Cell & Gene Therapy CDMO Partnerships

The global cell and gene therapy market is experiencing rapid growth. Valued at $12.2 billion in 2025, the cell and gene therapy market is projected to grow from $16.5 billion in 2026 to $143.6 billion by 2034, exhibiting a CAGR of 31% during the forecast period. This expansion is supported by a growing number of approved products, regulatory progress and a stronger focus on commercial execution. 

Currently, 49 cell and gene therapies (CGTs) have been approved within the U.S and pipelines are proliferating and maturing. As more therapies move from clinical development to market, demand is increasing for the capabilities needed to deliver these therapies at scale, namely manufacturing and supply chain solutions.

With the increasing complexity of CGT programs, sponsors are focusing on strategic partnerships to expand their offerings. Sponsors often engage contract development and manufacturing organizations (CDMOs) earlier in development, whether it’s for specialized platform technologies or for smoother tech transfer and scale up. This shift signifies the growing technical demands of CGTs as analytical complexity and scale-up constraints create challenges following the discovery stage.

The following perspectives from SMEs in the CGT CDMO space highlight the key reasons sponsors outsource, what they’re looking for in a CDMO, and what these partnerships entail. 

Factors Driving Outsourcing in the CGT Space

Developing and manufacturing CGTs involves a myriad of complexities, requiring specialized capabilities, infrastructure and GMP-compliant facilities. Building these in-house is challenging and costly. With available capacity, experience navigating evolving regulatory requirements and supply chain complexities, CDMOs have the necessary expertise to support the development manufacture of CGTs.

Sponsors outsource CGT development and manufacture for a range of reasons, and the starting point is not always the same, according to eXmoor Pharma’s Harvey Branton, Senior Translation Consultant, and Drew Hope, Senior Bio Manufacturing & Compliance Consultant & UK QP. “The most common reason is a lack of in-house GMP manufacturing infrastructure. But many organizations have some internal capability and still choose to outsource because their existing resource does not match the capacity, specialist experience, or timelines a specific program requires,” Branton and Hope contend. 

CDMOs provide established and readily available capacity, experienced technical staff and validated quality systems to help navigate production and support progression to clinical trials and into the market, according to Katherine Schewe, Director, Strategic Accounts, Advanced Therapies, Fujifilm Biotechnologies. “CDMOs also bring vast experience in supporting INDs and BLAs, institutional knowledge in CMC documentation and inspection readiness, and guidance in navigating evolving regulatory requirements,” Schewe said. 

Regulatory expectations continue to rise, with increasing emphasis on manufacturing robustness, comparability, and commercial readiness, according to Thomas Fellner, Vice President and Head of Commercial Development, Lonza Specialized Modalities. “As a result, sponsors look to CDMOs not just for capacity, but for risk reduction, speed, and execution certainty. Outsourcing is ultimately about creating a competitive advantage and enabling a smoother transition from development to reliable commercial supply,” he said.

Product complexity is another significant driver of outsourcing. CGTs can present unique manufacturing challenges, particularly where multiple drug substances or processing approaches need to be integrated within a single drug product, according to Branton and Hope of eXmoor Pharma. “RNA/LNP-based non-viral gene therapies are a good example: oligonucleotide synthesis, plasmid production via microbial fermentation, and lipid nanoparticle formulation each require distinct manufacturing approaches, making in-house delivery difficult without substantial investment and breadth of expertise,” Branton and Hope said.

As such, sponsors often seek specific, high-value capabilities from a CDMO. Luca Alberici, Executive Vice President of the Cell and Gene Technologies Division, AGC Biologics, said, “The market is facing some interesting structural imbalances, with an overcapacity in AAV vector manufacturing on one hand, and a persistent bottleneck in complex, labor-intensive autologous cell therapies on the other. This dynamic means sponsors are looking for partners with specialized expertise in their exact modality, making a CDMO’s scientific and technical skill the real differentiator.”

At the same time, therapeutic pipelines have sponsors seeking specialized partners. “There’s growing excitement around next-generation modalities such as in-vivo CAR-T and gene editing, which avoid complex ex-vivo cell handling,” said Alberici. “Sponsors are choosing to outsource to tap into a CDMO’s established excellence in these advanced platforms, which helps them accelerate their own entry into these cutting-edge fields.” 

Outsourcing has also become a key strategy for managing risk in an unpredictable market. According to Alberici, a CDMO with a global, multi-site network offers built-in supply chain resilience and operational continuity. He said, “We’ve seen how valuable this is when a program changes ownership during the clinical phase; a consistent CDMO partner preserves crucial process knowledge and ensures a smooth transition.” 

Meanwhile, Wade Macedone, CEO of Andelyn Biosciences, explained, “Outsourcing is not just about increasing capacity, it’s about readiness. Sponsors are looking for partners who can help them make informed decisions, avoid unnecessary risks, and maintain momentum as programs advance. 

“There’s also a practical reality: many CGT programs are still in early development. Outsourcing offers flexibility, enabling sponsors to scale thoughtfully without overbuilding too soon, while still maintaining a clear path toward clinical and commercial supply.” 

Selecting a CDMO

Beyond availability, key factors for sponsors when selecting a CDMO to support CGTs include advanced technology platforms, modality expertise, analytical capabilities, regulatory knowledge and importantly, a commercial track record. 

Choosing a CDMO for a cell or gene therapy should be viewed as selecting a strategic long-term partner that meets both technical needs and operational reliability, according to Schewe of Fujifilm Biotechnologies. “Established modality expertise, such as AAV, lentivirus, adenovirus, autologous or allogenic cells, robust GMP quality systems, and a strong regulatory track record are critical factors to consider when evaluating a CDMO partner,” she said. “Other factors to consider include proven tech transfer and analytical capabilities, and supply chain robustness.”

Meanwhile, manufacturability and cost of goods are also critical considerations according to Thomas Fellner of Lonza. “Many advanced therapies face challenges achieving commercial viability, so sponsors value CDMOs that can apply platform-based approaches and design efficient, scalable processes early in development. Strong regulatory expertise is also essential, given evolving CMC expectations and the need to advance programs without unnecessary delays,” said Fellner. Sponsors are also assessing a CDMO’s continued investment in next-generation technologies and emerging modalities beyond today’s programs.

AGC Biologics’ Alberici added, “While many CDMOs can produce GMP batches, only a handful have successfully guided multiple CGT products through the rigors of FDA and EMA approval. Sponsors are now scrutinizing a CDMO’s history, prioritizing partners with a portfolio of approved commercial products. This is the ultimate proof of their regulatory skill, quality systems, and ability to execute at scale.” The ability to prepare a single, robust CMC package that meets the distinct requirements of both the FDA and EMA is an invaluable capability.

Additionally, a CDMO’s analytical capabilities are key. “With the understanding that ‘you cannot control what you cannot measure,’ sponsors are choosing partners with a deep arsenal of in-house analytical tests and the expertise to develop robust, phase-appropriate methods to fully characterize a product,” Alberici added.

Sponsors want to know how CDMOs operate dependably in a regulated setting, according to Wade Macedone of Andelyn Biosciences. They evaluate a CDMO’s quality systems, how processes are documented and deviations are managed, as well as how consistently the organization performs over time. “Beyond that, experience is important. Not just technical skills, but also in different stages of development and program phases from preclinical to commercial within CGT. Sponsors want to see how a partner has handled complexity before and what they have learned from those experiences,” said Macedone.

Availability is also critical. Branton and Hope of eXmoor Pharma added, “CGT programs frequently run to tight timelines, and a CDMO that cannot commit capacity at the right point in a development plan offers limited value regardless of its technical capability. Cost matters, but needs to be weighed against quality, communication, regulatory readiness, and the downstream consequences of delays or rework.”

While some sponsors want a collaborative relationship, with the CDMO functioning as an extension of their own team, others prefer a more defined, transactional arrangement, according to Branton and Hope. “Neither approach is inherently better, but a mismatch in expectations can create friction that affects program delivery,” they said. “Location is also worth considering; proximity to clinical trial centers or target markets can reduce logistical complexity and regulatory burden in ways that are easy to underestimate at the outset.”

Sponsor, CDMO Partnerships 

In the CGT space, partnerships are often less transactional and more about a shared-risk-reward model where the CDMO’s investment in innovation helps to advance the sponsor’s program. Advancing CGTs requires partners have a sense of shared responsibility and goals, technical collaboration, and close coordination.

A true partnership in CGT is active and continuous with a shared responsibility across development, manufacturing, and quality, according to Wade Macedone of Andelyn Biosciences. “This involves early alignment on process strategy, analytical methods, and regulatory expectations. It requires ongoing data sharing and joint decision-making as programs develop,” he said. “It also means being prepared to pause, review, and modify when necessary to safeguard quality and patient safety.”

Katherine Schewe at Fujifilm Biotechnologies added, “Ongoing technical collaboration improves process development and design, helps avoid program delays, and ensures a strong analytical strategy. Ultimately, enduring partnerships are built on a foundation of trust between a sponsor and their CDMO and thrive as an alliance with mutual investment and accountability.”

Strong partnerships typically begin early, with CDMOs working alongside sponsors to shape development strategies, identify high-risk steps, and design processes that are scalable from the outset, according to Thomas Fellner of Lonza.

Early alignment is critical as decisions made at this stage directly influence cost, timelines, and the likelihood of commercialization, Fellner noted.  “As programs advance, the partnership extends across tech transfer, process verification, comparability planning and regulatory alignment across regions,” he said. “This requires close coordination, transparency, and shared accountability, particularly as programs increase in complexity.”

In today’s market, a CGT partnership is a deeply integrated strategic alliance, according to Alberici at AGC Biologics. “The CDMO acts as a stabilizing force, making proactive investments in next-generation technologies and capacity before the market demands it,” he said. “This de-risks the sponsor’s development path by reducing their upfront capital costs and giving them access to state-of-the-art infrastructure.”

Meanwhile, Branton and Hope of eXmoor Pharma pointed out that the nature of a sponsor, CDMO partnership in CGT varies considerably depending on the size and maturity of the sponsor. “Smaller companies tend to look for a deeply collaborative relationship, where the CDMO takes on a meaningful share of the CMC thinking and operates as an extension of their technical team, often because internal resource is limited,” said Branton and Hope.

On the other hand, larger organizations typically have more defined expectations and require a well-scoped manufacturing service with clear boundaries rather than broad collaborative input, according to Branton and Hope. “That said, a larger sponsor may still choose to work with a smaller, specialist CDMO for capability in a newer or more complex area and may accept that some mutual support is part of that arrangement as the CDMO develops towards commercial-scale supply.”

Importantly, a successful sponsor, CDMO partnership goes beyond timelines, costs, and manufacturing capacity, according to Susan D’Costa, Chief Technical and Commercial Officer, Genezen. “Sponsors value partners that demonstrate flexibility, creativity, and a willingness to problem-solve when unexpected challenges emerge,” she said. “Effective CDMOs take a long-term, lifecycle-focused approach, considering future scale-up and commercialization needs from the outset. Proactive risk management across technical, quality, and regulatory areas is also key to maintaining program momentum.”

Sponsors bring extensive knowledge of their therapy and program goals while CDMOs provide manufacturing expertise, operational discipline, and regulatory experience. When these perspectives come together effectively, the result is stronger, more resilient programs, according to Wade Macedone of Andelyn Biosciences. “At its best, the partnership provides a consistent way forward, able to adapt to complexities without compromising the integrity of the work,” he concluded.