Rare Kidney Diseases Market to reach USD 9.07 billion by 2032

The global rare kidney diseases market is expected to stand at USD 4.26 billion in 2025. It is anticipated to touch a valuation of USD 9.07 billion by 2032. It is estimated to display a CAGR of 11.4% during the forecast period (2025-2032).  

The advances in precision medicine, like genome sequencing, is expected to drive its demand significantly. Government initiatives funding the research of rare kidney diseases and their treatment can drive the market growth over the forecast period.

However, regulatory hurdles causing a delay in the launch of new medicines and the high cost of drug development are challenges faced in the market.

The rare kidney diseases market is anticipated to deliver staggering growth owing to government initiatives running awareness campaigns and investments by venture capital funds to kickstart the drug development of rare diseases.

The use of artificial intelligence (AI) for the identification and diagnosis of rare kidney diseases can drive the market growth. Its integration in the research process by helping scientists and the acceleration of the drug development process can reduce the overall production time. In August 2024, Healx, a U.K. biotechnology startup, leveraged AI to discover new drugs for rare diseases. It raised USD 42 million in funding in the same year from Atomico and R42. Furthermore, it received the green signal from the U.S. FDA for discovering new drugs and treatments using small molecules and existing chemical compounds.

Furthermore, drug approvals by regulatory bodies for rare kidney diseases can provide viable options for patients suffering from kidney-related ailments. The new product launches can bolster the competition and spur the market growth over the forecast period.

Pharmaceutical companies are collaborating with each other for the development of novel drugs and streamlining the regulatory process for faster drug approval. This is illustrated by the collaboration between the American Kidney Fund, the IgA Nephropathy Foundation, and the GlomCon Foundation, for the development of a consensus framework in May 20, 2025 for Centers of Excellence in Glomerular Disease Care. The collaboration is expected to accelerate research efforts and improve patient outcomes.

Stringent requirements by the U.S. FDA and European Medicines Agency (EMA) to ensure maximum safety and drug efficacy for patients is likely to be a major challenge facing the market. The small patient population and large clinical trial period are factors that make it difficult for drug manufacturers in gaining rapid approvals. Policy changes that streamline the regulatory process may benefit the market in the long run.

Novartis AG was granted approval by the U.S. Food & Drug Administration (FDA) for Vanrafia (atrasentan) on April 04, 2025. The non-steroidal drug can be used in the treatment of primary IgA nephropathy (IgAN) in adults.