‘Unprecedented’ HPV vaccine demand to fuel more Merck capacity investments

Having recently invested over $1.6 billion in its network, Merck says it is committed to further expand the supply of its HPV vaccines as worldwide demand continues to spiral.

Speaking at the at Morgan Stanley 17th Annual Global Healthcare Conference last month, Roger Perlmutter, EVP and president of Merck Research Laboratories, said human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 were the products that have the dominant near-term commercial potential for his firm.

But a lack of manufacturing capacity at Merck & Co. (known as MSD outside North America) has been a hurdle to Gardasil reaching its full potential, with Perlmutter saying the firm “had not expected that the demand would rise so suddenly as public health authorities around the world recognized that… by immunizing with Gardasil, you can potentially actually eradicate cervical cancer.”

Image: iStock/Artur

Merck spokeswoman Pamela Eisele confirmed Gardasil is suffering from a demand and supply issue, saying: “We are experiencing an unprecedented increase in global demand for our HPV vaccines as nations and global health initiatives work towards reducing the burden of HPV-related cancers.” Following five years of stable demand, demand for HPV vaccines has doubled between 2017 and 2018, and continues to increase significantly in 2019, she added.

HPV vaccine capacity expansions

Gardasil and Gardasil 9 pulled in $3.2 billion (€2.8 billion) in global sales in 2018 for the Big Biopharma firm.

“The sharp increase in demand – combined with the inherent manufacturing complexity, long lead times of up to four years from start to finish, essential quality control and the significant infrastructure required to manufacture our HPV vaccines to meet demand – limits our ability to increase supplies as rapidly as we would like.”

With the pressure on to make enough vaccine, Merck has recently committed to huge investments in its HPV vaccine production network. Specifically, in May the firm announced plans to invest $1 billion (€900 million) over the next three years at its Rockingham County, Virginia site. Weeks later, a $650 million investment was announced to build a facility at its Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, North Carolina.

With an estimated 200 million doses needed “to make enough vaccine to immunize the entire birth cohort of the world,” according to Perlmutter, further investments are likely. In 2018, Merck earmarked $16 billion to spend on capital projects through 2022, and so while no more concrete plans have been announced yet, Gardasil is will remain a high focus.

“Merck remains committed to expanding the supply of HPV vaccines to meet increasing global demand and to help prevent those HPV-related cancers and diseases for which the vaccines are indicated,” said Eisele.

“We are continuing to keep our partners and other stakeholders, including governments and multilateral organizations, informed about progress on increasing our manufacturing capabilities and the status of supply.”

Gardasil is not the sole HPV vaccine available on the market. GlaxoSmithKline (GSK) markets Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, though it has sat in the shadow of Merck’s rival vaccine. Cervarix was pulled from the US in 2016 due to low demand and GSK now focuses on the European and international market. Sales stood at $138 million in 2018.