Late Phase Market Outlook: 2018-2022


Keeping up-to-date with the evolving pharmaceutical market is no easy task. The constant flow of newsletters hitting our inboxes is almost too much to wade through. But stay abreast of the market we must. To this end, ISR publishes a series of Study Trends and Market Outlook reports aimed at providing our readers with a high-level view of the clinical development space. For this report, 115 Late Phase decision-makers were surveyed to share their insights into where the Late Phase market is now and where it’s expected to head over the next four years.

2018 Late Phase Study Trends and Market Outlook

What you will learn:

  • 4-year examination of the industry’s Late Phase market dynamics, such as study volume and outsourced spend, analyzed by study design (Interventional studies and Observational research) and by study type (Post-marketing Safety studies, Health Economics and Outcomes Research, and Expanded Access studies)
  • Average dollar value of outsourced Late Phase studies and how this varies by sponsor size
  • Criteria sponsors use to select (and disqualify) clinical service providers
  • Current and future predictions for Late Phase trends, including use of technology, study complexity, and reliance on EMRs

How you can use this report:

  • Gain understanding of the key decision-makers within sponsor organizations to develop more targeted communications
  • Learn the most desirable characteristics of a Late Phase service provider
  • Discover trends in Late Phase technology use

For Pharma:

  • Use the predictions of your peers to identify in what types of studies your competition is investing resources and understand how your company’s strategy compares to that of the industry.

For CROs:

  • Utilize this information to ensure your capabilities and capacity are in line with the study types and volume that will be needed in the near future.

Executive Summary

  • Market Dynamics
  • Provider Perceptions and Selection

Study Data

  • Market Dynamics
  • Provider Perceptions and Selection
  • Late Phase Trends


ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

For additional questions about any of ISR’s reports or custom research services, please contact us at

Late Phase Study Trends and Market Outlook

Executive Summary

Market Dynamics

Mean Late Phase spend by study design
Median Late Phase spend by study design
Outsourced proportion of Late Phase spend by study design–past 12 months
Mean Late Phase spend by study category
Largest study comfortable awarding to each provider type
Change in Late Phase spend by study type
Late Phase trends

Provider Perceptions and Selection

Outsourcing decision-making
Number of preferred providers
Difficulty using non-preferred providers
Late Phase service provider selection drivers
Most important selection drivers by study category
Desired provider characteristics
Reasons providers lose bids
CRO performance satisfaction drivers

Study Data

Market Dynamics

Market dynamics by study design
Market dynamics by study category
Largest study comfortable awarding to each provider type
Change in Late Phase spend by study type
Change in outsourced Late Phase spend by study type
Data sources allocation
Emerging markets for Late Phase studies

Provider Perceptions and Selection

Service provider familiarity
Number of preferred providers
Difficulty using non-preferred providers
Service provider use
Service provider preference
Desired provider characteristics
Provider selection attributes for Expanded Access studies
Provider selection attributes for Post-marketing Safety studies
Provider selection attributes for HEOR studies
Reasons providers lose bids
Decision-making influence: Designing the Late Phase study
Decision-making influence: Deciding whether to outsource study
Decision-making influence: Holding the budget for study conduct
Decision-making influence: Deciding which CROs to invite to bid
Decision-making influence: Making the final CRO Selection
Decision-making influence: Directly managing the CRO delivery
CRO performance satisfaction drivers

Late Phase Trends

Importance of technology
Incorporation of various drug development trends in clinical trial protocols
Study complexity
Global nature
Use of Electronic Medical Records (EMR)
Use of existing data sources


Company type
Areas of responsibility
Drug development responsibilities
Respondent location
Job title
Recent outsourcing involvement
Drug development involvement
Drug development involvement by phase

Additional information


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