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Antibody-Mediated Graft Rejection Market is expected to reach USD 2.5 billion by 2034

09-01-2025 12:17 PM CET | Health & Medicine

Press release from: Exactitude Consultancy

Antibody-Mediated Graft Rejection

Antibody-Mediated Graft Rejection

Antibody-mediated rejection (AMR) is one of the most serious complications following organ transplantation, particularly kidney, heart, and lung transplants. It occurs when antibodies attack the donor organ, leading to acute or chronic graft dysfunction and, in severe cases, graft failure. Despite advances in transplantation, AMR continues to pose significant challenges in patient management.

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The AMR patient pool is expanding globally, owing to increasing transplantation rates, improved survival rates, and rising organ donation awareness. As the number of patients at risk for AMR grows, demand for effective diagnostic tools, novel immunotherapies, and better post-transplant monitoring solutions is accelerating. By 2034, the AMR patient pool analysis market is expected to grow substantially, supported by clinical innovation, higher transplant volumes, and global collaborations in transplant medicine.

Market Overview
• Market Size (2024): USD 1.2 billion
• Forecast (2034): USD 2.5 billion
• CAGR (2025-2034): ~8.5%

• Key Growth Drivers: Increasing organ transplants worldwide, improved survival rates, and rising adoption of advanced immunotherapy and diagnostic tools.

• Key Challenges: High treatment costs, limited donor organ availability, and difficulties in early detection.

• Leading Players: Roche, Novartis AG, Sanofi, Pfizer, Alexion Pharmaceuticals, Bristol Myers Squibb, Thermo Fisher Scientific, Immucor.

The market is shifting from conventional immunosuppressants toward targeted biologics (e.g., anti-CD20, complement inhibitors) and advanced diagnostics for donor-specific antibodies (DSAs). These innovations are expected to significantly reduce graft loss due to AMR in the coming decade.

Segmentation Analysis
By Therapy Type
• Corticosteroids
• Plasmapheresis & IVIG
• Rituximab & other monoclonal antibodies
• Complement inhibitors (eculizumab, others)
• Emerging therapies

By Diagnostic Tool
• Donor-Specific Antibody (DSA) Testing
• Molecular and Histopathological Assays
• Flow Cytometry & Crossmatch Testing
• Next-Generation Sequencing (NGS) for Immunogenetics

By Organ Type
• Kidney Transplant
• Heart Transplant
• Lung Transplant
• Liver Transplant
• Others

By End Use
• Hospitals & Transplant Centers
• Specialty Clinics
• Research & Academic Institutes

Summary: While plasmapheresis and IVIG remain standard treatments, monoclonal antibodies and complement inhibitors are rapidly gaining ground as effective long-term solutions. DSA testing and molecular diagnostics dominate the diagnostic landscape due to their precision.

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Regional Analysis
• North America: Largest market share, driven by high transplant rates, advanced healthcare infrastructure, and availability of targeted biologics. The U.S. leads with well-established transplant registries.
• Europe: Significant market presence with strong adoption of advanced diagnostics and government-backed transplant programs. Germany, France, and the UK lead the region.
• Asia-Pacific: Fastest growth expected, fueled by rising organ donation awareness, government initiatives, and increasing adoption of immunotherapies in countries like Japan, China, and India.
• Middle East & Africa: Limited donor availability but growing transplant programs in GCC nations are boosting demand.
• Latin America: Brazil and Mexico lead transplant volumes in the region, supported by improving healthcare access and participation in global research collaborations.
Summary: North America and Europe remain dominant in value terms, but Asia-Pacific is expected to post the fastest CAGR through 2034, reflecting rapid expansion in healthcare capacity and clinical innovation.

Market Dynamics
Key Growth Drivers
• Rising number of organ transplants globally.
• Advances in donor-specific antibody testing and molecular diagnostics.
• Increasing adoption of biologics and targeted immunotherapies.
• Expansion of transplant registries and global collaboration networks.

Key Challenges
• High cost of biologic therapies and immunosuppressants.
• Organ donor shortages limiting transplant opportunities.
• Delayed AMR detection due to subtle early symptoms.
• Regulatory hurdles in developing new biologics for rare transplant complications.

Latest Trends
• Integration of AI-driven diagnostic platforms for early AMR detection.
• Research into gene-based therapies and novel complement inhibitors.
• Increasing role of personalized immunosuppression strategies to minimize rejection.
• Partnerships between pharma companies and transplant research consortia.

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Competitor Analysis
Major Players
• Roche - Leader in transplant immunology with robust diagnostic solutions.
• Novartis AG - Strong portfolio of immunosuppressive therapies.
• Sanofi - Expanding in rare diseases and transplant immunotherapy.
• Pfizer - Active in biologics for autoimmune and transplant-related conditions.
• Alexion Pharmaceuticals (AstraZeneca Rare Disease) - Strong with complement inhibitor (eculizumab).
• Bristol Myers Squibb - Expanding biologics pipeline for autoimmune and transplant complications.
• Thermo Fisher Scientific - Leader in molecular diagnostics and transplant testing solutions.
• Immucor - Specialized in donor-specific antibody testing and transplant diagnostics.
Summary: The competitive landscape combines global pharma giants with specialized diagnostic companies. While Roche, Novartis, and Sanofi dominate therapy, diagnostic leaders like Thermo Fisher and Immucor are equally crucial in shaping patient outcomes.

Conclusion
The antibody-mediated graft rejection (AMR) market is entering a transformative era as advances in biologics, diagnostics, and precision immunology converge. With transplant volumes rising and patient survival improving, the demand for effective AMR management is set to accelerate through 2034.

Key Takeaways:
• Patient pool is expanding due to rising global transplant rates.
• Biologics and complement inhibitors represent the fastest-growing therapeutic segment.
• North America and Europe dominate today, but Asia-Pacific offers the highest growth potential.
• Diagnostics and therapies will increasingly integrate with AI and personalized medicine.

The next decade will see greater innovation, earlier detection, and improved long-term outcomes for transplant patients, making AMR one of the most critical focus areas in transplant immunology.

This report is also available in the following languages : Japanese (抗体介在性移植拒絶反応患者プール分析市場), Korean (항체 매개 이식 거부 환자 풀 분석 시장), Chinese (抗体介导的移植物排斥患者库分析市场), French (Analyse du marché des patients ayant subi un rejet de greffe par anticorps), German (Markt für Patientenpoolanalyse bei Antikörper-vermittelter Transplantatabstoßung), and Italian (Analisi del mercato dei pazienti con rigetto di trapianto mediato da anticorpi), etc.

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About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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