Phase II/III Study Trends and Market Outlook (2020-2024)

Description

Welcome to ISR’s Phase II/III 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 II/III clinical development space to illustrate current market dynamics and inform strategic planning. For this report, 146 Phase II/III decision-makers were surveyed to share their insights into where the Phase II/III 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. Additionally, as the use of service providers is ubiquitous in the clinical development world, it is important to have a good grasp on the landscape of service provider selection. Finally, staying on top of trends such as use of risk-based monitoring, use of activity trackers, 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.

Phase II/III Study Trends & Market Outlook 2020-2024 Cover

What you will learn:

  • 4-year examination of the industry’s Phase II/III market dynamics (e.g. study volume, outsourced spend); including respondent rationale for their predictions
  • How Phase II/III spend is divided between large CROs, mid-size CROs, small/niche CROs, and AMCs – how this varies by sponsor size and how it is expected to change over time
  • Average dollar value of outsourced Phase II/III 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 II/III study outsourcing
  • Evolution of trends in the Phase II/III market (e.g. expansion into developing markets, responses to the COVID-19 pandemic, and use of methods such as Real-World Evidence, patient centricity, non-traditional monitoring, ePRO, sensors/patches, and activity trackers, 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 II/III 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
  • Gain understanding of the key decision-makers within sponsor organizations to develop more targeted communications
  • Learn the most desirable characteristics of a Phase II/III service provider

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 info@ISRreports.com.

Sponsor Leadership Example Data

Market Dynamics

Primary Section Takeaways
Spend on Phase II/III Studies
Outsourced Proportion of Phase II/III Spend
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
Preferred Provider Use
Number of Preferred Providers
Desired Provider Characteristics
Provider Selection Attributes

Trends and Predictions

Primary Section Takeaways
Locations of Phase II/III Studies
Service Provider Size Trends
Sponsor Interest in Orphan Drug/Rare Disease
Use of Adaptive Designs
Use of Risk-based Monitoring
Incorporation of Drug Development Trends and Technologies in Clinical Trial Protocols
Pandemic-related Changes in Discussion

Study Data

Market Dynamics

Spend on Phase II/III Studies
Reasons for Anticipated Increase in Phase II/III
Study Spend
Reasons for Anticipated Decrease in Phase II/III
Study Spend
Outsourced Proportion of Phase II/III Spend
Reasons for Anticipated Increase in Phase II/III Outsourcing Proportion
Reasons for Anticipated Decrease in Phase II/III Outsourcing Proportion
Value of Average Outsourced Phase II/III 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 Small or Niche Service CROs
Benefits of Academic Medical Centers
Locations of Phase II/III Studies

Provider Perceptions and Selection

Number of Preferred Providers
Proportion of Outsourced Phase II/III Activities Allocated to Preferred Providers
Service Provider Familiarity
Service Provider Use
Service Provider Preference
Desired Provider Characteristics
Provider Selection Attributes
Reasons Providers Lose Bids
Decision-making Influence: Designing the Phase II/III 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

Preference for Smaller CROs’ Customer Service
Therapeutic Expertise in Small CROs
Working Solely with Large CROs
Spend with Large CROs
Study Size Impact on CRO Consideration
Consolidation of CRO Spend
Recruiting in China
Recruiting in India
Change in Sponsor Interest in Orphan Drug / Rare Disease Compounds
Change in Sponsor Interest in Pediatric Drug Development
Importance of Technology in CRO Selection
Incorporation of Drug Development Trends and Technologies in Clinical Trial Protocols
Adaptive Design Use
Change in Adaptive Trial Design Use
Risk-based Monitoring Use
Change in Risk-based Monitoring Use
Use of Multiple Countries
Change in Conducting Trials in Multiple Countries
Change in Use of Hospitals or Academic Centers
Involvement in Discussions about Pandemic-related Changes
Pandemic-related Changes in Discussion

Demographics

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

License

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