2017 Was A Banner Year For Innovation. But Will It Be Short-Lived?1 February, 2018 / Articles
2017 was an extraordinary year in the history of medicine. It was the year when scientists beat cancer, and U.S. regulators approved the first therapy to fix a faulty gene. It was also a year that kept us enthralled with a quickening drumbeat of breathtaking news detailing spectacular advances – trials seemingly curing patients of hemophilia A and sickle cell anemia, and breakthroughs raising similar hopes for Huntington’s disease, Lou Gehrig’s disease, and even HIV. What is remarkable about these successes is that they are not just lucky breaks, but the products of new technologies that are ushering us into a new therapeutic space of vastly expanded possibilities.
True to their word, the regulators rose to the occasion, and approved a record 51 new therapies (figure 1) – 46 by FDA’s Center for Drug Evaluation and Research (CDER), and 5 by its Center for Biologics Evaluation and Research (CBER). The latter include last year’s two miracle drugs, Kymriah and Yescarta, both designed to harness the immune system to cure subtypes of leukemia and lymphoma. This tally, which excludes diagnostics but includes biologicals made with recombinant technology, matches the output achieved in 2015, the highest since WWII. But most would agree that the class of 2017 raised innovation to new heights.
Last year’s 51 approvals have gone to 42 companies, a surprisingly large number which shows that innovation remains very scattered. No matter how much resources one wields, no one seems to have yet figured how to mass-produce it. In 2017 the historic big pharma received 18 approvals or 35% of the total, largely unchanged from the two previous years.
Biologicals garnered 45% of the approvals, down from 55% the previous year. Other metrics that FDA uses to recognize impact on public health (first-in-class, orphan designation) and innovativeness (breakthrough therapies, priority review, accelerated approval, fast-track) were largely unchanged percentage-wise, with the exception of breakthrough designations whose share of approvals has nearly doubled since 2015, from 20% to 37%.
The ranking order of the most innovative big pharma has not changed much since 2015. Back then, the most innovative companies – based on the number of New Molecular Entities (NMEs) approved in the previous 10 years – were Johnson & Johnson, Novartis and GlaxosmithKline. Last year the same three continued to lead the industry, although the runners-up – Roche, AstraZeneca, and Merck/MSD – have narrowed the gap in the most recent five years. The least innovative companies in 2015 were Abbvie, Bayer and Lilly. They were still trailing in 2017, although they showed signs of improvement.