As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy.

Highlights8 factors predict the viability of vaccine manufacturers in developing countries.These factors have evolved as the vaccine landscape has changed over 2 decades.A new analysis updates a framework first published in 1997 to assess viability.The updated framework is useful for assessing investments in vaccine manufacturers.

We investigate the effect of specialisation upon the level of metropolitan wage per worker. Specialisation is measured by the share of metropolitan earnings in each of five traded goods and services sectors. Sectoral specialisations are assumed to be determinants of location-specific productivity, which in turn is treated as a term in a metropolitan production function. Panel data are used for estimating that production function for 313 metropolitan areas in the US, over the long period 1969-96 and two shorter periods. We find that some specialisations raise average metropolitan wages, some lower it and some have no effect, and that the effects of specialisation differ by time-period.

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