MSD opens $1bn plant for HPV vaccine in the US

MSD has opened the doors of a $1 billion manufacturing facility at its site in Durham, North Carolina, that will be used to produce the bulk drug substance for its HPV vaccine Gardasil.

The 225,000 sq. ft. plant – which is dedicated to vaccines production – is part of a broader $12 billion capital investment that MSD has made in its manufacturing capacity since 2018, with another $8 billion planned between now and 2028.

While the announcement of the opening comes at an opportune time for MSD (known as Merck & Co in the US and Canada), given President Trump's strident calls for more pharma manufacturing to be located within the US, the additional capacity for Gardasil comes at a time when sales of the vaccine have gone into reverse.

In the fourth quarter of 2024, worldwide sales of Gardasil products fell 17% to $1.6 billion, while for the full year they fell 3% to $7.6 billion. MSD has attributed the fall to lower demand in China – tied to reduced "discretionary consumer spending" – that was not able to offset "higher demand in most international regions, particularly in Japan."

The company is hoping to reverse the trend in China, following the approval in January of a broader label for the vaccine to include the prevention of certain HPV-related cancers and diseases in males between nine and 26 years of age.

In the meantime, however, it has temporarily paused shipments to China – beginning in February and lasting through at least the middle of this year – saying that would allow it to achieve a more rapid correction to its inventory levels.

Chief executive Robert Davis said last month that China "still represents a significant long-term opportunity for Gardasil, given the large number of females, and now males with our recent approval, that are not yet immunised," although the company has reined back its $11 billion peak sales prediction for the shot.

Meanwhile, the new facility is being hailed as a showcase for MSD's manufacturing prowess, boasting new technical and digital capabilities, including data analytics, generative AI, 3D printing, and a training centre equipped with a digital twin – a virtual model of the shop floor manufacturing process systems – that can simulate process changes before they are implemented.

"Expanding our state-of-the-art manufacturing facility in Durham marks a significant milestone in our efforts to strengthen our production and manufacturing capabilities in the US," said Sanat Chattopadhyay, executive vice president and president of Merck's manufacturing division.

"The cutting-edge technologies employed here empower our workforce and underscore our leadership in innovation to support patients everywhere."