October 2025 marked a watershed moment in the evolution of advanced therapies. After years of investment and scientific breakthroughs in ex vivo cell therapy – particularly CAR-T and other autologous approaches – the tide has turned. A growing number of strategic decisions from major pharmaceutical companies signals a pivot: is ex vivo out and in vivo in?
October has seen multiple announcements to note.
Galapagos – 21st Oct 2025 – $375 million estimated operating & restructuring costs
Galapagos have announced it will wind down its entire cell therapy division after failing to sell the unit. They didn’t receive any ‘viable’ offers which they have been exploring since May 2025. This follows their earlier announcement back in January 2025 to split into two separate public entities. The operating and restructuring costs they expect to incur is estimated to be €250-325 million.
Takeda – 1st Oct 2025 – $395 million impairment loss
Takeda are seeking a partner to take over its cell therapy platform and preclinical programme. This follows the disappointing results from the clinical trials of their leading asset, their gamma delta T-cell platform, which led to an impairment loss of $395million. This retreat also includes the closure of their 24,000 square-foot R&D cell therapy manufacturing facility in Massachusetts launched in 2020.
Novo Nordisk – 10th Oct 2025 – $598 million Heartseed deal
Novo Nordisk is ending all work in cell therapy, including laying off 250 employees and stepping back on their Type 1 diabetes program, Parkinson’s assets, and the $598 milion Heartseed deal. This is part of much bigger restructuring from the organisation that is not specific to advanced therapies, in which they aim to lay-off a total of 9000 employees across the company, in a bid to save around $1.3 billion annually by the end of 2026.
These events weren’t isolated. Instead, these companies have made strategic withdrawals from projects that have been commercially and logistically challenging to sustain.
Traditional ex vivo therapies involve extracting a patient’s own cells (autologous), modifying them in a lab and reinfusing them. They have faced persistent hurdles including high costs, complex logistics, limited scalability and narrow patient access. Even as approvals mounted, the reality is that only a fraction of eligible patients have received these therapies and few developers have achieved commercial success with them.
However, the clinical impact is undeniable, with the ability to cure end-stage cancer and otherwise incurable diseases. One approach to overcoming the cost and complexity hurdles has been to use ex vivo donor cells (allogeneic), as a way to produce ‘off-the-shelf’ cell therapies. Yet the resultant downside, in return for possible cost savings, is the unknown clinical efficacy and durability of allogeneic therapies. Both the Novo Nordisk and Takeda announcements were off the back of unsuccessful allogeneic cell therapy programmes. While Galapagos failed to reassure critics of the true scalability of its distributed business model.
In contrast, October 2025 has also seen an explosion of investment in in vivo cell therapy platforms. These approaches aim to reprogram cells directly inside the body, bypassing the need for extraction and lab-based manipulation, as well as by-passing the need for donor cells. The appeal is clear, providing off-the-shelf delivery, broader reach and dramatically lower costs, all, at least theoretically, without compromising on the clinical efficacy or durability of the treatment. This approach has the potential to be the best of both worlds, leveraging a patient’s own immune system to fight cancer and other diseases, while simplifying the manufacturing and delivery process. The investment for in vivo therapies in October alone has been far greater in monetary value than the retreats seen in the same month for ex vivo approaches.
Chiesi – 6th Oct 2025 – $2 billion partnership with Arbor Biotechnologies known for its in vivo CRISPR delivery tools.
Bristol Myers Squibb (BMS) – 10th Oct 2025 – $1.5 billion acquisition of Orbital Therapeutics expanding its in vivo RNA delivery capabilities.
Kite (Gilead) – 16th Oct 2025 – $1.6 billion acquisition of Progene Biopharma, doubling down on in vivo CAR-T delivery platforms.
A busy October for acquisition and partnership announcements follows a busy year:
AstraZeneca – 17th March 2025 – $1 billion acquisition of EsoBiotec a stealth-mode startup focused on in vivo immune cell engineering.
Eli Lilly – 17th June 2025 – $1.3 billion acquisition of Verve Therapeutics a pioneer in in vivo base editing for cardiovascular disease.
Abbvie – 30th June 2025 – $2.1 billion acquisition of Capstan Therapeutics a leader in targeted in vivo gene modulation.
Kite (Gilead) – 21st Aug 2025 – $350 million acquisition of Interius BioTherapeutics its first purchase away from its autologous ex vivo origins.
These investments reflect a fundamental rethinking of how advanced therapies will be delivered at scale. In vivo platforms promise to democratise access, reduce manufacturing bottlenecks and potentially expand indications beyond oncology more rapidly into autoimmune, cardiovascular, rare diseases and beyond.
Of course in vivo therapies aren’t without their own challenges. Safety concerns around in vivo gene delivery, particularly insertional mutagenesis and off-target effects, must be addressed. Regulatory frameworks are still evolving and clinical validation is ongoing, but the momentum and potential is exciting.
As the industry matures, the focus is rightly shifting from solely scientific possibility to equally consider commercial viability. In vivo therapies represent one path to achieving a sustainable business model. However, it is not the only route to achieving this. A viable route is still open to ex vivo cell therapy developers, should they choose to take it. The key is establishing manufacturing and distribution scalability, with economic viability, much earlier on in the therapy development pipeline.
Investment in the cell and gene therapy sector is not drying up, it is pivoting. The pivot we are witnessing is not really about the exit of one advanced therapy modality to make way for another. It is an industry learning that clinical success is not enough- manufacturing and scalability can no longer be an afterthought. We will continue to see innovation, investment and patient impact being achieved by those who can demonstrate a feasible route to commercial success from the beginning.
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