Cell & Gene Therapy in 2026

April 8, 2026 by Deepika Bhargo

From Cautious Optimism to Operational Reality

Anyone tracking the biotech sector will be familiar with the so‑called “biotech winter.” In recent years, capital has tightened considerably, making it harder for companies to fund and advance new research.

However, as leaders across biotech, investment, and commercialization gathered at Advanced Therapies Week in San Diego, a clear shift in sentiment emerged. Cautious optimism is giving way to measured confidence, driven by strong clinical data (particularly in autoimmune indications), renewed M&A activity in late 2025, and meaningful progress in next-generation approaches such as in vivo technologies.

While regulatory uncertainty persists, industry surveys point to growing confidence in both the science and the availability of capital—an encouraging signal after years of contraction.

A Shift in Sentiment
During one panel, “We’ve Solved for Science. What Now?,” panelists referred to the JP Morgan Healthcare Conference earlier this year, where indications were that investors are showing renewed interest, particularly with autoimmune readouts and acquisitions validating momentum in both ex vivo and in vivo cell therapies. While regulatory uncertainty remains, there appears to be rising confidence around investment and capital availability after years of contraction.

Commercial Reality: Innovation Must Translate
Scientific progress alone is not enough; commercial viability is now central to the conversation. Historically, the industry avoided talking openly about profitability or revenue generation. That is changing. Investors now routinely ask early-stage companies how they intend to bring products to market.

Two commercial models are emerging:

• Ultrarare and N of 1 indications may require cost recovery structures or philanthropic/public funding to ensure sustainability
• “Not rare but uncommon” cancers face a different challenge: too small for traditional investment models, yet too large for philanthropy. Without regulatory and reimbursement innovation, these programs risk falling into a development and commercialization gap.

A painful, persistent statistic underscores the issue: about 80% of eligible patients still do not receive cell therapies. The culprit is not science; it is adoption. Physician education, patient awareness, care site capacity, and misconceptions about when to use therapies continue to limit access.

Manufacturing Moves to the Strategy Table
Manufacturing remains a defining constraint and value driver. Investors traditionally prefer to avoid CapEx heavy infrastructure, but slow manufacturing ramps directly affect patient access and revenue. As one panelist noted, a therapy cannot scale if supply cannot keep up with demand.

This is a major reason in vivo therapy has captured investor imagination—it promises to bypass many of the bottlenecks inherent to ex vivo manufacturing. But the panel emphasized that in vivo will not replace ex vivo entirely. Solid tumors and highly engineered constructs will likely continue to rely on ex vivo approaches for the foreseeable future.

An In Vivo Wave – Promise, With Caveats
Early in vivo data suggests meaningful advantages: reduced time to treatment, potential elimination of lymphodepletion, and biologically “fitter” T cells generated inside the patient. However, durability requirements, vector choices, and expansion kinetics remain open questions. The current M&A trend—large pharma acquiring in vivo platforms—signals that the next phase of learning will likely happen inside organizations with the resources to answer these questions thoroughly.

Beyond CAR-T: The Broader Modality Landscape
Ex vivo innovation continues across NK cells, Tregs, macrophages, and iPSC-derived cell types. These represent parallel, not competing, tracks, and will move forward alongside in vivo approaches.

Looking Ahead
2026 is shaping up as a transition year: science validated, business models evolving, and This indicates that the true winners over the next five years will not just be the ones with the best science, but the ones with the smartest operational strategies. As one panelist put it, “We’ve proved the science. Now we have to retool the systems around it.” The next five years will favor organizations that pair scientific strength with the ability to execute at scale.

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