Panels at the Alliance for Regenerative Medicine’s Industry Briefing highlighted how CGTs are expanding beyond rare disease into broader indications, with 2026 success hinging on scalable platforms, manufacturing automation, regulatory momentum and real-world commercial infrastructure.
The cell and gene therapy (CGT) landscape has shifted from scientific novelty to scaled delivery in recent years and has become a revenue-producing category in the industry. Based on panels of the Cell and Gene State of the Industry Briefing event of the Alliance for Regenerative for Medicine (ARM), which took place on the 12th of January 2026 in San Francisco, the success of CGTs depends on manufacturing, infrastructure and commercial execution as much as clinical data.
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CGTs have significantly transformed treatment paradigms across genetic diseases, with development efforts still concentrated in oncology, blood disorders such as sickle cell disease, haemophilia and beta-thalassaemia, and central nervous system (CNS) disorders.
The commercial CGT market is solidifying and is forecast to rise through 2031, reaching $63bn, according to a report on CGT investment trends by GlobalData. The current cell therapy pipeline remains dominated by autologous approaches, reflecting both modality maturity and regulatory familiarity, while allogeneic therapies are increasingly focused on haematological malignancies as sponsors try to bring scalable, off-the-shelf therapies to the market.
Chimeric antigen receptor T-cell (CAR-T) assets such as Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) have demonstrated real revenue in terms of global sales. The rise of outpatient CAR-T therapies also marks the CGT field’s maturation, with outpatient adoption reaching 45% in 2025. According to ARM panelists, moving cell therapy outside academic hospitals is seen as a necessary step for the next wave of growth, particularly if CAR-T expands meaningfully into autoimmune disorders, where patient numbers are larger and care must be administered in community settings.
On the topic of manufacturing, speakers argued that the industry will need to invest aggressively in automation for ex vivo CAR-T, while pushing off-the-shelf biologic strategies and in vivo CAR-T approaches that could reduce cost and complexity. The takeaway was blunt: without cost compression and operational simplification, the category risks self-limiting its adoption.
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By GlobalDataFor big pharma, CGT investment strategies are increasingly being built around platforms rather than investments on isolated assets.
At ARM’s industry briefing, Lynelle Hoch, President of the Cell Therapy Organization at Bristol Myers Squibb, described how BMS’s entry into cell therapy began with the acquisition of Celgene five years ago to acquire deep expertise in T-cell approaches. That foundation has evolved into a broader push across solid tumours and autoimmune disorders, a sign that the company is treating engineered immune cells as a repeatable modality rather than a one-off oncology play. Hoch framed the opportunity as transformational but highlighted that scaling these therapies will require a deliberate buildout of manufacturing capabilities, automation and commercial infrastructure.
Big pharma is also viewing CGTs as a long-term investment with the broader goal of expanding from rare diseases to broader indications, according to a GlobalData report on CGT investment trends. This opinion was also echoed by Richard Wilson, Senior Vice President, Primary Focus Lead and Genetic Regulation at Astellas, who argued that while a rare indication provides a more direct route to clinical validation, the long-term prize is expansion into broader populations as delivery improves and durability becomes more predictable.
Although commercialisation still remains the bottleneck and persistent challenges of high manufacturing costs, complex supply chains, site infrastructure requirements and reimbursement models are still present, the FDA’s evolving stance was framed as a positive signal. Speakers praised new CMC guidance and what they described as increasing regulatory flexibility, including greater openness to real-world evidence and pragmatic development approaches, if sponsors can demonstrate credible control of manufacturing and quality.
Investor activity in CGTs peaked in 2021, as noted by a GlobalData report. Since then, fundraising and deal-making have slowed under macroeconomic pressure, commercial constraints and pricing debates and the overall funding environment has tightened even further due to CGT manufacturing complexity, supply chain fragility, reimbursement uncertainty and renewed safety concerns.
However, ARM panelists suggested that sentiment in CGT funding is recovering as venture capital and strategic pharma investors are re-engaging, increasingly favouring companies that pair differentiated technologies with clear regulatory pathways. Novel adeno-associated virus (AAV) capsids, vector optimisation strategies and scalable allogeneic platforms were repeatedly cited as the kinds of assets attracting attention by panelists. According to GlobalData’s report, investors are increasingly structuring financings around milestone-based contracts as a way to mitigate risk in CGT investments, which was also noted by speakers at ARM.
Additionally, rather than backing only therapeutic developers, capital is increasingly flowing towards acquiring scale-enabling technologies, including vector engineering, cell engineering platforms and manufacturing capabilities, to have opportunities such as partnerships, licensing and co-development.
Although clinical data and clear regulatory pathways are important, building systems to deliver these therapies to real-world patients efficiently and affordably is essential for the CGT field to move forward.
