Issue:June 2020

GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline

Part 4 of a Four-Part Series

Part 1: A Review of 2019 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals of 2019
Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2019
Part 4: The Drug Delivery and Formulation Pipeline

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

The pharmaceutical industry has certainly seen a major product shift in focus throughout the past decade from large population medical conditions to smaller, orphan type indications. This is exemplifi ed by the US Food and Drug Administration’s (FDA) approval of 21 new molecular entity (NME) products in 2019 that had received Orphan Drug designation, representing almost half, 44%, of all NME approvals in 2019. At this point, the FDA has granted 4,352 orphan designations, with 296 alone granted in 2019. There is however much more in the pipeline than orphan products. In fact, the pipeline of products has increased by 65% during the past 5 years, totaling almost 29,000 products and 60,000 programs by early 2020, stretching from Research to Preclinical to Phases 1, 2, and 3 to Registration. This review analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.

The fourth part of this review reinforces the common opinion that cancer therapeutics, often targeted to smaller populations, are receiving increasingly greater investment as expressed in larger numbers of product candidates. It also confirms that more products are being developed using novel molecular scaffolds, typically macromolecules modeled on biological constructs. This new generation of products are not obvious candidates for the majority of the technologies developed and validated for small molecule therapeutics, a suspicion reinforced by an examination of the pipeline in terms of drug delivery and formulation incorporation.

This year’s Drug Delivery and Formulation Pipeline analysis uses PharmaCircle’s new Pipeline Dynamics companion module to the Pipeline & Products Intelligence module and covers 6 years of pharmaceutical pipeline history. By capturing detailed records annually of what products were at what stage of development from 2015 through to 2020, it is now possible to better understand the dynamic history of product development. The following pages provide a pipeline snapshot according to a number of parameters that are of most interest to drug delivery professionals – Disease Area, Molecule Type, Delivery Route, Product Types, and Drug Delivery Technology Incorporation. Click here to download/view part 4 of the entire report.