Global Shifts And Strategic Resilience Will Shape CGT In 2026

By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

Which regions will lead the next wave of cell and gene therapy innovation? What will it take for the U.S. to keep pace?

Like you, I’ve pondered these questions, and to clear up the answers, I turned to two of our industry’s best. In my conversations with Dr. Miguel Forte, CEO of Kiji Therapeutics and President of ISCT, and Ali Pashazadeh, Founder of Treehill Partners, we covered why developers are now navigating a landscape defined not only by technological innovation but also by geography, regulatory agility, and investment dynamics. What’s clear is that speed, flexibility, and resilience will define which companies and regions thrive in 2026.

Geography as a Competitive Lens in CGT

One of the most striking trends Dr. Forte highlighted is the shifting geography of CGT development. “If you look at the number of new clinical trials and the number of new companies in the last quarter of 2025, Asia had overtaken the U.S.,” he said. “This surge is concentrated in China, where company creation, investment, and CDMO activities are expanding rapidly. They offer good quality, attractive cost, and very good speed,” he added. The strategic result is clear; developers can generate robust clinical data domestically in China, then leverage it for global partnerships and deals. This model is exemplified by the EsoBiotec-AstraZeneca collaboration, where rapid early-stage data enabled a timely acquisition.

Dr. Forte stressed that this evolution should not be viewed as a threat, but as a call to action for U.S. and European stakeholders. “I’m concerned about patients in Europe and the U.S. not having access to clinical trials as well as companies experiencing challenges around funding and speed of execution. So, really, it’s a call to action in a healthy, collaborative, competitive environment,” he said.

For Europe, regulatory complexity and slow trial execution remain persistent barriers. “If you look at the timelines, they can actually be extended, in the case of some gene therapies, under the justification that the complexity of the topic may need further assessment,” Dr. Forte noted. The U.S., in contrast, is actively exploring strategies to retain a competitive edge, including post-marketing adjustments and cost reduction measures that aim to make clinical trial execution more efficient.

Regulatory Flexibility: Speed Meets Safety

Across geographies, the theme of regulatory agility is central. Dr. Forte emphasized the importance of rapid, yet rigorous, decision-making. “Any clinical trial as well as any patient dosing needs to have a regulatory decision, a risk-benefit assessment. That is a must,” he said. The challenge lies in making these assessments not only accurate, but timely. “It’s important to have a risk-benefit assessment to decide on the execution of a clinical trial. It’s also important to be more flexible, to conduct investigator-initiated studies, and for people recognize that value,” he explained.

Pashazadeh shared a complementary operational perspective, highlighting how regulatory and manufacturing alignment directly impact execution. “If you don’t have a strong quality organization and a trained workforce in the right locations, you can’t scale rapidly,” he explained. Companies that integrate regulatory foresight with operational readiness will accelerate faster and reduce friction, particularly as trials become global and cross multiple jurisdictions.

Balancing Excitement with Realism around In Vivo Innovation

Technological evolution continues to reshape the CGT landscape with in vivo approaches gaining significant attention. Dr. Forte is cautiously optimistic. “Expectations are high, fed by some interesting data, and a significant opportunity around the in vivo business model approach. I believe this is going to spread and continue into 2026,” he said. Dr. Forte emphasized, however, that enthusiasm must be tempered with realism. “We need to recognize the fantastic opportunity around in vivo, but bear in mind that it’s going to be a portfolio of approaches. Some will be more suited for certain patients or indications than others.”

Pashazadeh underscored the operational implications of in vivo therapies. “The appeal is obvious by way of simpler supply chains, easier administration, and compatibility with traditional pharma models. But execution is not trivial. Clinical trial design, patient monitoring, and manufacturing at scale are still major hurdles,” he said.

The convergence of Dr. Forte’s strategic insight with Pashazadeh’s operational lens highlights a fundamental truth for CGT in 2026 in that technology alone does not drive success; alignment across business, clinical, and operational functions is essential.

Investment and Business Model Resilience for CGTs

Another critical theme for this year is capital strategy. Dr. Forte cautions that while strong investment could catalyze growth, the field must prepare for continued uncertainty. “If we continue to see reticence on investment, it will be challenging. Companies need to bear in mind that they must think about their end game (i.e. bringing their therapy to the market). Companies must ensure that they have an attractive business model, a value proposition that convinces their market, and a product that is easy to use.”

Pashazadeh echoes the need for flexibility and resilience in funding strategy. “VCs remain essential, but companies are increasingly exploring alternative sources, such as partnerships, licensing deals, and co-development arrangements,” he says. “The organizations that thrive will creatively finance their pipeline while maintaining execution discipline,” he noted.

Together, these insights underscore that strategic foresight, operational rigor, and financial resilience are intertwined imperatives.

Advice for CGT Global Expansion

For companies looking to play on the global stage, both Dr. Forte and Pashazadeh stress preparation and prudence. Dr. Forte’s guidance emphasized a disciplined, patient-centered approach. “Keep the end in mind, and be resilient to ensure progression of your project,” he said. Pashazadeh focused on operational execution, highlighting the importance of workforce, location, and integrated systems. “Being in the right geography with the right team is not just a nicety; it’s the difference between accelerating a program or getting stuck,” he said.

This dual lens of strategy and execution is particularly critical as CGT companies navigate 2026. From navigating complex European regulations to leveraging China’s rapid trial ecosystem and from harnessing the promise of in vivo technologies to building resilient business models, success will require simultaneous attention to both macro trends and the nuts-and-bolts realities of product development.

What to Expect in 2026 for CGT

As we begin 2026, cell and gene therapy is moving from an era of technological proof-of-concept to an era of operational sophistication and global competition. Dr. Forte and Pashazadeh’s insights converge on a simple but profound principle: speed, flexibility, and resilience matter as much as innovation. For CGT developers, this means the opportunity (and the imperative) to think globally, act strategically, and execute with precision.

In conclusion, Dr. Forte advises to think about the end game, to be resilient, and to find alternative solutions to sustain your project and your company. Pashazadeh reminds us that execution without preparation is just hope. According to Pashazadeh, “the companies that succeed are the ones that align people, process, and strategy, in every geography they play in.”