreover, the technical complexity involved in setting up, validating, and interpreting ELISpot and FluoroSpot assays can pose operational challenges. These assays demand precise handling, standardized protocols, and trained personnel to ensure reliable and reproducible results, making them less accessible to labs lacking technical expertise
• Incorrect execution can lead to data variability and false positives/negatives, which is particularly critical in clinical trials and immunological diagnostics where data accuracy is essential. This makes robust training and quality control protocols a necessity
• While ongoing efforts by kit manufacturers to simplify protocols and automate workflows are improving usability, the learning curve and operational demands remain a key challenge to broader implementation
• To overcome these restraints, increased investment in user-friendly assay kits, accessible training programs, and cost-effective platform innovations will be crucial in expanding the reach of ELISpot and FluoroSpot technologies across a wider range of end users

ELISpot and FluoroSpot Assay Market Scope

市場根據產品類型、來源、疾病、應用、最終用戶和分銷管道進行細分。

• 依產品類型

根據產品類型，市場細分為檢測試劑盒、分析儀以及補充或輔助產品。檢測試劑盒在酶聯免疫斑點 (ELISpot) 和螢光斑點 (FluoroSpot) 檢測市場中佔據主導地位，2024 年的市場份額為 50.1%，這得益於其易於使用、標準化操作規程以及在檢測細胞因子分泌細胞方面的高靈敏度，在研究和臨床應用中得到了廣泛的應用。

預計檢測試劑盒領域也將在2025年至2032年期間實現最快的複合年增長率，這得益於其在實現高通量、準確且用戶友好的診斷和研究工作流程方面的關鍵作用。個人化醫療、快速疾病檢測和簡化實驗室流程的需求日益增長，推動了這一成長。

• 按來源

根據來源，ELISpot 和 FluoroSpot 檢測市場細分為人類、小鼠、猴子和其他來源。由於人類在臨床診斷和治療研究中佔據主導地位，2024 年人類來源的檢測佔據了最高的市場份額。基於人類的檢測廣泛應用於臨床試驗，用於評估傳染病、疫苗和癌症治療的免疫反應。

預計到2032年，小鼠來源市場將以顯著的複合年增長率成長，這主要得益於小鼠模型在臨床前研究和免疫學研究中的廣泛應用。基於小鼠的ELISpot和FluoroSpot檢測有助於研究人員了解疾病機制，並在應用於人體之前篩選免疫療法。

• 按疾病

根據疾病類型，酵素連結免疫斑點 (ELISpot) 和螢光斑點 (FluoroSpot) 檢測市場細分為傳染病、癌症、自體免疫疾病、過敏症和其他疾病。傳染病領域在 2024 年將引領市場，這歸因於疫情、疫苗研發以及新興傳染病（例如 COVID-19、結核病和 HIV）等新興傳染病威脅導致全球對免疫監測工具的需求不斷增長。 ELISpot/FluoroSpot 檢測廣泛用於檢測抗原特異性 T 細胞反應，使其成為感染研究中不可或缺的工具。

由於對免疫腫瘤學和個人化癌症疫苗的日益重視，預計癌症領域將在預測期內實現最快的成長。這些檢測有助於評估腫瘤特異性T細胞活性，為療效提供寶貴的見解。

• 按應用

根據應用，ELISpot 和 FluoroSpot 檢測市場可分為診斷應用和研究應用。由於其在學術研究、臨床前和轉化研究中的廣泛應用，研究應用領域將在 2024 年佔據市場主導地位。研究人員利用 ELISpot 和 FluoroSpot 平台評估免疫概況、研究疾病發病機制並進行疫苗試驗。

預計診斷應用領域將從 2025 年到 2032 年大幅增長，這得益於臨床越來越多地採用這些檢測方法來識別潛在感染（如結核病）以及監測移植患者和免疫缺陷患者的免疫狀態。

• 按最終用戶

根據最終用戶，ELISpot 和 FluoroSpot 檢測市場可細分為醫院和臨床實驗室、研究機構、生物製藥公司和其他機構。由於大量的研究資金投入以及 ELISpot 和 FluoroSpot 檢測在免疫學、病毒學和疫苗開發項目中的廣泛應用，研究機構在 2024 年佔據了最大的收入份額。

由於臨床試驗、藥物開發和監管提交中越來越多地採用這些檢測方法進行免疫監測，預計生物製藥公司部門將在預測期內快速成長。

• 按分銷管道

根據分銷管道，ELISpot 和 FluoroSpot 偵測市場可分為直接招標和零售銷售。 2024 年，直接招標市場佔據最大份額，因為大多數檢測系統（尤其是在醫院和研究中心等機構環境中）都是透過長期供應商協議和公私招標採購的。

預計到 2032 年，零售額將穩定上升，尤其是隨著線上平台和專業經銷商提供的檢測試劑盒越來越多，以滿足尋求靈活採購選擇的小型實驗室和研究實體的需求。

ELISpot 和 FluoroSpot 偵測市場區域分析

• 北美在 ELISpot 和 FluoroSpot 檢測市場佔據主導地位，2024 年其收入份額最大，為 35.9%，這得益於對生物醫學研究的大力投資、先進的醫療基礎設施以及大量正在進行的以免疫分析為重點的臨床試驗，尤其是在美國
• 該地區受益於對免疫學研究、疫苗開發和臨床診斷的大量投資，尤其是在美國，美國國立衛生研究院和疾病預防控制中心等組織在政府支持下推出的舉措推動了高靈敏度免疫監測工具（如 ELISpot 和 FluoroSpot 檢測）的採用
• 此外，對個人化醫療和免疫腫瘤學研究的需求不斷增長，加上尖端實驗室設備的廣泛普及，進一步增強了市場成長

美國 ELISpot 和 FluoroSpot 檢測市場洞察

The U.S. ELISpot and FluoroSpot assay market captured the largest revenue share of 75.2% in 2024 within North America, driven by extensive biomedical research activities and a high number of clinical trials focusing on infectious diseases, cancer, and autoimmune disorders. The increasing adoption of immune-monitoring assays in both diagnostics and research applications supports market growth. Moreover, strong government funding and the presence of major assay manufacturers further boost demand. Growing integration of advanced assay technologies with automated systems is also significantly contributing to market expansion

Europe ELISpot and FluoroSpot Assay Market Insight

The Europe ELISpot and FluoroSpot assay market is projected to expand at a substantial CAGR throughout the forecast period, propelled by stringent healthcare regulations and increased focus on early disease diagnosis. Growing investments in research infrastructure and the rising prevalence of chronic diseases such as cancer and autoimmune conditions foster adoption of these assays. The market sees growth across clinical diagnostics and biopharmaceutical research, with countries such as Germany, France, and the U.K. leading demand for advanced immune monitoring solutions.

U.K. ELISpot and FluoroSpot Assay Market Insight

The U.K. ELISpot and FluoroSpot assay market is anticipated to grow at a noteworthy CAGR during the forecast period, driven by escalating investment in life sciences research and expanding clinical trial activities. Increased awareness about immune-based diagnostic techniques and a strong pharmaceutical research ecosystem stimulate demand. The U.K.’s robust healthcare infrastructure and government initiatives to enhance biomedical innovation are expected to continue propelling market growth

Germany ELISpot and FluoroSpot Assay Market Insight

The Germany ELISpot and FluoroSpot assay market is expected to expand at a considerable CAGR during the forecast period, fueled by rising research funding and strong focus on personalized medicine. Germany’s advanced biomedical research capabilities and emphasis on sustainable, precision diagnostics promote increased use of ELISpot and FluoroSpot technologies. Integration of these assays into both academic research and pharmaceutical development pipelines further drives market growth.

Asia-Pacific ELISpot and FluoroSpot Assay Market Insight

The Asia-Pacific ELISpot and FluoroSpot assay market is poised to grow at the fastest CAGR during the forecast period of 2025 to 2032, driven by rising investments in healthcare infrastructure, expanding immunology research, and increasing disease burden in countries such as China, Japan, and India. Government initiatives promoting biotechnology and growing awareness about immune-based diagnostics are significantly enhancing market penetration. Furthermore, APAC’s emerging role as a manufacturing and research hub supports greater affordability and accessibility of these assays.

Japan ELISpot and FluoroSpot Assay Market Insight

The Japan ELISpot and FluoroSpot assay market is gaining momentum due to the country’s strong focus on innovation in biomedical technologies and rapidly advancing research ecosystem. The aging population and increasing incidence of infectious and autoimmune diseases drive demand for precise immune-monitoring tools. In addition, integration with other diagnostic platforms and support for personalized medicine strategies fuel market growth in both clinical and research settings.

India ELISpot and FluoroSpot Assay Market Insight

The India ELISpot and FluoroSpot assay market accounted for the largest market revenue share in Asia Pacific in 2024, supported by rapid growth in biomedical research and expanding clinical diagnostic services. Increasing government funding for healthcare and biotechnology research, along with the rising prevalence of infectious diseases and cancer, underpins demand. The development of affordable assay kits by domestic manufacturers, combined with growing awareness of immune-based diagnostics, propels market expansion across research institutes, hospitals, and biopharmaceutical companies.

ELISpot and FluoroSpot Assay Market Share

The ELISpot and FluoroSpot Assay industry is primarily led by well-established companies, including:

• Revvity (U.K.)
• BD (U.S.)
• Mabtech (Sweden)
• Cellular Technology Limited (U.S.)
• Bio-Techne (U.S.)
• Abcam plc (U.K.)
• U-CyTech (Netherlands)
• Anogen-Yes Biotech Laboratories Ltd. (Canada)
• ProImmune Ltd. (U.K.)
• Merck KGaA (Germany)
• Thermo Fisher Scientific Inc. (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• ZellBio GmbH (Germany)
• BioLegend, Inc. (U.S.)
• AdipoGen Life Science (Switzerland)
• GenScript (U.S.)
• R&D Systems, Inc. (U.S.)
• Cellular Technology Limited (U.S.)
• Enzo Biochem Inc. (U.S.)
• ALPCO (U.S.)

Latest Developments in Global ELISpot and FluoroSpot Assay Market

• In April 2025, a study highlighted the optimization of cultured ELISpot/FluoroSpot technique for selective investigation of SARS-CoV-2 reactive central memory T cells. This advancement in methodology, particularly for detecting central memory T-cell IFNγ responses, emphasizes the balance between enhancing specific cognate central memory responses while limiting non-specific activation. This kind of research contributes to refining assay sensitivity and specificity in critical areas such as infectious disease monitoring
• In June 2022, BD and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the Monkeypox virus. Utilizing BD MAX open system reagents, the collaboration aims to validate the CerTest VIASURE Monkeypox CE/IVD molecular test on the BD MAX System, enhancing diagnostic capabilities for this rare disease
• In April 2022, ProImmune Ltd. introduced a B-cell ELISpot assay service designed to evaluate B cell immune responses. This assay enables researchers to assess vaccine efficacy and therapeutic interventions by quantifying B cells producing specific antibodies in response to stimuli
• In May 2021, BD participated in virtual investor healthcare conferences, including the Bank of America Securities 2021 Virtual Healthcare Conference and the UBS Global Healthcare Virtual Conference. These engagements facilitated global visibility and such asly attracted new customers, contributing to enhanced future market revenue for the company.
• In 2022, Mabtech (Sweden) made ELISpot kits available in a 100-plate format, including pre-coated plates to save time and reduce assay variability. They also introduced the Human IL-21 analyte in two colors in their FluoroSpot Flex platform, showcasing ongoing product development aimed at improving efficiency and expanding multiplexing capabilities

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