The BIOSECURE Act - intended to address national security concerns by restricting U.S. government contracts with certain Chinese biotechnology companies - has been omitted from the 2025 National Defense Authorization Act (NDAA), providing a temporary reprieve to targeted Chinese firms like WuXi AppTec, WuXi Biologics, and BGI Group.

Californian-based, SK pharmteco, has announced a brand unification initiative, bringing together several respected organizations under its umbrella to create a global CDMO. SK biotek, SK biotek Ireland, Center for Breakthrough Medicines, Yposkesi, AMPAC Fine Chemicals, and AMPAC Analytical, will now combine to operate as SK pharmteco, providing a comprehensive range of services from early-stage development to commercial manufacturing and analytical testing.

India-based CDMO, OneSource Specialty Pharma, is expanding its capacity to manufacture GLP-1 drug-device combinations, driven by growing global demand for diabetes and obesity treatments. The company, which specializes in drug-device combinations, including cartridge filling, assembly, and fill-finish, recently raised funding through equity issuance to fund this expansion.

Swiss manufacturing company, Lonza, has announced a strategic shift to focus on its CDMO business. The company will restructure its existing CDMO business into three new units - integrated biologics, advanced synthesis, and specialized modalities - as it focuses on its ambition to achieve and maintain leadership across therapeutic modalities.

Overall, 2024 was a good year to be working in the CDMO industry, but will the outlook stay positive for 2025?

Forecasts predict a steady rise in continuing growth trends from 2024, with estimates indicating the global pharmaceutical CDMO market is set to grow from USD 184.90 bn in 2024 to USD 197.40 bn in 2025, and looking further ahead, predicted to reach USD 368.70 bn by 2034.

CRDMO BioDuro has announced the appointment of Alan Findlater as their new CCO, who brings over 25 years of senior commercial leadership experience in the life sciences and pharmaceutical services industry to his new role. Findlater has experience leading high-performing teams and managing complex product and service portfolios, with his expertise also extending to executing successful strategic growth initiatives on a global scale and building high-value partnerships with industry leaders such as Amgen, Pfizer, and Roche.

The KPMG 2024 Life Sciences CEO Outlook report reveals that despite economic and geopolitical uncertainties, many CEOs remain optimistic. Growth prospects, new technologies, business models, and sustainability all feature within the report. 79% of CEOs expressed confidence in their companies' growth, with many planning to expand their workforce and engage in acquisitions.

Celltrion, a leading South Korean biosimilar developer, has announced plans to enter the CDMO market, investing 1.5 trillion won (USD 1 bn) to construct a 200,000-liter production facility in Korea.

To support this expansion, Celltrion will open R&D centers in India, the US, and Europe, hiring 500 Ph.D.-level researchers, aiming to offer a comprehensive range of CDMO services related to monoclonal antibodies, bispecific antibodies, and ADCs.

Florida biotech, Dyadic International, has secured a USD 3 mn grant from the Gates Foundation to develop affordable monoclonal antibodies for RSV and malaria, using its C1 protein production platform to address the limited access to mAb treatments in low- and middle-income countries.

BMS has announced plans to lay off 195 employees across its two facilities in Lanceville, New Jersey as part of a broader cost-cutting initiative. In addition to the New Jersey layoffs, BMS had previously announced plans to reduce its global workforce by approximately 3,300 positions, representing about 5% of its total employees.

Roche Holdings, Inc. has agreed to acquire Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in allogeneic cell therapies and genetic medicines, integrating the company into Roche's Pharmaceuticals Division, and enhancing their capabilities in allogeneic cell therapy.

The acquisition brings Poseida's innovative pipeline which includes a proprietary non-viral technology platform, which enables the development of allogeneic, T stem cell memory (T SCM)-rich CAR-T therapies, which include hematologic malignancies, solid tumors, and autoimmune diseases.

Schreiner MediPharm, a leading developer of functional labels for healthcare, has created a specialized Light-Protect-Label for CRDMO, WuXi XDC, to support the dual needs of light protection and drug blinding, to accelerate the process for a novel ADC in clinical trials.

Pharmaceutical CDMO, Hovione, has unveiled a multi-million expansion of its manufacturing facility in Cork, Ireland, which will double the company’s existing spray drying capacity, and reinforce its position as a global leader in spray drying technology for pharmaceutical applications, such as inhalable therapies and oral medications.

Munich-headquartered pharmaceutical CDMO, Adragos Pharma, has expanded its global footprint by acquiring Swiss aseptic fill-finish manufacturing company, Baccinex, as it targets expanding its capabilities in sterile production through the acquisition of its sixth worldwide manufacturing site.

Pharmaceutical industry deals have hit a decade-low in 2024, with only 558 deals totalling USD 67.2 bn by late November - the lowest since 2016. The largest biotech purchase of 2024, Vertex's USD 4.9 bn acquisition of Alpine Immune Sciences, is dwarfed by Pfizer's USD 43 bn Seagen takeover in 2023.

The decline in major acquisitions can be attributed to several factors: pharma companies digesting previous large deals, high valuations of listed biotech's deterring potential buyers, a focus on smaller, "bolt-on" deals under USD 5 bn, and antitrust concerns and political uncertainty in an election year.

The term CDMO has become ubiquitous in the pharmaceutical industry over the past decade, but is it merely a buzzword or does it represent a genuine paradigm shift?

Historically, service providers were identified as CROs (Contract Research Organizations) or CMOs (Contract Manufacturing Organizations), with each representing a clear delineation of services. As the biopharma landscape has evolved in response to changing industry dynamics, service providers have evolved to become "one-stop shops" capable of providing services for compounds through all development phases and into post-launch manufacturing.

GSK has entered a partnership with Vesalius Therapeutics to develop treatments for neurodegenerative diseases, including Parkinson's disease and another unspecified neurodegenerative condition. Utilizing its proprietary platform, Vesalius will lead the drug discovery efforts, while GSK will have development and commercialization rights to the preclinical small molecule targeting Parkinson's, along with options to advance other programs.

BioNTech has announced plans to acquire clinical-stage biotechnology company, Biotheus, as the company looks to enhance its oncology strategy. This acquisition will grant BioNTech full global rights to BNT327/PM8002 - and investigational bispecific antibody targeting PD-L1 and VEGF-A - which has shown encouraging clinical activity in various tumor types.

Biotech startup, Metsera, has secured USD 215 mn in a Series B funding round which the company will use to continue developing its portfolio of obesity treatments, including long-acting GLP-1 drug, MET-097i, injectable amylin analog, MET-233i, and oral GLP-1 peptide, MET-002, with plans to explore combination therapies.

AstraZeneca has announced a USD 3.5 bn investment to enhance its biopharmaceutical research and manufacturing capabilities in the U.S. by 2026, creating over 1,000 high-skilled jobs whilst targeting growth within the U.S. biopharmaceutical sector.