Likelihood of Success Analysis
Overview
Developing and introducing new health products is inherently risky. The ALIGN Global Hub provides insights into the “Likelihood of Success” for products in the pipeline.
Success Probability Framework
The Hub applies a multi-dimensional framework to assess the probability of a product reaching the market and achieving impact.
1. Technical and Regulatory Success
- Definition: The probability that a product will successfully complete clinical trials and receive regulatory approval.
- Assessment: Based on historical success rates for the product’s development archetype (e.g., using the P2I model).
2. Market and Policy Success
- Definition: The probability that an approved product will be successfully procured, introduced into guidelines, and achieve significant market uptake.
- Assessment: Based on signals such as inclusion in WHO EMLs, funding commitments from major donors (e.g., Global Fund, Gavi), and manufacturer capacity.
Portfolio-to-Impact (P2I) Model
The Hub utilizes the Portfolio-to-Impact (P2I) model to estimate these probabilities. The P2I model uses a rule-based approach to assign “archetypes” to products, which then drive the estimated success rates and development costs.
Interpreting Success Scores
- High Probability: Products with strong clinical data, clear regulatory pathways, and high public health demand.
- Moderate Probability: Products in mid-stage development with promising but incomplete data.
- Low Probability: Early-stage innovations or products targeting particularly challenging technical areas.
Note: Success scores are intended for strategic portfolio planning and should not be used as the sole basis for individual product decisions.
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