AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab deruxtecan this winter—AstraZeneca is placing a big bet on the cancer-fighting technology as it blueprints a massive manufacturing investment in Asia.

AstraZeneca on Monday unveiled plans to build a $1.5 billion ADC manufacturing facility in Singapore. The site, which will enjoy a boost from Singapore’s Economic Development Board (EDB), is slated to become the British pharma’s first site for end-to-end ADC production, AstraZeneca said in a release.

ADCs consist of an antibody attached via a chemical linker to a chemotherapy payload. The antibody targets cancerous cells where the ADC’s cytotoxic payload is ultimately released.

The site will “fully” incorporate all steps of the ADC manufacturing process at commercial scale, AZ said, ranging from antibody and chemotherapy production to conjugation of the drug-linker and filling of the completed ADC substance.

AZ plans to kick off construction on the new plant by the year's end, with the goal of getting the facility up and running by 2029. The project also marks AZ’s first manufacturing foray into Singapore, Png Cheong Boon, chairman for the country’s EDB, said in a statement.

The planned facility will support AZ’s portfolio of in-house ADCs, including six wholly owned cancer-fighting prospects in the clinic and “many more in preclinical development,” the company said in its release. As for Enhertu and Dato-DXd, both of those drugs are manufactured by Daiichi Sankyo. 

What’s more, the site is being designed to emit zero carbon from its first day of operations, AZ added.

AZ’s interest and investment in ADCs is likely well placed, given that the $10 billion market for the specialized cancer fighters has been tipped to grow more than 15% each year, Paul Tomasic, managing director and head of European healthcare at investment bank Houlihan Lokey, wrote in a note to clients Monday morning.

“This move reflects the industry's recognition of the complexities and costs associated with developing and manufacturing ADCs, which necessitates substantial investment in infrastructure to ensure quality and efficiency in production,” he said.

AstraZeneca is making its manufacturing play as the ADC market grows increasingly crowded with other large-cap pharma players, Tomasic pointed out. Within the last year, AbbVie and Pfizer each closed multibillion-dollar deals in the ADC space, buying out ImmunoGen and Seagen, respectively.

But despite a host of new challengers, AZ continues to stand out “as a leader in the increasingly competitive market for ADCs, with the development of the site in Singapore further cementing its position,” Tomasic said.

Indeed, the company’s current commercial ADC, the Daiichi-partnered Enhertu, has been doing gangbusters in recent months.

Over the first three months of 2024, the partners reported combined sales of $879 million for the medicine, which has enjoyed “sequential market share growth” in HER2-positive metastatic breast cancer and “continued adoption” in HER2-low disease, AZ’s oncology business head Dave Frederickson said on a recent earnings call.

In April, Enhertu bagged an accelerated FDA nod to treat adults with unresectable or metastatic HER2-positive solid tumors, making AZ and Daiichi’s drug the first tumor-agnostic HER2-directed ADC. Enhertu’s latest pan-tumor nod could help the med reach “several thousands” of patients across multiple tumor types, AZ’s Fredrickson noted on the company’s prior conference call in February.

AZ and Daiichi also have near-term commercial plans in the ADC space beyond Enhertu, thanks to a recent FDA filing acceptance for the partners’ TROP2-directed ADC datopotamab deruxtecan (or Dato-DXd) in non-squamous non-small cell lung cancer.

The regulator is expected to give its verdict on that drug’s approval by Dec. 20, Daiichi has said.

Elsewhere, Singapore has become a popular destination for drugmakers in recent years. Back in January, AbbVie said it broke ground on a $223 million expansion of its manufacturing plant in the country to help bolster global biologics capacity. And in March, Novartis started work on its own $256 million Singapore expansion, which will primarily support manufacturing of antibody drugs. Before that, Merck and Sanofi each charted large projects in the country in 2022.