Advanced Therapies Enter a More Selective Cycle

Amanda Micklus_Advanced Therapies

Amanda Micklus

Sydney Enokawa_Advanced Therapies

Sydney Enokawa

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Advanced Therapies Enter a More Selective Cycle

Amanda Micklus_Advanced Therapies

Amanda Micklus

Published

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Cell, gene, and nucleic acid therapies have been through plenty of cycles of excitement and doubt, and this latest one is more selective. Advanced therapies pipeline growth has slowed from 25% in 2021 to 7% in 2025, and several high-profile launches have missed forecasts. At the same time, in vivo CAR-T is pulling in some of the biggest deals of 2026. In the latest Evaluate Spotlight episode, we dig into the data on the advanced therapies pipeline, dealmaking, and funding.

The pipeline has more than doubled since 2018, from just over 2,000 therapies to nearly 5,000 in 2025, and most of it is still in early development. Advanced therapies constitute around 21% of the pipeline through Phase II, but just 2% of launched drugs.

Oncology dominates cell therapy, with around 1,400 pipeline drugs, well ahead of immunology, the next largest area. For developers, most of which are large pharma, this means crowded targets and heavy competition for patients, trial sites, and manufacturing capacity. The flip side is that non-oncology cell therapy remains largely a white space. In contrast, gene and nucleic acid therapies are spread across more therapy areas, in development by small and large pharma companies. The top five cell therapies, all in oncology and led by Carvykti, Yescarta and Breyanzi, earned $5.6 billion in 2025, nearly double what the top five gene and nucleic acid therapies brought in.

Dealmaking is holding pace – and Lilly is busy

Eli Lilly shows up all over a select list of 2026’s top deals so far, and its two biggest are in vivo CAR-T acquisitions, Kelonia and Orna. Novartis’s $7.8 billion alliance with Abogen, for an mRNA-encoded T-cell engager in autoimmune disease, is the largest by potential value. Overall volume fell in 2025, but 2026 is on pace to at least match it. Start-up funding is ticking up too.

But commercial prospects for these complex, hard-to-scale therapies remain a real challenge, particularly when it comes to hospital reimbursements. In a couple examples, BioMarin voluntarily withdrew Roctavian, and Casgevy and Lyfgenia sales have risen since their 2023 launches but sit well below analyst forecasts.

The Evaluate Spotlight webinar and report on advanced therapies go into more detail, including top companies by pipeline and sales, the biggest deals of 2026, and regulatory catalysts through mid-2027. Take a look if cell, gene, or RNA therapies feature in your pipeline or portfolio thinking.

You can find the full Evaluate Spotlight series here. You can also find the latest edition of our quarterly report on the advanced therapy space, produced in partnership with the American Society of Gene and Cell Therapy (ASGCT), here.

 

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Frequently Asked Questions

The pipeline grew from just over 2,000 therapies in 2018 to nearly 5,000 in 2025. Annual growth peaked at 25% in 2021 and slowed to 7% in 2025.

Traditional CAR-T cells are engineered outside the body from a patient’s T cells. In vivo approaches deliver a gene or mRNA directly into the body, turning the patient’s own T cells into CAR-T cells, which could make therapies cheaper, easier to deliver and more accessible.

Cell therapy sales sit with large pharma, led by Johnson & Johnson’s Carvykti, Gilead’s Yescarta, and Bristol Myers Squibb’s Breyanzi. The top five cell therapies earned $5.6 billion in 2025, nearly double the $3.0 billion earned by the top five gene and nucleic acid therapies.

Eli Lilly appears in seven of 12 select 2026 deals, including the in vivo CAR-T acquisitions of Kelonia and Orna. Novartis’s $7.8 billion alliance with Abogen is the largest by potential value. With 300 deals through the third quarter, 2026 is on pace to at least match 2025.