Report Highlights

CAR T cell therapy in the U.S.: Market Overview

The U.S. CAR T cell therapy market was valued at USD 3.42 billion in 2024, with six FDA-approved autologous products regulated by the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration. Kymriah and Yescarta, approved in 2017, created the category, followed by Tecartus, Breyanzi, Abecma and Carvykti. Private firms have led commercial development: Gilead Sciences through Kite, Novartis, Bristol Myers Squibb and Johnson & Johnson's Janssen unit hold most product revenue, while government shapes the market through payment rules rather than manufacturing.

Government has been the dominant force on the demand side. CMS created Medicare Severity Diagnosis Related Group (MS-DRG) 018 in the FY2019 Inpatient Prospective Payment System final rule to pay hospitals for CAR T administration, and Medicaid covers the therapy through the Medicaid Drug Rebate Program. Academic medical centers drove early clinical adoption, while the 21st Century Cures Act of 2016 created the Regenerative Medicine Advanced Therapy (RMAT) designation that accelerated the pipeline into approval.

Policy-driven growth in U.S. CAR T therapies

Three mechanisms drive demand. First, Section 3033 of the 21st Century Cures Act created RMAT designation, enabling rolling review and priority review for cell therapies that show serious-condition benefit. Second, the Inflation Reduction Act of 2022 broadened the orphan drug exclusion from Medicare drug price negotiation through the ORPHAN Cures Act provision, which protects manufacturer returns on CAR T indications with multiple orphan designations such as multiple myeloma and rare lymphomas.

Third, CMS's New Technology Add-on Payment (NTAP) under the Inpatient Prospective Payment System covers 65 percent of costs above the standard MS-DRG payment for eligible CAR T products, which de-risks capacity investment in cellular therapy units. Each mechanism links directly to volume: faster approvals expand indications, orphan exclusion sustains pricing, and NTAP lets hospitals absorb apheresis, manufacturing logistics and neurotoxicity monitoring costs that would otherwise suppress throughput.

Regulatory barriers and compliance costs for U.S. CAR T therapies

The principal barrier until mid-2025 was the Risk Evaluation and Mitigation Strategy (REMS) administered by CBER. Each authorized treatment center had to be certified, staff trained, and patients kept within proximity of the center for several weeks after infusion. The FDA's June 2025 action eliminated the REMS requirement for autologous CAR T products, but the boxed warning for cytokine release syndrome and neurological toxicities remains, and FACT accreditation remains the operating benchmark for cell collection and infusion programs.

Manufacturing and pricing rules add cost. Products are licensed under Section 351 of the Public Health Service Act and 21 CFR Parts 600 through 680, requiring Good Manufacturing Practice compliance and chain-of-identity controls that raise per-dose cost. The Medicaid Drug Rebate Program, administered by CMS, imposes a minimum 23.1 percent basic rebate on innovator products, while hospitals absorb bridging chemotherapy and ICU monitoring costs that the MS-DRG 018 rate does not fully cover.

Policy-created opportunities in U.S. CAR T therapies

The REMS removal creates an opening for community oncology practices. Sites that previously lacked certification capacity can now enter the market, generating demand for accreditation consulting, cell-processing logistics and point-of-care apheresis partnerships. Manufacturers including Kite and Bristol Myers Squibb have a direct commercial incentive to deploy satellite treatment models that retain patients currently referred to academic centers.

CMS's Cell and Gene Therapy Access Model, launched under the CMS Innovation Center for sickle cell disease, establishes outcomes-based contracting that CAR T sponsors can replicate. Participating Medicaid agencies gain a template for value-based agreements, and manufacturers that secure similar state arrangements gain payer access in a Medicaid market that currently lacks a national benchmark for cell therapy pricing.

Market at a Glance

Leading Market Participants

• Gilead Sciences
• Novartis
• Bristol Myers Squibb
• Johnson & Johnson
• Legend Biotech
• Autolus Therapeutics
• Arcellx
• Allogene Therapeutics
• Cabaletta Bio
• Caribou Biosciences

U.S. CAR T cell therapy: Regulatory and Policy Environment

Primary legislation includes the Federal Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act, which together govern biologics licensing. The Biologics Price Competition and Innovation Act of 2009, enacted as part of the Patient Protection and Affordable Care Act of 2010, grants 12 years of reference product exclusivity. CBER administers licensure and REMS, CMS administers the Inpatient Prospective Payment System under Title XVIII of the Social Security Act, and the Office of Inspector General enforces anti-kickback statutes governing hospital-manufacturer arrangements.

The FY2027 IPPS proposed rule, expected in April 2026 with a final rule by August 1, 2026, will set MS-DRG 018 relative weights and NTAP eligibility. FDA's final guidance on CAR T cell product development, issued in January 2024, governs post-approval monitoring. Compared with regional peers, the EU's Regulation (EC) No 1394/2007 on advanced therapy medicinal products and the EU HTA Regulation (EU) 2021/2282, which applied to ATMPs from January 2025 through joint clinical assessments, impose centralized health technology assessment the U.S. lacks, while Japan's PMDA grants conditional approvals earlier.

Long-term policy outlook for U.S. CAR T therapies

By 2032, CMS payment architecture will shift from fixed DRG rates toward outcomes-based contracting, following the template established by the Cell and Gene Therapy Access Model. Kymriah, licensed in 2017, becomes eligible for Medicare negotiation selection in 2028 under the eleven-year biologic threshold, which will compress manufacturer pricing on the earliest approved products.

Competition will reshape through allogeneic and in vivo platforms. Allogene Therapeutics and Caribou Biosciences will pursue approval under the same CBER framework, while bispecific antibodies continue to take later-line myeloma share. Market growth to 2032 will depend on outpatient delivery and payer contracts that reward durable remission rather than per-infusion volume.