Gilead's Strategy to Dominate Multiple Myeloma CAR-T Market

Gilead is strategically positioning itself to rival Johnson & Johnson (J&J) in the CAR-T cell therapy market for multiple myeloma, a market estimated to be worth $20 billion. Leveraging its established manufacturing network for cell therapies such as Yescarta and Tecartus, Gilead aims to produce anito-cel (anitocabtagene autoleucel), a promising new cell therapy, to gain a competitive edge. The significance of Gilead’s manufacturing capabilities was emphasized by CEO Daniel O’Day at a Bernstein event in May, citing the challenges of manufacturing CAR-T therapies using a patient’s own cells. This move is a clear reflection of Gilead’s commitment to innovation and differentiation in the rapidly evolving cell therapy landscape.

In addition to setting Gilead apart from its competitors, enhancing its manufacturing capabilities underscores the crucial role of efficient production in the CAR-T therapy market. By investing in this infrastructure, Gilead aims to establish a strong market position and meet the growing demand for advanced cell therapies. As Gilead continues to expand its portfolio and develop new treatments, its robust manufacturing network is expected to drive its success and leadership in the field.

The potential market for CAR-T therapies is projected to expand significantly, and Gilead’s strategic efforts position it well to capitalize on this growth. The company is targeting a 2026 launch for anito-cel, a therapy that could broaden the CAR-T multiple myeloma market through outpatient use.

Gilead’s rival, J&J, has witnessed significant success with its CAR-T therapy, Carvykti. Sales reached $963 million last year and are anticipated to cross the blockbuster threshold this year, with projected peak sales of around $7 billion in 2030. However, Gilead has valued the overall CAR-T multiple myeloma market higher. Cindy Perettie, Global Head of Gilead’s CAR-T unit Kite, predicted at a Leerink event in March that the market will be worth $15 billion to $20 billion in 2034, a larger opportunity than its current CAR-T stronghold in lymphoma.

Despite J&J’s multi-year head start, having first won FDA approval for Carvykti in 2022, Gilead believes it can capture market share by providing a drug with superior safety and comparable efficacy. Gilead’s manufacturing capabilities serve as the third pillar of its strategy, offering a competitive advantage.

In May, Gilead’s anito-cel partner, Arcellx, shared updated Phase II data on the cell therapy as a fourth-line or later treatment for relapsed or refractory multiple myeloma. The overall response rate in the 117 patients was 97%, with nearly 70% of patients having a complete response. Evan David Seigerman, an analyst at BMO Capital Markets, stated that anito-cel continues to demonstrate significant efficacy, comparable to Carvykti, and potentially better overall survival rates, comparing anito-cel’s 12-month overall survival rate of 95% favorably to the 89% rate in a Carvykti study.

In conclusion, Gilead’s strategic focus on leveraging its manufacturing capabilities, coupled with promising clinical trial results, positions it to be a formidable competitor in the burgeoning CAR-T therapy market for multiple myeloma.