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.

Key Market Insights

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.

• By target disease indication, lupus nephritis segment is estimated to account for more than 29% market share in 2025. This can be attributed to the high prevalence of systemic lupus erythematosus (SLE). Nearly 90% of cases occur in women of childbearing age, as per an article by Medscape in August 2024. The huge demand for effective treatments can spur the segment growth till 2032.
• By molecule type, the small molecules segment can account for 43.6% share of the rare kidney diseases market in 2025. Small molecule drugs modulate the complement pathway, a part of the immune system, to reduce the inflammation level caused by rare kidney diseases. For instance, Fabhalta (iptacopan) by Novartis was approved by the U.S. FDA and authorized for treatment on March 21, 2025. The drug will be applicable for patients with C3 glomerulopathy (C3G) to reduce protein levels in the urine.
• By route of administration, the parenteral segment is anticipated to capture a significant market share in 2025 owing to intravenous delivery of drugs like agalsidase alfa for the treatment of classic Fabry disease. Intradialytic parenteral nutrition is a customized nutrition strategy for patients on hemodialysis or at risk of malnourishment.
• By therapy, the monotherapy segment is likely to exhibit a strong growth rate over the forecast period. The use of a single therapeutic agent instead of multiple agents in combination therapy for the treatment of kidney diseases can drive the segment demand over the forecast period. As per a study published in April 2025 edition of the American Journal of Kidney Diseases, sucroferric oxyhydroxide monotherapy administered to adult kidney care patients led to lower serum phosphorus (sP) levels over 6 months of continuous treatment.
• By region, the Asia Pacific region is set to record a stellar growth rate during the forecast period owing to increasing cases of kidney failure and massive demand for dialysis treatments.

The full report is now available for purchase: https://www.coherentmi.com/industry-reports/rare-kidney-diseases-market

Rare Kidney Diseases Market Report Coverage

Report Coverage	Details
Market Revenue in 2025	USD 4.26 billion
Estimated Value by 2032	USD 9.07 billion
Growth Rate	11.4%
Historical Data	2020–2024
Forecast Period	2025–2032
Forecast Units	Value (USD billion)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	By Target Disease Indication, Molecule Type, Route of Administration, and Therapy
Geographies Covered	North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa)
Growth Drivers	Increasing Investment in Rising Kidney Research Rising Prevalence and Diagnosis of Rare Kidney Diseases
Opportunities	Expanding Research Collaborations Advancements in Gene Therapy and Precision Medicine
Trends	Product Innovation Collaborations between Companies to Expedite Drug Development
Restraints & Challenges	High Cost of Drug Development Regulatory Challenges in Rare Kidney Disease Drug Approval

Market Dynamics

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.

Market Opportunities

Collaborations between Companies to Expedite Drug Development

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.

Market Challenges

Regulatory Challenges in Rare Kidney Disease Drug Approval

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.

Analyst’s View

• The rare kidney diseases market is likely to scale due to personalized treatments for rare diseases and increased spending on research and development of novel drugs.
• Small molecules can assist in the treatment of acute kidney injury and nephronophthisis.
• Partnerships between players for product and technology licensing coupled with collaborations for research and development for the enhancement of drug portfolios.

 Recent Developments

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.

Competitor Insights

• Second Genome, Inc.
• Ferring Pharmaceuticals
• Finch Therapeutics Group, Inc.
• BIOHM Health
• FlightPath Biosciences, Inc.
• Gnubiotics Sciences
• Vedanta Biosciences Inc.
• YSOPIA Bioscience
• DayTwo
• Atlas Biomed
• Quantbiome, Inc.
• Synlogic, Inc.
• Viome Life Sciences, Inc.
• BioGaia
• AOBiome Therapeutics

Market Segmentation

• Target Disease Indication
• Fabry Disease
• Lupus Nephritis
• Focal Segmental Glomerulosclerosis
• Atypical Hemolytic Uremic Syndrome
• Immunoglobulin A Nephropathy
• Molecule Type
• Biologics
• Small Molecules
• Route of Administration
• Oral
• Parenteral
• Therapy
• Mono Therapy
• Combination Therapy

Regional Insights

• North America
  • U.S.
  • Canada
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Europe
  • Italy
  • Germany
  • U.K.
  • Spain
  • Russia
  • France
  • Rest of Europe
• Asia Pacific
  • South Korea
  • India
  • China
  • Japan
  • Australia
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
• Africa
  • South Africa
  • North Africa
  • Central Africa