ELISpot and FluoroSpot Assay Market

Industry Overview

Global ELISpot and FluroSpot assay market was estimated to be USD 0.34 billion in 2023 and is expected to reach USD 0.58 billion by 2030 with a CAGR of  6.8% during the forecast period, i.e., 2025-2030. 

ELISPOT and its variant, FluoroSpot (collectively called ImmunoSpot® Assays) detect in peripheral blood mononuclear cells (PBMC) rare antigen-specific T or B cells via their antigen-driven production of cytokines or antibodies. PBMC sit on a membrane coated with analyte-specific antibody that captures the analyte produced by the individual T or B cells in the immediate surrounding of the secreting cells, before the analyte would be diluted in the culture supernatant, absorbed by receptors of third-party cells, or they undergo proteolytic degradation.

ELISA (immunological assay commonly used to measure antibodies, antigens, proteins and glycoproteins in biological samples), rely on testing of samples in the culture medium in which the analyte has been diluted and degraded for ImmunoSpot® Assays to measure analyte release by cells with a far greater sensitivity. By using flow cytometry, ImmunoSpot® Assays are also much more sensitive for detecting rare antigen-specific T and B cells. 

By using colorimetric substrates, the FluoroSpot assay was developed as an adaptation of traditional enzymatic ELISPOT detection systems. The FluoroSpot is capable of detecting secreted cytokine or antibody (for B cell FluoroSpot) with the same high level of sensitivity as in ELISPOT, by utilization of  fluorochrome-conjugated detection antibodies. The most significant advantage of FluoroSpot assays is their ability to detect multiple different cytokines concurrently in the same assay well. With enzymatic/colorimetric substrate development systems as used in ELISPOT, the limitations of the method restrict the number of analytes to a maximum of two. Whereas Double-Color Enzymatic ELISPOT assays have been shown to be highly accurate and comparable in sensitivity to single-analyte detection done in parallel, the use of 2, 3 or even 4 color FluoroSpot has become more feasible and offers many advantages for researchers, while retaining the accuracy and sensitivity of classic ELISPOT assay methodologies.

Global ELISpot and FluoroSpot Assay Market Report Coverage

Market Segmentation

Insight by product type

The ELISpot and FluoroSpot assay market is segmented by product such as analyzers, assay kits, and ancillary products. The assay kits are further segmented into t-cell assay and cell assay. Due to the growing demand for cell-based assays in drug discovery and use of T-cell assays in cancer research, the assay kits segment is expected to dominate the ELISpot and FluoroSpot assay market.

Insight by application type

Based on application type, the global ELISpot and FluoroSpot assay market is segmented into diagnostic and research applications. The diagnostic applications are further sub-segmented into infectious diseases, transplants and others. The research applications are further sub-segmented into vaccine development, clinical trials, cancer research and others. Growing number of chronic infectious diseases, the diagnostic application segment is expected to dominate the ELISpot and FluoroSpot assay market. 

Insight by disease type

On the basis of disease, the ELISpot and FluroSpot market is segregated into infectious diseases, cancer, autoimmune diseases, allergy and others. Because of increasing number of chronic infectious diseases and increased productivity towards the use of ELISpot and FluoroSpot assays, the infectious diseases segment is expected to dominate the ELISpot and FluoroSpot assay market 

Insight by enduser type

Based on end user the global ELISpot and FluroSpot assays market is segmented into hospitals & clinical labs and biopharmaceutical companies. The availability of enhanced diagnostic infrastructure and healthcare insurance policies, hospitals and clinics segment is expected to dominate the ELISpot and FluoroSpot assay market.

Industry Dynamics

Growth Drivers

Growth in biotechnology & biopharmaceutical industries and chronic diseases like cancer are the  grotto wth drivers for the expansion of ELISpot and FluroSpot assay market. Increasing vaccine development to face the challenge of various infections is expected to spur the market growth during the forecast period. Technological advancements in ELISpot and FluroSpot assay kits and analyzers is the another growth driver for this market. Awareness about early disease diagnosis, to cater the chronic and infectious diseases, plays a significant role for the substantial growth in EliSpot and FluoroSpot assays market.

Restraint

Shortage of skilled professionals and availability of other detection technologies are the challenges of the global ELISpot and FluroSpot assays market. Also, the high cost of ELISpot and FluoroSpot assay kits and analyzers acts as a restraint for the growth and adoption of these assays in various research. The ELISpot assay does not provide information on the phenotype of responding cells, also expression and/or upregulation of co-receptors or lineage markers and cytokine secretion cannot be simultaneously analyzed are some of the disadvantages.

Geographic Overview

• North America

• Europe

• Asia Pacific (APAC)

• Rest of the Worl

Geographically, the global ELISpot and FluroSpot market is dominated by North America. Well established healthcare infrastructure is mainly the growth driver of this market. Healthcare facilities, research institutions and state-of-the-art laboratories provides a favorable environment to adopt advanced diagnostic technologies like ELISpot and FluroSpot assays. 

Germany is forecasted to be the fastest growing market of ELISpot and FluroSpot assay market in Europe due to its strong biomedical research universities, institutions and healthcare facilities. 

Germany also has well equipped biotechnological and pharmaceutical industry that are aggressive in research and development. Whereas in Asia Pacific region, China is anticipated to have the largest share for ELISpot and FluroSpot assays market. This market plays important role in China market due to the burden of increase in infectious diseases and their chronic conditions.Going forward, growth opportunities exist from increasing R&D spending in emerging countries like China and India. Leveraging ELISpot to monitor immune response for COVID-19 vaccines also holds potential.

Overall, ELISpot and FluoroSpot assays provide a sensitive platform for gaining valuable insights into immune function. Challenges can be conquered by continued product innovation and standardization.

Key Players Covered in the Report

The major companies providing the global ELISpot and FluoroSpot assay are Oxford Immunotec USA, Inc., BD, Thermo Fischer Scientific, Covalab, Inc., CellCarta, Oxford BioSystems, AUTOIMMUN DIAGNOSTIKA GMBH, DIACLONE SAS, R&D Systems, Inc., Mabtech, Abcam plc, Covance Inc., U-CyTech, Bio-Techne, Cellular Technology Ltd, MIKROGEN GmbH among others.

Collaboration, joint ventures and other strategies by the market player is enhancing the company market in the global ELISpot and FluoroSpot assay market which also provides the benefit for organisation to improve their offering for Treatment Products. The strategic initiatives by market players along with new technological advancements for ELISpot and FluoroSpot assay are bridging the gap for diagnosis and assessment of cytokines.

Recently, Mabtech released ELISpot Flex: human IL-29 and FluoroSpot Flex: human IL-29, we can now study IL-29 secretion and combine it with other analytes in the FluoroSpot Flex platform. The detection antibody is available with two different fluorophores to enable various combinations. To trigger the release of IL-29 in ELISpot and FluoroSpot one needs to make sure to stimulate the cells with 2'3'-cGAMP!

Thermo Fisher Scientific, the world leader in serving science, announced an exclusive distribution agreement with Aesku.Group (Aesku), a leading provider of innovative diagnostic solutions, to market, sell, and support their portfolio of FDA-Cleared IFA products, automated instruments, and software in the United States. With this agreement, Thermo Fisher positions itself to offer laboratories a comprehensive suite of automated diagnostic systems and methodologies available in the U.S. market. This agreement between Thermo Fisher Scientific and Aesku gives customers access to a comprehensive portfolio of autoimmune diagnostics and automated instrumentation, complimenting both the EliA™ autoimmune testing portfolio and Phadia™ laboratory instruments with Aesku IFA testing and Helios® HTC systems.

The ELISpot and FluoroSpot assay market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2025–2030.

Segments Covered in the Report

• By Product type

• Analyzers

• Assay kits

• Ancillary 

• By Application type

• Vaccine development

• Clinical trials

• Cancer research 

• By Disease type

• Infectious disease

• Transplants 

• By Enduser type

• Hospitals and clinical labs

• Biopharmaceutical companies

Region Covered in the Report

• North America

• U.S.

• Canada

• Mexico

• Europe

• Germany

• U.K.

• France

• Italy

• Spain

• Russia

• Rest of Europe

• Asia-Pacific (APAC)

• China

• Japan

• India

• Rest of the World

• Brazil

• Saudi Arabia

• South Africa

•  U.A.E

• Other Countries