A record number of new drugs — 59 in the United States alone — were approved in 2018, “The Changing Landscape of Research and Development” report released this week by the IQVIA Institute for Human Data Science has revealed.
Of those new active substances (NASs), 27% are new therapies for cancer, and 20% are for the treatment of infectious diseases.
The number of new drugs for cancers increased 63% during the past 5 years; new cancer drugs made up 40% of the total pipeline increase. Conversely, the number of vaccines declined during that period by 4%.
In the past year, other areas of therapy that have seen a large boost in new drug options are amyotrophic lateral sclerosis (ALS) and other degenerative musculoskeletal conditions, rare gastrointestinal diseases, and non-narcotic pain treatments, the report indicates.
In 2018, almost half of new drugs (46%) were approved on the basis of trials that included fewer than 500 persons, reflecting the growing need for specialty, niche, and orphan drugs.
The report also indicated that the drug development process remains slow and risky: 2018 NASs in the United States required an average 13.7 years from patent filing to market. However, that was 2 years faster than drugs launched in the 2 years before and 6 months faster than the average over 5 years.
The total number of clinical trials that started in 2018 was up 9% from the year before and 35% during the past 5 years. Most of the growth comes from phase 2 trials, the report authors write, up 26% over the prior year and 61% over 5 years. The increase has been fueled by oncology and neurology trials.
The number of trials for gastrointestinal diseases and non-alcoholic steatohepatitis was up 42%, and oncology trials were up 27% during those 5 years. The number of trials of drugs to treat respiratory and endocrine diseases declined.
One of the notable areas of frustration has been in treatments for Alzheimer disease.
Since 2008, for Alzheimer disease, “only one product received regulator approval, while 86 other development projects were discontinued, including four in 2018,” according to the report.
However, new treatments are in development.
The report states: “Treatments for nervous system disorders like MS [multiple sclerosis], Parkinson’s, ALS, Alzheimer’s and other neuromuscular disorders account for 18 next-generation biotherapeutics treatments, up from just five in 2009. Gene therapies are also under investigation for Parkinson’s disease, Alzheimer’s disease and spinal muscular atrophy.”
REFERENCE: The Changing Landscape of Research and Development: Innovation, Drivers of Change, and Evolution of Clinical Trial Productivity; https://www.iqvia.com/institute/reports/the-changing-landscape-of-research-and-development