Issue:April 2022

GLOBAL REPORT - 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals

Part One of a Three-Part Series

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: Kurt Sedo, Vice President Operations, PharmaCircle LLC


The big question hanging over the pharmaceutical industry and healthcare professionals has been what impact COVID-19 would have on the development and approval of pharmaceutical products. Areas for concern varied widely from how pandemic-related public health restrictions might impact human resources, at the industry, patient, medical infrastructure, regulatory, and supplier levels, and how this might affect productivity. Given the lifecycle of product development and approval, it is likely the real impact of almost two “lost” years will only be revealed in the years to come. Once pivotal clinical trials are completed for a novel pharmaceutical product, a couple of years are required for the preparation of dossiers and review by regulatory bodies, both of which are less likely to be influenced by pandemic restrictions. The larger impact is expected to be related to the conduct of patient trials, particularly those that require regular patient and medical facility availability.

Some sense of the impact on industry productivity is offered by the 2021 FDA new product approval numbers. As suggested earlier, the impact is less likely to be seen in the new molecular entity (NME) products as these products have a longer development cycle and receive a greater sense of urgency from industry and regulatory authorities for commercial and public health reasons. Resources will be allocated by both groups as appropriate to get these products over the finish line. By contrast, products such as new dosage forms and especially new formulations and manufacturers are likely to receive less attention as they bring incremental patient benefits. At the bottom of the list are generic drug approvals. The figures bear this out. While NME approvals by the FDA were up slightly in 2021 versus 2020, generic (ANDA) approvals were down by a third compared with the previous two years. New dosage forms were down a quarter versus the previous year while new formulations were up a little.

The comparable figures for European and Japanese approvals are harder to reliably interpret. The European Medicines Agency (EMA) approvals relate only to specific classes of pharmaceutical products and don’t capture the full range of products. The Japanese Pharmaceutical Medical and Medical Devices Agency (PMDA) published approvals are hard to access and properly assess. Taking these considerations into account, neither regulatory jurisdiction saw a drop in 2021 approvals compared with 2020, which might be considered a relatively normal year. The EMA approvals in 2021 were markedly higher than for 2020 and comparable to the 2019 approval numbers. For the European Union and the EMA, the challenge in 2020 was not limited to COVID-19 but also the reorganization and relocation arising from Brexit.

There seemed to be little impact of COVID-19 beyond approval numbers. Longer term trends in terms of dosage form, administration route, and molecule type were largely consistent with the two earlier years. Simple dosage forms continue to be preferred. Biologics as a group continue to make inroads in terms of new molecular entities leading to a greater number of approved injectable products.

The impact of COVID-19 has not yet squeezed approvals. The pharmaceutical pipeline by development phase will be reviewed in Part 3 and may provide additional insights on what can be expected in the years to come. Click here to download/view part 1 of the report.