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2013 Phase I Study Trends and Market Outlook
2013 Phase I Study Trends and Market Outlook
2013 Phase I Study Trends and Market Outlook
2013 Phase I Study Trends and Market Outlook
2013 Phase I Study Trends and Market Outlook
2013 Phase I Study Trends and Market Outlook
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2013 Phase I Study Trends and Market Outlook

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ISR’s report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct and outsourcing activities. This report provides novel, first-hand insight into phase-specific …

ISR’s report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct and outsourcing activities. This report provides novel, first-hand insight into phase-specific study trends and the use of service providers for Phase I studies.

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  • 1. +COUNTRIES2016+SITES+COMPLEX2013+PATients2013 Phase I StudyTrends and MarketOutlookInfo@ISRreports.com ©2013 Industry Standard Research www.ISRreports.comPREVIEW
  • 2. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 22act with confidenceReport OverviewISR’s report surveyed 119 respondents with responsibility and decision-making for Phase I study conduct andoutsourcing activities. This report provides novel, first-hand insight into phase-specific study trends and the useof service providers for Phase I studies.72pages119respondents73charts and graphsMajor Sections:What you will learn in this report:• How study complexity, the use of patient populations, using multiple sites, and geographic locationswill impact sponsor activities and CRO needs• Current and expected volume of Phase I trials for various sponsor segments• Outsourcing market dynamics, including expectations for study distribution among types of serviceproviders, dollar value of outsourced studies, and sponsors’ in-house Phase I capabilities• Sponsor preferences for 22 different Phase I service providers and the attributes seen as mostimportant when selecting a Phase I providerActionable Insights:For Sponsors:• Determine to what degree access to patient populations, alternative geographies, and multi-site andmulti-country studies should figure into your strategic planning• Benchmark internal policies to select service providers and identify which of 22 service providers maybe the best fit your organizational needsFor Service Providers:• Plan for sponsors’ anticipated increase/decrease in study volume, identify needs for anticipated futurestudy complexity, and for their upcoming Phase I studies• Understand the competitive environment and how to best position your service offeringsValuable for:Clinical Operations, Research & Development, Medical Directors, Project Managers, and Service Providers1. An Analysis of Phase I Market DynamicsStudy Volume: This section explores the current and expected volume of Phase I trials for various segmentsof sponsors. We also delve into how the composition of these trials is expected to change moving forward interms of study complexity, use of patient populations, and use of multiple sites and geographic locations.Outsourcing: In this section, ISR details the outsourcing market, including expectations for the proportions ofstudies to be outsourced, dollar value of outsourced studies, and in-house Phase I capabilities. Additionally,we examine how the outsourced work is split between various types of service providers as well as the uniquebenefits of large CROs, mid-size CROs, dedicated Phase I providers, and Academic Medical Centers.2. Selection of Phase I Service Providers – This section explores sponsor preference for 22 different serviceproviders as well as the strategies behind outsourcing both simple and very complex Phase I studies. Wehighlight which provider attributes stand out as being important in provider selection for a very complex study aswell as critical attributes considered when searching for a provider for a simple study.3. Geographical Analysis – ISR details the current geographic market for Phase I studies and what changessponsors expect to see in this landscape in upcoming years.4. Appendix of Charts and Graphs – As always, ISR includes the responses to all questions asked in this study in theAppendix of Charts and Graphs.
  • 3. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 33act with confidenceTable of ContentsFull table of contents and additional sample pages available in the full preview,free on our website:http://isrreports.com/industry-reports/2013-phase-i-study-trends-and-mar-ket-outlook
  • 4. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 44act with confidenceSample Pagewww.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 11act with confidence          8      Phase  I  Market  Dynamics  Study  Volume  Pharma  and  Biotech  respondents  predict  that  their  volume  of  Phase  I  studies  will  increase  over  the  next  three  years.          “About  how  many  Phase  I  studies  would  you  estimate  your  company  conducts  on  average  per  year  /  3  years  from  now?    Your  best  estimate  is  fine.”  (Base  =  118)  Phase  I  Study  Volume    Biotechs  with  smaller  (<$500M)  R&D  budgets  predict  that  they  will  nearly  double  their  number  of  Phase  I  studies  while  Pharma  companies  with  smaller  (<$500M)  R&D  budgets  predict  substantial  year  over  year  growth  as  well.    The  bulk  of  the  volume  of  additional  studies,  however,  will  continue  to  come  from  the  larger  pharma  and  biotech  companies.          19.6  15.6  0   5   10   15   20  Eshmated  #  of  Studies  in  3  Years  Current  #  of  Studies  #  of  Studies  Main  forces  leading  to  increased  volume:  pipeline  success,  funding  increases  92%  22%  69%  27%  0%   50%   100%   150%  Biotech  R&D  <$500M  (Base=21)  Biotech  R&D  $500M+  (Base=8)  Pharma  R&D    <$500M  (Base=28)  Pharma  R&D  $500M+  (Base=61)  3  Year  Eshmated  Phase  I  Growth  Current  Avg.  #  of  Studies  25.0  6.3  13.4  1.7  © 2013 Industry Standard ResearchBiotechs with smaller (<$500M) R&D budgets predict that they will nearly double theirnumber of Phase I studies by 2016.Phase I Market DynamicsStudy VolumeData available in full report
  • 5. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 55act with confidenceSample PageFull table of contents and additional sample pages available in the full preview,free on our website:http://isrreports.com/industry-reports/2013-phase-i-study-trends-and-mar-ket-outlook
  • 6. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 66act with confidenceOrdering InformationIndustry Standard Research (ISR) is the premier, full service market research provider to thepharma and pharma services industries.  With over a decade of experience in the industry, ISRdelivers an unmatched level of domain expertise.  For more information about our off-the-shelf intelligence and custom research offerings,please visit our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us ontwitter @ISRreports.About Industry Standard ResearchPricing and ordering information is available on our website:http://isrreports.com/industry-reports/2013-phase-i-study-trends-and-mar-ket-outlook

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