Antibody-Mediated Rejection Market Set to Expand Significantly During the Forecast Period (2025-2034) Amid Advances in Diagnostics and Targeted Therapies | DelveInsight

The antibody-mediated rejection market is expanding as the number of organ transplants rises and awareness of AMR's impact on graft survival grows. Advances in diagnostic assays, biomarker-driven monitoring, and targeted therapies, including Felzartamab (Biogen), Imlifidase (Hansa Biopharma), Riliprubart (Sanofi), Efgartigimod PH20 SC (argenx), ALXN2030 (AstraZeneca), and others, are driving the market.

LAS VEGAS, Nov. 11, 2025 /PRNewswire/ -- DelveInsight's Antibody-mediated Rejection Market Insights report includes a comprehensive understanding of current treatment practices, antibody-mediated rejection emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan). 

Antibody-mediated Rejection Market Summary

• The market size for antibody-mediated rejection in the leading markets is expected to grow significantly by 2034.
• The United States accounted for the highest antibody-mediated rejection treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
• According to DelveInsight analysis, among the 7MM, the US accounted for the highest number of transplant cases in 2024, with approximately 55,000 cases. These cases are anticipated to increase by 2034.
• Leading antibody-mediated rejection companies developing emerging therapies, such as Biogen, Hansa Biopharma, Sanofi, argenx, AstraZeneca, and others, are developing new therapy for antibody-mediated rejection that can be available in the antibody-mediated rejection market in the coming years. 
• The promising antibody-mediated rejection therapies in clinical trials include Felzartamab, Imlifidase, Riliprubart, Efgartigimod PH20 SC, ALXN2030, and others.

Discover the antibody-mediated rejection new treatment @ New Treatments for Antibody-mediated Rejection

Key Factors Driving the Growth of the Antibody-mediated Rejection Market 

Rising Number of Transplants and Transplant Candidates

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.

Advances in Diagnostics and Biomarker Monitoring

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.

Launch of Emerging Antibody-mediated Rejection Therapies

The pipeline features several promising drugs, including Felzartamab (Biogen), Imlifidase (Hansa Biopharma), Riliprubart (Sanofi), Efgartigimod PH20 SC (argenx), and ALXN2030 (AstraZeneca), among others.

Felzartamab Demonstrates Strong Disease-Modifying Potential in Late AMR

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.

Antibody-mediated Rejection Market Analysis

Management of AMR generally relies on immunosuppressive therapies, plasmapheresis or plasma exchange (PLEX), intravenous immunoglobulin (IVIG), and complement inhibitors, 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.

Talaris Therapeutics discontinued its FREEDOM-1 and FREEDOM-2 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 Biogen, Hansa Biopharma, Sanofi, argenx, AstraZeneca, and others.

To know more about antibody-mediated rejection treatment options, visit @ Approved Antibody-mediated Rejection Drugs

Antibody-mediated Rejection Competitive Landscape

Some of the drugs in the pipeline include Felzartamab (Biogen), Imlifidase (Hansa Biopharma), Riliprubart (Sanofi), Efgartigimod PH20 SC (argenx), ALXN2030 (AstraZeneca), and others.

Biogen's Felzartamab 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.

Hansa Biopharma's Imlifidase is a novel antibody-cleaving enzyme derived from Streptococcus pyogenes 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.

Sanofi's SAR445088, 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.

Discover more about therapy for antibody-mediated rejection @ Antibody-mediated Rejection Clinical Trials 

Recent Developments in the Antibody-mediated Rejection Market

• In June 2025, the US FDA granted Orphan Drug Designation (ODD) to riliprubart for the investigational treatment of AMR in solid organ transplantation.
• In March 2025, Biogen announced the initiation of dosing in the global clinical study, TRANSCEND. The Phase III study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late AMR.

What is Antibody-mediated Rejection?

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.

Antibody-mediated Rejection Epidemiology Segmentation

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 33,000 in the US.

The antibody-mediated rejection market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

• Total Incidence Cases of Transplant
• Total Incidence Cases of AMR

Scope of the Antibody-mediated Rejection  Market Report

• Therapeutic Assessment: Antibody-mediated Rejection current marketed and emerging therapies
• Antibody-mediated Rejection Market Dynamics: Key Market Forecast Assumptions of Emerging Antibody-mediated Rejection Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Antibody-mediated Rejection Market Access and Reimbursement

Download the report to understand which factors are driving antibody-mediated rejection therapeutics market trends @ Antibody-mediated Rejection Market Trends

Table of Contents

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