What have been some key recent investments in manufacturing by the large bio/pharmaceutical companies? What areas, small-molecule APIs, biologics, or drug products, have been attracting the investment dollars? DCAT Value Chain Insights rounds up key projects.

A roundup of recent and announced investments
Boehringer Ingelheim. In April (April 2022), Boehringer Ingelheim (BI) announced plans to invest EUR 7 billion ($7.6 billion) in production technologies and its supply network and EUR 25 billion ($27 billion) in research and development over the next five years. The company expects to launch 15 new human health products by 2025. BI outlined its growth plans as part of its 2021 financial results.

BI says it plans to spend EUR 7 billion ($7.6 billion) over the next five years (as reported on April 5, 2022) in production technologies and its supply network, including further expansion of biopharmaceutical production capacities. In 2021, the company invested EUR 968 million ($1.05 billion) in tangible fixed assets, which included a large-scale biomanufacturing facility in Vienna, Austria, which was inaugurated in October 2021, and a new development center for biopharmaceuticals in Biberach, Germany. The new biomanufacturing facility in Vienna is for both BI internal products and the company’s contract biomanufacturing business. In 2021, its contract biomanufacturing business posted net sales of EUR 917 million ($994 million).

Lilly. In May (May 2022), Eli Lilly and Company announced it is investing $2.1 billion to expand its manufacturing footprint with the addition of two new manufacturing sites in Indiana. These new facilities, which will be in the LEAP Lebanon Innovation and Research District in Boone County, Indiana, will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, such as genetic medicines and support Lilly’s existing products and the company’s clinical pipeline. The proposed project is expected to create up to 500 new roles at the company. Lilly’s most recent expansion in Indiana was announced in 2019 and capped a series of investments in research and manufacturing in and around Indianapolis. Those investments totaled more than $2.5 billion over five years and created additional manufacturing jobs bringing the total current number of Lilly manufacturing employees in Indiana to more than 3,700.

Lilly is also investing over $1 billion for a new manufacturing site for parenteral drugs (injectables) and devices in Concord, North Carolina, and $500 million for a new biopharmaceutical manufacturing facility in Limerick, Ireland. Over the last five years, Lilly has invested over $4 billion in global manufacturing, including more than $2 billion in the US. The new $1-billion site in Concord, North Carolina, follows a $470- million investment, announced in 2020, in North Carolina’s Research Triangle Park. The new site in Concord will create nearly 600 new jobs for scientists, engineers, and manufacturing personnel, In addition, an estimated 500 additional positions will be required while the facility is under construction. Lilly also plans to invest $500 million in a new biopharmaceutical (active ingredient) manufacturing facility in Limerick, Ireland. The proposed project is expected to create more than 300 new jobs for workers such as engineers, scientists, and operations personnel and an estimated 500 additional positions while the facility is under construction. Both projects were announced earlier this year (January 2022) and were subject to local planning board and government approvals.

Bayer. In March (March 2022), Bayer announced that it is investing approximately EUR 2 billion ($2.2 billion) over the next three years to upscale its pharmaceutical manufacturing and supply-chain capabilities. Bayer says it is planning to invest in its core manufacturing plants and strengthen their operational responsibilities to support the implementation of the company’s strategy for its pharmaceuticals business. A significant part of these investments will be made for enhanced capacities in biotechnology by further strengthening the company’s cell- and gene-therapy production as well as the expansion of its manufacturing site in Berkeley, California.

Germany will remain an important strategic manufacturing location for the company. The company’s Supply Center in Berlin will be transformed into a Center of Excellence for parenterals and the Supply Center in Leverkusen into a Center of Excellence for non-hormonal solids. The Supply Center Bergkamen will become a Center of Excellence for contrast media and hormone products while expanding capacities for therapeutics. Major investments will also be made in the company’s Supply Center in Wuppertal, with the investments focused on launch production and new production technologies. In these sites, the company will invest around EUR 1 billion ($1.1 billion) over the next three years.

Bayer’s Pharmaceutical Division is headquartered in Berlin, Germany, and is based at four major locations in Germany. The company plans to invest more than EUR 1.4 billion ($1.5 billion) in its pharmaceutical production sites in Germany (in Bergkamen, Berlin, Leverkusen, Weimar and Wuppertal) in technologies, new production facilities, and digitalization in the coming years (as reported on March 3, 2022). In addition, at the end of last year (2021), Bayer announced an investment of more than EUR 400 million ($444 million) at its sites in Turku, Finland, and Alajuela, Costa Rica, to reinforce a commitment to providing 100 million women with access to family planning by 2030, especially in low- and middle-income countries.

While Bayer is strengthening its production network through these investments, it is analyzing in parallel which manufacturing activities might not be of strategic focus any longer. For example, the company has already divested its production plant in Karachi, Pakistan. To continue strengthening the competitiveness of its manufacturing capabilities by focusing on core activities and technologies, the company’s manufacturing plant in São Paulo Cancioneiro, Brazil, will be transferred to a new operator. In addition, Bayer is planning to transfer parts of the infrastructure and services at the German sites in Bergkamen, Wuppertal, and Berlin to external partners.

In addition, last month (June 2022), BlueRock Therapeutics, part of Bayer, established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany. A multidisciplinary BlueRock team will be set up during 2022 to provide clinical development and operational support for Europe, including activities for chemistry, manufacturing and controls (CMC). The move enables the expansion and acceleration of BlueRock’s clinical trials to Europe. BlueRock recently closed enrollment for a Phase I clinical trial for BRT-DA01, its cell therapy for treating Parkinson’s disease and intends to initiate a global study in the second half of 2022. With the establishment of its new site in Berlin, BlueRock broadens its geographical footprint, which includes the US, Canada, and now Europe.

Sanofi. In April (April 2022), Sanofi broke ground on a new EUR 400 million ($435 million) vaccine-manufacturing facility in Tuas, Singapore. The company had announced plans for the facility last year (2021). 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 facility will be 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) in a multi-year investment to create two new EVFs globally in Singapore and in France. In December 2019, the company announced plans to invest EUR 490 million ($550 million) in vaccine production in France through the creation of an EVF facility in Neuville sur Saône, France.

In addition, Sanofi announced last year (2021) that it is investing more than EUR 600 million ($705 million) to build a new manufacturing vaccine facility in Toronto to increase supply of its influenza vaccines for Canada, the US, and Europe. The new facility will provide additional antigen and filling capacity for Sanofi’s Fluzone High-Dose Quadrivalent influenza vaccine. The facility is expected to be operational in 2026.

Also, Sanofi detailed in March (March 2022) 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 last June (June 2021). Last year (June 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.

Sanofi says its investment plan covers the entire value chain of mRNA technology platforms and includes an acceleration of R&D at its Marcy l’Etoile Center of Excellence in France, which involves production of clinical batches, development of the formulation of lipid nanoparticles, and developing production capacities and other components used in the production of future vaccines.

On the small-molecule active pharmaceutical ingredient (API) side, earlier this year (2022), Sanofi spun off commercial and development API activities from six of its European production sites (Brindisi, Italy; Frankfurt, Germany; Haverhill, UK; St. Aubin les Elbeuf, France; Vertolaye, France; and Újpest, Hungary) to launch a stand-alone, independent CDMO, Euroapi. Sanofi says it expects the new manufacturing company to bring in EUR 1 billion ($1.05 billion) in sales in 2022 and that the stand-alone company will rank number one in small-molecule APIs in Europe and number two in the global API market. Sanofi is furthering its support for the CDMO by establishing a long-term customer relationship with Euroapi and has committed to holding a minority stake of approximately 30% in the CDMO for a two-year lock-up period. As of December 31, 2021, Euroapi represented approximately 1% of the total consolidated assets of Sanofi, mainly in the form of dedicated industrial facilities at the chemicals sites included in the spin-out and API inventories manufactured and commercialized by Euroapi.

Novartis. As part of a reorganization announced earlier this year (2022), Novartis is combining its Technical Operations and Customer & Technology Solutions units to create a new Operations unit to provide an operational backbone to accelerate multiple technology transformation initiatives, create digital solutions at scale, and increase productivity. Steffen Lang, formerly Global Head of Novartis Technical Operations, became President, Operations in April (April 2022). The company is adapting its manufacturing capacity and capabilities to meet changing needs, shifting from high-volume products toward lower-volume, customized and personalized medicines. As of December 31, 2021, the company had closed, exited or sold 18 manufacturing sites since 2018 and had announced the closure, exit or sale of 10 additional manufacturing sites.

At the same time, it is investing in new technologies at its sites, such as a nucleic acid facility in Kundl, Austria, and the company’s first small-interfering RNA (siRNA) oligonucleotide manufacturing facility in Schweizerhalle, Switzerland. Also, in 2021, the company integrated Novartis Gene Therapies into its existing manufacturing and supply structure, created a new ophthalmology supply unit, and launched a contract manufacturing organization in biotechnology and cell and gene therapy services.

Earlier this year (2022), the US Food and Drug Administration (FDA) granted commercial licensure approval for a Novartis’ multi-product gene-therapy manufacturing facility in Durham, North Carolina, which allows the 170,000 square-foot facility to make, test, and release commercial quantities of Novartis’ gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), as well as produce gene-therapy product for current and future clinical trials. This clearance brings on line the second commercially licensed manufacturing facility for Novartis Gene Therapies, joining the company’s Libertyville, Illinois, site, which was approved for manufacturing and distribution of Zolgensma in 2019.

Separately, Novartis is investing in the expansion of radioligand production capabilities at its sites in Millburn, New Jersey, and Ivrea, Italy, and is building a new radioligand manufacturing facility in Indianapolis, Indiana, which will be operational in 2023.

Also, in May (May 2022), Novartis agreed to sell its active pharmaceutical ingredient (API) manufacturing facility and assets in Grimsby, Kato Humber Industrials, a subsidiary of International Process Plants (IPP), which specializes in redeveloping manufacturing sites. Novartis says it will continue manufacturing at the Grimsby site until the fourth quarter of 2022. Operations will then move into cleaning alongside the wider site exit program. The site will be formally transferred to the new owners in late 2023. As part of a cost-savings move, Novartis first announced plans in 2018 to close the facility, which at that time was targeted for closure by the end of 2020. In May 2020, the company decided to maintain operations at the site through the end of 2022 due to demand for two products manufactured at the site. The site spans 229-acres and makes active ingredients for Novartis products.

Pfizer. In May (May 2022), Pfizer opened a new EUR 300-million ($313-million) high-containment drug-product manufacturing facility in Freiburg, Germany. The facility will support Pfizer CentreOne, Pfizer’s CDMO business embedded within Pfizer. At 13,500 m², the new Freiburg facility is capable of producing up to 7 billion additional solid dosage forms. Overall, the site has now increased its total capacity to produce up to 12 billion tablets and capsules per year.

Late last year (2021), Pfizer opened a new $68.5-million clinical manufacturing facility for gene therapies in Durham, North Carolina. The Durham facility is part of a multi-year $800-million investment to build three scalable, gene-therapy manufacturing facilities to support Pfizer in gene therapy research, development, and manufacturing. The Durham facility houses Pfizer’s BioTherapeutics Pharmaceutical Sciences Group, which is responsible for the manufacturing and analytical release of clinical supplies for Pfizer’s gene-therapy and biologics portfolio.

Also, in November 2020, Pfizer announced a EUR 300-million ($351-million) investment in its Irish operations to support the further development of its existing manufacturing sites in Grange Castle, Newbridge, and Ringaskiddy. Part of the investment includes a new development facility on the existing Ringaskiddy site to manufacture pharmaceutical compounds for Pfizer’s clinical trials globally.

Amgen. In March (March 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. Amgen first announced the plans for construction and the $365-million investment for the plant in July 2021. At full capacity, Amgen plans to hire up to 400 full-time staff, including technicians and engineers, along with quality assurance, quality control, administrative, and management positions.

AstraZeneca. Last month (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. In addition, AstraZeneca and the Qingdao Municipal Government signed a memorandum of cooperation to announce the establishment of AstraZeneca’s China regional headquarters in Qingdao, an innovation center focused on rare diseases, a life-science innovation park, and an industrial fund to support those efforts.

Earlier this year (2022), Alexion, AstraZeneca’s Rare Disease group, announced a EUR 65 million ($68 million) investment in new and enhanced capabilities across three sites in Ireland: College Park, Blanchardstown, and Monksland Industrial Park, Athlone. The investment covers the installation of new drug-substance production equipment and warehousing facilities to support ambient and cold storage at its sites in College Park and Athlone and the construction of a Manufacturing Sciences & Technology Lab at College Park to facilitate biologics drug-substance manufacturing. The investment follows the company’s announcement last year (2021) to build an API facility at its College Park campus. The company is investing $360 million in the small-molecule API manufacturing plant for late-stage development and early commercial supply for AstraZeneca’s pipeline.

Merck & Co. Inc. In April (April 2022), Merck & Co. expanded its vaccines-manufacturing facility in Elkton, Virginia, by completing the construction of 120,000 square feet to increase capacity and supply of its human papillomavirus (HPV) vaccines. In 2019, Merck committed more than $1 billion to expand production capacity at existing manufacturing facilities and build new facilities to address global demand for its HPV vaccines. The company expanded and maximized its existing facilities and nearly doubled supply of its HPV vaccines from 2017-2020. Merck expects supply of its HPV vaccines to double again between 2020-2023 as the company continues to expand capacity at existing facilities and as new facilities come on line.

Bristol-Myers Squibb. In May (May 2022), Lotte Corporation, a Seoul, Korea-based holding company of Lotte Group with holdings in chemicals, food & beverage, retail, and hotel & service, agreed to buy Bristol Myers Squibb’s (BMS) commercial-scale biologics manufacturing facility in East Syracuse, New York. The facility will serve as the Lotte Center for North America Operations for Lotte’s new biologics CDMO business in the US. Lotte acquires the East Syracuse site’s operations and assets, which include the property, plant and equipment, and workforce.

Separately, BMS is investing in a new cell-therapy manufacturing site in Leiden, the Netherlands. Leiden will be BMS’ fifth cell-therapy manufacturing facility and its first in Europe. BMS announced the investment last year (2021). Also in 2021, BMS announced it is investing in a new cell-therapy manufacturing facility at its biomanufacturing site in Devens, Massachusetts.

Gilead Sciences. Earlier this year (2022), the US Food and Drug Administration approved commercial production for Kite’s, part of Gilead Sciences, new CAR T-cell-therapy manufacturing facility in Frederick, Maryland. The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, the Netherlands. The company estimates its network capacity is increased by 50%. Kite began construction of the 275,000-square-foot facility in Maryland in 2019. The site has unfinished space to add future capacity, is purpose-built for cell-therapy manufacturing, and incorporates increased automation. The company anticipates having more than 400 employees working at the Maryland site by the end of 2022.

In addition, in March (March 2022), Gilead Sciences completed the purchase of additional land in Oceanside, California, to expand its manufacturing operations. Under the agreement, Gilead acquires approximately 27 acres of undeveloped land neighboring its existing facility in Oceanside. The Oceanside location focuses on supporting clinical manufacturing and process development for Gilead and Kite, a Gilead company focused on cell and gene therapies.

Astellas Pharma. Last month (June 2022), Astellas Pharma opened a new late-stage clinical and commercial gene-therapy manufacturing facility in Sanford, North Carolina. The 135,000-square-foot stand-alone facility provides clinical- and commercial-scale manufacturing for Astellas’ pipeline of adeno-associated virus gene therapies. The company’s $100-million investment will also support global supply chain needs and in-house quality control testing.

Note: Currency conversions are as of time of company announcements.