The global biopharmaceutical industry is entering a new phase in cell therapy innovation, marked by significant investments in next-generation, off-the-shelf (allogeneic and in vivo) CAR-T technologies. Leading this momentum, Eli Lilly and Company announced a $2.4 billion acquisition of Orna Therapeutics, signaling a broader strategic pivot among major pharmaceutical companies.
Strategic Industry Movement
In recent months, several global pharmaceutical leaders have advanced into the in vivo CAR-T space through targeted acquisitions:
- Bristol Myers Squibb – $1.5B acquisition of Orbital Therapeutics (Oct 2025)
- Gilead Sciences (Kite Pharma) – $350M acquisition of Interius BioTherapeutics (Aug 2025)
- AbbVie – $2.1B acquisition of Capstan Therapeutics (June 2025)
- AstraZeneca – $1B acquisition of EsoBiotec (March 2025)
These transactions reflect a coordinated industry effort to overcome the manufacturing complexity, long wait times, and scalability constraints associated with traditional autologous CAR-T therapies.
Market Opportunity
While approved CAR-T therapies have achieved blockbuster commercial success, their individualized production processes limit patient access and speed to treatment. Off-the-shelf and in vivo approaches aim to:
- Simplify manufacturing
- Reduce treatment timelines
- Expand patient accessibility
- Lower overall system costs
- Enable scalable global distribution
Strategic Rationale
The focus on CD19-targeted therapies for autoimmune diseases and oncology highlights a major growth opportunity across lupus, rheumatoid arthritis, multiple sclerosis, lymphoma, and multiple myeloma.
Industry leaders are leveraging:
- Advanced genetic platforms (e.g., circular RNA, lipid nanoparticle delivery)
- Clinical and regulatory expertise
- Global commercialization infrastructure
Outlook
The acceleration of M&A activity in 2025–2026 positions off-the-shelf CAR-T as the next major evolution in cell therapy. With strong capital investment and established development capabilities, Big Pharma is poised to transform CAR-T from a complex specialty treatment into a more accessible therapeutic standard.
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