Renal Transplant Therapeutics - Market Insights, Competitive Landscape, and Market Forecast - 2032

Renal Transplant Therapeutics Market by Drug Class (Calcineurin Inhibitors, Interleukin Inhibitors, mTOR Inhibitors, IMPDH Inhibitors, and Others), Route of Administration (Oral and Parenteral), Modality (Small Molecule and Biologics), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing number of kidney transplant performed globally and the rising prevalence of chronic kidney disease, renal failure, end-stage renal disease (ESRD) and its associated risk factors.

The renal transplant therapeutics market was valued at USD 11.35 billion in 2024, growing at a CAGR of 6.29% during the forecast period from 2025 to 2032 to reach USD 18.39 billion by 2032. The demand for renal transplant therapeutics is being driven by several key factors. Foremost among these is the growing number of kidney transplants performed globally, alongside the rising prevalence of chronic kidney disease (CKD), renal failure, and end-stage renal disease (ESRD). These conditions often lead to permanent damage to kidney function, thereby increasing the need for transplantation. In addition, a surge in research and development activities, along with the introduction of new products aimed at preventing transplant rejection, is contributing significantly to market growth. The efforts by leading pharmaceutical companies to innovate and expand their therapeutic offerings are creating a favorable environment for the renal transplant therapeutics market. Together, these trends are positioning the market for robust and steady expansion from 2025 to 2032.

Renal Transplant Therapeutics Market Dynamics:

According to the data provided by the World Health Organization Global Observatory on Donation and Transplantation (2024), in 2023, approximately 172,409 organ transplants were performed worldwide, including kidney, liver, heart, and other organs. Kidney transplants accounted for the majority, with 111,135 procedures, a notable 9% increase from the 102,090 kidney transplants conducted globally in 2022. Of the kidney transplants performed in 2023, GODT data revealed that 43,101 were from living donors, while 68,034 were from deceased donors. This upward trend in transplant procedures highlights an increasing global need for effective post-transplant care, which is critical in preventing organ rejection and ensuring long-term graft survival.

A cornerstone of post-transplant management is the use of immunosuppressant medications, commonly referred to as anti-rejection drugs. These therapies play a vital role in kidney transplant success by suppressing the immune system's natural response to recognize the transplanted kidney as a foreign object. Without immunosuppressants, this immune reaction can lead to graft damage or complete rejection. Typically, these medications are administered long-term to reduce the risk of both acute and chronic rejection episodes.

The growing number of kidney transplants is also increasing in countries. For example, data from Kidney Care UK (2022) reported that approximately 3,600 kidney transplants were performed annually in the United Kingdom, while nearly 5,000 individuals remained on the waiting list. Similarly, in Australia, the Australian Institute of Health and Welfare (2024) reported 938 kidney transplants in 2022, with 90% being first-time transplants. Of these, 713 were from deceased donors (76%), and 225 from living donors (24%). The global rise in kidney transplant procedures is driving a parallel increase in demand for comprehensive and long-term renal transplant therapies. This includes not only immunosuppressants and anti-infective agents but also innovations aimed at improving transplant outcomes.

Moreover, product development and regulatory approvals are fostering growth in the transplant therapeutics market. For instance, in March 2024, Unicycive Therapeutics, Inc., a clinical-stage biotechnology company focused on kidney disease therapies, announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to UNI-494. This investigational therapy is aimed at preventing Delayed Graft Function (DGF), a serious complication following kidney transplantation.

However, the long-term risk and potential adverse effects associated with kidney transplant drugs and stringent regulatory requirements for drug approval, among others, are some of the key constraints that may limit the growth of the renal transplant therapeutics market.

Renal Transplant Therapeutics Market Segment Analysis:

Renal Transplant Therapeutics Market by Drug Class (Calcineurin Inhibitors, Interleukin Inhibitors, mTOR Inhibitors, IMPDH Inhibitors, and Others), Route of Administration (Oral and Parenteral), Modality (Small Molecule and Biologics), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the drug class segment of the renal transplant therapeutics market, the calcineurin inhibitors category is estimated to account for the largest market share in 2024. The growth of the calcineurin inhibitors category is being significantly driven by the rising global cases of kidney transplants and the critical clinical role of calcineurin inhibitors (CNIs) in preventing organ rejection. These agents are well-established, FDA-approved, and remain the cornerstone of immunosuppressive regimens in renal transplantation.

One of the key strengths of calcineurin inhibitors lies in their high efficacy in preventing acute rejection episodes. By targeting the calcineurin pathway, CNIs inhibit T-cell activation and suppress the production of interleukin-2 (IL-2), a cytokine essential for T-cell proliferation. This mechanism significantly lowers the risk of early acute rejection when compared to older immunosuppressive strategies. Beyond acute rejection prevention, CNIs have played a pivotal role in improving long-term graft survival. Their ability to suppress T-cell-mediated immune responses helps mitigate chronic graft injury, a major contributor to late transplant failure.

In clinical practice, CNIs are typically administered as part of a triple immunosuppressive regimen, often in combination with antimetabolites such as mycophenolate mofetil and corticosteroids. This multimodal approach allows physicians to balance efficacy and safety by using lower doses of each agent, thereby reducing drug-specific toxicities while maintaining robust immune suppression.

Among the most prominent calcineurin inhibitors are:

• PROGRAF® (tacrolimus) by Astellas Pharma is indicated for the prevention of organ rejection in kidney transplant recipients. It is widely considered a first-line therapy due to its potent immunosuppressive profile.
• NEORAL® (cyclosporine capsules, USP) by Novartis is a widely used calcineurin inhibitor, approved to reduce the risk of graft rejection, particularly in patients who may not tolerate tacrolimus or require tailored immunosuppressive management.

Thus, the factors mentioned above are likely to boost the market segment and thereby increase the overall market of renal transplant therapeutics across the globe.

North America is expected to dominate the overall renal transplant therapeutics market:

North America is projected to hold the largest share of the renal transplant therapeutics market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising prevalence of kidney diseases such as CKD and ESRD, a growing number of kidney transplants, a well-established healthcare infrastructure, and ongoing product development by leading companies. Collectively, these factors are positioning North America as the leading market in the global renal transplant therapeutics market.

According to the Centers for Disease Control and Prevention (CDC, 2024), in 2023, approximately 35.5 million U.S. adults, about 14% of the population, were living with CKD. Supporting this, the American Kidney Fund (2024) reported that around 808,000 individuals were living with kidney failure, with 135,000 new cases diagnosed in 2022, underscoring the escalating burden of kidney-related conditions in the country.

As per the data from the Kidney Foundation of Canada (2023, every 1 in 10 people, accounting for approximately 4 million people, were suffering from kidney disease in Canada. This growing burden of kidney disease in the region has led to increased transplant procedures, fueling the need for effective immunosuppressive and anti-infective therapies to support long-term graft survival, thereby driving the market growth.

As per the latest data from the Organ Procurement and Transplantation Network (OPTN, 2025), in 2023, over 27,759 kidney transplants were performed in the United States, while the National Kidney Foundation (2023) noted more than 25,000 kidney transplants in 2022 alone. These high transplant volumes are driving demand for renal transplant therapeutics, particularly immunosuppressants and infection-preventive therapies.

Furthermore, key industry players in the region are actively advancing transplant-related drug development. For example, in October 2024, Biogen announced that felzartamab, an investigational anti-CD38 monoclonal antibody, received Breakthrough Therapy Designation (BTD) from the U.S. FDA for treating late antibody-mediated rejection (AMR) in kidney transplant recipients, without concurrent T-cell-mediated rejection.

Therefore, the combination of a rising number of kidney transplant procedures, a high prevalence of kidney disease, and ongoing innovation in transplant therapeutics is expected to significantly propel the growth of the renal transplant therapeutics market in the North America from 2025 to 2032.

Renal Transplant Therapeutics Market Key Players:

Some of the key market players operating in the renal transplant therapeutics market include Novartis AG, Sanofi, Astellas Pharma Inc., Asahi Kasei Corporation, F. Hoffmann-La Roche Ltd., Pfizer Inc., Bristol-Myers Squibb Company, GSK plc, Biogen, Zydus Group, Eledon Pharmaceuticals, Inc., AbbVie Inc., CSL, Teva Pharmaceutical Industries Ltd., Johnson & Johnson Services, Inc., and others.

Recent Developmental Activities in the Renal Transplant Therapeutics Market:

• In March 2025, Zydus announced the launch of ANVIMO (Letermovir), marking a significant advancement in the prevention of Cytomegalovirus (CMV) infection among kidney transplant recipients. ANVIMO offers a safer, well-tolerated, and effective alternative to existing therapies, with superior safety, fewer side effects, and the potential to enhance post-transplant outcomes, making it a valuable addition to renal transplant care.
• In March 2025, Hansa Biopharma AB announced the completion of enrollment for its 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study, an open-label, Phase 3 confirmatory trial in Europe. The study is evaluating one-year patient and graft survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with imlifidase, aiming to further validate the therapy's clinical effectiveness and safety.
• In February 2025, Eledon Pharmaceuticals, Inc. announced that its investigational anti-CD40L antibody, tegoprubart, was utilized as a key component of the immunosuppressive regimen in a groundbreaking xenotransplantation procedure. On January 25, 2025, a patient received a genetically modified pig kidney at Massachusetts General Hospital (MGH), with the transplant performed in collaboration with eGenesis, marking a significant milestone in the advancement of cross-species organ transplantation.  

Key takeaways from the renal transplant therapeutics market report study

• Market size analysis for current renal transplant therapeutics market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the renal transplant therapeutics market.
• Various opportunities available for the other competitors in the renal transplant therapeutics market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current renal transplant therapeutics market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for renal transplant therapeutics market growth in the coming future?

Target audience who can benefit from this renal transplant therapeutics market report study

• Renal transplant therapeutics product providers
• Research organizations and consulting companies
• Renal transplant therapeutics-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in renal transplant therapeutics
• Various end-users who want to know more about the renal transplant therapeutics market and the latest technological developments in the renal transplant therapeutics market.

Frequently Asked Questions for the Renal Transplant Therapeutics Market:

1. What are renal transplant therapeutics?

• Renal transplant therapeutics are drugs used to support kidney transplant patients by preventing organ rejection and ensuring the long-term function of the transplanted kidney. These therapies primarily include immunosuppressive drugs, anti-infective agents, and supportive medications.

2. What is the market for renal transplant therapeutics?

• The renal transplant therapeutics market was valued at USD 11.35 billion in 2024, growing at a CAGR of 6.29% during the forecast period from 2025 to 2032 to reach USD 18.39 billion by 2032.

3. What are the drivers for the renal transplant therapeutics market?

• The demand for renal transplant therapeutics is increasing due to the growing number of kidney transplants worldwide and the rising prevalence of chronic kidney disease, renal failure, and end-stage renal disease (ESRD). These conditions often cause permanent kidney damage, leading to a greater need for transplants. Additionally, ongoing R&D efforts and new product launches by key players in transplant rejection drugs are supporting market growth. Together, these factors are expected to drive steady expansion of the renal transplant therapeutics market from 2025 to 2032.

4. Who are the key players operating in the renal transplant therapeutics market?

• Some of the key market players operating in the renal transplant therapeutics market include Novartis AG, Sanofi, Astellas Pharma Inc., Asahi Kasei Corporation, F. Hoffmann-La Roche Ltd., Pfizer Inc., Bristol-Myers Squibb Company, GSK plc, Biogen, Zydus Group, Eledon Pharmaceuticals, Inc., AbbVie Inc., CSL, Teva Pharmaceutical Industries Ltd., Johnson & Johnson Services, Inc., and others.

5. Which region has the highest share in the renal transplant therapeutics market?

• North America is projected to hold the largest share of the renal transplant therapeutics market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising prevalence of kidney diseases such as CKD and ESRD, a growing number of kidney transplants, a well-established healthcare infrastructure, and ongoing product development by leading companies. Collectively, these factors are positioning North America as the leading market in the global renal transplant therapeutics market.

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