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.

• By treatment, the IVIG segment is expected to capture an 18% share of the market in 2025. The segment can attain continuous demand over the forecast period owing to its use in kidney and heart transplant recipients.
• By drugs in development, the Imlifidase segment is anticipated to retain 48.7% market share in 2025. This can be attributed to its potential for desensitization in transplant patients. Furthermore, discussions between the European Union (EU) and the U.S. to make it a first-class targeted AMR therapy can boost the segment’s growth over the forecast period.
• By therapeutic approach, the complement inhibitors segment is anticipated to capture a huge market share in 2025. This can be attributed to the use of Eculizumab and Bortezomib for specifically targeting antibody-producing cells. The push towards precision medicine in transplant care can create new opportunities for complement inhibitors.
• By patient type, the acute AMR patients segment is expected to attain a higher share of the antibody-mediated rejection market in 2025. This can be on account of these patients requiring immediate attention to preserve grafts.
• By geography, the North America region is projected to lead the market in 2025. This can be attributed to the robust healthcare infrastructure, investments in advanced organ transplantation research, and the domination of the U.S. and Canada in the development of immunosuppressants and monoclonal antibodies.

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Antibody-mediated Rejection Market Report Coverage

Report Coverage	Details
Market Revenue in 2025	USD 142.7 Million
Estimated Value by 2032	USD 331.6 Million
Growth Rate	12.8%
Historical Data	2020–2024
Forecast Period	2025–2032
Forecast Units	Value (USD Million)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	By Treatment, Drugs in Development, Therapeutic Approach, and Patient Type
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)
Growth Drivers	Increasing Number of Organ Transplants Globally Advancements in Therapies Targeting the Immune System’s Rejection Mechanisms
Opportunities	Development of Novel Drugs Like Clazakizumab and Imlifidase, which Target Key Inflammatory Pathways Growing Investment in Genomic Studies and Diagnostic Assays for Better Management of AMR
Trends	Combination Therapy Strategies Expansion of Transplant Programs
Restraints & Challenges	High Treatment Costs and Limited Access to Novel Therapies Lack of FDA-approved Drugs for AMR, Making Treatments Heavily Dependent on Off-label Us

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

• The rising number of organ transplants and their risks can drive the antibody-mediated rejection market.
• The complement inhibitors segment is expected to gain a significant market share in 2025, owing to the shift towards precision medicine for the treatment of AMR.
• Key players are investing in the development of monoclonal antibodies and immunosuppressants to keep patients with AMR desensitized.

 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

• Hansa Biopharma AB
• Horizon Therapeutics
• CSL Behring
• Viela Bio
• Pfizer
• HI-Bio
• Sanofi
• Janssen Biotech

Market Segmentation

• By Treatment
• Plasma Exchange
• IVIG
• Complement Inhibitors
• Proteasome Inhibitors
• By Drugs in Development
• Clazakizumab
• Imlifidase
• By Therapeutic Approach
• Monoclonal Antibodies
• Complement Inhibitors
• By Patient Type
• Pre-sensitized Transplant Recipients
• Acute AMR Patients

Regional Insights

• North America
  • U.S.
  • Canada
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Europe
  • Italy
  • Germany
  • U.K.
  • Spain
  • Russia
  • France
  • Rest of Europe
• Asia Pacific
  • South Korea
  • India
  • China
  • Japan
  • Australia
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
• Africa
  • South Africa
  • North Africa
  • Central Africa