HPV vaccine makers eye growth overseas

Companies make notable inroads abroad amid near market saturation in domestic sector

A medical staff member injects domestically produced bivalent HPV vaccine to a girl in Lianyungang, Jiangsu province, in May 2023. (ZHU HUANAN/FOR CHINA DAILY)

As the domestic market approaches a potential saturation point and intensified price competition becomes more of a challenge, China's human papillomavirus vaccine manufacturers are seeking to expand incremental markets and explore overseas opportunities to secure further growth.

According to its latest financial report, in the first three quarters, Beijing-based Wantai Biopharm, a major HPV vaccine producer in China, reported revenue of 1.95 billion yuan ($269 million), down 60.8 percent year-on-year, while net profit stood at 267 million yuan, a significant decline of 85.25 percent.

Wantai Biopharm in its statement attributed the sharp decline in performance to factors including extended market impact of nine-valent HPV vaccines, intensified competition and inventory adjustments, which have all added up to sales declines.

Similarly, over the same period, another major player in the country's HPV vaccine market — Kunming, Yunnan province-based Walvax Biotechnology — also recorded revenue of 2.14 billion yuan, a decrease of 32.2 percent year-on-year, with a net profit of 256 million yuan, down 53.7 percent, which points to sustained sales pressure on vaccine companies in the sector.

Currently, five HPV vaccines have been approved for use in China — three bivalent, one quadrivalent, and one nine-valent. Among these, domestic manufacturers account for two bivalent HPV vaccines produced by Wantai and Walvax. By the end of August, 18 clinical trial approvals had been granted for domestically developed HPV vaccines from 10 companies.

Wantai's bivalent vaccine, the first domestically approved HPV vaccine, had previously driven substantial growth for the company.

Launched in May 2020, its batch release volume reached over 2 million doses that year, generating nearly 700 million yuan in annual revenue and accounting for 80 percent of the company's vaccine business. The vaccine's release volume surpassed 10 million doses in 2021 and rocketed to 25 million doses in 2022, said the National Institutes for Food and Drug Control.

However, with more players entering the market and intensified government procurement competition, sales performance of the bivalent vaccine has been greatly impacted.

In 2023, its annual sales plummeted to about 13 million doses, with the price dropping significantly from the original release level of over 300 yuan to around 110 yuan per dose that year.

A historical point came when earlier this year, Wantai's bivalent HPV vaccine was priced at 86 yuan per dose in Jiangsu province's government procurement project, marking the official entry of domestic bivalent HPV vaccines into the "below 100 yuan" era. Yet, price reductions did not stop there.

In August, Shandong province's online procurement platform revealed that Walvax's bivalent HPV vaccine was priced at just 27.5 yuan per dose — about the same price as a cup of coffee.

"Eyeing a higher public health level, a lot of local governments have beefed up efforts to provide free bivalent HPV vaccines for females under 15 through government procurement. And reasonable price reductions happening in this progress are a good thing, as they enhance vaccine accessibility, accelerate domestic substitution and promote a higher vaccination rate, benefiting the industry's healthy development," said Tao Ran, CEO of Beijing Health Guard Biotechnology Inc, an innovative vaccine producer.

According to the National Health Commission, as of mid-October, the free HPV vaccination policy had covered about 40 percent of women of eligible age nationwide.

Tao suggested that as competition intensifies in the lower-valent vaccine market, breakthroughs may lie in the higher-valent vaccine segment and the development of vaccines for male indications.

Health Guard's nine-valent HPV vaccine, covering both male and female indicators, is currently in phase-III clinical trials. Nine-valent products of other players, such as Jiangsu Recbio Technology Co Ltd and Shanghai-based Bovax Biotechnology, are also in advanced clinical stages. Notably, Wantai's application for market entry of its nine-valent HPV vaccine was accepted in August, marking the first such domestic application.

"Lower and higher-valent vaccines may complement each other in meeting different market needs," Tao said, adding that the former, being cost-effective, meet basic prevention needs, while the latter provide more comprehensive protection and may be chosen by more and more consumers as life quality has been largely improved during recent years.

Tao also said with the sequential approval of domestic nine-valent vaccines, competition is expected to gradually extend from the female market to the male market and eventually boost overall immunization levels worldwide.

"China's HPV market still holds tremendous potential. To date, only five HPV vaccines for females have been approved in the country, without anything of the same category for males," he said.

Data from consultancy Frost &Sullivan showed that in 2020, the number of males in China eligible for HPV vaccination (aged 9 to 45) reached 344 million, requiring about 980 million doses for full vaccination coverage. To date, there are merely three HPV vaccines designed for male use that have entered phase-III clinical trials in China.

"Many women are already well-informed about cervical cancer and HPV vaccines. With the expansion of indicators to include males in the future, more people are expected to gain awareness of this topic, which will further aid in educating the public about cervical cancer prevention and eradication efforts," said Sun Xiaodong, deputy director of the Shanghai Municipal Center for Disease Control and Prevention.

For many Chinese vaccine manufacturers, tapping the expanding overseas markets has also become a key step to counter fierce domestic competition and achieve broader growth.

For example, Health Guard said it is conducting phase-III trials for its nine-valent HPV vaccine in Indonesia and plans to submit a market application to relevant departments by 2025. The company also seeks broader market expansion in other ASEAN countries, it said.

Wantai's bivalent HPV vaccine has also gained market access in 18 countries, primarily in Asia and Africa, with registration applications underway in 10 additional countries across Asia, Africa and Latin America, the company said.

In addition, Recbio announced earlier this year a comprehensive strategic partnership with Saudi pharmaceutical company Spimaco, authorizing it to develop, register, and commercialize a nine-valent HPV vaccine in 15 countries in the Middle East and North Africa.

"There is still significant demand in many developing countries, offering new opportunities for Chinese manufacturers," said Yang Huaiyu, a consumer industry analyst.

"Southeast Asia, with its large population and low vaccination coverage, presents a promising direction for exports and a vast potential market," said Liu Lihe, executive director at China Insights Consultancy.

However, the diverse income levels and healthcare systems in Southeast Asian countries mean Chinese manufacturers must adopt tailored sales and consumer education strategies, while also engaging extensively with local public health systems, Liu said.