Researchers from the Tufts Center for the Study of Drug Development report that taking a new drug from discovery to market approval requires about $2.6 billion, more than twice what it cost in 2003. They based their estimate on data provided by 10 pharmaceutical companies on 106 randomly chosen drugs, including 19 anticancer agents.

The cost of bringing a new prescription drug to market has more than doubled in the last 10 years, according to researchers at the Tufts Center for the Study of Drug Development (CSDD) in Boston, MA. Last month, they reported that taking a new drug from discovery to the point of submission to the FDA for approval requires about $2.6 billion (in 2013 dollars), up from their 2003 estimate of about $800 million (about $1 billion in 2013 dollars).

Principal investigator Joseph A. DiMasi, PhD, and his colleagues based their new findings on information provided by 10 pharmaceutical companies on 106 randomly chosen drugs, including 19 anticancer agents, says DiMasi, the CSDD's director of economic analysis. These drugs were first tested on people between 1995 and 2007.

Although the researchers have not yet completed a full cost analysis of different categories of drugs, DiMasi says the cost of developing cancer drugs, which have higher-than-average clinical trial failure rates—due in part to the complex nature of the disease and insufficient preclinical models—could exceed $2.6 billion.

Only about 13% of investigational cancer drugs that begin phase I testing are eventually approved by the FDA, according to a DiMasi-led study published in Clinical Pharmacology and Therapeutics in 2013.

“With high approval risks and trial subjects who are very ill, the cost per approved drug could be higher for cancer drugs than for an average of all investigative drugs,” he says.

The researchers attribute skyrocketing development expenses to a number of factors, including the rising cost of health care as part of the trial and the increasing complexity of clinical trial protocols. DiMasi notes that high development costs threaten innovation in drug research, which “doesn't bode well for the future unless we can find ways to increase the efficiency of the development process.”

Critics of the study say the $2.6 billion price tag is exaggerated and could help pharmaceutical companies justify high prices for consumers. The Union for Affordable Cancer Treatment, for example, has called on the authors to provide more details about how they determined that sum.

DiMasi says his group's full analysis could be published early next year.

©2014 American Association for Cancer Research.
2014