ELISA Assay Trends 2016
|出版日期||內容資訊||英文 52 Pages
This market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on enzyme-linked immunosorbent assays (ELISA) carried out in April 2016.
The survey was initiated by HTStec as part of its tracking of life science marketplaces and to update HTStec's previous ELISA Assay Trends report (June 2012). The questionnaire was compiled to meet the needs, requirements and interests of the ELISA assay vendor community.
The objective was to comprehensively document current practices and preferences in ELISA assays, and to understand future user requirements. It also examined barriers to change that might limit the adoption of new or emerging ELISA platforms with potential to significantly improve performance.
Equal emphasis was given to soliciting opinion from all organizations where ELISA assays are currently being applied, with no geographic bias in the location of persons contacted.
The survey looked at the following aspects of ELISA assays, as practiced today (2016) and in many cases as predicted for the future (2019): where ELISA technology is used; main application areas of ELISA research; main sample sources analyzed; enzyme/detection chemistry most used; level of automation applied; what is driving the implementation of ELISA automation; number of different ELISA assays run per year and how many of these ELISA assays are self-build; number of ELISA plates typically run per year; maximum ELISA throughput achieved and wanted; microplate format used; the need for commercially available ELISA kits to be offered in miniaturized formats; % of ELISA assays wells (data points) multiplexed and number of different analytes multiplexed; interest in performing multi-parametric analysis on the same samples; how ELISA assays are detected (read); how analysis/graph fitting is performed on ELISA assay data; software used as part of respondent's ELISA assay workflow; main advantages and disadvantages of using an ELISA format; average cost per single assay (well); price paid for ELISA kits; annual budget for ELISA assay consumables and the breakdown of that budget into components; most important factors in the decision to purchase a particular vendor's ELISA kit; main suppliers of ELISA kits purchased; biggest issues (problems) with ELISAs today; relevance of ELISAs today or are there new emerging or alternatives technologies which will replace it; barriers to change that would limit adoption of a new improved ELISA platform; willingness to change assay buffers and/or protocols and devote training time to enable a new ELISA platform; any unmet needs in commercial ELISA offerings; and willingness to contacted to discuss ELISA assay requirements further; and interest in performing in-lab evaluations on a new ELISA platform.
The main questionnaire consisted of 31 multi-choice questions and 1 open-ended question. In addition, there were 6 questions related solely to survey demographics.
The survey collected 91 validated responses, of these 70% provided comprehensive input.
Responses were geographically split: 40% North America; 32% Europe; 23% Asia (excluding Japan & China); 4% Japan; and 1% Rest of World.
Survey respondents were drawn from persons or groups interested in immunoassays and biomarkers, were end-users of ELISA and met the following criteria: 1) were currently undertaking ELISA assays; & 2) make or influence purchasing decisions for ELISA kits or related consumables.
Respondents came from 30 University/Research Institute/Not-for-Profit Facilities; 19 Pharma; 9 Biotech; 7 Hospital/Clinic; 6 Food Safety; 5 Diagnostics; 5 Government/Military/Defence; 4 Contract Research Organisation, 4 Other; 1 Agri Biotech/Plant Genomics; and 1 Veterinary.
Most survey respondents had a senior job role or position which was in descending order: 17 research scientists; 15 senior scientists/research associates; 15 principal investigators; 11 lab/ research managers; 7 section/group leaders; 7 directors; 6 professors/assistant professors; 5 others; 3 graduate students; 3 department heads; 2 vice presidents; 1 post-doc; and 1 president.
Survey results were expressed as an average of all survey respondents. In addition, where appropriate the data was fully reanalyzed after sub-division into the following 5 survey groups: 1) Basic Research; 2) Applied Research; 3) Routine Testing; 4) Only Purchase ELISA Kits; 5) Mainly Self-Build ELISAs.
The main uses of ELISA assays were basic research and applied research (with 29% of respondents using each); this was followed by clinical analysis/testing (18%); non-clinical analysis/testing (16%); and then quality control/manufacturing/bioprocessing (9%).
The main application areas for respondents ELISA assays were immunology and biomarkers.
The main sample source analyzed by ELISA assays was serum.
The enzyme/detection chemistry most used in ELISA assays today was enzymatic-colorimetric.
Most survey respondents have not applied any automation to their ELISA assays today.
More reliable/reproducible data, better quality of assay results was ranked the major driver for the implementation of ELISA automation.
The median number of different ELISA assays run per year today was 6-10.
The median number of self-build ELISA assays run per year today was 5.
The median number of 96-well ELISA plates run per year today was 50-100.
The median maximum ELISA throughput achieved per 8h day was 5x96-well plates.
Most respondents were using the 96-well standard volume format for their ELISA assays today.
Most respondents did not see the need for commercially available ELISA kits to be miniaturized, indicating that the 96-well standard volume format met their needs.
The median number of ELISA assay wells (data points) multiplexed today was none (0%).
The median number of analytes per ELISA assay today was 1 (i.e. they were NOT multiplexing).
Most respondents are considering performing multi-parametric analysis on the same samples as an alternative to multiplexing in the future.
Most respondents detect (read) their ELISA assays using a standalone multi-mode microplate reader.
The majority of analysis/graph fitting on ELISA assay data was performed off line by exporting raw data files to third party software.
Microsoft Excel was the software most used as part of respondent's ELISA assay workflow.
Highly sensitive, accurate and specific was ranked as the main advantage of ELISA assays.
Cross-reactivity and non-specific binding was ranked as the main disadvantage of ELISA assays.
The median cost per single assay (well) for ELISA today was $0.75-$1.
The median average price paid per ELISA kit of 96-wells was $250-$300.
The median maximum price paid for a high relevance ELISA kit of 96-wells was $300-$400.
The median annual ELISA assay budget spent per lab per year in 2015 was $5K-$10K per lab.
The greatest proportion of the annual ELISA assay budget was spent on ELISA assay kits for single analyte assays.
A bottom-up model was developed around the respondent's annual budgets (actual, allocated and estimated) for ELISA assay consumables to estimate the global market, which in 2015 was around $700M. Nearly 50% of this market was spent on assays kits. The market was segmented into routine testing, applied research and basic research with CAGR estimates for 2016 and 2019 made.
Specificity (i.e. cross-reactivity & interference with related analytes) was rated as the factor of greatest importance in a decision to purchase a vendor's ELISA kit.
The main (most used) supplier of ELISA assay kits purchased by respondents was R&D Systems.
Getting increased sensitivity was ranked as the biggest issue (problem) with ELISA assays today.
All respondents thought ELISA was still relevant in its established formats today. Some respondents gave feedback on new, emerging or alternative technologies which have the potential to replace conventional ELISA within 5 years.
Facilitates improved performance/greater sensitivity/better uniformity was ranked the main motivator/driver for adopting a new improved ELISA platform.
Cost per well (data point) was rated the most important barrier to change that would limit ability to adopt a new improved ELISA platform.
The majority of respondents were amenable to changing assay buffers and/or protocols to work with a new ELISA platform with potential to significantly improve performance.
Most respondents would devote a moderate amount of training time (maximum 1 day) to learn/ enable a new ELISA platform with potential to significantly improve performance.
Some feedback on the improvements wanted in current ELISA capabilities/performance and any gaps in commercial ELISA offerings were documented.
33% of respondents were willing to be contacted to discuss their ELISA assay requirements further.
28% of respondents were interested in performing in-lab evaluations on a new ELISA platform.
The full report provides the data, details of the breakdown of the responses for each question, its segmentation and some estimates for the future (2019). It also highlights some interesting differences between the segmented survey groups.