MSD Pioneers Male HPV Vaccination in China, Reshaping the National Vaccine Market Landscape

In recent years, as global attention to human papillomavirus (HPV) infection has continued to rise, HPV vaccines have gradually evolved from a sole means of cervical cancer prevention into a vital public health tool safeguarding the health of the entire population, both men and women. As a pioneer in the global HPV vaccine field, Merck & Co. is once again leading innovation in the Chinese market by being the first to enter the male HPV vaccine segment with its Gardasil^®Multiple new indications for HPV vaccines have recently received marketing approval from the National Medical Products Administration, making them applicable for vaccination in males aged 9 to 26 years, thereby becomingThe first and currently only approved product in China that is applicable to menHPVVaccine. This approval not only signifies broader recognition of the importance of male vaccination in HPV prevention and control, but will also reshape the landscape of China’s vaccine market, unlocking the substantial incremental market potential in this field.

Although HPV infection is often considered a virus associated with cervical cancer in women, in fact, the health threat of HPV to men is equally severe. According to research,Approx.90%of males will be infected at least once in their lifetimeHPV¹, and natural clearance after infection often takes more than two years, with a high likelihood of reinfection. The lack of routine HPV screening and testing methods for men, coupled with the absence of obvious symptoms in the early stages of infection, has led to a long-term underestimation of their infection risk.

More importantly, HPV infection poses a significant health threat to men, including various serious conditions such as genital warts, anal cancer, and oropharyngeal cancer. Studies have shown that 90% of genital warts are attributable to HPV types 6 and 11.²; 100% of cervical cancers, 88% of anal cancers, 78% of vaginal cancers, 48% of penile cancers, 29% of oropharyngeal cancers, and 24.1% of vulvar cancers are attributable to infection with relevant HPV types³。

In recent years, the associated incidence rates have continued to rise. For instance, the incidence of anal cancer in men is growing at an annual rate of 6.3% and is projected to more than triple by 2030 compared with 2016 levels. Meanwhile, the psychological burden of HPV infection on men should not be overlooked; patients often experience negative emotions related to concerns about cross-transmission, which not only impair their quality of life but also have ripple effects on families and society.

From the perspective of health economics, HPV-related diseases also impose a healthcare economic burden on society at the scale of tens of billions. A 2023 study in China on the disease burden associated with HPV infection revealed that the total economic burden attributable to HPV-related diseases in China amounted to RMB 18.03 billion. The mean total cost per case during the first year for HPV-related cancers ranged from RMB 58,189 to RMB 79,567, while the mean total cost per case for genital warts was RMB 11,879.

In the field of public health, the use of HPV vaccines is regarded as the most effective measure for preventing and controlling HPV-related diseases, and male vaccination has been proven globally to yield significant health benefits. Multiple international studies have demonstrated that vaccinating men not only effectively reduces their own risk of HPV infection and related diseases but also interrupts transmission chains, thereby providing indirect protection to women. This gender-neutral vaccination strategy of “joint prevention for both sexes” is not only advocated by the World Health Organization (WHO) but also constitutes a core component of vaccine policies in many European and American countries.

As of the latest data from November 29, 2024, among the 195 member states of the World Health Organization (WHO), 146 countries have included HPV vaccines in their national immunization programs, with 76 of these countries extending coverage to males. For instance, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination for adolescents and young adults aged 9–26 years, while catch-up vaccination for individuals aged 27–45 years is determined based on clinical circumstances. In Canada, HPV vaccination is covered through public programs or insurance, with particular emphasis on benefits for high-risk populations. Since 2008, the United Kingdom has provided HPV vaccines to girls aged 12–13 years; this program was expanded to include boys in 2019. In 2023, the UK adjusted its strategy to include one-dose, two-dose, or three-dose regimens, tailored to specific groups such as the general population, men who have sex with men, and immunocompromised patients. These national policies demonstrate a sustained commitment to achieving population-wide coverage and protecting high-risk groups.

The Chinese male HPV vaccine market boasts broad development prospects. According to statistical data from Frost & Sullivan’s report⁴In 2020, the global population of males eligible for HPV vaccination (aged 9 to 45) stood at 2.152 billion, and is projected to grow to 2.229 billion by 2025. In China, this figure reached 344 million as of 2020, corresponding to approximately 980 million doses required for full vaccination coverage. Driven by factors such as the response to the WHO’s initiative to eliminate cervical cancer and the unlocking of market potential for male vaccination, China’s HPV vaccine market is expected to enter a period of rapid growth after 2025, with its market size reaching RMB 62.54 billion by 2031, representing a compound annual growth rate (CAGR) of 18.2% from 2025 onwards.

The report also projects that, assuming the approval and market launch of male HPV vaccines in 2025, the number of men receiving HPV vaccination in China will grow from approximately 790,000 in 2025 to 7 million in 2031, representing a compound annual growth rate (CAGR) of 43.9%. The market potential for male HPV vaccination in China remains to be fully realized, and its substantial market demand will undoubtedly bring significant commercial opportunities to the HPV vaccine industry.Merck Gardasil^®HPVApproval of New Indications for Vaccines Is Expected toHPVVaccine Market Potential Further Unleashed, with Promising Growth Prospects。

In addition to the large target population base, policy and public health needs also provide strong impetus for this market. In recent years, China has actively responded to the WHO’s Global Strategy to Accelerate the Elimination of Cervical Cancer. As a key area for increasing vaccine coverage, male vaccination is bound to become a focal point of future public health strategies.

Of course, alongside the broad prospects are challenges posed by insufficient awareness. Although the market potential for male HPV vaccines is substantial, public understanding of the risks of HPV infection in men and the benefits of vaccination remains inadequate, requiring sustained collaborative efforts from all sectors of society.

As the world’s first company to launch both the 9-valent and quadrivalent HPV vaccines, Merck & Co. has secured a significant first-mover advantage in China’s HPV vaccine market, leveraging its leading R&D capabilities and extensive market experience. Gardasil^®Not only is it the world’s first HPV vaccine, but it has also become the first HPV vaccine approved in China for male indications.

Gardasil^®Accumulated extensive clinical data to support its use. For example, a randomized, double-blind, placebo-controlled trial conducted in Guangxi, China, among males and females aged 9 to 45 years, demonstrated that over 96% of participants developed antibodies against HPV types 6, 11, 16, and 18 after receiving the quadrivalent HPV vaccine, with high antibody titers. Adverse reactions following vaccination were mostly mild to moderate in severity, including pain, pruritus, and swelling at the injection site; no serious adverse events were observed. These findings fully validate Gardasil^®Safety and Efficacy in Chinese Males.

Relevant studies have also confirmed that,Gardasil^®/Gardasil^®9It provides durable protection with a favorable safety profile. In a 10-year long-term follow-up study, there were zero breakthrough cases of vaccine-type-related genital warts, anal cancer, and precancerous lesions among the age-appropriate population, and zero vaccine-related serious adverse events. The approval of this new indication not only offers health protection for men but also contributes to reducing HPV transmission across the entire population in the long term, holding significant importance and value for broader public health.

Merck's Gardasil^®Pioneering entry into the male market has not only redefined the landscape of the HPV vaccine market but also provided a new paradigm for innovative development in China’s public health sector. In the future, promoting gender-neutral HPV vaccination strategies will be central to expanding the male market and will serve as a key breakthrough in public health. By embracing the concept of “joint prevention for both men and women,” HPV vaccination will benefit a broader population, accelerate China’s goal of eliminating cervical cancer, improve men’s health, and significantly reduce the burden of HPV-related diseases.

1. A model-based study in the U.S. population estimated1,a: Chesson HW, et al. Sex Transm Dis. 2014;41(11):660-664.

2.Anogenital Warts. Https://www.cdc.gov/std/treatment-guidelines/anogenital-warts.htm

3. Yuan Meiwen, et al. Chinese Journal of Epidemiology. 2022;43(5):702-708.

4. Frost & Sullivan, Global and China Vaccine Industry Report, March 2022