About the Report
The remarkable advances in basic science combined with improvements in translational science and approaches to clinical development have resulted in record levels of novel medicines reaching patients in recent years. While the COVID-19 pandemic has caused disruption of clinical trial activity with expected delays in trial programs and subsequent filings and launches, the pandemic has simultaneously unleashed a flurry of new innovations.
It has also prompted unprecedented collaboration and decisions by regulatory authorities to adapt review and approval processes. For example, the expanded adoption of approaches driven by data, analytics, and technology - such as the use of home health patient services and connected devices, direct to patient delivery of lab tests and trial drugs, remote data monitoring, and virtual study support services for sites - are enabling clinical research to continue in some instances.
Longer-term, COVID-19 will provide an opportunity to learn as Human Data Science paves the way for new and different approaches to research and human health. There will likely be a general uplift in discovery and R&D leading to new breakthroughs in novel therapies and vaccines, particularly in infectious diseases, which are likely to remain an area of focus. The elevated agility and urgency toward R&D in infectious diseases by regulators, investigators, study sponsors and supporting service providers will have a halo effect on pharmaceutical and regulatory innovation across all critically important disease areas.
This report assesses the current status in the R&D of medicines at the end of 2019. It provides an analysis of the number of initiated clinical trials and insight into the success rate of products as they more through phases of development. The current state of innovation is explored by examining the record numbers of new active substances (NAS) launched in 2019, analyzing their features and development path, as well as the significant contributions of both NAS and non-NAS therapies.
As levels of life science venture capital activity and large pharma R&D spend continue to grow, this report also investigates the expanding pipeline of therapies still under development, examines trends among therapy areas, and analyzes the growing number of Next- Generation Biotherapeutic products, which include cell, gene, and nucleotide therapies.