July 11, 2013

Number of Annual New Drug Approvals to Treat Neglected Diseases Has Nearly Doubled Between the Early-2000s and 2009-12

BOSTON — July 11, 2013 — The annual number of new drug approvals worldwide to treat neglected diseases has nearly doubled in recent years, with HIV/AIDS and malaria drugs accounting for 60 percent of the most recent approvals, according to a newly completed analysis from the Tufts Center for the Study of Drug Development. 

From 2000 to 2008, an average of 2.6 new drug products—including new molecular entities, vaccines, indications, combinations, and formulations—were approved each year to combat neglected diseases. That number increased to an average of five per year in 2009–12, according to Tufts CSDD.

“The trend in approvals is clearly going in the right direction, but annual R&D spending to treat neglected diseases has leveled off at $3 billion in total, after rising rapidly from 2000 to 2007, which is a cause of concern,” said Joshua Cohen, PhD, assistant professor at Tufts CSDD who served as principal investigator on the study.

Cohen noted, “While increased approvals may result in greater access to new medicines, policy makers need to ensure that safe, effective, and easy-to-administer products are adopted by health care systems, that they are affordable, and that they reach the people who need them.”

The analysis, reported in the July/August Tufts CSDD Impact Report, released today, is the latest in an ongoing series of studies that track progress in drug development targeting neglected diseases, as well as patient access to existing products through donation programs. Among its other findings:

  • Public-private partnerships accounted for 50% of new product approvals in 2009-12, up from 46% in 2000-08.
  • The research-based industry’s share of sponsorship of neglected disease drug development increased to 44% in 2009-12, from 36% in 2000-08.
  • During 2009-12, drugs to treat HIV/AIDS, malaria, and tuberculosis, known as the ”Big Three,” accounted for 81% of products in development to treat neglected diseases.

Neglected diseases are typically tropical infections most commonly found in developing countries where the population lacks the income to pay for drug treatments. The lack of purchasing power has dissuaded some drug developers from investing in therapeutics to treat these indications.


Tufts Center for the Study of Drug Development
Sandra Peters

Business Communication Strategies
Peter Lowy