In Vivo CAR-T Cell Therapy Market

How big is In Vivo CAR-T Cell Therapy Market in 2026?

In vivo CAR-T cell therapy revenue rises from USD 136.2 million in 2025 to an estimated USD 180.0 million in 2026 and USD 2,934.9 million by 2036. Demand for in vivo CAR-T cell therapy is projected to expand at a 32.2% CAGR from 2026 to 2036, as trial supply gives way to approved use.

Key drivers of the in vivo CAR-T cell therapy market include one-dose delivery, strong early patient data and large-pharma funding. In March 2026, Nature Medicine reported that a single ESO-T01 infusion produced responses in four of five myeloma patients, with three stringent complete remissions [1]. Kelonia Therapeutics also reported in December 2025 that all four of the first KLN-1010 patients reached MRD-negative status [2]. As per FMI, lentiviral vector particles hold the leading 48.7% share in 2026, as one vial dose can write the CAR gene into T cells without cell collection. Eli Lilly and Company agreed in April 2026 to acquire Kelonia for up to USD 7.0 billion [3]. Sponsors are widening cell and gene therapy clinical trials to more sites. First approvals later this decade are expected to move in vivo CAR-T from trial supply into routine use at cancer centers.

Key Market Trends & Insights

• By vector platform, lentiviral vector particles capture 48.7% of demand in 2026, as one dose writes the CAR gene into T cells for lasting expression.
• By target antigen, CD19 leads at 34.8% in 2026, owing to use in both B-cell cancer and autoimmune programs. Umoja Biopharma gained FDA Fast Track designation for CD19-directed UB-VV111 in September 2025 [4].
• By indication, B-cell malignancies account for 28.7% of demand in 2026, and FMI expects the lead to hold as hematologists already give ex vivo CAR-T in these cancers.
• By end user, specialty cancer centers take 44.3% in 2026 and carry most early dosing. Vyriad opened a Phase 1 study of VV169 at Mayo Clinic in September 2026 for up to 40 patients [5].

Regional Highlights

• Fastest-growing profiled country: South Korea (39.1% CAGR, 2026 to 2036).
• By country: USA (38.5%) and UK (34.3%) come next, and Japan posts the lowest profiled CAGR at 24.7% through 2036.
• In April 2026, MFDS approved Curocell's Rimqarto, the first home-grown CAR-T product in South Korea, after a 67.1% complete response rate in the approval trial [6]. FMI expects this treatment base to help local in vivo CAR-T trials enrol patients.

Market Size & Forecast

Table 1: Market Size and Forecast for the In Vivo CAR-T Cell Therapy Market (USD million and percentage), 2025 to 2036

Metric	Value
2025 Market Size	USD 136.2 million
Estimated Market Size in 2026	USD 180.0 million
Projected Market Size by 2036	USD 2,934.9 million
CAGR, 2026 to 2036	32.2%
Added Revenue, 2026 to 2036	USD 2,754.9 million
Market Expansion Multiple	16.3x

Revenue from in vivo CAR-T cell therapy currently comes from early-phase trials at a small group of cancer centers. Sponsors buy vector lots for these studies, as no in vivo product has yet reached an approved label. Kelonia's FDA clearance in January 2026 opened US sites for a trial of up to 40 patients that began in Australia [7]. Approved ex vivo products already give the class a known revenue base, with Bristol Myers Squibb reporting USD 1,358 million of Breyanzi sales in 2025, up 82% [8]. However, all five ESO-T01 patients had grade 3 or higher adverse events, which keeps dosing under close specialist watch [1]. Hospital adoption is likely to stay trial-led until the first approvals and then widen as labelled products reach more treatment centers.

Patient Data, Ex Vivo Sales and Platform Deals

Key trends in the in vivo CAR-T cell therapy market point to multi-site trials, as one vector lot can treat many patients. ESO-T01 was given as a single intravenous infusion without leukapheresis, ex vivo manufacturing or lymphodepleting chemotherapy [1]. Ex vivo CAR-T, however, still needs cell collection, shipping and a plant slot for every patient. FDA clearance in January 2026 let Kelonia's Australian trial of up to 40 patients add US sites [7], and Vyriad opened a trial at Mayo Clinic in September 2026 [5]. Safety results differ by platform, as all five ESO-T01 patients had grade 3 or higher adverse events and three had grade 3 cytokine release syndrome [1]. Kelonia reported no cytokine release syndrome of grade 3 or above in the first four KLN-1010 patients [2]. Due to this, hospitals are expected to favour therapies with steady safety data. Spending on ex vivo CAR-T shows what payers already accept for the class. Gilead reported USD 1,839 million of cell therapy sales in 2025, down 7% [9]. Bristol Myers Squibb reported USD 1,358 million for Breyanzi, up 82%, and USD 427 million for Abecma [8]. Together these lines earned USD 3,624 million in 2025, and FMI expects in vivo products to compete for this revenue pool after approval. Apart from that, more centers can now give CAR-T, as the FDA removed REMS for six autologous products in June 2025 and set monitoring at two weeks [10].

Drug makers are paying well ahead of revenue for in vivo CAR-T platforms. AstraZeneca completed the EsoBiotec purchase in May 2025 for up to USD 1.0 billion, including USD 425 million upfront [11]. AbbVie closed the Capstan Therapeutics deal in August 2025 [12], valued at USD 2.1 billion [13]. Kite agreed to buy Interius BioTherapeutics for USD 350 million [14], and Bristol Myers Squibb agreed to buy Orbital Therapeutics for USD 1.5 billion [15]. Eli Lilly and Company agreed in February 2026 to buy Orna Therapeutics for up to USD 2.4 billion [16], then Kelonia for up to USD 7.0 billion in April [3]. Lilly completed both deals in the second quarter of 2026 [17]. Together, the six deals carry headline values of up to USD 14,350 million. These prices reflect the 16.3-fold rise in market value that FMI projects to 2036, and trial funding is likely to stay steady through the late 2020s. New programs are already moving, with Umoja expecting first VIBRANT-1 dosing of UB-VV400 in the third quarter of 2026 [18]. Public funders are active too, as AMED selected an academic glioblastoma CAR-T program in Japan in June 2026 [19].

Table 2: Patient Data, Ex Vivo Sales and Platform Deal Indicators for the In Vivo CAR-T Cell Therapy Market (patients, response rates, trial sites, approvals and USD values), mixed reporting years from 2025 to 2026

Indicator	Data Point	Market Relevance	Source
ESO-T01 Phase 1 results	Responses in four of five patients; three stringent complete remissions; grade 3 or higher events in all five	Strong responses draw sponsors, and side effects keep dosing in specialist centers.	[1]
KLN-1010 first-in-human data	All four patients MRD-negative; no grade 3 or higher cytokine release syndrome	Dosing without lymphodepleting chemotherapy can widen the pool of eligible patients.	[2]
KLN-1010 US IND	Cleared January 2026; trial of up to 40 patients adds US sites	Myeloma enrolment widens to more US cancer centers.	[7]
VV169 Phase 1 trial	Up to 40 patients at Mayo Clinic from September 2026	A second US myeloma program is now dosing patients.	[5]
Gilead cell therapy sales	Full-year 2025 total of USD 1,839 million, down 7%	Ex vivo CAR-T revenue sets the spending pool open to in vivo therapies.	[9]
Breyanzi and Abecma revenue	USD 1,358 million, up 82%, and USD 427 million in 2025	Revenue from CAR-T in B-cell cancer and myeloma keeps growing.	[8]
FDA REMS removal	June 2025; six autologous CAR-T products; two-week monitoring and stay near care	New centers can give CAR-T with fewer barriers.	[10]
AstraZeneca and EsoBiotec deal	Completed May 2025; up to USD 1.0 billion, USD 425 million upfront	The ESO-T01 lentiviral platform joins a large pharma pipeline.	[11]
Lilly and Kelonia deal	Deal value up to USD 7.0 billion, with USD 3.25 billion upfront, April 2026	Large-company funding supports later-stage lentiviral trials.	[3]
Rimqarto approval in South Korea	MFDS approval April 2026; 67.1% complete response rate	Hospitals in the fastest-growing country gain more CAR-T experience.	[6]
UB-VV400 IND	Cleared July 2026; first patient dosing expected in Q3 2026	In vivo CAR-T reaches a CD22 target for patients who relapse after CD19 therapy.	[18]

Table 3: Ex Vivo Sales Benchmarks and In Vivo Platform Deal Values for the In Vivo CAR-T Cell Therapy Market (USD million, percentage and multiples), 2025 to 2036, mixed years

Metric	Value	Source
In vivo CAR-T market 2026	USD 180.0 million	Future Market Insights
In vivo CAR-T market 2036	USD 2,934.9 million	Future Market Insights
Gilead cell therapy sales 2025	USD 1,839 million	[9]
Breyanzi revenue 2025	USD 1,358 million	[8]
Abecma revenue 2025	USD 427 million	[8]
Three ex vivo lines combined 2025	USD 3,624 million	Gilead [9], Bristol Myers Squibb [8]
In vivo market 2026 as share of ex vivo lines	about 5%	Future Market Insights, Gilead [9], Bristol Myers Squibb [8]
In vivo market 2036 as share of ex vivo lines	about 81%	Future Market Insights, Gilead [9], Bristol Myers Squibb [8]
AstraZeneca and EsoBiotec	Up to USD 1,000 million	[11]
AbbVie and Capstan Therapeutics	USD 2,100 million	[13]
Kite and Interius BioTherapeutics	USD 350 million	[14]
Bristol Myers Squibb and Orbital Therapeutics	USD 1,500 million	[15]
Eli Lilly and Company and Kelonia Therapeutics	Up to USD 7,000 million	[3]
Eli Lilly and Company and Orna Therapeutics	Up to USD 2,400 million	[16]
Headline deal value total	Up to USD 14,350 million	Deal announcements [11] [13] [14] [15] [3] [16]
Deal total as multiple of 2026 market	about 80 times	Future Market Insights, deal announcements [11] [13] [14] [15] [3] [16]
Deal total as multiple of 2036 market	about 4.9 times	Future Market Insights, deal announcements [11] [13] [14] [15] [3] [16]
Market growth 2026 to 2036	16.3-fold	Future Market Insights

Analyst Perspective

“Cancer centers will move from trial use to routine adoption of in vivo CAR-T once the first products carry an approved label and steady safety data. Developers that can supply consistent vector lots to many sites at once are set to gain the larger share of growth through 2036.”

- Anurag Sharma, Principal Consultant, Future Market Insights.

How is the in vivo CAR-T cell therapy market segmented?

The in vivo CAR-T cell therapy market is organised across vector platform, target antigen, indication, end user and region. For 2026, FMI places lentiviral vector particles at 48.7%, CD19 at 34.8%, B-cell malignancies at 28.7% and specialty cancer centers at 44.3%.

By vector platform: lentiviral vector particles, lipid nanoparticle mRNA delivery, adeno-associated viral vectors, and targeted protein nanocarriers.

By target antigen: CD19, BCMA, CD20, CD22, and multi-antigen targets.

By indication: B-cell malignancies, multiple myeloma, autoimmune diseases, and solid tumors.

By end user: specialty cancer centers, hospitals and transplant centers, and academic research institutes.

By region: North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia and Pacific, and Middle East and Africa.

Why do lentiviral vector particles hold the top vector platform position?

Nearly half of vector platform demand in 2026, at 48.7%, goes to lentiviral vector particles, owing to lasting CAR expression from one dose.

Table 4: Vector Platform Share for the In Vivo CAR-T Cell Therapy Market (percentage share), 2026

Vector Platform	Share (2026)
Lentiviral Vector Particles	48.7%
Other Segments Combined	51.3%
Total	100%

Table 5: Vector Platform Leadership and Market Growth for the In Vivo CAR-T Cell Therapy Market (segment and CAGR percentage), 2026 to 2036

Metric	Value
Global CAGR (2026 to 2036)	32.2%
Leading Segment	Lentiviral Vector Particles

Lentiviral vector particles hold 48.7% of vector platform demand in 2026, the largest share of any delivery route. Sponsors prefer this vector, as the CAR gene enters the T cell genome and modified cells keep dividing after one infusion. Leading myeloma programs such as ESO-T01, KLN-1010 and VV169 use this route and draw on methods from the viral vector development market. In May 2025, AstraZeneca completed the acquisition of EsoBiotec and the targeted lentiviral platform for up to USD 1.0 billion [11]. Lipid nanoparticle mRNA delivery is the main alternative, with Capstan, now part of AbbVie, aiming a shorter-lived CAR at autoimmune disease [12]. FMI expects lentiviral particles to stay ahead through 2036 as more programs open multi-site trials.

• A single vial dose with stable gene insertion keeps lentiviral vector particles at a 48.7% share in 2026.
• Each lentiviral lot can supply many patients, so treatment centers review vector titer and lot-to-lot consistency before adoption.

What gives CD19 the largest target antigen share?

CD19 programs take 34.8% of target antigen demand in 2026, with use spanning lymphoma and autoimmune disease.

CD19 leads the target antigen segment with 34.8% of demand in 2026, as the same marker serves hematologists treating B-cell cancers and rheumatologists treating autoimmune disease. In August 2025, AbbVie completed the purchase of Capstan Therapeutics, adding CPTX2309, a targeted lipid nanoparticle therapy that makes CD19-directed CAR-T cells inside the body [12]. BCMA ranks next on the strength of early data in multiple myeloma. Adoption of CD19-directed in vivo CAR-T is likely to widen as lupus and related programs reach patients.

• Use across both cancer and autoimmune programs gives CD19 a 34.8% share of target antigen demand in 2026.
• Rheumatology clinics entering CD19 trials will need CAR-T safety training and fast access to intensive care beds.

Why do B-cell malignancies stay ahead among indications?

B-cell malignancies capture 28.7% of indication demand in 2026, as hematologists already use CAR-T in these cancers.

B-cell malignancies account for 28.7% of indication demand in 2026, the largest share among disease groups. Hematologists in this field already give ex vivo CAR-T and other adoptive cell therapy for cancer treatment options, so early in vivo responses are judged quickly. Patients relapsing after CD19-directed treatment form a ready group for new targets. In July 2026, Umoja Biopharma received FDA IND clearance for CD22-directed UB-VV400, with the VIBRANT-1 study open to patients who progressed after prior CAR-T [18]. Multiple myeloma follows with the strongest early in vivo data, and the share of this indication is expected to rise as BCMA programs advance.

• B-cell malignancies hold 28.7% share in 2026, as hematologists in this field already manage CAR-T patients and side effects.
• Relapse after CD19 treatment opens room for CD22 and multi-antigen products, which are set to gain share as second-line trials enrol.

Why do specialty cancer centers place the largest share of end user orders?

Specialty cancer centers account for 44.3% of end user demand in 2026, owing to early in vivo trial activity at these sites.

Specialty cancer centers account for 44.3% of end user demand in 2026, as these sites already manage cytokine release syndrome and neurotoxicity after CAR-T. In September 2026, Vyriad began a Phase 1 trial of BCMA-directed VV169 at Mayo Clinic for up to 40 patients after the FDA accepted the IND [5]. Hospitals and transplant centers are expected to adopt later, once product labels and payment terms are settled. The June 2025 FDA removal of REMS rules for six approved autologous CAR-T products is also making CAR-T easier to give at new centers [10].

• Specialty cancer centers account for 44.3% share in 2026, and this share is expected to ease as hospitals and transplant centers adopt after the first approvals.
• Approved CAR-T rules require patients to stay near the treatment site for two weeks after infusion, adding to center planning [10].

What are the drivers, restraints, and opportunities in the in vivo CAR-T cell therapy market?

Off-the-shelf dosing draws sponsors and centers to in vivo CAR-T, serious side effects slow wider adoption, and autoimmune programs open a second patient group through 2036.

• Driver: Adoption of in vivo CAR-T cell therapy is rising, as centers seek ready-made doses that need no cell collection or per-patient manufacturing.
• Restraint: Serious adverse events after infusion are the top challenge for in vivo CAR-T developers, due to which each patient needs close monitoring inside specialist centers.
• Opportunity: Key opportunities in the in vivo CAR-T market lie beyond cancer, as CD19 programs in lupus and other autoimmune diseases add rheumatology clinics as new adopters.

Ready-made Doses Draw Sponsors

Developers are moving to in vivo CAR-T, as a single vector lot can treat many patients without cell collection or a manufacturing slot for each person. Kelonia reported in December 2025 that CAR-T cells expanded in patients given KLN-1010 without lymphodepleting chemotherapy [2]. Vector and nanoparticle lots for these trials draw on suppliers in the cell therapy manufacturing market. Shorter waits between diagnosis and dosing are expected to bring more myeloma and lymphoma patients into in vivo trials through the late 2020s.

Side Effects Keep Dosing in Specialist Hands

Serious adverse events after infusion are slowing the move from trials to routine use. All five ESO-T01 patients had grade 3 or higher adverse events, and three had grade 3 cytokine release syndrome [1]. Centers giving these doses keep buying supportive care from the cytokine release syndrome management market and keep intensive care beds on hand. However, Kelonia reported no grade 3 or higher cytokine release syndrome in the first four patients, so safety results differ by platform [2]. Hospitals outside specialist networks are likely to wait for larger safety data sets before adoption.

Autoimmune Programs Add a Second Patient Group

CD19-directed in vivo CAR-T can reset B cells in lupus and related diseases, adding rheumatology patients to the cancer base. In July 2026, CREATE Medicines gained Australian ethics approval for a Phase 1/2 trial of CRT-402 in lupus, systemic sclerosis and inflammatory myopathies [20]. Bristol Myers Squibb also agreed in October 2025 to buy Orbital Therapeutics for USD 1.5 billion, gaining an RNA-based CD19 CAR program for autoimmune disease [15]. Rheumatology clinics are expected to become new adopters once these trials report results.

Which country CAGRs are profiled in the in vivo CAR-T cell therapy market?

South Korea leads the five profiled countries with a 39.1% CAGR over 2026 to 2036, and Japan posts the lowest rate at 24.7% through 2036. Growth in each market follows regulator approvals, trial clearances and payer decisions on CAR-T vectors given by infusion.

Table 6: Country CAGRs and Primary Growth Levers for the In Vivo CAR-T Cell Therapy Market (CAGR percentage), 2026 to 2036

Country	CAGR (2026-2036)	Primary Growth Lever
South Korea	39.1%	Law change for gene delivery inside the body
USA	38.5%	FDA trial clearances at cancer centers
UK	34.3%	Updated trial rules at NHS specialist hospitals
Germany	31.6%	Pricing against hospital-made CAR-T
Japan	24.7%	Local trial data ahead of PMDA filings

Source: Future Market Insights

South Korea In Vivo CAR-T Cell Therapy Market Outlook (2026-2036)

Korean adoption of in vivo CAR-T is set for a 39.1% CAGR through 2036, the highest of any profiled country. On 13 March 2026, the National Assembly Health and Welfare Committee passed a bill that counts genetic material as part of human cells [21]. The bill brings gene therapy given inside the body under the regenerative medicine law, pending Legislation and Judiciary Committee review and a full Assembly vote. Hematology centers gained the first home-grown CAR-T product when MFDS approved Curocell's Rimqarto in April 2026 [6]. More than 10 Korean drug developers, Curocell among them, were working on in vivo CAR-T by June 2026, and most compete on in-house delivery platforms [22].

Key takeaway: Final passage of the gene therapy bill would let Korean hospitals and developers start in vivo CAR-T studies at home.

USA In Vivo CAR-T Cell Therapy Market Outlook (2026-2036)

The USA ranks second in the country table at a 38.5% CAGR through 2036. Demand for in vivo CAR-T trials is building at US cancer centers as FDA clearances arrive. Kelonia's KLN-1010 study expanded to US sites in January 2026 [7], and Umoja's CD22-directed UB-VV400 was cleared in July 2026 [18]. Vector makers gained room to adjust production in January 2026, when the FDA set out a flexible approach to manufacturing and quality requirements for small-batch cell and gene therapies [23]. However, patients given approved CAR-T still stay near the treatment center for two weeks after infusion [10], so early in vivo use will stay at large academic sites.

Key takeaway: FDA clearances for new US trial sites will set the pace of early American adoption.

UK In Vivo CAR-T Cell Therapy Market Outlook (2026-2036)

Adoption of in vivo CAR-T in the UK is set to rise at a 34.3% CAGR through 2036, the third-fastest rate of the five. In November 2025, NICE recommended the UK-developed AUCATZYL from Autolus for NHS patients in England and Wales. The recommendation covers adults aged 26 and over with relapsed or refractory B-cell acute lymphoblastic leukaemia [24]. Sponsors opening early in vivo studies at NHS specialist hospitals now work under updated clinical trial regulations, in force since 28 April 2026, with new model research agreements [25].

Key takeaway: Faster study set-up at NHS specialist hospitals offers the clearest path to UK growth.

Germany In Vivo CAR-T Cell Therapy Market Outlook (2026-2036)

Revenue from in vivo CAR-T in Germany is forecast at a 31.6% CAGR through 2036, just below the global rate. Hospital-made CAR-T competes on price with in vivo products in the German market. Heidelberg University Hospital became the first German hospital with a special licence to make CAR-T cells, for the Heidi-cel product, in February 2026 [26]. Approved CAR-T products launched in Germany at EUR 282,000 to EUR 420,000 per dose, and list prices fell by 18.3% on average after AMNOG price talks [27].

Key takeaway: Launch prices measured against hospital-made cells will shape German adoption of in vivo CAR-T.

Japan In Vivo CAR-T Cell Therapy Market Outlook (2026-2036)

Japan is set for a 24.7% CAGR through 2036, the lowest in the table, as hospitals wait for local trial data and PMDA approval. Japan's national health insurance lists Novartis's Kymriah at about JPY 33.5 million per patient, a price set in May 2019 [28]. Developers of one-dose in vivo CAR-T will price against that figure in Japan. Public research money is going to academic CAR-T projects, such as an AMED-selected glioblastoma program from June 2026 [19].

Key takeaway: Japanese hospitals will hold back adoption until local in vivo trial data support a PMDA filing.

Who are the notable companies in the in vivo CAR-T cell therapy market?

AbbVie, Gilead Sciences, AstraZeneca, Bristol Myers Squibb, Umoja Biopharma, Kelonia Therapeutics, Vyriad, CREATE Medicines, Orna Therapeutics, and Azalea Therapeutics are the key companies profiled in this market.

Ownership of in vivo CAR-T platforms is moving to large drug makers, and smaller developers compete on clinical data and in-house vector supply. Kite, a Gilead company, agreed in August 2025 to buy Interius BioTherapeutics for USD 350 million [14]. Eli Lilly and Company completed the Kelonia and Orna deals in the second quarter of 2026 [17]. Umoja Biopharma, Vyriad and CREATE Medicines remain independent, with Umoja running a lentiviral vector plant in Louisville, Colorado [18]. As per FMI, treatment centers that approve one product for internal protocols are likely to be slow to switch suppliers.

• Large pharmaceutical acquirers: AbbVie, Gilead Sciences, AstraZeneca, and Bristol Myers Squibb added in vivo platforms through 2025 deals and are now building clinical records.
• Lentiviral program developers: Umoja Biopharma, Kelonia Therapeutics, and Vyriad, with Kelonia now owned by Eli Lilly and Company and the other two still independent.
• RNA and gene-insertion developers: CREATE Medicines, Orna Therapeutics, and Azalea Therapeutics treat delivery technology as the main asset, which is set to draw further partnerships.

Competitive Benchmarking: In Vivo CAR-T Cell Therapy Market

Table 7: Competitive Benchmarking for the In Vivo CAR-T Cell Therapy Market (qualitative capability ratings), 2026

Company	Human Data	Antigen Range	Vector Supply	Reach
AbbVie	Medium	Medium	Low	High
Gilead Sciences	Medium	Medium	Low	High
AstraZeneca	High	Medium	Low	High
Bristol Myers Squibb	Low	Medium	Low	High
Umoja Biopharma	Medium	High	High	Medium
Kelonia Therapeutics	High	Medium	Low	Medium
Vyriad	Medium	Medium	Medium	Low
CREATE Medicines	Medium	High	Low	Medium
Orna Therapeutics	Low	High	Low	Medium
Azalea Therapeutics	Low	Low	Low	Low

High means several documented programs or disclosures for that criterion, Medium means one documented example, and Low means limited public documentation.

Key Developments in the In Vivo CAR-T Cell Therapy Market

• In September 2026, Vyriad began a Phase 1 trial of BCMA-directed VV169 at Mayo Clinic after FDA acceptance of the IND [5].
• CREATE Medicines formed a research and licensing collaboration with WestGene in August 2026 for targeted lipid nanoparticle delivery, covering dual CD19 and BCMA programs [29].
• In July 2026, Umoja Biopharma gained FDA IND clearance for CD22-directed UB-VV400 and plans to run the Phase 1/2 VIBRANT-1 study [18].
• Eli Lilly and Company agreed in April 2026 to acquire Kelonia Therapeutics for up to USD 7.0 billion, including USD 3.25 billion upfront [3]. The new funding is expected to move KLN-1010 toward registration trials.

Key Players in the In Vivo CAR-T Cell Therapy Market

Large Pharmaceutical Acquirers

• AbbVie Inc.
• Gilead Sciences, Inc.
• AstraZeneca PLC
• Bristol-Myers Squibb Company

Lentiviral Program Developers

• Umoja Biopharma
• Kelonia Therapeutics
• Vyriad

RNA and Gene-Insertion Developers

• CREATE Medicines
• Orna Therapeutics
• Azalea Therapeutics

In Vivo CAR-T Cell Therapy Market - Report Scope

Table 8: Report Scope for the In Vivo CAR-T Cell Therapy Market (coverage fields and definitions), 2026 to 2036

Coverage field	Report scope
Market breakdown	Vector platform; target antigen; indication; end user; region
Quantitative units	USD million
Market definition	Net sales of administered vector or nanocarrier drug products that generate CAR-T cells inside patients, with bundled delivery components counted once. The scope excludes ex vivo engineered cell products, non-T-cell therapies, general-purpose reagents, separately billed services, licensing and acquisition payments, and downstream care charges.
Regions covered	North America; Latin America; Western Europe; Eastern Europe; East Asia; South Asia and Pacific; Middle East and Africa
Countries covered	South Korea; USA; UK; Germany; Japan
Key companies profiled	AbbVie, Gilead Sciences, AstraZeneca, Bristol Myers Squibb, Umoja Biopharma, Kelonia Therapeutics, Vyriad, CREATE Medicines, Orna Therapeutics, Azalea Therapeutics
Forecast period	2026 to 2036
Approach	Bottom-up build from trial sites, dosing volumes and expected approval dates, checked top-down against ex vivo CAR-T sales and price benchmarks in each profiled country.

In Vivo CAR-T Cell Therapy Market - Research Methodology

Table 9: Research Methodology for the In Vivo CAR-T Cell Therapy Market (research methods and approach), 2026 edition

Method	Approach
Primary Research	Analysts interviewed in vivo CAR-T developers, hematologists, rheumatologists, cell therapy center managers, vector suppliers and trial sponsors on dosing, safety monitoring, expected pricing and site set-up.
Desk Research	Sources include regulator decisions, peer-reviewed trial results, company releases and filings, trial registries and health technology assessment guidance.
Market Sizing and Forecasting	The 2025 base value is combined with trial enrolment, expected approval timing, ex vivo CAR-T price benchmarks, segment shares and country treatment capacity to build the forecast.
Data Validation	Estimates are cross-checked against company disclosures, regulator records and interview findings. Ex vivo cell products, licensing income and acquisition payments are excluded to avoid double counting.

In Vivo CAR-T Cell Therapy Market by Segments

In Vivo CAR-T Cell Therapy Market segmented by Vector Platform:

• Lentiviral vector particles
• Lipid nanoparticle mRNA delivery
• Adeno-associated viral vectors
• Targeted protein nanocarriers

In Vivo CAR-T Cell Therapy Market segmented by Target Antigen:

• CD19
• BCMA
• CD20
• CD22
• Multi-antigen targets

In Vivo CAR-T Cell Therapy Market segmented by Indication:

• B-cell malignancies
• Multiple myeloma
• Autoimmune diseases
• Solid tumors

In Vivo CAR-T Cell Therapy Market segmented by End User:

• Specialty cancer centers
• Hospitals and transplant centers
• Academic research institutes

In Vivo CAR-T Cell Therapy Market by Region

• North America
  • United States
  • Canada
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Chile
• Western Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Benelux
  • Nordics
• Eastern Europe
  • Poland
  • Czech Republic
  • Romania
  • Hungary
• East Asia
  • Japan
  • South Korea
• South Asia and Pacific
  • ASEAN
  • Australia and New Zealand
• Middle East and Africa
  • GCC Countries
  • South Africa
  • Türkiye
  • Israel

Research Sources and Bibliography

• [1] Nature Medicine (An, N., Wang, D., Zhang, P., et al.). (2026, March). In vivo generation of anti-BCMA CAR-T cells in relapsed or refractory multiple myeloma: a phase 1 study.https://www.nature.com/articles/s41591-026-04244-6
• [2] Kelonia Therapeutics. (2025, December). Kelonia Therapeutics Presents First-in-Human Data From Phase 1 inMMyCAR Study of KLN-1010 in vivo BCMA CAR-T Therapy at the American Society of Hematology (ASH) 2025 Annual Meeting.https://www.businesswire.com/news/home/20251209935959/en/Kelonia-Therapeutics-Presents-First-in-Human-Data-From-Phase-1-inMMyCAR-Study-of-KLN-1010-in-vivo-BCMA-CAR-T-Therapy-at-the-American-Society-of-Hematology-ASH-2025-Annual-Meeting
• [3] Eli Lilly and Company. (2026, April). Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies.https://investor.lilly.com/node/54136
• [4] CGTLive. (2025, October). Umoja Biopharma's In Situ CAR-T Therapy UB-VV111 Fast Tracked for Several B-Cell Malignancy Indications.https://cgtlive.com/view/umoja-biopharma-in-situ-car-t-therapy-ub-vv111-fast-tracked-several-b-cell-malignancy-indications
• [5] Vyriad. (2026, September). Vyriad Begins Phase 1 Clinical Trial for Lead In Vivo CAR T Cell Therapy VV169 Following FDA Acceptance of IND Application.https://vyriad.com/newsevents/vyriad-begins-phase-1-clinical-trial-for-lead-in-vivo-car-t-cell-therapy-vv169-following-fda-acceptance-of-ind-application/
• [6] Curocell. (2026, April). Curocell's RIMQARTO Inj. Wins Full Regulatory Approval, Poised to Enter CAR-T Market with 67% Complete Response Rate.https://www.businesswire.com/news/home/20260429207749/en/Curocells-RIMQARTO-Inj.-Wins-Full-Regulatory-Approval-Poised-to-Enter-CAR-T-Market-with-67-Complete-Response-Rate
• [7] Kelonia Therapeutics. (2026, January). Kelonia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KLN-1010, an in vivo BCMA CAR-T Therapy for Relapsed and Refractory Multiple Myeloma.https://www.businesswire.com/news/home/20260107179212/en/Kelonia-Therapeutics-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-KLN-1010-an-in-vivo-BCMA-CAR-T-Therapy-for-Relapsed-and-Refractory-Multiple-Myeloma
• [8] Bristol Myers Squibb. (2026, February). Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2025 (Form 8-K, Exhibit 99.1).https://www.sec.gov/Archives/edgar/data/14272/000001427226000002/a2025q4ex991.htm
• [9] Gilead Sciences. (2026, February). Gilead Sciences Announces Fourth Quarter and Full Year 2025 Financial Results.https://www.businesswire.com/news/home/20260210935221/en/Gilead-Sciences-Announces-Fourth-Quarter-and-Full-Year-2025-Financial-Results
• [10] U.S. Food and Drug Administration. (2025, June). FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies.https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
• [11] AstraZeneca. (2025, May). Acquisition of EsoBiotec completed (Form 6-K).https://www.sec.gov/Archives/edgar/data/0000901832/000165495425005901/a3029j.htm
• [12] AbbVie. (2025, August). AbbVie Completes Acquisition of Capstan Therapeutics.https://news.abbvie.com/2025-08-19-AbbVie-Completes-Acquisition-of-Capstan-Therapeutics
• [13] Drug, Chemical & Associated Technologies Association (DCAT). (2025, August). AbbVie Completes $2.1-Bn Acquisition of Capstan Therapeutics.https://www.dcatvci.org/top-industry-news/abbvie-completes-2-1-bn-acquisition-of-capstan-therapeutics/
• [14] Fierce Biotech. (2025, August). Gilead's Kite sails into in vivo CAR-T space with $350M Interius buyout.https://www.fiercebiotech.com/biotech/gileads-kite-sails-vivo-car-t-space-350m-interius-buyout
• [15] Bristol Myers Squibb. (2025, October). Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics.https://www.businesswire.com/news/home/20251009968216/en/Bristol-Myers-Squibb-Strengthens-and-Diversifies-Cell-Therapy-Portfolio-with-Acquisition-of-Orbital-Therapeutics
• [16] Eli Lilly and Company. (2026, February). Lilly to acquire Orna Therapeutics to advance cell therapies.https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-orna-therapeutics-advance-cell-therapies
• [17] Eli Lilly and Company. (2026, August). Lilly reports second-quarter 2026 financial results, raises full-year guidance, and highlights continued growth and pipeline progress (Form 8-K exhibit).https://www.sec.gov/Archives/edgar/data/0000059478/000005947826000077/q226lillysalesandearningsp.htm
• [18] Umoja Biopharma. (2026, July). Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry's First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies.https://www.biospace.com/press-releases/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv400-the-industrys-first-known-cd22-directed-in-vivo-car-t-cell-therapy-for-relapsed-refractory-b-cell-malignancies
• [19] Research Institute for Cell Design Medical Science, Yamaguchi University. (2026, June). Research and Development of Next-Generation CAR-T Cell Therapy for Malignant Brain Tumor (Glioblastoma) selected by AMED.https://ds0n.cc.yamaguchi-u.ac.jp/~celldesign/en_news/260602en/
• [20] CREATE Medicines. (2026, July). CREATE Medicines Receives Approval to Initiate First-in-Human Phase 1/2 Clinical Trial of In Vivo CAR-T Candidate CRT-402 for Autoimmune Diseases.https://www.biospace.com/press-releases/create-medicines-receives-approval-to-initiate-first-in-human-phase-1-2-clinical-trial-of-in-vivo-car-t-candidate-crt-402-for-autoimmune-diseases
• [21] The Asia Business Daily (Asiae). (2026, April). Big Pharma and Biotech Firms Eye 'In-Vivo CAR-T'... One Step Closer to Legalization.https://view.asiae.co.kr/en/article/2026033117494547009
• [22] BizWatch. (2026, June). 'Making anticancer drugs inside the body': in vivo CAR-T development heats up (in Korean).https://news.bizwatch.co.kr/article/healthcare/2026/06/17/0038
• [23] U.S. Food and Drug Administration. (2026, January). FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation.https://fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation
• [24] Autolus Therapeutics. (2025, November). NICE Recommends AUCATZYL (obecabtagene autoleucel) as a Treatment Option for Adult Patients (≥26 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL).https://autolus.gcs-web.com/news-releases/news-release-details/nice-recommends-aucatzylr-obecabtagene-autoleucel-treatment
• [25] Health Research Authority. (2026, April). Clinical trials regulations: a round-up of HRA operational changes.https://www.hra.nhs.uk/about-us/news-updates/clinical-trials-regulations-a-round-up-of-hra-operational-changes/
• [26] Heidelberg University Hospital. (2026, February). First German hospital with special manufacturing license for CAR-T cells.https://www.heidelberg-university-hospital.com/24022026-first-german-hospital-with-special-manufacturing-license-for-car-t-cells/
• [27] ISPOR Europe 2024, Value in Health (Cullen, K., Owens-Smith, I.). (2024, December). The Cost of Innovation: Evaluating the Evolution of Willingness-to-Pay for CAR-T Therapies in Germany.https://www.ispor.org/heor-resources/presentations-database/presentation/euro2024-4018/144884
• [28] PHARMA JAPAN (Jiho). (2019, May). Kymriah Gets 33.5 Million Yen Price Tag, Peak Sales Put at 7.2 Billion Yen.https://pj.jiho.jp/node/239968
• [29] CREATE Medicines (via Eastern Progress newswire). (2026, August). CREATE Medicines Expands Clinical In Vivo CAR Pipeline and LNP Technology Suite by Forming Strategic Collaboration with WestGene.https://www.easternprogress.com/create-medicines-expands-clinical-in-vivo-car-pipeline-and-lnp-technology-suite-by-forming-strategic/article_aaffa8eb-a640-5d26-900a-ee2b542ef9a2.html
• [30] Azalea Therapeutics (via Eagle-Tribune newswire). (2026, May). Azalea Therapeutics Announces Late-Breaking Oral Presentation at ASGCT Annual Meeting.https://www.eagletribune.com/region/azalea-therapeutics-announces-late-breaking-oral-presentation-at-asgct-annual-meeting/article_85f49ac8-b08c-5d12-9d32-9cf36170bb3a.html

This bibliography is provided for reader reference. The full report contains the complete reference list and detailed citations.

This Report Answers

• What is the size of the in vivo CAR-T cell therapy market in 2026?
• By 2036, what value will in vivo CAR-T cell therapy sales reach?
• Which vector platform holds the largest share of in vivo CAR-T demand, and why?
• Why do CD19 programs and B-cell malignancies lead early in vivo CAR-T use?
• Which profiled country shows the fastest in vivo CAR-T growth through 2036?
• Who are the leading drug makers and developers in the in vivo CAR-T market?