Antibody-mediated Rejection (AMR) Market Expected to Grow Significantly by 2034 Driven by Rising Transplants and Emerging Therapies | DelveInsight

Antibody-mediated rejection (AMR), a major cause of graft dysfunction and failure following solid organ transplantation, represents a persistent challenge in the field of transplant immunology. Characterized by donor-specific antibodies (DSAs) targeting the graft endothelium, AMR often leads to rapid organ damage and is associated with high rates of morbidity. The condition is most prevalent in kidney and heart transplant recipients, with diagnosis and management remaining complex due to the heterogeneity of clinical presentations and a lack of standardized treatment protocols.

Despite these challenges, the AMR market is evolving steadily due to increasing awareness, enhanced diagnostic capabilities, and an expanding pipeline of targeted immunotherapies. Advances in immunological testing, including highly sensitive assays for DSAs and molecular pathology techniques, are enabling earlier and more accurate detection of AMR. This progress supports more timely intervention, helping to preserve graft function and improve patient outcomes.

Therapeutically, the landscape is shifting from conventional regimens such as plasmapheresis, IVIG, and corticosteroids to novel approaches, including anti-CD20 monoclonal antibodies, proteasome inhibitors, and complement pathway inhibitors. These emerging therapies are being investigated for their potential to more effectively deplete pathogenic antibodies and modulate immune responses. Several candidates are progressing through clinical trials, signaling a promising shift toward more targeted, mechanism-based interventions.

DelveInsight's report, Antibody-mediated Rejection - Market Insight, Epidemiology, and Market Forecast - 2034, provides a comprehensive overview of the evolving AMR landscape across the 7MM (United States, EU4, the United Kingdom, and Japan). It covers granular epidemiological trends, current and emerging treatment strategies, unmet needs, and competitive dynamics. As research momentum grows and innovative therapies receive regulatory backing, the AMR market is poised for meaningful expansion by 2034, offering hope for better long-term transplant outcomes.

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Some of the key insights of the Antibody-mediated Rejection Market Report:
• The Antibody-mediated Rejection market is expected to grow significantly through the forecast period (2024-2034).
• The United States accounted for nearly 70% of the Antibody-mediated Rejection (AMR) market, surpassing the combined market size of the EU4, UK, and Japan.
• In 2023, over 42K kidney transplants were performed in the 7MM, contributing to around 60% of all transplant cases.
• Kidney, lung, and liver transplants were the leading contributors to AMR cases across the 7MM in 2023.
• The US represented over 60% of total AMR cases in the 7MM, according to DelveInsight's estimates.
• There are currently no FDA-approved therapies for AMR, but several off-label treatments are in use, including complement inhibitors, anti-CD20 antibodies, proteasome inhibitors, and IL-6 inhibitors.
• In October 2024, Biogen revealed that its investigational anti-CD38 monoclonal antibody, felzartamab, received Breakthrough Therapy Designation (BTD) from the FDA for treating late antibody-mediated rejection (AMR) in kidney transplant patients. This designation reflects felzartamab's potential to become a novel treatment option for those suffering from this severe condition that threatens transplant success.
• Emerging therapies for Antibody-mediated Rejection include Imlifidase, BIVV020, Felzartamab, Clazakizumab, Efgartigimod PH20 SC - prefilled syringe, Belatacept, Tacrolimus, ALXN2030, and others.
• Key companies involved in the treatment of Antibody-mediated Rejection include CSL Behring, Hansa Biopharma, Sanofi, Talaris Therapeutics, Horizon Therapeutics, and others.

To know in detail about the Antibody-mediated Rejection market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: https://www.delveinsight.com/report-store/antibody-mediated-rejection-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Antibody-Mediated Rejection Overview
Antibody-mediated Rejection (AMR) is a serious and often challenging complication following organ transplantation, particularly kidney, heart, lung, and liver transplants. It occurs when the recipient's immune system produces donor-specific antibodies (DSAs) that target and damage the transplanted organ, leading to graft dysfunction or failure. Unlike cellular rejection, which involves T-cells, AMR is primarily driven by the humoral immune response and is characterized by complement activation, endothelial injury, and inflammation within the graft.

The diagnosis of AMR is based on a combination of clinical signs of graft dysfunction, histological evidence from biopsy, and the presence of circulating DSAs. Common diagnostic markers include C4d deposition in peritubular capillaries and evidence of microvascular inflammation. AMR can be classified as acute or chronic, with the chronic form often leading to long-term graft deterioration.

Management of AMR remains a clinical challenge due to the lack of FDA-approved therapies. Current treatment strategies rely on off-label use of therapies such as plasmapheresis, intravenous immunoglobulin (IVIG), rituximab (an anti-CD20 monoclonal antibody), bortezomib (a proteasome inhibitor), and complement inhibitors like eculizumab. Despite these approaches, treatment outcomes are often suboptimal, highlighting a significant unmet need for targeted and effective therapies.

Research and clinical trials are ongoing to explore new therapeutic avenues, including novel biologics and immunomodulatory agents. As understanding of the underlying immunopathology deepens, the development of standardized diagnostic criteria and innovative treatment options is expected to improve patient outcomes and prolong graft survival in AMR cases.

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Antibody-Mediated Rejection Epidemiology
The epidemiology section offers an overview of historical, current, and projected trends in the seven major countries (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends.

Antibody-mediated Rejection Epidemiology Segmentation:

The Antibody-mediated Rejection market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
• Region
• Transplant Incidence Cases
• Antibody‐mediated Rejection Cases

Antibody-mediated Rejection Drugs Uptake and Pipeline Development Activities
The Drug Uptake section offers a detailed analysis of the adoption trends of newly launched and upcoming therapies for Antibody-mediated Rejection throughout the study period. It evaluates patient adoption rates, market penetration, and the commercial performance of each therapy, providing a clear understanding of the factors driving or hindering the market acceptance of these treatments.

The Therapeutics Assessment further highlights the Antibody-mediated Rejection drugs, demonstrating the most rapid uptake. It examines the underlying drivers contributing to their swift adoption and compares the market share of these therapies to identify those gaining significant traction.

Additionally, the report provides an in-depth overview of the current therapeutic pipeline for Antibody-mediated Rejection, covering investigational drugs at various stages of development. It profiles the key pharmaceutical and biotech companies actively involved in advancing targeted treatments and presents the latest updates on partnerships, mergers and acquisitions, licensing deals, and other strategic developments shaping the future of Antibody-mediated Rejection therapeutics.

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Antibody-Mediated Rejection Market Outlook
The Antibody-mediated Rejection (AMR) market is expected to experience steady growth from 2024 to 2034, driven by increasing transplant rates and advancements in diagnostic technologies that enable earlier and more accurate detection. The United States dominates the market, accounting for approximately 70% of the total market size, which is larger than the combined market of the EU4 countries (Germany, Spain, Italy, France), the United Kingdom, and Japan. France holds the second-largest market share in the 7 major markets (7MM) during the forecast period.

Key pharmaceutical companies such as Sanofi and Hansa Biopharma are actively advancing their lead candidates through various stages of clinical development, aiming to address the unmet needs in AMR treatment. Among emerging therapies, imlifidase is expected to capture the largest market share by 2034 in the 7MM, signaling a promising shift toward more targeted and effective treatment options.

Overall, the AMR market growth will be supported by ongoing research, development of novel therapies, and improved clinical awareness, which together are expanding treatment possibilities and enhancing patient outcomes in the transplant community.

Antibody-Mediated Rejection Market Drivers
• The increasing number of organ transplants worldwide is driving demand for effective AMR treatments, expanding the patient pool.
• Advances in diagnostic technologies enable earlier detection and better management of AMR, supporting market growth.

Antibody-Mediated Rejection Market Barriers
• Lack of FDA-approved therapies specifically for AMR limits treatment options and slows market expansion.
• High costs and complexity of developing targeted AMR therapies pose challenges for pharmaceutical companies and healthcare systems.

Scope of the Antibody-mediated Rejection Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan].
• Key Antibody-mediated Rejection Companies: CSL Behring, Hansa Biopharma, Sanofi, Talaris Therapeutics, Horizon Therapeutics, and others.
• Key Antibody-mediated Rejection Therapies: Imlifidase, BIVV020, Felzartamab, Clazakizumab, Efgartigimod PH20 SC - prefilled syringe, Belatacept, Tacrolimus, ALXN2030, and others.
• Antibody-mediated Rejection Therapeutic Assessment: Antibody-mediated Rejection currently marketed, and Antibody-mediated Rejection emerging therapies.
• Antibody-mediated Rejection Market Dynamics: Antibody-mediated Rejection market drivers and Antibody-mediated Rejection market barriers.
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies.
• Antibody-mediated Rejection Unmet Needs, KOL's views, Analyst's views, Antibody-mediated Rejection Market Access and Reimbursement.

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Table of Contents
1. Antibody-mediated Rejection Market Report Introduction
2. Executive Summary for Antibody-mediated Rejection
3. SWOT analysis of Antibody-mediated Rejection
4. Antibody-mediated Rejection Patient Share (%) Overview at a Glance
5. Antibody-mediated Rejection Market Overview at a Glance
6. Antibody-mediated Rejection Disease Background and Overview
7. Antibody-mediated Rejection Epidemiology and Patient Population
8. Country-Specific Patient Population of Antibody-mediated Rejection
9. Antibody-mediated Rejection Current Treatment and Medical Practices
10. Antibody-mediated Rejection Unmet Needs
11. Antibody-mediated Rejection Emerging Therapies
12. Antibody-mediated Rejection Market Outlook
13. Country-Wise Antibody-mediated Rejection Market Analysis (2020-2034)
14. Antibody-mediated Rejection Market Access and Reimbursement of Therapies
15. Antibody-mediated Rejection Market Drivers
16. Antibody-mediated Rejection Market Barriers
17. Antibody-mediated Rejection Appendix
18. Antibody-mediated Rejection Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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