The global vaccine market grew significantly in 2021, with more than double the amount of doses distributed compared to 2019, according to a new report by the World Health Organization. But the vaccine market remains largely dependent on a few manufacturers — and this leaves several widely used, critical vaccines for emergencies at risk of shortages, and out of reach of people in low-income countries.
The COVID-19 pandemic has significantly contributed to the growth of the market in 2021, with the vaccines accounting for 70.2% of the market value that year, based on data provided to WHO by its member states, covering 47 vaccines.
Market value, according to the report, refers to the volume of vaccines times how much end users paid for it. Approximately 16 billion vaccine doses were distributed globally in 2021, a bulk of which — 10.8 billion doses — were COVID-19 vaccines that cost $99 billion.
But despite an uptick in global vaccine supply, the vaccine market continues to rely on a few manufacturers. According to the report, the global vaccine market is “highly dependent” on just nine manufacturers that provided 64% of the global vaccine supply in 2021, excluding COVID-19 vaccines. The market for human papillomavirus vaccines, pneumococcal conjugate vaccines, and the measles, mumps and rubella vaccines are also largely dependent on two manufacturers that account for more than 80% of vaccines distributed globally.
“We're not only dealing with oligopolies, which we know underdeliver relative to need, but also these manufacturers are concentrated in a few countries and a few regions,” said Tania Cernuschi, head of the global access, agenda, policy & strategy unit at the WHO Department of Immunization, Vaccines and Biologicals, in a media briefing Tuesday.
Early COVID-19 vaccine manufacturers topped the list of companies that cover the bulk of the vaccine market value in 2021. Pfizer, which produced the mRNA-based COVID-19 vaccine Comirnaty, accounted for 30%, followed by Moderna (12%), which produced another mRNA-based COVID-19 vaccine called Spikevax, and Sinovac (12%), a Chinese biotech company. German biotech company BioNTech, which co-developed Comirnaty, accounted for 2% of the market value.
Meanwhile, 3% of the market share value went to AstraZeneca, which produced the COVID-19 vaccine Vaxzevria, and 4% went to the Serum Institute of India, or SII, which produced the AstraZeneca COVID-19 vaccine under the name Covishield.
When excluding COVID-19 vaccines, MSD — known as Merck in the U.S. and Canada — topped the list, followed by GSK and Sanofi.
Manufacturers that had a bigger share of the market value weren’t always the biggest suppliers however. While Pfizer also tops the list of manufacturers in terms of supplied volumes in 2021, Moderna only ranked seventh, contributing just 6% of the vaccine supply, while SII contributed 15%.
Ten of the 19 COVID-19 vaccine manufacturers — which includes Moderna — have no other vaccines in the market. Only six of the 94 vaccine manufacturers included in the WHO report are producing more than eight vaccines and distributing them globally, and that includes SII.
The report highlights limited manufacturing capacities in the African and the eastern Mediterranean regions, both of which rely on external manufacturers for over 90% of their vaccine needs. Manufacturers from Southeast Asia provide for the majority of the two regions’ vaccine needs.
Both regions also received the lowest volumes of vaccines in 2021, driven largely by their limited access to COVID-19 vaccines. According to the report, the African and eastern Mediterranean regions received only 3% and 6% of the total distributed vaccines in 2021, respectively.
The limited number of manufacturers per vaccine also poses supply constraints, and delayed vaccine introductions, such as in the case of the human papillomavirus vaccine, or HPV, which has so far only been introduced in 41% of low-income countries versus 83% of high-income countries. Pneumococcal conjugate vaccine, meanwhile, which is used in 161 countries, only has six manufacturers.
Six of the eight vaccines that could be needed in case of a disease outbreak are at high risk of supply constraints. They include vaccines for cholera, typhoid, meningococcal disease, smallpox/monkeypox, and Ebola. Some of these vaccines don’t even have an established stockpile in case of a surge in demand.
Cernuschi said several efforts are being made to address these challenges. For example, several manufacturers are expected to also start producing HPV vaccines, which she hopes would soon reduce the market’s reliance on a few manufacturers.
But this is also why WHO is calling on governments to ensure transparency and oversight of the vaccine value chain, and “tighten” its hold on innovations for the sake of public health, she said.
“We need greater public investments and more government oversight across the value chain … Without a strong public engagement, the strategic focus and investments of manufacturers will continue to concentrate on more profitable pharmaceutical interventions and high-income markets,” she said.
Another reason for the need for greater oversight of the value chain is that a lot of the innovation in the vaccine space originates from public sources, she said.
Kate O’Brien, director of WHO’s Department of Immunization, Vaccines and Biologicals, meanwhile also underscored the importance of strong regulation in countries to address some of the challenges in vaccine supply and access.
“For many countries, a single product will have regulatory authorization for importation and use. And so for any single manufacturer, if anything goes wrong with that manufacturer, a country is left without a source of supply because they haven't authorized … another secondary source of vaccine,” she said in the same briefing.
Strong regulation is also needed amid efforts to increase regional vaccine manufacturing, as is the case in Africa.
“Getting increased manufacturing in countries is not only about actually making the products. It's about having in-country regulatory authorities who have the processes, expertise and means to oversee the safe development and the safe manufacturing of those vaccines,” she added.