That, according to the Pharmaceutical Research and Manufacturers of America (PHRMA), only one out of every 10,000 potential medicines investigated by research-based pharmaceutical companies makes it through the research/ development pipeline and is approved for patient use by the FDA?
The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems. According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion. After a product is successfully launched, the manufacturer must continue to comply with regulatory requirements to stay in business.
Read More about the challenges pharmaceutical companies face in bringing a new drug to market, and how these challenges can be easily managed.