Pharma and biotech companies are doubling down on innovation and, often, outsourcing just about everything else. That shift has turned contract development and manufacturing organisations (CDMOs) into critical partners, not just service providers. The sector is booming, but pressure is building fast: demand is surging, capacity is stretched, and new therapies are bringing greater complexity. To stay ahead, CDMOs must combine speed, precision, and adaptability at scale. We spoke with European leaders to find out how they are evolving their operations and redefining what it means to be a partner in the next era of drug development.
A Booming Market Under Pressure
The global CDMO market is projected to reach USD 185 billion by the end of 2024, fuelled by an industry-wide push to streamline operations and focus on core innovation. For many pharma and biotech companies, outsourcing is no longer optional. “The industry no longer needs to assume that every innovator must also become a manufacturer,” says Christian Houborg, GM and SVP of Fujifilm Biotechnologies Denmark.
This shift has created a new set of demands. CDMOs are now expected to go beyond capacity and offer flexibility, speed, and advanced technical capabilities. Timelines are tighter, therapies are more complex, and expectations are higher. The pressure is on to scale intelligently, adapt rapidly, and deliver with precision.
Scaling up with Flexibility
To meet these demands, many CDMOs are expanding aggressively and embracing modular, single-use manufacturing systems that allow for scalable and flexible production.
AGC Biologics for one has pursued expansion ever since it was founded in Denmark as CMC Biologics in 2001. After acquiring a biologics site in Seattle, joining AGC Inc., the firm further developed its Copenhagen facility – the largest in its network – to focus on protein-based biologics using both microbial and mammalian systems.
“Our most recent expansion, which came online under GMP conditions in 2024, has more than doubled our mammalian production capacity,” says Kasper Møller, the firm’s chief technical officer and executive VP for Europe and Japan. “With 2,000-litre single-use bioreactors, the new facility can deliver up to 200 batches annually, making us one of the world’s leading CDMOs in terms of mammalian single-use capacity.”
Møller also emphasises that scalability is just one part of the equation. The company’s flexible operating model is built around each client’s unique product profile rather than a rigid one-size-fits-all framework.
At Fujifilm, strategic acquisitions and investment have helped the company evolve beyond a traditional CDMO role. “We positioned ourselves as a true extension of our partners’ operations,” explains Houborg. By acquiring an ex-Biogen site and investing over USD 8 billion in facilities across the US and Europe, including a major plant in Holly Springs, North Carolina, Fujifilm has established a globally integrated network of “gigasites.”
Meanwhile, Switzerland-based ten23 health is carving out a niche by focusing exclusively on sterile injectables. “We saw an opportunity to differentiate in a space that demands both technical precision and innovation,” says CEO Christian Mahler. Since its 2021 launch, ten23 has rapidly scaled its manufacturing capabilities, making key acquisitions and expanding across two Swiss sites to meet surging demand.
Adapting to Advanced Therapies
On top of increasing capacity and adapting production models, CDMOs are aligning their operations to more efficiently handle next-generation modalities like antibody-drug conjugates (ADCs) and cell and gene therapies.
“We’re seeing a continued shift toward more complex modalities. Many of the antibodies entering clinical development today are bispecific, trispecific, or fusion proteins,” Møller recognises. “While this doesn’t fundamentally change our manufacturing layout, it does put greater demands on our analytical and process development capabilities. We’re continuously investing to stay ahead of this curve, adapting our technologies and workflows to meet the rising expectations in both scientific and regulatory terms.”
Swiss CDMO giant Lonza adapted its approach to advanced therapeutics, placing them under the umbrella of “Specialised Modalities” to better foster collaboration and eliminate silos. “The simplified and streamlined operating model reflects our broadened scope and collaborative approach to supporting diverse therapeutic modalities,” says Daniel Palmacci, the unit’s president and head. “Specialised Modalities encompasses traditional cell and gene therapy alongside personalised medicine, mRNA therapeutics, microbial platforms and bioscience technologies. This structural evolution recognises that many of these modalities share common manufacturing challenges and regulatory pathways. By consolidating expertise, we can leverage synergies and provide more comprehensive support.”
Startups are also stepping into this space with innovation-led strategies. Swiss-based NewBiologix aims to transform gene therapy manufacturing by tackling the high cost of AAV vector production. “Today, manufacturing costs can push gene therapy prices to over USD 1–2 million per patient,” says CEO Igor Fisch. “We’re developing stable producer cell lines to reduce costs by an order of magnitude and shorten timelines significantly.”
Technology: The Next Frontier
As the complexity of therapies grows, CDMOs are betting on technology to boost efficiency, quality, and scalability. Automation, AI, and data analytics are at the core of this transformation.
“Automation and digitalisation are becoming key to how we design and operate our facilities and this is especially evident at our new site in Copenhagen,” AGC’s Møller affirms. “The facility incorporates more advanced automation systems, and this evolution will continue with our next major project: a new manufacturing plant under construction in Yokohama, Japan. The insights we gain from these developments are shaping future builds, and we’re also applying them to existing sites.”
AGC is also launching AI, Møller maintains, to improve manufacturing efficiency and flexibility. “We’re piloting AI in process development and R&D, primarily for optimisation purposes.
Fujifilm takes a similar approach by embedding AI and analytics within its quality organization. “This ensures that data insights enhance both quality and efficiency,” says Houborg.
Lonza too has adopted automation tools like its Cocoon cell therapy production platform whose “true value,” according to Palmacci, “lies in being part of an integrated capability. This extends to our electroporation systems and even our in-house media and buffer production.”
For the Lonza executive, these vertical integration capabilities enable the CDMO to develop deeper process understanding and more responsive optimisation. “This allows us to co-develop economically viable solutions with partners while maintaining rigorous quality standards.”
Beyond specific technologies or tools, Lonza is readying itself to be able to support emerging technological breakthroughs, whatever they be. “Rather than predicting which technology will dominate, we are positioning ourselves to support the advancement of all promising approaches,” says Palmacci.
