Bringing a cell or gene therapy from the lab to patients is no longer just a scientific challenge. It is a manufacturing one. Personalized biologics, mRNA platforms, and other advanced therapies demand production systems that can scale quickly, adapt to new processes, and meet strict regulatory standards, often all at once.
Cytiva’s 2025 Global Biopharma Index, based on a survey of 1,250 senior biopharma executives across 22 countries, shows how dramatically the industry has shifted to meet that reality. The report found that 57 percent of biopharma companies increased their reliance on contract development and manufacturing organizations (CDMOs) in the past year, as biopharma manufacturing agility increasingly depends on external partners to deliver speed, quality, and flexibility.
Rather than building every capability in-house, companies are turning to CDMO partnerships to move complex therapies through development and into commercial production.
Why CDMO partnerships now define biopharma manufacturing agility
Biopharma manufacturing agility measures how quickly organizations can move from development to commercial production while maintaining quality and compliance. The 2025 index shows that many firms struggle to scale internal facilities for newer modalities. About one-third of companies report that they would be slow or very slow to ramp up production of mRNA vaccines, cell and gene therapies, and hormone-based products such as insulin.
The root of the problem lies in process fragmentation. Advanced therapies often rely on unique, highly customized workflows that make technology transfer and multi-site production difficult.
Joanne T. Beck, COO of Elektrofi, said that many companies develop processes with different requirements and little standardization, which makes scaling cell and gene therapy manufacturing across CDMO networks more challenging.
CDMO partnerships help overcome these barriers by providing facilities and teams that already operate under validated, multiproduct conditions. Instead of replicating infrastructure at every sponsor site, companies can move processes into environments built for tech transfer, regulatory oversight, and rapid scale-out.
Outsourcing supports quality, speed, and regulatory readiness
Biopharma manufacturing agility is no longer measured by cost alone. Companies now prioritize quality and speed as much as efficiency, especially as regulatory scrutiny increases for advanced therapies.
The index shows that 72 percent of companies are satisfied with CDMO quality, 70 percent with CDMO speed, and 66 percent with CDMO availability. These figures explain why CDMO partnerships continue to grow even as biopharma companies invest in new internal capacity.
Countries that rank highest for biopharma manufacturing agility, including Switzerland, South Korea, and Ireland, share three traits: strong CDMO ecosystems, advanced biomanufacturing infrastructure, and reliable regulatory frameworks that support fast technology transfer. These environments allow cell and gene therapy manufacturing to move from pilot scale to commercial production without lengthy delays.
John Milne, director of bioprocessing training alliances and innovation at the National Institute for Bioprocessing Research and Training, said flexibility and agility are now the most important capabilities for manufacturing organizations, especially when products must scale up or scale out quickly.
Collaboration and digital tools reinforce CDMO partnerships
CDMO partnerships operate most effectively when supported by strong digital infrastructure. High-growth biopharma companies are significantly more likely than underperformers to use advanced analytics, automation, and AI across discovery, development, and manufacturing.
Gary Lye, director of the UCL East Manufacturing Futures Lab, explained that companies are building data lakes and moving from paper-based systems to consolidated digital infrastructure, which provides the foundation needed for advanced analytics and AI.
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For cell and gene therapy manufacturing, digitalization enables real-time monitoring, batch consistency, faster release, and better regulatory documentation across internal and external sites. These tools allow CDMO partnerships to function as extensions of in-house operations rather than disconnected vendors.
What this shift means for laboratory and manufacturing leaders
As biopharma pipelines grow more complex, biopharma manufacturing agility increasingly depends on how well organizations integrate CDMO partnerships into their operating models. Cell and gene therapy manufacturing requires rapid technology transfer, highly trained staff, validated digital systems, and production environments that can adapt as demand changes.
Many internal facilities cannot deliver that level of flexibility alone. Strong CDMO partnerships allow companies to scale advanced therapies, manage regulatory risk, and maintain quality without duplicating infrastructure across every site.
For laboratory and manufacturing leaders, the priority is no longer just building capacity. It is building networks, digital systems, and collaborative workflows that allow advanced therapies to move quickly from development to patients.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
