PUBLISHER: DelveInsight | PRODUCT CODE: 1259776
PUBLISHER: DelveInsight | PRODUCT CODE: 1259776
Key Highlights
DelveInsight's"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.
Study Period: 2019-2032
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 reported…
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).
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 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).
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.
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.
DelveInsight'sanalysts 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
We perform 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.
Key Questions
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies