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    ELISpot and FluoroSpot Assay Market

    ID: MRFR/LS/5483-HCR
    90 Pages
    Kinjoll Dey
    September 2025

    ELISpot and FluoroSpot Assay Market Research Report, by Product (Assay Kit, Ancillary Products), Application (Transplant, Vaccines), End-User (Hospitals and Clinics, Ambulatory Surgical Centres, Diagnostic Centres, Research Centers) – Forecast Till 2035.

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    ELISpot and FluoroSpot Assay Market Infographic
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    ELISpot and FluoroSpot Assay Market Summary

    The Global ELISpot and FluoroSpot Assays Market is projected to grow significantly from 0.19 USD Billion in 2024 to 1.15 USD Billion by 2035.

    Key Market Trends & Highlights

    ELISpot and FluoroSpot Assays Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 17.99% from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 1.15 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 0.19 USD Billion, reflecting the current demand for ELISpot and FluoroSpot assays.
    • Growing adoption of advanced immunological techniques due to increasing research funding is a major market driver.

    Market Size & Forecast

    2024 Market Size 0.19 (USD Billion)
    2035 Market Size 1.15 (USD Billion)
    CAGR (2025-2035) 17.99%

    Major Players

    Oxford Immunotec (UK), Cellular Technologies (US), Mabtech (Sweden), Becton, Dickinson and Company (US), Abcam (UK), Bio-Techne (US), Autoimmun Diagnostika (Germany), Biotech Investissement (France), Lophius Biosciences (Germany), U-CyTech (Netherlands)

    ELISpot and FluoroSpot Assay Market Drivers

    Market Trends and Growth Projections

    The Global ELISpot and FluoroSpot Assays Market Industry is characterized by dynamic trends and robust growth projections. The market is anticipated to expand significantly, with a valuation of 0.19 USD Billion in 2024 and a forecasted increase to 1.15 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate (CAGR) of 17.99% from 2025 to 2035. Key factors driving this expansion include rising demand for immunological testing, technological advancements, and increased investment in research and development. These trends indicate a promising future for the ELISpot and FluoroSpot assays in various applications.

    Expansion of Biopharmaceutical Sector

    The expansion of the biopharmaceutical sector significantly impacts the Global ELISpot and FluoroSpot Assays Market Industry, as biopharmaceutical companies increasingly rely on these assays for drug development and clinical trials. The need for accurate immune response assessment in therapeutic interventions drives demand for ELISpot and FluoroSpot assays. With the biopharmaceutical market projected to grow substantially, the assays are expected to play a crucial role in ensuring the efficacy and safety of new therapies. This trend contributes to the market's anticipated growth from 0.19 USD Billion in 2024 to 1.15 USD Billion by 2035.

    Rising Demand for Immunological Testing

    The Global ELISpot and FluoroSpot Assays Market Industry experiences a notable increase in demand for immunological testing, driven by the growing prevalence of infectious diseases and autoimmune disorders. As healthcare providers seek efficient diagnostic tools, ELISpot and FluoroSpot assays offer precise quantification of antigen-specific T cells, enhancing patient management. In 2024, the market is valued at 0.19 USD Billion, with projections indicating a substantial rise to 1.15 USD Billion by 2035. This growth reflects a compound annual growth rate (CAGR) of 17.99% from 2025 to 2035, underscoring the assays' critical role in modern diagnostics.

    Increased Focus on Personalized Medicine

    The Global ELISpot and FluoroSpot Assays Market Industry is witnessing a shift towards personalized medicine, where tailored therapeutic approaches require precise immune profiling. As healthcare systems increasingly adopt personalized treatment strategies, the demand for assays that can accurately measure immune responses becomes paramount. ELISpot and FluoroSpot assays provide valuable insights into patient-specific immune profiles, facilitating the development of individualized therapies. This growing focus on personalized medicine is expected to drive the market from 0.19 USD Billion in 2024 to an estimated 1.15 USD Billion by 2035, reflecting a CAGR of 17.99% from 2025 to 2035.

    Growing Investment in Research and Development

    Investment in research and development (R&D) plays a pivotal role in shaping the Global ELISpot and FluoroSpot Assays Market Industry. Increased funding from government and private sectors fosters innovation in assay technologies, leading to the development of novel applications and improved assay performance. This trend is particularly evident in the field of vaccine development and cancer immunotherapy, where precise immune response monitoring is essential. As R&D efforts intensify, the market is projected to grow from 0.19 USD Billion in 2024 to 1.15 USD Billion by 2035, indicating a robust CAGR of 17.99% from 2025 to 2035.

    Technological Advancements in Assay Techniques

    Technological advancements significantly influence the Global ELISpot and FluoroSpot Assays Market Industry, as innovations in assay methodologies enhance sensitivity and specificity. The introduction of automated systems and high-throughput screening capabilities allows laboratories to process larger sample volumes efficiently. These advancements not only improve the accuracy of results but also reduce turnaround times, making assays more appealing to clinical and research settings. As a result, the market is poised for growth, with an expected valuation of 1.15 USD Billion by 2035, reflecting the increasing reliance on sophisticated diagnostic tools in immunology.

    Market Segment Insights

    ELISpot and FluoroSpot Assays Product Insights

    The market, by product is categorised into various assay kit, analyzer, ancillary products. The assay kit is sub-segmented into T Cell assay and B Cell assay. 

    ELISpot and FluoroSpot Assays Application Insights

    On the basis of application, the market is segmented into transplant, vaccines development, clinical trials, cancer treatment. 

    ELISpot and FluoroSpot Assays End User Insights

    On the basis of end-user, the market is segmented into hospitals and clinics, ambulatory surgical centres, diagnostic centres, research centers, and others.

    Get more detailed insights about ELISpot and FluoroSpot Assay Market Research Report – Global Forecast till 2032

    Key Companies in the ELISpot and FluoroSpot Assay Market market include

    Industry Developments

    ImmunoSpot introduced SpotStat Software in September 2021 for statistical analysis of ELISPOT/FluoroSpot data. The major purpose of SpotStat is to give statistically confirmed antigen-induced and negative controls differentiation. Ardigen and ImmuMap began collaborating on research in April 2021. The collaboration between ImmuMap and Ardigen will focus on finding T-cell receptors (TCRs) that are reactive to tumor-associated neoantigens. The researchers will use ELISpot assays (enzyme-linked immunosorbent assays), next-generation sequencing (NGS), MHC multimer labeling and sorting, and 10x Genomics Single Cell Immune Profiling.

    Intended Audience:

      • Pharmaceutical companies
      • Biotechnological institutes
      • Government and private laboratories
      • Research and Development (R&D) companies
      • Medical research laboratories
      • Market research and consulting service providers

    ELISpot and FluoroSpot Assay Market Industry Developments

    • Q2 2024: Oxford Immunotec Launches T-SPOT Discovery SARS-CoV-2 ELISpot Kit for Research Use Oxford Immunotec announced the launch of its new T-SPOT Discovery SARS-CoV-2 ELISpot kit, designed to support research into cellular immune responses to COVID-19, expanding its portfolio of immunology assay products.
    • Q2 2024: Bio-Techne Expands ELISpot and FluoroSpot Assay Manufacturing Facility in Minnesota Bio-Techne completed an expansion of its Minnesota facility to increase production capacity for ELISpot and FluoroSpot assay kits, aiming to meet rising global demand from clinical and research laboratories.
    • Q3 2024: Merck KGaA Partners with ImmunoSpot to Co-Develop Next-Generation FluoroSpot Assay Kits Merck KGaA announced a strategic partnership with ImmunoSpot to co-develop advanced FluoroSpot assay kits targeting multiplex cytokine detection for immuno-oncology and vaccine research applications.
    • Q3 2024: Thermo Fisher Scientific Receives CE Mark for New FluoroSpot Analyzer Platform Thermo Fisher Scientific received CE Mark approval for its new FluoroSpot Analyzer, enabling clinical laboratories in Europe to adopt high-throughput multiplex immune cell analysis for diagnostic use.
    • Q4 2024: Cellular Technology Limited Wins Major Contract to Supply ELISpot Assay Kits for Global TB Vaccine Trials Cellular Technology Limited secured a multi-year contract to supply ELISpot assay kits for use in international tuberculosis vaccine clinical trials, supporting immune monitoring in diverse populations.
    • Q4 2024: Bio-Rad Laboratories Launches Automated ELISpot Reader for Clinical Diagnostics Bio-Rad Laboratories introduced a fully automated ELISpot reader system designed to streamline immune cell analysis in clinical diagnostic laboratories, improving workflow efficiency and accuracy.
    • Q1 2025: ImmunoSpot Announces $30 Million Series C Funding to Accelerate FluoroSpot Assay Development ImmunoSpot raised $30 million in Series C funding to expand its R&D efforts and scale production of next-generation FluoroSpot assay kits for immunotherapy and infectious disease research.
    • Q1 2025: Thermo Fisher Scientific Acquires Small Biotech Specializing in ELISpot Reagents Thermo Fisher Scientific completed the acquisition of a biotech firm specializing in proprietary ELISpot reagents, strengthening its portfolio in immune monitoring and diagnostic assay solutions.
    • Q2 2025: Oxford Immunotec Receives FDA Clearance for Updated T-SPOT.TB ELISpot Assay Oxford Immunotec received FDA clearance for its updated T-SPOT.TB ELISpot assay, enabling improved tuberculosis diagnosis and immune response monitoring in U.S. clinical settings.
    • Q2 2025: Bio-Techne Signs Distribution Agreement with Japanese Diagnostics Firm for FluoroSpot Kits Bio-Techne entered a distribution agreement with a leading Japanese diagnostics company to supply FluoroSpot assay kits to hospitals and research institutions across Japan.
    • Q3 2025: Cellular Technology Limited Opens New ELISpot Manufacturing Facility in Germany Cellular Technology Limited inaugurated a new manufacturing facility in Germany dedicated to producing ELISpot assay kits for European clinical and research markets.
    • Q3 2025: Bio-Rad Laboratories Appoints New VP of Immunoassay Product Development Bio-Rad Laboratories announced the appointment of a new Vice President of Immunoassay Product Development to lead innovation in ELISpot and FluoroSpot assay technologies.

    Future Outlook

    ELISpot and FluoroSpot Assay Market Future Outlook

    The ELISpot and FluoroSpot Assays Market is projected to grow at a 17.99% CAGR from 2024 to 2035, driven by advancements in immunology and personalized medicine.

    New opportunities lie in:

    • Develop novel assay kits targeting emerging infectious diseases.
    • Invest in automation technologies to enhance assay throughput and accuracy.
    • Expand into emerging markets with tailored solutions for local healthcare needs.

    By 2035, the market is expected to achieve substantial growth, reflecting increased demand for advanced diagnostic solutions.

    Market Segmentation

    ELISpot and FluoroSpot Assay Region Outlook

    • Americas
    • Europe
    • Asia-Pacific
    • Middle East & Africa 
    • Pharmaceutical companies
    • Biotechnological institutes
    • Government and private laboratories
    • Research and Development (R&D) companies
    • Medical research laboratories
    • Market research and consulting service providers
    • Q2 2024: Oxford Immunotec Launches T-SPOT Discovery SARS-CoV-2 ELISpot Kit for Research Use Oxford Immunotec announced the launch of its new T-SPOT Discovery SARS-CoV-2 ELISpot kit, designed to support research into cellular immune responses to COVID-19, expanding its portfolio of immunology assay products.
    • Q2 2024: Bio-Techne Expands ELISpot and FluoroSpot Assay Manufacturing Facility in Minnesota Bio-Techne completed an expansion of its Minnesota facility to increase production capacity for ELISpot and FluoroSpot assay kits, aiming to meet rising global demand from clinical and research laboratories.
    • Q3 2024: Merck KGaA Partners with ImmunoSpot to Co-Develop Next-Generation FluoroSpot Assay Kits Merck KGaA announced a strategic partnership with ImmunoSpot to co-develop advanced FluoroSpot assay kits targeting multiplex cytokine detection for immuno-oncology and vaccine research applications.
    • Q3 2024: Thermo Fisher Scientific Receives CE Mark for New FluoroSpot Analyzer Platform Thermo Fisher Scientific received CE Mark approval for its new FluoroSpot Analyzer, enabling clinical laboratories in Europe to adopt high-throughput multiplex immune cell analysis for diagnostic use.
    • Q4 2024: Cellular Technology Limited Wins Major Contract to Supply ELISpot Assay Kits for Global TB Vaccine Trials Cellular Technology Limited secured a multi-year contract to supply ELISpot assay kits for use in international tuberculosis vaccine clinical trials, supporting immune monitoring in diverse populations.
    • Q4 2024: Bio-Rad Laboratories Launches Automated ELISpot Reader for Clinical Diagnostics Bio-Rad Laboratories introduced a fully automated ELISpot reader system designed to streamline immune cell analysis in clinical diagnostic laboratories, improving workflow efficiency and accuracy.
    • Q1 2025: ImmunoSpot Announces $30 Million Series C Funding to Accelerate FluoroSpot Assay Development ImmunoSpot raised $30 million in Series C funding to expand its R&D efforts and scale production of next-generation FluoroSpot assay kits for immunotherapy and infectious disease research.
    • Q1 2025: Thermo Fisher Scientific Acquires Small Biotech Specializing in ELISpot Reagents Thermo Fisher Scientific completed the acquisition of a biotech firm specializing in proprietary ELISpot reagents, strengthening its portfolio in immune monitoring and diagnostic assay solutions.
    • Q2 2025: Oxford Immunotec Receives FDA Clearance for Updated T-SPOT.TB ELISpot Assay Oxford Immunotec received FDA clearance for its updated T-SPOT.TB ELISpot assay, enabling improved tuberculosis diagnosis and immune response monitoring in U.S. clinical settings.
    • Q2 2025: Bio-Techne Signs Distribution Agreement with Japanese Diagnostics Firm for FluoroSpot Kits Bio-Techne entered a distribution agreement with a leading Japanese diagnostics company to supply FluoroSpot assay kits to hospitals and research institutions across Japan.
    • Q3 2025: Cellular Technology Limited Opens New ELISpot Manufacturing Facility in Germany Cellular Technology Limited inaugurated a new manufacturing facility in Germany dedicated to producing ELISpot assay kits for European clinical and research markets.
    • Q3 2025: Bio-Rad Laboratories Appoints New VP of Immunoassay Product Development Bio-Rad Laboratories announced the appointment of a new Vice President of Immunoassay Product Development to lead innovation in ELISpot and FluoroSpot assay technologies.

    ELISpot and FluoroSpot Assay Product Outlook

    • Assay Kit
    •  T Cell assay
    • B Cell assay
    • Analyzer
    • Ancillary Products 

    ELISpot and FluoroSpot Assay End-User Outlook

    • Hospitals and clinics
    • Ambulatory surgical centers
    • Diagnostic centers
    • Research centers
    • Others

    ELISpot and FluoroSpot Assay Application Outlook

    • Transplant,
    • Vaccines
    • Clinical Trials
    • Cancer Treatment

    Report Scope

    Report Attribute/Metric Details
    Market Size 2022 NA (USD Billion)
    Market Size 2023 NA (USD Billion)
    Market Size 2032 0.8 (USD Billion)
    Compound Annual Growth Rate (CAGR) 13 % (2024- 2032)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2022
    Market Forecast Period 2023 - 2032
    Historical Data 2019 - 2022
      Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
      Key Vendors   Oxford Immunotec (UK), Cellular Technologies (US), Mabtech (Sweden), Becton, Dickinson and Company (US), and Abcam (UK)Bio-Techne (US), Autoimmun Diagnostika (Germany), Biotech Investissement (France), Lophius Biosciences (Germany), and U-CyTech (Netherlands), and Others.
      Key Market Opportunities   Increasing research & development investments by industry players
      Key Market Drivers ·  Increasing incidence of chronic diseases ·  rising vaccine development

    Market Highlights

    Author
    Kinjoll Dey
    Research Analyst Level I

    He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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