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Antibody-Mediated Rejection Market Set to Expand Significantly During the Forecast Period (2025-2034) Amid Advances in Diagnostics and Targeted Therapies | DelveInsight
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The rising number of organ transplants has driven a parallel increase in AMR cases, highlighting the need for better diagnostics, closer monitoring, and innovative therapies. This mounting burden positions AMR as a critical challenge in transplant medicine and a key frontier in drug development.
Improved assays (high-resolution anti-HLA/DSA testing, cell-free DNA, complement activation markers) enable earlier and more precise detection of AMR — driving uptake of monitoring services and treatment interventions, and creating a market for companion diagnostics.
The pipeline features several promising drugs, including (Biogen), (Hansa Biopharma), (Sanofi), (argenx), and (AstraZeneca), among others.
Felzartamab shows strong disease-modifying potential in late AMR, supported by encouraging Phase II results, positioning it as a much-needed, safer, and more effective option in an area with limited treatments.
Management of AMR generally relies on , reflecting the central role of the complement pathway in its pathogenesis. Additional treatment options include anti-CD20 monoclonal antibodies, proteasome inhibitors, and IL-6 inhibitors. In severe or early-onset cases, surgical splenectomy, splenic embolization, or splenic irradiation may be employed as last-resort interventions.
Currently, there are no FDA-approved therapies for AMR, posing a significant challenge in transplant medicine. The lack of robust, randomized clinical trials with meaningful endpoints further complicates progress, and existing therapies often fail to prevent chronic rejection or recurrent AMR adequately. There remains a pressing need for safer, more effective treatments with improved tolerability.
discontinued its kidney transplant trials due to poor enrollment. At the same time, clazakizumab development was terminated in 2024 following the Phase III IMAGINE trial's failure to meet its primary efficacy endpoint in patients with chronic active AMR after kidney transplant. Key players pursuing therapeutic development in this space include , and others.
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Some of the drugs in the pipeline include (Biogen), (Hansa Biopharma), (Sanofi), (argenx), (AstraZeneca), and others.
is an investigational human monoclonal antibody targeting CD38, a protein found on mature plasma cells. It represents a potential first-in-class therapy with broad applicability across various immune-mediated diseases, embodying a "pipeline-in-a-product" approach. Initially developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company), Felzartamab has been exclusively licensed to Human Immunology Biosciences (HI-Bio) for development and commercialization in all regions except China (including Hong Kong , Macau , and Taiwan ). In July 2024 , Biogen acquired HI-Bio. The therapy is currently undergoing evaluation in a Phase III clinical trial.
is a novel antibody-cleaving enzyme derived from that specifically targets IgG, thereby inhibiting IgG-mediated immune responses. It is currently being tested in a Phase III clinical trial in the U.S. for kidney transplantation in highly sensitized patients. A Phase II study (NCT03897205) investigating its use in treating antibody-mediated rejection (AMR) in kidney transplant recipients has been completed. According to the company's pipeline, results from the U.S. Phase III ConfIdeS trial (NCT04935177) are expected in the second half of 2025, while the European Phase III readout for kidney transplant desensitization is anticipated in 2026.
, also known as Riliprubart, is a humanized monoclonal antibody that targets complement component C1s. It is being investigated for the prevention and treatment of AMR and is under evaluation in multiple clinical trials across transplant and neurological indications. A Phase II trial (NCT05156710) is currently in progress, assessing its efficacy in kidney transplant recipients.
The anticipated launch of these emerging therapies are poised to transform the antibody-mediated rejection market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the antibody-mediated rejection market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
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Antibody-mediated rejection is a major post-transplant complication that leads to both short- and long-term graft injury in recipients. Even with desensitization strategies, as many as one-third of highly sensitized patients can still experience acute AMR after transplantation.
The antibody-mediated rejection epidemiology section provides insights into the historical and current antibody-mediated rejection patient pool and forecasted trends for the leading markets. In 2024, among transplant cases, kidney transplants accounted for the highest number, totaling approximately in the US.
The antibody-mediated rejection market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:
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report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key antibody-mediated graft rejection companies, including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key GvHD companies, including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including among others.
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