Phase I Market Outlook: 2020-2024


Welcome to ISR’s Phase I Study Trends and Market Outlook (2020-2024) report. The goal of this report is to provide readers with a high-level view of the Phase I clinical development space to illustrate current market dynamics and inform strategic planning. For this report, 137 Phase I decision-makers were surveyed to share their insights into where the Phase I market is now and what changes they expect over the next four years. Current and predicted study spend and outsourcing proportions are key pieces of information with which sponsors and service providers should be familiar. Understanding the service provider selection environment is also critical due to the pervasive use of service providers in the Phase I space; respondents have shared key service provider selection criteria for both complex and simple Phase I studies. Finally, staying on top of trends such as use of challenge trials, diagnostic development, and how companies are responding to the COVID-19 pandemic helps readers stay current with market happenings and plan for what the market is expected to look like in 2024.

Cover Image for 2020 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); including respondent rationale for their predictions
  • How outsourced Phase I spend is divided between large CROs, mid-size CROs, dedicated Phase I providers, and AMCs – how this varies by sponsor size and how it is expected to change over time
  • Average dollar value of outsourced Phase I studies and the dollar value of studies respondents are comfortable awarding to each provider type
  • Which roles have the most responsibility for each of six different decisions related to Phase I study outsourcing
  • Evolution of trends in the Phase I market (e.g. diagnostic development, challenge trials, in-silico modeling and simulation, geographic expansion, responses to the COVID-19 pandemic, etc.)

How pharma can use this report:

  • 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
  • Ensure your Phase I outsourcing practices are industry standard or better

How CROs can use this report:

  • 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
  • Learn which roles are key decision-makers for specific outsourcing-related tasks within sponsor organizations to develop more targeted communications
  • Understand the criteria used to select service providers and how the top criteria differ between simple and complex studies

Market Dynamics

Provider Perceptions and Selection

Trends and Predictions

Study Data

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

Sample data from the Preview of 2020 Phase I Trends and Market Outlook, "For CRO Operations"

Market Dynamics

Primary Section Takeaways
Spend on Phase I Studies
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 Perceptions and Selection

Primary Section Takeaways
Decision-making Influence by Role
Preferred Providers
Number of Preferred Providers
Desired Provider Characteristics
Sample Verbatim Responses
Top Provider Selection Attributes–Simple vs. Complex Studies

Trends and Predictions

Primary Section Takeaways
Locations of Phase I Studies
Sponsor Interest in Current Trends
Pandemic-related Changes in Discussion

Study Data

Study Volume and Design
Spend on Phase I Studies
Reasons for Anticipated Increase in Phase I Study Spend
Reasons for Anticipated Decrease in Phase I Study Spend
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
Outsourcing Practices
Outsourced Proportion of Phase I Spend
Reasons for Anticipated Increase in Phase I
Outsourcing Proportion
Reasons for Anticipated Decrease in Phase I
Outsourcing Proportion
Average Value of 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 Mid-size, Multi-service CROs
Benefits of Dedicated Phase I Providers
Benefits of Academic Medical Centers
Phase I Activity Outsourcing
Provider Perceptions and Selection
Number of Preferred Providers
Proportion of Outsourced Phase I Activities Allocated to Preferred Providers
Service Provider Familiarity
Service Provider Use
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
Decision-making Influence: Designing the Phase I 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 CRO Delivery
Trends and Predictions
Recruiting Patient Populations in China
Recruiting Healthy Volunteers in China
Study Complexity
Access to Clinic/Bed Space
Interest in Challenge Trials
Interest in Diagnostic Development
Interest in In-silico Modeling and Simulation
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
Involvement in Discussions about Pandemic-related Changes
Pandemic-related Changes in Discussion


Company Size
Areas of Responsibility
Drug Development Responsibilities
Respondent Location
Job Title
Recent Outsourcing Involvement
Drug Development Involvement
Drug Development Involvement by Phase

Additional information


, ,