The global antibody-mediated rejection market size is estimated to be valued at USD 142.7 Million in 2025. It can reach a valuation of USD 331.6 Million by 2032, exhibiting a staggering CAGR of 12.8% throughout the forecast period (2025-2032).
The increasing number of organ transplants globally as well as successful surgeries is one of the primary drivers of the market. The demand for antibody-mediated rejection (AMR) drugs to improve the outcome of transplant surgeries can drive the market growth. The promising potential of gene therapy and immunosuppressants can open new growth avenues for the market.
But the limited access to therapies can hamper the market growth.
Key Market Insights
The antibody-mediated rejection market is predicted to be shaped by advances in monoclonal antibody therapies, new diagnostic biomarkers, and the expansion of global transplant programs.
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Antibody-mediated Rejection Market Report Coverage
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Report Coverage |
Details |
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Market Revenue in 2025 |
USD 142.7 Million |
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Estimated Value by 2032 |
USD 331.6 Million |
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Growth Rate |
12.8% |
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Historical Data |
2020–2024 |
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Forecast Period |
2025–2032 |
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Forecast Units |
Value (USD Million) |
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Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
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Segments Covered |
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Geographies Covered |
North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa) |
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Growth Drivers |
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Opportunities |
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Trends |
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Restraints & Challenges |
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Market Dynamics
The advancements in biomarker diagnostics for the early detection and prevention of AMR can drive the market growth. The need for non-invasive tests that detect donor-derived cell-free DNA (dd-cfDNA) can bode well for the market. On March 11, 2025, CareDx expanded the AlloSure dd-cfDNA assay for kidney transplant recipients. The launch of more tests can reduce the financial burden on clinicians and patients.
Furthermore, the expansion of organ transplant programs globally can open up new opportunities for the antibody-mediated rejection market. The investments of countries in the Middle East, Latin America, and the Asia Pacific in transplant infrastructure and surgical success can bode well for the market.
Market Opportunity: Orphan Drug Designations to Offer Promise
With acute AMR being the cause of major graft dysfunctions or transplantation failures, the proper drugs can be the solution to stabilize them. The rarity of AMR has made it difficult to gain approval from regulatory bodies, but the orphan drug designation given to certain drugs can offer respite to patients after transplants. On June 25, 2025, the U.S. FDA granted orphan drug designation to Riliprubart, developed by Sanofi, for the prevention and treatment of AMR in kidney transplant patients.
Market Challenge: Limited Approval of Therapeutics
The shortage of AMR-specific, regulatory-approved drugs can lead to the off-label use of immunosuppressants, plasmapheresis, and IVIG. The therapeutic gap has led to frequent hospitalizations and graft dysfunction. This can be attributed to the rarity of AMR and the lack of large-scale trials to provide affordable treatment to patients.
Analyst’s View
Recent Developments
Biogen announced the commencement of the Phase-3 trial of felzartamab on March 11, 2025. The study will investigate the effects of the drug on adult kidney transplant recipients with antibody-mediated rejection.
Competitor Insights
Market Segmentation
Regional Insights
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