**San Francisco**: In January 2025, Samsung Biologics announced a six-year, $1.4 billion contract with a European pharmaceutical firm, coinciding with plans for its fifth biomanufacturing plant in South Korea, addressing increasing demands and potential drug shortages in the industry.
In January 2025, Samsung Biologics secured a significant six-year contract manufacturing agreement valued at $1.4 billion with a yet-to-be-named European pharmaceutical company. This arrangement will see production conducted at Samsung’s state-of-the-art manufacturing facility located in Songdo, South Korea. The announcement coincided with the J.P. Morgan Healthcare Conference held in San Francisco, during which Samsung also declared plans for the completion of its fifth biomanufacturing plant, set to open in April 2025 on a newly established campus. Additionally, the company indicated potential plans for a sixth plant to further accommodate increasing market demands.
The forthcoming fifth plant is expected to enhance Samsung’s global biomanufacturing capacity by 180,000 litres, raising the total to 784,000 litres. The proposed sixth plant could increase this total to 964,000 litres. This expansion reflects the pressing capacity concerns and drug shortages that many companies are grappling with early in 2025.
John McQuaid, president and managing director of Almac Pharma Services, expressed insights regarding the heightened demand for manufacturing capabilities during an interview with Pharmaceutical Technology at the CPHI Milan event in October 2024. “There’s never been a larger number of molecules in clinical development, and we’re certainly seeing that increasing demand,” McQuaid stated. He noted specific pressures in terms of manufacturing related to highly potent active pharmaceutical ingredients (APIs), age-appropriate formulations for paediatric patients, poorly soluble compounds, and the growing field of personalised medicine, particularly cell and gene therapies, which require specialised fill/finish and cold chain processes.
The emergence of glucagon-like peptide-1 (GLP-1) drugs has further intensified supply chain concerns in the industry. Kevin Li, MBA, chief marketing officer at BioDuro-Sundia, also articulated the complexities of outsourcing strategies within the biopharmaceutical sector, as he discussed how firms can either adopt a traditional approach—partnering with multiple contract development and manufacturing organisations (CDMOs) and separate contract research organisations (CROs)—or pursue a more integrated model. “It’s very difficult and time-consuming to manage multiple vendors,” Li explained, indicating that integration under a single vendor simplifies the management of drug development processes.
The 2024 CPHI Annual Report suggests that by 2028, there may be a significant shift in market dynamics. It predicts that contract manufacturing organisations (CMOs) and hybrid entities, which utilise spare capacity for both proprietary pipelines and contract services, could account for approximately 54% of the global biologics capacity. The report highlights that capacity limitations for new clinical products could emerge in the United States, while Europe and Asia might supply up to 75% of the CMO resources by that time.
Tara Dougal, Brand & Content director of Pharma at Informa, emphasised the increasing number of biotechnology firms and early-stage companies attending initiatives like CPHI Europe to identify suitable capacity for their production needs, particularly for smaller-scale manufacturing runs.
Several companies have announced strategic responses to address capacity shortages in the latter part of 2024. For instance, in November, Ascend Advanced Therapies entered a partnership with EW Healthcare Partners to enhance capabilities and infrastructure in the United States. This collaboration included the acquisition of EW Healthcare’s Advanced BioScience Laboratories in Rockville, Maryland, which adds good manufacturing practice capacity for adeno-associated virus production.
Similarly, SEKISUI Diagnostics announced in November an investment of £15.7 million (approximately $20.7 million) to expand its microbial CDMO operations at its Maidstone site in the UK, aiming to meet the rising demand from biopharmaceutical companies. President and CEO Robert Schruender noted the need for experienced partners at a time of significant demand pressures.
Lastly, in December, Israeli biopharmaceutical company Scinai Immunotherapeutics confirmed the establishment of a subsidiary in the United States to provide CDMO services, coinciding with the signing of its first contract with a customer based in Virginia.
The ongoing evolution of the pharmaceutical manufacturing landscape underscores the urgent requirement for companies to address supply chain challenges while positioning themselves strategically for future market demands.
Source: Noah Wire Services
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