In November 2023, Revvity unveiled the national release of its T-SPOT TB test for the detection of latent tuberculosis during the 46th Edition of MICROCON in Lucknow. The company asserts that its product is the sole commercially accessible IGRA (interferon gamma release assay) approved by the FDA, utilizing the ELISPOT technology. This technology encompasses the process of separating, cleansing, and quantifying peripheral blood mononuclear cells (PBMCs) from whole blood in order to provide a consistent test and yield consistent outcomes for accurate detection, particularly in difficult-to-screen populations such as those with weakened immune systems. Given that almost 40% of the Indian population carries latent TB, it is crucial to identify the infection before it develops into active disease, which is characterized by symptoms and contagiousness. The T-SPOT TB test, which utilizes the ELISPOT technology, is the sole IGRA recommended by the World Health Organization (WHO) that use a standardized sample. This helps minimize the impact of blood-related factors that could potentially impair its performance and allows for normalization in cases of cell number variation. The diagnostic recommendations of the World Health Organization (WHO) recognize the advantages of the normalization stage that is necessary before cell stimulation in the T-SPOT TB test.
In September 2023, Virax Biolabs Group Limited, a cutting-edge diagnostics firm specializing in detecting immune responses and diagnosing viral illnesses, announced the initiation of an early access program for the research-use-only of their exclusive SARS-Cov-2 ViraxImmune T-cell-based test. The early access program provides exclusive access to cutting-edge immune evaluation breakthroughs for chosen research organizations. The RUO (Research Use Only) version of Virax's T-cell-based test is specifically developed to evaluate the activation of memory T-cells that are specific to the SARS-Cov-2 virus. This is achieved by combining an ELISpot assay with a peptide pool that covers particular protein segments of the virus. The test necessitates the extraction of peripheral blood mononuclear cells from blood samples, which are subsequently placed onto the Company's pre-coated ELISpot plate.
ELISpot and FluoroSpot Assays Market Segment Insights
The ELISpot and FluoroSpot Assay Market is segmented on the basis of product, application, and end-user.
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.
ELISpot and FluoroSpot Assays Regional Insights
On the basis of region, the ELISpot and FluoroSpot Assay Market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The Americas is sub-segmented into North America and South America. The North American region is further segmented into the US and Canada. The European region is divided into two, namely, Western Europe and Eastern Europe. Western Europe is further classified into Germany, Italy, France, the UK, Spain, and the rest of Western Europe. The Asia-Pacific region is sub-segmented into Japan, China, India, Australia, the Republic of Korea, and the rest of Asia-Pacific. The Middle Eastern and African region is sub-segmented into the United Arab Emirates, Saudi Arabia, Oman, Kuwait, Qatar, and the rest of the Middle East and Africa.
Key players:
Some of the key players in the ELISpot and FluoroSpot Assay Market are
- 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)
Regional Market Summary:
Sources: National Cancer Institute, Cancer research UK, the American Cancer Society, Inc, US Department of Health and Human Services National Institutes of HealthIt is estimated that North America dominated the ELISpot and FluoroSpot Assay Market owing to the increasing cardiac diseases, innovations in clinical practice, increasing research and development in pharmaceutical industries boost the market growth. According to the Centers for Disease Control and Prevention 2017 publication 83.4% of children aged 19-35 months were vaccinated with Diphtheria, Tetanus, Pertussis in the US. The increasing demand for vaccines will boost the market growth.
Europe stood second largest in the ELISpot and FluoroSpot Assay market owing to the increasing number of pharmaceutical companies, rising in the development of innovative vaccines for the treatment of various viral diseases. The growing funding from government and private agencies for drug development also support the market in this region. Asia-Pacific was estimated to be the fastest growing region for the Market in 2017. The market is expected to witness growth owing to the rising prevalence of viral infection, increasing geriatric population in this region and growing demand for ELISpot and FluoroSpot Assay in research field.
The Middle East and Africa holds the least share in the ELISpot and FluoroSpot Assay Market due to the presence of low health expenditure, lack of skilled technicians and less pharmaceutical company in this region. However, the market is expected to witness growth due to increasing research & development in the Middle East.
ELISpot and FluoroSpot Assays Market Segmentation
ELISpot and FluoroSpot Assay Product Outlook
- Assay Kit
- T Cell assay
- B Cell assay
- Analyzer
- Ancillary Products
ELISpot and FluoroSpot Assay Application Outlook
- Transplant,
- Vaccines
- Clinical Trials
- Cancer Treatment
ELISpot and FluoroSpot Assay End-User Outlook
- Hospitals and clinics
- Ambulatory surgical centers
- Diagnostic centers
- Research centers
- Others
ELISpot and FluoroSpot Assay Region Outlook
- Americas
- Europe
- Asia-Pacific
- Middle East & Africa
Recent Development
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