BAFF 및 APRIL 표적 치료제 : 표적 집단, 경쟁 구도, 시장 예측(2034년)

Key Highlights:

• BAFF and APRIL, key TNF family members, regulate B cell survival and activation via receptors BAFF-R, TACI, and BCMA. Dysregulation of this axis drives autoimmune diseases through excessive B cell activation. Therapies targeting BAFF/APRIL aim to restore immune balance by modulating pathogenic B cell responses and have shown promising clinical results in reducing autoimmune disease activity.
• 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), sjogren's syndrome, and other B cell-mediated autoimmune conditions, offering promising new options to modulate pathogenic B cell activity and improve patient outcomes.
• The total diagnosed prevalent population of IgAN in the 7MM comprised ~400,000 cases in 2024.
• Among the 7MM, the United States accounted for the highest number of diagnosed cases of lupus nephritis with ~195,000 cases in 2024.
• 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 May 2024, Vera Therapeutics announced that the US FDA has 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.
• In November 2024, the European Medicines Agency (EMA) granted orphan medicine designation to Atacicept for the treatment of IgAN.
• Telitacicept has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the US FDA for the treatment of Myasthenia Gravis.

DelveInsight's "BAFF- and APRIL-targeted therapies - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the BAFF-and APRIL-targeted therapies, historical and competitive landscape as well as its market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The BAFF- and APRIL-targeted therapies' market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM BAFF- and APRIL-targeted therapies' market size from 2020 to 2034. The report also covers current BAFF- and APRIL-targeted therapies' 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

Study Period: 2020-2034

BAFF- and APRIL-targeted therapies Understanding and Treatment Algorithm

BAFF- and APRIL-targeted therapies Overview

BAFF and APRIL are members of the TNF family that play central roles in B cell survival, maturation, and immunoglobulin class switching through interactions with receptors BAFF-R, TACI, and BCMA. Dysregulation of the BAFF/APRIL axis contributes to autoimmune disease pathogenesis, as overexpression of these ligands can lead to excessive B cell activation and autoimmunity. BAFF predominantly signals through BAFF-R to activate both classical and alternative NF-κB pathways, while APRIL binds TACI and BCMA, also engaging heparan sulfate proteoglycans to enhance B cell responses. The critical role of BAFF/APRIL in immune regulation has made them attractive therapeutic targets, with clinical trials demonstrating that BAFF blockade can effectively reduce disease activity in several autoimmune disorders. Targeted therapies against these ligands aim to restore immune balance by modulating pathogenic B cell responses.

BAFF- and APRIL-targeted Therapies Market Overview

BAFF- and APRIL-targeted therapies are emerging as promising treatments across multiple autoimmune diseases, including IgA nephropathy, lupus nephritis, myasthenia gravis, systemic lupus erythematosus, and Sjogren's syndrome. Their development signals a positive shift in the autoimmune treatment landscape, potentially expanding therapeutic options and driving growth across these high-need indication markets.

BAFF- and APRIL-targeted Therapies Epidemiology

The epidemiology chapter of BAFF- and APRIL-targeted therapies in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for BAFF- and APRIL-targeted therapies, total eligible patient pool in selected indications for BAFF- and APRIL-targeted therapies, and total treated cases in selected indications for BAFF- and APRIL-targeted therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• The total diagnosed prevalent population of IgA nephropathy in the 7MM comprised ~400,000 cases in 2024.
• As per the analysis, IgA Nephropathy shows male predominance, with ~60% cases of IgAN in males and ~40% cases in females, in 2024, in the US.
• Among the 7MM, Japan accounted for the highest number of diagnosed prevalent cases of IgA nephropathy, i.e., ~45% of the total population in 2024.
• Among the 7MM, the United States accounted for the highest number of diagnosed cases of Lupus Nephritis with ~195,000 cases in 2024.
• In 2024, Class IV accounted for the highest number of cases of Lupus Nephritis in the US and this trend is likely to remain the same.
• It was observed that SLE occurs majorly in the age group of 40-59 years.
• Among EU4 and the UK, the United Kingdom accounted for the highest diagnosed prevalent cases of Sjogren's syndrome, whereas Spain accounted for the least number of cases.

BAFF- and APRIL-targeted therapies Drug Chapters

The drug chapter segment of the BAFF- and APRIL-targeted therapies report encloses a detailed analysis of approved BAFF- and APRIL-targeted therapies, late-stage (Phase III and Phase II) BAFF- and APRIL-targeted therapies. It also helps understand the clinical trial details of BAFF- and APRIL-targeted therapies, 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 BAFF- and APRIL-targeted therapies

As of 2025, no BAFF/APRIL-targeting fusion protein is FDA-approved, highlighting a significant gap in therapies directly modulating B cell survival via dual ligand inhibition. Current treatment options primarily focus on single-target approaches or broader immunosuppression. Emerging fusion proteins like Atacicept, Telitacicept, and AUR200 aim to meet this unmet need by offering a more targeted strategy to reduce disease-driving B cell activity in autoimmune conditions, potentially improving efficacy and minimizing off-target effects.

Emerging BAFF- and APRIL-targeted therapies

Atacicept: Vera Therapeutics

Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines BAFF and APRIL. These cytokines are members of the TNF family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. Currently, atacicept is in Phase III of the development process for IgAN.

Telitacicept: RemeGen

Telitacicept is a fusion protein targeting both BAFF and APRIL, developed by RemeGen for B cell-mediated autoimmune diseases. It is currently in global clinical trials, including in the United States, for myasthenia gravis, SLE, and Sjogren's syndrome. In the US, telitacicept has been granted ODD and FTD by the US FDA for the treatment of Myasthenia Gravis. Notably, in August 2024, the first US patient was enrolled in a global Phase III trial for generalized myasthenia gravis, marking a significant milestone in its clinical development.

BAFF- and APRIL-targeted therapies Market Outlook

The therapeutic landscape for BAFF- and APRIL-targeted therapies is evolving rapidly, driven by a clear unmet need for precise B cell modulation in autoimmune diseases. As of 2025, no such fusion proteins are FDA-approved, but promising candidates are progressing through late-stage development. Atacicept (Vera Therapeutics), in Phase III for IgAN, has secured BTD and is on track for a BLA submission in late 2025, with a potential US launch in 2026. Telitacicept (RemeGen) is being evaluated in US trials for myasthenia gravis, SLE, and Sjogren's syndrome, supported by ODD and FTD, with pivotal data due in mid-2025. Additionally, AUR200 (Aurinia Pharmaceuticals) began Phase I trials in late 2024, with early results expected in 2025.

These advancements are highly positive for the BAFF/APRIL-targeted therapy landscape, signaling a shift toward more effective, dual-pathway immunotherapies that may overcome the limitations of current treatments and offer new hope for patients with difficult-to-treat autoimmune diseases.

BAFF- and APRIL-targeted therapies Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging BAFF- and APRIL-targeted therapies expected to be launched in the market during 2025-2034.

BAFF- and APRIL-targeted therapies Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. The presence of numerous drugs under different stages is expected to generate immense opportunity for BAFF- and APRIL-targeted therapies market growth over the forecast period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for BAFF- and APRIL-targeted therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on BAFF- and APRIL-targeted therapies' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Washington University and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or BAFF- and APRIL-targeted therapies 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 analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. 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 event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 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 may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

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 Updates on BAFF- and APRIL-targeted therapies

• In May 2025, Vera Therapeutics announced that primary endpoint results from the pivotal Phase III ORIGIN 3 trial of atacicept in IgAN are expected in Q2 2025, with plans to submit a BLA to the US FDA in Q4 2025 for accelerated approval, targeting a potential PDUFA date and commercial launch in 2026.
• In November 2024, EMA granted Orphan medicine designation to Atacicept for the treatment of IgAN.
• In September 2024, the first participant was dosed in a Phase I study of AUR 200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF and APRIL. The Company continues to expect to report initial results from this study in the first half of 2025.
• In May 2024, Vera Therapeutics announced that the US FDA has granted 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.

The abstract list is not exhaustive and will be provided in the final report.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the BAFF- and APRIL-targeted therapies, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the BAFF- and APRIL-targeted therapies market, historical and forecasted market size, and market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM BAFF- and APRIL-targeted therapies market.

BAFF- and APRIL-targeted therapies Report Insights

• BAFF- and APRIL-targeted therapies Targeted Patient Pool
• Therapeutic Approaches
• BAFF- and APRIL-targeted therapies Pipeline Analysis
• BAFF- and APRIL-targeted therapies Market Size and Trends
• Existing and future Market Opportunities

BAFF- and APRIL-targeted therapies Report Key Strengths

• 10 years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

BAFF- and APRIL-targeted therapies Report Assessment

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

Key Questions:

• What was the total market size of BAFF- and APRIL-targeted therapies, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for BAFF- and APRIL-targeted therapies?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for BAFF- and APRIL-targeted therapies evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with BAFF- and APRIL-targeted therapies? What will be the growth opportunities across the 7MM for the patient population of BAFF- and APRIL-targeted therapies?
• What are the key factors hampering the growth of the market for BAFF- and APRIL-targeted therapies?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for BAFF- and APRIL-targeted therapies?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the BAFF- and APRIL-targeted therapies market.
• Understand the existing market opportunities 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) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive 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 needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of BAFF- and APRIL-targeted therapies

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 BAFF- and APRIL-targeted 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
  • 10.2.5. Analyst Views
• 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
  • 9.3.5. Analyst Views

10 BAFF- and APRIL-targeted therapies: Seven Major Market Analysis

• 10.1 Key Findings
• 10.2 Market Outlook of BAFF- and APRIL-targeted therapies
• 10.3 Conjoint Analysis of BAFF- and APRIL-targeted therapies
• 10.4 Key Market Forecast Assumptions of BAFF- and APRIL-targeted therapies
  • 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 Size of BAFF- and APRIL-targeted therapies by Indications in the 7MM
• 10.6 The United States
  • 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 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