IQVIA Report: Biopharma R&D Investment Has Increased 32% Over Last 5 Years
The IQVIA Institute for Human Data Science released a new report titled, “The Changing Landscape of Research and Development: Innovation, Drivers of Change, and Evolution of Clinical Trial Productivity.” The report finds, among many other things, that in the last year, 27% of drugs launched were for cancer or its symptoms, and 20% were for infectious diseases. Of the 59 drug launches in 2018, 16 were for cancer, 12 for infectious diseases and 12 for orphan drugs.
The report also provides a great deal of background data. For example, the average drug takes 13.6 years to go from patent filing to launch. However, that was two years faster than the average in 2016 and 2017. Both biopharma and the U.S. Food and Drug Administration (FDA) are using processes to speed up the approval process, with more than 70% of new drugs coming through FDA pathways designed to speed the process.
In 2018, there were 2,891 molecules in late-stage development, a growth of 39% over the last five years. But that’s in total. The rate increased by 63% for cancer drugs. Next-Generation Biotherapeutics (NGB), which includes cell, gene and nucleotide therapies, have doubled in the past three years, although they make up less than 10% of late-stage pipelines.
In terms of research-and-development investment, the report found that venture capital firms invested over $23 billion in 2018, while the 15 largest pharma companies reported more than $100 billion in R&D expenditure for the first time—an increase of 32% over the past five years.
Similarly, the total number of clinical trials launched in 2018 is an indication of that R&D growth, with an increase of 9% over the previous year and 35% over the last five years. The report says, “The average progression time for a drug from beginning of Phase I trials to the end of development has increased by 26% over the past 10 years and rose by six months in 2018 to 12.5 years. The composite success rate for clinical development stages from Phase I trials to regulatory submission—based on the percent of drugs successfully progressing to each next stage of development—fell to 11.4% in 2018. Across therapy areas composite success rates also varied, ranging between 6-15%, with rates for rare diseases and GI/NASH exceeding averages.”
IQVIA also developed a new metric calls the Clinical Development Productivity Index. It measures clinical trial success rates in relation to the effort invested in clinical trials. They applied it across trials in nine of the most common therapy areas. The index found that productivity had dropped 27% overall from 2013 to 2018. This was significantly influenced by a decrease in Phase I clinical trial productivity of 55%, in addition to drops in Phase III productivity since 2016. The report notes, “In Phase I, declines reflect diminishing success of 7% and 6% increases in trial complexity (which includes numbers of trial participants, eligibility criteria, research sites countries, and endpoints).”
One startling statistic that came out of the study was that of the drugs launched in 2018, 46% were approved base on clinical trials with fewer than 500 total subjects. This is likely a reflection of the growth of approvals in rare diseases, which by their nature have fewer patients to draw on. Twenty of the new active substances (NAS) were drugs that stratify patient selection using predictive biomarkers. Four had a companion diagnostic approved along with it. Sixteen were cancer drugs.
The report also cited eight emerging trends, including digital health and mobile technologies; an increased focus on patient-reported outcomes, the use of real-world data (RWD); predictive analytics and artificial intelligence; next-generation biotherapeutics and targeted therapies; more availability of biomarker testing; changes to the regulatory landscape; and the availability of pools of pre-screened patients and direct-to-patient recruitment.