Biopharmaceutical companies are developing a total of 907 new biologic drugs and vaccines for more than 100 diseases, according to a new report by The Pharmaceutical Research and Manufacturers of America (PhRMA)—just slightly higher than the number counted by the industry group two years ago.
Cancer drugs remain a plurality (338, or 37% of the total) of the new medicines under development, according to Biologic Medicines in Development, though the number has dipped from the 352 counted in PhRMA’s 2011 report Biotechnology Medicines in Development—39% of the 901 drug candidates counted two years ago. The category includes therapeutics designed to fight solid tumors, leukemia, and lymphoma.
The next highest disease category with 176 medicines (19%)—including 134 vaccines—in development was infectious diseases, down from 188 in 2011 (almost 21%). As with the earlier report, some of the drug candidates cited by PhRMA this year were listed in more than one disease category.
Another 71 medicines were for autoimmune diseases including lupus, multiple sclerosis, and rheumatoid arthritis, up from 69 two years ago. And the fourth-largest disease category, cardiovascular, has 58 new treatments in the proverbial pipeline, almost flat from the previous report’s 59 such drug prospects.
Among product categories of medicines, a more than one-third plurality (338, or 37%) being developed were monoclonal antibodies, up significantly from 300 (33.3%) in 2011. mAbs have zoomed ahead of vaccines, which saw development decline to 250 candidates (about 28%) from 300 two years ago (33%).
Recombinant hormone or protein drug candidates, however, have increased from 78 in 2011 to 93 in the new report—from under 8% to 10%. Cell therapy development showed only a slight gain, rising from 64 treatments in 2011 to 69 now.
“These medicines reflect the cutting-edge research being conducted across the country by biopharmaceutical companies in order to provide new treatment options to patients,” PhRMA president and CEO John J. Castellani said in a statement.
How many of those medicines ultimately make it to market, Castellani added, will depend in no small measure on Washington responsiveness to industry. FDA has stepped up approvals of drug marketing applications over the past two years, following industry criticism that the agency’s efforts to balance drug risks and benefits too often held back promising medicines from patients.
“In order to realize the full potential of novel biologics to improve human health, it is essential to maintain public policy and regulatory environments to support the research and development that drives biomedical innovation," Castellani said.