Eduardo Schur and Rares Barbu, Life Science Leader
There has been much speculation about the health of the biopharmaceutical pipeline, and questions remain about how strong the pipeline really is and what it can tell us about future expectations. We set out to answer these questions by analyzing key indicators of pipeline strength over the past three years, including research & development (R&D) spend, new chemical entity approvals, and Phase 2 and Phase 3 development. We also studied pricing and performance data to determine key challenges and considerations for products launching in 2019 and beyond.
By all accounts, 2018 was a productive year for the industry. Worldwide R&D spending rose 3.5% from 2016 to 2018 to a total of $161 billion, new chemical entity approvals more than doubled over the same period from 22 to 56, and pipelines remain robust, with significant growth in late-stage development. Based on this data, we anticipate a promising year ahead for manufacturers and patients.
A total of 59 new chemical entities gained FDA approval in 2018, reflecting a 28.3% increase from 2017 and a 168% increase from 2016 approvals. This trend may continue in 2019, assuming regulatory authorities continue their efforts to strengthen communications, streamline processes, and accelerate approvals in response to increasing development in areas of unmet need. Our forecast also assumes that the FDA resumes operations and is well funded for 2019.
The number of assets in late-stage development also grew significantly in both U.S. and European pipelines.
Biologics outpaced small molecules in terms of growth, with the number of biologics increasing 54% over the past year vs. 37% for small molecules.
In addition, more companies experienced growth in late-stage development. In 2016, just 258 companies had products in Phase 2 or Phase 3. That number grew to 379 in 2017 and jumped further to a total of 550 companies with late-stage development programs in 2018.
With few exceptions, all the major biopharma companies show strong pipelines this year — with Novartis, Merck, Pfizer, Janssen, Roche, and AstraZeneca’s late-stage pipelines being particularly robust.