capacities is of particular interest in observing the evolution of the vaccine global

market. It is very likely that new strategic investments following the COVID-19

pandemic situation will be made by many countries to create sustainable vaccine

biomanufacturing capacities, which will probably change the overall global vaccine

market shape.

The WHO role has been critical in providing guidance to country national

health authorities and regulatory bodies especially in time of pandemic or si-

tuation of “global concern,” as it has been the case with the Ebola epidemics

in 2013–14. Each country relies on a national regulatory authority such as the

US-FDA in the United States, Health Canada, EMA in Europe, China-CDC etc.

to approve vaccines in each country. Additionally, the WHO has the responsi-

bility to provide “pre-qualification” of vaccine manufacturing capacity to com-

mercialize vaccines in other countries. Details on the mandate of the WHO,

organizational structure, and associated centers can be found on the WHO

website (WHO, https://www.who.int).

1.3

THE VACCINE MARKET AND ECONOMIC DRIVERS

Vaccine economics is also very specific to the field. Vaccines as commodities are

made available at the global scale with the support of public and governmental

organizations, charity organizations such as the Bill and Melinda Gates Foundation:

https://www.gatesfoundation.org, the Welcome trust: https://wellcome.org, the

Rockefeller Foundation: https://www.rockefellerfoundation.org, and many others.

Distribution of vaccines at global scale is managed through vaccine alliances such

as GAVI: https://www.gavi.org and international bodies like UNICEF: https://

www.unicef.org, the World Bank: https://www.worldbank.org/en/home and the

World Health Organizations (WHO): https://www.who.int).

The vaccine market, in terms of total value used to be very small corresponding

to 2/3 of a percent of the global pharmaceutical market. It is important to note that

these figures are pre-COVID-19 pandemic and will be probably significantly re-

vised post-pandemic. However, the importance of vaccines in preventing diseases

largely outbalances the cost of the vaccines.

The vaccine market is generally segmented essentially in pediatric vaccines as

opposed to adult vaccines, where growth is becoming very sustained with vacci-

nation of aging populations in many countries.

The distribution in the revenue market shares and volume of vaccine sales is

monitored by the WHO [12] through the Market Information for Access to Vaccines

(MI4A) initiative to enhance vaccine market transparency and understand global

vaccine market dynamics. A report of 2019 indicates that a small number of manu-

facturers dominates the global market with many products in the following order:

GSK, Sanofi-Pasteur, Serum Institute of India (SII), Microgen, Merck, Bharat

Biotech-Vaccines International Ltd (BBIL), Bio Farma, and Pfizer with five or more

licensed vaccines in their portfolio. In perspective, the top five selling vaccines by

2020 are Pfizer’s Prevnar 13 for prevention of pneumococcal infection with a sus-

tained sale’s growth generating nearly US$6 billion; Pentacel against diphtheria/

pertussis/whooping cough/tetanus/polio/Haemophilus influenza type B from Sanofi-

4

Bioprocessing of Viral Vaccines