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

  • ID: 5188142
  • Report
  • September 2020
  • Region: Global
  • 91 Pages
  • Industry Standard Research (ISR)

The goal of this report is to provide readers with a high-level view of Phase II/III clinical development space to illustrate current market dynamics and inform strategic planning. For this report, 146 Phase II/III decision-makers was 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 the 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.

What you will learn:

  • 4-year examination of the industry’s Phase II/III market dynamics (e.g. study volume, outsourced spend); including the 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
  • The 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 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 an understanding of the key decision-makers within sponsor organizations to develop more targeted communications
  • Learn the most desirable characteristics of Phase II/III service provider

Major Topics:

  • Market Dynamics
  • Provider Perceptions and Selection
  • Trends and Predictions
  • Study Data
Note: Product cover images may vary from those shown

1. 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

2. 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

3. 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

4. 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

5. Provider Perceptions and Selection

  • Number of Preferred Providers
  • The 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 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

6. 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

7. Demographics

  • Company size
  • Areas of responsibility
  • Drug development responsibilities
  • Respondent location
  • Job title
  • Recent outsourcing involvement
  • Drug development involvement
  • Drug development involvement by phase
Note: Product cover images may vary from those shown

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