Alain Pralong1,3 Renaud Jacquemart2,3 Katrina Cordovado2,3
- Pharma Consulting ENABLE GmbH
- Omnium Global Consulting Inc.
- ENABLE Biotech AG
2025 has certainly been a dynamic year for the cell and gene therapy (CGT) industry. Following several years of rapid expansion, the sector entered a period of recalibration marked by CDMO restructuring, more selective investment behavior, and a renewed emphasis on operational discipline. At the same time, regulatory agencies continued to demonstrate increased flexibility and commitment to standardization, helping to reduce friction across development and manufacturing pathways. For example, the EMA ATMP Guideline formally took effect in July 20251 and the FDA recently announced their flexible CMC approach for CGT in January 20262. Together, these forces shaped a year that was less about sheer volume and more about strategic focus, setting the stage for the next phase of CGT growth.
2025 ATMP Development trends
According to the American Society of Gene & Cell Therapy (ASGCT), clinical development activity slowed in 2025, reflecting broader market caution. Overall CGT clinical trial initiations declined by 13% year-over-year, with only 125 new CGT trials initiated in Q3. Despite this slowdown in new trial starts, the global CGT pipeline remains substantial, with a total of 3,243 ongoing clinical trials worldwide.
The breadth of innovation across advanced therapy medicinal products (ATMPs) remains striking. ASGCT reports a total of 4,341 CGT therapies currently in development. Of these, 2,129 are gene-modified or gene therapies, while 920 are non-genetically modified cell therapies, underscoring continued diversification across modalities and mechanisms of action3.
Within gene-modified cell therapies, CAR-T therapies continue to dominate the landscape, accounting for approximately 50% of all genetically modified cell therapies in development. However, the field is no longer defined by CAR-T alone. Other novel cell therapy types—including TCR-T, CAR-NK, and engineered macrophages—now represent 32% of genetically modified cell therapies, highlighting sustained innovation beyond first-generation platforms.
Non-genetically modified cell therapies show a markedly different profile. In this segment, non-oncology indications dominate, accounting for 63% of programs in development. These therapies are most commonly targeting diseases such as osteoarthritis, Type 1 diabetes, and Parkinson’s disease, reflecting innovation in applications of cell-based approaches for chronic, degenerative, and autoimmune conditions outside of cancer3.
Taken together, these trends suggest that while clinical activity has moderated, the CGT pipeline remains robust and increasingly diversified, both in terms of technology platforms and therapeutic indications.
CGT deals are rebounding
After a muted deal environment in prior years, 2025 showed clear signs of recovery in CGT transaction activity. According to the International Society for Cell & Gene Therapy (ISCT), total disclosed deals across the six major therapeutic platforms reached $7.5B in Q2–Q3 of 2025. The majority of this value, $5.65B, was driven by mergers and acquisitions, with the remaining portion attributed to investment deals.
CAR-T therapies once again played a central role in dealmaking, accounting for approximately $4B in disclosed transaction value during this period. RNA-based therapies also demonstrated strong momentum, contributing $1.7B in deal value across Q2–Q3. Notably, CAR-T startups alone raised $400M in publicly disclosed investment funding over this time period4.
ASGCT data further reinforces this rebound in deal activity. In Q3 of 2025 alone, dealmaking increased by 9% from the previous quarter to a total of 99 transactions. This included a notable uptick in early-stage financing, with startup funding rising quarter-over-quarter to $231M across 11 Seed and Series A rounds. Nearly half of these early-stage investments were attributed to APAC-based startups, highlighting the growing geographic diversification of CGT innovation and capital deployment3.
While deal volume remains below peak levels seen earlier in the decade, the rebound in both strategic transactions and early-stage financing suggests renewed confidence, particularly in platforms and allogeneic therapies with simpler paths to commercialization.
what's driving growth looking ahead
Despite near-term volatility, long-term growth expectations for CGT remain strong. According to Towards Healthcare, the CGT market is projected to grow at a compound annual growth rate (CAGR) of 18.9% over the next 10 years. This anticipated expansion is underpinned by several powerful structural drivers.
First, demand for personalized medicine continues to accelerate, particularly in the United States, where CGTs are increasingly viewed as viable solutions for patients with limited or no treatment options. Second, regulatory support has strengthened, with agencies adopting more adaptive frameworks that better accommodate the unique challenges of CGT development and manufacturing. Third, the growing prevalence of rare genetic diseases and complex chronic conditions continues to expand the addressable patient population for CGT products. From oncology to autoimmune and neurodegenerative diseases, CGT platforms are being applied across a broader range of indications than ever before5.
From a technology perspective, CAR-T and RNA-based therapies remain key growth engines, supported by continued innovation, improved safety profiles, and expanding commercial infrastructure. In parallel, large pharmaceutical companies are increasingly using partnerships, licensing agreements, and acquisitions to access CGT innovation, further validating the sector and accelerating therapeutic development4.
IMPlications for Sponsors
BioPlan Associates reports that over 80% of CGT sponsors are now outsourcing manufacturing activities to CDMOs in 20256. This trend underscores the critical role of experienced and dedicated external manufacturing partners in enabling sponsors to focus on clinical development while leveraging specialized expertise and scalable production capabilities. For CGT sponsors, particularly emerging and mid-sized biotech companies, the trends observed in 2025 carry several important implications for development strategy, capital allocation, and partner selection.
First, the slowdown in new clinical trial initiations underscores the importance of prioritization. With capital deployed more selectively, sponsors are increasingly expected to demonstrate strong scientific rationale, clear differentiation, and realistic development plans early in the lifecycle. Programs that can clearly articulate their clinical value proposition, target indication strategy, and path to scalability are better positioned to advance, even in a more cautious funding environment.
Second, the continued diversification of CGT modalities and indications means sponsors must navigate greater technical and regulatory complexity. While CAR-T remains dominant, the growth of novel engineered cell therapies and non-genetically modified cell therapies, particularly in non-oncology indications, requires thoughtful decisions around manufacturing strategy and scale-up from the outset.
Third, the rebound in deal activity highlights renewed opportunities for partnership and exit pathways. Increased M&A activity, growing early-stage financing, and strong participation from investors is encouraging following recent challenges in the field. For sponsors, aligning development milestones with potential partnering or financing inflection points remains critical.
Finally, strong long-term growth projections reinforce the value of building programs with durability in mind. As regulators continue to support CGT innovation and personalized medicine demand rises, sponsors that invest early in robust CMC strategies, scalable manufacturing approaches, and regulatory alignment will be better equipped to transition from clinical development to commercialization.
In this environment, success for CGT sponsors in 2025 and beyond will be defined not by speed alone, but by clarity of strategy, quality of execution, and the ability to adapt to an increasingly sophisticated and competitive CGT landscape.
REFERENCES
- EMA Guideline on Clinical-Stage ATMPs Comes Into Effect: On the Verge of Convergence?. Cell & Gene. (2025, June 19). https://www.cellandgene.com/doc/ema-guideline-on-clinical-stage-atmps-comes-into-effect-on-the-verge-of-convergence-0001
- FDA Announces a “Flexible Approach” on Chemistry, Manufacturing and Control for Cell and Gene Therapies. Covington & Burling LLP. (2026, January 14). https://www.cov.com/en/news-and-insights/insights/2026/01/fda-announces-a-flexible-approach-on-chemistry-manufacturing-and-control-for-cell-and-gene-therapies
- Gene, Cell, & RNA Therapy Landscape Report Q3 2025 Quarterly Data Report. ASGCT. (2025, November). https://www.asgct.org/uploads/files/general/Landscape-Report-2025-Q3.pdf
- Tracking Capital in CGT: Emerging Trends in M&A and Series Funding. ISCT. (2025, December 8). https://www.isctglobal.org/telegrafthub/blogs/francheska-juliano/2025/12/08/tracking-capital-in-cgt-emerging-trends-in-ma-and
- What Trends are Boosting the 18.9% CAGR in the CGT Pharmaceuticals Market?. BioSpace. (2025, December 4). https://www.biospace.com/press-releases/what-trends-are-boosting-the-18-9-cagr-in-the-cgt-pharmaceuticals-market
- Timol, Y. (2025, July 25). Outsourcing Hits Record Levels for All Bioprocess Platforms. BioPharm International. https://www.biopharminternational.com/view/outsourcing-hits-record-levels-all-bioprocess-platforms
