How Novartis Built a $925 Million Cell & Gene Therapy Business and Invested $23 Billion in U.S. Manufacturing

Key Takeaways

• $23 billion U.S. manufacturing investment 
• Expansion into RNA therapeutics and radioligand therapy 
• More than 20 gene therapies are under development 
• Strong CAR-T pipeline in oncology

Novartis Drives the Next Era of Cell & Gene Therapy Innovation

Cell and gene therapies are rapidly transforming modern medicine by offering treatments that can potentially cure, prevent, or significantly reduce the impact of chronic and genetic diseases. This enables replacements, inactivation, or introduction of genes into the body, or modification & transfer of living cells to fight disease. Surging instances of diverse genetic neuromuscular disorders and oncology are impacting the overall emphasis on advancing gene replacement in neuroscience, & the latest CAR-T by leading firms, including Novartis.

Primarily, Novartis is known as a major global innovator in the pharmaceutical industry, which has been transitioning towards innovative market plans. Recently, it announced the launch of Itvisma, i.e., intrathecal onasemnogene abeparvovec, its one-time fixed-dose gene replacement therapy for older children, teens, & adults. Onwards to the US approval, the European Medicines Agency (EMA) approved an Itvisma for broader EU accessibility.

Major Strategic Developments Driving Novartis’ Growth in 2026

Novartis continues to strengthen its position in the cell and gene therapy market through aggressive investments, manufacturing expansion, and pipeline innovation. These strategic developments contributed to the company reaching an estimated $925 million market value in the sector.

Key developments include:

• In May 2026, Novartis introduced its new 46,000 sq. ft radioligand therapy (RLT) manufacturing site in Denton, Texas. This covered its massive $23 billion investment in US manufacturing & research. Initiation of construction on the company’s first Texas based manufacturing facility explores US RLT production closer to patients across the southern US, which is the fifth RLT site across the nation.
• In April 2026, Novartis announced a plan to inaugurate a 56,200-sq-ft API facility in Morrisville, North Carolina, emphasizing active pharmaceutical ingredient (API) manufacturing for solid dosage tablets, capsules & RNA therapeutics.
• At the 2026 ASCO and EHA Congresses, Novartis will publish data from 15 abstracts from its kidney portfolio to bolster the scientific study of progressive immune-mediated kidney diseases & assist in the development of kidney care.

Elevating $23 Billion Investment in Transformation & Growth of Major Facilities Across the U.S.

Firstly, Novartis announced $23 billion of total investments for a total of 5 years, which will generate nearly 1,000 direct Novartis jobs & nearly 4,000 additional construction & assist roles across the U.S. This is further promoting 10 facilities in the U.S., with seven novel sites, comprising;

Spotlight on Three FDA-approved Cell & Gene Therapies in Novartis Portfolio, Includes

A key role of the U.S. Food and Drug Administration has hastened approvals across the cell & gene therapy sector in the last few years, which is advantageous for both oncology and rare disease treatments.

Novartis has made a pivotal goal in chemistry, biotherapeutics, cell and gene therapy, xRNA therapy & radioligand therapy, coupled with the evolution of contract manufacturing sales in these areas.

In 2025, Novartis sells products in around 120 countries across the globe, with net sales significantly shown in the US & Europe, such as

Moreover, more than 20 gene therapy projects of Novartis are under development, while Novartis is emphasizing expanding the effect of cell therapy in oncology by expanding into B-cell malignancies. Probably, these cell therapies will have an increased impact on patients in other hematological cancers & solid tumors. Also, a firm is leading with novel research activities of next-generation CAR-Ts that aim at new targets & leverage groundbreaking technologies.

Key Competitors of Novartis in the Cell and Gene Therapy Sector

• Bristol Myers Squibb (BMS): A prominent leader in immuno-oncology that provides approved CAR-T therapies, including Breyanzi & Abecma.
• Gilead Sciences (Kite Pharma): It is playing a pivotal role in the CAR-T therapy area, and is also known for Yescarta & Tecartus for blood cancers.
• Pfizer: This is a vital player specializes in genetic therapies, like gene replacement & hemophilia treatments, such as Beqvez.
• Bluebird Bio: A company that emphasises severe genetic diseases, competing with its own gene therapies for sickle cell disease & beta-thalassemia.
• Sarepta Therapeutics: A leading company in gene therapies that recognizes Duchenne muscular dystrophy (DMD).
• CRISPR Therapeutics: It is a major developer of the latest CRISPR-Cas9 gene-editing therapies, like Casgevy.

Conclusion

As global demand for precision medicine accelerates, Novartis is positioning itself as one of the most influential players in the cell and gene therapy market. Through aggressive manufacturing investments, next-generation CAR-T innovation, and expansion of gene therapy pipelines, the company is building long-term leadership in advanced therapeutics and personalized medicine