Big drug makers, meanwhile, saw their share of the pipeline drop from 31% to 20% over the past decade.
But the 15 largest drug makers, in total, recorded more than $100 billion for the first time in R&D spending in 2018, up 32% over the past five years. Total spending by large pharma from 2013 to 2018 showed a five-year compounded annual growth rate of 8%. The R&D percentage of sales by large pharma rose over the same period. In 2018, 19% of total sales went to R&D, up from 16% in 2013.
The total number of clinical trials that got underway last year was up 9% over 2017 and 35% over the past five years. Much of this uptick was attributed to a larger number of Phase 2 trials, which rose 26% in 2018 and 61% from five years ago, driven by oncology and neurology. In general, trials across phases in gastro-intestinal diseases, the fatty liver disease known as NASH, and oncology rose significantly, up 42% and 27%, respectively in 2018.
Also, the number of molecules in development in Phase 2 or later stages rose 11% last year to 2,891, and by 39% during the five-year period from 2013-2018, which amounted to a compounded annual growth rate of 7%. A 63% rise in oncology meds since 2013 contributed 40% of the increase. Last year, oncology treatments accounted for 29% of the industry pipeline, according to IQVIA.
Other therapeutic categories showing increases included GI, which jumped 42% in the past five years and represent 6% of the pipeline. This growth is marked by the expansion of a late-stage NASH pipeline that now includes 32 medications. Among nervous system disorders products, 47% are potential Alzheimer’s treatments. And the number of painkillers rose 52%, of which 36 are not narcotics.
So-called next-generation biotherapeutics — defined as cell, gene, and nucleotide therapies — were less than 10% of the total late-stage R&D pipeline, but more than doubled over the past three years, reaching 269 by the end of 2018, up from 120 in 2015. Treatments for nervous system disorders such as ALS, Parkinson’s, multiple sclerosis, and Alzheimer’s account for 18 treatments, up from five in 2009.
The number of subjects trials cited in FDA approvals varied widely across the novel new drugs. Almost one-third last year included more than 1,000 subjects, but another 46% of molecules enrolled under 500. And the average number of patient-years in trials cited for approval has fallen, reflecting more niche, specialty, and orphan drugs, which typically enroll fewer subjects and have shorter trials.
Last year, 1,308 life science venture capital deals were closed with an overall value of over $23 billion, and deal values have grown sharply in the past five years, with a five-year compounded annual growth rate of 19%. Growth in 2018 was in part due to a strong run on public markets, including seven of the 10 largest initial public stock offerings in the 2018 fourth quarter coming from the healthcare sector.
Even so, progress remains slow in other ways.
For instance, the likelihood that a drug entering clinical development would be a success was 11 percent last year, down from 14 percent in 2017. And developing new drugs remains a slow process. In the U.S. last year, novel drugs took a median of 13.7 years to launch from the time of patent filing, although this was two years faster than drugs launched in the prior two years.
Also, the composite success rate of clinical development from Phase 1 trials to regulatory submission — based on the percent of drugs successfully progressing to each next stage of development — fell to 11.4% in 2018, down from 14.4% in 2017, and was below the average of 14% in the prior 10 years, IQVIA wrote. And all stages of clinical development saw declines in success rates last year.