Vaccine development costs: a review

Abstract

The cost of drug development is commonly cited between US$800 and US$1.8 billion. A similar statistic for vaccines is yet to be estimated, and it is unclear whether the cost of vaccines is similar to drug development. Financial and regulatory policy significantly impacts the extent and cost of pharmaceutical development, and as such it is important that governments should be informed about the costs of developing vaccines. The purpose of this paper is to review the concept of drug and vaccine R&D costs, to review the associated literature and to relate these findings to the area of vaccine industry’s financial and regulatory policy.

Keywords::

• cost of drug development
• cost of vaccine development
• development pipeline
• pharmaceutical investment
• vaccine policy

Acknowledgements

The authors would like to acknowledge the contributions of L Babiuk, S Halperin, C Adams, and H Levine for their helpful insight into the process and related costs of vaccine R&D. R Husereau, M-A Gagnon, and J Lexchin also provided valuable contextual information for this review.

Financial & competing interests disclosure

This research has been made possible by a financial contribution from Alberta Innovates – Health Solutions. The views expressed herein do not necessary represent the official policy of Alberta Innovates – Health Solutions. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • The cost of vaccine R&D is unknown.

• • Estimated costs of drug development are not automatically generalizable to vaccines.

• • Methods used to calculate drug development over-estimate opportunity costs of R&D.

• • Estimated costs of drug development do not include government expenditures.

• • A project level vaccine R&D expenditure statistic is needed.

• • Modified methods of costing drug development should be applicable to vaccine costing.

• • New public financial policies to improve vaccine industry performance need to be well informed.

• • Economic costs should be used as an indicator to monitor existing financial and regulatory policy.