Issue:June 2019

2018 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline

Four of a Four-Part Series

Part 1: A Global Review of 2018 Product Approvals

Part 2: Notable Product Drug Delivery and Formulation Approvals of 2018

Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018

Part 4: The Drug Delivery and Formulation Pipeline

By: Kurt Sedo, VP of Operations, and Tugrul Kararli, PhD, President & Founder, PharmaCircle


Understanding the pharmaceutical pipeline from the perspective of drug delivery and formulation is tricky. Once you start looking too far into the earlier stage pipeline, you find yourself dealing with incomplete and often undisclosed information. Many of these earlier development products, especially Phase 1 and earlier, are “moonshots” of sorts in which companies are pushing the boundaries of experience in hopes of a breakthrough. For these reasons among others, the pipeline portion of this 2018 Global Drug Delivery & Formulation Report is restricted to products in either Phase 3 or Registration stages of development. These products generally have disclosed indication targets and administration routes, but in some cases, lack details regarding dosage form and formulation.

This review compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.

The net/net of this analysis, presented over the following pages, reveals more consistency than change in the pipeline products. There are more Oncology products in later stage development, generally targeted antibodies, proteins, and small molecules. This is offset by a drop in the proportion of Infectious Disease agents in development.

The increase emphasis on Oncology and other specific molecular mechanism-targeted therapeutics, often with macromolecules, has resulted in a shift to more Injection-based therapeutics. In terms of molecule types in the pipeline, there is little or no change seen in the ratio of small molecule to macromolecule therapeutics. But among the macromolecules in development, there appears to be an increased proportion of Peptides, was well Gene and Cell Therapy products, at the apparent expense of Protein and Antibody therapeutics. Click here to download/view part 4 of the entire report.