Drugs travel a long and arduous road between discovery of a “new active substance” and a launched product—this is a well known attribute of the industry. Now, a longitudinal study (of sorts) for how drugs progress from discovery to launch highlights some fascinating dynamics, even though the overall picture is one of a “stubbornly long” delay between the two events. The QuintilesIMS Institute study, “Lifetime Trends in Biopharmaceutical Innovation,” looks at 667 drugs launched in the US between 1996 and 2005, broken into five-year cohorts. And although the trend since 2008 has been for a shorter elapsed time (from an average of 211 months in the 2008 group to 158 for the 2011-2015 cohort—a reduction of about four-and-a-half years), that 2011-2015 measure is still above the 128 months seen in the late 1990s. Each month—even each day—that a drug retains patent exclusivity can mean millions of dollars of revenue for the originator company; loss of exclusivity (LOE) of a drug when its patent runs out is a big event in a product’s life cycle.
The usual rap about the time to launch is that if FDA were more efficient, the approval would come sooner. While the QuintilesIMS study does not look at elapsed time from drug application filing to approval (it does find an average on-patent life of a launched drug to be 12 years, 10 months, and cites other studies that find a range of 5.1 to 14.5 years for the patent-to-NDA stage), its analysis reveals some other key factors:
- When the same company that discovered a drug carried it through to launch, the elapsed time from patient to launch was 36 months shorter; also, nearly three-quarters of launches were not carried out by the original patent holder
- When a drug demonstrates blockbuster status (annual sales >$1 billion) within the first five years after launch, the elapsed time of patent-to-launch was 27 months shorter, and from launch to LOE was 23 months longer
- Conversely, only 19 drugs have reached blockbuster status within five years of launch over the past 20 years. However, nine of those were launched in the past five years, pointing to some degree of better targeting by pharma companies (or, on the other hand, more aggressive pricing).
Other trends revealed in the analysis have been recognized generally, but QuintilesIMS can put numbers to them: oncology represented 28% of launches in the 2011-2015 period, versus 11% in the 1996-2000 period. Similarly, orphan drugs represent 42% of the 2011-2015 period, double that of 1996-2000.
And there’s one finding that has a distinct political implication in the rising debate over drug pricing, drug importation and the like: “The US market remains of vital importance to biopharmaceutical innovation, accounting for more than 61% of a new drug’s sales over its first five years following launch, and 68% for the cohort of launches in the 2011–15 period. Ex-US markets are generally proving more challenging for biopharmaceutical innovation from both a pricing and volume perspective.” Another way of demonstrating the connection between pharma innovation and US pricing policy.