Big Pharma’s Manufacturing Investments: The Key Capital Projects
What have been some key recent investments in manufacturing by the large bio/pharmaceutical companies? What areas, small-molecule APIs, biologics, or drug products, are targets of capital projects of the large companies? DCAT Value Chain Insights rounds up key projects.
Recent manufacturing investments
In April (April 2023), Eli Lilly and Company announced that it will invest an additional $1.6 billion at its two new manufacturing sites within the LEAP Innovation Park in Boone County, Indiana. Last year (May 2022), Lilly announced a $2.1-billion investment to build the two new facilities there to expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, such as genetic medicines. The now combined $3.7-billion investment represents the largest manufacturing investment at a single location in the company’s history.
In addition, in March (March 2023), Lilly broke ground on a new $1-billion biotech manufacturing campus in Raheen, County Limerick, Ireland, which will be Lilly’s most advanced manufacturing site for existing monoclonal antibodies. This site will produce existing products as well as the company’s pipeline of clinical products by 2026. Additionally, the company plans to invest $500 million in Limerick to create a new biologics active ingredients site. The $1.5-billion combined investment in Ireland is in addition to an $1-billion investment that the company announced in January 2022, for a new injectable products and devices manufacturing site in Concord, North Carolina.
Also, earlier this year (2023), Lilly announced plans to invest an additional $450 million to expand its manufacturing site in Research Triangle Park, North Carolina. The expansion includes additional parenteral filling, device assembly, and packaging capacity to support increased demand for Lilly’s incretin products that treat diabetes. Lilly says it is on track to achieve a previously announced goal made in November 2022 to double incretin capacity by the end of this year (2023). The company anticipates initial production at Research Triangle Park to begin this year (2023).
Earlier this month (June 2023), Novo Nordisk announced plans to invest DKK 15.9 billion ($2.3 billion) to expand an existing active pharmaceutical ingredient (API) production facility at its site in Hillerød, Denmark. The new facility will be approximately 65,000 square meters and will be designed as a multi-product facility. Construction is underway, and the facility is expected to start producing APIs by early 2029. In addition, last November (November 2022), Novo Nordisk announced a DKK 5.4 billion ($742 million) expansion of clinical-scale API manufacturing capacity. The investment includes expansion of the company’s existing facilities in Bagsværd, Denmark, and the construction of a new plant. These expansions will provide capacity for developing Novo Nordisk’s future oral and injectable product portfolio. The investment project is expected to be finalized in 2024.
Last December (December 2022), Pfizer announced a series of investments, totaling approximately $3.29 billion, to expand its manufacturing sites in Ireland, Belgium, and Michigan. The company is investing EUR $1.2 billion ($1.27 billion) each in its sites in Grange Castle, Dublin Ireland, and Puurs, Belgium, and is investing $750 million to expand its site in Kalamazoo, Michigan.
The $1.27-billion expansion at its site in Grange Castle, Dublin, Ireland, which is Pfizer’s biggest expansion investment to date in Ireland, includes a new facility to double manufacturing capacity for biological drug substances. The project (as reported on December 1, 2022) is in preliminary design phase with construction expected to commence onsite in 2024. The new facility is slated for completion in 2027.
The $1.27-billion expansion at the company’s site in Puurs, Belgium, which is slated to be completed over the next three years, is divided into three areas: expansion of production capacity, expansion of cold-storage options and expansion of packaging processes. The site is a production site for COVID-19 products and is a launch site for innovative medicines. The expansion includes the construction and equipment of a new isolator facility center with two production modules for additional filling capacity. In addition, Pfizer is building a flexible freezer warehouse that consists of two different freezer modules with independent temperature regulation for cold storage. The site is also expanding its Center for Secondary Packaging, which has already undergone a large-scale expansion, to add 16 additional packaging cabins.
The $750-million expansion at its sterile injectables manufacturing facility in Kalamazoo, Michigan, will add aseptic manufacturing equipment, systems, and design, including multiple self-contained modular manufacturing lines. Proposed products under the expansion will use new mRNA technology and ultra-low temperature storage. One of Pfizer’s largest plants, the Kalamazoo facility is a global supplier of sterile injectable, liquid, and semi-solid medicines, and APIs and produces more than 144 products. The new investment builds upon the company’s initial investment of $465 million to build the modular aseptic processing facility at the Kalamazoo site, announced in 2018, and a $120-million expansion announced in 2022.
In March (March 2023), Takeda announced that it will invest approximately JPY 100 billion ($754 million) to build a new manufacturing facility for plasma-derived therapies in Osaka, Japan. This represents Takeda’s largest investment ever for a manufacturing capacity expansion in Japan. The site is expected to be operational by approximately 2030. The facility will be a fully integrated plant, comprising teardown, fractionation, purification, filling, and finishing capabilities as well as a cold storage warehouse. The design will be environmentally friendly to support Takeda’s goal of achieving net-zero greenhouse gas emissions related to operations, including for Scopes 1 and 2 emissions, before 2035. Takeda’s existing plasma manufacturing site in Narita, Japan, will continue day-to-day operations until at least the end of the decade, with continued necessary investments for maintenance.
Also, last September (September 2022), Takeda announced a EUR 300-million ($300 million) investment to expand its biotechnology manufacturing site in Lessines, Belgium, to add a new production facility for the manufacturing of plasma-derived therapies and a net-zero carbon emissions warehouse. The expansion is targeted for plasma-derived therapies for rare diseases. With the investment, Takeda says Belgium is a long-term strategic production location for the global manufacturing and distribution of plasma-derived therapies.
Last September (September 2022), Novartis announced a multi-year $300-million investment to bolster its capacity and capabilities for early technical development of biologics for both drug substances and drug products across existing Novartis sites in Switzerland, Slovenia, and Austria. With the investment, the company is seeking to build end-to-end development and manufacturing environments by embedding biologics development within existing Novartis commercial manufacturing facilities in Slovenia and Austria as well as by establishing a biologic’s hub on the company’s St. Johann campus in Basel, Switzerland. Specifically, the investment will be split into: (1) $100 million to strengthen the company’s St. Johann campus in Basel, Switzerland, to establish a biologics hub to complement the company’s existing Novartis Institutes for BioMedical Research’s Biologics Center; (2) $110 million to create a biocampus for clinical manufacturing (non cGMP and cGMP) and technical development capabilities in Mengeš, Slovenia; and (3) $60 million for development manufacturing capacity and capabilities in its Schaftenau, Austria campus.
In March (March 2023), Sandoz, the generics and biosimilars business of Novartis, signed a memorandum of understanding to build a new biologics production plant in Lendava, Slovenia, with an investment of at least $400 million. Work on the new plant, which will support Sandoz’s biosimilars portfolio, is set to begin this year (2023), with full operations provisionally planned for late 2026. Sandoz also recently announced an additional EUR 50 million ($53 million) investment to expand its European-based antibiotics production network, bringing the total new investment commitment to its manufacturing network in the past few years to EUR 250 million ($265 million). Anti-infectives (primarily antibiotics) are the second largest Sandoz business after bio/pharmaceuticals. Novartis had announced in April 2022 its plans to spin off Sandoz into a new publicly traded stand-alone company, The spin-off is expected to be completed in the second half of 2023, subject to final Novartis Board of Directors and shareholder approvals.
In February (February 2023), Roche’s Genentech broke ground for a new $450-million biologics manufacturing facility at its Oceanside, California campus. When operational in early 2025, the facility will be Genentech’s first location for commercial production of biologics for smaller patient populations, including products to treat rare diseases and personalized medicines. Separately, Genentech announced in June (June 2023) plans to divest its biomanufacturing facility in Vacaville, California, as part of a broader strategy to evolve its manufacturing capabilities in line with future pipeline requirements. The Vacaville site has more than 427,000 square feet of space devoted to manufacturing, maintenance, laboratories, office space, and warehousing, and specializes in large-scale production of biologics. In addition, last August (August 19, 2022), Genentech opened a new $250-million clinical supply center in South San Francisco, California. The 78,520-square-foot clinical supply is Genentech’s flagship small-batch biologics facility.
Bristol-Myers Squibb recently added to its cell- and gene-therapy manufacturing network. Earlier this month (June 2023), the US Food and Drug Administration (FDA) has approved commercial production at the company’s new 244,000-square-foot cell-therapy manufacturing facility at its site in Devens, Massachusetts. Devens adds to the company’s network of three cell-therapy manufacturing facilities in the following locations: Bothell, Washington; Warren, New Jersey; and Summit, New Jersey. Another manufacturing site is in development in Leiden, the Netherlands. BMS also recently announced (April 2023) the addition of a new manufacturing facility and its operations for in-house viral vector production in Libertyville, Illinois.
Last October (October 2023), Johnson & Johnson (J&J) and Legend Biotech, a Somerset, New Jersey-based bio/pharmaceutical company, nnounced an additional investment of $250 million in their joint CAR-T manufacturing facility in Raritan, New Jersey. The additional investment brings the total investment in the facility to $500 million. The site currently manufacturers Carvykti (ciltacabtagene autoleucel, or cilta-cel), a jointly developed B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy for treating multiple myeloma. J&J and Legend Biotech formed an exclusive worldwide license and collaboration agreement to develop and commercialize cilta-cel in December 2017. It was approved by the US Food and Drug Administration for treating relapsed or refractory multiple myeloma in February 2022, by the European Commission in May 2022, and by Japanese regulatory authorities in September 2022. The additional investment in the Raritan facility will enable the companies to have production capacity to address industry-wide supply constraints for lentiviral vectors and to meet demand for projected $5-billion-plus peak sales for the product. The partnership between the companies now includes two joint CAR-T manufacturing facilities, one in Raritan, New Jersey, and one in Nanjing, China. Another facility is under construction in Ghent, Belgium.
Last October (October 2022), as part of a five-year, $500-million expansion in Singapore, Merck & Co. announced the opening of a new secondary packaging facility to support the production of vaccines and biologics, including the company’s cancer immunotherapy products, and the ground-breaking of an inhaler production facility. The new facilities are located within the company’s existing 72-acre, multi-product manufacturing hub in Tuas, Singapore. The secondary packaging facility will house a semi-automated, vial-packaging line to produce Keytruda (pembrolizumab), Merck’s immunotherapy for treating multiple cancers, and three fully automated syringe-packaging lines to produce the company’s Gardasil9 (human papillomavirus [HPV] 9-valent vaccine, recombinant), an HPV vaccine for cervical, vaginal, vulvar, anal cancer, certain head and neck cancers and genital warts. In 2021, the site commenced the sterile filling process of Keytruda vials. Secondary packaging, cold storage and a quality control laboratory are part of the expanded facility, which further adds to the supply chain footprint for this product in Singapore. The new inhaler production facility will manufacture inhaler devices and is expected to be ready in 2026. The new manufacturing facilities are part of a multi-year, $500-million investment over five years that started in 2020.
Earlier this year (2023), Sanofi broke ground on a new formulation and filling facility at its Swiftwater, Pennsylvania, site. The new facility is in partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, to increase US-based domestic production capabilities for recombinant pandemic influenza vaccines. The facility represents one of three investments in the Sanofi–BARDA partnership, which supports the clinical development of an adjuvanted recombinant pandemic influenza vaccine that uses the same technology as Sanofi’s recombinant quadrivalent influenza vaccine. The contract also expands the Swiftwater site’s capacity to be a Center of Excellence for pandemic preparedness by enhancing vaccine manufacturing and adding both recombinant and adjuvant technologies to current egg-based platform capabilities.
Last year (2022), Sanofi broke ground on new EUR 400 million ($435 million) vaccine-manufacturing facility in Tuas, Singapore. The facility is what Sanofi is calling an “Evolutive Vaccine Facility (EVF),” which is designed around a central unit that is comprised of several digitalized modules. The EVF is designed to allow production of three to four vaccines simultaneously and will be able to “switch” its configuration toward one vaccine process to boost supply levels and adapt to evolving public health emergencies. The facility is slated for completion by the end of 2025. Overall, Sanofi is investing EUR 900 million ($978 million) over five years to create two new EVFs globally in Singapore and in France.
In addition, in 2022, Sanofi detailed an investment plan of EUR 935 ($1 billion) from 2022 to 2026 that is designed to provide a complete value chain in mRNA technology, from R&D to production. The investment is part of larger EUR 2-billion ($2.1-billion) plan to accelerate Sanofi’s mRNA strategy, which the company announced in 2021. In 2021, Sanofi launched a dedicated mRNA Center of Excellence in Lyon, France, with a planned annual commitment of approximately EUR 400 million ($475 million) to develop and deliver mRNA vaccines.
In 2022, Amgen broke ground on a new $550-million biomanufacturing facility in Holly Springs, North Carolina. The facility is expected to be operational by 2025. The company has manufacturing facilities in California, Ireland, the Netherlands, Ohio, Puerto Rico, Rhode Island, and Singapore. Amgen is also investing $100 million for the construction of a new vial-filing line and new site infrastructure at its manufacturing plant in Dun Laoghaire, County Dublin, Ireland. The Dun Laoghaire plant specializes in formulation, aseptic drug-product filling, lyophilization, packaging as well as testing using onsite laboratories. The expansion is due to be completed and fully operational by 2024. In addition, Amgen is building a new final product advanced assembly and packaging plant in New Albany, Ohio. The plant is expected to be operational by 2024.
Last June (June 2022), AstraZeneca announced plans to construct a production and supply base and a regional headquarters in Qingdao, Shandong, China. AstraZeneca signed a strategic cooperation framework agreement with the Qingdao High-tech Zone for plans to construct an inhalation aerosol production and supply base for a drug for treating chronic obstructive pulmonary disease. The drug was approved by China’s National Medical Products Administration in 2020 and will be included in China’s National Medical Insurance Drug List. The production site will be the largest in China for the company after its production and supply bases in Wuxi and Taizhou, Jiangsu, China.
Note: currency conversions are at the time of the announced investments.