Cell and gene therapies (CGTs) are currently at the heart of dynamic trends in the pharma sector. While oncology remains the dominant focus for CGTs, there is an increasing effort to apply these therapies to new disease areas, including rare diseases and autoimmune conditions. Notably, CAR-T therapies, which have been the most prevalent, are now being approved for second-line cancer therapy, expanding their use beyond terminal cases[1]. Clinical trials are also being conducted in areas such as metabolic genetic disorders and central nervous system diseases, although many of these trials are still in the early stages.
Research by GlobalData for their latest survey report, The State of the Biopharmaceutical Industry 2025, indicates that CGT still ranks among sector leaders’ top five trends for the year ahead. According to GlobalData, CGT is currently carving a more prominent role in treating solid tumors, with the approval of the first tumor-infiltrating lymphocyte (TIL) therapy, Iovance’s Amtagvi (lifileucel) for melanoma, and the first gene-modified cell therapy (GMCT) for solid tumors, Adaptimmune’s Tecelra (afamitresgene autoleucel) for synovial sarcoma[2].
Overall, the global market for CGT is projected to reach $80 billion by 2029, with oncology expected to represent 44% of the CGT market. The full potential of CGTs is still to be discovered.
Advanced therapies and the future of healthcare
In November 2024, leaders from the CGT sector came together on a virtual panel, orchestrated by STAT Brand Studio, to discuss the latest trends in advanced therapies, genetic medicines and how collaborative partnerships are crucial for driving progress forward.[3]
The participants were:
Moderator:
Jesse McQuarters, Editor at STAT Brand Studio
Panelists:
Daria Donati, Chief Scientific Officer, Genomic Medicine, Cytiva;
Iwan Roberts, VP, Technology and Innovation Strategy, Cytiva;
Palani Palaniappan, Chief Technology Officer, Pioneering Medicines;
and Michael Chambers, Co-Founder of Aldevron
Accelerated speed of approval
One of the key points raised in the discussion was how advanced therapies, including gene editing and cell-based therapies, are being developed at an unprecedented rate, with a focus on patient impact.
As Daria Donati of Cytiva, who has over 20 years of diverse management and technology solutions experience within biotech and biomanufacturing, points out, 10-20 new therapies in the space of genomic medicine or ATMPs are expected over the coming year; in the whole decade leading up to 2023 there were under 22. “This is a revolution,” she continues. “These types of approvals are really focusing on new therapeutics implementation, like the utilization of CRISPR or RNA.”
The speed of development has been remarkable, says Donati, and has helped patients to get access to new therapeutics.
“Up to now, there have been more than 35,000 patients treated with cell therapies, and that’s really impressive. Initially focusing on blood cancers, leukemia cell lymphomas, now they are moving into much more challenging areas like autoimmune disease. This is one of the key areas of focus and activity for the future. All these trends are really bringing hope to the future of genomic medicine.”
While there have been significant advancements in genomic medicine — including CRISPR and RNA therapies — developing new therapies for rare diseases presents unique challenges around product quality, safety and manufacturing. Platforms are essential, requiring standardization, robustness and regulatory compliance.
Palani Palaniappan explains that Pioneering Medicines develops products focused on many different diseases, working with advanced therapeutic standard modalities. “We focus on three things,” Palaniappan explains. “First, you have to be able to make safe products. Second, you have to be able to make products that are efficacious. Third, the products have to be viable. You have got to be able to make sure these products are available for everybody who needs them.”
Collaboration drives success
Collaboration and partnerships between academia, startups and pharmaceutical companies are crucial for driving progress in this complex, multi-modal field. Companies like Cytiva are developing new technologies to boost access to transformative therapies.
“Collaboration and industry partnerships… are absolutely critical in the development of these therapies, especially in a multimodality world, as these therapies require expertise across so many different disciplines,” says Michael Chambers, co-founder of Aldevron, a development and manufacturing services organization that manufactures nucleic acids, recombinant enzymes and products used in molecular diagnostics, CGTs, gene editing and vaccines.
“One of the great strengths of Cytiva is that they have tremendous expertise across all of these areas. And through these industry partnerships, we can combine diverse capabilities and knowledge. We can address complex challenges with process scalability, regulatory compliance and ultimately patient accessibility. In a recent project that integrated several therapeutic platforms, we had to bring together antibodies, cell therapies and genetic technologies. This required collaboration from multiple companies and it would not have happened without those partnerships,” he says.
With scientific innovation happening in so many directions, Cytiva is working to develop technologies that increase the accessibility of antibodies, drug conjugates and CGTs. Iwan Roberts applies engineering principles to the scaling up of both protein and cell-based therapies across R&D, business development, and strategy at Cytiva. He focuses on ensuring that healthcare innovators have access to the best solutions available, enabling them to bring transformative therapies to patients.
Roberts agrees that partnering with innovators is vital to developing the next generation of CGTs. “Without partnerships, we don’t understand exactly what [innovators] need,” he says. “Cytiva needs to be there on the ground and figure out what technologies you need. For example, we had a collaboration with Kite, who are developing a CAR-T cell technology. We worked with them to develop a new automation platform, which is really enabling them to make more of these therapies and increase patient access. While that’s very much focused on one particular collaborator, obviously now this is a technology that we’re making available to others.”
Looking forward, the panelists agreed that the future of advanced therapies is bright, with the potential for faster, more personalized treatments. Simplification of manufacturing, analytics and AI-assisted processes will be key to improving access, while emerging modalities like bi-specific peptides also show promise.
To watch the full webinar — including a more detailed discussion of current trends and developments within the CGT space — and to learn about how working with a partner like Cytiva can help firms navigate the changing biopharmaceutical landscape, fill in your details on this page.
[1] https://investor.chemometec.com/static-files/245234d4-6c8d-4102-b163-3a9b320b6d18
[2] GlobalData: The State of the Biopharmaceutical Industry, 2025 Edition, page 22.
[3] https://sbs.statnews.com/p/1
