Automated Patch Clamping Trends 2015
|出版日期||內容資訊||英文 53 Pages
本報告針對使用全自動膜片鉗 (APC) 技術的離子通道藥物篩選基準調查結果、提供APC目前使用狀況與今後使用、購買計畫、預算、選擇基準、各種喜好與條件、希望。
This market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on ion channel drug screening using automated patch clamping (APC) technology carried out in September 2015.
The study was initiated by HTStec as part of its ongoing tracking of life science marketplaces and to update HTStec's previous report on the subject (published April 2014).
The questionnaire was compiled to meet the needs and interests of ephys/APC vendor community.
The objective of this global benchmarking study was to comprehensively document current practices, preferences and metrics in ion channel drug screening using APC technology. The questionnaire also addressed the use of 384-well APC systems, HTS integration and data analysis of APC systems, safety and transporter assays, and fluorescence as an alternative technique to APC.
Equal emphasis was given to soliciting opinion from Pharma, Other Screening Labs, Academic Research and Contract Research Organisation segments in North America, Europe and Japan.
The survey looked at the following aspects of ion channel screening using APC technology, as practiced today (2015) and in some cases as predicted for the future (2017): ion channels classes of greatest interest; number of ion channel programs investigated; number of APC patch wells expected to be processed per year; proportion of APC assays using different cell types; current access to APC ion channel platforms; preferred vendor's APC systems for different criteria; importance of features found in some APC systems; likelihood of purchasing a new APC platform over the next few years; factors that most influence a decision to purchase a particular APC platform; APC consumables budget for ion channel screening; what factors most prevent making greater use APC consumables today; preferences for multi-hole patch chips; whether the recent introduction of new 384-well APC screening platforms will affect screening activities; prohibitive and stimulative APC consumable pricepoints; most important features in a 384-well plate APC system; success rates required for completed experiments; preferred partners for system integration of an APC system into an automated HTS environment; steps which must be fully automated in an APC HTS system; flexibility required to modify or adapt vendor-recommended product protocols; number of plates to be processed in a fully automated APC HTS system; interest in purchasing a 1536-well APC system; screening solution utilized for APC data analysis and the integration needs of the preferred screening solution; how APC data is analysed and the frequency of reanalyzing measured APC data; awareness of the FDA CIPA working group and its potential impact on safety assays undertaken; techniques expected to be applied when fulfilling CIPA requirements; techniques used to investigate transporter assays; interest in Surfe2r technology for transporters; where fluorescence-based assays are still used as an alternative to APC for ion channel screening; main drivers for continuing to deploy fluorescence-based assays; and for which ion channel targets are fluorescence-based assays an acceptable alternative to APC assays.
The survey questionnaire consisted of 32 mainly multi-choice questions. In addition, there were 6 questions related solely to survey demographics.
The survey collected 138 validated responses, of these 62% provided comprehensive input.
Survey responses were geographically split: 44% Europe; 33% North America; 10% Japan; 5% India; 4% Rest of World; and 4% China.
Survey respondents were drawn from persons or groups actively involved in ion channel screening, selectivity profiling and safety assessment against ion channel liabilities using APC systems.
Respondents represented: 61 University/Res.Inst./Gov't Lab/Not-For-Profit; 26 Contract Research Organisation; 21 Large Pharma; 14 Medium-Small Pharma; 10 Biotech Company; 3 Agrochemical/Agri-Biotech Company; 2 Biopharma; and1 Academic Screening Center.
Most survey respondents had a senior job role or position which was in descending order: 46 senior scientists/researchers; 15 post-docs; 15 section/group leaders; 14 principal investigators; 10 professors/ assistant professors; 10 directors; 9 research scientists/associates; 8 lab managers; 5 others; 3 department heads; and 3 vice presidents.
Survey results were expressed as an average of all survey respondents. In addition, where appropriate the data was reanalyzed after segmentation into the following 6 survey groups: 1) Pharma; 2) Other Screening Labs; 3) Academic Research; 4) CROs; 5) Europe; and 6) North America.
The ion channel research activity undertaken by most respondents was assay development.
The class of ion channels of most interest was voltage-gated sodium channels.
A median of 3 ion channel programs were under investigation in respondent's organisations.
A median 1K-5K wells were processed per year using APC in all drug discovery areas.
The cell type most used for APC assays today was recombinant cell lines.
The most common APC system available for use in respondent's labs was the Sophion QPatch 8, 16 or HT.
Based on the prevalence of available APC instruments Nanion had the greatest vendor share.
From a list of desired characteristics/attributes Nanion was the most preferred APC vendor.
Suitability for different cell types was rated as the most important feature found in APC systems.
The likelihood of purchasing a new APC platform by end of 2017 was medium (10-50% probability).
The APC platforms respondents currently find most appealing for purchasing were Nanion Syncropatch 384/768PE and Sophion Qube.
The quality of the results was the factor which would most influence a decision to purchase a particular brand/model of APC platform.
The median annual APC consumable budget was $10K-$25K/year today.
Several bottom-up models were developed around the respondent's feedback to calculate the global APC markets. In 2015 these were estimated to be around $115M for APC consumables and $36M for new 384-well APC platforms. Segmentation & some CAGR estimates are in the full report.
The factor that most prevents greater use of APC consumables today was lack of projects.
The preferred patch chips were those with a single hole or pore per well.
The availability of patch chips with holes of different aperture sizes was identified as important.
The most predicted effect of the introduction of new 384-well APC screening platforms was to initiate APC screening at an earlier point in the drug discovery process.
For new 384-well APC screening platforms the median prohibitive price point (i.e. limits use to certain applications & inhibits adoption) was $1.00 per APC data point and $250-$300 per 384 patch plate.
The possibility to perform repetitive ligand applications (in well normalization) was the feature most want to access in a 384-well APC system.
Most respondents prefer to operate an APC instrument standalone (i.e. not integrated).
The preferred system integration partner for APC into an HTS environment was Beckman Coulter.
APC measurement was rated the step most want to fully automate when integrating an APC system.
Moderate software flexibility (i.e. example methods provided with option to change method and parameters) was most wanted in a benchtop APC platform.
The median number of plates to be processed without user intervention or per 8h day in a fully automated APC platform was 5 to 10 plates.
The majority had no interest in purchasing APC systems in 1536-well format.
The majority utilized an in house/customer-build solution in their organization for APC data analysis.
In terms of the integration needs with respect to the screening solution used for APC data analysis most respondents wanted full raw data current/voltage traces.
The majority reported additional manual steps (e.g. formatting) are required before analysing APC data.
The majority occasionally revisit measured APC data and perform reanalysis with a different set of parameters (cursors).
The majority were aware of the FDA CIPA working group where the cardiac risk panel was questioned and predict an increase in their future safety assay budget as a result of CIPA requirements.
The majority expect APC on stem cells/cell lines to feature highly when fulfilling CIPA requirements.
The majority reported they are not investigating transporter assays. Of those respondents investigating transporter measurements the most used technique was fluorescence uptake assays.
The majority were aware of the direct transport assay for electrogenic transporters using Surfe2r technology from Nanion and expressed possible interest in deploying this technology.
The area where fluorescence-based assays are still most routinely used as an alternative to APC for ion channel testing was primary screening (HTS), with throughput needs ranked the major driving force to continue to deploy fluorescence-based assays today.
Slow voltage-gated channels are the targets where fluorescence-based assays are regarded as the most acceptable alternative to APC assays.
The full report provides the data, details of the breakdown of the responses for each question, its segmentation and the estimates for the future (2017). It also highlights some interesting differences between the survey groups.