In 2025, immunology moved from breadth to discipline: sharper focus on durability, convenience, and access, and a growing expectation that therapies must prove value beyond efficacy alone.
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The 2025 Immunology Storyline: Three Shifts That Kept Repeating
Platform convergence over novelty
Across autoimmune and inflammatory diseases, success no longer came from simply targeting a new cytokine. Programs built on repeatable platforms—IL-23, JAK and TYK2 modulation, TL1A, FcRn inhibition, and bispecific immune-reset strategies—continued to attract capital, partnerships, and regulatory momentum, while isolated one-off mechanisms struggled to justify late-stage risk.
Oral, topical, and subcutaneous pressure on IV biologics
Convenience became strategic. Oral peptides, small molecules, and fully subcutaneous induction regimens repeatedly demonstrated that comparable efficacy with reduced treatment burden can materially shift prescribing behavior, particularly in chronic diseases where persistence determines long-term outcomes.
Access and substitution as competitive differentiators in immunology
Biosimilars, interchangeability designations, and payer-driven switching moved from background noise to primary market forces. In multiple regions, access dynamics directly shaped utilization patterns, guideline positioning, and commercial performance, forcing innovators to compete on total system value rather than headline trial results alone.
Practice-Shaping Immunology Readouts That Defined 2025
1) Icotrokinra (JNJ-2113): Oral IL-23 pathway inhibition
In ulcerative colitis and psoriasis, icotrokinra delivered 63.5 percent clinical response at week 12 versus 27 percent with placebo, with 30.2 percent clinical remission and continued improvement through week 28.
In psoriasis, adolescent and adult studies showed 75 percent complete skin clearance (IGA 0) at week 24, with fewer adverse events than placebo. The consistency across indications reframed oral IL-23 modulation as a credible alternative to injectables and raised expectations for first-line positioning.
2) TREMFYA (guselkumab): IL-23 class consolidation
Data from GALAXI, ASTRO, and APEX confirmed that guselkumab is not only effective but structurally disease-modifying. In ulcerative colitis, more than 35 percent clinical remission versus 9.4 percent with placebo was achieved using fully subcutaneous induction.
In psoriatic arthritis, TREMFYA became the first IL-23 inhibitor to significantly slow radiographic progression. The combination of efficacy, dosing flexibility, and expanding labels repositioned it as a foundational immunology asset rather than a niche biologic.
3) Nipocalimab: FcRn blockade in Sjögren’s disease
Phase 2 data showed greater than 70 percent improvement in systemic disease activity and 77 percent IgG reduction at 24 weeks, supporting both FDA Breakthrough Therapy and Fast Track designations.
The signal validated FcRn inhibition beyond myasthenia gravis and reinforced immune-reset strategies as viable options in systemic autoimmunity long considered refractory to targeted intervention.
4) Sotyktu (deucravacitinib): TYK2 maturity test
In psoriatic arthritis, Sotyktu achieved 54 percent ACR20 response with durable benefit and a favorable safety profile, increasingly positioning it ahead of biologics and as a true Otezla challenger.
At the same time, clinician caution around higher-threshold endpoints such as ACR50 and ACR70 underscored that TYK2’s long-term role will depend on sustained differentiation rather than convenience alone.
Immunology 2025 Approvals, Guidelines, and Access Decisions
United States: Substitution becomes structural
The FDA granted interchangeability to multiple biosimilars, including adalimumab- and ustekinumab-based products, enabling pharmacy-level substitution without prescriber intervention. Pediatric label expansions in Crohn’s disease and atopic dermatitis broadened addressable populations, while cost-driven switching accelerated biosimilar uptake across inflammatory bowel disease and dermatology.
European Union and United Kingdom: IL-23 ascendance and NICE leverage
Guselkumab secured approvals for Crohn’s disease across the EU and UK. In parallel, NICE recommended mirikizumab for biologic-refractory Crohn’s disease, supported by approximately 45 percent one-year remission. These decisions reinforced IL-23 inhibitors as preferred advanced therapies and confirmed the continued influence of health technology assessments on clinical practice.
Asia-Pacific: Immunology growth through access and diagnostics
Forecasts projected growth for the Asia-Pacific rheumatology market driven by earlier diagnosis, tele-rheumatology adoption, and biosimilar availability. Regulatory openness to JAK and IL-23 therapies without restrictive conditions positioned the region as a volume-driven growth engine.
Safety and Supportive Care in Immunology: Keeping Patients on Therapy
Guardrails over warnings
Rather than headline safety scares, 2025 emphasized practical guardrails—dose flexibility, monitoring simplification, and formulation advances—to minimize discontinuation. Topical and oral agents repeatedly showed that lower systemic burden translates into higher persistence.
Switching risk becomes visible in real-world immunology data
Real-world analyses revealed higher discontinuation rates among women and obese patients receiving biologics, underscoring that safety and tolerability are population-specific and increasingly relevant to payer and guideline decisions.
Adherence as an endpoint in Immunology
Needle-free epinephrine, autoinjector biosimilars, and long-interval dosing schedules reframed adherence as a design objective rather than an afterthought.
Diagnostics, Stratification, and Measurement: Better matching and better endpoints
Biomarkers and diagnostics increasingly influenced treatment choice rather than merely confirming disease. Biomarker-positive ulcerative colitis stratification, IBS food-trigger diagnostics, and AI-enabled flare prediction shifted care toward anticipatory intervention.
Importantly, these tools changed decisions—who to treat, when to escalate, and when to switch—without adding procedural burden, supporting adoption in routine clinical practice.
Immunology 2025 Catalyst Calendar (Only Timelines Explicitly Stated)
Second half of 2025
• TL1A assets in Phase 3 and others in Phase 2b with planned initiation in H2 2025
• FDA decisions on pediatric and topical immunology expansions
Late 2025
• Top-line induction data from large phase 3 ulcerative colitis programs
• Regulatory filings for oral and subcutaneous IL-23 assets
2026
• Long-term durability data for oral IL-23 and TYK2 inhibitors
Key 2025 Immunology Takeaways
Immunology in 2025 was by proof of durability, scalability, and system fit. Therapies that aligned efficacy with convenience, safety with persistence, and innovation with access emerged as category leaders. For executives and investors, disciplined platforms—not mechanistic novelty alone—now set the pace for sustainable impact.
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