Next Generation Sequencing Trends (Clinical Applications, Systems Used, Accreditation Status, Regulated Patient Sample Handling and Other Trends)

 
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Published Jul 1, 2013 | 159 Pages | Pub ID: KLI5088424

Next Generation Sequencing Trends (Clinical Applications, Systems Used, Accreditation Status, Regulated Patient Sample Handling and Other Trends)

Next-generation sequencing is discussed frequently as a key to clinical diagnostics in the future. This report looks at the status of NGS today, and seeks to provide insights on the “on-the-ground” status of clinical sequencing. In the course of doing this, the report seeks to answer the following questions: What is the status of clinical applications for Next Gen in laboratories currently? What vendors are winning? What systems are seeing usage and for what applications? How are labs responding to business pressures and regulatory challenges? What disease areas are seeing the most applications? What are labs future purchasing plans and how are clinical applications driving these decisions?

This study, Next Generation Sequencing Trends focuses on an email and telephone consultation of 110 laboratories which was carried out from April to June of 2013, with the majority in the latter portion. The survey effort targeted labs likely to be doing, or likely to be planning, applications of sequencing in either diagnostic or clinical research settings. Due to the increasing importance of 2nd and 3rd-generation systems in the market, the scope leans towards these types of sequencers. There are only 13 laboratories that have exclusively capillary systems, but these systems are still widely used. About 30% of the systems in the respondents’ labs overall are capillary systems. The mix of labs reached in the surveys provides both a range of industry segments as well as groups of labs with both types of systems.

The survey asked labs about the following trends in Next Generation Sequencing and provides insights into the status of sequencing applications, including the following:
  • Number of Sequencers Owned
  • Models Owned
  • Applications Run
  • Number of Samples Run
  • Outsourcing Trends
  • Accreditation Status For Regulated Patient Samples
  • Future Accreditation Plans
  • Sequencers Used for Regulated Patient Samples
  • Volume Change Expected In NGS
  • Use of Capillary Systems and Expectation for Future
  • Bottlenecks in Sequencing Process
  • Future Purchase Plans
  • Data Analysis and Management Challenges
  • Other (non NGS) technologies Used
  • Regional Differences (Europe, US, ROW)
A particular focus of this report is on the clinical future of sequencing. Questions address how labs are dealing with the handling of regulated patient samples and what disease areas are seeing the most applications and sample runs. Labs were queried on which systems were seeing the most clinical applications and the usage. Capillary systems are covered in the survey’s scope, and survey details the extent to which these systems are used vs. NGS and what future purchasing plans are.

The survey was conducted by Justin Saeks the author of Kalorama Information's DNA Sequencing and Equipment Markets, published in several editions. The survey effort targeted any lab that uses a sequencer for any application, but with the goal of achieving as close a representative breadth of labs as possible. Due to the increasing importance of next generation systems in the market, the scope leans towards these types of sequencers. However, the market inevitably includes labs that use capillary systems as well.

Labs were mostly contacted by phone and asked to participate in a phone interview/survey for around 10 to 15 minutes. A small fraction of the labs completed the survey on a website set up with the questions. The survey included both open-ended and multiple-choice type questions. In most cases, 49% of labs, the lab manager was the party interviewed. Research scientists or associates were spoken to in 35% of cases. The remaining respondents were technicians, executives, professors or others.

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  • $1,385.00 Included

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      •   Distribution of Respondent Labs

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      •   Primary Industry/ Segment Labs Belong To
      •   Industry/ Segment(s) Labs Belong To, by Region

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      •   Major Function(s) of Respondent Labs
      •   Major Function(s) of Labs, by Region

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        •   Distribution of Total Sequencers in Labs

      • $93.00 Included
        •   Number of Next-Generation Sequencers in Labs

      • $93.00 Included
        •   Number of Capillary Sequencers in Labs

    • $186.00 Included
      •   Brand(s)/ Type(s) of Sequencers Owned by Labs
      •   Number of a Given Brand / Type in Labs Owning That Type

    • $93.00 Included
      •   Position/ Role of Respondent

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    • $157.00 Included
      •   Sequencer Models in Respondents' Labs

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      •   Installed Base of Labs, by System(s) Owned (# of Systems)
      •   Installed Base of Labs, by System(s) Owned (% of Systems)
      •   Installed Base of Labs, by System(s) Owned (% of Systems)

    • $340.00 Included
      •   Distribution of NGS vs. Capillary Systems (# of Labs)
      •   # of NGS Systems by # of Capillary Systems (% of Labs)
      •   # of Capillary Systems by # of NGS Systems (% of Labs)

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      • $368.00 Included
        •   Number of Systems Installed in Labs, by Region
        •   Sequencer Models in Respondents' Labs, by Region (# of Systems)
        •   Sequencer Models in Respondents' Labs, by Region (% of Systems)

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      •   NGS Models in Respondents' Labs, by Region (# of Systems)
      •   NGS Models in Respondents' Labs, by Region (% of Systems)

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      •   Capillary Models in Respondents' Labs, by Region (# of Systems)
      •   Capillary Models in Respondents' Labs, by Region (% of Systems)

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      • $1,067.00 Included
        •   Number of Systems Installed, by Industry/ Segment(s)
        •   Brand / Type of Sequencer Systems Installed, by Industry/ Segment (# of Systems)
        •   Brand / Type of Sequencer Systems Installed, by Industry/ Segment (% of Systems)
        •   Brand / Type of Sequencer Systems Installed, by Industry/ Segment (% of Systems)
        •   Number of NGS Systems Installed, by Industry/ Segment
        •   Next-Generation Models in Respondents' Labs, by Industry/ Segment (# of Systems)
        •   Next-Generation Models in Respondents' Labs, by Industry/ Segment (% of Systems)
        •   Next-Generation Models in Respondents' Labs, by Industry/ Segment (% of Systems)
        •   Number of Capillary Systems Installed in Labs Owning, by Industry/ Segment

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      • $627.00 Included
        •   Number of Systems Installed by Laboratory Function
        •   Brand / Type of Sequencer System Installed, by Lab Function (# of Systems)
        •   Brand / Type of Sequencer System Installed, by Lab Function (% of Systems)
        •   Brand / Type of Sequencer System Installed, by Lab Function (% of Systems)
        •   Brand / Type of Sequencer System Installed, by Lab Function (% of Systems)
        •   Number of NGS Installed in Labs Owning, by Lab Function
        •   NGS Models in Respondents' Labs, by Lab Function (# of Systems)
        •   NGS Models in Respondents' Labs, by Lab Function (% of Systems)
        •   NGS Models in Respondents' Labs, by Lab Function (% of Systems)

    • $353.00 Included
      •   Number of Capillary Systems Installed in Labs Owning, by Lab Function

      • $293.00 Included
        •   Recent Systems Installed, 2001- Q2 2013 (# of Systems)
        •   Recent NGS Systems Installed, 2007 - Q2 2013 (# of Systems)

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        •   NGS Application Volume by Model (% of Sequencing)

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        •   Applications Expected to Increase the Most
        •   Applications Expected to Increase, by NGS Brand Owned (# of Labs)
        •   Applications Expected to Increase, by NGS Brand Owned (% of Labs)

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        •   Expected Growth in Sequencing Volume (# of Labs)
        •   Expected Growth in Sequencing Volume (% of Labs)

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        •   Avg. Percentage of Systems' Capacity Used, by Brand

    • $258.00 Included
      •   Percentage of Sequencing Volume Outsourced
      •   Percentage of Sequencing Volume Outsourced, by Region
      •   Reasons for Outsourcing

    • $3,522.00 Included

      • $176.00 Included
        •   How Labs Address Sequencing of Regulated Patient Samples (# of Labs)
        •   How Labs Address Sequencing of Regulated Patient Samples (% of Labs)
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      • $1,490.00 Included
        •   Plans for New or Additional Certification
        •   Type of Accreditation Planned/ Considered (# of Labs)
        •   Type of Accreditation Planned/ Considered (% of Labs)
        •   Distribution of Samples, Est. 2013 (# of Labs)
        •   Distribution of Samples, Est. 2013 (% of Labs)
        •   Distribution of Samples, Expected 2014 (# of Labs)
        •   Distribution of Samples, Expected 2014 (% of Labs)
        •   Volume of Regulated vs. Non-Regulated Samples (% of Sequencing)
        •   Distribution of Samples, Est. 2013 (# of Labs)
        •   Distribution of Samples, Est. 2013 (% of Labs)
        •   Distribution of Samples, Expected 2014 (# of Labs)
        •   Distribution of Samples, Expected 2014 (% of Labs)
        •   Volume of Regulated vs. Non-Regulated Samples, Est. 2013 (% of Sequencing)
        •   Distribution of Samples, Est. 2013 (# of Labs)
        •   Distribution of Samples, Est. 2013 (% of Labs)
        •   Distribution of Samples, Expected 2014 (# of Labs)
        •   Distribution of Samples, Expected 2014 (% of Labs)
        •   Sequencers Used for Regulated Patient Samples
        •   Sequencers Likely to be Used for Regulated Patient Samples (% of Labs)
        •   Sequencers Used for Non-Regulated Patient/Human Samples
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        •   Disease Areas Where Sequencing Applied, by NGS vs Capillary (Percentage and Number of Systems)

      • $186.00 Included
        •   Disease Areas Where Sequencing Applied, by NGS vs Capillary (% of Volume)

      • $190.00 Included
        •   Regulated Sequencing Expected to Grow Fastest
        •   Non-Regulated Patient/ Human Sequencing Expected to Grow Fastest

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        •   Other Technologies Used in Lab

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        •   Challenges for Growth of Clinical Sequencing

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      •   Major Changes or Improvements Wanted by End-Users
      •   Bottleneck in Sequencing Process

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        •   Difficulty Level of Data Analysis

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        •   Difficulty Level of Data Management

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      • $125.00 Included
        •   Time Frame for Future Purchase

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        •   Time Frame for Future Purchase, by Brand Owned (# of Labs)
        •   Time Frame for Future Purchase, by Brand Owned (% of Labs)

      • $104.00 Included
        •   Time Frame for Future Purchase, by Lab Function (# of Labs)
        •   Time Frame for Future Purchase, by Lab Function (% of Labs)

      • $115.00 Included
        •   Time Frame for Future Purchase, by Region (# of Labs)
        •   Time Frame for Future Purchase, by Region (% of Labs)

    • $1,056.00 Included

      • $1,023.00 Included
        •   Sequencer Models Likely to Consider
        •   Sequencer Models Likely to Consider, by Brand/ Type Owned (# of Labs)
        •   Sequencer Models Likely to Consider, by Brand/ Type Owned (% of Labs)
        •   Sequencer Models Likely to Consider, by Industry/ Segment Owned (# of Labs)
        •   Sequencer Models Likely to Consider, by Lab Function (# of Labs)
        •   Sequencer Models Likely to Consider, by Lab Function (% of Labs)
        •   Sequencer Models Likely to Consider, by Region (# of Labs)
        •   Sequencer Models Likely to Consider, by Region (% of Labs)

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