DelveInsight’s “Rheumatoid Arthritis – Pipeline Insight, 2025” report provides a comprehensive analysis of the current and emerging rheumatoid arthritis therapeutic landscape across the globe. The report offers detailed profiles of more than 75 companies developing over 80 pipeline drugs in various stages of clinical development, from discovery and preclinical phases through Phase III and registration. This exhaustive assessment covers the mechanism of action, clinical progress, collaborative agreements, and technological developments shaping the future rheumatoid arthritis treatment landscape.
Rheumatoid arthritis represents a significant global health challenge, with a worldwide prevalence of approximately 0.24%. Furthermore, the annual incidence in the US and other Western European nations averages about 40 per 100,000 persons, underscoring the urgent need for innovative therapeutic approaches.
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The current rheumatoid arthritis treatment landscape relies heavily on disease-modifying antirheumatic drugs (DMARDs), with methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine serving as conventional backbone therapies. More recently, Janus kinase (JAK) inhibitors like RINVOQ from AbbVie Inc. (approved in 2019), OLUMIANT from Eli Lilly and Company (approved in 2018), and XELJANZ from Pfizer have emerged as important therapeutic options. Despite these advances, significant unmet needs persist, particularly for patients who don’t respond adequately to existing treatments or experience treatment-limiting side effects.
DelveInsight’s analysis reveals several promising candidates advancing through the pipeline. SinoMab Bioscience’s SM03 (Suciraslimab) stands at the forefront as a potential first-in-target anti-CD22 monoclonal antibody. In September 2023, the National Medical Products Administration (NMPA) accepted its biologics license application for rheumatoid arthritis treatment. SM03’s novel mechanism disrupts CD22 homomultimeric configuration, induces internalization of CD22 from human B cells, and modulates B-cell immune response, potentially offering a unique therapeutic approach with a favorable safety profile.
Another advanced candidate, Telitacicept (RC18) from RemeGen, is in the pre-registration phase. This novel fusion protein targets two critical cell-signaling molecules for B-lymphocyte development- B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL)-effectively reducing B-cell-mediated autoimmune responses implicated in rheumatoid arthritis.
IRL201805, developed by Immune Regulation, represents a first-in-class compound derived from an endogenous immuno-regulatory protein, demonstrating durable activity and disease remission with a favorable safety profile. Additionally, ORYN 1001 from Oryn Therapeutics has completed Phase IB trials for rheumatoid arthritis, validating its systemic safety profile for patients with mild disease managed with DMARDs.
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Recent developments in the rheumatoid arthritis treatment landscape include the FDA’s June 2024 expansion of RINVOQ’s approved indications to include pediatric patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis, as well as patients aged 2 to under 18 years with psoriatic arthritis. This expansion addresses significant unmet needs in younger patient populations and offers a weight-based oral solution as a treatment option.
Additionally, in April 2024, the FDA approved a high-concentration, citrate-free version of CYLTEZO (adalimumab-adbm), marking the fifth high-concentration HUMIRA biosimilar available in the US. This new formulation aims to enhance accessibility and affordability for rheumatoid arthritis patients and other autoimmune conditions.
Moreover, several biosimilars of ACTEMRA have received FDA approval. Specifically, in January 2025, Celltrion’s AVTOZMA was approved, followed by Fresenius Kabi’s TYENNE, which received FDA approval for the treatment of rheumatoid arthritis in March 2024.
In February 2025, AnaptysBio announced promising results from a global Phase IIb trial (RENOIR) for rosnilimab, a novel PD-1+ T cell modulator. The trial, involving 424 patients with moderate-to-severe RA, showed statistically significant improvements in disease activity with a safety profile comparable to placebo.
In March-April 2025, the second stage of the AuToDeCRA2 clinical trial began in Newcastle, UK, investigating tolDC therapy. This approach involves extracting and modifying a patient’s dendritic cells to reset the immune system. Phase I established safety, and Phase II is now assessing the optimal injection site and immune effects. The goal is to induce long-term remission and reduce reliance on lifelong immunosuppressants
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Looking ahead, the rheumatoid arthritis pipeline reflects a shift toward more targeted therapies, including novel monoclonal antibodies, fusion proteins, and small molecules addressing specific inflammatory pathways. As these candidates progress through clinical development, they promise to diversify treatment options, potentially improving efficacy, safety, and quality of life for patients struggling with this chronic, debilitating condition.
Table of Contents
1. Introduction
2. Executive Summary
3. Rheumatoid Arthritis : Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Rheumatoid Arthritis – DelveInsight’s Analytical Perspective
7. Late Stage Products (Registration)
8. Early Stage Products (Phase I/II)
9. Preclinical and Discovery Stage Products
10. Inactive Products
11. Rheumatoid Arthritis Key Companies
12. Rheumatoid Arthritis Key Products
13. Rheumatoid Arthritis – Unmet Needs
14. Rheumatoid Arthritis – Market Drivers and Barriers
15. Rheumatoid Arthritis – Future Perspectives and Conclusion
16. Rheumatoid Arthritis Analyst Views
17. Rheumatoid Arthritis Key Companies
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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