At the 28th annual American Society of Gene & Cell Therapy (ASGCT) conference in New Orleans, ASGCT’s CEO David Barrett and Citeline’s Dan DiGaudio, Senior Associate, Consulting and Analytics, shared key findings from the most recent Cell and Gene Therapy Quarterly Landscape Report—a collaborative effort between ASGCT and Citeline, a Norstella company. Their presentation not only showcased a data-rich snapshot of industry activity but also reinforced Norstella’s position as a guiding force in the evolving gene, cell, and RNA therapy landscape.
“As the field grapples with some very big questions, we are still seeing progress,” Barrett said. “There’s been a cooling in the market, yes—but we continue to track meaningful movement in approvals and trial initiations.”
Barrett highlighted major regulatory milestones in the first quarter of 2025: the approval of Selto, an engineered therapy for rare eye disease; Qfitlia, an siRNA therapeutic for hemophilia A and B; and China’s approval of the first mesenchymal stromal cell (MSC) therapy for refractory acute graft-versus-host disease. These approvals reflect a broader trend of innovation across both genetically modified and non-modified modalities.
Norstella is able to synthesize and deliver decision-grade intelligence to stakeholders through Citeline’s integrated product suite.
“Our global teams combine domain expertise with proprietary data to help clients avoid risk, maximize opportunity, and plan for what’s next,” DiGaudio said.
He cited the use of products like PharmaProjects, TrialTrove, and Biomedtracker to provide clients with visibility across clinical, regulatory, and commercial areas.
This data was foundational in identifying a key trend: Over 4,400 therapies are currently in development globally, with gene and genetically modified cell therapies representing nearly half the pipeline, according to Barrett. RNA therapeutics have grown by 30% year-over-year.
While deal volume has softened compared to peak periods, Barret said, Norstella’s analysis still captured 90 industry deals in the first quarter alone.
“That’s not an insignificant number,” he said. “We’re seeing sustained startup activity even as total dollar amounts decline.”
Importantly, Citeline’s data suggests stability.
“We tracked 12 startup deals this past quarter, which tells us that while funding amounts may dip, early-stage innovation remains very much alive,” DiGaudio said. He also underscored Citeline’s role in helping clients pinpoint high-opportunity assets and navigate dynamic deal landscapes.
Beyond the numbers, Norstella’s reporting offered insight into therapeutic directionality. In non-genetically modified cell therapy, trials targeting non-oncology indications now comprise more than 60% of the pipeline—hinting at broader clinical application beyond cancer. Meanwhile, in gene therapy, oncology programs are regaining ground, approaching a 60/40 oncology/rare disease split.
“We’re also starting to see more gene therapies aimed at immunological diseases like lupus, MS, and HIV,” Barrett said, highlighting growing diversity in indication targets.
As Barrett emphasized, ASGCT’s collaboration with Citeline isn’t just about tracking current activity—it’s about equipping the field for what’s ahead.
“We’re looking at potentially 10 regulatory approval decisions worldwide by the end of 2025,” he said. “That’s the kind of forward-looking insight our members value.”
A new publication co-authored by Barrett and DiGaudio, soon to appear in Molecular Therapy, will include a comprehensive table of all approved cell, gene, and RNA therapies—further cementing Norstella’s role as both an authority and advocate for transparency in the sector.
“The field is evolving. It’s not linear,” DiGaudio said. “But with strong data, consistent analysis, and a willingness to adapt, we believe we can help stakeholders move from uncertainty to action.”
From tracking trial momentum to forecasting future approvals, Norstella continues to provide the intelligence the biotech ecosystem needs to advance lifesaving therapies—in cell and gene therapy and beyond.
“Ultimately, we help companies better understand the landscape so they can make smarter, more strategic decisions,” DiGaudio said.
View the complete quarterly report.
Managing Editor, Custom Content | Norstella
Senior Associate, Consulting and Analytics | Citeline