7MMの腎臓移植拒絶反応治療薬市場規模は2034年までにかなりのCAGRで成長すると予測、DelveInsight

DelveInsight’s “Kidney Transplant Rejection Market Insights, Epidemiology, and Market Forecast – 2034” report provides an in-depth understanding of kidney transplant rejection, including historical and forecasted epidemiology, as well as therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Kidney Transplant Rejection Market Report

• June 2025 Update: Biogen announced a clinical trial evaluating the efficacy of felzartamab versus placebo in kidney transplant recipients with late active or chronic active antibody-mediated rejection (AMR).
• June 2025 Update: Tract Therapeutics Inc. organized a Phase 2 trial assessing the safety and efficacy of expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
• In 2023, there were an estimated 44 thousand total incident cases of kidney transplants across the 7MM, expected to rise by 2034.
• According to DelveInsight’s estimates, there were approximately 27 thousand incident cases of kidney transplants in the US in 2023, projected to increase by 2034.
• In 2023, the US reported about 2 thousand acute and 8 thousand chronic cases of kidney transplant rejection, with numbers expected to rise by 2034.
• In 2023, among EU4 and the UK, the UK had the highest number of living kidney transplants (approximately 46 thousand), followed by France (nearly 45 thousand), while Italy had the lowest (around 28 thousand).
• In 2023, EU4 and the UK reported about 2 thousand acute and 4 thousand chronic cases of kidney transplant rejection, projected to increase to nearly 4 thousand acute and 7 thousand chronic cases by 2034.
• In 2023, Japan had approximately 2 thousand incident cases of kidney transplants, expected to grow at a 0.7% CAGR by 2034.
• Leading Kidney Transplant Rejection Companies include Amgen Inc., Amyndas Pharmaceuticals LLC, Astellas Pharma Inc., Bristol-Myers Squibb Co., Alphamab Oncology, AltruBio Inc., Cynata Therapeutics Ltd., Eledon Pharmaceuticals Inc., Enceladus Pharmaceuticals BV, Hansa Biopharma AB, Helocyte Bi, Taiwan Bio Therapeutics Co., Ltd., and others.
• Promising Kidney Transplant Rejection Pipeline Therapies include Sonazoid, Belatacept, VIB4920, Thymoglobulin, AT-1501, Tacrolimus, Simulect, Belimumab, TRK-001 (TregCel), and others.

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Kidney Transplant Rejection Epidemiology Segmentation in the 7MM

• Total Kidney Transplant Rejection Incident Cases
• Total Kidney Transplant Rejection Living Cases
• Kidney Transplant Rejection Type-Specific Cases

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Marketed Kidney Transplant Rejection Prophylaxis Drugs

• MYHIBBIN: Azurity Pharmaceuticals MYHIBBIN 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, it is used in combination with other immunosuppressive therapies. It inhibits inosine monophosphate dehydrogenase (IMPDH), suppressing T and B lymphocyte proliferation and cytokine production to prevent graft rejection.
• THYMOGLOBULIN: Sanofi THYMOGLOBULIN is an immunosuppressive therapy from rabbit serum immunized with human thymocytes. This purified, pasteurized IgG targets T lymphocyte antigens for preventing acute kidney transplant rejection. Administered intravenously, it clears circulating T cells and modulates their activation, homing, and cytotoxic functions by targeting markers like CD2, CD3, CD4, and HLA-DR.
• NULOJIX: Bristol Myers Squibb NULOJIX (belatacept) is a selective T-cell costimulation blocker approved for preventing organ rejection in adult kidney transplant recipients. Given intravenously with basiliximab induction, mycophenolate mofetil, and corticosteroids, it targets CD80 and CD86 on antigen-presenting cells, preventing CD28-mediated T-cell activation, reducing proliferation and cytokine production like interleukin-2 and TNF-α.

Emerging Kidney Transplant Rejection Drugs

• MDR-101: Medeor Therapeutics MDR-101 is a cellular therapy from donor blood and peripheral stem cells to induce donor-specific immune tolerance and prevent kidney transplant rejection. It reprograms the recipient’s immune system, eliminating the need for lifelong immunosuppressants. Positive Phase III interim data were presented at ASN Kidney Week in November 2023. It has Orphan Drug Designation (ODD) in the US and EU, FDA Special Protocol Assessment (SPA), RMAT designation (September 2020), and CIRM funding (USD 18.8 million in January 2018).
• Tegoprubart (AT-1501): Eledon Pharmaceuticals Tegoprubart is a humanized monoclonal antibody targeting the CD40L pathway to prevent kidney transplant rejection by blocking CD40-CD40L interaction. It aims to replace calcineurin inhibitors like tacrolimus for better graft survival. Enrollment for the Phase II BESTOW trial completed in September 2024, four months early, with topline results expected in Q4 2025. Phase Ib data at ATC in June 2024 showed safety and tolerability.
• Riliprubart (BIVV020, SAR445088): Sanofi Riliprubart is an IgG4 humanized monoclonal antibody for antibody-mediated rejection (AMR) in kidney transplants. It inhibits activated complement component C1s, reducing inflammation. Phase II trials are evaluating its efficacy and safety in AMR patients or those at risk. Administered intravenously.
• TRK-001 (TregCel): Taiwan Bio Therapeutics Co., Ltd. TRK-001 (TregCel) is an autologous regulatory T cell therapy promoting immune tolerance, developed by Taiwan Bio Therapeutics Co., Ltd. in Taiwan. It is in Phase II trials, with an ongoing multinational study where the first patient has been enrolled, involving FDA/TFDA and orphan designation.
• No novel anti-rejection candidate in Phase 1–3 currently with local sponsorship: Japanese pharma (e.g., Astellas, Takeda) Japanese pharma companies like Astellas and Takeda in Japan currently use established immunosuppressants clinically, with no active novel transplant rejection trials identified as industry-sponsored.
• None identified in public registries for transplant rejection therapeutics: Korean biotech/pharma Korean biotech/pharma in South Korea focuses on regenerative medicine but has no registered kidney transplant rejection trials from local sponsors.

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Kidney Transplant Rejection Market Outlook

Kidney transplant rejection is a major issue for recipients, as the immune system attacks the donor kidney, damaging the graft. Types include acute (within the first year) and chronic (gradual over years, more common). Chronic rejection links to inadequate immunosuppression or non-compliance, causing scarring and kidney loss. About 15–20% of recipients experience rejection, emphasizing monitoring and adherence to immunosuppressants.

Kidney Transplant Rejection Drugs Market Insights

Current prophylaxis uses approved treatments like ENVARSUS XR, IDEFIRIX, NULOJIX, THYMOGLOBULIN, MYHIBBIN, and SIMULECT with varied mechanisms for long-term success. Treatment manages immune responses, prevents damage, and ensures graft function via immunosuppressants, monitoring, and care. Goals include preserving function, reducing inflammation, minimizing complications, and improving quality of life. Lifestyle changes and medication adherence are key. Research advances therapies for better survival.

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Scope of the Kidney Transplant Rejection Market Report

• Coverage: 7MM
• Study Period: 2020–2034
• Kidney Transplant Rejection Companies: Amgen Inc., Amyndas Pharmaceuticals LLC, Astellas Pharma Inc., Bristol-Myers Squibb Co., Alphamab Oncology, AltruBio Inc., Cynata Therapeutics Ltd., Eledon Pharmaceuticals Inc., Enceladus Pharmaceuticals BV, Hansa Biopharma AB, Helocyte Bi, Taiwan Bio Therapeutics Co., Ltd., and others.
• Kidney Transplant Rejection Pipeline Therapies: Sonazoid, Belatacept, VIB4920, Thymoglobulin, AT-1501, Tacrolimus, Simulect, Belimumab, TRK-001 (TregCel), and others.
• Therapeutic Assessment: Current Marketed and Emerging Therapies
• Market Dynamics: Market Drivers and Barriers
• Unmet Needs, KOL’s Views, Analyst’s Views, Market Access, and Reimbursement

Table of Contents

1. Key Insights
2. Report Introduction
3. Market Overview at a Glance
4. Executive Summary
5. Key Events
6. Disease Background and Overview
7. Methodology
8. Epidemiology and Patient Population
9. Patient Journey
10. Marketed Drugs
11. Emerging Drugs
12. Kidney Transplant Rejection – 7MM Market Analysis
13. KOL Views
14. Unmet Needs
15. SWOT Analysis
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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