IgA Nephropathy Market By Therapy Type (Corticosteroid-Sparing Therapies, Endothelin Receptor Antagonists, Complement Inhibitors, Supportive Care); By Route of Administration (Oral, Injectable); By End User (Academic and Tertiary Hospitals, Specialty Nephrology Clinics, Retail and Specialty Pharmacies); By Geography, Segment Revenue Estimation, Forecast, 2025–2030

Introduction And Strategic Context

The Global IgA Nephropathy Market is projected to grow at a steady CAGR of 6.5% , reaching an estimated market size of USD 5.8 billion by 2030 , up from USD 3.8 billion in 2024 , according to Strategic Market Research.

 

IgA nephropathy ( IgAN ), also known as Berger’s disease, is a rare but chronic autoimmune condition affecting the kidneys. It’s characterized by the deposition of immunoglobulin A in the glomeruli, often leading to inflammation and progressive renal impairment. Historically, this space was managed primarily with supportive care—like corticosteroids, blood pressure control, and immunosuppressants. But between 2024 and 2030, the landscape is shifting dramatically.

 

The turning point came with the emergence of targeted therapies, particularly oral corticosteroid-sparing drugs and endothelin receptor antagonists that address the underlying inflammatory process. For years, nephrologists had to rely on generalized immunosuppression. That’s changing fast. Regulatory momentum is now behind several novel therapies designed to slow disease progression and delay the onset of end-stage renal disease (ESRD).

 

Geographically, incidence rates are highest in East Asia, particularly Japan and China. But underdiagnosis remains a major barrier in North America and Europe—something that improved biopsy protocols and growing awareness campaigns are beginning to address. There’s also increased screening in populations with microscopic hematuria , which often leads to earlier detection.

 

Key stakeholders across the board are taking note. Biopharmaceutical companies are ramping up rare disease pipelines, particularly in nephrology. Health authorities are streamlining fast-track approvals, especially in the U.S., where breakthrough therapy designations are unlocking quicker pathways to market. Meanwhile, patient advocacy groups are pushing for wider access and earlier diagnosis.

 

Investment interest is climbing as well. Analysts are beginning to treat IgA nephropathy as a viable standalone market, not just a niche within nephrology. There’s a clear shift from off-label drug use to approved, indication-specific therapies—creating clearer commercial potential for pharma players.

 

By 2030, treatment decisions may look very different. With combination therapies, biomarker-guided protocols, and real-world evidence supporting newer agents, IgA nephropathy is on track to become one of the most dynamic sub-segments within the broader rare renal disease space.

 

Market Segmentation And Forecast Scope

The IgA nephropathy market breaks down along four key dimensions: therapy type , route of administration , end user , and geography . Each layer reflects how drug developers, regulators, and providers are responding to the clinical complexity and chronic nature of this autoimmune kidney disease.

By Therapy Type

Therapeutic segmentation is now the backbone of commercial strategy in this space. Historically dominated by supportive care —like renin-angiotensin system (RAS) inhibitors and corticosteroids—the market is now pivoting toward targeted therapies . These include selective corticosteroid formulations , endothelin receptor antagonists (ERAs) , and complement pathway inhibitors .

Among these, corticosteroid-sparing drugs such as delayed-release budesonide have seen rapid uptake in patients with persistent proteinuria despite optimized RAS blockade. This class is expected to hold the largest revenue share in 2024, largely due to first-mover advantage and regulatory exclusivity.

The fastest-growing sub-segment is likely to be complement pathway inhibitors , as multiple candidates are advancing through Phase 2 and 3 pipelines. Their ability to modulate inflammation without broad immunosuppression is gaining traction among both clinicians and regulators.

 

By Route of Administration

Most approved therapies and candidates in the pipeline are oral drugs , a major advantage given the chronic nature of treatment. Oral formulations improve patient adherence and reduce the burden on health systems compared to IV biologics or hospital-administered treatments.

That said, injectable biologics are still in development, particularly those targeting complex immune or complement pathways. These may be reserved for high-risk or steroid-refractory patients.

Oral therapies are projected to account for over 68% of the market share in 2024, with growth expected as newer once-daily and low-toxicity formulations come to market.

 

By End User

The primary prescribers of IgA nephropathy treatments are nephrologists operating across different care environments:

• Hospitals and Academic Medical Centers : These are the early adopters of novel therapies, often participating in clinical trials or early access programs.

• Specialty Clinics : Growing in urban areas, especially in North America and Europe, where kidney disease management is now more outpatient-focused.

• Retail Pharmacies and Specialty Distributors : Becoming key channels for oral rare disease therapies, especially as more drugs receive FDA and EMA approvals.

Use is concentrated in specialty care settings, but broader adoption in community nephrology clinics is expected as awareness and payer coverage expand.

 

By Region

The market shows the strongest maturity in North America and Japan , where diagnostic rates, patient registries, and trial infrastructure are more advanced. Europe is following closely, although variability in national reimbursement is slowing down uniform access.

Asia Pacific , particularly China, represents a high-potential but under-penetrated region. Despite high disease prevalence, delayed diagnosis and inconsistent access to specialty nephrology care remain challenges.

Across Latin America and the Middle East & Africa , the market remains nascent, although international patient advocacy is starting to drive policy shifts.

The Asia Pacific region is projected to have the highest growth rate during the forecast period, driven by rising biopsy rates and a growing middle-class patient population seeking specialty care.

 

Market Trends And Innovation Landscape

The innovation cycle in the IgA nephropathy market has moved from stagnation to acceleration. Just five years ago, treatment options were largely off-label and generalized. Today, the space is seeing focused innovation—spanning advanced formulations, novel targets, and biomarker-driven approaches. This shift is not only reshaping clinical strategies but also redefining commercial competition.

Oral Targeted Therapies Are Setting the Pace

The launch of steroid-sparing agents, especially targeted-release budesonide, marked a turning point. Unlike systemic steroids, these drugs release selectively in the ileum—where gut-associated lymphoid tissue plays a central role in IgA production. That gut-kidney axis is now a therapeutic target, not just a theory.

With regulatory bodies granting accelerated approvals and breakthrough designations, these oral therapies have become the benchmark for newer entrants. Their convenience and tolerability have also raised expectations for future treatments.

 

Complement Pathway Inhibitors Are the Next Big Bet

A growing body of evidence links IgA nephropathy to overactivation of the alternative and lectin complement pathways. Drug developers are now racing to exploit this insight. Several biotech and mid-cap pharma players are advancing complement inhibitors through Phase 2/3 pipelines—ranging from small molecules to monoclonal antibodies.

While these therapies tend to be injectable and higher cost, they’re aimed at severe or progressive cases where proteinuria persists despite first-line treatment. If any of these programs succeed in delaying ESRD, they could reset the pricing ceiling for this market.

 

AI Is Making Biopsy-Free Diagnosis a Possibility

Another under-the-radar trend? Using artificial intelligence to interpret lab patterns and imaging data in patients with persistent hematuria or proteinuria—potentially reducing the need for invasive kidney biopsies. While still early, a few startups are building machine learning models trained on histopathology and urinalysis data to improve diagnostic accuracy in community clinics.

If these tools reach clinical-grade performance, they could accelerate early diagnosis—especially in underserved regions like Southeast Asia and Latin America.

 

Real-World Evidence Is Shaping Regulatory and Payer Decisions

IgAN is a chronic, slow-progressing disease—making traditional endpoints hard to measure in trials. That’s led regulators to accept proteinuria reduction as a surrogate endpoint for accelerated approval. But payers and HTA bodies are asking for more.

Companies are responding by investing in real-world evidence (RWE) studies that track renal function, patient-reported outcomes, and quality of life over years, not months. This could influence future label expansions and pricing negotiations, especially in Europe.

 

Pipeline Activity Is Widening the Field

As of 2024, more than 15 clinical programs are in mid- to late-stage development, many backed by biotech firms that see IgA nephropathy as a gateway into broader renal inflammation indications. Some are pursuing combination trials —pairing corticosteroid-sparing agents with complement inhibitors or SGLT2 inhibitors to extend response durability.

That’s a big shift from the single-mechanism approach of the past. The future of IgAN therapy may well lie in tailored drug regimens guided by genetic and inflammatory markers.

In short, this is no longer a one-drug market. It’s becoming a multi-pathway, multi-product landscape—driven by innovation, data, and an urgency to delay kidney failure without compromising safety.

 

Competitive Intelligence And Benchmarking

Competition in the IgA nephropathy market is intensifying—and it’s not just the usual big pharma players. What makes this space unique is the blend of mid-cap biotechs , nephrology specialists , and rare disease innovators , each bringing their own strategy to what was once an overlooked condition. As newer therapies move beyond proteinuria reduction into long-term kidney preservation, the race for clinical and commercial leadership is heating up.

Calliditas Therapeutics

One of the key first-movers, Calliditas brought global attention to the IgAN market with its targeted-release budesonide. Approved under the brand name in both the U.S. and EU, it was the first therapy specifically developed and approved for IgA nephropathy.

Their strength lies in execution. By leveraging accelerated pathways, they reached the market quickly—and with a product tailored to the disease’s unique gut-kidney pathophysiology. Calliditas now serves as the commercial benchmark for future entrants, especially in terms of physician education and payer engagement.

 

Travere Therapeutics

Travere gained FDA accelerated approval for its endothelin receptor antagonist in 2023, positioning itself as a direct competitor in patients with persistent proteinuria despite standard care. Unlike Calliditas , Travere’s approach targets glomerular inflammation systemically, aiming for broad efficacy in high-risk patients.

The company is leaning into long-term renal outcome data and real-world evidence to expand its market position. If their confirmatory trial hits, they may push into frontline treatment in progressive cases.

 

Omeros Corporation

Omeros is advancing a MASP-2 inhibitor that targets the lectin pathway of complement activation. Though earlier in development, the company is banking on the growing link between complement overactivation and IgAN progression.

Their product is biologic and injectable, which may limit mass-market use but could gain traction in steroid-refractory patients or those with rapidly declining renal function.

 

Novartis

While not historically focused on IgAN , Novartis is entering the space through pipeline programs that repurpose existing renal or immunologic therapies. Their scale and reach give them an edge in global commercialization, but whether they can tailor their messaging to this highly specialized condition remains to be seen.

If Novartis decides to acquire or license from smaller innovators, they could quickly become a major force here.

 

Chinook Therapeutics (acquired by Sanofi)

Chinook was one of the most aggressive biotechs in kidney disease before its acquisition. Its pipeline focused on precision nephrology, including therapies aimed at the APOL1 pathway and complement regulation. Sanofi’s acquisition signals that larger players are finally seeing the commercial value in renal rare diseases like IgAN .

Sanofi may now use Chinook’s development engine to build out a full nephrology franchise—starting with IgAN and expanding into FSGS and other glomerular diseases.

 

Competitive Snapshot

• Calliditas owns the advantage of being first-to-market with the only approved gut-targeted steroid.

• Travere is positioned as the systemic anti-inflammatory player with potential in progressive disease.

• Omeros and other complement-focused developers are chasing severe, refractory populations.

• Novartis and Sanofi are entering through partnerships and acquisitions, not internal innovation.

In this market, being first matters—but so does follow-through. The companies that pair innovation with real-world data, patient engagement, and long-term safety are the ones that will shape how IgA nephropathy is treated over the next decade.

 

Regional Landscape And Adoption Outlook

Adoption of IgA nephropathy therapies isn’t just driven by disease burden. It’s shaped by diagnostic practices, health system readiness, payer access, and the local regulatory stance on rare diseases. Some countries are treating IgAN as a distinct strategic category, while others still bundle it into broader nephrology care. The result is a fragmented global market with clear hot spots—and cold zones.

North America

The U.S. leads in drug adoption, clinical trial activity, and regulatory velocity . The FDA’s willingness to accept proteinuria reduction as a surrogate endpoint has fast-tracked multiple therapies, turning the U.S. into the commercial launchpad for new entrants. Specialty nephrology clinics and academic centers are well-equipped to manage rare glomerular diseases, making uptake relatively smooth—at least in major metro areas.

That said, access isn’t universal. Payer policies vary widely by insurer, with some requiring biopsy-confirmed IgAN and prior RAS blockade before covering newer therapies. Canada follows a slower regulatory track but has strong specialist infrastructure and growing clinical trial participation.

 

Europe

Europe presents a complex patchwork. EMA approvals don’t guarantee uniform reimbursement across the EU , and health technology assessment (HTA) bodies like NICE (UK) or IQWiG (Germany) take a cautious stance on rare disease drugs, often demanding long-term renal outcomes rather than just surrogate markers.

Still, France, Germany, and the Nordics are moving faster to adopt approved agents, especially in tertiary nephrology centers . The European Renal Association (ERA) is helping standardize diagnostic and treatment pathways, which may accelerate access over the next few years.

Southern and Eastern Europe lag behind. In countries like Poland or Romania, even biopsy-confirmed IgAN may be managed with generics due to reimbursement limitations.

 

Asia Pacific

This region holds the highest disease prevalence —especially in Japan, China, and South Korea —but the adoption dynamics vary widely. Japan leads in early diagnosis and biopsy rates , supported by a culture of annual urinalysis screenings. As a result, Japan has the most mature IgAN care ecosystem in Asia, with high uptake of novel therapies.

In China, IgA nephropathy is the most common primary glomerular disease. However, access to innovative therapies remains restricted to top-tier hospitals in Tier 1 cities. Government drug pricing reforms and the national reimbursement drug list (NRDL) process will be key to broader access.

India shows potential but remains underdeveloped in this space. Low biopsy rates, shortage of nephrologists, and out-of-pocket healthcare spending are major barriers.

 

Latin America, Middle East, and Africa (LAMEA)

In most of these regions, IgAN remains underdiagnosed and undertreated . Brazil and Mexico have a handful of specialty nephrology centers managing cases with off-label or supportive therapies. Approval timelines tend to lag, and patient advocacy is just beginning to gain traction.

In the Middle East, Saudi Arabia and the UAE are investing in modern renal care infrastructure, including genomic testing and biopsy services. These markets could emerge as early adopters if multinational drugmakers prioritize regional partnerships.

Africa remains a white space—limited diagnostics, virtually no confirmed incidence data, and few specialists. Most kidney disease cases are managed symptomatically, with IgAN rarely identified until advanced stages.

 

Regional Outlook Summary

• North America : Innovation and trial hub, with payer friction in community settings.

• Europe : High clinical standards, slower payer alignment.

• Asia Pacific : High prevalence, uneven access—Japan far ahead.

• LAMEA : Early-stage ecosystem, scattered specialty care pockets.

For companies, regional strategy is critical. You can’t scale IgAN therapy globally without factoring in local infrastructure, payer logic, and diagnostic culture. This isn’t a one-size-fits-all launch—it’s a stepwise rollout, tailored to regional maturity.

 

End-User Dynamics And Use Case

In the IgA nephropathy market, end users are more than just prescribers—they’re critical gatekeepers of adoption. The success of any therapy hinges on its fit within nephrology workflows, access pathways, and clinical decision-making patterns. From large academic hospitals to suburban specialty clinics, the way treatment is initiated and monitored varies considerably.

Academic and Tertiary Hospitals

These are the early adopters and clinical trial powerhouses. Most novel IgAN therapies enter the system through renal divisions at major academic centers , where nephrologists have the training and institutional support to integrate new drugs quickly.

Here, patients typically have access to:

• Advanced diagnostics, including repeat biopsies and genomic screening

• Structured care teams with renal pharmacists, dietitians, and research coordinators

• In-house access to Phase 2/3 clinical trials or expanded access programs

These centers also influence national treatment guidelines and help validate real-world outcomes through registries and observational studies.

One nephrology lead at a U.S. teaching hospital put it this way: “We’re not just treating IgAN , we’re shaping the playbook.”

 

Specialty Nephrology Clinics

As more therapies gain full approval and become reimbursable, community-based nephrology clinics are stepping in as major prescribers. These settings often handle long-term monitoring and dose adjustments for stable patients who were initially diagnosed in hospitals.

Their biggest needs?

• Oral formulations that don’t require hospital-based administration

• Clear lab-based monitoring tools (e.g., proteinuria tracking)

• Streamlined prior authorization workflows with insurers

This is where payer policy meets provider practicality . If drugs are too complex to initiate or monitor, uptake stalls—regardless of efficacy.

 

Retail and Specialty Pharmacies

Once a patient is diagnosed and stabilized on therapy, distribution shifts to pharmacy channels . Specialty pharmacies, in particular, are being used to deliver high-cost rare disease therapies with built-in patient support programs and remote monitoring.

Pharmacists now play a bigger role in:

• Educating patients on adherence

• Managing drug-drug interactions

• Coordinating refill authorizations with prescribers

In some U.S. states, pharmacists are even authorized to adjust renal dosing under collaborative practice agreements—an emerging but impactful trend.

 

Use Case Highlight

A nephrology clinic in Munich, Germany, began using targeted-release budesonide in a subset of IgAN patients with persistent proteinuria post-RAS blockade. The clinic initially limited use to patients who had previously declined systemic steroids due to side effect concerns.

Within six months, over half of the patients saw a 30–50% reduction in proteinuria without corticosteroid-associated weight gain or glucose spikes. Based on this success, the clinic shifted its treatment algorithm—making targeted-release budesonide the default second-line option after ACE inhibitors or ARBs.

The result? Higher patient acceptance, fewer dose reductions, and a stronger case to local payers for therapy reimbursement.

Across the board, end users are asking for targeted, tolerable, and easy-to-manage solutions . The companies that deliver on those dimensions—while reducing complexity around prescribing and reimbursement—are the ones that will win sustained loyalty in this market.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Calliditas Therapeutics received full FDA approval for its targeted-release budesonide treatment in early 2024, expanding its U.S. label to include adult patients with biopsy-proven IgA nephropathy and proteinuria >1g/day.

• Travere Therapeutics completed its confirmatory Phase 3 trial for its endothelin receptor antagonist in late 2023, with data showing sustained reduction in proteinuria and slowed eGFR decline at 18 months.

• Omeros Corporation advanced its MASP-2 inhibitor into Phase 3 after completing successful mid-stage trials, targeting the lectin pathway as a novel complement strategy for IgAN patients with high disease activity.

• Novartis announced a pipeline collaboration in 2024 with a Chinese biotech to co-develop oral complement inhibitors specifically aimed at high-prevalence Asian populations.

• Sanofi , through its acquisition of Chinook Therapeutics, initiated a multi- center trial for a dual-mechanism therapy combining APOL1 targeting and complement regulation in patients with IgAN and coexisting glomerular inflammation.

 

Opportunities

• Global Expansion in Underserved Markets
  Asia Pacific, Eastern Europe, and the Middle East show high disease prevalence but limited access to specialty nephrology care. Companies investing in regional partnerships and pricing flexibility will find long-term upside.

• AI-Powered Diagnostics and Real-World Evidence Tools
  Diagnostic algorithms that flag potential IgAN cases from electronic health records or urinalysis data could boost early detection, especially in community settings. Paired with real-world data collection, this may also support post-market access.

• Combination Therapy and Companion Biomarkers
  As the market evolves, there’s demand for rational combination regimens—pairing complement inhibitors, corticosteroid-sparing drugs, and SGLT2 inhibitors based on biomarkers. This could open doors to personalized protocols and premium pricing.

 

Restraints

• High Cost of Therapy and Reimbursement Friction
  Many of the new therapies are priced as rare disease drugs, but IgAN doesn’t always meet formal orphan drug definitions in every market. This puts pressure on payers to justify coverage without long-term outcome data.

• Underdiagnosis and Biopsy Hesitancy
  In many countries, especially emerging markets, IgA nephropathy remains underdiagnosed due to the invasive nature of kidney biopsies and lack of routine screening. This directly limits the addressable market—even where the drugs are approved.
   

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2025 – 2030
Market Size Value in 2024	USD 3.8 Billion
Revenue Forecast in 2030	USD 5.8 Billion
Overall Growth Rate	CAGR of 6.5% (2025 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2025 – 2030)
Segmentation	By Therapy Type, Route of Administration, End User, Geography
By Therapy Type	Corticosteroid-Sparing Therapies, Endothelin Receptor Antagonists, Complement Inhibitors, Supportive Care (RAS Blockers, Immunosuppressants)
By Route of Administration	Oral, Injectable
By End User	Academic and Tertiary Hospitals, Specialty Nephrology Clinics, Retail and Specialty Pharmacies
By Region	North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Canada, Germany, UK, France, Japan, China, India, Brazil, UAE, South Korea
Market Drivers	- Rise in early-stage IgAN diagnoses - Expansion of oral targeted therapies - Regulatory incentives for rare renal diseases
Customization Option	Available upon request