Drugs

Asian-Pacific Drug R&D Increasing: Report

While the U.S. continues to lead worldwide drug research and development, China, India, and South Korea are emerging as important players on the global R&D stage, according to an analysis of new active substances reported in the latest Tufts Center for the Study of Drug Development Impact Report (purchase or subscription required). The report finds that strong economic conditions globally during 2013-2017 helped spur new product development.

Oncology products accounted for 34% of the global pipeline, Tufts says, dominating recent development. While the 34% is up from 28% in 2010, the report cautions that a low success rate from Phase 3 to regulatory filing (40% compared to 58% for all drugs) and other factors are dampening investor enthusiasm in this therapeutic area.

During the 2013-2017 study period, oncology, diabetes, and orphan drugs comprised 37% to 54% of new active substance launches worldwide, “indicating that nearly half of all new drug approvals globally addressed a limited set of public health threats.”

Tufts says the U.S. share of first launches remained dominant at 60%-65% during 2013-2017, according to FDA data, having risen steadily from 45% in 2010. The report says the country’s dominance is due in part to the fact that almost half of the 4,000 biopharma firms worldwide are headquartered in the U.S., more than 50% of clinical trials are conducted here, and the U.S. represents over half of the global market for medicines.

Asia is rising fast, the report says, with the number of Chinese firms developing new active substances increasing 20% in the last year and the new active substance output of Japan nearly equal to the entire output of the European union.

A regional focus on specific therapeutic areas is emerging, Tufts says. The majority (60%) of overall new active substance launches occur in the U.S., with an even higher share of infectious disease drugs (65%) and oncology drugs (82%) launched here. The metabolic-endocrine field is more evenly divided among the U.S. (just over 50%) and Europe and Japan (20% each). The Asia-Pacific region is the major source of vaccines for the worldwide market, providing 50% of vaccine new active substances.

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