Phase II/III Market Outlook: 2022-2026

Welcome to ISR’s Phase II/III Study Trends and Market Outlook (2022-2026) 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, 132 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 several 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 – how much influence various departments have over outsourcing decisions, preferred provider dynamics, etc. Finally, staying on top of trends such as the locations of Phase II/III studies, the pipeline of rare disease and cell/gene therapies, and the use of methods such as decentralized trials, patient centricity, risk-based monitoring, and adaptive designs 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 II/III market dynamics (e.g. study volume, outsourced spend); including respondent rationale for predicted changes
• How Phase II/III spend is divided between large CROs, mid-size CROs, small/niche CROs, and AMCs and how this varies by sponsor size
• 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., the use of methods such as Real-World Evidence, patient centricity, ePRO, sensors/patches, and activity trackers, etc.)
• Overall CRO performance on Phase II/III studies across North America, Europe, and Asia-Pacific

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 II/III 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 decisionmakers within sponsor organizations to develop more targeted communications

Major Topics:

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