Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.
Contract development and manufacturing organizations (CDMOs) are invaluable to the pharmaceutical industry, supporting ever-growing demand with efficiency, consistency, and innovation.
With the biologics market expected to be worth more than $800 billion by 2028, CDMOs—especially those working with complex cell and gene therapies—will be critical to ensuring that these advanced, targeted therapies can reach the most patients possible.
Below are 5 CDMOs who are poised to make the biggest impact on biopharma in 2025:
With its $16 billion acquisition by Novo Holdings now complete, Catalent is set to assume an even more significant role in the development and manufacture of advanced therapies. In 2024, Catalent announced several new development and manufacturing partnerships, including with IsomAB for its first-in-class antibody for peripheral artery disease; and Siren Biotechnology for its adeno-associated virus (AAV) immuno-gene therapies. It also recently expanded its OneBio integrated platform to include antibody and recombinant proteins, cell and gene therapies, and mRNA.
Coining the phrase “IDMO,” Cellares is innovating cell therapy development and manufacturing by offering a fully integrated experience for its customers. Touting process automation and seamless tech transfer to the company’s global network of “smart factories,” several major cell therapy players have partnered with the company to validate Cellares’ Cell Shuttle platform for cell therapy manufacturing, including Caballeta Bio for its CABA-201 candidate for autoimmune disease, and Lyell’s CAR-T cell therapy.
A long-standing CDMO powerhouse, Lonza is continuing to expand its footprint in the space with continued investment into their biologics manufacturing sites, including a new drug substance and active pharmaceutical ingredient plant and a commercial drug product facility, both in Switzerland, and the addition of a biologics manufacturing site in the US that it acquired from Roche.
A CDMO spinoff of its larger parent company, WuXi Advanced Therapies continues to lead the cell and gene therapy space thanks to tools and technologies that help bring new therapies to market faster. Cell banking tools and scalable AAV production, as well as advanced analytical techniques, speed up the development process and help keep clients in compliance with regulatory standards.
The Seattle-based biologics CDMO is already the manufacturing partner for several FDA-approved advanced therapies, including a CAR-T therapy from Autolus Therapeutics and a gene therapy from Orchard Therapeutics. It’s expanding portfolio of services is designed to bring speed and precision to the space, making it a strong competitor in several burgeoning sectors, including monoclonal antibodies, lentiviral vectors, AAVs, and antibody drug conjugates (ADC).
Of course, there are many other players in the CDMO ecosystem who are rapidly expanding their offerings to keep up with pharma’s demands. Emerging CDMOs, including South Korea’s Lotte Biologics, have our attention with their rapidly expanding focus in the cell and gene therapy, monoclonal antibody, and ADC sectors. We’re also keen on watching how CDMO-adjacent service providers, including Ori Biotech and AiCella, continue to mold their offerings to help bring life-changing therapies to market faster.