BAFF 및 APRIL 표적 치료제의 전망은 자가면역질환에서 정확한 B 세포 조절이라는 명확한 미충족 요구에 따라 빠르게 진행되고 있습니다. 2025년 현재, 이러한 융합 단백질은 FDA 승인되지 않았지만, 유망한 후보가 후기 개발 단계까지 진행되고 있습니다. IgAN 치료제로서 3단계 단계에 있는 Atacicept(Vera Therapeutics)는 BTD를 취득하여 2025년 후반의 BLA 신청, 2026년 미국 상시를 목표로 하고 있습니다. Telitacicept(RemeGen)는 중증 근무력증, SLE, 셰글렌 증후군을 대상으로 한 미국 시험에서 평가 중이며 ODD와 FTD를 지원합니다. 또한 AUR200(Aurinia Pharmaceuticals)은 2024년 후반에 1단계 시험을 시작했으며 2025년에 조기 결과가 나올 전망입니다.
이러한 진보는 BAFF 및 APRIL 표적 치료제의 상황에 매우 바람직하며, 현재 치료의 한계를 극복하고 치료가 어려운 자가면역 질환 환자에게 새로운 희망을 초래할 수 있는 보다 효과적인 2-경로 면역요법으로의 변화를 보여줍니다.
본 보고서에서는 BAFF 및 APRIL 표적 치료제의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대해 조사 분석하여 각 지역 시장 규모, 현재의 치료법, 암메트니즈, 신약 등의 정보를 제공합니다.
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.
Study Period: 2020-2034
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.
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 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.
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.
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
The abstract list is not exhaustive and will be provided in the final report.