EXTON, PA, Aug. 25, 2025 (GLOBE NEWSWIRE) -- According to the latest findings from Spherix Global Insights’ Market Dynamix™: Rheumatoid Arthritis (US) 2025, the most notable near-term disruption in the RA market stems from continued TNF biosimilar adoption at the expense of branded biologics, namely AbbVie’s Humira. The analysis, based on an online survey of 104 rheumatologists fielded in June and July of 2025, highlights both the pressures shaping today’s landscape and the innovations expected to transform future patient care.
Payer mandates requiring step-throughs are now impacting nearly half of advanced systemic-treated RA patients, further embedding biosimilars into frontline prescribing. Despite this shift, rheumatologists maintain confidence in the effectiveness of existing options, noting that TNF inhibitors remain the first-line choice at treatment initiation.
Fatigue persists as the top unmet need in RA, affecting nearly half of patients and cited by over half of rheumatologists as a key treatment gap. Additional challenges—including cardiovascular and infection risk, systemic involvement, Medicare coverage barriers, and treatment of obese patients—highlight opportunities for differentiation. Most notably, nearly one in five RA patients are considered refractory and/or difficult-to-treat (D2T), population rheumatologists consistently describe as driving innovation in the coming years. While refractory RA is generally defined as failing multiple biologic or targeted therapies, the D2T label is broader—capturing patients who may also have significant comorbidities, intolerances, or psychosocial barriers. As one rheumatologist noted, “They’re two separate groups, but there is substantial overlap. Refractory RA is about biologic failure. D2T includes people with pain amplification, depression, and other stuff layered on top.”
For these difficult-to-treat patients, rheumatologists look to the pipeline with optimism. Sanofi’s oral TNF inhibitor balinatunfib is widely regarded as a promising mechanism in late-stage development. Physicians see it as pairing the reliability of a well-established and proven MOA with the convenience of oral delivery—an advancement that many describe as a potential game changer if efficacy and safety match current injectables. One rheumatologist noted, “TNF inhibitors remain the gold standard starting advanced therapy in RA and an oral option would be nice.”
Beyond TNFs, Anaptys Bio’s PD-1 agonist rosnilimab is also emerging as a strong contender, particularly given recent positive Phase 2b data in refractory RA. Indeed, one-fifth of rheumatologists were aware of the Anaptys announcement that rosnilimab achieved positive results in the recent Phase 2b trial, with the highest ever reported CDAI LDA response over 6 months.
Additional mechanisms are also drawing interest, including Bristol Myers Squibb’s BTK inhibitor branebrutinib, Eli Lilly’s anti-CD19 monoclonal antibody LY3541860, RemeGen’s BAFF/APRIL dual inhibitor telitacicept, Immunovant’s FcRn inhibitor IMVT-1402 (being advanced specifically for the difficult-to-treat RA segment), and Johnson & Johnson’s anti-FcRn antibody nipocalimab. Together, these assets, among others, underscore the breadth of innovation on the horizon and the potential for a more personalized, mechanism-driven approach to RA management.
Looking ahead, rheumatologists anticipate a treatment paradigm that balances biosimilar-driven cost pressures with an influx of innovative therapies. The consensus is that oral formulations of trusted mechanisms and entirely new MOAs could reshape prescribing, particularly for patients with limited options today. While payer restrictions are likely to remain a formidable hurdle, the market is poised for meaningful evolution. With refractory patients at the center of unmet need, and with innovation advancing across small molecules and biologics, rheumatologists foresee an RA landscape that looks markedly different within the next three to five years.
Market Dynamix™ is an independent, data-driven service focused on understanding the evolving dynamics of specialty markets poised for disruption. Leveraging quantitative and qualitative research, the service evaluates current treatment approaches, unmet needs, and likely impact of pipeline agents over a three-to-five-year horizon.
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Andy Stankus, Rheumatology Franchise Head Spherix Global Insights 4848794284 andy.stankus@spherixglobalinsights.com
