Part 1: A Review of 2021 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals and Technologies of 2021
Part 3: Drug Delivery and Formulation Pipeline Trends

By: By: Kurt Sedo, Vice President Operations, and Selda Candan, Vice President Data Analytics, PharmaCircle LLC

Introduction
What immediately pops out when surveying the pharmaceutical product development pipeline is a slowdown in pipeline growth at all stages of clinical and non-clinical development. For products not yet in the clinic, Research and Preclinical, there was a 7% growth rate last year versus an average of 16% to 22% throughout the past 6 years. Clinical-stage annual pipeline growth that averaged 6% to 14% the past 6 years slowed to 3% to 6% this past year. The most obvious reason for the drop in pipeline growth is COVID-19. With companies restricted in terms of operations, and medical institutions focused on treating COVID-19 patients while limiting hospital access, there was little capacity for the initiation of new clinical trials. Even existing trials were slowed down by recruitment issues. This implied that fewer products would be entering the clinic and fewer products transitioning from one stage of development to another.

It may also be that companies are showing more discipline with respect to the products they are selecting to enter clinical trials and those they are choosing to advance in the clinic. Several notable product failures in the past year may have also caused companies to pause and rethink their development plans. While a large number of emerging companies received considerable financing, venture and public market, many were not in a position to actually use the funding to advance their programs. It is likely that 2021 will be turn out to be aberration in terms of pipeline growth. Strong funding and the considerable number of medical needs will continue to drive innovation.

Beyond the slowdown in the growth of the pharmaceutical product pipeline, there were few surprises regarding the nature of the pipeline itself. Small molecule therapeutics continued to be the leading molecule type in development this past year, accounting for 59% of all molecule types, although its share continues to shrink. Injection continued to be the favored delivery route in 2021 with a 52% share of all clinical-stage products. Even though small molecules can generally be delivered orally, the large number of cancer and infectious disease products lean on injection routes to optimize effi cacy and safety by permitting greater control over administration and distribution.

Whether 2021 was an aberration or the new normal is a question that will be answered over the next few years. The following pages provide additional insights into the nature of the current pipeline in terms of development phase, delivery route, molecule type, and disease area taken from PharmaCircle’s Pipeline Dynamics module. Click here to download/view the entire report.