Kidney Transplant Rejection Market Predicted to Grow at a CAGR of 4.72% during 2025-2035, Impelled by the Growing Prevalence of Chronic Kidney Diseases

February 27, 2025 | Healthcare

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Kidney Transplant Rejection Market Outlook 2025-2035:

The 7 major Kidney Transplant Rejection markets are expected to exhibit a CAGR of 4.72% during 2025-2035. The Kidney Transplant Rejection market is growing rapidly due to the rising number of kidney transplants and the increasing occurrence of chronic kidney diseases. Advances in immunosuppressive drugs and better diagnostic methods for early rejection detection are fuelling demand. Additionally, greater awareness of organ transplantation and supportive government policies are driving market growth. Innovations in personalized medicine and targeted therapies are improving patient outcomes, further boosting the market. With continuous research and strategic partnerships among leading companies, the market is expected to see continued growth in the coming years.

Growing Prevalence of Chronic Kidney Diseases: Driving the Kidney Transplant Rejection Market

The growing prevalence of chronic kidney diseases (CKD) is significantly driving the expansion of the kidney transplant rejection market. As CKD cases continue to rise globally due to factors like diabetes, hypertension, and aging populations, the demand for kidney transplants is increasing. This surge in transplants elevates the need for effective immunosuppressive therapies and monitoring solutions to prevent organ rejection. Additionally, advancements in diagnostic technologies, such as non-invasive biomarkers, are enhancing early detection of rejection, fuelling market growth. Increasing awareness among patients and healthcare providers about transplant rejection management is also boosting demand. Moreover, supportive government policies and improved healthcare infrastructure are facilitating better access to transplant procedures, further driving market expansion. As research and development continue to innovate immunosuppressive drugs, the kidney transplant rejection market is poised for substantial growth in the coming years.

Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The kidney transplant rejection treatment market is experiencing significant growth, driven by the introduction of new therapies and advanced drugs. Innovations in immunosuppressive drugs, such as calcineurin inhibitors, mTOR inhibitors, and monoclonal antibodies, are effectively reducing the risk of organ rejection while minimizing side effects. Additionally, new approaches like biologics and cell-based therapies are gaining traction due to their targeted action and potential to improve long-term graft survival. Advanced techniques such as gene editing and personalized medicine are leading to tailored treatment plans that better suit individual patient needs, enhancing effectiveness and reducing negative side effects. Clinical trials are also exploring new medications and combination therapies aimed at increasing immune tolerance and reducing reliance on traditional immunosuppressants. Pharmaceutical companies are investing heavily in research and development, paving the way for next-generation drugs that offer improved safety and effectiveness. Collaborations between biotech companies and research institutions are accelerating the discovery and commercialization of these innovative treatments. Regulatory approvals for new drugs and expanded applications for existing ones are also contributing to market growth. As awareness of these advanced treatment options continues to rise among healthcare providers and patients, and with an increasing number of organ transplants being performed, the demand for cutting-edge kidney transplant rejection therapies is set to grow, driving substantial market expansion.

Marketed Therapies in Kidney Transplant Rejection Market

Envarsus XR (Tacrolimus extended-release): Veloxis Pharmaceuticals

Envarsus XR (Tacrolimus extended-release) developed by Veloxis Pharmaceuticals is an immunosuppressant medication used to prevent kidney transplant rejection. It works by inhibiting the immune system to prevent the body from attacking the transplanted kidney. With its extended-release formulation, Envarsus XR offers convenient once-daily dosing, helping to maintain effective drug levels and reduce the risk of rejection.

Nulojix (Belatacept): Bristol-Myers Squibb

Nulojix (Belatacept) by Bristol-Myers Squibb is an approved immunosuppressive medication designed to prevent kidney transplant rejection. It works by blocking specific immune system signals that would typically target and attack the transplanted kidney. Nulojix is often used in combination with other approved medications, offering a personalized treatment approach to manage transplant rejection and improve long-term outcomes for kidney transplant recipients.

Rapamune (Sirolimus): Pfizer

Rapamune (Sirolimus) by Pfizer is an approved immunosuppressant used to prevent kidney transplant rejection. It works by inhibiting certain immune system functions that can cause the body to attack the transplanted kidney. Rapamune is typically used in combination with other medications to help ensure long-term success of kidney transplants by reducing the risk of rejection.

Emerging Therapies in Kidney Transplant Rejection Market

AT-1501 (Tegoprubart): Eledon Pharmaceuticals

AT-1501 (Tegoprubart) is an experimental monoclonal antibody developed by Eledon Pharmaceuticals to prevent kidney transplant rejection. It targets CD40L to modulate the immune system, reducing the likelihood of organ rejection while decreasing the dependence on traditional immunosuppressive medications. This novel treatment aims to enhance long-term graft survival and improve patient outcomes in transplant care.

VIB4920 (Dazodalibep): Horizon Therapeutics

VIB4920 (Dazodalibep), developed by Horizon Therapeutics, is an investigational biologic designed to prevent organ rejection in kidney transplant recipients. It works by targeting specific immune pathways to induce immune tolerance and reduce the need for long-term immunosuppressive therapy. VIB4920 aims to promote graft survival and improve transplant outcomes by modulating immune responses and minimizing rejection episodes.

MDR-101 (Sizavaleucel): Medeor Therapeutics

MDR-101(Sizavaleucel), developed by Medeor Therapeutics, is an innovative cellular therapy designed to prevent kidney transplant rejection by promoting donor-specific immune tolerance. By utilizing the donor's blood and bone marrow cells, MDR-101 aims to induce mixed chimerism, enabling transplant recipients to discontinue immunosuppressive drugs while maintaining kidney function and survival. This approach offers a potential long-term solution to improve transplant outcomes and reduce the need for lifelong immunosuppression.

Drug Name	Company Name	MOA	ROA
AT-1501 (Tegoprubart)	Eledon Pharmaceuticals	CD40 ligand inhibitors	Intravenous
VIB4920 (Dazodalibep)	Horizon Therapeutics	CD40 ligand inhibitors	Intravascular
MDR-101 (Sizavaleucel)	Medeor Therapeutics	Cell replacements; Immunologic cytotoxicity	Intravenous Infusion

Detailed list of emerging therapies in Kidney Transplant Rejection is provided in the final report…

Leading Companies in the Kidney Transplant Rejection Market:

The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global kidney transplant rejection market, several leading companies are at the forefront of developing integrated platforms to enhance the management of Kidney Transplant Rejection. Some of the major players include Pfizer, Novartis, Bristol-Myers Squibb, Veloxis Pharmaceuticals, and others. These companies are driving innovation in the kidney transplant rejection market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for kidney transplant rejection.

Key Players in Kidney Transplant Rejection Market:

The key players in the Kidney Transplant Rejection market who are in different phases of developing different therapies are Bristol-Myers Squibb, Medeor Therapeutics, Veloxis Pharmaceuticals, Horizon Therapeutics, Pfizer, Novartis, Eledon Pharmaceuticals, ThermoFisher, Sangamo therapeutics, CSL Behring, and others.

Key Players in Kidney Transplant Rejection Market

Regional Analysis:

The major markets for Kidney Transplant Rejection include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for Kidney Transplant Rejection while also representing the biggest market for its treatment. Recent advancements in kidney transplant rejection are centered on enhancing early detection and treatment methods. The use of biomarkers and genetic analysis is allowing for earlier identification of potential rejection, even before clinical symptoms emerge. New immunosuppressive drugs are being designed to reduce side effects while still preventing rejection. Research is also delving into the immune system's memory and tolerance mechanisms, with the aim of achieving long-term graft survival without ongoing immunosuppression. Additionally, innovative therapies, such as regulatory T-cell treatments, are being explored to provide more personalized and effective management of transplant rejection.

Recent Developments in Kidney Transplant Rejection Market:

In January 2025, Eledon Pharmaceuticals revealed that tegoprubart, its experimental anti-CD40L antibody, played a crucial role in the immunosuppressive treatment regimen for a patient who underwent a kidney transplant from a genetically modified pig. The procedure, conducted on January 25, 2025, at Massachusetts General Hospital (MGH), was a collaborative effort with their partner eGenesis.
In December 2024, the University of Alabama at Birmingham announced a breakthrough in understanding BK polyomavirus (BKPyV) replication, revealing potential drug targets to safeguard transplanted kidneys. The research, led by the Department of Microbiology at UAB, used single-cell analysis to examine BKPyV infection in primary kidney cells. The findings challenge previous beliefs about the molecular mechanisms involved in BKPyV production, offering new avenues for developing more effective treatments for kidney transplant recipients. These groundbreaking insights have been published in the journal PLOS Pathogens.
In September 2024, Eledon Pharmaceuticals revealed that it has successfully finished enrolling participants for its Phase 2 BESTOW clinical trial. The trial aims to evaluate the safety and effectiveness of tegoprubart, an investigational immunosuppressive therapy, in preventing organ rejection in kidney transplant recipients. The study reached its target of 120 participants about four months ahead of the initial timeline.
In May 2024, Thermo Fisher Scientific introduced a new testing service designed to improve the management of kidney transplant patients. The innovative CXCL10 testing service uses noninvasive urine sample collection and delivers results within 24 hours. By detecting the CXCL10 chemokine, the test offers faster insights compared to existing methods. Elevated levels of urinary CXCL10 are linked to inflammation and early signs of kidney transplant rejection, making this new service a valuable tool for early intervention.
In November 2023, Medeor Therapeutics shared promising interim results from its global Phase III clinical trial. Kidney transplant recipients who received kidneys from HLA-matched living donors successfully achieved functional tolerance, allowing them to remain off the usual immunosuppressive drug regimen. These drugs are typically necessary to prevent transplant rejection and failure. The study’s findings are set to be presented as part of a late-breaking oral session at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting.

Key information covered in the report.

Base Year: 2024
Historical Period: 2019-2024
Market Forecast: 2025-2035

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the Kidney Transplant Rejection market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the Kidney Transplant Rejection market
Reimbursement scenario in the market
In-market and pipeline drugs

Competitive Landscape:

This report offers a comprehensive analysis of current Kidney Transplant Rejection marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

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Kidney Transplant Rejection Market Predicted to Grow at a CAGR of 4.72% during 2025-2035, Impelled by the Growing Prevalence of Chronic Kidney Diseases

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