Key Players
Competitive Landscape
Competition in in vivo CAR-T cell therapy splits between large drug makers that bought platforms and smaller developers still running independent trials. AstraZeneca, AbbVie, Gilead Sciences and Bristol Myers Squibb added in vivo programs through acquisitions, and Eli Lilly and Company now owns Kelonia Therapeutics and Orna Therapeutics. Umoja Biopharma and Vyriad are advancing lentiviral candidates, and CREATE Medicines and Azalea Therapeutics work on RNA delivery and site-specific gene insertion. Human response data, safety records and vector supply to many sites are expected to shape rivalry through 2036.
Activity in 2026 centered on new trial sites and further deal closings. In January 2026, the FDA cleared Kelonia's KLN-1010 IND, allowing the trial to add US sites [7]. Eli Lilly and Company agreed in February 2026 to buy Orna Therapeutics for up to USD 2.4 billion [16]. In May 2026, Azalea Therapeutics presented primate data showing that one intravenous dose without lymphodepletion cleared most B cells by day 10 [30]. CREATE Medicines added targeted lipid nanoparticle technology through a WestGene collaboration in August 2026 [29]. Developers with human data and secure delivery technology are likely to attract the next round of partnerships.
Company developments mapped to drivers, trends and opportunities (2026-2036)
| Development | Driver | Trend | Opportunity |
|---|---|---|---|
| September 2026: Vyriad opened a Phase 1 VV169 trial at Mayo Clinic. | Myeloma patients need treatment without manufacturing delays. | Large US centers are enrolling the first in vivo patients. | BCMA-directed lentiviral doses can enter myeloma care after approval. |
| August 2026: CREATE Medicines formed a WestGene delivery collaboration. | Sponsors want one delivery system for several targets. | RNA developers are licensing delivery technology across borders. | Dual CD19 and BCMA programs can widen the patient pool. |
| July 2026: Umoja Biopharma gained FDA IND clearance for CD22-directed UB-VV400. | Patients relapsing after CD19 therapy need new targets. | Pipelines are adding second-line antigens. | CD22 products can reach patients after CD19 relapse. |
| April 2026: Eli Lilly and Company agreed to acquire Kelonia Therapeutics. | Later-stage trials need large funding. | Platform ownership is shifting to large drug makers. | Acquirer funding can speed KLN-1010 toward registration trials. |
Source: Future Market Insights, In Vivo CAR-T Cell Therapy Market Report, 2026-2036.
AstraZeneca and Eli Lilly and Company hold the in vivo programs with the most reported human data, through ESO-T01 and KLN-1010. AbbVie, Gilead Sciences and Bristol Myers Squibb gained platforms through 2025 acquisitions and are building clinical records. Umoja Biopharma and Vyriad remain independent and advance on trial progress, and Azalea Therapeutics is still at the primate stage.
Who leads the in vivo CAR-T cell therapy market?
Leadership in in vivo CAR-T is still open, as no product has yet reached an approved label. AstraZeneca, through ESO-T01, and Eli Lilly and Company, through KLN-1010, own the programs with published or conference-reported patient results [1] [2]. Umoja Biopharma stands out for in-house lentiviral vector production [18]. The first developer to pair approval with steady supply to many cancer centers is expected to take the lead.
Which companies have documented product-level evidence?
ESO-T01 has published Phase 1 myeloma results, and KLN-1010 reached MRD-negative status in all four early patients [1] [2]. Vyriad and Umoja Biopharma run FDA-accepted trials for VV169 and UB-VV400, and Azalea Therapeutics has reported primate data [5] [18] [30]. Human results across these programs are set to grow quickly as trials enrol patients.
What should buyers evaluate before approving a supplier?
Cancer centers review response and safety data, vector lot release tests, dosing steps and post-infusion monitoring needs before adoption. Supply terms, cold storage needs and developer support for staff training also shape product choice. Therapies with simple dosing and steady safety records are expected to reach hospital formularies faster.
How is competition expected to change through 2036?
Rivalry is set to move from deal-making to clinical results as acquired programs enter larger trials. Developers without a large partner may find funding harder, and new targets such as CD22 and dual-antigen programs are adding entrants. The first approvals later this decade are expected to set price and safety benchmarks for every later product.
Representative Company Overview
| Company | Positioning | Recent Development |
|---|---|---|
| AstraZeneca | Targeted lentiviral platform | May 2025: EsoBiotec acquisition completed for up to USD 1.0 billion. |
| AbbVie | Lipid nanoparticle CAR-T | August 2025: Capstan Therapeutics acquisition completed. |
| Gilead Sciences | In vivo platform buyer | August 2025: Kite agreed to buy Interius for USD 350 million. |
| Bristol Myers Squibb | RNA CAR for autoimmunity | October 2025: Orbital Therapeutics acquisition announced for USD 1.5 billion. |
| Kelonia | Lentiviral BCMA program | January 2026: FDA IND clearance announced for KLN-1010. |
| Orna | RNA in vivo platform | February 2026: Eli Lilly and Company agreed to acquire Orna. |
| Azalea | Site-specific gene insertion | May 2026: primate B-cell depletion data presented at ASGCT. |
| Umoja | Lentiviral developer | July 2026: FDA IND clearance for CD22-directed UB-VV400. |
| CREATE Medicines | mRNA-LNP CAR-T | July 2026: Australian ethics approval for the CRT-402 lupus trial. |
| Vyriad | BCMA lentiviral therapy | September 2026: Phase 1 VV169 trial opened at Mayo Clinic. |
Research Methodology
The profiled companies represent the present in vivo CAR-T development base. Inclusion requires a disclosed clinical or preclinical program that makes CAR-T cells inside the body. Kelonia Therapeutics and Orna Therapeutics are profiled as separate platforms within Eli Lilly and Company. Interviews covered developers, cancer and rheumatology centers and vector suppliers, and desk research drew on regulator records, peer-reviewed studies and company releases. Estimates are checked against trial activity, deal disclosures and country approval conditions.
