Legend Biotech's Strategic Shift to In-House Manufacturing in the U.S.: Operational Efficiency and Long-Term Competitive Positioning in the CAR-T Therapy Market

Legend Biotech's strategic pivot to in-house manufacturing in the U.S. and Europe represents a pivotal moment in its journey to dominate the CAR-T therapy market. By investing $150 million in a new facility in Ghent, Belgium, and expanding its Raritan, New Jersey, plant, the company is not only addressing immediate supply constraints but also positioning itself to capitalize on the growing demand for its flagship product, CARVYKTI, a BCMA-directed autologous CAR-T therapy for multiple myeloma, according to a Biospace report. This shift underscores a calculated move to enhance operational efficiency, a critical factor in a market where production complexity and scalability have historically limited commercial success.

Operational Efficiency: A Cornerstone of Competitive Advantage

Legend Biotech's manufacturing prowess is evident in its ability to maintain a 97% success rate in CAR-T cell production and a median turnaround time of 30 days-metrics that outpace industry benchmarks, according to a BeyondSpx analysis. These efficiencies are not accidental but the result of iterative improvements in release specifications and process optimization. For instance, the company has reduced out-of-specification rates through refined protocols, ensuring consistent product quality while minimizing delays, as noted in a FiercePharma article. Such operational discipline is vital for CAR-T therapies, where patient-specific manufacturing and stringent regulatory standards create inherent bottlenecks.

The expansion of in-house capacity further amplifies these advantages. By 2025, Legend aims to double CARVYKTI production to 10,000 annualized doses, with a long-term goal of 20,000 doses by 2027. This scaling is supported by a diversified supply network, including partnerships with Novartis for contract manufacturing in New Jersey, according to the Biospace report. The redundancy in production sites-spanning Belgium, New Jersey, and Novartis facilities-mitigates risks associated with single-point failures, a critical consideration in a market where supply chain disruptions can erode market share.

Market Positioning: Outpacing Competitors in a High-Stakes Race

Legend's strategic investments are paying dividends in the form of market leadership. In Q2 2025, CARVYKTI generated $439 million in net trade sales, a 136% year-over-year increase, making it the highest-selling CAR-T therapy in a single quarter, according to the BeyondSpx analysis. This growth is driven by the therapy's expanded label for second-line multiple myeloma treatment, a regulatory milestone achieved in April 2024 that significantly broadened its patient pool, per the Biospace report. At U.S. treatment centers where both CARVYKTI and BMS' Abecma are available, Legend's therapy holds approximately 80% of the late-line market share, a testament to its clinical differentiation and supply reliability (Biospace report).

Competitors like Bristol Myers Squibb face challenges in matching Legend's production scale and operational agility. While Abecma, BMS' BCMA-targeted CAR-T, has shown promise, its adoption has been hampered by manufacturing delays and a less favorable safety profile, including higher rates of cytokine release syndrome (CRS), according to the BeyondSpx analysis. CARVYKTI's delayed onset of CRS and outpatient administration model, by contrast, enhance treatment accessibility and reduce hospitalization costs-a critical differentiator in a value-conscious healthcare landscape (BeyondSpx analysis).

Long-Term Implications: Blockbuster Potential and Pipeline Diversification

The financial stakes are high. With a projected peak sales potential of $5 billion, CARVYKTI is on track to become a blockbuster, a rare feat in the CAR-T space, as highlighted in the FiercePharma piece. Legend's manufacturing expansion is designed to support this trajectory, ensuring that supply can meet the demand generated by label expansions and international approvals. The company's focus on earlier-line treatment settings-such as second- to fourth-line therapy-further amplifies its revenue potential, as these segments represent a larger proportion of the multiple myeloma patient population.

Beyond CARVYKTI, Legend is diversifying its pipeline to reduce reliance on a single product. Investments in next-generation CAR-T therapies and allogeneic (off-the-shelf) cell therapies are already underway, with a focus on hematologic malignancies and solid tumors, according to the Biospace report. These initiatives, coupled with digital transformation in R&D and manufacturing, position Legend to maintain its competitive edge as the CAR-T market matures.

Conclusion: A Model for Sustainable Growth

Legend Biotech's strategic shift to in-house manufacturing is more than a response to supply constraints-it is a masterclass in aligning operational efficiency with market dynamics. By prioritizing scalability, quality, and innovation, the company has not only solidified its leadership in multiple myeloma but also laid the groundwork for long-term dominance in the CAR-T therapy market. For investors, the combination of blockbuster potential, a robust supply network, and a disciplined approach to cost management makes Legend a compelling case study in how biotech firms can navigate the complexities of advanced therapies.