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2013
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2013 Phase I Study
Trends and Market
Outlook
Info@ISRreports.com 		
				
			
©2013 Industry Standard Research www.ISRreports.com
PREVIEW
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 2
2
act with confidence
Report Overview
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.
72
pages
119
respondents
73
charts and graphs
Major Sections:
What you will learn in this report:
•	 How study complexity, the use of patient populations, using multiple sites, and geographic locations
will 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 service
providers, 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 most
important when selecting a Phase I provider
Actionable Insights:
For Sponsors:
•	 Determine to what degree access to patient populations, alternative geographies, and multi-site and
multi-country studies should figure into your strategic planning
•	 Benchmark internal policies to select service providers and identify which of 22 service providers may
be the best fit your organizational needs
For Service Providers:
•	 Plan for sponsors’ anticipated increase/decrease in study volume, identify needs for anticipated future
study complexity, and for their upcoming Phase I studies
•	 Understand the competitive environment and how to best position your service offerings
Valuable for:
Clinical Operations, Research & Development, Medical Directors, Project Managers, and Service Providers
1. An Analysis of Phase I Market Dynamics
Study Volume: This section explores the current and expected volume of Phase I trials for various segments
of sponsors. We also delve into how the composition of these trials is expected to change moving forward in
terms 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 of
studies 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 unique
benefits 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 service
providers as well as the strategies behind outsourcing both simple and very complex Phase I studies. We
highlight which provider attributes stand out as being important in provider selection for a very complex study as
well 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 changes
sponsors 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 the
Appendix of Charts and Graphs.
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 3
3
act with confidence
Table of Contents
Full 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
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 4
4
act with confidence
Sample Page
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 1
1
act 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 Research
Biotechs with smaller (<$500M) R&D budgets predict that they will nearly double their
number of Phase I studies by 2016.
Phase I Market Dynamics
Study Volume
Data available in full report
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 5
5
act with confidence
Sample Page
Full 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
www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 6
6
act with confidence
Ordering Information
Industry Standard Research (ISR) is the premier, full service market research provider to the
pharma and pharma services industries.  With over a decade of experience in the industry, ISR
delivers 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 on
twitter @ISRreports.
About Industry Standard Research
Pricing 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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2013 Phase I Study Trends and Market Outlook

  • 1. +COUNTRIES 2016 +SITES +COMPLEX 2013 +PATients 2013 Phase I Study Trends and Market Outlook Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com PREVIEW
  • 2. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 2 2 act with confidence Report Overview 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. 72 pages 119 respondents 73 charts and graphs Major Sections: What you will learn in this report: • How study complexity, the use of patient populations, using multiple sites, and geographic locations will 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 service providers, 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 most important when selecting a Phase I provider Actionable Insights: For Sponsors: • Determine to what degree access to patient populations, alternative geographies, and multi-site and multi-country studies should figure into your strategic planning • Benchmark internal policies to select service providers and identify which of 22 service providers may be the best fit your organizational needs For Service Providers: • Plan for sponsors’ anticipated increase/decrease in study volume, identify needs for anticipated future study complexity, and for their upcoming Phase I studies • Understand the competitive environment and how to best position your service offerings Valuable for: Clinical Operations, Research & Development, Medical Directors, Project Managers, and Service Providers 1. An Analysis of Phase I Market Dynamics Study Volume: This section explores the current and expected volume of Phase I trials for various segments of sponsors. We also delve into how the composition of these trials is expected to change moving forward in terms 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 of studies 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 unique benefits 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 service providers as well as the strategies behind outsourcing both simple and very complex Phase I studies. We highlight which provider attributes stand out as being important in provider selection for a very complex study as well 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 changes sponsors 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 the Appendix of Charts and Graphs.
  • 3. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 3 3 act with confidence Table of Contents Full 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 4 4 act with confidence Sample Page www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 1 1 act 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 Research Biotechs with smaller (<$500M) R&D budgets predict that they will nearly double their number of Phase I studies by 2016. Phase I Market Dynamics Study Volume Data available in full report
  • 5. www.ISRreports.com ©2013 | Preview of: 2013 Phase I Study Trends and Market Outlook 5 5 act with confidence Sample Page Full 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
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