The Arc of Innovation in Cell & Gene Therapy: A Decade of Milestones and Signals Ahead
For much of the 2000s, cell and gene therapy was synonymous with viral delivery. AAV, lentiviral, and retroviral platforms defined the way the field engineered cells, delivered payloads, and approached manufacturing. These systems enabled the first wave of approvals and proved that genetic medicine could be real, but they also brought with them limitations—complex scale-up, safety concerns, and payload constraints.
The last decade has marked a clear shift. New modalities—non-viral, protein-only, mRNA-only, and in vivo approaches—have begun to reshape expectations for what therapies can look like and how they can be made. That is where our lens begins: in 2016, with the infusion of CRISPR-edited T cells. Not because it was the first milestone, but because it marked the start of a new era in which the dominance of viral vectors began to give way to a more diverse landscape.
Looking back, we can trace a clear progression:
2017 cemented viral validation with Luxturna and the first CAR-T approvals.
2020 redefined delivery as mRNA vaccines demonstrated at global scale that non-viral modalities could be safe, effective, and manufacturable.
2023 brought the first durable in vivo base editing data, showing that protein-only systems could drive meaningful clinical outcomes.
2024–2025 is set to be remembered for strategic bets: Interius entering the clinic with in vivo CAR-T, and AstraZeneca acquiring EsoBiotec to gain a foothold in reprogramming.
Each milestone tells its own story—but together they map a larger narrative: viral dominance giving way to a more diverse delivery landscape, and a steady march from ex vivo manipulation toward in vivo reprogramming.
Why this matters now
For enabling technology providers—the companies building the assays, platforms, and processes that make therapies possible—these shifts are not abstract. They determine where demand will concentrate, which capabilities will command premiums, and what regulators will expect as standards. The move toward protein-only, RNA-only, and in vivo modalities means that tools once designed for viral vectors are no longer sufficient.
Signals ahead
The next five years will test whether early promises translate into durable platforms.
By 2027, pivotal RNP-only programs in blood disorders could establish protein-only delivery as a credible alternative to viral editing.
By 2029, the first approvals of mRNA-only therapies in oncology and autoimmune disease, alongside in vivo CAR-T, would confirm that the delivery ecosystem has truly diversified.
Explore the narrative
We created The Arc of Innovation Timeline as a companion to this story - an interactive way to walk through the milestones, compare modalities, and see how today’s shifts set the stage for tomorrow’s breakthroughs. It reflects the philosophy behind our VantagePoint™ services: transforming complex data into clear, engaging insights that don’t just inform, but illuminate. For us, making data interactive is about helping enabling technology providers see the bigger picture and act with confidence.
Explore The Arc of Innovation Timeline below.
