ARM's Tim Hunt On Expanding Patient Access, Smarter Regulation, And A More Sustainable Market In 2026

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

With 2026 underway, the cell and gene therapy sector is at an inflection point. After years of scientific breakthroughs (and just as many hard lessons about access, scalability, reimbursement, and real-world delivery) CGT is maturing. The question is no longer just can these therapies work, but how we make them work for more patients, in more places, and in more sustainable ways. I caught up with Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM) for a clear-eyed look at where the field is shedding its early growing pains, how access and regulatory frameworks are evolving, and what new models of growth, financing, and global competition mean for developers. Here's what he had to say.

What promising advancements are happening in the CGT sector to improve real-world delivery, efficiency, and patient access as it continues to grow and mature?

Hunt: History shows that new and disruptive science inevitably meets early challenges. Look no further than the story of monoclonal antibodies, which faced a series of crises in the early 1990s, only to now emerge as a $ 200 billion+ global market. The CGT sector has faced its own set of growing pains, including managing small patient populations, addressing safety concerns, and navigating reimbursement challenges. However, companies are actively adapting to the challenges faced in the first generation of products, and the industry is transitioning to a disciplined and sustainable growth cycle.

One such example is developers sharpening their focus on best-in-class opportunities with larger patient populations, such as Rett syndrome, Duchenne muscular dystrophy, Huntington’s disease, and Parkinson’s disease. We’re also seeing AAV gene therapy programs adopt safer and gentler conditioning regimens to ensure patient safety and further demonstrate a strong risk-benefit profile.

The sector is also seeing positive trends in patient access. Take CAR-T cell therapy, for example. A bleak statistic has been cited in recent years: an estimated 2 in 10 patients eligible for CAR-T cell therapies actually receive them, largely due to the complexity of their administration regimens. However, numerous efforts are actively addressing this issue. Take CARVYKTI, for example, a CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma, marketed by Johnson & Johnson and Legend Biotech. Currently, 50% of CARVYKTI use now takes place in outpatient settings—an encouraging trend towards improved efficiency and affordability.

This new era of cell and gene therapy will bring about even bigger shifts as research and development expand to larger disease populations, such as Parkinson’s disease and Type 1 Diabetes, to name just two examples.

One of ARM’s 2025 priorities was advancing patient and societal access through frameworks such as the Gene Therapy for Patients and Societies (GPS) advocacy mission. What progress has been made in 2025 to address value assessment, payment models, and real-world access barriers? What new strategies are emerging to scale access globally as more therapies launch?

Starting more broadly, we’re seeing that global competition in CGT has been surging, with the U.S., China, the European Union, and the Middle East vying for scientific advancement. In the U.S., this global competition has translated to a push for modernization. The Trump Administration has emphasized the Center for Medicare & Medicaid Innovation’s (CMMI) CGT Access Model, with an initial focus on improving access to sickle cell disease gene therapies. Last year, 33 states plus the District of Columbia and Puerto Rico confirmed participation in the model—marking tangible, system-wide progress.

Another important step for access in 2025 was the FDA’s updates to CAR-T labels and the removal of Risk Evaluation and Mitigation Strategies (REMS). This step reflects the strong benefit-risk profile established by various CAR-Ts and the agency’s commitment to reducing the burden on the healthcare system. These labeling changes reduce logistical and cost burdens on patients who live far from specialized treatment centers where CAR-Ts are mainly delivered.

Globally, ARM is encouraged to see regulatory agencies, such as the FDA, the EMA, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), unlock new clinical trial pathways for broader patient populations by advancing frameworks for gene editing platforms.

2025 saw continued capital market challenges for the CGT sector after the highs of 2021. What are ARM’s expectations for industry financing and consolidation in 2026?

Strategic biopharma and investors are noticing the commercial promise in the CGT sector and are driving a disciplined, sustainable growth cycle. A clear indication is continued commitment by the biggest industry players, as 20 of the 30 largest biopharma companies by market capitalization are currently invested in CGT. We’re now seeing the earlier clinical breakthroughs transition into commercial success, with the sector achieving two additional blockbuster products in 2025, bringing the sector’s total to four. The strength of the commercial pipeline is also only beginning to emerge, as over a dozen diseases with blockbuster potential now have a CGT product in or near the pivotal stage of clinical trials.

Additionally, reinvigorated investor activity signifies continued growth and confidence in the value of these transformative medicines. In 2025, the sector saw three acquisitions exceeding $1 billion, including AbbVie’s acquisition of Capstan Therapeutics for $2.1 billion, which is the largest CGT-related acquisition since 2020. Investors also facilitated more than 15 private financing deals totaling $70 million or more, while companies also tapped into a more favorable public market, raising nearly $4 billion, often on the heels of promising data.

In 2026, what are the most encouraging trends, milestone achievements, or advances that ARM sees as fueling optimism for the cell and gene therapy sector?

As always, the impact that CGTs have on patients in need is simply undeniable. ARM, the CGT community, and citizens at large were jointly inspired by incredible patient stories in 2025, and we believe there is much to look forward to in 2026.

In the U.S., the near-term pipeline remains incredibly robust with four CGT regulatory decisions scheduled for the first four months of 2025 and 10+ other regulatory submissions possible in the next year. But what gives us the most hope is seeing the patients whose lives are transformed. At our 2025 Cell & Gene Meeting on the Mesa, we welcomed Marci McCue, the first patient to participate in a CAR-T clinical trial for multiple sclerosis. Her description of how cell therapy empowered her to live her life without fear is emblematic of what this sector aspires to do.

As science and global competition accelerate modernization, we’re confident more stories like Marci’s will become a reality in 2026 and beyond.