Immunoassay Automation Trends 2014
|出版日||ページ情報||英文 56 Pages
This market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on immunoassays and their automation carried out in August 2014.
The survey was initiated by HTStec as part of its tracking of life science marketplaces and to partially update HTStec's previous ELISA Trends report (dated June 2012).
The questionnaire was compiled to meet the needs, requirements and interests of the immunoassay vendor community.
The objective was to comprehensively document current practices and preferences in immunoassays and to understand future user requirements, particularly with respect to immunoassay automation.
Equal emphasis was given to soliciting opinion from all organisations where immunoassays are currently being undertaken, with no geographic bias in the distribution of persons contacted.
The survey looked at the following aspects of immunoassays, as practiced today (2014) and in many cases as predicted for the future (2017): main use of immunoassay technology today; main application area of immunoassay research; target classes investigated by immunoassays; main sample sources analyzed; enzyme/detection chemistry most used; level of automation applied; capital cost of automated solutions implemented; brief details of automated solution implemented; level of automation respondents want to achieve; how respondents prefer to access immunoassay automation; plans to purchase an automated immunoassay workstation and preferred automation vendors; factors influencing a decision to select a vendor for immunoassay automation; maximum capital cost for an automated (hands free) immunoassay workstation; awareness of new emerging immunoassay platforms or alternatives technologies; main drivers for adopting a new automated immunoassay platform; barriers to change that would limit adoption of a new automated immunoassay platform; enthusiasm to change assay buffers and/or protocols to work with a new automated immunoassay platform; number of immunoassay plates typically run per year; maximum immunoassay throughput achieved and wanted; assay formats used for immunoassay analysis; final immunoassay (incubation) volume; number of different immunoassays developed (self-built) per year; average cost per single immunoassay (per well); price paid for immunoassay kits and application area pricing relates to; annual budget for immunoassay consumables and the breakdown of that budget into components; most important factors in the decision to purchase a particular vendor's immunoassay kit; main suppliers of immunoassay kits purchased; biggest hurdles (limitations) that still need to be addressed with immunoassays today; and any unmet needs that exist in immunoassay automation today.
The main questionnaire consisted of 28 multi-choice questions and 1 open-ended question. addition, there were 6 questions related solely to survey demographics.
The survey collected 86 validated responses, of these 87% provided comprehensive input.
Responses were geographically split: 51% North America; 36% Europe; 6% Asia (excluding China Japan); 4% Rest of World; 1% Japan; and 1% China.
Survey respondents were end-users of immunoassays and met the following criteria: 1) were currently undertaking immunoassays; & 2) made or influenced purchasing decisions for immunoassay kits, related consumables, instrumentation or automation.
Respondents came from 38 University/Research Institute/Not-for-Profit Facilities; 13 Biotech Companies; 11 Pharma; 8 Other; 5 Hospitals/Clinics; 4 Diagnostics Companies; 3 Contract Research Organisations; 2 Government/Military/Defence Facilities; and 2 Food Safety Companies.
Most survey respondents had a senior job role or position which was in descending order: 15 lab/ research managers; 14 research scientists; 11 principal investigators; 11 professors/assistant professors; 7 section/group leaders; 7 senior scientists/research associates; 6 directors; 3 presidents; 3 post-doctoral associates/fellows; 2 vice presidents; 2 others; and 1 graduate student.
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 based on their main use of immunoassay technology: 1) Basic Research; 2) Applied Research; 3) Non-Clinical Analysis/Testing; 4) Clinical Analysis/Testing; 5) QC/Manufacturing/Bioprocessing.
The main application areas of respondents immunoassay research was biomarkers and immunology.
The target class respondents were most interested in being setup and run in immunoassay format was inflammation markers.
The main sample source analyzed by immunoassays was cultured cells.
The enzyme/detection chemistry most used today was horseradish peroxidase-colorimetric.
Only 14% of respondents had applied full automation to their immunoassays to date.
The median capital cost of immunoassay automation already implemented to date was $40K-$60K.
The level of automation implemented is tabulated versus the capital cost paid for that automation.
Brief details of the immunoassay automation solutions respondents have already implemented were listed.
Most respondents want to achieve in the future full workflow (walkaway) immunoassay automation on an open generic platform.
The median interest in acquiring a fully automated immunoassay workstation over the coming years was possible (26-50% probability), with Bio-Rad and Tecan currently the most preferred automation vendors.
Precision was rated the greatest impact on a decision to select an immunoassay automation vendor.
The median maximum price respondents would pay for an automated system that could run their immunoassay requirements hands free was $60K.
Of a list of new emerging automated immunoassays platforms or alternative technologies respondents were most aware of Luminex microparticle-based flow tests; PerkinElmer AlphaLISA; qPCR-based alternative tests; and MesoScale Discovery ECL multiarray technology.
Facilitates improved performance/greater sensitivity/better uniformity was ranked the main motivator/driver for adopting a new improved or automated immunoassay platform.
The requirement to invest in new capital equipment was rated the most important barrier to change that would limit the adoption of a new improved or automated immunoassay platform.
The majority of respondents were amenable to changing assay buffers and/or protocols to work with a new immunoassay platform with potential to significantly improve performance.
The median number of 96-well immunoassay plates run per year was 100.
The median maximum immunoassay throughput achieved was five 96-well plates per 8h day.
The majority of immunoassay samples were analyzed in or from a 96-well microplate format today.
The median final assay volume for immunoassays assays today was 50μL to 100μL.
67% of respondents reported that they develop (self-build) immunoassays.
A median of 3 new immunoassays were developed per year.
The median cost per single immunoassay (well) today was $1-$2.50.
$300-$400 was the median average price paid per immunoassay kit of 96-wells.
$400-$500 was the median maximum price respondents would want to pay for an immunoassay kit of 96-wells.
The cost paid per immunoassay kit was tabulated with the application area of the kits priced.
The median annual immunoassay consumables budget per lab per year today was $25K-$50K.
The greatest proportion of the immunoassay consumables budget was spent on immunoassay kits (single analyte assays), followed by antibodies and then immunoassays kits (multiplexed assays).
A bottom-up model was developed around the respondent's annual budget for immunoassay consumables to estimate the global market, which in 2014 was around $900M. Nearly 50% of this market was allocated to immunoassays kits (both single and multiplexed analytes). The market was segmented by immunoassay activity focus and geography, with CAGR estimates for 2017 made.
Specificity (i.e. cross-reactivity & interference with related analytes) was rated as the factor of greatest importance in a decision to purchase a supplier's immunoassay kit.
The main (most used) supplier of immunoassay kits purchased by respondents was R&D Systems.
Improving detection capability in complex samples was ranked the biggest hurdle (limitation) with immunoassays today.
Feedback on some unmet needs that exist in immunoassay automation today were listed.
The full report provides the data, details of the breakdown of the responses for each question, its segmentation and some estimates for the future (2017). It also highlights some interesting differences between the survey groups.
PLEASE NOTE: this market report covers all types of immunoassays, it includes conventional ELISAs, immunoassays that are linked to some non-enzymatic reporters or are homogenous (no-wash) (e.g. PerkinElmer AlphaLISA) and those microparticle-based methods (e.g. Luminex, BioScale, Gyros) that remove samples from microplates for analysis and utilize flow-based detection.