The most important users of this market are clinical diagnostic institutions that apply these assays and academic research centers. They employ the assays in formulating preliminary exploratory studies and controlled trials. Some of the market components are the assay kits (ELISpot and FluoroSpot) in addition to the detection reagents, pre-coated plates and analyzers.
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Market Drivers
- Broaden the Clinical Uses in the Profiling of Immunes Cells
Influencing the adoption of ELISpot and FluoroSpot assays is the increase in clinical attention and hence interest in tracing the cellular immune response. With the advent of personalized treatments (in particular T-cell based treatments), these assays will be crucial in understanding the presence of cytokine secreting cells and therefore be useful in evaluating therapeutical efficacy. As an example, they are allegedly being used in immune surveillance of tuberculosis and cytomegalovirus (CMV) activities in hospitals and diagnostic centres all over the world.
- Recent Development in the Multiplex Assay Technology
Using the FluoroSpot technology, it is possible to measure several cytokines produced by a single cell and there is an ability to multiplex without cross-reactivity. This tech first offers a huge gain in data richness and throughput over standard ELISpot. The increased sensitivity of fluorochrome panels, combined with high-resolution imaging platforms, allows strong characterization of immune cells, and have been critical in extending the uses of the assays to complex disease models.
Product Type Segment Analysis : Assay Kits
Assay Kits business dominates the ELISpot and FluoroSpot assay industry because pre-formulated products are standardized, reproducible and convenient to be used. IFN-g, IL-2, TNF alpha and dual or triple color FluoroSpot kits are well selling immunology research and diagnostics products. Academic studies and clinical trials often use kits that have been validated to guarantee the integrity of data.Rapid expansion in this market is due to stronger investment in translational immunology and partnership between pharmaceutical firms and developers of diagnostic assays. Commercially available kits in which the plates are pre-coated and selection of controls built-in assist in eliminating the occurrence of manual error, therefore, they are the most desirable tools that aid in immune response monitoring in human subject and animal representatives.
Application Segment Analysis: Clinical Diagnostics
Compared to other sectors of applications, the Clinical Diagnostics is the fastest-growing segment within the application landscape. In a number of territories ELISpot assays have been approved or applied within the laboratory-developed test (LDT) status to identify latent disease like tuberculosis infections and to survey transplant patients regarding the risk of viral reactivation. Such assays are particularly useful in immunocompromised patients in which standard serological tests are insensitive.ELISpot has been of key use as a clinical tool in assisting therapeutic decision making particularly in transplant immunology and in monitoring post-vaccination.
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Regional Analysis :North America and Europe:
North America accounts to a major share of ELISpot and FluoroSpot assay market and this is selectively due to the existence of major biotechnology corporations, state sponsored immunology-related research initiatives, and the research infrastructure. The United States is an important market, where there is a high demand among the academic research centers, vaccine manufacturers, and centralized diagnostic units. Market pressure is also served by regulatory encouragement toward immunodiagnostics and early-stage clinical trial models.
Europe is also a key area where such countries as Germany, the UK, or Sweden are engaged in the advancement of immunodiagnostics with the help of institutional grants and through their academic-industry collaborations. Considerable involvement in international manufacture of the vaccines and availability of the centrally located manufacturing companies in the region further add up to the European contribution in market growth.
Competitive Landscape & Industry Players
The market of ELISpot and FluoroSpot assays is very competitive and the companies are concentrated on the innovations in multiplexing, automation and applications in data analysis. Major players in the industry are:
Oxford Immunotec (Revvity)
Mabtech AB
Bio-Techne (R&D Systems)
Cellular Technology Limited (CTL)
BD Biosciences
These competitors are competing based on product sensitivity, assay throughput, simplicity of data interpretation and support of regulatory activities in the clinical environments. Others are incorporating automated readers and cloud based analysis systems to enhance consistency and the size of study data.Joint ventures with clinical research networks, diagnostic centres and manufacturers of vaccines are helping these firms to achieve greater market shares. Other companies also provide pharma sponsors who need proprietary immune monitoring solution with custom assay development.
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