Idecabtagene Vicleucel

DUBLIN--(BUSINESS WIRE)--The "CAR T-Cell Therapy for Multiple Myeloma Market - A Global and Regional Analysis: Focus on Product, End User, and Region - Analysis and Forecast, 2025-2035" has been added to ResearchAndMarkets.com's offering. The chimeric antigen receptor (CAR) T-cell therapy has emerged as a groundbreaking treatment modality, offering new hope for patients with relapsed or refractory multiple myeloma (RRMM). Building upon traditional treatments such as autologous stem cell transplantation and monoclonal antibody therapies, CAR T-cells are engineered to recognize and destroy myeloma cells by targeting specific surface antigens. The recent approval of two CAR T-cell therapies - Abecma and Carvykti - by the FDA has demonstrated promising clinical outcomes, including high response rates and improved survival in heavily pretreated patients. Ongoing clinical trials continue to investigate novel CAR constructs, combination strategies, and earlier-line use to further enhance efficacy and overcome existing limitations such as high costs, manufacturing complexity, and side effect profiles. These developments signal a transformative shift in Multiple myeloma treatment and pave the way for more personalized and effective therapeutic approaches. The CAR T-Cell Therapy for Multiple Myeloma market is primarily driven by the high efficacy of BCMA-targeted therapies such as Abecma and Carvykti, which have demonstrated deep, durable responses in relapsed or refractory cases, significantly outperforming traditional treatment options. Additionally, the rising global incidence of multiple myeloma, particularly among aging populations, is increasing the demand for advanced, personalized treatment approaches. Regulatory agencies like the FDA and EMA are further propelling market growth by granting fast-track approvals and priority designations to CAR T therapies, recognizing their transformative potential. Moreover, substantial investments from pharmaceutical giants and biotech firms in manufacturing capabilities, research and development, and clinical infrastructure are accelerating the commercialization and accessibility of CAR T-cell therapies worldwide. Despite its therapeutic promise, the CAR T-Cell Therapy for Multiple Myeloma market faces several significant challenges. One of the most pressing issues is the high cost of treatment, often exceeding USD 400,000 per patient, which poses substantial reimbursement hurdles and limits affordability - particularly in low- and middle-income countries. The complex and individualized manufacturing process further adds to the burden, creating supply chain bottlenecks and scalability issues that hinder widespread adoption. Additionally, CAR T-cell therapies are associated with severe side effects such as cytokine release syndrome (CRS) and neurotoxicity, necessitating intensive care and restricting use to highly specialized treatment centres. In many developing regions, limited healthcare infrastructure, a shortage of trained personnel, and low awareness further constrain market expansion and equitable access. The competitive landscape of the global CAR T-Cell Therapy for Multiple Myeloma market is rapidly advancing, fuelled by increasing demand for precision oncology treatments and breakthroughs in cell and gene therapy. The market, once limited to conventional therapies such as immunomodulatory drugs and proteasome inhibitors, is now witnessing a surge in innovation with the approval and commercialization of BCMA-targeted CAR T-cell products like Abecma and Carvykti. Leading biopharmaceutical companies, including Bristol-Myers Squibb, Johnson & Johnson (Legend Biotech), Novartis, and Gilead Sciences, are actively expanding their pipelines and scaling manufacturing capabilities to meet rising global demand. Additionally, emerging biotech firms and academic spin-offs are entering the space with next-generation and allogeneic CAR T constructs, further intensifying competition. The growing number of strategic partnerships, licensing agreements, and M&A activities reflects a dynamic market environment focused on improving access, reducing production timelines, and enhancing therapeutic durability. As regulatory bodies worldwide offer accelerated pathways and supportive frameworks, the market is poised for robust expansion, especially as CAR T-cell therapies move into earlier lines of treatment and explore novel antigen targets beyond BCMA. The CAR T-Cell Therapy for Multiple Myeloma market holds substantial growth potential, particularly through expansion in emerging markets such as India, China, and Latin America. Improvements in clinical infrastructure and local regulatory approvals - like NexCAR19 in India - are paving the way for greater access in cost-sensitive regions. Additionally, there is increasing momentum in diversifying the therapeutic pipeline beyond BCMA, with new targets like GPRC5D and FcRH5 offering treatment options for patients who relapse after BCMA-based therapies. Advancements in manufacturing technologies, including automation, closed-loop systems, and point-of-care platforms, promise to enhance scalability and reduce turnaround times. Furthermore, integrating CAR T-cell therapy with combination treatments - such as checkpoint inhibitors or monoclonal antibodies - presents a promising strategy to extend response durability and reduce the risk of relapse, thereby broadening the clinical utility of these therapies. Market Segmentation Segmentation 1: by Product Segmentation 2: by End Users Segmentation 3: by Region Companies Profiled For more information about this report visit https://www.researchandmarkets.com/r/2y4leu About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

The European Commission cleared a fourth indication for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), this time to treat adults with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy, including a BTK inhibitor. Highlighting that a large proportion of patients who experience a relapse or are resistant to front-line therapies carry a diminished survival outlook, Emma Charles, senior VP of Europe region at  BMS said, “Breyanzi has the opportunity to address a treatment gap for this patient population.”The latest approval is supported by data from the MCL cohort of the Phase I TRANSCEND NHL 001 trial, wherein the CD19-directed CAR T cell therapy demonstrated an overall response rate (ORR) of 82.7% and a complete response rate of 71.6%, achieving the study's primary and key secondary goals, respectively. Responses, moreover, proved durable, with 50.8% of patients maintaining response at 24 months.Breyanzi holds previous EU authorisations to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) who relapse within 12 months of, or are refractory to, first-line chemoimmunotherapy. It is further approved for adults with relapsed or refractory DLBCL, PMBCL, FL3B, or FL after two or more prior systemic therapies.Eyeing yet another approval for the CAR-T therapy in relapsed or refractory marginal zone lymphoma, the company reported positive results from the TRANSCEND FL study in June, demonstrating an ORR of 95.5%. The treatment is currently under priority FDA review for the same, with a decision expected next month.Breyanzi, which brought in $747 million in sales last year, remains a key growth driver for BMS, alongside the multiple myeloma therapy Abecma (idecabtagene vicleucel).