On June 4, 2025, Gilead Sciences is preparing vigorously to challenge Johnson & Johnson's dominance in the $20 billion multiple myeloma CAR-T market. Although Johnson & Johnson has gained a first-mover advantage with its CAR-T therapy Carvykti, Gilead aims to capture market share in this rapidly growing sector with superior safety, comparable efficacy, an outpatient treatment model, and a well-established production network.1. The Battle for a 20 Billion Market: Gilead vs. Johnson & Johnson in CAR-TJohnson & Johnson's Carvykti has demonstrated strong market potential in the multiple myeloma field. The drug's sales reached $963 million in 2024, surged over 100% year-over-year to $369 million in the first quarter of 2025, and are expected to surpass the blockbuster threshold (annual sales of $1 billion) within the year. Market analysts widely predict its peak sales to reach approximately $7 billion by 2030.
Gilead is more optimistic about the valuation of the entire multiple myeloma CAR-T market. In March this year, Cindy Perettie, Global Head of Gilead's CAR-T division Kite, predicted at a Leerink event that the market size would reach $15 billion to $20 billion by 2034, surpassing Gilead’s current market expectations in the lymphoma CAR-T field ($10 billion to $12 billion). This enormous market potential is attracting Gilead to accelerate its strategic layout.
Johnson & Johnson gained FDA approval in 2022 with Carvykti, securing a multi-year first-mover advantage. However, Gilead believes that its development of anitocabtagene autoleucel (anito-cel) could capture market share through superior safety and at least comparable efficacy. Additionally, manufacturing capacity will be the third pillar of its competitive strategy, as Gilead plans to leverage the infrastructure established for other CAR-T therapies as a competitive edge.2. Gilead's Anito-cel Differentiation Competition Strategy
In May 2025, Arcellx, Gilead's anito-cel partner, announced updated Phase II data for the cell therapy in fourth-line and above treatment of relapsed or refractory multiple myeloma. Among 117 patients, the overall response rate reached 97%, with nearly 70% achieving complete remission. Evan David Seigerman, an analyst at BMO Capital Markets, noted that anito-cel "continues to demonstrate meaningful efficacy, at least comparable to Carvykti, and may offer a better overall survival rate." He compared anito-cel’s 95% 12-month overall survival rate with the 89% overall survival rate observed in Carvykti studies, suggesting anito-cel has an advantage.
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Peretti said that in the Phase II trial, about 10% of patients received anito-cel treatment in an outpatient setting. Gilead has increased the proportion of outpatients in the Phase III trial to 20%. The company plans to leverage its network of more than 550 authorized treatment centers worldwide, established for other CAR-T therapies, to supplement outpatient treatment options.3. Johnson & Johnson Carvykti's Defense Barriers
However, BMO analyst Kostas Biliouris questioned the view that anito-cel is safer and more effective than Carvykti based on cross-trial comparisons. In a report to investors, he pointed out that there are "significant differences" in the enrolled populations of the anito-cel and Carvykti trials, which could confuse the comparison results. Biliouris noted that the use of corticosteroids for CRS management in the anito-cel trial was three times higher, "further ruling out direct efficacy/safety comparisons." He cited real-world data and post-hoc analyses indicating that the use of corticosteroids might create apparent differences in the safety and efficacy of CAR-T cell therapies.
Birioris is optimistic about Carvykti, reflecting that Johnson & Johnson and its partner Legend Biotech have demonstrated a statistically significant improvement in overall survival and are increasing the use of the drug in earlier treatment lines. The FDA has approved Carvykti for second-line treatment. Gilead's Phase III trial is enrolling patients who have received one to three prior lines of therapy, including anti-CD38 antibodies and immunomodulatory drugs.
The analyst also mentioned that Carvykti's "differentiated (seven-day) CRS onset time, facilitating outpatient administration" is an advantage of this cell therapy. Johnson & Johnson is conducting two trials that allow patients to receive Carvykti treatment on an outpatient basis. Based on the understanding of the timing of CRS and other adverse reactions, patients are initially required to remain within 30 minutes of the hospital, but will be admitted on the fifth day of the study.4. Manufacturing Capability: Gilead's Another Ace
Gilead CEO Daniel O’Day explained at the Bernstein event in May 2025 that the company has built a network supporting the lymphoma cell therapies Yescarta and Tecartus, and plans to leverage the manufacturing capabilities established for Yescarta and Tecartus to produce anito-cel, gaining an edge over competitors. "We have the largest manufacturing network with the shortest turnaround time. Short turnaround times are critical because patients are immunosuppressed while waiting for their cells to be reinfused, and you need to ensure the cells are returned as quickly as possible for optimal clinical benefit," O'Day said.
Gilead's outpatient treatment regimen may prove to be more flexible and attractive for patients, but it will face Johnson & Johnson, a well-funded incumbent, which is leveraging its first-mover advantage to expand and solidify the use of Carvykti. With Gilead's anito-cel expected to launch in 2026, the intense competition in the $20 billion multiple myeloma CAR-T market is about to unfold. It remains to be seen who will gain the upper hand in this contest, and the situation warrants continued attention.Reference Source: https://www.biospace.com/business/gilead-gears-up-to-challenge-j-j-in-20b-multiple-myeloma-car-t-market
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