As the industry moves toward the fourth quarter of 2024, what have been the key highlights thus far this year from the bio/pharma majors. Which companies are best positioned to finish strong?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

This year has been noteworthy for several large manufacturing expansions by the large bio/pharmaceutical companies as they seek to increase capacity to meet demand for key products. A roundup of some of the most noteworthy deals are below.

Product and manufacturing upside: Novo Nordisk and Lilly
By far, the largest news developments thus far in 2024 and that will continue to make news in 2024 evolve around Novo Nordisk and Eli Lilly and Company as they ride their strengths of their blockbuster obesity/weight management and Type 2 diabetes drugs,  Ozempic/Wegovy/Rybelsus (semaglutide) by Novo Nordisk and and  Mounjaro/Zepbound (tirzepatide) by demand. With strong demand for these products, the companies continue to invest in manufacturing expansions for these products—both organically and through acquisitions.

Novo Nordisk is targeting year-end 2024 to complete its $16.5-billion acquisition of Catalent, a CDMO, one of the largest acquisitions in the industry thus far in 2024. Announced in February (February 2024), the acquisition will net Novo three fill–finish sites and related assets in Anagni, Italy, Bloomington, Indiana, and Brussels, Belgium. After closing, Novo Holdings, the parent company of Novo Nordisk, plans to sell the three fill–finish sites to Novo Nordisk for $11 billion. The Catalent acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.

The acquisition is in addition to a multi-billion capital expansion plan by Novo Nordisk to increase manufacturing capacity. In June (June 2024), Novo Nordisk announced plans to invest $4.1 billion to build a second fill–finish manufacturing facility at its site in Clayton, North Carolina. Marking one of the largest manufacturing investments in Novo Nordisk’s history, the expansion will add 1.4 million square feet of production space for aseptic manufacturing and finished production processes, doubling the combined square footage of all three of the company’s existing facilities in North Carolina. Early clearing and foundational work are already underway to prepare the 56-acre facility footprint. Construction will gradually be finalized between 2027 and 2029.

Overall, in 2024, Novo Nordisk will increase actual investments in production and plans to invest approximately $6.8 billion in production compared to actual investments of $3.9 billion in 2023 to increase supply. Novo Nordisk has a global manufacturing  network with five strategic production sites in Denmark, the US, France, Brazil, and China.

For Lilly, earlier this week (September 12, 2024), the company announced the opening of a $800-million facility expansion at its site in Kinsale, Ireland,  to increase capacity for its diabetes and obesity treatments.

Outside of its obesity/Type 2 diabetes drugs, the company also announced this week (September 12, 2024) a $1-billion expansion of its Limerick, Ireland, manufacturing site to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer’s disease. Once complete, Limerick will join Lilly’s global manufacturing network producing the biologic active ingredients for the company’s Alzheimer’s disease portfolio and other biologic medicines. This new investment brings Lilly’s total Limerick investment to $2 billion, doubling the investment the company announced in March 2023. As a part of this expansion, Lilly says it will create another 150 jobs at the site, including engineers, scientists, quality assurance professionals, and operations personnel, for a total of 450 employees. Lilly initially announced the Limerick site in 2022 and broke ground in March 2023. Production of biologic active ingredients for Lilly medicines is on track to start in 2026. The Limerick investment project is subject to planning approval, and the company says it plans to submit a planning application to the Limerick City and County Council in due course.

These new investments are part of what Lilly is calling its “most ambitious” manufacturing expansion agenda in the company’s history. Since 2020, Lilly has committed more than $20 billion to build, expand, and acquire manufacturing facilities in the US and Europe.

Other major capex: AstraZeneca, Sanofi, Daiichi Sankyo, Bristol-Myers Squibb, J&J
AstraZeneca. Earlier this year (May 2024), AstraZeneca announced plans to build a $1.5-billion manufacturing facility in Singapore for antibody drug conjugates (ADCs). The planned greenfield facility, supported by the Singapore Economic Development Board, will be AstraZeneca’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. AstraZeneca says it aims to begin design and construction of the manufacturing facility by the end of 2024, with targeted operational readiness from 2029.

In addition, AstraZeneca is investing $300 million in a new cell-therapy manufacturing facility in Rockville, Maryland, initially for clinical-trial-material supply. The company also plans to invest £450 million ($482 million) to research, develop, and manufacture vaccines at its site Speke, Liverpool, UK, according to information from the UK government.

Sanofi. In May 2024, Sanofi announced an investment of EUR 1.1 billion ($1.2 billion) to create new bioproduction capacity at its sites in France: Vitry-sur-Seine (Val de Marne), Le Trait (Seine-Maritime), and Lyon Gerland (Rhône). This biomanufacturing investment project is in addition to EUR 2.5 billion ($2.71 billion) already committed in major projects in France.

In Vitry-sur-Seine, Sanofi will invest EUR 1 billion ($1.1 billion) to build a new facility that will double the site’s monoclonal antibody production capacity to meet anticipated demand for several biologics that the company pegs as potential blockbusters. The company projects that 12 potential blockbusters could be produced in Vitry. At its site in Le Trait, Normandy, Sanofi will invest EUR 100 million ($109 million) to develop new capacity for biologics formulation, filling, device assembly, and packaging to support the launch of future biologics and vaccines, as well as the continued growth of Dupixent (dupilumab), an anti-inflammatory drug for multiple indications, including atopic dermatitis and asthma. Dupixent was the company’s top-selling drug in 2023 with sales of EUR 10.7 billion ($11.6 billion). At its site in Lyon Gerland, Sanofi is investing EUR 10 million ($11 million) to locate the production in France of TZield (teplizumab-mzwv), a drug to treat Type 1 diabetes. Sanofi acquired the drug in April 2023 through its $2.9-billion acquisition of Provention Bio, a Red Bank, New Jersey-based bio/pharmaceutical company; the drug had been manufactured outside of Europe.

Sanofi’s latest biomanufacturing investments are in addition to EUR 2.5 billion ($2.71 billion) already committed in major projects in France. The largest piece of that investment is EUR 500 million ($543 million) to build a manufacturing facility for biological drugs and vaccines, including mRNA, at it is site in Neuville-sur-Saône, France, scheduled to launch in 2025.

Other investment projects in France include: (1) EUR 250 million ($272 million) at its site in Val de Reuil, to build a flu vaccine production unit and locate several production stages of Fluzone High-Dose /Efluelda, its high-dose flu vaccine; (2) EUR 60 million ($65 million) to build a small-volume launch unit for the production of active ingredients at is site in Sisteron; (3) EUR 20 million ($22 million) to increase production capacity by 140 million boxes per year for Doliprane (acetaminophen), an analgesic, at its site in In Lisieux; in Tours, EUR 15 million ($16 million) to locate the production of an anti-cholesterol drug in France and to construct a new high-volume granulation unit and a tablet-coating line in a new building, with capacity of the new unit of approximately 700 million boxes per year.

In addition, in June (June 2024), Sanofi opened a new CAD $800 million (US $584 million) pediatric and adult vaccine manufacturing facility at its campus in Toronto, Canada. The new facility increases capacity to meet growing Canadian and global demand for pediatric and adult vaccines for pertussis (whooping cough), diphtheria, and tetanus.

Daiichi Sankyo. Daiichi Sankyo is investing approximately EUR 1 billion ($1.1 billion) to expand its production and development site in Pfaffenhofen an der Ilm, Germany (north of Munich) into an international innovation center. The expansion is expected to be completed by 2030 at the latest, according to the company. Production capacity will be added to support cardiovascular drugs, and new laboratories will be established for antibody drug conjugates (ADCs). The new building for Daiichi Sankyo’s ADCs is expected to be completed by the end of 2026. In the future, cancer therapies for breast, lung, and stomach cancer, among other cancer drugs, will be developed and manufactured in Pfaffenhofen.

Bristol-Myers Squibb. Earlier this year (2024), Bristol Myers Squibb announced a $400-million investment at its Dublin, Ireland (Cruiserath) campus for the build and design of a sterile drug-product (SDP) manufacturing facility.  This will be the company’s first European SDP facility for biologics and will add drug-product manufacturing capabilities to the site, which now supports biologic manufacturing operations for bulk drug substances. The facility is expected to be completed in 2026.

Johnson & Johnson. In June (June 2024), Johnson & Johnson Innovative Medicine, the pharmaceutical segment of Johnson & Johnson (formerly named Janssen) announced a projected investment of EUR 580 million ($620 million) in Italy over the next five years, of which EUR 125 million ($134 million) will support an increase in production capacity. The company’s site in Latina, Italy, is part of Johnson & Johnson’s global supply chain network. The site produces more than four billion tablets every year, for about 30 different products, with 97% of its production exported. The investment plan will enable a production capacity increase of more than 25%, as it includes projects to support pipeline products and new production technologies, such as a Flex Line, to more efficiently handle the packaging of small production batches and a new continuous manufacturing line.

Other investments: AbbVie, Novartis & Takeda
AbbVie. Earlier this year (2024), AbbVie broke ground on a new $223-million expansion of its Singapore manufacturing facility. AbbVie’s Singapore plant is a small-molecule and biologics manufacturing facility. The new investment will add 24,000 liters of biologics drug-substance capacity. With this latest investment, AbbVie has invested more than $740 million in acquiring, modernizing and expanding its Singapore facility over the past 10 years. The expansion is slated to begin operations in 2026.

Novartis. Earlier this year (March 2024), Novartis broke ground for a $256-million expansion of its biopharmaceutical manufacturing plant in Singapore to deploy digital and automation to enhance manufacturing productivity.

Takeda. In June (June 2024), Takeda announced a $230-million expansion of manufacturing capacity for plasma-derived therapies at its plasma-fractionation facility in Los Angeles, California. This represents one of Takeda’s largest single investments in manufacturing capacity expansion at Los Angeles site, which is Takeda’s largest fractionation site in terms of capacity globally.