IgA Nephropathy (IgAN) - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• Most IgA Nephropathy patients are diagnosed accidentally; the disease is mostly diagnosed during routine checkups.
• In 2022, the market size of IgA Nephropathy was highest in the US among the 7MM, accounting for approximately USD 160 million, which is further estimated to increase by 2032.
• Calliditas Therapeutics' TARPEYO was the first FDA-approved treatment for IgA Nephropathy, which the US FDA approved in December 2021, and the drug entered the market by the end of January 2022.
• In February 2023, Travere Therapeutics' dual endothelin angiotensin receptor antagonist FILSPARI, became the first non-immunosuppressive FDA-approved treatment for IgA Nephropathy, although still being put on REMS due to its potential hepatotoxic and embryo-fetal toxic effects.
• The expected launch of narsoplimab (Omeros Corporation) in 2024 is set to bring major changes in the treatment landscape of IgA Nephropathy, bringing in safer and more effective treatment options for IgA Nephropathy patients.
• The recently published Part B results of the Phase III trial are expected to grant complete approval to TARPEYO, further increasing its availability to IgAN patients, but it is comparatively high cost still possesses a barrier.
• Other emerging therapies like Novartis' iptacopan, Omeros Corporation's narsoplimab, Chinook Therapeutics' atrasentan and BION-1301, Vera Therapeutics' atacicept, Visterra's sibeprenlimab, and Remegen's telitacicept are expected to contribute significantly to the growing IgA Nephropathy market.

This “IgA Nephropathy (IgAN) - Market Insights, Epidemiology and Market Forecast - 2032 report delivers an in-depth understanding of the IgA Nephropathy, historical and forecasted epidemiology as well as the IgA Nephropathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China.

The IgA Nephropathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM and China IgA Nephropathy market size from 2019 to 2032. The report also covers current IgA Nephropathy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan
• China

Study Period: 2019-2032

IgA Nephropathy Disease Understanding and Treatment Algorithm

IgA Nephropathy Overview

IgA Nephropathy (IgAN) is an autoimmune condition affecting the kidneys' small blood vessels and filtration. It happens when an abnormal protein harms the filtration system in the kidneys.

The most prevalent glomerular disease in the world is IgAN, but the prevalence differs significantly by region. IgAN is more common in Asian populations than in Western populations, according to epidemiological study studies.

IgA Nephropathy Diagnosis

The diagnosis of IgAN relies on revealing IgA as the dominant or co-dominant immunoglobulin in the glomerular mesangium by kidney biopsy. Although renal biopsy is still the gold standard for diagnosing IgAN, novel biomarkers to predict IgAN without a biopsy have recently been sought after. But uncertain pathogenesis makes noninvasive diagnosis more difficult.

A nonprofit organization called Kidney Disease: Improving Global Outcomes (KDIGO) creates and puts evidence-based clinical practice recommendations for kidney diseases. The Clinical Practice Guideline for Glomerulonephritis was released by KDIGO in 2012, and KDIGO also published a draught revision of these recommendations in 2020.

Further details related to country-based variations are provided in the report.

IgA Nephropathy Treatment

Based on real-world data analysis, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are two common main therapies for IgAN to control symptoms like high blood pressure. Corticosteroids to halt the disease's progression and other immunosuppressants like mycophenolate mofetil (MMF), cyclophosphamide, etc., are among the other treatments.

The first medication for treating IgAN to receive FDA approval is TARPEYO (budesonide) delayed-release tablet. It is indicated for IgAN patients at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) =1.5 g/g. In December 2021, the US FDA approved it through an accelerated approval process, acknowledging the pressing need for safe and effective treatments. The recently approved FILSPARI (sparsentan) by Travere Therapeutics, Inc./Vifor Pharma provides the IgAN population with another treatment choice.

Although TARPEYO was approved and launched for IgAN, it is only a reformulated corticosteroid; and FILSPARI, despite bringing a novel MoA to the treatment landscape, has major concerns regarding its hepatotoxic and embryo-fetal toxic effects. Hence there is a huge unmet need for effective therapies with a tolerable safety profile for patients with extensive disease. To meet the need for disease-specific targeted treatments with a novel MoA, there are a few promising therapies in development, including narsoplimab (Omeros Corporation), atrasentan (Chinook Therapeutics), Iptacopan (Novartis Pharmaceuticals), sibeprenlimab (Otsuka Pharmaceutical), telitacicept (RemeGen), atacicept (Vera Therapeutics), and BION-1301 (Chinook Therapeutics).

IgA Nephropathy Epidemiology

As the market is derived using a patient-based model, the IgA Nephropathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of IgA Nephropathy, diagnosed prevalent cases of IgA, gender-specific cases of IgA Nephropathy, and age-specific cases of IgA Nephropathy in the 7MM and China covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, Japan, and China from 2019 to 2032.

• The total prevalent cases of IgA Nephropathy in the 7MM and China were ~1,899,000 cases in 2022 and are projected to increase during the forecast period (2023-2032).
• The total number of prevalent cases of IgA Nephropathy in the United States was around ~193,700 cases in 2022.
• Among the EU4 countries, Germany accounted for the largest IgA Nephropathy prevalent cases, followed by France, whereas Spain accounted for the lowest number of prevalent cases in 2022.
• According to the publisher's estimates, there were ~1,414,000 prevalent cases of IgA Nephropathy in China in 2022, and the prevalence is projected to increase during the forecast period.
• Japan accounted for about 88,000 diagnosed prevalent cases of IgA Nephropathy in 2022.

IgA Nephropathy Drug Chapters

The drug chapter segment of the IgA Nephropathy report encloses a detailed analysis of IgA Nephropathy marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IgA Nephropathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

TARPEYO/ KINPEYGO (budesonide): Calliditas Therapeutics/STADA/Viatris/Everest Medicines

TARPEYO is a patented oral formulation of a potent and well-known active substance of budesonide for targeted release. The formulation delivers the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models.

The TARGIT technology, which is the basis of TARPEYO, enables the substance to pass through the stomach and intestine without being absorbed and to only release in the form of a pulse when it hits the lower small intestine. Another benefit of using this active ingredient is its extremely low bioavailability 90% of it is inactivated in the liver before it enters the systemic circulation and its strong local effect. In other words, a high concentration can be applied where required, but with very little systemic exposure and side effects.

TARPEYO received accelerated approval for the treatment of primary IgA Nephropathy patients at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) =1.5g/g, in December 2021 in the United States. Following this, it received Conditional Marketing Authorization (CMA) in the EU and the UK in July 2022 and February 2023 under the brand name KINPEYGO. Calliditas is developing it for its launch in the Japanese and China markets through collaborations with Vitaris and Everest Medicines.

Even though it was the first IgA Nephropathy treatment to receive approval, there are still some issues with it, particularly concerning cost. Budesonide is an easily available corticosteroid that comes in a delayed-release formulation called TARPEYO. However, patients and healthcare professionals have expressed concern due to its considerably higher price. As a result, TARPEYO's expensive cost has established itself as a significant impediment to IgAN patients using it more frequently.

Note: Detailed current therapies assessment will be provided in the full report of IgA Nephropathy

Emerging Drugs

Narsoplimab: Omeros Corporation

Narsoplimab is a human monoclonal antibody (mAb) targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. The lectin pathway is one of the principal complement pathways, activated primarily by tissue damage and microbial infection. Importantly, inhibition of MASP-2 does not appear to interfere with the classical complement pathway, a critical component of the acquired immune response to infection. This novel proprietary drug is designed to prevent complement-mediated inflammation and endothelial damage while leaving intact the respective functions of the other innate immunity pathways.

The drug could potentially be the best-in-class treatment for IgA Nephropathy patients. The Phase II study demonstrated very promising preliminary results, with an encouraging reduction in proteinuria and manageable adverse events. These results supported its continued evaluation in a Phase III study, which, if successful, will lead to the FDA approval of the drug before 2025. Key opinion Leaders (KOLs) are convinced with the tolerability and effectivity in proteinuria reduction of narsoplimab in clinical trials and have shown a preference towards narsoplimab over TARPEYO and FILSPARI for the treatment of IgA Nephropathy. The US FDA granted narsoplimab BTD and ODD for the treatment of IgA Nephropathy.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing IgA Nephropathy treatment is mainly dominated by RAS-pathway inhibition (ACE inhibitors and ARBs) and immunosuppression.

The approval of FILSPARI for the treatment of IgA Nephropathy established the efficacy of dual endothelin angiotensin receptor antagonists (DEARA) in the treatment of IgA Nephropathy, which works by selectively targeting two critical pathways in the disease progression of IgA Nephropathy (i.e., endothelin A and angiotensin II type 1). However, the safety of endothelial receptor inhibition is still of concern due to its well-characterized embryo-fetal toxicity profile. Hence emerging endothelial receptor antagonists, if approved, can potentially be put on the REMS program due to their toxicity profiles.

Various other novel mechanisms are being explored through the different classes of drugs for the treatment of IgA Nephropathy. This includes monoclonal antibodies inhibiting novel pathways like MASP-2 (mannan-binding lectin-associated serine protease-2), humanized IgG2, and IgG4 monoclonal antibodies inhibiting a proliferation-inducing ligand (APRIL). Small molecule complement pathway inhibitors are also being explored, accompanied by recombinant fusion proteins, which function as a dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).

IgA Nephropathy Market Outlook

The mainstay of therapy in IgA Nephropathy is optimized supportive care, including measures to lower blood pressure, reduce proteinuria, reduce lifestyle risk factors, and reduce non-specific kidney insult. The value of immunosuppression has become debatable; if at all, systemic high-dose corticosteroid treatment for a few months should be considered, taking into account patient characteristics that would warn against or preclude such therapy. Furthermore, as GFR decreases, AEs associated with corticosteroid treatment significantly increase. Except for mycophenolate mofetil in Asian patients, there is little proof that additional immunosuppression is beneficial beyond corticosteroids.

Calliditas Therapeutics AB, Chinook Therapeutics, Inc., Novartis Pharmaceuticals, Omeros Corporation, Otsuka Pharmaceutical, RemeGen, and Vera Therapeutics are the main market players in the IgAN treatment landscape.

Calliditas' TARPEYO/KINPEYGO (budesonide) delayed-release capsules were the first FDA-approved medication for treating IgAN. It is recommended for IgAN individuals who have a urine protein-to-creatinine ratio (UPCR) of 1.5 g/g or higher. It was authorized by the US FDA under an accelerated approval pathway in December 2021, recognizing the critical need for safe and effective therapies.

FILSPARI (sparsentan), developed by Travere Therapeutics/Vifor Pharma, will be launched in the IgAN treatment space through an accelerated approval pathway in February 2023. Sparsentan is a first-in-class, orally active single-molecule that acts as a high-affinity dual-acting antagonist of the ETA and AT1 receptors, which are linked to the development of kidney disease. It received accelerated clearance based on preliminary findings from the ongoing pivotal Phase III PROTECT study. The EMA has also accepted the CMA application, and the second half anticipates a review judgment in 2023.

A few promising therapies in development to meet the unmet need for disease-specific targeted treatments, and novel MoA, include narsoplimab (Omeros Corporation), atrasentan (Chinook Therapeutics), iptacopan (Novartis Pharmaceuticals), sibeprenlimab (Otsuka Pharmaceutical), cemdisiran (Alnylam Pharmaceuticals/Regeneron Pharmaceuticals), and telitacicept (RemeGen (Chinook Therapeutics).

In a nutshell, there are only two FDA-approved treatments for managing IgAN. Though recent drug approvals provide novel treatment choices for IgAN, there is still a high demand in the IgAN therapeutic landscape for more efficacious and targeted therapies. According to our analysis, the IgAN treatment space will undergo significant changes during the forecast period due to the launch of upcoming novel therapies and a robust pipeline of drugs in development for the treatment of IgAN.

• The total market size of IgA Nephropathy in the 7MM and China is approximately USD 500 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM and China will increase at a CAGR of ~20% due to increased diagnosis of the disease and the launch of emerging therapies.
• Among EU4 countries, Germany accounted for the maximum market size in 2022, while Spain occupied the bottom of the ladder.
• There are no approved therapies for IgA Nephropathy in Japan and China, with current treatment being done primarily by ACE inhibitors/ARBs, immunosuppressants, and corticosteroids.

IgA Nephropathy Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, for iptacopan, we expect the drug uptake to be medium with a probability-adjusted peak share of 2.7% in the US; years to the peak is expected to be 7 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report.

IgA Nephropathy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for IgA Nephropathy emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on IgA Nephropathy evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Professors at Geffen School of Medicine, University of Leicester and doctors at Helios Hospital and members of KDIGO.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the Institute for Molecular Cardiovascular Research, Geffen School of Medicine at UCLA, Helios Hospital, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or IgA Nephropathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, order of entry, designations, and trial design. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in IgA Nephropathy trials, one of the most important primary outcome measures is the reduction in proteinuria levels of the therapy in IgA Nephropathy patients.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited impact on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of IgA Nephropathy, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, along with treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the IgA Nephropathy market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM and China drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM and China IgA Nephropathy market.

IgA Nephropathy Report Insights

• Patient Population
• Therapeutic Approaches
• IgA Nephropathy Pipeline Analysis
• IgA Nephropathy Market Size and Trends
• Existing and future Market Opportunity

IgA Nephropathy Report Key Strengths

• Ten Years Forecast
• 7MM and China Coverage
• IgA Nephropathy Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

IgA Nephropathy Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market insights

• What was the IgA Nephropathy total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• How will endothelial receptor antagonists as a class affect the treatment paradigm of IgA Nephropathy?
• What kind of uptake endothelial receptor antagonists will be seen in IgA Nephropathy patients in the coming 10 years?
• What will be the impact of emerging therapies on off-label treatment usage?
• How will Narsoplimab compete with TARPEYO and FILSPARI?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology insights

• What are the disease risk, burdens, and unmet needs of IgA Nephropathy? What will be the growth opportunities across the 7MM and China concerning the patient population of IgA Nephropathy?
• What is the historical and forecasted IgA Nephropathy patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China?
• What factors are affecting the increase in the prevalent cases of IgA Nephropathy?

Current treatment scenario, marketed drugs, and emerging therapies

• What are the current options for the treatment of IgA Nephropathy?
• How many companies are developing therapies for the treatment of IgA Nephropathy?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of IgA Nephropathy?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What key designations have been granted for the emerging therapies for IgA Nephropathy?
• What will be the impact of narsoplimab and iptacopan on off-label ACE inhibitor/ARB usage?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What is the 7MM and China historical and forecasted market of IgA Nephropathy?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the IgA Nephropathy Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, Japan, and China.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.