Why has Merck’s nine-valent HPV vaccine struggled in sales?

Indeed, the HPV vaccine is undeniably effective in preventing cancer—especially cervical cancer—and also helps prevent genital warts. It is, without question, a valuable health product. So when HPV vaccines gradually entered China a decade ago (GSK’s bivalent vaccine was approved in 2016; Merck’s quadrivalent in 2017; and Merck’s nine-valent in 2018), especially after the nine-valent vaccine’s approval in 2018, it quickly became extremely scarce—triggering frenzied demand, long waiting lists, and rampant scalping. After all, this is a critical health resource for cancer prevention; who wouldn’t want it? Yet supply was strictly limited. The most important statistical indicator for vaccines is the ‘batch release volume’—i.e., the number of doses manufacturers submit for inspection and that pass national quality checks before being cleared for market distribution. This figure essentially reflects the manufacturer’s intended market supply. From 2017 to 2020, the batch release volumes for imported HPV vaccines were 1.46 million, 7 million, 10.87 million, and 15.43 million doses, respectively. Though these numbers show steady annual growth and appear substantial, China’s target population—women aged 9–45—numbers approximately 360 million. Even if only one-tenth of them chose vaccination, that would still amount to 36 million people—and each requires three doses. Hence, the market remained chronically undersupplied, with persistent shortages and price premiums. Yet any market propped up solely by scarcity will inevitably collapse once supply catches up. And indeed, over the past two years, the situation has flipped entirely: inventory buildup, sluggish sales, and suspended supply. In 2024, Zhifei Biological’s distribution of Merck’s quadrivalent HPV vaccine saw a full-year batch release of just 466,000 doses—a staggering 95.5% year-on-year decline; its nine-valent vaccine dropped 14.8% to 31.14 million doses, and vaccinations are now widely available without waiting. In the first half of 2025, the quadrivalent vaccine’s batch release volume was—zero. The turning point originated first on the demand side. When HPV vaccines first entered China, they faced a vast eligible female population. But once those who wanted vaccination had received it, annual new demand shrank to only the small cohort of women newly entering the eligible age range—and even this ‘incremental’ demand is declining, as we’ll detail later. More crucially, the issue lies on the supply side. Strictly speaking, it’s not that ‘HPV vaccines overall are oversupplied’, but rather that ‘Zhifei Biological’s distribution of Merck’s HPV vaccines is oversupplied’. Vaccines differ by manufacturer. Back in 2006—20 years ago—the first HPV vaccines approved for marketing in the U.S. and Australia were Merck’s quadrivalent vaccine; GSK’s bivalent followed shortly thereafter (in 2007 or 2009). Merck’s nine-valent vaccine gained approval in 2014. All three entered China around the same time, with Merck’s two vaccines exclusively distributed in China by Zhifei Biological. Historically, Merck’s nine-valent vaccine was the most chronically undersupplied. Thanks largely to HPV vaccines, Zhifei Biological’s annual revenue surged from hundreds of millions to over 50 billion RMB. The first major turning point came in 2020, when domestic vaccines emerged: Wantai’s bivalent vaccine launched at a price of 329 RMB. That may not sound cheap—but prices soon began falling steadily. After all, for GSK and Merck in other countries, HPV vaccines are a must-have regardless of price—you have no choice but to get yours from them—so why lower prices? But for domestic competitors rushing into the market, the calculus is different: production costs are low, so winning each order means securing an additional profit.

GSK’s strategic overhaul targets top-ten status in China

In just three years, the innovative drug landscape has undergone dramatic transformation. / 01 / GSK’s renewed strategic realignment To better respond to the rapidly evolving domestic innovative drug ecosystem, multinational pharmaceutical companies are adjusting their strategies with increasing frequency. Take GSK, for example: its strategic adjustments this year have been particularly active. According to the industry publication 'Pharmaceutical Representative', GSK recently undertook a corporate structural reorganization. Starting in 2024, GSK will align its market strategy around product portfolios and prioritize investment in core products. Specifically, following the reform, GSK will restructure its China operations into three core business units in 2024: the Vaccines Business Unit, the Respiratory Business Unit, and the Specialty Medicines Business Unit. GSK’s traditional strength—the Vaccines Business Unit—remains under the leadership of Feng Bixia. The Respiratory Business Unit covers both generic drugs and the IL-5 monoclonal antibody mepolizumab, led by Yu Jinyi. In fact, Yu Jinyi joined GSK China on January 4, 2024, assuming the role of Vice President and Head of the Respiratory Business. Then, on September 11, he was reassigned to serve as Vice President and Head of the Specialty Medicines Business. He has now returned to lead the Respiratory Business Unit. The Specialty Medicines Business Unit—covering systemic lupus erythematosus, hepatitis B, and HIV—will be temporarily headed by Qi Xin, GSK’s Vice President and General Manager for China. Notably, earlier this month, the Specialty Medicines Business Unit underwent another personnel change: Deng Qiao, former National Sales Director for Benlysta, departed due to family reasons; Jian Jun, formerly from the Vaccines Business Unit, assumed his position—but the Specialty Medicines leadership role is currently vacant. Under this restructuring, GSK aims to rank among the top ten multinational pharmaceutical companies in China by 2030. In fact, GSK’s organizational restructuring in China is not entirely unexpected—it mirrors GSK’s global business realignment. In 2022, GSK spun off its Consumer Healthcare business. Post-spinoff, GSK’s business segments comprise Specialty Medicines, Vaccines, and General Medicines. Such organizational transformation enables GSK to remain laser-focused on its areas of strength and maximize commercial excellence for its flagship products—a priority that is especially critical for GSK today. / 02 / From China’s No. 1 to Top Ten Many may have forgotten that GSK—now ranking outside China’s top ten pharmaceutical sales performers—was once a dominant player in the Chinese drug market. Between 2009 and 2012, GSK China’s revenues stood at approximately 3.978 billion, 4.862 billion, 5.529 billion, and 6.975 billion RMB, respectively. During those years, while GSK’s global revenue declined annually, its China business grew double-digit year-on-year, and its share of total global revenue rose steadily—from 14% to 26%. China was unequivocally GSK’s strongest-performing region globally, playing a pivotal role in its overall performance. However, following the 2013 bribery scandal involving GSK China, the company embarked on a painful, multi-year internal overhaul in the Chinese market. This triggered a severe downturn in GSK China’s business post-2013, with revenue declining for 12 consecutive quarters.

GSK shares dive as weaker vaccine sales unnerve investors

1 min ago

GSK shares tumbled after third-quarter results showed vaccine sales dipping despite overall revenue growth, sparking investor concern over patent expiries. CEO Luke Miels outlined cost-saving measures and acquisitions while reaffirming long-term revenue targets.

theguardian

2026-07-08

Alector and GSK End Partnership Following Dementia, Alzheimer's Drug Failures

2026-10-28

GSK Tops Third-Quarter Estimates as New Medicines Drive Growth, Maintains Outlook

2026-10-28

GSK shares dive as weaker vaccine sales unnerve investors

GSK shares dive as weaker vaccine sales unnerve investors

FAQ