For a long time, the global vaccine market has been dominated by four major players: Pfizer, Merck, GSK, and Sanofi. This landscape was briefly disrupted by the unexpected COVID-19 pandemic, providing new players a rare opportunity to compete on equal footing with the established giants.
Looking back, the four giants did not demonstrate their traditional advantages in this competition, with only Pfizer making a strategic move by partnering with BioNTech. This collaboration led to a historic achievement, pushing Pfizer's overall revenue beyond $100 billion in 2022. In contrast, the other three companies had lackluster performances. Meanwhile, another mRNA vaccine company, Moderna, also rose to prominence, holding its own against Pfizer in direct competition. Other traditional pharmaceutical giants, including Johnson & Johnson and AstraZeneca, also secured a share of the market. At that time, the vaccine industry seemed poised for a significant shift.
However, as the pandemic subsided and vaccination efforts transitioned into a routine phase, most companies quickly retreated from the vaccine sector. Even BioNTech, which amassed significant wealth from COVID-19 vaccines, shifted its focus toward acquiring oncology drug projects, with its first cancer drug expected to receive approval by 2026. Meanwhile, its vaccine revenue plummeted to €2.751 billion ($3 billion) in 2024. Moderna, on the other hand, remained dedicated to vaccines, but even with its second mRNA vaccine, the market potential was severely hindered by the CDC's Advisory Committee on Immunization Practices (ACIP) recommendations for RSV vaccines. In 2024, Moderna’s COVID-19 vaccine Spikevax and RSV vaccine mRESVIA collectively generated $3.109 billion in revenue, marking a 53% decline year-over-year, with mRESVIA contributing only $25 million despite launching in Q3 2024.
In terms of revenue, Moderna and BioNTech were evenly matched in 2024. However, investors favored BioNTech, which had shifted its focus toward "IO+ADC" (Immuno-Oncology and Antibody-Drug Conjugates), pushing its market capitalization ahead of Moderna. Investors remain skeptical of Moderna's aggressive pursuit of the vaccine market dominated by the four giants. Perhaps only if its cancer vaccine, developed in collaboration with Merck, achieves groundbreaking success upon approval, will Moderna regain strong upward momentum.
Ultimately, the global vaccine market has reverted to its previous dynamics post-pandemic, with the four giants continuing to lead vaccine research and supply worldwide.
Among Pfizer’s vaccine portfolio, its pneumococcal vaccine line, Prevnar Family, remains the flagship product. In 2024, it generated $6.411 billion in revenue, maintaining its 2023 performance levels. Approximately two-thirds of this revenue came from the pediatric segment, with the company expecting stable market share through 2030. However, the adult market, which contributes the remaining third of sales, faces intense competition.
The 20-valent pneumococcal conjugate vaccine, Prevnar 20, approved in 2021, holds a dominant position in the U.S. market with an 87% market share. While Pfizer sees limited growth potential among individuals aged 65 and older, there is an opportunity in the 50-64 age group, which comprises 30 million people. Additionally, as eligibility expands, international markets continue to grow.
To maintain its global leadership in the pneumonia vaccine sector, Pfizer is preparing its next move. Its 25-valent pneumococcal conjugate vaccine, PF-07872412, which has received FDA Fast Track designation, is currently in Phase II trials for adults and infants, with plans to begin a pivotal Phase III trial in late 2025. Phase I clinical results showed that Prevnar 25 improved response rates against serotype 3 by fourfold compared to Prevnar 20. Since serotype 3 accounts for approximately 20% of pneumonia cases in individuals aged 65 and older in Western countries, an approval for Prevnar 25 could help Pfizer capture a larger share of this demographic. These findings will also guide Pfizer’s development of pneumococcal vaccines beyond 30-valency.
However, Pfizer must remain vigilant against competitors. In addition to Merck, GSK, and Sanofi, its biggest challenger may be California-based Vaxcyte. The company is developing a 31-valent pneumococcal vaccine for infants and adults aged 50 and above. Vaxcyte plans to launch a pivotal Phase III non-inferiority clinical trial in mid-2025, with safety, tolerability, and immunogenicity data expected in 2026.
Aside from the Prevnar series, the biggest revenue driver for Pfizer in the past four years has been its COVID-19 mRNA vaccine, Comirnaty, co-developed with BioNTech. Even though Comirnaty's revenue declined 52% year-over-year to $5.353 billion in 2024, it remains one of the top-selling vaccines, with cumulative sales exceeding $90 billion.
Pfizer anticipates further declines in COVID-19 vaccine revenue but remains committed to the sector. It continues collaborating with BioNTech on a combination COVID-19 and influenza vaccine, PF-07926307. In August 2024, the companies released Phase III trial results for individuals aged 18-64. The study met one of its two primary immunogenicity endpoints, showing strong responses against influenza A and COVID-19, though it failed to meet the target for influenza B. Meanwhile, another Phase II trial for Pfizer’s second-generation trivalent mRNA flu vaccine demonstrated strong immune responses across all strains without safety concerns compared to standard flu vaccines.
Originally, Pfizer hoped that its RSV vaccine, Abrysvo, approved in May 2023, could offset the decline in COVID-19 vaccine sales. In its first year, Abrysvo performed well, generating $890 million in revenue and competing fiercely with GSK’s Arexvy. However, in 2024, both vaccines faced a major setback when the CDC's ACIP restricted RSV vaccination to individuals aged 70 and older, significantly shrinking the market. As a result, Abrysvo's revenue declined 15% to $755 million. Fortunately, increased market share among adults and strong demand among pregnant women helped stabilize sales. Abrysvo’s unique approval for pregnant women gives it an edge over its competitors, Arexvy and Moderna’s mRESVIA. Additionally, strong international sales, particularly the anticipated approval for individuals aged 18-59 in the EU in 2025, could further boost Abrysvo's revenue.
In Pfizer’s 2024 earnings report, it highlighted four major vaccine products: pneumococcal, COVID-19, and RSV vaccines, along with its tick-borne encephalitis (TBE) vaccine, FSME-IMMUNE/TicoVac. This vaccine generated $280 million in 2024, a 5% year-over-year increase. TicoVac was approved by the FDA in August 2021 for individuals aged one and older to prevent TBE, a viral infection affecting the brain and spine transmitted through tick bites. With up to 2% mortality and long-term neurological effects in a third of patients, TicoVac remains a key preventive measure. In Europe, it is marketed under FSME-IMMUNE and TicoVac, while in the U.S., it is sold as TicoVac.
Additionally, Pfizer is advancing its C. difficile vaccine candidate, PF-07831694, designed to prevent Clostridioides difficile infections. Based on previous studies, Pfizer has optimized the formulation and plans to initiate a pivotal Phase III trial in late 2025.
Merck’s leading vaccine product is undoubtedly the HPV vaccine Gardasil. However, compared to its 29% surge in 2023, reaching $8.886 billion, the Gardasil series generated $8.583 billion in revenue in 2024, a 3% decline year-over-year, primarily due to decreased demand in the Chinese market. As a result, Merck decided to suspend shipments to China until mid-2025, depending on market conditions, hoping to rapidly deplete inventory during this period. This move comes especially as China approved the quadrivalent Gardasil for males aged 9-26 in January 2025. With domestic Chinese HPV vaccines set to enter the market soon, Gardasil, as the only HPV vaccine currently approved for males, may drive a new wave of vaccinations before and after this major competitive shift.
Considering the uncertainty surrounding China’s economic recovery, Merck has withdrawn its previous $11 billion revenue target for Gardasil. However, growth expectations outside China remain unchanged, with strong expansion projected over the next three years.
PROQUAD/M-M-R II/VARIVAX (measles, mumps, rubella, and varicella combination live vaccines) generated a total revenue of $2.485 billion in 2024, reflecting a 5% year-over-year increase. The pentavalent rotavirus live attenuated vaccine RotaTeq contributed $711 million in revenue, down 8% compared to the previous year.
Although Pfizer dominates the pneumococcal vaccine market, Merck's three pneumococcal conjugate vaccines still hold a portion of the market. VAXNEUVANCE (15-valent) generated $808 million in 2024 (+22%), while PNEUMOVAX 23 continued its decline to $263 million. The 21-valent CAPVAXIVE, approved by the FDA in June 2024 and recommended by the Advisory Committee on Immunization Practices (ACIP), recorded $50 million in revenue, primarily from the retail pharmacy channel. CAPVAXIVE recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is expected to gain approval in the second quarter of this year. A direct competition between CAPVAXIVE and Pfizer’s Prevnar 20 is anticipated.
Beyond challenging Pfizer’s dominance in pneumococcal vaccines, Merck is also set to go head-to-head with Sanofi. Merck’s long-acting RSV monoclonal antibody, Clesrovimab (MK-1654), is designed as a passive immunization measure to protect infants from RSV infections during their first RSV season. In a pivotal Phase IIb/III clinical trial (CLEVER), a single dose of Clesrovimab significantly reduced RSV-related medical visits requiring at least one lower respiratory tract infection (LRI) indicator. Compared to the placebo group, it demonstrated a 60% improvement in efficacy within the first five months after administration.
Additionally, Clesrovimab reduced RSV-related hospitalization rates and RSV-related LRI hospitalization rates by 84% and 91%, respectively, over a five-month period. In December 2024, the FDA accepted Merck’s Biologics License Application (BLA) for Clesrovimab, with a Prescription Drug User Fee Act (PDUFA) date set for June 10, 2025. Once approved, this drug will directly compete with Sanofi’s RSV monoclonal antibody, Beyfortus.
GSK’s vaccine business reported an annual revenue of ￡9.138 billion (~$11.697 billion, -7%) in 2024. Similar to Pfizer and Merck, GSK heavily relies on individual vaccine products.
The largest single product is the shingles vaccine Shingrix, a recombinant subunit adjuvanted vaccine that utilizes varicella-zoster virus glycoprotein E and the proprietary AS01B adjuvant system to generate a strong and long-lasting immune response. It is administered in two intramuscular doses, with the second dose given between 2-6 months after the first.
Shingrix contributed ￡3.364 billion in revenue in 2024, a 2% year-over-year decline. In the U.S., after years of effort, the cumulative vaccination rate for Shingrix has now reached 40%, up five percentage points from 12 months ago, with a price increase. However, despite these factors, annual sales still fell by 18%, as market penetration among hard-to-reach unvaccinated populations slowed down, seemingly hitting a ceiling. Additionally, changes in U.S. Medicare reimbursement policies affected GSK’s long-standing retail pharmacy advantage.
Shingrix now primarily relies on markets outside the U.S. for growth. In 2024, 56% of its revenue came from outside the U.S. (up from 45% in 2023), with an average vaccination rate of around 7% across ten key markets. The European market overall showed growth, except for Germany, where demand declined. The international market also saw significant growth, aided by a national vaccination program in Australia and supply agreements in China. However, GSK is concerned about a decline in Shingrix shipments to China in Q4 2024, signaling a drop in sales in that market.
GSK’s meningitis vaccine portfolio generated ￡1.437 billion in revenue, growing 14% year-over-year. The Group B meningitis vaccine Bexsero surpassed ￡1 billion in annual sales for the first time, thanks to favorable pricing strategies, U.S. CDC purchases, Germany’s vaccination policy recommendations, and its launch in Vietnam. However, sales of the quadrivalent meningitis vaccine Menveo (ACWY) declined due to the U.S. CDC replenishing its stock in Q4 2023.
A major positive development was GSK’s announcement on February 15, 2025, that its five-in-one meningococcal conjugate vaccine Penmenvy (MenABCWY) received FDA approval.
Arexvy, the world’s first RSV vaccine, was approved in 59 countries, with 17—including the U.S.—recommending it for elderly populations and implementing reimbursement policies. However, due to the U.S. CDC limiting coverage to seniors aged 75 and above, Arexvy’s revenue plummeted 52% year-over-year to ￡590 million in 2024.
Initial stockpiling from the vaccine’s 2023 launch was cleared in 2024. Despite this, Arexvy remained the market leader in retail channels, the preferred vaccination method for most consumers. Since its launch in Q3 2023, over 10 million Americans aged 60 and older have been vaccinated.
Outside the U.S., market reception was positive, with strong policy support in Germany, Saudi Arabia securing its first contract, and stockpiling efforts beginning in Australia and Brazil. However, Canada saw a decline in demand in Q4, possibly influenced by U.S. policies.
The flu vaccine Fluarix/FluLaval faced competitive pressure and declining U.S. demand, leading to a 19% drop in revenue to ￡408 million in 2024. However, pricing strategies helped drive a return to growth in Q4.
Other legacy GSK vaccines contributed a combined ￡3.339 billion.
Boostrix, previously FDA-approved for tetanus, diphtheria, and pertussis (Tdap) in individuals aged 10 and older, received new approval to protect infants under two months from pertussis, boosting growth in the U.S. and Europe. It generated ￡681 million in 2024, an 11% increase.
The combination vaccines Infanrix (DTaP) and Pediarix (DTaP-HepB-IPV) saw revenue decline by 8% to ￡512 million due to a large CDC stockpile replenishment in 2023. Similarly, the oral rotavirus vaccine Rotarix saw a 4% decline to ￡587 million for the same reason.
Hepatitis vaccine sales rose across major markets, up 13% year-over-year to ￡692 million. The live attenuated MMR/V vaccines (Priorix/Priorix Tetra/Varilrix) performed well in international and U.S. markets, growing 22% year-over-year to ￡323 million. However, GSK’s much-touted adjuvant platform did not deliver any major breakthroughs in 2024.
Unlike its competitors, Sanofi maintains a balanced vaccine portfolio. In 2024, its vaccine revenue reached €8.299 billion, growing 13.5% year-over-year, largely driven by the strong performance of RSV monoclonal antibody Beyfortus (€1.686 billion, +214.4%), with significant contributions from Germany and the U.S. Expanded production capacity, approved in H2 2024, is expected to support further growth in 2025.
Sanofi’s traditional PPH (Polio/Pertussis/Hib) vaccines, including Pentaxim in China, generated €2.741 billion in 2024 (+1.2%).
The flu vaccine segment saw a sharp 36.8% decline in Q4 2024 due to shipments being concentrated in Q3, unlike in 2023. Annual sales dropped slightly (-1.3%) to €2.555 billion, also impacted by a product recall in China in August 2024.
Meningitis and other vaccines earned €1.316 billion (+5.4%), despite unfavorable U.S. CDC procurement policies. The meningococcal conjugate vaccine MenQuadfi continued to gain market share elsewhere.
Sanofi is entering the pneumococcal vaccine race alongside SK Bioscience. Their SP0202 vaccine began Phase III trials in December 2024 in Australia, aiming to enroll 7,700 participants across multiple regions. It is the first ≥20-valent pneumococcal conjugate vaccine in Phase III trials for infants.
Another late-stage vaccine candidate is the 9-valent Escherichia coli (E. coli) sepsis conjugate vaccine (ExPEC) SP0282, which Sanofi licensed from Johnson & Johnson. Phase III clinical trial data is expected to be released in 2026. Additionally, influenza, a traditional area of strength for Sanofi, remains a key focus of its R&D efforts. Sanofi is also actively developing next-generation vaccines for emerging threats such as COVID-19, the breakthrough RSV virus, and even human metapneumovirus (hMPV), which was discovered in 2001. This includes the development of multivalent vaccines.
When analyzing the product portfolios of the four major vaccine giants, Merck and GSK each hold exclusive dominance in the HPV and shingles vaccine markets, respectively. Meanwhile, Pfizer has outpaced the other three companies in the COVID-19 vaccine space. However, in other key areas—pneumococcal, RSV, influenza, meningococcal, and MMRV (measles, mumps, rubella, varicella) combination vaccines—the competition is highly intense. This has led to a fierce battle among the four giants.
The vaccine market operates under unique rules. The four major players must not only guard against internal and external competitors but also navigate significant challenges arising from changing market conditions—especially in the two most critical markets, the U.S. and China.
In China, the four giants seem to have reached an unspoken understanding, maintaining clear boundaries and avoiding direct competition. Each company primarily markets its flagship vaccines: Pfizer with pneumococcal vaccines, Merck with HPV vaccines, GSK with shingles vaccines, and Sanofi with influenza vaccines, pentavalent polio vaccines, and RSV monoclonal antibodies. The competition they face in China comes mainly from domestic vaccine manufacturers and the challenge of adapting to China’s regulatory and commercial landscape. However, a key difference lies in their business strategies: except for Sanofi, which retains its own commercial team and manufacturing facilities in China, the other three companies have opted to work with local distributors. This approach reflects the unique regulatory environment and the intense competition within the Chinese vaccine market.
While the U.S. vaccine market offers greater opportunities, it also presents significant challenges. With Donald Trump returning to the White House, the new administration includes staunch anti-vaccine advocates and is cutting personnel at key health regulatory agencies such as the FDA and CDC. Given Trump’s handling of the COVID-19 pandemic during his first term, the four vaccine giants are understandably on edge. How will they respond to these changes? That remains to be seen. However, one thing is certain: thanks to their longstanding industry presence and expertise, these four companies will continue to dominate the global vaccine market.
