IgA Nephropathy Market Summary
IgA Nephropathy (IgAN) Insights and Trends
The IgA Nephropathy market has emerged as one of the most dynamic and rapidly evolving segments within the rare kidney disease space. According to DelveInsight’s analysis, the IgA Nephropathy (IgAN) market size was found to be approximately USD 1.5 billion in the leading markets – the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan – in 2025.
IgAN reported approximately 135,000 diagnosed prevalent cases in the US. Improved diagnostic practices, greater disease awareness, and wider use of kidney biopsies are expected to drive the growing prevalence of IgAN in the coming years.
There is no cure for IgAN, and treatment focuses on reducing proteinuria, controlling blood pressure, and slowing disease progression. Standard therapies include ACE inhibitors (ACEis), ARBs, and SGLT2 inhibitors, while newer approaches target underlying disease mechanisms, offering precision, disease-modifying strategies that go beyond supportive care and aim to improve long-term renal outcomes.
The IgAN-approved drug portfolio currently includes:
- Iptacopan (FABHALTA)
- Atrasentan (VANRAFIA)
- Budesonide (TARPEYO/KINPEYGO)
- Sparsentan (FILSPARI)
- Sibeprenlimab (VOYXACT)
Among these, VOYXACT has recently received US FDA approval, providing a first-in-class APRIL-blocking therapy that offers a novel, disease-modifying option to reduce proteinuria and slow disease progression.
The IgAN pipeline includes several late-stage therapies targeting key disease mechanisms. Major Phase III candidates include:
- BAFF/APRIL dual inhibitors (povetacicept, atacicept)
- Anti-CD38 antibodies (felzartamab, mezagitamab)
- Complement inhibitors (ravulizumab, ARO-C3)
- Anti-APRIL therapy (zigakibart)
- Gene-silencing agent sefaxersen
These biologics, monoclonal antibodies, and RNA-based therapies aim to modify disease progression and expand treatment options beyond supportive care.
IgAN is more prevalent in men than in women. In most studies, except for Japan and Brazil, IgAN was over-represented in male patients compared with female patients.
Recent Developments:
- Vera Therapeutics reported positive Phase III ORIGIN atacicept data in IgAN, presented at ASN Kidney Week 2025 and published in the New England Journal of Medicine
- In June 2025, 100-week Phase I/II data for zigakibart presented at the ERA Congress showed sustained proteinuria remission, stable kidney function, and a favorable safety profile in patients with IgAN, supporting its continued clinical advancement
Heterogeneity in IgAN phenotypes and variable disease progression complicate patient stratification and therapy selection, often delaying initiation of optimal targeted treatments.
The total IgAN market size is expected to expand over the forecast period. Growth is primarily driven by an increasing diagnosed and treated patient population across the 7MM, supported by earlier detection through routine urine screening, wider adoption of renal biopsy, and enhanced disease awareness – collectively contributing to a steady expansion of the addressable treatment pool.
IgAN Epidemiology
Key Findings from IgAN Epidemiological Analysis and Forecast
Tracking the epidemiological landscape is central to understanding IgA Nephropathy market research and investment potential. The total number of diagnosed prevalent cases of IgAN in the 7MM is approximately 415,000 in 2025.
- According to DelveInsight’s estimates, the US reported nearly 135,000 diagnosed prevalent cases of IgAN in 2025
- IgAN diagnoses across Spain showed a gender disparity in 2025, with 67% of cases occurring in males and 33% in females, highlighting a greater susceptibility among men; Germany emerged as the leading contributor to the regional disease burden, recording the highest number of diagnosed cases in both sexes
- The 18–45 years age group accounted for the highest number of IgAN cases in Japan, with nearly 70,000 diagnosed cases; this figure is projected to rise due to improved diagnostic recognition and evolving demographic trends
- In 2025, individuals aged 18–45 years accounted for the largest share of diagnosed IgAN cases in EU4 and the UK, comprising 41% of the total across all age groups, followed by the 46–65 years cohort; the under-18 years age group represented the smallest proportion of the overall case burden
Approved Therapies for IgAN
Budesonide (TARPEYO/KINPEYGO) – Asahi Kasei / Calliditas Therapeutics
Budesonide delayed-release capsules (TARPEYO) are a gut-targeted oral corticosteroid for primary IgAN, designed for targeted ileal release. By modulating mucosal immune responses and suppressing Gd-IgA1 production from Peyer’s patch B cells, the therapy significantly reduces proteinuria and helps stabilize kidney function, representing a disease-modifying approach that addresses the underlying immune dysregulation in IgAN.
- In July 2024, Calliditas Therapeutics reported that its partner, Viatris Pharmaceutical, had initiated a Phase III clinical trial in Japan for NEFECON, marketed locally as VR-205, in Japanese patients diagnosed with IgAN, with the Phase III readout expected in 2026
The approval of multiple agents in IgAN reflects a significant evolution in IgA Nephropathy market insight, as the field rapidly transitions from purely supportive care toward targeted, mechanism-based interventions with the potential to alter long-term disease trajectories.
IgAN Pipeline Analysis
Zigakibart (FUB523) – Novartis
Zigakibart (FUB523; formerly BION-1301) is a subcutaneously administered monoclonal antibody that selectively targets APRIL, a key driver of pathogenic IgA production. The therapy is currently in Phase III clinical development for IgAN, with Novartis planning regulatory submissions in 2027.
- In June 2025, 100-week Phase I/II data for zigakibart presented at the ERA Congress showed sustained proteinuria remission, stable kidney function, and a favorable safety profile in patients with IgAN, supporting its continued clinical advancement
The robust pipeline of next-generation agents reinforces the positive IgA Nephropathy market trends, with multiple late-stage candidates poised to redefine the standard of care and generate substantial commercial value in the years ahead.
IgAN Key Players, Market Leaders, and Emerging Companies
The competitive landscape of the IgAN market features a mix of established pharmaceutical companies and emerging biotechs advancing differentiated clinical programs:
- Travere Therapeutics
- Otsuka Pharmaceutical / PANTHERx Rare
- Novartis
- Vertex Pharmaceuticals
- Takeda Pharmaceutical
- And others
IgAN Market Outlook
The expanding IgAN market is driven by improved disease recognition among nephrologists, broader use of renal biopsy enabling earlier diagnosis, and growing focus on slowing progression to end-stage kidney disease. In parallel, the emergence of next-generation pipeline therapies – including povetacicept, atacicept, felzartamab, zigakibart, TAK-079, sefaxersen, ARO-C3, ULTOMIRIS, and others – is broadening the therapeutic landscape by targeting diverse disease mechanisms, sustaining long-term market growth and treatment innovation.
Conclusion
The IgA Nephropathy space stands at a pivotal inflection point, with a maturing pipeline, multiple approved therapies, and a growing diagnosed patient population collectively reshaping the treatment paradigm. As precision medicine approaches gain traction and regulatory momentum builds across the 7MM, the market is poised for sustained expansion. Continued advances in early detection, biomarker-driven patient stratification, and novel mechanism-based therapies will be key in addressing the unmet needs that remain in this progressive kidney disorder.
About DelveInsight
DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharmaceutical companies by providing comprehensive end-to-end solutions to improve their performance. It also offers healthcare consulting services that leverage market analysis to accelerate business growth and overcome challenges with practical approaches.
Media contact
Name: Abhishek kumar
E-mail:abhishek@delveinsight.com
