Vaccines are developed by a network of organizations working together: pharmaceutical companies, government agencies, university research labs, small biotech startups, and global health coalitions. No single entity handles the entire process alone. A vaccine typically takes 10 to 15 years of research and an estimated $887 million to bring to market, and different players contribute at different stages.
Large Pharmaceutical Companies
Four major pharmaceutical companies dominate global vaccine production. As of the most recent comprehensive market data, Merck & Co. held the largest share at about 23%, followed by Sanofi at 22%, GlaxoSmithKline at 20%, and Pfizer at 17%. Together, these four companies accounted for roughly 80% of global vaccine revenue. The remaining share is split among dozens of regional manufacturers spread across about 50 countries.
These large companies have the manufacturing infrastructure, regulatory expertise, and financial resources to move a vaccine through large-scale clinical trials and into mass production. They often don’t discover the initial vaccine concept themselves. Instead, they license promising candidates from universities or smaller biotech firms, then handle the expensive late-stage development and global distribution. The vaccine industry has actually shrunk in recent years, with companies like Baxter and Novartis exiting the business entirely due to financial pressure, leaving fewer major players to carry the load.
University and Government Research Labs
The earliest stages of vaccine development, identifying a target on a virus or bacterium, testing different approaches in cell cultures and animal models, often happen in academic labs. University researchers working with government funding are responsible for much of the foundational science that makes vaccines possible in the first place.
The Center for Vaccine Development and Global Health at the University of Maryland, for example, has produced over 100 patents through basic science research, vaccine development, and field studies conducted worldwide. Similar centers exist at institutions like Oxford, Baylor, and Emory. These labs focus on diseases that may not be commercially attractive to pharmaceutical companies, including infections that primarily affect low-income countries. When their discoveries show enough promise, they typically partner with or license the technology to a company that can fund the costly clinical trial phases.
On the government side, agencies like the National Institutes of Health in the U.S. play a direct role in vaccine research. The U.S. government invested $31.9 billion in the development of mRNA COVID-19 vaccines alone, with $337 million of that invested before the pandemic even began. That public funding laid the scientific groundwork years before any company began manufacturing doses.
Biotech Startups
Small and mid-sized biotech companies are often where the most innovative vaccine technologies originate. These firms tend to focus on a single platform or delivery method, pushing the science forward before larger companies adopt it. The mRNA technology behind the COVID-19 vaccines from Moderna and Pfizer-BioNTech is the most prominent example, but a new generation of startups is already building the next wave.
Several companies are developing circular RNA, a modified form of genetic material that doesn’t degrade as quickly in the body as conventional mRNA. Because it lacks exposed ends, cellular machinery doesn’t break it down as fast, leading to longer-lasting protein production from a single dose. One company, Orna Therapeutics, launched with over $100 million in funding to pursue this approach. Another, Laronde, reported that its circular RNA constructs produced sustained protein levels in mice for weeks to months after a single administration. These firms also point to manufacturing advantages: circular RNA molecules assemble themselves efficiently, skipping expensive chemical steps required for standard mRNA production.
Other startups are working with self-amplifying RNA, which can copy itself inside cells to boost potency. Replicate Bioscience, for instance, launched with $40 million to develop cancer vaccines designed to prevent drug resistance in patients on immunotherapy. These companies typically don’t manufacture vaccines at global scale themselves. They develop the technology, prove it works, and then either partner with a large pharmaceutical company or license it out.
Global Health Coalitions
For diseases that primarily threaten low-income countries, the commercial incentive to develop a vaccine may be weak. That gap is filled by international organizations that fund, coordinate, and distribute vaccines where the market alone wouldn’t.
The Coalition for Epidemic Preparedness Innovations (CEPI), founded in 2017, finances and coordinates vaccine development for potentially epidemic diseases with limited market potential. CEPI built a portfolio of rights to specific vaccine platforms and products, then pivoted that portfolio toward COVID-19 candidates when the pandemic hit. Its role is to get vaccines into development that private industry might otherwise skip.
Gavi, the Vaccine Alliance, operates on the other end of the pipeline. Rather than funding research, Gavi focuses on procurement and delivery. Since 2000, it has expanded routine childhood immunization coverage across lower-income countries through innovative financing mechanisms. During the COVID-19 pandemic, Gavi led the COVAX Facility’s vaccine procurement and managed the Advance Market Commitment, a financing tool that guaranteed purchase orders so manufacturers would produce doses for countries that couldn’t afford to compete with wealthier nations on price. The World Health Organization and UNICEF round out this ecosystem by supporting national planning for vaccine rollout.
Contract Manufacturers
Even companies that develop a vaccine don’t always manufacture it themselves. Contract development and manufacturing organizations (CDMOs) handle production for clients who lack the facilities or capacity. These third-party manufacturers perform technology transfer, scale up production processes, and produce vaccine doses under strict quality standards. Some CDMOs operate specialized high-containment facilities capable of working with dangerous pathogens. During the COVID-19 pandemic, contract manufacturers became critical bottlenecks and then critical accelerators, as vaccine developers outsourced production to meet global demand faster than their own factories could manage alone.
Regulatory Agencies
Developing a vaccine is only half the equation. Before any vaccine reaches the public, it must clear a rigorous review by regulatory agencies. In the United States, the FDA evaluates scientific data from all phases of clinical trials, assessing safety, effectiveness, and manufacturing quality. The agency also provides scientific guidance to developers throughout the process, not just at the end. In Europe, the European Medicines Agency performs a parallel function.
After a vaccine is authorized or approved, oversight doesn’t stop. The FDA and the Centers for Disease Control and Prevention share responsibility for ongoing safety monitoring, tracking for rare side effects that may not have appeared during trials. This post-approval surveillance is what catches problems like unusual clotting events or elevated rates of heart inflammation, issues too rare to detect in trials of tens of thousands of people but visible once millions receive a dose.
How These Players Work Together
The typical path looks something like this: a university lab or small biotech company identifies a promising vaccine approach using government grant funding. If early results are strong, a larger pharmaceutical company licenses the technology or acquires the startup. The pharmaceutical company then runs large clinical trials, sometimes with help from contract research organizations that manage trial sites and patient enrollment. A CDMO may handle some or all of the manufacturing. Regulatory agencies review the data and decide whether to authorize the vaccine. Global coalitions like CEPI and Gavi then work to ensure the vaccine reaches populations beyond wealthy countries.
The entire process, from initial lab work to approved product, averages about 10 years and costs close to $900 million per vaccine. COVID-19 compressed that timeline dramatically through massive parallel investment, but the underlying structure of who does the work remained the same: a relay between public researchers, private companies, contract manufacturers, regulators, and global health organizations, each contributing a piece that the others can’t easily replicate.