Cell and gene therapies have demonstrated the potential for transformative efficacy and are now being recognized as having viable commercial potential. In the last two years, we have seen a slowdown in funding in the market, mostly impacting pre-clinical and early clinical pipelines. In parallel, we are also seeing a shift of market focus to late phase and commercialization and this is driving strong growth. Over the next five years, we forecast the cell and gene CDMO market to grow by approximately 15%1.
In the cell and gene CDMO market, reduced levels of funding in the pharma and biotech space have contributed to the trend of increased outsourcing over in-house development, which requires larger, long-term investments in CAPEX. Furthermore, the increased number of commercialized cell and gene therapies increases value for CDMOs supporting those therapies and producing cell and gene therapies for patients. The cell and gene space is still an emerging field and relies on highly manual processes that are not yet fully established. Access to expertise and know-how remains a key driver to successful manufacturing, further contributing to an increase in outsourcing to experienced, established CDMOs like Lonza in the cell and gene market.
With a track record of efficient and reliable manufacturing and strong capabilities to support our customers in bringing their products to market, we are well positioned to capture future market value.
Lonza internal analysis, Citeline
Our Cell & Gene division comprises three synergistic business units that provide a combination of products and services. Our Cell & Gene Technologies business unit offers CDMO services and is becoming a “commercialization engine” for cell and gene therapies. The Bioscience business unit delivers specialty products that support the growth of the biologics and cell and gene markets. The Personalized Medicine business unit focuses on the Cocoon® Platform and has the aim of revolutionizing cell therapy manufacturing through automation.
Together, our business units address key customer challenges and needs. In addition, our CDMO expertise enables us to tailor and innovate our products and services.
years of Cell and Gene cGMP manufacturing experience
process development projects
active, pre-clinical therapies supported by Bioscience
active, clinical and commercial therapies supported by Bioscience
Our value proposition is predicated on quality, expertise and trust. Over the last twenty years, we have established a leading position based on our process development and GMP manufacturing experience. With a robust position in key modalities, from process development to commercial manufacturing, our offering is one of the most complete in a highly fragmented industry.
Cell and gene processes are predominantly smaller-scale and still highly manual. As a result of leveraging our strong manufacturing expertise and reputation to deliver highly complex therapies, we have gained and also retained a large proportion of outsourced, late-stage clinical and commercial cell and gene products in the CDMO industry. As of 2023, Lonza manufactured three of the 12 outsourced commercial cell and gene therapy products approved in Europe and the United States.
Our Bioscience business unit has a strong portfolio of products and services that support the growth of the biologics and cell and gene markets. Our customers rely on our offering to deliver improved reliability, reduced variability, ease of use, high performance and cost efficiency. Our Bioscience products and services range from cell culture and discovery technologies for research, to quality control tests and software for biomanufacturing.
For example, Endotoxin testing is a critical test required to ensure the safe release and use of every parenteral product delivered intravenously to a patient. In 2023, we launched a new microplate reader, the Nebula® Absorbance Reader, as part of our Endotoxin and pyrogen testing portfolio to support QC labs. The updated reader provides improvements in accuracy, consistency and greater flexibility for use.
The cell therapy production process is extremely complex. It can take four to six weeks between collecting the cells and infusing the treatment back to the patient. Furthermore, current solutions are not sufficiently scalable to meet patient demand.
Our Cocoon® Platform is a functionally closed, highly flexible and scalable autologous cell manufacturing solution, addressing many of these challenges.
To date, we have installed more than 100 Cocoon devices and currently work with more than 20 customers. Through our large-scale, point-of-care manufacturing partnership with Galapagos, we have been able to consistently deliver treatments with vein-to-vein turnaround times in as little as seven days.
Our Cell & Gene division provides comprehensive solutions that accelerate the development, manufacturing and commercialization of novel life-changing treatments. We also offer tools and technologies that enable cell and gene innovators to develop, de-risk and industrialize their therapies.
Facility owned and operated by Nikon Cell innovation Co. Ltd. under Nikon-Lonza partnership
In 2023, our Cell & Gene division delivered top line growth driven by a complementary portfolio of products and services as well as operational excellence. As the market matures, we are working to facilitate the commercialization of more therapies, which remains the cornerstone of our strategy.
The cell and gene market is dynamic and new modalities and technologies are gaining traction. Our long-term success depends on our capability to drive innovation and invest strategically in novel technologies. As part of our commitment in this space, we have entered into a strategic partnership with Vertex to accelerate the development and commercialization of Vertex’s potentially transformative cell therapies for Type I Diabetes. We are building a new dedicated facility in Portsmouth (US), spanning more than 130,000 square feet. This will complement our global cell and gene technology manufacturing network. The facility is anticipated to create up to 300 new jobs when operating at peak capacity.
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Sales growth, expressed as a percentage (%), are at constant exchange rate (CER)
In Bioscience, we continue to maintain a focus on innovation as a means of driving competitive advantage, by developing products like cell culture media that deliver superior performance levels. Our two new cell culture media launches in 2023 underline our commitment to innovation as a means of meeting key customer needs. Our TheraPEAK® T-Vivo can be used to accelerate CAR T-cell therapy development without using human or animal serum, thereby solving a critical market need. TheraPro®, optimizes productivity and quality for therapeutic monoclonal antibody production. This fully scalable and versatile system has been developed to support customers with protein manufacturing.
Both TheraPEAK® and TheraPRO® are GMP based solutions that are chemically defined, of non-animal origin and are designed to take therapies from discovery through to commercialization. The new medium delivers greater consistency and process control and simplifies regulatory approval to support faster time-to-market.
President, Cell & Gene Division
In Cell & Gene, we celebrated the groundbreaking of a new cell therapy manufacturing facility in Portsmouth (US) to support the development and commercialization of the Vertex type 1 diabetes cell therapy portfolio.
We launched two new rapid monocyte activation test (MAT) systems to streamline and simplify rabbit-free testing. The PyroCell® MAT Rapid System and PyroCell® MAT Human Serum (HS) Rapid System will replace our current MAT system kit offerings. They contain PeliKine Human IL-6 Rapid ELISA kits that reduce time to results from two days to two hours.
As part of our continued investment in the MODA® Platform, we upgraded the MODA-ES® Module v4.0 to help pharmaceutical customers expedite batch release by minimizing paper-based processes. The improved module has a number of new features to simplify processes, materials and item management, as well as enhancing approvals, data tracking and connectivity.
Viral vectors represent the most effective methods of therapeutic gene transfer and have been used to treat a wide range of acute and chronic conditions. One of the most vital components of the viral vector manufacturing is ensuring sufficient manufacturing capacity and output, as these therapies often require scale-up during development and commercialization. With the majority of viral vector candidates being in the pre-clinical stage, developing a reliable and scalable viral vector manufacturing platform is key to ensuring the future success of these therapies.
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