Rare Kidney Diseases Market Size, Share & Trends Analysis Report By Target Indication, By Type of Molecule (Small Molecules, Biologics, By Route of administration (Oral, Intravenous, Subcutaneous, Others), By End-User, By Distribution, By Region, And By Segment Forecasts, 2025-2034

Global Rare Kidney Diseases Market Size is valued at USD 2.9 Billion in 2024 and is predicted to reach USD 8.1 Billion by the year 2034 at a 11.0% CAGR during the forecast period for 2025-2034.

Key Industry Insights & Findings from the Report:

• The emergence of the rare kidney disease market is credited to the improved understanding and identification of these conditions, resulting in higher diagnosis rates.
• The increasing incidences and prevalence of kidney diseases are expected to drive industry growth.
• North America dominated the market and accounted for a global revenue share in 2024.
• One of the significant concerns restraining industry growth is the slow drug approvals and complex disease mechanisms.

Kidney diseases have the potential to intensify over time, eventually leading to kidney failure, which is when the kidneys completely stop working. In addition, having one of these diseases can put you at a higher risk for developing another condition, such as cardiovascular disease. At least 150 distinct conditions are classified as rare kidney diseases, and the majority are inherited. The diagnosis and treatment of rare kidney diseases as a group may present overlapping difficulties, even though individual cases of these diseases present unique obstacles. Diagnosis, management, and treatment of inherited kidney disorders are complicated, especially when multisystem complications are present. These diseases can result in numerous physical and mental impairments, lowering life expectancy and reducing the quality of life. In the last two years, the COVID-19 infection severely affected the human lifestyle and approach towards chronic disease treatment. This led to delayed detection of rare kidney diseases and became responsible for the increase in the number of patients.

Several important factors are responsible for the growth of the rare kidney disease market. It is anticipated that the increasing use of next-generation sequencing techniques will improve diagnostic accuracy for rare kidney diseases, aid in elucidating the molecular mechanism of disease, facilitate genetic counselling, and provide opportunities for carrier testing. Renal replacement therapy advancements and increased accessibility allow for more prolonged patient survival, but frequently at the expense of their quality of life. FDA approvals, Government initiatives and funding also contribute to expanding the market for such complicated diseases. In 2021, IgA nephropathy was rare kidney disease, and the FDA approved the first medication to reduce urine protein. The FDA had approved Tarpeyo (budesonide) delayed-release capsules to treat adults with primary immunoglobulin A (IgA) nephropathy who are at risk of rapid disease progression by lowering proteinuria (increased protein levels in the urine).

Multiple factors, including unresolved genetic defects, a lack of biomarkers to track disease progression, heterogeneous clinical phenotypes, and outdated diagnostic classifications that do not reflect underlying pathophysiological mechanisms, have impacted therapeutic advancements in rare kidney diseases. Slow drug approvals and complex studies will also restrain the market's growth.

Market Segmentation

The Rare Kidney Diseases market is segmented into target indications, type of molecule, and route of administration. Target indication segment includes IgA Nephropathy, Lupus Nephritis, Focal Segmental Glomerular Sclerosis, Membranous Nephropathy, C3 Glomerulopathy and others. Another segment is a type of molecule, which comprises Small Molecules and biologics. The subsegment biologics include Monoclonal Antibody, Hormone, Recombinant Protein, and Others. The last segment is the route of administration which has Oral, Intravenous, Subcutaneous, and other routes as subsegments.

According to regional analysis, North America will lead the global Rare Kidney Diseases market during the forecast period due to rapid clinical advancement breakthroughs and research for treatments of kidney diseases.

Recent Developments:

• In Aug 2023, Novartis successfully finalized its acquisition of Chinook Therapeutics, a clinical-stage biopharmaceutical business based in the United States. Chinook Therapeutics specializes in the research and production of precision medicines specifically designed for the treatment of kidney ailments. The agreement comprised a $3.2 billion initial payment, with a potential total purchase value of up to $3.5 billion.

• In March 2024, Travere Therapeutics, Inc. submitted a sNDA to the U.S. FDA to convert the current accelerated approval of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) to full approval. In February 2023, the FDA granted expedited approval to FILSPARI as the initial and exclusive non-immunosuppressive therapy specifically designed to address glomerular damage in the kidney and decrease proteinuria in people with primary IgAN who might be at risk of rapid disease progression.

Competitive Landscape

Some major key players in the Rare Kidney Diseases Market:

• GlaxoSmithKline,
• Recordati Rare Diseases,
• Amicus Therapeutics,
• Calliditas Therapeutics,
• Alexion Pharmaceuticals (A subsidiary of AstraZeneca),
• Travere Therapeutics,
• Aurinia Pharmaceutical,
• Advicenne,
• Protalix Biotherapeutics,
• AstraZeneca,
• Chinook Therapeutics,
• Reata Pharmaceuticals,
• Roche,
• Novartis Pharmaceuticals,
• Merk & co.,
• Apellis Pharmaceuticals,
• Omeros Corporation,
• Lonza,
• Other Prominent Players.

Rare Kidney Diseases Market Report Scope

Market Segmentation:

Global Rare Kidney Diseases Market, by Target Indication, 

• IgA Nephropathy

• Lupus Nephritis

• Focal Segmental Glomerular Sclerosis

• Membranous Nephropathy

• C3 Glomerulopathy

• Cystinosis

• Dense Deposit Disease

• Distal Renal Tubular Acidosis

• Fabry Disease

• Refractory Gout

• Atypical Hemolytic Uremic Syndrome

• Others

Global Rare Kidney Diseases Market, by Type Of Molecule, 

• Small Molecules
• Biologics
  • Monoclonal Antibody
  • Hormone
  • Recombinant Protein
  • Others

 Global Rare Kidney Diseases Market, by Route Of Administration, 

• Oral
• Intravenous
• Subcutaneous
• Others

 Global Rare Kidney Diseases Market, by Region, 

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

 North America Rare Kidney Diseases Market, by Country, 

• U.S.
• Canada

 Europe Rare Kidney Diseases Market, by Country, 

• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe

 Asia Pacific Rare Kidney Diseases Market, by Country, 

• India
• China
• Japan
• South Korea
• Australia & New Zealand

 Latin America Rare Kidney Diseases Market, by Country, 

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa Rare Kidney Diseases Market, by Country, 2022-2030 (Value US$ Mn)

• GCC Countries
• South Africa
• Rest of Middle East & Africa