Johnson & Johnson’s Carvykti: A Blockbuster Growth Engine in the Evolving CAR-T Landscape

Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) is emerging as a standout growth engine in the CAR-T cell therapy space, driven by accelerating sales, strategic manufacturing expansion, and a robust clinical profile. With Q2 2025 net trade sales hitting $439 million—a 136% year-over-year surge—Carvykti is now a $1.7 billion annualized product, fueled by its expanding role in earlier treatment lines and compelling long-term survival data [2]. This momentum positions J&J to dominate the $20 billion multiple myeloma CAR-T market, even as rivals like Gilead Sciences prepare to enter the fray.

Sales Growth: A Rocket Ship Powered by Clinical Data

Carvykti’s sales trajectory has been nothing short of explosive. After plateauing in late 2023 due to manufacturing bottlenecks [3], the therapy’s adoption has surged in 2025, driven by two key factors:
1. Expanded FDA Approval: In 2024, Carvykti received approval for second-line treatment of relapsed/refractory multiple myeloma, tripling its eligible patient population [5].
2. Outstanding Clinical Outcomes: Data from the CARTITUDE-1 trial revealed that one-third of patients achieved progression-free survival of five years or more without maintenance therapy [5]. These results, presented at major conferences like ASCO, have solidified Carvykti’s reputation as a durable, curative option.

The therapy’s Q2 2025 performance—$439 million in sales—exceeds even the most optimistic projections. Analysts note that Carvykti’s adoption in community oncology settings has accelerated, with over 50% of patients now receiving the treatment as outpatients, up from 30% in 2024 [2]. This shift not only improves patient access but also reduces hospital costs, making the therapy more attractive to payers.

Manufacturing Expansion: Scaling to Meet Demand

J&J and partner Legend Biotech have invested heavily to eliminate supply constraints. A $150 million facility in Ghent, Belgium, is set to boost annualized production capacity to 10,000 doses by late 2025 [2]. This expansion, combined with upgrades to the Raritan, New Jersey site and a partnership with Novartis for outsourced manufacturing, ensures Carvykti can meet growing demand [2].

The company’s focus on outpatient administration is equally critical. By reducing inpatient hospital stays—enabled by Carvykti’s delayed cytokine release syndrome profile—J&J is optimizing treatment capacity. With 104 U.S. treatment centers already certified for Carvykti, the goal is to expand into community practices by 2026 [5]. This strategy not only broadens access but also insulates J&J from near-term competition.

Competitive Positioning: Can Gilead’s Anito-Cel Disrupt the Market?

Gilead’s anitocabtagene autoleucel (anito-cel) is the most direct threat, with a projected 2026 launch. While anito-cel shows comparable efficacy—97% overall response rate in the iMMagine-1 trial [3]—its safety profile is arguably superior. Anito-cel reports 15% cytokine release syndrome (CRS) and 8% immune effector cell-associated neurotoxicity syndrome (ICANS) rates, compared to Carvykti’s 95% and 23% [1]. Additionally, anito-cel has no reported cases of delayed Parkinsonism, a rare but notable side effect of Carvykti [1].

However, J&J’s head start and Carvykti’s cost-effectiveness provide a buffer. A cost-per-responder analysis shows Carvykti’s total cost per complete responder at $963,941, significantly lower than standard of care therapies ($3.85 million) [4]. Gilead’s pricing strategy for anito-cel remains undisclosed, but J&J’s established reimbursement infrastructure and earlier adoption in community settings give it a first-mover advantage.

Moreover, Gilead’s manufacturing network for Yescarta and Tecartus may not translate seamlessly to BCMA-targeted therapies. Carvykti’s unique production requirements—particularly its reliance on viral vectors—pose a challenge for rapid scaling [3]. J&J’s $150 million investment in Belgium and its partnership with Novartis ensure it can maintain a production edge through 2026.

The Bottom Line: A Blockbuster with Long-Term Legs

Carvykti’s accelerating sales, manufacturing expansion, and clinical differentiation make it a standout growth driver for J&J. While Gilead’s anito-cel introduces meaningful competition, J&J’s first-mover advantage, cost efficiency, and community-based adoption strategy position Carvykti to dominate the BCMA CAR-T market for years. Investors should also note J&J’s broader Innovative Medicine segment, which grew 5.8% year-over-year in Q2 2025, providing a stable foundation for Carvykti’s ascent [1].

As the CAR-T landscape evolves, Carvykti’s ability to deliver durable remissions and reduce long-term healthcare costs will likely cement its role as a cornerstone of multiple myeloma treatment—and a key contributor to J&J’s top-line growth.

Source:
[1] Gilead Gears Up To Challenge J&J in $20B Multiple Myeloma CAR-T Market [https://www.biospace.com/business/gilead-gears-up-to-challenge-j-j-in-20b-multiple-myeloma-car-t-market]
[2] J&J, Legend to Invest $150M in Belgium Cell Therapy Facility [https://www.fiercepharma.com/pharma/jj-legend-invest-150m-belgium-cell-therapy-facility-new-carvykti-rival-looms]
[3] EHA 2025: Anito-Cel to Disrupt CAR-T Market in Multiple Myeloma [https://www.clinicaltrialsarena.com/analyst-comment/eha-2025-anito-cel-car-t-multiple-myeloma/]
[4] Cost-Per-Responder Analysis of Patients with Lenalidomide [https://pmc.ncbi.nlm.nih.gov/articles/PMC11372240/]
[5] Single Infusion of CARVYKTI® Delivered Lasting Treatment-Free Remissions [https://www.jnj.com/media-center/press-releases/single-infusion-of-carvykti-ciltacabtagene-autoleucel-delivered-lasting-treatment-free-remissions-for-at-least-five-years-in-patients-with-relapsed-or-refractory-multiple-myeloma]