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Vouching for Holistic Tests Kits

Aseem Kumar Tiwari, Associate Director and Incharge, Department of Transfusion Medicine, Medanta-The Medicity Hospital, Gurgoan

Aseem Kumar Tiwari, Associate Director and Incharge, Department of Transfusion Medicine, Medanta-The Medicity Hospital, Gurgoan

Majority of the end-users are opting for multiplex proteomic arrays, as a result of which ELISA products have largely been restricted to laboratories seeking cost-effective technology options, writes Anshuman Ojha, Elets News Network (ENN)

E nzyme-Linked Immunosorbent Assay (ELISA) is one of the few assay formats that has man- aged to command widespread popu- larity, in terms of reproducibility, per- formance, and validation, particularly in a rapidly changing life sciences and drug discovery market. Adherence with stringent quality control and vali- dation requirements has ensured min- imal high-cost failures. The advent of proteomics led to a significant expan- sion in the availability of protein tar- gets for assay development, thereby fostering the development of kits for large family of proteins as well as for proteins in unrelated, niche research segments.

Majority of the end-users are opt- ing for multiplex proteomic arrays, as a result of which ELISA prod- ucts have largely been restricted to laboratories seeking cost-effective technology options. On the other hand, the commoditisation of ELISA products has enhanced price-related pressures for manufacturers, par- ticularly from bulk purchase custom- ers. With the advent of proteomics which largely expand the availability of pro- tein targets for as- say development, the ELISA instru- ments and reagents market is chal- lenged. The multi- plex technology as well as multiple-an- alyte quantification microarray tech-nique restricts the further popularity of ELISA products.

However, favourable reputation of ELISA kits as a trusted technolo- gy for research markets, continued use in secondary validation for select targets by multiplex customers, and developments in the field of biomark- ers resulting in the availability of new targets is expected to ensure revenue generation in the ELISA market. The cost-effective ELISA products are pre- ferred by laboratories and research- ers that focus on less number of ana- lytes and high sensitivity of assay.

Market Dynamics

The global ELISA market is projected to reach US$ 165 million by 2020, driven by its continued use as a secondary validation technique, and increasing investments in research related to immunology and medicine, according to a report by Global Industry Analysts. Demand for ELISA products, in the short to medium term, is expected to come largely from small sized laboratories dealing with less number of analytes and high sensitivity of assays. Development of automated platforms for running ELISA will further encourage market growth by offering improved performance, productivity, sensitivity, and flexibility to adapt a range of assays/protocol. The United States represents the largest market for Research ELISA worldwide. Asia- Pacific ranks as the fastest growing market led by medical tourism and demand for cost effective biochemical screening technologies.

Market Trends

ELISA kit manufacturers boast that they perform a tremendous amount of validation and quality control with stringent requirements on each kit, ensuring that costly failures are kept to a minimum. With an extremely high level of inter- and intra-assay reproducibility, quality ELISA kits provide validated, publishable results for academics and proven consistency for large studies by pharma firms.

Despite the technology’s solid rep- utation, the ELISA market has seen minimal growth over the past five years as researchers adopt newer technologies, especially the multi- plex proteomic array platforms. Many studies that previously employed single-analyte ELISAs for target de- tection and quantification are now utilising proteomic arrays for the con- venience of multiplexing capabilities.

The ELISA, however, has assumed a new complementary role serving as the benchmark technology to multi- plexing and other new assays, demon- strating that these product markets may be sustainable simultaneously. Researchers tend to use multiplex platforms to measure many targets at a time in a small number of samples and then switch to the ELISA technol- ogy to carefully measure many differ- ent samples for a selected target.

Additionally, researchers who do not need the advantages of multi- plexing, lack the funding to purchase expensive array instrumentation and reagents, focus only on a few analytes, or require high assay sen- sitivity, continue to use ELISA kits. While the trend toward multiplex proteomic arrays has accounted for a declining growth rate in the overall ELISA market, unless newer plat- forms dramatically decrease in price and improve on sensitivity levels, the ELISA will continue to maintain a role in research.

Interestingly, ELISA providers have reacted to newer technologies in different ways. Determined to take advantage of the trend toward mul- tiplexing, several companies have stalled expansion of their ELISA kit portfolios over the past five years in favour of focusing resources toward the development of multiplex or oth- er new assay types. Other providers vehemently defend the complemen- tary role of ELISAs to proteomic ar- rays and continue expansion of their ELISA lines while building multiplex assay portfolios as well.

Smaller companies without the R&D budgets to develop new multi- plex assays have sought niche mar- kets to penetrate to circumvent heavy competition. In general, new ELISA product introductions attempt to serve a different market sector than multiplex assays currently reach.

Companies that continue to bring unique ELISA products to the mar- ket are experiencing market share growth; companies abandoning ELI- SA product development are general- ly experiencing stagnant-to-negative growth for their ELISA lines, contrib- uting to an overall decline in market revenues.

Developing unique ELISA products and targeting niche markets appear to be successful strategies for over- coming both market erosion by newer technologies and increasing commod- itisation. Furthermore, companies with the resources to develop portfo- lios for new assay types may reap the benefits of diversification, including expansion of their customer bases and increased exposure for other product lines.

Nevertheless, the overall ELISA kit segment is likely to experience the greatest erosion by proteomic array technologies, as the ELISA develop- ment components segment caters to price-sensitive laboratories unlikely to switch exclusively to more expensive technologies. The percentage of total research revenues generated by kits is expected to decrease as the percent- age of revenues generated by develop- ment components increases.

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