CDMO Roundup

According to the latest study from BCC Research, the demand for “Global Market Opportunities and Competitive Landscape for CDMOs” was valued at $128.0 billion in 2023 and is expected to grow from $136.6 billion in 2024 to $191.6 billion by the end of 2029. BioPlan Associates’ annual biomanufacturing capacity surveys report CDMOs account for around 25% of mammalian cell culture capacity globally (2023 data).

With CDMOs playing such a prominent role in biomanufacturing, GEN asked several CDMO leaders for their take on the top trends in the industry, the main challenges facing CDMOs today, and the most important innovation their company has implemented to move the bioprocessing field forward.

3PBIOVIAN

CDMOs face key challenges in scaling complex biologics and gene therapies, which demand adaptable manufacturing platforms that ensure high quality and productivity. Flexibility is crucial, as client pipelines range from early-stage to commercial-scale production.

Cost control is equally important: CDMOs must closely monitor COGS to keep manufacturing economically attractive for clients while maintaining profitability. At the same time, adopting new technologies and advancing digitalization are essential to boost efficiency and agility, which require substantial investment and specialized, continuously trained talent.

The current uncertainty around U.S. tariffs also presents concerns for European CDMOs. We are actively monitoring and implementing new measures to meet our American clients’ needs.

3PBIOVIAN will soon launch an innovative initiative in partnership with Eleva, aiming to transform bioprocessing with a novel moss-based cell expression platform. This technology will be offered as a service for producing complex therapeutic proteins at pre-commercial scales (up to 2,000 liters) using suspension cultures that align with conventional fermenters. As this platform is integrated into 3PBIOVIAN’s operations, it will broaden the company’s capabilities to support client programs from early-stage development to clinical manufacturing. In addition to supporting Eleva’s proprietary pipeline, including the complement pathway regulator Factor H, the platform will be made available to others. When combined with emerging tools like single-use systems, automation, and digital quality frameworks, this new service will streamline processes, lower production risks, and enhance flexibility. With this initiative, 3PBIOVIAN is poised to lead the next wave of biomanufacturing innovation and help clients bring breakthrough therapies to market faster.

Agilent

Bioprocessing in the CDMO industry is experiencing strong growth driven by rising demand for GLP-1 manufacturing, personalized medicine, and biologics. At the same time, advanced manufacturing technologies—such as continuous processing, automation, and AI—along with platform-based approaches are transforming the speed and scalability of production. Additionally, there is a significant buzz around mergers and acquisitions, as well as capacity expansion in high-growth areas like cell and gene therapies (CGT) and antibody-drug conjugates (ADCs). Another major trend is the globalization of CDMO capacity, especially in Asia, where countries like China and South Korea are scaling up rapidly.

CDMOs are under pressure to scale quickly while maintaining quality and compliance across diverse regulatory environments. This is especially challenging in the context of newer modalities, where analytical standards are still evolving. Another major challenge is capacity planning and flexibility. With biologics and CGTs requiring highly specialized infrastructure, CDMOs must balance long-term investments with the need to stay agile. Additionally, talent shortages in new modality development and bioprocessing are a growing concern. CDMOs are looking for partners who can not only provide instrumentation but also training, support, and method development expertise—areas where Agilent adds significant value.

Agilent’s acquisition and integration of BIOVECTRA  expanded our CDMO capabilities into sterile fill-finish, pDNA and mRNA production, and lipid nanoparticle formulation—key enablers for next-gen therapeutics. Additionally, Agilent has helped CDMOs modernize compliance workflows by replacing spreadsheet-based qualification with automated, audit-ready systems.

Aldevron  

The gene-modified cell therapy space is experiencing a wave of innovation, with CDMOs at its center. One notable trend is the rise of personalized CRISPR-based therapies, including the successful treatment of “Baby KJ” with the world’s first mRNA-based personalized CRISPR therapy for which Aldevron manufactured the RNA. This milestone has accelerated interest in rapid, bespoke gene-editing solutions, and CDMOs are being called upon to deliver faster, more flexible manufacturing models to support them.

Another major trend is the expansion of gene-modified therapies beyond oncology. Over half of new gene therapy trials now target cardiovascular, neurological, and rare pediatric diseases. This shift is driving demand for CDMOs with broad technical capabilities and regulatory expertise across diverse therapeutic areas.

There’s also growing excitement around purpose-built manufacturing systems that support the scalability and speed required for rare disease therapies. CDMOs that can offer integrated, end-to-end services are becoming preferred partners.

Finally, regulatory innovation is creating buzz. Agencies are exploring platform approvals for gene-editing technologies, which could streamline the path to market for future therapies.

Aldevron’s most significant bioprocessing innovation is the ability to manufacture end-to-end mRNA drug product—from sequence to sterile vial—within a single facility and under one quality system. This capability represents a major shift in mRNA-based therapeutic development, addressing one of the most complex challenges in the field: coordinating multiple manufacturing partners while maintaining quality, consistency, and regulatory compliance. We are helping to set a new standard in the bioprocessing industry, particularly for personalized and scalable mRNA-based therapies.

Axio BioPharma

Speed and scalability continue to be top priorities for biotech sponsors. We are seeing strong demand for partners who can accelerate timelines without sacrificing quality, particularly those leveraging AI to make development and manufacturing more efficient. When applied effectively, real-time data and machine learning are helping reduce batch variability, anticipate issues earlier, and streamline tech transfer.

Another clear trend is the growing preference for U.S.-based manufacturing. Sponsors are prioritizing closer collaboration, more responsive support, and increased visibility into operations. Whether it’s preparing for an IND or scaling production post-approval, being able to align quickly and solve problems locally adds meaningful value. That proximity and control have become key differentiators in today’s environment.

At Axio, we have developed a proprietary AI-driven platform that identifies scalable biomanufacturing processes in hours instead of months or years. By combining high-throughput manufacturing data with our AI platform, we are building a model that can quickly predict upstream and downstream workflows with greater speed and precision than traditional process development approaches. This allows us to replace months of trial-and-error with rapid, data-backed insights.

What makes this platform unique is how tightly it is integrated into our operations. It is not just a digital layer; it is how we drive faster turnaround, reduce risk, and help our clients move from discovery to clinic with confidence. For our clients, especially early-stage biotech companies, these time and cost savings can be the difference between missing a milestone and advancing to the next phase.

Charles River  

Several trends in manufacturing share a singular goal: to make innovative, potentially curative therapies widely accessible.

First, autologous cell therapy is in a supply-constrained environment, with 20–25% of the eligible U.S. and 5% of the eligible global population being treated. One solution focuses on decentralization, thus bringing manufacturing closer to the patient, ultimately reducing vein-to-vein times. Regulatory agencies in the U.S. and the U.K. have issued recommendations and guidance along these lines.

Second, the field is moving towards closed, automated processing, but questions remain about scaling manufacturing. Several companies are working to solve this with robotic automation. As this automation is implemented, more options will become available to therapeutic developers, and an interesting question will arise for regulators: if there is no process change, but you change how you interact with the process (humans vs. robotics), will a comparability study be required?

Finally, we are witnessing the maturation of in vivo CAR T, where a vector with a gene-of-interest is administered directly to a patient, negating the need for ex vivo genetic modification. This promising new space has limited but promising clinical data, and recently we’ve seen several acquisitions by large pharma.

At Charles River, we have various avenues to engage with companies looking to deploy novel manufacturing methods. Our integrated platform technologies are designed to accelerate process readiness while maintaining regulatory and analytical continuity. We also continue to engage with the regulators to discuss these innovative manufacturing workflows and combine them with our integrated digital oversight, modular manufacturing, and cross-platform comparability to future-proof client programs.

FUJIFILM Biotechnologies

Artificial intelligence (AI) is creating buzz in our industry for its potential to transform biomanufacturing processes with real-time data analytics. AI applications include the ability to optimize manufacturing conditions, resulting in higher yields and more rapid, reliable biologics production. AI also plays a crucial role in enhancing quality control by consistently analyzing production data to ensure that products adhere to safety and regulatory standards.

Beyond manufacturing, AI drives critical administrative efficiency. AI tools can automate routine tasks, including writing of processes, allowing teams to focus on strategic, high-value activities.

The overall industry is faced with geopolitical uncertainties right now, which could disrupt supply. We are all working toward solutions to mitigate supply challenges, as we all want to see that patients receive the medicines that they need. We learned a lot about supply chain vulnerabilities through the COVID-19 pandemic. To ensure uninterrupted product supply in the event of another pandemic or a geopolitical disruption, efforts to diversify manufacturing locations are critical.

For FUJIFILM Biotechnologies, our strategy has been and will continue to be to secure and build manufacturing capacity in strategic locations close to our customers and patients. We are doing this through entry points in Denmark for Europe and the U.S. for the Americas. Our industry must create more manufacturing capacity to meet the growing demand. To that end, we are building the industry’s largest interconnected modular network of biomanufacturing facilities, which enables us to take an existing facility design blueprint and build it with the same materials, equipment, and quality/IT systems.

GeneFab  

The cell and gene therapy market is still recovering from a multi-year financial downturn, with many CDMO customers struggling to obtain adequate funding to advance their innovative therapies. At the same time, scientific progress continues at a fast pace and customers are demanding that CDMOs have deep technical expertise and timeline flexibility.

The blessing and curse of cell and gene therapies is that their broad design space also creates complexity in manufacturing. A core belief of GeneFab is that the combination of genetic design (through our synthetic biology services) with flexible GMP infrastructure is essential to efficiently support our clients to bring their products into the clinic and ready for commercial scale.

Lonza Group

As commercialization becomes an increasing focus in the cell and gene therapy space, CDMOs are facing some of their most complex challenges yet to deliver at scale and speed while upholding the highest standards of quality. First and foremost is the issue of industrialization. A transformational shift in how we approach cost of goods management is necessary to ensure long-term sustainability. This shift requires continual investment in automated platforms and standardized processes, since relying on fragmented or manual systems lacking automation can hinder progress.

Biotechs and pharma companies today need true collaborators, not just service providers. Successfully navigating the product lifecycle requires deep technical knowledge, broad operational experience, global regulatory expertise, and scalable approaches aligned with each phase of development and commercialization. Talent remains a major differentiator for CDMOs. Attracting, training, and retaining qualified and specialized staff is a critical component of ensuring seamless execution and regulatory compliance.

Mature daily management systems and real-time decision-making are essential to help reduce deviations and ensure operational excellence. Product and analytical development bring their own complexity to the equation. Missteps in assay design or process characterization can result in major approval delays. Precision and deep technical experience are vital.

Finally, digital integration and automation remain a work in progress across much of the sector. While tools like MODA® are gaining traction, the sector still lacks harmonized digital systems that support real-time monitoring and control. These challenges demand more than capacity; they require strategic, sustained commitment.

Novartis  

One notable trend in drug substance manufacturing is the adoption of intensified fed-batch/N-1 production processes. This technology significantly enhances the efficiency and productivity of biomanufacturing processes.

Sustainability is also becoming an increasingly important priority in pharmaceutical manufacturing. Novartis is leading the way by championing innovation and adopting advanced technologies to minimize resource consumption. The company is committed to driving meaningful change, with a focus on integrating cleaner, renewable alternatives where absolute reductions in resource use are not feasible.

BioFuture is an innovation introducing continuous manufacturing technology to the production of biologic drug substances in Novartis. The manufacturing plant located in Schaftenau, Austria, implements the first continuous GMP plant in our manufacturing network. It is the most modern continuous manufacturing plant worldwide.

This cutting-edge technology offers significant benefits, including cost reduction, enhanced flexibility, and adaptability to shifting demand. With a consistent single-scale process throughout the product lifecycle, BioFuture accelerates the delivery of medicines to patients, transforming the efficiency of biologic drug manufacturing.

Roslin CT 

The growing interest in applying cell therapies to autoimmune diseases is a major industry trend. While oncology remains a core focus, we’re seeing a shift as more companies expand into high-prevalence indications. This contrasts with gene therapy, which continues to focus largely on rare diseases, and highlights a divergence in how these modalities are evolving.

With the first CAR T therapy on track to become a blockbuster in oncology, scalability is no longer a future challenge; it’s a current one.

We’re seeing increased interest from companies that anticipate success and the capacity limits that come with it. For CDMOs, that means thinking proactively about both physical infrastructure and workforce planning. Rapid scalability now depends just as much on skilled teams as it does on cleanroom space.

One of the biggest ongoing challenges for CDMOs is the recruitment, development, and retention of talent. We invest significantly in onboarding, training, and continuous development, helping us maintain strong retention and operational excellence. These are key drivers for ensuring we can scale with our clients as they reach more patients and require increasing capacity.

Streamlined manufacturing, with minimal open processing steps, is essential for scaling cell-based therapies. Experts have long advocated for closed systems to reduce risk, but the shift to more common, high-volume diseases makes this approach critical for meeting demand.

As cell therapies evolve beyond rare indications, scalability, talent, and efficiency are no longer optional—they’re essential.