Drug Development Costs Rise Dramatically, Now Nearly $2.6 Billion per Medicine
New study from Tufts Center for the Study of Drug Development shows 145% increase in last decade
Washington, D.C. (November 18, 2014) – BIO issued the following statement in response to a study released today by the Tufts Center for the Study of Drug Development, which estimated the cost of developing a new prescription medicine that gains marketing approval at $2.558 billion (in 2013 dollars), including the cost of promising therapies that did not achieve FDA approval. These findings represent an increase of 145 percent, or 8.5 percent compound annual growth, since a previous study in 2003, in which Tufts estimated that cost at $1.044 billion (also in 2013 dollars).
The following may be attributed to BIO President and CEO Jim Greenwood:
“This study confirms what we have known for years: drug development remains an extremely expensive, complex, and risky endeavor, and grows more so each year. Despite these hurdles, biotechnology companies are committed to continue the search for new cures and therapies for patients in need. In fact, U.S. spending on R&D by public biotechnology companies climbed 20% last year, outpacing revenue growth.
“In recent years, these investments have paid off with dramatic results, saving or improving the quality of life for millions of patients around the world. Biopharmaceutical innovation has contributed to a 22 percent decline in cancer deaths over the past 20 years, and exciting new advances in cancer therapy are on the horizon. New Hepatitis C therapies boast a cure rate of over 90 percent, with minimal side effects. HIV, once a death sentence, is now a manageable chronic condition, with newly diagnosed patients expected to live well into their 70s. These and many other achievements are a result of the hard work and financial risks taken every day by biopharmaceutical companies.
“Companies make these investments because they recognize that a robust pipeline of products in development today is critical to delivering the next generation of cures and treatments tomorrow. Today, there are more than 5,000 medicines in clinical development, 70 percent of which are potential first-in-class molecules that can provide a new and hopefully better way to treat or cure patients suffering from disease. These investments are only sustainable with a policy, regulatory, and reimbursement environment that recognizes the value of medical innovation and spurs patient access to new medicines, including through insurance mechanisms that ensure such products are available to patients at an out-of-pocket cost that makes them truly accessible.
“I thank the researchers at the Tufts Center for the Study of Drug Development for their important work quantifying the many costs associated with drug development. Their work in this area remains authoritative, providing information of critical importance to all stakeholders in biopharmaceutical research and policy.”
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