Lifetime trends in Biopharmaceutical Innovation.

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Improvements in the treatment of disease are directly linked to advances in medicines available to patients. 
The biomedical innovation system that underpins advances in medical treatment is a critical driver of improvement for patients suffering from a wide range of diseases. Recent public health crises such as the outbreaks of Ebola and the Zika virus and the urgent calls for vaccines to be developed have reinforced this importance. Similarly, while remarkable progress has been made in the discovery and development of medicines to address rare diseases, several thousand such conditions still have no effective treatments. 

Over the past 20 years, over 700 New Active Substances (NASs)—new small or large molecular entities—have successfully been discovered, developed and authorized by regulatory bodies for use with patients. Over 600 of these have additionally been authorized by the U.S. Food and Drug Administration and are used in treating American patients. The time between when a medicine is discovered and when the originator ceases to receive revenues from it can be thought of as its lifetime. Two measures of a new medicine’s lifetime are of particular importance. 

• -The first is the time taken from the discovery of a new molecule until it reaches patients; 
• -the second is the time that molecule has exclusivity in the market based on patents or other forms of protection. 

The first of these measures determines how quickly patients can receive the benefit of the biopharmaceutical innovation. 
The second determines how long a company has to recover its research and development investment in the particular molecule—as well as those molecules that failed to ever make it to market—and is therefore a critical measure for the sustainability of investment in future innovation.

This report profiles the NASs launched in the U.S. over the past 20 years with a view to both measures of a molecule’s lifetime, trends in these measures over time and by molecule characteristics, and implications for investors and manufacturers.

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