Real time pcr market & end user needs survey


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Real time pcr market & end user needs survey

  1. 1. PARIOFORMA Summary Report – September 2010PARIOFORMA LTD55 Princes GateExhibition RoadLondon SW7 2PNUnited KingdomTel: +44 (0) 20 7225
  2. 2. PARIOFORMA Real-time PCR is becoming a mature technique. Instruments are very robust and reliable, and optimised assays can be ordered from multiple vendors. Although the technique will be further refined and more niche products will be developed, main future improvements are not expected within the qRT-PCR technology itself. Growth drivers include: ◦ Increasingly robust assays ◦ Automation ◦ Increasing demand for high-throughput ◦ Multiplexed analytical strategies ◦ Increasingly affordable machines Technology trends have focused on: ◦ Increased throughput ◦ Faster analysis time ◦ Quantitative resolution ◦ Ready to use reagents and assays – including probe and primer sequences to facilitate compliance with evolving MIQE guidelines Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 2
  3. 3. PARIOFORMA ◦ Automation:  Sample processing  Liquid handling & filling − User friendly instrument operation:  Software driven controls – “menu” driven devices  Sophisticated data analysis software – integration with existing LIMs Future challenges will be to improve the down and upstream steps of real time PCR: ◦ Downstream:  Reagents: quality, specificity and consistency  Sample management and preparation ◦ Upstream:  The challenge is to handle, annotate and analyse the very large amounts of data that will be generated.  The implication is increasing sophistication of dedicated software for real-time PCR quality control, data management and analysis. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 3
  4. 4. PARIOFORMA For existing qRT-PCR users factors limiting the maximum use of the technology include: – The cost of instrumentation and consumables. – Machine access - more than 70% of scientists often share instrumentation with 10-12 other colleagues. Factors inhibiting the uptake of qRT-PCR by new users identified in interviews include: – The perceived difficulty and complexity of running qRT-PCR assays – Lack of experience in the technique – Perceived cost of instrumentation and reagents – although existing methods take longer, they are cheaper to run – Barriers to change existing working practices Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 4
  5. 5. PARIOFORMA Early adopters include: Real time PCR is a mature technique but not Biotech & Pharma; a mature market Academia and Government research. These are well established in their use of Saturation level Saturation level Saturation level Saturation level Saturation level Saturation level GMO qRT-PCR with a large Forensics Biodefense installed machine base. Smaller food labs Large food Labs Late adopters include: Veterinary Clinical Labs forensics, veterinary Academia Diagnostics diagnostics. These are just Big Large beginning to acquire Roche Pharma CROs machines and develop new Biotech ABI methods. Others are somewhere in between – e.g. hospital & clinics; food & GMO testing; environment testing. These are expanding existing use The diffusion of innovation technology With successive groups of consumers adopting of qRT-PCR into new areas. the new technology (shown in blue), its market share (yellow) will eventually reach the saturation level. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 5
  6. 6. PARIOFORMA Primary application areas for qRT-PCR analyses are basic research and diagnostics (detecting the presence of target genetic material) – others are derivatives thereof: Basic Research Diagnostics In research settings, qRT-PCR is mainly used to provide Molecular diagnostics on the other hand, involves the quantitative measurements of gene transcription – or measurement of DNA, RNA, proteins or metabolites to gene expression which is the process by which detect genotypes, mutations or biochemical changes. information from a gene is used to synthesize a Diagnostic qRT-PCR is applied to rapidly detect nucleic functional gene product (e.g. a protein). acids that are diagnostic of, for example, infectious The technology may be used in determining how the diseases, cancer and genetic abnormalities –in humans, genetic expression of a particular gene changes over plants and animals, etc. time, such as in the response of tissue and cell cultures The introduction of qRT-PCR assays to the clinical to an administration of a pharmacological agent, microbiology laboratory has significantly improved the progression of cell differentiation, or in response to diagnosis of infectious diseases, and is deployed as a changes in environmental conditions. tool to detect newly emerging diseases, such as flu, in Gene expression profiling can help researchers diagnostic tests. understand disease pathways which in turn helps them to identify means to interfere with those disease pathways (e.g. pharmacological) to develop treatments. Another important research application is genotyping. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 6
  7. 7. PARIOFORMATHROUGHPUT The most widely used assay format is 96-well – “96-well” although not set as standard has become the industry standard across all applications. Below 96-well is considered “low throughput” – users in this sector are looking for flexibility in sample numbers per run – e.g. as provided by the Roche LightCycler® 2.0 Instrument (1 – 32 samples per run) The second most widely used assay format was found to be 384-well pcr plate.ASSAY VOLUME The majority of respondents were using a total assay volume range 10-25μl. A preference for 5μl of sample in a overall sample volume of 25μl was identified. The second most widely used assay volume range was found to be 25-50μl. End users in diagnostics (food, clinical, veterinary) all indicated a need for higher sensitivity and higher overall reaction volumes – in these applications precision and accuracy are paramount. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 7
  8. 8. PARIOFORMAAUTOMATION Laboratories employ automation as a solution to achieve higher throughput and increased walk- away time – an automated solution must deliver improved productivity and workflow. Key needs for automated solutions: ◦ Cost-effective ◦ Fully-scalable ◦ Simplifies processes within the lab without compromising accuracy and precision ◦ Natural fit to lab work-flow (no added steps) ◦ Plug-and-play – software driven ◦ Bench-top ◦ Minimal manual reloading Interview findings suggest the end-users most well established in the use of automation are the early adopters of qRT-PCR (Pharma & Biotech R&D; Academia; Government research) – these have applied automation to many of their high throughput lines (>96 well). Adoption of automation outside of these segments is patchy and tends to follow how well established the lab is in using qRT-PCR (more frequent in larger labs than smaller ones). Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 8
  9. 9. PARIOFORMAREAGENTS The majority of respondents indicated a preference for pre-optimized qRT-PCR mastermixes (used according to manufacturers instructions) as opposed to qRT-PCR bulk reagents bought separately (optimized & validated in own lab). End-users want reagent systems that work first time without optimisation or validation. A large majority of consumables budget is spent on commercial kits – nevertheless, it must be clarified that end users are budget conscious. Many standard test kits are now available at very attractive prices while others (notably food and some diagnostic assays) command very high prices. End users tailor the use of commercial and in-house (home brew) assays to suit their budget and productivity needs:  Sometimes it is more cost effective to buy a test (even if expensive) rather than develop and validate an in- house system (typical in large food labs);  However, many large, busy clinical labs are now finding it more cost effective to develop in-house systems for high volume, routine analysis. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 9
  10. 10. PARIOFORMAREAGENTS – immobilized systems The majority of Interviews revealed a high level of interest in lyophilized reagents: Advantages Disadvantages Convenient and time saving Expensive Easy to use Potential for wastage De-skills end user staff requirements Storage and shelf-life concerns Proven to improve quality and reliability of the End users dislike instrument systems with “tied” qRT-PCR reaction assays It was reported that there is increasing demand for lyophilized systems – but the market remains embryonic with a limited number of suppliers which includes the large recognised names as well as emerging niche suppliers. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 10
  11. 11. PARIOFORMA Data quality expectation is the major buying selection criteria. Interview feedback indicated that end users buy “brands” – where the brand name conveys quality and confidence in instrument performance. Other important selection criteria included: ◦ Data analysis capability features ◦ Assay design ◦ HRM capability ◦ Running costs – cost of consumables ◦ Past experience ◦ Availability of training Instrument cost was cited as being less important overall than the aforementioned criteria. The instrument market is crowded – success depends on offering a quantum leap in features and benefits as perceived by the end-user: ◦ “It is very difficult for any newcomer to come to market with a “me-too” device and grab significant market share. Market penetration occurs by word of mouth – one lab has one and another will want it!” – Director of Research, Medical Genomics. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 11
  12. 12. PARIOFORMAParioforma Ltd. Is an independent business consultancy headquartered in London, UK.Key benefits of working with Parioforma: Bespoke studies – tailored to client needs and timelines. LONDON OFFICE ASSOCIATE OFFICES Affordable research prices – makes your budgets go further. Intrix Corp, Darien Charles Rowlands USA High quality research – experienced science-based Connecticut team, all with post-graduate science and/ or MBA Senior Partner qualifications and with 10-25+ years experience in Life Eastern Science and High Technology industries. 55 Prince’s Gate IMRP, Moscow Europe Unique problem solving approach – the team is Exhibition Road highly specialised, but diverse in experience and London SW7 2PN Intrix Corp, São background, enabling analysis of problems from Brazil United Kingdom Paulo different perspectives. Tel: +44 (0) 7803 907577 Strategic Pointers – helps clients better understand Japan TRN, Tokyo the research and implications for their business. Practical implementable solutions – not just “over-clever analysis.” This is a sample report only. Please dontOur knowledge is extensive and experience hesitate to contact us for an informal discussionbroad – please visit our website for a full on your market research needs – either bylisting of all our services. telephone on +44 (0) 207 225 3538 or by email at: Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom 12