Zebra is regularly asked about what type of research and intelligence should be explored at different stages of the drug development cycle. We have therefore created a series of posts that look to provide some answers, including those pertaining to market landscape. The posts in this series will follow the different phases of the drug development process. Therefore, we have created an image showing the key commercial activities throughout the drug development pathway. Please click here to download the graphic that follows along with these posts.
Market Landscape Commercial Activities between Phase 2 & 3
For any business analysis and market research department, the amount of information and insight required for a product launch starts to increase between Phase 2 and 3; this increase will continue to launch and beyond. Some of the activities undertaken at this time will also prove valuable in life cycle management.
For this part of drug development, a detailed market landscape document needs to contain an up-to-date commercial review on both the disease/market and commercial analysis. So, this should include confirmation of:
- Disease definition and progression of the disease
- Incidence/prevalence of external market trends which may impact the epidemiology
- Customer and patient characteristics and dynamics
- Current medical practice including treatment goals
- Management of unmet therapeutic needs
- A comprehensive competitor review and any threats to the business
- All future market (life cycle) opportunities
- A market forecast with a gap analysis for future activities required to support development
Therefore, the types of questions you need to answer in the document include:
Marketing
Firstly, what’s the…
- Market definition for the product?
- Potential size in terms of value/volume?
- Competitive market landscape?
Clinical (from a Marketing Perspective)
- What are the clinical critical success factors required by customers? Do they meet an unmet medical need?
- What are the specific claims for launch? Additionally, are the claims relevant to each customer group? What main endpoints are needed in the trial? Are the endpoints and comparators in the trial appropriate?
- What are the critical success factors to succeed in this market?
In short, the major activities that lead into Phase 3 and the development for launch depend on the product and disease area in question. However, one could consider segmentation by key customers to include patient segments, needs, verbal descriptors and patient/customer profiles. Patient segment profiling may be valuable in conditions such as osteoarthritis and migraine, where insights into behaviour and attitudes would help develop a target profile.
For example, for one company, Zebra held a group discussion between patients and the development team. The idea was for the development team to hear first-hand the impact OA had on patients’ and their own lives; it was a powerful discussion. As a result, there was a change in secondary endpoints and included additional QoL measures in the trial.
Stay tuned for our next post, in which we’ll discuss Concept Testing (Part 2), including patient research, unmet needs, and refinement of the product.
If you would like more company-specific ideas of how to conduct this work, please feel free to reach out to us.
