NEWARK, DE / ACCESSWIRE / January 13, 2025 / The IgA Nephropathy Market is poised for significant growth over the forecast period from 2025 to 2035, driven by advancements in diagnostics, therapeutic innovations, and an increasing prevalence of chronic kidney disease (CKD). In 2025, the market is valued at USD 46,821.70 million, with projections estimating a substantial increase to USD 99,655.4 million by 2035, reflecting a robust CAGR of 7.6%.

Key factors fueling this growth include the rising adoption of biologics and biosimilar, an uptick in government funding for research and treatment programs, and improved accessibility to healthcare in emerging markets. The growing awareness among healthcare professionals and patients about IgA nephropathy, also known as Berger's disease, further strengthens market momentum.

The emergence of targeted therapies, such as corticosteroids, immunosuppressant, and advanced monoclonal antibodies, has revolutionized treatment regimens. These therapies effectively manage proteinuria and inflammation, improving patient outcomes. Meanwhile, innovations in molecular diagnostics ensure early and precise disease detection, playing a pivotal role in reducing disease progression.

North America currently dominates the market, owing to strong healthcare infrastructure, high awareness levels, and the availability of advanced treatment options. However, Asia-Pacific is anticipated to exhibit the fastest growth rate due to increasing patient populations and government investments in healthcare infrastructure.

IgAN is an autoimmune disease that attacks the kidneys. It affects blood filtration in the small blood vessels of the kidneys. It occurs when an abnormal protein damages the filtering unit (glomerulus) inside the kidneys. This, in turn, causes pain leading to patients undertaking different forms of treatments.

IgA Nephropathy Market

Which are Some Prominent Drivers of IgA Nephropathy Market?

Conventional treatments and approval of medication favoring the growth of the market

Conventional major treatments to manage IgAN include ACE inhibitors (angiotensin-converting enzyme inhibitors) and ARBs (angiotensin II receptor blockers), to manage symptoms like high blood pressure, etc. Other treatments include corticosteroids, to slow the progression of the disease, and other immunosuppressants like MMF, cyclophosphamide, etc.

TARPEYO (budesonide) delayed-release capsules are the first and only FDA-approved drug for the treatment of IgAN. It is indicated for IgAN patients, who are at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It was approved by the US FDA in December 2021, under an accelerated approval pathway, recognizing the urgent need for safe and efficacious therapies.

The availability of therapeutic treatments creates lucrative opportunities for the IgA nephropathy market

Tarpeyo: Calliditas Therapeutics AB

Tarpeyo (developed under the project name Nefecon) is a patented oral formulation of a potent and well-known active substance- budesonide for targeted release. The formulation is designed to deliver the drug to the Peyer's patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Tarpeyo is derived from the TARGIT technology, which allows the substance to pass through the stomach and intestine without being absorbed and released in a pulse-like fashion only when it reaches the lower small intestine.

In addition to its potent local effect, another advantage of using this active substance is its very low bioavailability, i.e., around 90% of it is inactivated in the liver before it reaches systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.

Sparsentan: Travere Therapeutics, Inc

Spartan is a first-in-class, orally active, single-molecule that functions as a high-affinity dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors which are associated with kidney disease progression.

Endothelin I and angiotensin II lead to a decline in kidney function by contributing to inflammation and fibrosis in the kidney, changes to the shape of podocytes, podocyte loss, and increased permeability of the glomerular filtration barrier. Endothelin I and angiotensin II are also vasoconstrictive, meaning they cause a narrowing of blood vessels and an increase in pressure in the glomeruli.

Reimbursement of treatments propelling the growth of the IgA nephropathy market

Proactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select markets with better market access can be a critical business and price strategy.

To assist patients and their healthcare providers who prescribe Tarpeyo, Calliditas has launched a comprehensive patient support program - Tarpeyo Touchpoints. It is a full-service patient and provider support program designed to accelerate and streamline access to Tarpeyo. It utilizes biologics by McKesson's Pharmacy Elite model integrated hub and exclusive specialty pharmacy under one roof and is staffed by care navigators and a designated rare pod team (nurses, pharmacists, fulfillment, and distribution team).

Key Takeaways from Market Study

  • The global IgA Nephropathy Market size will grow from USD 46,821.70 million in 2025 to USD 99,655.4 million by 2035, with a CAGR of 7.6%.

  • Biologics and biosimilars are projected to dominate the therapeutic segment, offering enhanced efficacy and fewer side effects.

  • North America leads the market, accounting for over 40% of revenue share in 2025. Asia-Pacific is expected to witness the fastest CAGR during 2025-2035.

  • Increased healthcare expenditure and favorable government initiatives are boosting market dynamics globally.

  • Innovative technologies in diagnostics and the adoption of digital health platforms will further drive market growth.

"The IgA Nephropathy Market is entering an era of transformative growth fueled by advancements in targeted therapies and precision medicine. Stakeholders focusing on R&D collaborations, digital health integration, and market expansion in developing economies will be well-positioned to capitalize on this growth trajectory. The integration of AI in diagnostics and a surge in biosimilar approvals further underscore the market's evolution," Says Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.)

Country-wise Insights:

The section below discusses the industry analysis for the IgA nephropathy market in several nations. Market demand analysis for important nations in numerous areas of the world, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, and Middle East & Africa, is provided.

The United States is expected to remain the leader in North America, with a larger market share through 2035. In South Asia and the Pacific, India is expected to grow at a CAGR of 9.1% by 2035.

Countries

Value CAGR (2025 to 2035)

United States

6.2%

Germany

4.4%

China

9.0%

France

2.4%

India

9.1%

Spain

5.7%

Australia & New Zealand

6.5%

South Korea

6.0%

IgA Nephropathy Market Day-by-Day Opportunities:

The IgA Nephropathy Market offers opportunities for stakeholders across the value chain, including pharmaceutical companies, diagnostic service providers, and healthcare technology firms. Key opportunities include:

  • R&D in Precision Medicine: Investments in personalized medicine to create patient-specific therapies will likely transform disease management strategies.

  • Expanding Biosimilars Market: Development and commercialization of cost-effective biosimilars will ensure accessibility in cost-sensitive regions.

  • Technological Advancements in Diagnostics: AI-powered diagnostic tools and molecular biomarker research present avenues for early diagnosis.

  • Strategic Collaborations: Partnerships between biotech companies and research institutions are expected to accelerate drug discovery processes.

Component Insights:

  • Therapeutics: Biologics are expected to dominate, accounting for more than 50% of market revenue by 2035. Monoclonal antibodies such as belimumab and rituximab show promise in reducing renal inflammation and improving patient prognosis.

  • Diagnostics: Molecular diagnostics are anticipated to grow at a CAGR exceeding 8%, driven by the demand for early and accurate detection of IgA nephropathy.

  • Services: Increased focus on patient-centered care has led to growth in home-based care services and telemedicine adoption.

How do biomarkers contribute to the early diagnosis of IgA nephropathy?

Biomarkers play a crucial role in the early diagnosis of IgA nephropathy (IgAN), also known as Berger's disease, by providing non-invasive and specific indicators of the disease's presence and progression. Here are the main ways in which biomarkers contribute to the early diagnosis of IgA nephropathy:

Identification of Disease-Specific Biomarkers:

  • Galactose-Deficient IgA1 (Gd-IgA1): Elevated levels of Gd-IgA1 in serum and urine have been identified as significant biomarkers for IgAN. Studies have shown that Gd-IgA1 levels correlate with disease activity, making it a potential marker for early diagnosis and monitoring of the disease

  • Immune Complexes: The presence of Gd-IgA1-containing immune complexes is associated with the pathogenesis of IgAN. Measuring these complexes can help in identifying patients at risk for developing the disease

Correlation with Disease Activity:

  • Biomarkers such as serum Gd-IgA1 and Gd-IgA1-specific antibodies have been linked to disease activity. Their levels can indicate inflammation and damage within the kidneys, allowing for earlier intervention before significant renal impairment occurs

Non-Invasive Testing:

  • The use of serum and urinary biomarkers allows for non-invasive testing methods compared to traditional kidney biopsies, which are invasive and carry risks. This non-invasive approach can facilitate earlier diagnosis and monitoring without subjecting patients to unnecessary procedures

Differentiation from Other Kidney Diseases:

  • Certain biomarkers help differentiate IgAN from other renal diseases. For instance, assessing serum IgA levels and the serum IgA/C3 ratio can aid in distinguishing IgAN from conditions that present similarly, such as minimal change disease or focal segmental glomerulosclerosis

Monitoring Progression and Treatment Response:

  • Biomarkers not only assist in diagnosis but also in monitoring disease progression and response to treatment. For example, changes in urinary protein excretion can indicate worsening kidney function or effectiveness of therapeutic interventions

Predictive Models:

  • Recent advancements include the use of machine learning models that incorporate various biomarkers to predict the likelihood of IgAN development or progression. These models analyze multiple factors, including age, serum albumin levels, and urinary findings, providing a comprehensive assessment that enhances diagnostic accuracy

Regional Analysis of IgA Nephropathy Market:

North America:

  • Leading region with over 40% of revenue share in 2025.

  • Strong focus on R&D and patient access to advanced therapies.

Europe:

  • Second-largest market, driven by government funding and adoption of biosimilars.

  • Key focus on collaborative research initiatives.

Asia-Pacific:

  • Fastest-growing region, with a CAGR of over 8%.

  • Increasing awareness, expanding healthcare infrastructure, and government support.

Latin America & Middle East:

  • Emerging markets with growing adoption of biologics and molecular diagnostics.

Competitive Landscape:

Key players in the IgA Nephropathy Market are employing a variety of strategies to maintain their competitive edge. Among these, product innovation remains a top priority, with companies focusing on developing unique formulations and advanced treatment options. To ensure effective market penetration, firms are forging strategic alliances with healthcare providers, aiming to streamline distribution networks and enhance accessibility to their products.

Additionally, many organizations are actively pursuing partnerships and collaborations to diversify their product portfolios and strengthen their foothold in the global market. These partnerships not only accelerate R&D activities but also open avenues for expansion into emerging markets, boosting their overall market presence.

Recent Industry Developments in IgA Nephropathy Market:

  • March 9, 2023: Sandoz announced plans to establish a state-of-the-art biologics manufacturing facility in Lendava, Slovenia, by signing a memorandum of understanding (MOU).

  • February 9, 2023: Takeda completed its acquisition of Nimbus Lakshmi, Inc., a subsidiary of Nimbus Therapeutics, thereby enhancing its pipeline of innovative therapeutics.

  • January 11, 2023: Sanofi Ventures increased its capital commitment to over USD 750 million for its Evergreen Venture Fund, with a focus on scaling its investment capabilities and expanding its global influence.

Key Players of IgA Nephropathy Market:

  • Novartis AG

  • Sanofi S.A.

  • AstraZeneca

  • Takeda Pharmaceutical Company Limited

  • Pfizer Inc.

  • Validus Pharmaceuticals LLC

  • Organon Group of Companies

Key Segments of IgA Nephropathy Market:

By Diagnosis & Treatment:

In terms of diagnosis & treatment, the industry is divided into- diagnosis and treatment.

By Disease Type:

In terms of disease type, the industry is segregated into- primary IgA nephropathy and secondary IgA nephropathy.

By Indication:

In terms of indication, the industry is segregated into- hematuria, proteinuria, hypertension, edema and others.

By Population Type:

In terms of population type, the industry is segregated into- pediatrics and adults.

By Route of Administration:

In terms of route of administration, the industry is segregated into- oral and parenteral.

By End User:

In terms of end user, the industry is segregated into- hospitals, specialty clinics, homecare and others.

By Region:

Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.

Author

Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.

Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.

Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.

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