Governing Access to Living Medicines: Regulation, Reimbursement and Manufacturing Capacity in CAR T-cell Therapy
Year: 2026
Type: article
Abstract: The CAR T-cell Therapy Market is expanding rapidly, driven by advances in personalised cellular treatments for blood cancers and emerging applications in autoimmune diseases. However, market growth and patient access depend not only on clinical demand but also on regulatory frameworks, reimbursement policies, and manufacturing capacity. This study examines how these institutional factors shape access to CAR T-cell therapy and influence the sector's growth trajectory through 2030. Drawing on Next Move Strategy Consulting's market outlook, regulatory notices, company disclosures, public cancer statistics, and healthcare payment policy documents published between June 2025 and October 2026, the research evaluates the relationship between market expansion and healthcare-system governance. The analysis identifies three major findings. First, market growth is uneven across competing products, reflecting differences in commercial performance, treatment-centre networks, and geographic reach. Second, regulatory changes, including the removal of certain U.S. safety certification requirements in June 2025, alongside European joint clinical assessment and Medicare reimbursement policies, are reshaping the conditions under which hospitals can provide these therapies. Third, emerging in vivo CAR T-cell engineering technologies and major investment transactions could shift the industry's primary constraints from manufacturing capacity toward regulatory evidence and long-term safety governance. The study concludes that treatment-centre capacity, reimbursement timing, manufacturing infrastructure, and long-term safety obligations are critical determinants of market access and investment exposure. It argues that CAR T-cell therapy should be understood not simply as a high-growth therapeutic market, but as a developing system of regulatory, financial, and operational structures that determines who can access these advanced treatments.
DOI: 10.17613/pqded-3zy82
Author: Deb, Sanyukta
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7224963122