This market report summarizes the results of HTStec's 2nd industry-wide global web-based benchmarking survey on epigenetic screening assays carried out in May 2012.
The survey was initiated by HTStec as part of its tracking of this emerging life science marketplace and to update HTStec's previous report (June 2010). The questionnaire was compiled to meet the needs, requirements and interests of the epigenetic vendor community. The objective was to comprehensively document current practices and preferences in epigenetic enzyme screening assays, to understand future user requirements, and interest in outsourcing. Equal emphasis was given to soliciting opinion from Pharma, Biotech and Academic Research market segments in both North America and Europe.
The survey looked at the following aspects of epigenetic enzyme screening assays, as practiced today (2012) and in some cases as predicted for the future (2014): level of enthusiasm for epigenetic target biology; key diseases/therapeutic area(s) investigating epigenetic enzyme assays; epigenetic target classes/proteins of greatest interest, where assay feasibility has been investigated and primary screens run; main source/origin of epigenetic enzymes/proteins; where current commercial recombinant proteins are adequate; where improved biochemical assay kits and cell-based alternatives are still needed; assay formats/detection technologies that have proven useful and those most associated with assay advantages; types of substrates most commonly used; the challenges of assay development of epigenetic targets; new tools required to drive the investigation of epigenetic enzyme assays; what limits epigenetic enzyme screening; aspects of epigenetic drug discovery that are most limiting today; where the situation concerning the main limitations of epigenetic screening assays has improved in the past 2 years; number of FTE devoted to epigenetic research; number of different epigenetic targets supported; number of epigenetic primary screens and wells per screen; approach to the primary screening (HTS) of epigenetic enzymes; proportion of epigenetic primary screens that are biochemical assays; epigenetic target classes investigated with cell-based assays and assay formats used for screening; epigenetic assay reagent budget and its breakdown into components purchased; source the reagents and tools used to assay epigenetic enzymes; average cost per well of epigenetic screening assays; interest in outsourcing epigenetic research; proportion of epigenetic enzyme testing outsourced and number of wells outsourced; budget for outsourcing epigenetic assays and services; preferred fee-for-service providers; and unmet needs in epigenetic enzyme assays and screening today.
The main questionnaire consisted of 29 multi-choice questions and 3 open-ended questions. In addition, there were 6 questions related solely to survey demographics.
The survey collected 66 validated responses, of these 58% provided comprehensive input. Responses were geographically split: 42% North America; 30% Europe; 12% Rest of World; 11% Asia (excluding Japan); and 5% Japan.
Survey respondents were drawn from persons or groups undertaking epigenetic enzyme screening assays or planning future investigation in this area.
Respondents represented 30 University/Research Institute/Government Lab/Not-for-Profit Facilities; 11 Biotech Company; 8 Large Pharma; 8 Academic Screening Centers; 4 Medium-Small Pharma; 4 CROs; and 1 Other.
Most survey respondents had a senior job role or position which was in descending order: 10 section/ group leaders; 10 senior scientists/researchers; 10 principal investigators; 9 directors; 7 professor/ assistant professors; 6 research scientists/associates; 6 post-docs; 4 other job roles; 2 lab managers and 2 department heads.
Respondents represented the followings labs: 15 basic research; 9 primary screening (HTS); 8 with a combination of drug discovery roles; 7 applied research; 6 other areas; 4 assay development; 3 therapeutic areas; 3 hits-to-leads; 1 compound profiling; and 1 secondary screening. Survey results were expressed as an average of all survey respondents. In addition, where appropriate the data was reanalyzed after sub-division into the following 5 survey groups: 1) Pharma; 2) Biotech; 3) Academic Research; 4) Europe; and 5) North America.
61% of respondents were currently routinely undertaking epigenetic enzyme screening assays. The remaining 39% of respondents were planning future investigation.
The majority of respondents had a high level of enthusiasm for epigenetic target biology. The majority of respondents were targeting epigenetic assays within the oncology therapeutic area.
The epigenetic enzyme class/protein ranked of greatest interest, most investigated for feasibility or run as primary screens were histone methyltransferases.
The main source/origin of epigenetic enzyme proteins used today (2012) were commercial sources.
The adequacy of commercial assays and tools available for the main epigenetic enzyme classes/proteins was rated most adequate for histone deacetylases, but as a whole the ratings for all enzyme classes/proteins did not exceed moderately adequate.
The epigenetic target class most in need of better biochemical assays kits was histone demethylases.
The epigenetic target class most in need of better cell-based assay alternatives was histone deacetylases.
The assay format/detection technology that had proven most useful to date and wanted to deploy in the future was ChIP-Seq (chromatin immunoprecipitation sequencing).
Based on a list of desirable assay advantages TR-FRET was the most preferred assay format/detection technology for epigenetic assays, it was followed by radiometric.
Respondents most commonly used peptides as substrates for their epigenetic enzyme assays.
Specificity was ranked as the most important challenge of epigenetic enzyme assay development.
32% had encountered specific assay challenges when working with epigenetic enzymes.
Lack of follow-up cell-based assays and counter-screens was rated the most limiting (major obstacle) in the exploitation of epigenetic enzyme targets today.
The aspect of epigenetic drug discovery ranked most limiting was target validation.
Some improvement in the general limitations of epigenetic screening assays was seen in the past 2 years.
A median of 2 FTE's were allocated to enable/support in house epigenetic enzyme research (investigation and screening) in 2012.
A median of 3 different epigenetic targets/projects/programs were undertaken in house in 2012.
A median of 1-5 epigenetic enzyme primary screens, each with 25K-50K wells were done in 2012.
The preferred way to primary screen epigenetic enzymes involved a combination of library approaches.
A median of 45% of all epigenetic primary screens were enzyme/biochemical assays in 2012.
The epigenetic target class most investigated using cell-based assays today or planned future cell-based assays were histone methyltransferases.
The assay formats currently most used for cell-based primary screening of epigenetic target classes were HCS methods/imaging.
A median budget of $25K-$50K/lab was allocated for epigenetic enzyme assay reagents in 2012, with the greatest share assigned to assay specific probes and biochemical assay kits.
A bottom-up model developed around respondent's annual budget for epigenetic screening assay reagents estimated the global market to be around $40M in 2012. Nearly 50% of this budget was allocated to assay specific probes and biochemical assay kits.
The most used commercial sources of reagents and tools for in house epigenetic enzyme assays were from PerkinElmer, Abcam and Life Technologies.
The median cost per single well for epigenetic screening assays undertaken in house was $0.25-$0.5 for biochemical assays versus $0.75-$1 for cell-based assays.
Profiling against panels using mass spec approaches was the aspect of epigenetic research respondents were most interested to outsource to a fee-for-service provider.
The median % of all epigenetic primary screening and profiling outsourced was 'none' in 2012.
The median total number of single wells outsourced to a fee-for-service provider for epigenetic primary screening and profiling was 'none'.
Where outsourcing was done a median budget of $10K-$25K/lab was allocated for outsourced epigenetic testing and services in 2012.
The 2012 global market for outsourced epigenetic testing and services was estimated to be very small.
The preferred fee-for-service providers of epigenetic screening and profiling assay services were Life Technologies, Cerep and Caliper CDAS (PerkinElmer).
Respondent feedback on the improvements they think are required and the unmet needs that exist today in epigenetic enzyme screening assays were documented.
The full report provides the data, details of the breakdown of the responses to each question, its segmentation, the market and CAGR estimates. It also highlights some interesting differences, particularly between Pharma versus the other survey groups