OBJECTIVES: Examine launch performance by company size and therapeutic archetype and identify common reasons for underperformance

METHODS: We analyzed 284 new drugs (new indications) approved by US FDA CDER in the US from 2012 to 2021 using EvaluatePharma data, comparing launch forecasts to actual sales. Analyst reports for 91 underperforming drugs were reviewed. Products were categorized into four therapeutic archetypes: general medicine, high-volume specialty, oncology, and rare disease.

RESULTS: Midsize companies (71% meet or exceed forecasts) consistently outperform the industry average (66%). Large companies’ performance (61%) shows the greatest variability.

Common reasons for underperformance:

1. market access (57%)
2. poor product differentiation (47%)
3. inadequate understanding of market needs (41%)
4. unfavorable clinical findings (41%)
5. low prioritization/resource allocation for launch activities (15%)
6. unexpected events (7%)

Large companies more frequently underperform due to inadequate market understanding (56%) and poor product differentiation (58%), but less often due to market access (53%).

Reasons differ by therapeutic archetypes: e.g., in oncology, unfavorable clinical findings (65%) is the number one reason, whereas market access is number four (30%).

All segments do well with oncology launches (72-87%); midsize (80%) and small (78%) do well with rare disease launches. Fewer than half of general medicine products (42%) meet expectations. But even here, midsize do better (46%) than large companies (38%). With high-volume specialty, midsize companies’ launch performance (89%) is significantly higher than that of large companies (62%).

CONCLUSIONS: Treat launches as a reflection of overall organization strategy. Companies should question whether their operating model, portfolio strategy, research and development, and ways of collaborating enable launch success. Three strategic questions can help rethink future launches:

• Is your operating model optimized for today’s market?
• Can you play the long and short games at the same time?
• Are you playing it too safe (with clinical trial design)?