Drug companies still under great and growing pressure to bring more products to market

Jan 7 2010

Although drug developers are improving R&D efficiency, in part by terminating more unpromising drugs earlier in development, their continued success will depend on how well they partner with other firms at specific points on the development spectrum, according to the Tufts Center for the Study of Drug Development.

"Developers have made important progress in reducing R&D times, but because only three in 10 new drugs, on average, generate sufficient revenue to sustain R&D, pharmaceutical and biotech firms are under great and growing pressure to generate revenue to bring more products to market," commented Tufts CSDD Director Kenneth I Kaitin in connection with the release today of the Tufts Center's Outlook 2010 report on pharmaceutical and biopharmaceutical trends.

"The simple fact is that product launches are not keeping pace with patent expirations," he added.

According to Tufts CSDD, worldwide sales for all drugs coming off patent from 2009 through 2012 will exceed $88 billion. Currently, it costs, on average, more than $1 billion and takes more than seven years from the start of clinical trials to conduct the necessary studies and win approval to market a new drug in the United States.

Kaitin noted that while new technologies and improved protocol designs are helping to improve R&D efficiency, "Future success for many sponsors will depend on their ability to collaborate with other drug companies, and how well they engage and partner with outside service providers."

Among the near-term trends cited in the Tufts CSDD's Outlook 2010 report are the following:

* More firms will focus on improving clinical protocol design -- to help reduce trial costs and speed development cycles -- to mitigate a trend toward increased protocol complexity.

* After the U.S. Congress concludes the current health care reform debate, a more activist Food and Drug Administration will focus on a regulatory pathway for follow-on biologics approvals, over-the-counter product and drug safety, foreign facility inspections, preventable deaths from chronic diseases, and vaccine manufacturing capacity.

* Clinical development time for novel protein products, which now averages seven years, is unlikely to decrease due to disease complexity, growth of study protocols that lengthen studies, and difficulty recruiting and retaining volunteers.

* Off-label prescribing of biopharmaceuticals in the U.S. will be subject to increased economic scrutiny, such as comparative effectiveness assessments, drug utilization reviews, and prior authorization.

* A tougher global operating environment that is forcing marginal research sites to exit clinical development will ultimately create a less fragmented global development landscape; higher performing research investigators will be available to partner with sponsors.