PUBLISHER: DelveInsight | PRODUCT CODE: 1652666
PUBLISHER: DelveInsight | PRODUCT CODE: 1652666
DelveInsight's "Kidney Transplant Rejection - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of kidney transplant rejection, historical and forecasted epidemiology, as well as the kidney transplant rejection market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The kidney transplant rejection market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM kidney transplant rejection market size from 2020 to 2034. The report also covers kidney transplant rejection treatment practices and unmet medical needs to curate the best opportunities and assess the market's potential.
Kidney transplant rejection overview
Kidney transplant rejection occurs when the recipient's immune system identifies the transplanted kidney as foreign and attacks it, potentially impairing its function. While kidney transplantation is the gold standard treatment for End-Stage Renal Disease (ESRD) and advanced Chronic Kidney Disease (CKD), offering better survival rates and quality of life than dialysis, its success depends on precise donor-recipient matching to minimize immune responses. Rejection is primarily driven by T lymphocytes through both innate and adaptive immune mechanisms, amplified by costimulatory molecules and cytokines, highlighting the complexity of the immune response and the critical need for effective immunosuppressive strategies.
The underlying causes of kidney transplant rejection include nonadherence to immunosuppressive therapy, infections triggering immune activation, mismatched organs in terms of HLA compatibility or blood type, and immune responses such as acute cellular or chronic antibody-mediated rejection. Key risk factors include younger recipient age, non-compliance with prescribed medications, infections, donor-specific antibodies, and transplant-related challenges like delayed graft function. Effective prevention and management rely on strict adherence to therapy, regular monitoring, and timely intervention to address complications.
Key primary symptoms of kidney transplant rejection can include decreased urine output, swelling in the legs or feet, high blood pressure, and fatigue. Other indicators can include fever, flu-like symptoms such as chills, nausea, and body aches, as well as tenderness over the transplant site. Elevated creatinine levels in blood tests can further suggest impaired kidney function. If left untreated, these signs can lead to reduced graft function, potential graft failure, and a decline in quality of life, requiring increased medical intervention or dialysis.
Kidney transplant rejection diagnosis
Kidney transplant rejection is diagnosed through kidney biopsy and classified using the Banff system to identify types like Antibody-mediated rejection (AMR) and T cell-mediated rejection (TCMR). Blood tests for creatinine and BUN, urine tests for markers like NGAL, and non-invasive imaging techniques like ultrasound, MRI, and PET scans aid in detection. In AMR, histological and serological evidence are used, while acute TCMR is identified by biopsy showing cell infiltration.
Kidney transplant rejection treatment
The treatment of kidney transplant rejection involves a multifaceted approach tailored to the type and severity of rejection. Hyper acute rejection, being irreversible, necessitates immediate removal of the transplanted kidney. Acute rejection, whether TCMR or AMR, is typically managed with targeted therapies. TCMR responds to corticosteroids and T-cell-depleting agents like rabbit anti-thymocyte globulin, while AMR is treated with plasmapheresis, intravenous immunoglobulin, and monoclonal antibodies targeting B cells or plasma cells. Immunosuppressive regimens, including calcineurin inhibitors like tacrolimus, antimetabolites such as mycophenolic acid, and corticosteroids, are critical for both prevention and treatment. Early detection through vigilant monitoring and timely intervention is vital for reversing acute rejection and preserving kidney function. However, chronic rejection remains a challenge, highlighting the need for emerging therapies and ongoing research to improve long-term outcomes.
As the market is derived using a patient-based model, the kidney transplant rejection epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of kidney transplants, total living cases of kidney transplants and type-specific cases of kidney transplant rejection in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the kidney transplant rejection report encloses a detailed analysis of kidney transplant rejection prophylaxis marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the kidney transplant rejection clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Kidney Transplant Rejection - Prophylaxis Drugs
MYHIBBIN: Azurity Pharmaceuticals
MYHIBBIN, developed by Azurity Pharmaceuticals, is the first ready-to-use mycophenolate mofetil (MMF) oral suspension approved for preventing organ rejection in patients aged 3 months and older who have received allogeneic kidney, heart, or liver transplants. Approved by the US FDA in May 2024, MYHIBBIN is intended for use in combination with other immunosuppressive therapies. The product works by inhibiting inosine monophosphate dehydrogenase (IMPDH), a key enzyme in the de novo guanosine nucleotide synthesis pathway, leading to the suppression of T and B lymphocyte proliferation and cytokine production, which prevents graft rejection.
THYMOGLOBULIN: Sanofi
THYMOGLOBULIN, developed by Sanofi, is an immunosuppressive therapy derived from rabbit serum through immunization with human thymocytes. This purified, pasteurized IgG product targets T lymphocyte antigens and is designed for the prevention of acute kidney transplant rejection. Administered via intravenous infusion, it exerts therapeutic effects by clearing circulating T cells and modulating their activation, homing, and cytotoxic functions. Its mechanism includes targeting multiple T-cell markers, such as CD2, CD3, CD4, and HLA-DR, promoting immune suppression and reducing the risk of transplant rejection.
Initially approved in Japan (2011), the EU (2013), and the US (2017), THYMOGLOBULIN has been pivotal in kidney transplant immunosuppression. The US FDA designated it as an Orphan Drug Designation (ODD) in 2010, highlighting its critical role in renal transplantation. With an established safety and efficacy profile, THYMOGLOBULIN remains a cornerstone therapy for transplant recipients, reducing acute rejection rates and enhancing long-term graft survival.
NULOJIX: Bristol Myers Squibb
NULOJIX (belatacept), developed by Bristol Myers Squibb, is a selective T-cell costimulation blocker approved for the prevention of organ rejection in adult kidney transplant recipients. Administered via intravenous infusion, NULOJIX is used alongside basiliximab induction, mycophenolate mofetil, and corticosteroids. Its mechanism of action involves targeting CD80 and CD86 on antigen-presenting cells, thereby preventing CD28-mediated T-cell activation, a key driver of immunologic rejection. This results in reduced T-cell proliferation and cytokine production, including interleukin-2 and TNF-a, mitigating the immune response in transplant rejection.
NULOJIX received the US FDA and EMA approval in June 2011 and was designated an ODD by the US FDA in 2008 for prophylaxis of organ rejection in renal allograft recipients.
Emerging Drugs
MDR-101: Medeor Therapeutics
MDR-101, developed by Medeor Therapeutics, is an innovative cellular therapy derived from the blood and peripheral stem cells of a living kidney donor. The therapy is designed to induce donor-specific immune tolerance, effectively preventing kidney transplant rejection. By reprogramming the recipient's immune system to accept the donor organ, MDR-101 eliminates the need for lifelong immunosuppressive drugs and their associated side effects, thereby enhancing transplant kidney function and long-term survival. Positive interim data from a Phase III trial, presented as a late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week in November 2023, highlighted its potential as a breakthrough in transplantation medicine.
MDR-101 has received ODD in both the US and EU. The clinical trial is being conducted under an FDA Special Protocol Assessment (SPA). In September 2020, the US FDA also granted Regenerative Medicine Advanced Therapy (RMAT) designation to MDR-101 for the prevention of kidney transplant rejection. Further, in January 2018, the California Institute for Regenerative Medicine (CIRM) awarded USD 18.8 million to support the Phase III clinical trial under its clinical trial funding initiative.
Tegoprubart (AT-1501): Eledon Pharmaceuticals
Tegoprubart, developed by Eledon Pharmaceuticals, is a humanized monoclonal antibody targeting the CD40L pathway, designed to prevent kidney transplant rejection by blocking the CD40-CD40L interaction. This innovative immunosuppressive therapy aims to replace traditional calcineurin inhibitors (CNIs), such as tacrolimus, potentially improving long-term graft survival and patient outcomes. In September 2024, Eledon completed enrollment for the Phase II BESTOW trial, four months ahead of schedule, with topline results anticipated in Q4 2025. Phase Ib trial data presented at the American Transplant Congress (ATC) in June 2024 demonstrated the drug's safety and tolerability.
In addition to clinical progress, Eledon Pharmaceuticals secured a securities purchase agreement in May 2023, yielding up to USD 185 million in funding, including USD 35 million upfront and milestone-based funding of up to USD 105 million. The company plans to release updated interim clinical data and long-term safety results by mid-2025.
Riliprubart (BIVV020, SAR445088): Sanofi
Riliprubart, developed by Sanofi, is an IgG4 humanized monoclonal antibody under investigation for the treatment of Antibody-Mediated Rejection (AMR) in kidney transplants. The drug works by selectively inhibiting activated complement component C1s, a critical mediator of the inflammatory processes associated with AMR. Phase II clinical trials are currently underway to evaluate the efficacy and safety of Riliprubart in patients diagnosed with or at risk of AMR. Administered intravenously, Riliprubart represents a promising therapeutic approach to addressing AMR in kidney transplant recipients.
Drug Class Insights
Currently, a variety of medication approaches for kidney transplant rejection prophylaxis involve approved treatments that utilize different mechanisms of action to support long-term transplant success. These include ENVARSUS XR, IDEFIRIX, NULOJIX, THYMOGLOBULIN, MYHIBBIN, and SIMULECT, among others, all of which play a crucial role in managing immune responses and minimizing the risk of rejection.
Kidney transplant rejection aims to manage immune responses, prevent further organ damage, and ensure long-term transplant success. Treatment involves a combination of immunosuppressive therapies, close monitoring, and supportive care to address acute and chronic rejection. Key goals include preserving graft function, reducing inflammation, minimizing complications, and improving the patient's quality of life. Lifestyle adjustments, including dietary management and adherence to medication regimens, are essential for long-term success. While challenges remain, ongoing research is focused on advancing therapies to enhance graft survival and improve outcomes for transplant recipients.
Kidney transplant rejection is a major concern for recipients, as it can severely affect the long-term success and function of the transplanted organ. Rejection happens when the recipient's immune system recognizes the donor kidney as foreign, prompting an immune response that damages the graft. There are two main types of rejection: Acute, which usually occurs within the first-year after transplantation, and chronic, which develops gradually over several years and is more prevalent. Chronic rejection is often associated with insufficient immunosuppression or non-compliance with medication regimens, leading to ongoing immune attacks that result in scarring and eventual loss of kidney function. Around 15-20% of transplant recipients experience some form of rejection, highlighting the importance of regular monitoring and strict adherence to immunosuppressive therapy to reduce this risk.
The treatment landscape for kidney transplant rejection has evolved significantly, with an emphasis on personalized immunosuppressive therapies to address both acute and chronic rejection episodes. Acute rejection, which can be TCMR or AMR, typically necessitates prompt intervention with escalated doses of immunosuppressants. TCMR may require intravenous steroids or T-cell-depleting agents, while AMR may involve plasmapheresis or intravenous immunoglobulins. Early detection through regular monitoring and kidney biopsies is essential, as timely intervention can often reverse acute rejection and preserve graft function.
A diverse array of approved medications is utilized to manage kidney transplant rejection, each with unique mechanisms of action aimed at ensuring long-term graft success. Key treatments such as ENVARSUS XR, IDEFIRIX, NULOJIX, THYMOGLOBULIN, MYHIBBIN, and SIMULECT are instrumental in regulating immune responses and minimizing rejection risks.
The development pipeline for prophylaxis kidney transplantation rejection features promising candidates, including MDR-101, tegoprubart (AT-1501), riliprubart (BIVV020, SAR445088), TRK-001 (Treg), TX200, and VEL-101, among others, also showing potential clinical trials focused on specific mechanisms within well-defined patient subgroups are expected to refine therapeutic strategies and identify the most effective interventions. Additionally, the identification of biomarkers and molecular targets associated with immune activation and graft injury holds significant promise for enhancing the understanding of kidney transplant rejection and developing novel therapeutic strategies to mitigate its complex immunopathology.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.
Kidney Transplant Rejection Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for kidney transplant rejection.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on kidney transplant rejection evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Johns Hopkins University, Kentucky, US, University of California, US, Charite Universitatsmedizin Berlin, Germany, Paris Cite University, France, Sapienza University, Italy, University of Valencia, Spain, University of Cambridge, UK, and University of Tokyo, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or kidney transplant rejection market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, significant progress is being made in understanding and managing kidney transplant rejection, with a particular emphasis on optimizing immunosuppressive therapies. Recent studies have focused on the development of targeted treatments, such as costimulatory blockade agents, which have demonstrated potential in reducing both acute and chronic rejection episodes, ultimately improving graft survival. These therapies aim to offer better precision in managing immune responses, minimizing side effects, and enhancing long-term transplant outcomes. As research continues to evolve, these innovations hold great promise for the future of kidney transplantation.
As per the KOLs from UK, rejection episodes are unfortunately, a common challenge in kidney transplants, but they can often be mitigated with the right medications and constant surveillance. However, the real issue lies in ensuring that patients are being monitored consistently. Too many patients do not receive the level of care they require following a transplant, which places them at greater risk of rejection and graft failure. As a medical community, need to strengthen the patient pathway from the moment of transplant, improving access to specialist centers.
As per the KOLs from Japan, the issue of kidney transplant rejection remains a significant challenge in Japan, despite the advancements in transplantation techniques and immunosuppressive therapies. It is no surprise that acute rejection episodes continue to affect a proportion of kidney transplant recipients, with approximately 10-15% of patients experiencing rejection within the first year post-transplant. This issue is compounded by the growing number of individuals requiring transplants, coupled with an increase in sensitized patients and ABO-incompatible cases.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
DelveInsight's 'Kidney Transplant Rejection - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of kidney transplant rejection.
ENVARSUS XR (Tacrolimus Extended-release Tablets)
? ENVARSUS XR savings and support
ENVARSUS XR is committed to supporting kidney transplant patients through various means. When prescribed by a healthcare provider, it is essential for patients to have access to the medication through pharmacies and to afford it. ENVARSUS XR offers savings programs designed to assist patients with a range of insurance types. A dedicated team is available to guide how to obtain prescriptions and navigate the process of accessing the medication.
? Insurance-covered patients can access cost savings on ENVARSUS XR
Eligible patients with commercial insurance may qualify for the ENVARSUS XR USD 0 co-pay card, which offers a reduced or zero co-payment option. This program is designed to assist patients in accessing ENVARSUS XR at minimal or no cost, depending on their insurance coverage and eligibility
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
Kidney transplant rejection report insights
Kidney transplant rejection report key strengths
Kidney transplant rejection report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies