Avalere experts have identified four major themes in the policy, regulatory, and market landscape to monitor for the remainder of 2025.

Uncertain Policy and Regulatory Environment

Like many aspects of the US healthcare system, the outlook for kidney care in 2025 will be informed by the newly reconfigured federal government.

The first Trump administration introduced the Advancing American Kidney Health initiative in 2019, which established specific goals to reduce the number of individuals developing end-stage renal disease (ESRD) while increasing home dialysis and kidney transplants. This initiative also created the mandatory ESRD Treatment Choices model and the voluntary Kidney Care Choices model through the Centers for Medicare & Medicaid Innovation (CMMI).  In March 2025, the Trump administration announced its intention to end the ETC model two years early, at the end of 2025.

In addition to CMMI initiatives, stakeholders should monitor federal rulemaking for potential changes to the ESRD payment system under Medicare. These include potential refinements to payment designations that were introduced or refined under the first Trump administration as well as broader reforms to the transplant system that have been underway over the past several years.

Transplant System Reforms

Research continues to demonstrate both the improved clinical outcomes and robust cost savings that kidney transplantation offers for patients with ESRD compared to dialysis. Despite its benefits, patients with ESRD often experience a wait time of three to five years or more waiting for a kidney transplant.

In November 2024, CMS finalized the Increasing Organ Transplant Access model, a two-sided risk, mandatory payment model for selected transplant hospitals aimed at boosting transplant volume, improving organ use, and increasing the number of living donors. The model is scheduled to begin on July 1st, 2025, and run for six years. It is designed to incentivize increased rates of kidney transplantation and address persistent health equity gaps present in the current landscape of care.

One of the Biden administration’s final initiatives was ending the national organ transplant system’s nearly 40-year “contract monopoly” by awarding modernization contracts to 14 vendors to manage various system functions for the first time in the program’s history. These changes to the Organ Procurement Transplantation Network (OPTN) follow the enactment of the 2023 Securing the U.S. OPTN Act, which aims to promote increased competition for the management of the OPTN by allowing multiple grants, contracts, or cooperative agreements to operate it.

Advancements in Transplant Research

Recent innovations in kidney transplant research, particularly in xenotransplantation, offer promising solutions to the shortage of human donor organs. Xenotransplantation involves transplanting organs, tissues, or cells from one species to another, with pig organs being the primary focus due to their anatomical and physiological similarities to human organs.  Recently, the FDA has approved two companies to begin clinical trials for transplanting these genetically modified animal organs to patients with kidney failure, with the goal of alleviating human organ shortages and saving lives.

To date, doctors have performed three kidney transplants with an organ from a genetically modified pig (the first surgery of its kind performed in the world). The approach is intended to provide a longer-term, viable solution for patients that can address health disparities in organ failures and access.

Additionally, new research is supporting the expansion of kidney donations to include organs from deceased donors who received dialysis due to severe acute kidney injury (AKI). While it is known that kidneys affected by AKI are at a higher risk of delayed graft function (a condition where the transplanted kidney does not function immediately), there is still uncertainty about whether using kidneys from donors with a history of AKI leads to reduced life expectancy or long-term organ dysfunction.

Expanded Use of GLP-1s and SGLT2s in CKD

Recently expanded indications for existing drugs present new opportunities in the CKD space for early intervention and proactive management of kidney disease. Both GLP-1s and SGLT2s have emerged as significant therapeutic agents in managing CKD, offering benefits beyond their initial indications for diabetes and heart failure, respectively. GLP-1s have demonstrated potential in slowing CKD progression, as seen in the FLOW trial results published in May 2024, indicating that these agents could decelerate kidney function decline in individuals with Type 2 diabetes and CKD. In January 2025, the FDA approved Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and CKD. SGLT2 inhibitors have shown efficacy in reducing the risk of kidney failure and other major kidney outcomes by 30–40% over two to three years, irrespective of diabetes status.

Looking Ahead

While the future of kidney care offers promising advancements in early detection, prevention, and treatment, transplantation, as well as a shift into value-based care, it remains to be seen how leadership decisions at the US Department of Health and Human Services will impact chronic disease in these next four years. While it is expected that stakeholders will continue to tackle the associated challenges in care coordination and disease management, the reorganization of CMMI’s risk-based portfolio may shift the kidney care landscape.

Avalere is monitoring these developments and will continue to leverage its expertise across policy, market access, data analytics, and quality disciplines to assess how kidney care policy and markets evolve in the coming months. To learn more about the evolving kidney care space and how Avalere can help your business drive access and continuity of care in this dynamic time, connect with us.