Cell and gene therapies are rapidly evolving from innovative concepts into commercially viable treatments, as evidenced by nine Food and Drug Administration (FDA) cell therapy initial approvals in 2024. This upward trend is projected to continue, with numerous additional therapies expected to reach the market in the coming years1. Venture capital funding in the cell and gene therapy (CGT) field has stabilized to pre-pandemic levels1, and this is particularly benefiting companies with late-stage products by supporting their clinical trial advancements. Concurrently, the cell and gene Contract Development and Manufacturing Organization (CDMO) market is anticipated to grow at an annual rate of 12%2 over the next five years, driven by increasing demand for specialized manufacturing services and a robust pipeline of therapies.
To navigate regulatory complexities and manage financial constraints, many companies are turning to outsourcing. Cell and gene CDMOs such as Lonza play a pivotal role by providing regulatory expertise and scalable, cost-effective manufacturing solutions. This collaboration enables companies to concentrate on innovation, while relying on CDMOs to manage production and related compliance at clinical and commercial scales, to unlock the full potential of cell and gene therapies.
Souce: Lonza internal analysis.
Our Cell & Gene division1 provides comprehensive solutions that facilitate the accelerated development, manufacturing and commercialization of life-changing treatments. We also offer tools and technologies that help enable cell and gene, biologics and small molecule innovators to develop, de-risk and industrialize their therapies. The 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, small molecules and cell and gene markets. The Personalized Medicine business unit focuses on the Cocoon® Platform, with 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.
Our new organizational structure, announced in December 2024, will become operational on 1 April 2025 with three integrated business platforms: Integrated Biologics, Advanced Synthesis and Specialized Modalities. Capsules & Health Ingredients, which we plan to exit at the appropriate time, will operate as an independent business platform.
years of cell and gene cGMP manufacturing experience
process development projects
active therapies supported by Bioscience1
commercial batches delivered by our CGT
CDMO network
Third party therapies (excluding Lonza manufactured drugs).
Our value proposition is founded on the quality, expertise and trust in our experience and track record. Over the last 25 years, we have established a leading position in contract development and manufacturing for cell and gene therapies. Our expertise spans a wide range of modalities across cell and gene, including exosomes-based therapies, iPSCs, MSCs, NKs and other allogeneic cell therapies, autologous CAR-T, TIL, HSC, TCR, T-reg gene therapies, and viral vectors including AAVs and LVVs among others. From process development to commercial manufacturing, our offering is one of the most complete and integrated in a highly fragmented industry.
In 2024, we expanded our portfolio of commercial cell and gene therapies and continue to be a trusted partner in supporting late-stage clinical and commercial cell and gene products in the industry. As of 2024, we manufacture the viral vector, cell therapy or gene therapy for five commercial cell and gene therapy products in three continents: the United States, Europe and Asia. Our network of CGT manufacturing sites also completed a combined total of seven Pre-Licensing Inspections (PLI) and Pre-Approval Inspections (PAIs).
While expanding our portfolio of commercial products, we also launched a range of key offerings focused on the development and manufacturing services to enable our customers’ next milestones: Investigational New Drug (IND) filing, tech transfer and commercialization planning.
Our Bioscience business unit has a strong portfolio of products and services that support the growth of the biologics, small molecule and cell and gene markets. Our customers value our improved reliability, reduced variability, ease of use, high performance and cost efficiency. Our expertise in primary human cell biology tools help enable customers to develop more predictive models and accelerate the path to IND. Our Bioscience products and services range from cell culture and discovery technologies for research to cell culture medium, quality control tests and software for biomanufacturing.
Recently, we expanded the use of our TheraPEAK® T-VIVO® Cell Culture Medium to support the growth and expansion of gamma delta (γδ) T cells. These cells possess a unique capability to infiltrate solid tumors. By optimizing their expansion at clinical scale, we offer a solution with the potential to revolutionize solid tumor drug development, paving the path for a healthier world.
The end-to-end process for the production of a cell therapy can be long and involves complex supply chain logistics and manual manufacturing processes. At present, it can take four to six weeks between collecting the cells and infusing the treatment back to the waiting patient. Furthermore, most of the current manufacturing solutions are not sufficiently scalable to meet patient demand as cell therapies are approved for earlier lines of treatment or for more prevalent indications.
Designed to address many of these challenges, our Cocoon® Platform is a functionally closed, highly flexible and scalable autologous cell manufacturing solution. The platform enables decentralized manufacturing models that have the potential to reduce vein-to-vein times, deliver fresh cells, improve physician control and enhance patient experience. It is highly automated, which can help reduce both the costs associated with manual intervention and the risks associated with human error. It is also scalable, as multiple instruments may be connected in the future, enabling the ability to save significant clean room space.
To date, we have installed more than 150 Cocoon® Instruments, and we work with more than 30 customers.
The exosome asset will be transferred to Houston in 2025.
Facility owned and operated by Nikon Cell innovation Co. Ltd. under Nikon-Lonza partnership.
In 2024, our Cell & Gene division reported sales growth of 1.1% CER compared to the prior year. This was driven by strong operational performance in Cell & Gene Technologies and partially offset by softer performance in Bioscience. Compared to 2023, the division significantly improved its CORE EBITDA margin, supported by Cell & Gene Technologies achieving positive margins and productivity measures in Bioscience. The business’ long-term portfolio continued to shift towards increased commercial manufacturing.
Comparison vs. Prior Year
Sales (CHF)
CORE EBITDA (CHF)
CORE EBITDA Margin
Sales growth at Constant Exchange Rates (CER).
In 2024, we announced a long-term commercial supply agreement with Vertex for CASGEVY®. CASGEVY® is the first approved gene-edited therapy using CRISPR/Cas-9, a Nobel-Prize winning gene editing technology. This groundbreaking therapy offers a one-time treatment option for patients with transfusion-dependent beta-thalassemia or sickle cell disease, representing a significant advancement for patients. CASGEVY® will be manufactured at our cGMP cell therapy facilities in Geleen (NL), with plans to expand to our Portsmouth (US) site. Our Geleen site was granted a GMP license by the FDA, the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
We also entered into an agreement with Cabaletta Bio focused on the development and tech transfer of potentially curative targeted cell therapies for patients with autoimmune diseases. Under the terms of the agreement, we will supply Good Manufacturing Practices (GMP) products to support Cabaletta's current and planned clinical trials for resecabtagene autoleucel (rese-cel), including potential late-stage trials and preparations for commercial readiness.
Furthermore, in 2024, we placed a strong emphasis on delivering attractive and competitive solutions tailored to early-stage cell and gene therapy developers. We launched the “Early Advantage” range of standard bench-to-IND offerings, providing customers with pre-defined terms, accelerated timelines and a legal framework, designed to help them achieve their milestones efficiently. This offering has resonated strongly with the market, attracting a significant number of new customers.
President, Cell & Gene Division
We have seen continued customer interest in our commercial offering within Cell & Gene, highlighted by our long-term supply agreement with Vertex to manufacture CASGEVY® for sickle cell disease and beta-thalassemia. Such agreements reflect our ambition to expand our portfolio of commercial products, with more additions expected in the mid-term.
To meet the growing demand for endotoxin assay products, we commenced an expansion of our endotoxin assay production facility in Walkersville (US). The site manufactures the materials required to execute the endotoxin assay, which is used to help ensure the safety and compliance of parenteral drugs and medical devices. The upgraded facility will incorporate sustainable technologies and streamline manufacturing processes, reflecting our continued drive for operational excellence.
Our Cologne (DE) site manufactures Nucleofector® transfection technology utilized in the research, development, and manufacturing of novel therapeutics. To meet growth expectations, the site has expanded to a new facility to modernize and increase manufacturing capacity, streamline production and logistics processes and improve our throughput.
We are committed to providing the expertise and tools to support customer needs. Our MODA-ES® Platform, a next-generation manufacturing execution system for cell and gene therapies, enables a cost-effective transition to electronic record-keeping. The Champalimaud Foundation has adopted the platform to enhance and streamline cell therapy manufacturing, helping to make life-saving treatments more accessible for cancer patients with unmet medical needs.
Viral vectors are among the most efficient methods of therapeutic gene transfer and have been used to treat a wide range of acute and chronic conditions. The field has recently undergone unprecedented growth and by the end of 2024, seven Adeno-associated virus (AAV) therapies were approved by the U.S. Food and Drug Administration (FDA) with approximately 600 further therapies in the development pipeline.
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