Phase I Market Outlook: 2022-2026

Welcome to ISR’s Phase I Market Outlook (2022-2026) 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, 125 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 widespread 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 2026.

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 predicted changes
• How Phase I spend is divided between large CROs, mid-size CROs, dedicated Phase I providers, and AMCs and how this varies by sponsor size
• 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, changes in study complexity, geographic expansion, pandemic-related changes expected to remain in place after the pandemic has subsided, etc.)

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

CROs:

• Utilize this information to ensure your capabilities and capacity are in line with the study types and volume that will be needed by sponsors in the near future
• Gain understanding of the key decision-makers 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 Phase I studies

Major Topics:

• Market Dynamics
• Provider Selection
• Trends and Predictions
• Study Data
• Demographics