Eli Lilly to build $2.5 billion injectable drug plant in Germany

Eli Lilly said on Nov. 17, 2023 that it will build its first manufacturing plant in Germany, a 2.3 billion euro ($2.5 billion) site in the western town of Alzey that will make injectable incretin medicines, including Mounjaro and Trulicity, and the injection pens used to deliver them ^[1]. Construction is scheduled to begin in 2024, and the plant is expected to start operating in 2027, according to the company ^[1][2].

Incretins are peptide-based drugs such as Mounjaro that mimic gut hormones to suppress appetite and stimulate insulin secretion ^[1]. Lilly said the Alzey site will use automation and high-speed manufacturing lines to boost its ability to supply incretins for its diabetes and obesity products ^[2]. The site will employ up to 1,000 "highly skilled" workers, including engineers, technicians and scientists, Lilly said ^[1].

The plant is the latest piece of a broad manufacturing build-out. Lilly said it has announced more than $11 billion in global manufacturing investments over the past three years ^[1][2]. In its third-quarter report, the company said it had earmarked more than $8 billion for ongoing expansions in Indiana, North Carolina and Limerick, Ireland ^[1]. Those include $1.7 billion committed to its Research Triangle Park, North Carolina, facility — a total that includes a $450 million expansion aimed at meeting Mounjaro demand — and $1.6 billion announced in April 2023 for two sites in Indiana's LEAP Innovation Park in Boone County, bringing funding at that location to $3.7 billion ^[2]. Lilly has also put more than $500 million into an active pharmaceutical ingredient plant in Ireland, lifting its investment there to 927 million euros, or about $1 billion ^[2].

Supply has been the constraint behind much of that spending. Lilly has said it expects supply constraints to continue for some time as it adds manufacturing capacity, and in a Nov. 2 interview it asked doctors outside the United States to stop putting new patients on Trulicity to cope with increased demand ^[1]. Novo Nordisk, Lilly's main rival, has said the industry is far from producing enough to meet demand ^[1]. The two companies are competing for an estimated $100 billion future global market for anti-obesity treatments, according to Reuters ^[1].

Mounjaro, whose molecule is tirzepatide, was cleared in the United States for weight loss in the week before the German announcement and can now be promoted by Lilly as an obesity treatment ^[1]. FiercePharma identified the weight-loss brand as Zepbound ^[2]. Mounjaro is also likely to be approved for weight loss in the European Union after the bloc's drug regulator recommended it for that use ^[1].

In Germany, the state health insurance system is barred by law from paying for weight-loss drugs, so patients without diabetes who get a prescription for weight loss will likely have to pay for Mounjaro out of their own pockets, Reuters reported ^[1]. Health Minister Karl Lauterbach said on Nov. 17 that any review of those rules was not currently on the agenda ^[1]. Lauterbach said the investment "encourages the government in its efforts to make Germany more attractive as a pharmaceutical centre" and would "secure fast access to new therapy options and reduce dependency on fragile supply chains" ^[1].

Lilly manufacturing head Edgardo Hernandez said the company's plants in France and Italy also make incretin drugs such as Mounjaro, and cited Germany's engineering workforce, existing infrastructure and equipment makers as reasons for the location ^[1]. Lilly has been in Germany since 1960 and already has 1,000 employees there in development, distribution, marketing and administration ^[1]. The investment comes as drugmakers oppose a European Union plan to shorten the standard period of protection before generics can enter the market to eight years from 10; despite Lilly's objection, Hernandez said the company wanted to invest in the region to "help drive the conversation in another direction" ^[1].

Why it matters for patients

A new factory does not change what is available at a pharmacy today. The Alzey plant is not expected to produce anything until 2027 ^[1][2], so it will not affect supply or availability in the near term for people in the United States taking tirzepatide or other injectable incretins.

The announcement is one measure of how tight supply has been. Lilly's decision to ask doctors outside the U.S. to stop starting new patients on Trulicity, and its repeated statements that shortages will persist while capacity is added, point to limits that new plants are meant to relieve over time ^[1].

It has not been disclosed how much of the Alzey plant's output would be sold in the United States versus Europe, or which specific products would be made there beyond injectable incretins and their pens ^[1][2]. The German rules on who pays for weight-loss drugs apply in Germany's public insurance system and do not change coverage rules in the United States ^[1].

What happens next

Construction at Alzey is set to begin in 2024, with operations starting in 2027 ^[1][2]. Lilly has also said it expects supply constraints for some time as it adds manufacturing capacity ^[1]. A final European Union decision on Mounjaro for weight loss, following the regulator's recommendation, has not been scheduled in the reporting on the plant ^[1].