Phase I Market Outlook: 2018-2022


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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, 143 Phase I decision-makers were surveyed to share their insights into where the Phase I market is now and where it’s expected to head over the next four years.

Phase I Study Trends and Market Outlook

What you will learn:

  • 4-year examination of the industry’s Phase I market dynamics (e.g. study volume, outsourced spend)
  • Average dollar value of outsourced Phase I studies and how this varies by sponsor size
  • How large, mid-size, Phase I specialists, and AMCs are selected for patient vs. healthy volunteer studies and what proportion of Phase I spend goes to each provider type
  • How trends are evolving in the Phase I market (e.g. expanse into developing markets, evolving study complexity, and use of methods such as Real-World Evidence, patient centricity, non-traditional monitoring, ePRO, sensors/patches, and activity trackers, etc.)

How you can use this report:

  • Build your sales, marketing, and strategic plans using dependable industry figures
  • Ensure your Phase I outsourcing practices are industry standard or better

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 Selection
  • Trends and Predictions

Study Data:

  • Phase I Study Volume and Design
  • Phase I Outsourcing Practices
  • Provider Perceptions and Selection
  • Trends and Predictions

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

Phase I Study Trends and Market Outlook

Executive Summary

Market Dynamics

Forces impacting Phase I study volume
Spend on Phase I studies
In-house Phase I units
Outsourced proportion of Phase I spend
Average value of outsourced Phase I study
Largest study comfortable awarding to each provider type
Outsourced spend by provider type

Provider Selection

Departmental decision-making influence
Preferred provider agreements
Desired provider characteristics
Top 3 provider selection attributes–simple vs. complex studies

Trends and Predictions

Geographic trends
Study complexity

Study Data

Phase I Study Volume and Design

Spend on Phase I studies
Forces positively impacting Phase I study volume
Forces negatively impacting Phase I study volume
Locations of Phase I studies
Phase I study subjects
Development stage assets vs. marketed products
In-house Phase I units
Locations of Phase I units
Number of beds at in-house Phase I units
Adaptive trial use

Phase I Outsourcing Practices

Outsourced proportion of Phase I spend
Value of average outsourced Phase I study
Largest study comfortable awarding to each provider type
Outsourced spend by provider type
Benefits of large, full-service CROs
Benefits of using mid-size, multi-service CROs
Benefits of using dedicated Phase I providers
Benefits of using Academic Medical Centers
Phase I activity outsourcing
Forces with potential to increase outsourced proportion of Phase I work
Forces with potential to decrease outsourced proportion of Phase I work

Provider Perceptions and Selection

Number of preferred providers
Difficulty using non-preferred providers
Service provider familiarity
Service provider usage
Service provider preference
Desired provider characteristics
Top considered providers–complex studies
Provider selection attributes–complex studies
Top considered providers–simple studies
Provider selection attributes–simple studies
Reasons providers lose bids
Departmental decision-making influence: Designing the Phase I Study
Departmental decision-making influence: Deciding whether to outsource the study
Departmental decision-making influence: Holding the budget for study conduct
Departmental decision-making influence: Deciding which CROs to invite to bid
Departmental decision-making influence: Making the final CRO selection
Departmental decision-making influence: Directly managing the CRO delivery

Trends and Predictions

Recruiting patient populations in China
Recruiting healthy volunteers in China
Recruiting patient populations in India
Recruiting healthy volunteers in India
Study complexity
Access to clinic/bed space
Incorporation of various drug development trends in clinical trial protocols
Change in study volume using patient populations
Change in study volume executed in multiple sites/centers
Change in study volume executed in multiple countries
Change in study volume executed in hospitals or academic centers


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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