Cell & Gene

Market Trends

With almost 2,8001 products in development across the industry, the cell and gene therapy sector has seen tremendous growth and interest over the last few years. Novel treatment candidates demonstrate the potential to change the way patients with cancer and genetic diseases are treated.

In 2022, the market saw clinical pipeline growth. Autologous products make up around 40% of the cell and gene therapy pipeline, followed by allogeneic products (around 30%) and in vivo viral vector products (around 30%)1.

While the autologous cell therapy area grew significantly in the last five years, it is showing signs of slowing down, partly due to the impact of the COVID-19 pandemic on patient treatment. Nonetheless, while allogeneic cell therapy surpassed other modalities in 2022, autologous cell therapy is expected to remain the primary market category in the near future.

Immune cell-based therapies dominate the market, with T-cells and natural killer (NK) cell products driving interest due to their potential to address potential bottlenecks of autologous cell therapies, including cost-of-goods, scale-up efforts, and the ability to ramp up or down based on demand. Viral vector continues to benefit from healthy market growth both as a therapy and raw material.

There is a developing market tension as funding across the biotech industry is decreasing while competition in rare disease areas is increasing. In this context, speed to clinic and market is set to become even more critical, alongside access to complex manufacturing technology, safety and efficacy.

Regulators are paying increasing attention to the cell and gene therapy space. Despite accelerated pathways, cell and gene therapies remain subject to the same approval processes as traditional biologics. Ensuring safety and efficacy is not the only focus. Therapy developers also need to demonstrate the mechanism of action, process robustness, scalability and potency of their drug candidates. In response to these imperatives, process and analytical development are expected to play an increasingly important role towards commercialization.

The cost of production remains a significant hurdle on the path to commercialization. This means that investing in platforms that increase productivity and offer flexible manufacturing ramp-up or ramp-down in response to demand is becoming more important to success. As a result, companies need to consider commercialization challenges from the early phases of drug development.

New emerging modalities and tools continue to grow within the cell and gene therapy sector, including exosomes, induced pluripotent stem cell (iPSC)-based immunotherapies, allogeneic versions of autologous CAR T-cells, NK cells, and in vivo gene editing. Continuing innovation in therapy development and manufacturing will be essential for long-term success and commercial viability. In this context, CDMOs are likely to take a more prominent role in the path to commercialization, supported by robust quality systems, expertise and an accelerated approach to scalable manufacturing.

  1. Citeline Pharmaprojects Pipeline Search July 1, 2022, internal analysis

Our Offering

Our broad offering includes development and manufacturing services, products, solutions, testing and automation platforms. We also offer tools and technologies to enable our customers to develop, de-risk and industrialize therapies, from basic research to commercialization.

Our Cell & Gene division includes three business areas: Cell & Gene Technologies, Personalized Medicine, and Bioscience.


Years of C&G cGMP manufacturing experience


Process Development Projects


pre-clinical therapies supported by Bioscience


clinical and commercial therapies supported by Bioscience

Cell & Gene Technologies (CGT) is focused on providing an integrated range of CDMO services that span the full value chain of cell and gene therapy modalities (allogeneic and autologous therapies and viral vector).

Our integrated service proposition relies on two core pillars of CDMO services:

  • Process development: leveraging our large team of expert scientists in process development to provide a step-by-step approach to the phase-appropriate development of robust, reproducible and commercially viable processes. This is based on current GMP (cGMP) design considerations and de-risking the path to commercialization. With an increase in demand for best-in-class process development services, we announced in 2022 the significant expansion of our process development laboratories at our Houston (US) and Geleen (NL) facilities.
  • Clinical and commercial manufacturing: Best-in-class services are enabled by large teams of highly-skilled manufacturing personnel operating in dedicated suites within commercially approved cell and gene facilities.

Additional CDMO services include:

  • Regulatory consulting: support to achieve successful fast-track approval for accelerated regulatory pathways and special designations.
  • Bioassay services: full analytical methods lifecycle including development, optimization, qualification and validation of tailored assays. This is supported by a library of pre-developed, fast-qualified assays towards IND filing, first-in-human or later-phase trials.
  • Tissue Acquisition: customized research and GMP Tissue Acquisition services for allogeneic and autologous cell therapy.

We provide these service offerings across a wide range of modalities to bring our customers the expertise they need for their therapies. These include:

  • Autologous cell therapy: end-to-end development and manufacturing services to achieve commercial viability.
  • Allogeneic cell therapy: flexible and scalable development and manufacturing services to bring allogenic cell therapy from concept to patient.
  • Viral Vectors: advanced viral vector technologies and easy access to proprietary novel vectors to support gene therapy applications.
  • Exosomes: 2D/3D cell culture and the latest exosome characterization technology.
  • iPSCs: proprietary cGMP iPSC custom generation, expansion and differentiation services for tailor-made, fully cGMP iPSCs production.

The Personalized Medicine business develops breakthrough technologies to accelerate the industrialization of cell and gene therapy manufacturing. A primary focus is our Cocoon® Platform, a functionally closed, highly flexible and scalable cell manufacturing solution. The Cocoon® integrates multiple unit operations including isolation, cell selection, activation, transduction/transfection, expansion, and harvest into a single system. This degree of process automation has the potential to drive down costs and provide greater access to patients. The Cocoon® Platform is commercially available and being deployed across a number of clinical programs in centralized and point of care manufacturing settings.

Our Bioscience business provides a range of solutions for customers working at different stages of the therapeutic journey across multiple modalities, from cell & gene therapies to recombinant proteins, vaccines, and injectable drugs. Our expertise in primary human cell biology tools enable customers to develop more predictive models and accelerate the path to IND. We are also a trusted, committed partner for critical raw materials and technologies that enable better processes and quality decisions for bioprocessing customers.

Our offering includes:

  • Discovery tools
    • Primary human cells and assays for in vitro models
    • Specialized research use only (RUO) media for primary cell culture
    • Non-viral transfection systems for gene modification & related drug discovery screening
  • Bioprocessing Solutions
    • For Further Manufacturing (FFM) cell culture media for the manufacturing of protein, vaccines and cell & gene therapies
    • Large volume transfection systems for cell & gene therapy clinical production
    • Endotoxin/pyrogen testing solutions, including reagents and automation
    • Informatics solutions for GMP manufacturing and quality control
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Our Global Development and Manufacturing Footprint

Our offering includes development and manufacturing services, products, solutions, testing and automation platforms. We also offer tools and technologies to enable cell and gene innovators to develop, de-risk and industrialize their therapies. We support customers from research to commercial production through our global network spanning three continents.

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  1.  Facility owned and operated by Nikon Cell innovation Co. Ltd. under Nikon-Lonza partnership

Highlights and Initiatives

In 2022, the Cell & Gene division benefitted from strong overall performance in the Bioscience business unit.

In our Cell & Gene Technologies business, two additional cell and gene therapies manufactured at our Houston (US) site achieved FDA approval. However, delays in clinical trials and customer product challenges impacted sales growth.

Our Personalized Medicines business unit remained focused on key R&D initiatives and scaling manufacturing, with multiple clinical-stage therapies now being manufactured on the Cocoon® Platform.

The Bioscience business continues to experience strong customer demand across its portfolio, especially in testing and media. A strategic reconfiguration in Bioscience in 2022 will support the business to deliver innovative products at scale in the long-term, with an emphasis on capturing market share in growth modalities, specifically cell and gene therapies and next-generation biologics.

Financial Performance in Full-Year 2022

Comparison vs. Prior Year


Sales (CHF)





  1. Sales growth is at constant exchange rate (CER)

Clinical and Commercial Programs

Our site in Houston (US) is dedicated to cell and gene therapy development and manufacturing. In Q3 2022, two cell and gene therapies manufactured at the site were approved by the FDA for commercial use, demonstrating our continued focus on improving quality and operations in collaboration with regulatory authorities. ZYNTEGLO®, for the treatment of transfusion-dependent beta-thalassemia, and SKYSONA®, for the treatment of early, active cerebral adrenoleukodystrophy, are both produced by bluebird bio of Somerville, Massachusetts and were approved in August and September 2022, respectively.

Also in 2022, the CGT business enhanced the New Product Introduction (NPI) process to standardize the customer journey from early-stage development to commercialization. It provides a roadmap and a systematic approach to development and manufacturing, ensuring necessary quality standards are met for tech transfers, cGMP manufacturing and pre-approval inspection readiness. This NPI process has been designed to support more CGT customers in reaching commercialization.

Personal Perspective

Daniel Palmacci

President, Cell & Gene Division

Since joining Lonza in November 2022, I have been impressed with the focus on meeting customers’ needs and driving technological innovation across the Cell & Gene division.

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Personalized Medicine

Through our Cocoon® Platform, we are addressing challenges traditionally associated with autologous cell therapy. The platform enables our partners to provide personalized immunotherapies to critically ill patients at a higher speed and quality, while managing the costs associated with such personalized treatments.

During 2022, we expanded the functionality of the Cocoon® Platform by releasing a second-generation instrument that includes integrated capabilities in cell binding, cell separation, and bead removal. The Magnetic Selection capability, which can be utilized at any point in the manufacturing process, provides a high level of customization and consistency and expands the end-to-end solution for cell therapy manufacturing. This innovative new functionality will further strengthen the Cocoon® Platform’s leading role in the commercialization of cell therapies. Ultimately, it will help to advance discoveries into the clinic where they can benefit patients.

Moving forward, we will maintain our focus on building additional capability and functionality into the platform to address unmet market needs, while continuing to ensure system robustness and exceptional customer service. Our goal is to build an autologous cell therapy manufacturing capability focused on cancer and monogenic rare diseases, while building further on the high market potential of Cocoon®.


Across the year, we leveraged our expertise to develop new products that support the cell and gene market. One example is the launch of the PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System), which uses human serum instead of fetal bovine serum for in vitro pyrogen testing. This new system exhibits enhanced sensitivity for the detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals.

In early 2022, we began offering large batch sizes of human cord blood CD34+ hematopoietic stem cells for creating humanized mouse models. These are critical for the preclinical safety testing of immunotherapies. We are currently one of the leaders in the market with this offering. The additional offering will facilitate the more rapid and cost-effective creation of large and HLA-matched humanized mouse cohorts to streamline biologics testing and research.

In August 2022, we launched the Nebula® Multimode Reader, the first multimode reader qualified for use with Lonza’s turbidimetric, chromogenic and recombinant endotoxin detection methods. The new compact reader, designed to minimize laboratory footprint, is compatible with all of Lonza’s quantitative endotoxin tests and allows for an easier selection of the best-suited assay for specific samples. This addition to our portfolio complements our competitive advantage in QC automation.

Innovation Spotlight

Developing novel analytical techniques for AAV-based therapies

The gene therapy field has achieved transformative progress over the past half-century, continually evolving to bring life-changing therapies to patients. Viral vectors lie at the heart of the field as a primary delivery vehicle of novel gene-based therapies. Recently, this area of the market has witnessed unprecedented growth, supported by a number of landmark regulatory approvals. This culminated in the recent regulatory approval of an adeno-associated viral vector (AAV)-based therapy for haemophilia B.

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