DelveInsight’s “TARPEYO/KINPEYGO Market Size, Forecast, and Market Insight Report” highlights the details around TARPEYO/KINPEYGO, delayed-release capsules. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TARPEYO/KINPEYGO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Asahi Kasei’s TARPEYO/KINPEYGO (budesonide) Overview
TARPEYO, originally developed under the name Nefecon, is a patented oral formulation of budesonide, a well-established and powerful active ingredient, engineered for targeted delivery. The formulation is specifically designed to release the drug in the Peyer’s patches of the lower small intestine—believed to be the origin site of the disease based on leading pathogenesis models. This targeted delivery is enabled by TARGIT technology, which allows the drug to bypass absorption in the stomach and upper intestines, releasing it in a controlled, pulse-like manner only upon reaching the lower small intestine.
A key benefit of budesonide, in addition to its strong localized action, is its low systemic bioavailability—approximately 90% of it is metabolized by the liver before entering the bloodstream. This enables high local drug concentrations where needed, with minimal systemic exposure and reduced side effects.
In the US, budesonide delayed-release capsules are marketed as TARPEYO and approved for reducing proteinuria in adults with primary IgA nephropathy at risk of rapid progression. The drug works by modulating immune responses involved in IgA-driven disease processes, effectively lowering proteinuria and helping preserve kidney function. In Europe, it is marketed as KINPEYGO through a partnership with STADA Arzneimittel, benefiting from orphan drug status and exclusivity until 2032. In Japan, Viatris is developing the therapy under the name NEFECON (VR-205), with Phase III trial results anticipated in 2026.
TARPEYO/KINPEYGO at a Glance
Drug Name: TARPEYO/KINPEYGO (budesonide)
Molecule type: Small molecule
Developer: Asahi Kasei (Calliditas Therapeutics)
Primary Indication: Immunoglobulin A nephropathy
Mechanism of action: Glucocorticoid receptor agonists
Route of administration: Oral
Learn more about TARPEYO/KINPEYGO projected market size for IgAN @ TARPEYO Market Potential
IgA nephropathy (IgAN) is an autoimmune disease that affects the kidneys by impairing the filtration process in the small blood vessels. The condition is triggered by an abnormal protein that damages the glomeruli—the kidney’s primary filtering structures. According to DelveInsight, there were 415K diagnosed prevalent IgAN cases across the seven major markets in 2024, with this figure expected to increase by 2034 at a CAGR of 0.6%. Standard treatments currently include ACE inhibitors and angiotensin II receptor blockers (ARBs), which are mainly used to manage symptoms such as high blood pressure.
Currently, only a few drugs have been approved for IgAN treatment, including VANRAFIA (Atrasentan) and FABHALTA (Iptacopan) by Novartis, FILSPARI (Sparsentan) by Travere Therapeutics, and TARPEYO/KINPEYGO (budesonide) by Asahi Kasei (Calliditas Therapeutics), among others. The treatment landscape is anticipated to evolve significantly between 2025 and 2034, fueled by the emergence of novel therapies. DelveInsight reports that the IgAN market across the 7MM was worth roughly USD 730 million in 2024, and it is forecast to expand at a robust CAGR of 30.5% over the 2025–2034 period.
With targeted therapies for IgAN only recently becoming available and an urgent need for interventions that can delay the onset of end-stage kidney disease (ESKD), any major advancements in treatment are expected to have a transformative impact on the market in the years ahead.
Emerging Competitors of TARPEYO/KINPEYGO
Major key players involved in the development of IgA nephropathy therapies include Novartis (Zigakibart (FUB523)), F. Hoffmann-La Roche/Ionis Pharmaceuticals (Sefaxersen (RG6299; IONIS-FB-LRx)), AstraZeneca (Alexion Pharmaceuticals) (ULTOMIRIS), Vera Therapeutics (Atacicept), Vertex Pharmaceuticals (Povetacicept), Otsuka Pharmaceutical (Sibeprenlimab), Biogen (Felzartamab), Arrowhead Pharmaceuticals (ARO-C3), NovelMed (NM8074), Q32 Bio (ADX-097), Walden Biosciences (WAL0921), Takeda Pharmaceutical (TAK-079), and others.
In June 2025, Vera Therapeutics announced that the ORIGIN Phase III trial of atacicept successfully met its primary endpoint, demonstrating a 46% reduction in proteinuria. In June 2025, Vertex Pharmaceuticals and Ono Pharmaceutical revealed an exclusive collaboration and licensing agreement to jointly develop and commercialize Vertex’s povetacicept in the Japanese market.
In March 2025, Otsuka Pharmaceutical submitted a Biologics License Application (BLA) to the FDA for sibeprenlimab, an experimental monoclonal antibody designed to specifically block the activity of APRIL (A PRoliferation-Inducing Ligand) in adult patients with IgAN.
In July 2022, the EC granted ODD to BION-1301 for the treatment of primary IgAN, providing regulatory incentives to support its development in Europe. Further bolstering its IgAN pipeline, Novartis acquired Chinook Therapeutics in August 2023 in a deal worth up to USD 3.5 billion, integrating zigakibart and other renal-focused assets into its late-stage portfolio.
Key Milestones of TARPEYO/KINPEYGO
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In July 2024, Calliditas Therapeutics’ partner, STADA, received full approval from the European Commission (EC) for KINPEYGO to treat IgAN, with orphan medicinal product status and market exclusivity until 2032.
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In May 2024, Asahi Kasei Corporation acquired Calliditas Therapeutics, a Swedish biopharmaceutical company, in a deal valued at USD 1.1 billion.
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In March 2024, Calliditas Therapeutics announced that the FDA had granted an orphan drug exclusivity period of seven years for TARPEYO, expiring in December 2030, based on when the company obtained full approval with a new indication for this drug product.
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In December 2023, the FDA granted full approval to TARPEYO for treating adults with IgA nephropathy at risk for disease progression.
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In February 2023, the UK MHRA granted CMA for KINPEYGO for IgAN treatment.
Discover how TARPEYO/KINPEYGO is shaping the IgAN treatment landscape @ TARPEYO Coupon
TARPEYO/KINPEYGO Market Dynamics
TARPEYO (developed by Calliditas Therapeutics and marketed as KINPEYGO in Europe) is the first and only FDA- and EMA-approved treatment specifically targeting the underlying autoimmune cause of proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. It is a delayed-release formulation of budesonide designed to deliver the corticosteroid directly to the ileum, where the Peyer’s patches—associated with mucosal immune activation in IgAN—are located. This novel approach offers a more targeted and potentially safer treatment compared to systemic corticosteroids, positioning TARPEYO/KINPEYGO as a unique entrant in the niche but high-unmet-need IgAN therapeutic market.
The addressable market for TARPEYO/KINPEYGO is growing, driven by improved diagnosis rates, increased awareness among nephrologists, and the lack of approved therapies for IgAN before TARPEYO’s approval. Estimates suggest that IgAN affects around 130,000–150,000 patients in the U.S. alone, with a significant subset at risk for progressive kidney failure. While supportive care with RAAS inhibitors remains the standard of care, TARPEYO has filled a critical therapeutic gap by demonstrating the ability to significantly reduce proteinuria, a key marker for disease progression.
From a competitive standpoint, the market is becoming increasingly dynamic. New entrants like Novartis’ VANRAFIA and Travere Therapeutics’ FILSPARI are giving tough competition to TARPEYO/KINPEYGO. However, TARPEYO’s head start, established safety profile, and its unique mechanism of gut-targeted immune modulation could help maintain its competitive edge.
Market access and pricing dynamics are also critical. In the US, TARPEYO was granted accelerated approval based on proteinuria reduction, but full approval is contingent on long-term renal outcome data. Its pricing reflects the orphan status and unmet need, but payer adoption could be challenged by high costs, especially as competitors emerge. In Europe, KINPEYGO faces a more conservative reimbursement landscape, which could moderate uptake despite clinical need. Still, the global push for precision medicine and disease-modifying therapies in rare renal diseases supports long-term growth potential for TARPEYO/KINPEYGO.
Table of Contents
1. Report Introduction
2. TARPEYO/KINPEYGO: Asahi Kasei (Calliditas Therapeutics)
2.1. Product Overview
2.2. Other Development Activities
2.3. Clinical Development
2.4. Clinical Trials Information
2.5. Safety and Efficacy
2.6. Product Profile
2.7. Market Assessment
2.7.1. The 7MM Analysis
2.7.1.1. Cost Assumptions and Rebate
2.7.1.2. Pricing Trends
2.7.1.3. Analogue Assessment
2.7.1.4. Launch Year and Therapy Uptake
2.7.2. The United States Market Analysis
2.7.3. EU4 and the United Kingdom Market Analysis
2.7.3.1. Germany
2.7.3.2. France
2.7.3.3. Italy
2.7.3.4. Spain
2.7.3.5. UK
2.7.4. Japan Market Analysis
2.8. Market Drivers
2.9. Market Barriers
2.10. SWOT Analysis
3. Key Cross of Marketed Competitors of TARPEYO/KINPEYGO
4. Key Cross of Emerging Competitors of TARPEYO/KINPEYGO
Related Reports
IgA Nephropathy Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key IgAN companies such as Calliditas Therapeutics AB, Travere Therapeutics, Inc., Omeros, Novartis Pharmaceuticals, Chinook Therapeutics, Inc., Vera Therapeutics, Inc., among others.
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