ELISpot And Fluorospot Assay Market (2025 - 2030) Size, Share & Trends Analysis Report By Product (Prospective, Retrospective), By Application (Oncology, Neurology, Cardiology), By End-use, By Region, And Segment Forecasts

ELISpot And Fluorospot Assay Market Summary

The global ELISpot and fluorospot assay market size was estimated at USD 311.8 million in 2024 and is projected to reach USD 450.0 million by 2030, growing at a CAGR of 6.3% from 2025 to 2030. This growth can be attributed to the rising incidences of chronic and infectious diseases, increasing drug discovery activities, rising adoption in research and diagnostics, and expanding pre-clinical and clinically regulated bioanalysis.

The ELISpot and fluorospot assays are used to access immune responses, increasing their importance in understanding the effect of various diseases on the immune system, including cancer. ELISpot and Fluorospot assay are used to detect and characterize naturally occurring tumor-reactive T-cells, which serve as suitable mediators of cancer immunotherapy. Moreover, these assays are also being used for epitope mapping, identification of tumor antigens, and monitor vaccine-induced T and B-cell responses. Moreover, the development of hepatocellular carcinoma (HCC) and cervical cancer is closely linked to high-risk infections with human papillomavirus (HPV) and hepatitis B virus (HBV), respectively. Tumor-specific vaccines are frequently tested in animal models and cell lines; for example, the HPV vaccine was assessed in mice and cell lines using the IFN-γ and IL-2 ELISPOT assay.

Detection of antigen-specific T cell responses via the IFN-γ ELISPOT assay in a patient with metastatic cervical cancer aids researchers in developing new treatment strategies. Researchers are working to halt cancer progression by inducing tumor-specific cytotoxic T lymphocytes (CTLs) through dendritic cells loaded with tumor DNA or tumor homogenate. Another approach involves generating virus-vectored genetic vaccines, such as using an Adenovirus vector encoding tumor antigens. The response of tumor-specific CTLs can be determined by the ELISPOT assay.

The IFN-γ ELISPOT assay is also used to evaluate the immunological efficacy of high-dose IL-2 treatment in patients with metastatic melanoma and renal cell carcinoma. These increasing applications of ELISpot and Fluorospot assays in cancer research are anticipated to drive their demand with increasing cancer incidences. According to National Cancer Institute data, the number of cancer cases per year is anticipated to increase to 29.9 million and cancer-related deaths to reach 15.3 million. This surge in cancer cases is anticipated to drive the market growth over the forecast period.

These assays provide a powerful tool for assessing a potential drug substance’s effect on the immune system. ELISpot is emerging as a critical tool in vaccine development for various conditions, such as immunodeficiency syndrome (AIDS), malaria, tuberculosis, cancer, and flu. The ELISpot test is widely utilized in clinical studies to evaluate vaccines. According to the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) data, 54,952 clinical trials were performed globally in 2022 alone. These increasing clinical trials and drug discovery activities are expected to increase the demand for ELISpot and Fluorospot assay, thereby driving market growth.

Moreover, several market players are increasing their efforts to develop advanced solutions based on ELISpot and Fluorospot assays for various health conditions, which is further driving the market growth. For instance, in November 2023, Revvity announced the launch of its FDA-approved ELISPOT technology-based T-SPOT test in India for latent TB screening. The test uses a standardized sample, which reduces the influence of blood factors that can impact the test performance and normalization for T-cell count.

Product Insights

Assay kits dominated the market and accounted for a share of 49.6% in 2024. The enzyme-linked immunospot (ELISpot) assay is a highly sensitive and effective immunoassay for monitoring immune responses in vitro. By allowing ex vivo measurements of antibody-secreting cells or cytokines at the single-cell level, these kits employ sandwich immuno-enzyme technology to accurately detect and quantify secretory products. Applicable across transplantation, vaccine development, autoimmune diseases, and infections, ELISpot kits are invaluable for research and clinical applications.

The demand for analyzers is expected to grow lucratively over the forecast period, owing to the rising availability of advanced models and increasing demand for high-throughput analysis. In research areas such as immunology and drug discovery, the need for efficient processing of large sample volumes drives the demand for high-throughput analyzers. CTL’s ImmunoSpot Analyzers are market leaders, offering multifunctionality for various immune monitoring tests to meet diverse needs and budgets.

Application Insights

Diagnostic applications led the market with a revenue share of 66.1% in 2024. ELISpot and Fluorospot assays provide high sensitivity and specificity for detecting immune responses to pathogens and antigens, enabling accurate diagnosis of infectious diseases such as tuberculosis, HIV, and viral infections. Their utility in autoimmune disease diagnosis and growth in immunology and oncology are expected to further enhance their diagnostic applications.

Research applications are expected to register significant growth over the forecast period due to the capability of these assays to identify potential drug candidates that modulate immune responses. The ELISPOT assay serves as a key immune monitoring tool, applicable in evaluating responses to infections, transplant antigens, tumor antigens, and autoantigens. Its utility in assessing drug impacts on immune cell activation and cytokine production is expected to further drive demand.

End-use Insights

Hospitals and clinical labs held the largest revenue share of 46.4% in 2024. Hospitals and clinical labs serve as direct contact points for patients suffering from various diseases, increasing the pressure on these healthcare systems for rapid diagnosis. ELISpot and fluorospot assays, emerging as important tools for disease diagnosis, are thus anticipated to witness growth in the hospitals and clinical labs segment.

Biopharmaceutical companies are projected to grow at the fastest CAGR of 6.6% over the forecast period. Biopharmaceutical companies are driven to use ELISpot and Fluorospot assays due to their high quantitative accuracy, ability to measure a wide range of immune responses, and versatility in evaluating T-cell functions, B cells, and innate immune cells. Their proven clinical relevance, particularly in predicting therapeutic outcomes in cancer vaccine trials, enhances their appeal in clinical applications.

Regional Insights

North America ELISpot and fluorospot assay market dominated the global market with a revenue share of 35.4% in 2024, driven by established healthcare infrastructure, robust R&D activities, and widespread adoption of advanced diagnostics. The region’s high testing volume, with over 20 million individuals tested annually for TB in the U.S., and the preference for IGRA tests such as the T-SPOT.TB, are key factors contributing to the segment’s growth and increasing acceptance of ELISpot technology.

U.S. ELISpot and Fluorospot Assay Market Trends

The ELISpot and fluorospot assay market in the U.S. dominated the North America market with a revenue share of 83.0% in 2024, fueled by the high funding for biomedical research, high presence of various research institutions and strong presence of pharmaceutical and biotechnology companies investing in vaccine development, drug discovery, and clinical trials. U.S. accounts for the largest number of clinical trials performed globally. According to the WHO ICTRP data, 168,520 clinical trials were performed in the U.S. from 1999 to 2022. Such focus on R&D is anticipated to drive the demand for ELISpot and Fluorospot assays in the country.

Europe ELISpot and Fluorospot Assay Market Trends

Europe ELISpot and fluorospot assay market held substantial market share in 2024, driven by factors such as the growing burden of chronic and infectious diseases, increasing emphasis on early disease diagnosis, and high research focus. Europe has a robust research infrastructure and a strong commitment to scientific progress. These factors foster the development and application of ELISpot and Fluorospot assays in various research areas, such as vaccine development and immunology.

The ELISpot and fluorospot assay market in UK is expected to grow in the forecast period due to the rising prevalence of chronic diseases, increased research in immunology, and greater awareness of early diagnostic practices. With approximately 18% of the population aged over 65, there is a mounting demand for advanced diagnostic technologies to effectively monitor immune responses and address elevated healthcare needs.

Asia Pacific ELISpot and Fluorospot Assay Market Trends

Asia Pacific ELISpot and fluorospot assay market is expected to register the fastest CAGR of 7.2% in the forecast period. This can be attributed to the increasing prevalence of various diseases such as diabetes, cancer, tuberculosis, and hepatitis B. For instance, according to the WHO data, around 2.3 million people in Southeast Asia region are diagnosed with cancer each year, and it causes around 1.4 million mortalities each year. The rising prevalence has increased the need for the development of advanced treatments, leading to R&D activities in the region and thereby driving its growth.

The ELISpot and fluorospot assay market in China is projected to grow at the fastest CAGR of 9.4% over the forecast period, propelled by rapid advancements in biotechnology and a rising incidence of chronic diseases. With a population surpassing 1.4 billion, the demand for effective diagnostic tools is critical. Furthermore, government initiatives to enhance healthcare infrastructure and fund biomedical research further facilitate the growth of these assays in addressing public health challenges.

Key ELISpot And Fluorospot Assay Company Insights

Some key companies operating in the market include BD; U-CyTech; Cellular Technology Limited; Mabtech; Abcam Limited; Autoimmun Diagnostika GmbH; among others. Organizations are undertaking various initiatives to strengthen their market presence and increase the reach of their products and services, such as expansion activities and partnerships are playing a key role in propelling market growth.

• U-CyTech specializes in ELISA and ELISpot assays, offering T and B cell solutions for ex vivo detection of protein-secreting cells. They develop specific monoclonal and polyclonal antibodies enhancing assay sensitivity and reliability for immunology research and diagnostics.

• Mabtech develops innovative ELISpot and FluoroSpot assay solutions for high-throughput detection of immune responses at the single-cell level. Their products include advanced readers and assay kits for comprehensive immunological studies and vaccine and cancer research applications.

Recent Developments

• In September 2023, Virax Biolabs Group Limited launched a program offering researchers early access to its SARS-Cov-2 ViraxImmune T-cell-based test. This test assesses the activation of memory T-cells specifically to the SARS-Cov-2 by combining the company’s precoated ELISpot assay to a peptide pool covering a specific part of the virus.

ELISpot and Fluorospot Assay Market Report Scope

Global ELISpot And Fluorospot Assay Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global ELISpot and fluorospot assay market report based on product, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Assay Kits

  • Analyzers

  • Ancillary Products

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Research Applications

  • Diagnostics Applications

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital and Clinical Labs

  • Academic and Research Institutes

  • Biopharmaceutical Company

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait