BAFF- and APRIL-targeted Therapies Market Sees Surge in Activity Amid Rising Autoimmune Disease Burden | DelveInsight
The BAFF- and APRIL-targeted therapies market is experiencing steady growth driven by the rising prevalence of autoimmune diseases such as systemic lupus erythematosus (SLE), IgA nephropathy, and Sjögren's syndrome. Advancements in biologics and the entry of pipeline agents with improved efficacy profiles are further fueling market expansion.
LAS VEGAS, June 24, 2025 /PRNewswire/ -- DelveInsight's BAFF- and APRIL-targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging BAFF- and APRIL-targeted therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM.
Key Takeaways from the BAFF- and APRIL-targeted Therapies Market Report
- As per DelveInsight's analysis, the total market size of BAFF- and APRIL-targeted therapies in the 7MM is expected to surge significantly by 2034.
- BAFF and APRIL-targeted therapies are actively being developed to address a broad spectrum of autoimmune diseases, including IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions, offering promising new options to modulate pathogenic B-cell activity and improve patient outcomes.
- Leading BAFF- and APRIL-targeted therapies companies, such as Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others, are developing novel BAFF- and APRIL-targeted therapies that can be available in the BAFF- and APRIL-targeted therapies market in the coming years.
- Some of the key BAFF- and APRIL-targeted therapies in the pipeline include Atacicept, Telitacicept, AUR200, and others.
- In May 2025, Vera Therapeutics announced that primary endpoint results from the pivotal Phase III ORIGIN 3 trial of atacicept in Immunoglobulin A Nephropathy (IgAN) are expected in Q2 2025, with plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in Q4 2025 for accelerated approval, targeting a potential PDUFA date and commercial launch in 2026.
- In November 2024, the European Medicines Agency (EMA) granted orphan medicine designation to Atacicept for the treatment of IgAN.
- In May 2024, Vera Therapeutics announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase IIb ORIGIN clinical trial of atacicept for IgAN, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN.
Discover which indication is expected to grab the major BAFF- and APRIL-targeted therapies market share @ BAFF- and APRIL-targeted Therapies Market Report
BAFF- and APRIL-targeted Therapies Market Dynamics
The BAFF- and APRIL-targeted therapies market is evolving rapidly, driven by a growing understanding of B-cell biology and its role in autoimmune diseases. BAFF and APRIL are crucial for B-cell survival, maturation, and function. Overexpression of these cytokines has been implicated in diseases such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. Therapies targeting these pathways aim to modulate abnormal B-cell activity, offering more precise immunomodulatory approaches compared to broad immunosuppressants.
Market interest in this space has intensified with the development of biologics like atacicept and, more recently, telitacicept. These agents work by neutralizing excess BAFF and/or APRIL, reducing pathogenic autoantibody production. The differentiated mechanism of dual targeting is believed to offer superior efficacy in certain patient subtypes, fueling competitive development programs.
The market dynamics are shaped by both unmet clinical needs and strategic commercial considerations. Autoimmune diseases, particularly lupus and IgAN, have long suffered from limited treatment options with poor tolerability or efficacy. As a result, payers and clinicians are keen on alternatives that offer disease modification and long-term remission. However, safety remains a concern, especially the risk of hypogammaglobulinemia and infections due to B-cell suppression. This risk-benefit balance is a key differentiator in positioning products within the competitive landscape.
Overall, the BAFF/APRIL-targeted therapy market is transitioning from experimental to established, with first-in-class and best-in-class competition intensifying. Pipeline diversity, biomarker-driven patient selection, and combinatorial strategies with other immunotherapies will be central to shaping the future landscape. As real-world evidence accumulates and regulatory agencies refine guidance, these therapies may move from niche indications to broader frontline use in autoimmune care.
BAFF- and APRIL-targeted Therapies Treatment Market
The landscape for BAFF- and APRIL-targeted therapies is undergoing rapid transformation, fueled by the pressing need for more precise B cell modulation in autoimmune disorders. As of 2025, no fusion proteins targeting these pathways have received FDA approval, but several promising candidates are advancing through late-stage clinical trials. This progress reflects a positive shift in the field, pointing toward more effective dual-pathway immunotherapies that could address the shortcomings of existing treatments and provide renewed hope for patients with challenging autoimmune conditions.
Learn more about the BAFF- and APRIL-targeted therapies @ BAFF- and APRIL-targeted Therapies Analysis
Key Emerging BAFF- and APRIL-targeted Therapies and Companies
Some of the BAFF- and APRIL-targeted therapies in the pipeline include Atacicept (Vera Therapeutics), Telitacicept (RemeGen), AUR200 (Aurinia Pharmaceuticals), and others.
Atacicept is an investigational fusion protein composed of the soluble form of the TACI receptor, which binds to the cytokines BAFF and APRIL—members of the TNF family involved in supporting B-cell survival and promoting the production of autoantibodies linked to autoimmune conditions such as IgAN and lupus nephritis. Vera Therapeutics views atacicept as a strong contender for best-in-class status due to its dual targeting of B cells and plasma cells to lower autoantibody levels. The drug has already been tested in over 1,500 patients across multiple indications in clinical trials. Atacicept is currently undergoing Phase III trials for the treatment of IgAN.
Telitacicept, developed by RemeGen, is another fusion protein that also targets BAFF and APRIL, aiming to treat autoimmune diseases driven by B cells. It is being studied globally, including in the U.S., for conditions such as myasthenia gravis, systemic lupus erythematosus (SLE), and Sjögren's syndrome. The U.S. FDA has granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for telitacicept in myasthenia gravis. A notable advancement in its development came in August 2024, when the first U.S. patient was enrolled in a global Phase III trial for generalized myasthenia gravis.
The anticipated launch of these emerging therapies are poised to transform the BAFF- and APRIL-targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the BAFF- and APRIL-targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about BAFF- and APRIL-targeted therapies clinical trials, visit @ BAFF- and APRIL-targeted Therapies Treatment
BAFF- and APRIL-targeted Therapies Overview
BAFF and APRIL, both part of the TNF family, are key regulators of B cell survival, development, and antibody class switching through their interactions with the receptors BAFF-R, TACI, and BCMA. When the BAFF/APRIL pathway becomes dysregulated, often due to ligand overexpression, it can trigger abnormal B cell activation and drive the development of autoimmune diseases.
BAFF mainly signals through BAFF-R, activating both the classical and alternative NF-κB pathways, while APRIL binds to TACI and BCMA and also interacts with heparan sulfate proteoglycans to amplify B cell responses. Given their pivotal role in immune system regulation, BAFF and APRIL have emerged as promising therapeutic targets. Clinical studies have shown that inhibiting BAFF can significantly reduce disease activity in various autoimmune conditions by curbing harmful B-cell activity and helping to restore immune homeostasis.
BAFF- and APRIL-targeted Therapies Epidemiology Segmentation
The BAFF- and APRIL-targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Cases in Selected Indications for BAFF- and APRIL-targeted Therapies
- Total Eligible Patient Pool in Selected Indications for BAFF- and APRIL-targeted Therapies
- Total Treated Cases in Selected Indications for BAFF- and APRIL-targeted Therapies
BAFF- and APRIL-targeted Therapies Report Metrics | Details |
Study Period | 2020–2034 |
BAFF- and APRIL-targeted Therapies Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions |
Key BAFF- and APRIL-targeted Therapies Companies | Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others |
Key BAFF- and APRIL-targeted Therapies | Atacicept, Telitacicept, AUR200, and others |
Scope of the BAFF- and APRIL-targeted Therapies Market Report
- BAFF- and APRIL-targeted Therapies Therapeutic Assessment: BAFF- and APRIL-targeted Therapies current marketed and emerging therapies
- BAFF- and APRIL-targeted Therapies Market Dynamics: Conjoint Analysis of Emerging BAFF- and APRIL-targeted Therapies Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, BAFF- and APRIL-targeted Therapies Market Access and Reimbursement
Discover more about BAFF- and APRIL-targeted therapies in development @ BAFF- and APRIL-targeted Therapies Clinical Trials
Table of Contents
1. | Key Insights |
2. | Report Introduction |
3. | Executive Summary |
4. | Key Events |
5. | Epidemiology and Market Forecast Methodology |
6. | BAFF- and APRIL-targeted Therapies Market Overview at a Glance in the 7MM |
6.1. | Market Share (%) Distribution by Therapies in 2025 |
6.2. | Market Share (%) Distribution by Therapies in 2034 |
6.3. | Market Share (%) Distribution by Indications in 2025 |
6.4. | Market Share (%) Distribution by Indications in 2034 |
7. | BAFF- and APRIL-targeted Therapies: Background and Overview |
7.1. | Introduction |
7.2. | Potential of BAFF- and APRIL-targeted Therapies in Different Indications |
7.3. | Clinical Applications of BAFF- and APRIL-targeted Therapies |
8. | Target Patient Pool of BAFF- and APRIL-targeted Therapies |
8.1. | Assumptions and Rationale |
8.2. | Key Findings |
8.3. | Total Cases of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM |
8.4. | Total Eligible Patient Pool of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM |
8.5. | Total Treatable Cases in Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM |
9. | Emerging Therapies |
9.1. | Key Competitors |
9.2. | Atacicept: Vera Therapeutics |
9.2.1. | Product Description |
9.2.2. | Other developmental activities |
9.2.3. | Clinical development |
9.2.4. | Safety and efficacy |
9.3. | Telitacicept: RemeGen |
9.3.1. | Product Description |
9.3.2. | Other developmental activities |
9.3.3. | Clinical development |
9.3.4. | Safety and efficacy |
List to be continued in the report | |
10. | BAFF- and APRIL-targeted Therapies: Seven Major Market Analysis |
10.1. | Key Findings |
10.2. | Market Outlook |
10.3. | Conjoint Analysis |
10.4. | Key Market Forecast Assumptions |
10.4.1. | Cost Assumptions and Rebates |
10.4.2. | Pricing Trends |
10.4.3. | Analogue Assessment |
10.4.4. | Launch Year and Therapy Uptakes |
10.5. | Total Market Sizes of BAFF- and APRIL-targeted Therapies by Indications in the 7MM |
10.6. | The United States Market Size |
10.6.1. | Total Market Size of BAFF- and APRIL-targeted Therapies in the United States |
10.6.2. | Market Size of BAFF- and APRIL-targeted Therapies by Indication in the United States |
10.6.3. | Market Size of BAFF- and APRIL-targeted Therapies by Therapies in the United States |
10.7. | EU4 and the UK |
10.7.1. | Total Market Size of BAFF- and APRIL-targeted Therapies in EU4 and the UK |
10.7.2. | Market Size of BAFF- and APRIL-targeted Therapies by Indications in EU4 and the UK |
10.7.3. | Market Size of BAFF- and APRIL-targeted Therapies by Therapies in EU4 and the UK |
10.8. | Japan |
10.8.1. | Total Market Size of BAFF- and APRIL-targeted Therapies Inhibitors in Japan |
10.8.2. | Market Size of BAFF- and APRIL-targeted Therapies by Indications in Japan |
10.8.3. | Market Size of BAFF- and APRIL-targeted Therapies by Therapies in Japan |
11. | SWOT Analysis |
12. | KOL Views |
13. | Unmet Needs |
14. | Market Access and Reimbursement |
15. | Appendix |
15.1. | Bibliography |
15.2. | Report Methodology |
16. | DelveInsight Capabilities |
17. | Disclaimer |
18. | About DelveInsight |
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