Multi-Indication Strategies Reshape Immunology's R&D Strategy

By Mahmoud Choueib, Gaja Gasiorek, and Pooja Goyal, Lifescience Dynamics

At EULAR 2025, the future of immunology was defined by not only novel mechanisms and therapies but also a strategic evolution in how companies develop and position their assets. A clear trend emerged across presentations and pipelines: leading biopharma players are increasingly embracing multi-indication strategies, designing assets to work across dermatology, rheumatology, and gastroenterology indications.

This approach, sometimes described as the “pipeline-in-a-product” model, reflects a convergence of clinical science and commercial strategy, one that leverages shared immunopathology to unlock value across disease areas and patient populations.

From TNF Inhibitors to Tremfya and Rinvoq: The Model Matures

This model is not new. It was pioneered by TNF-alpha inhibitors like Enbrel (etanercept, Amgen), Remicade (infliximab, Johnson & Johnson), and Humira (adalimumab, AbbVie), each achieving success across rheumatoid arthritis (RA), psoriatic arthritis (PsA), Ankylosing spondylitis (AS), and more. However, what was once an opportunistic expansion into new indications after initial success has now evolved into an intentional, integrated R&D strategy from the outset.

This strategy was clearly on display this year at EULAR. Janssen’s Tremfya (guselkumab), originally approved for plaque psoriasis, presented new Phase 3 PsA data (LB0010) showing rapid and meaningful improvements across joint, skin, and physical function outcomes. These results underscored Tremfya’s cross-specialty relevance, emphasizing its applicability in both rheumatology and dermatology practices.

Meanwhile, AbbVie’s Rinvoq (upadacitinib) continues to expand its label; now spanning RA, PsA, AS, non-radiographic axial apondyloarthritis, ulcerative colitis, Crohn’s Disease, and atopic dermatitis. Its trajectory illustrates how mechanism-informed development (in this case, selective JAK1 inhibition) can support a coherent, multi-indication franchise. AbbVie is further pursuing Rinvoq in five additional indications, which are in late-stage clinical trials or have already been filed such as giant cell arteritis, alopecia areata, hidradenitis suppurativa, systemic lupus erythematosus, and vitiligo, reinforcing this intentional and scalable approach.

Why This Strategy Works and Risks Involved: Scientific And Strategic Rationale

The underpinning science is strong. Many autoimmune and inflammatory diseases share key molecular drivers, such as TNF, IL-17, IL-23, and JAK/STAT signaling. As a result, a therapy proven effective in one indication often shows promise in others, requiring only limited clinical adjustment. These adaptations typically involve changes to dosing regimens, administration routes, or endpoint selection rather than changes to the underlying mechanism. This ultimately supports an accelerated development and a more efficient regulatory navigation.

Strategically, the benefits are manifold:

• Lifecycle extension: Products can remain commercially viable long after their initial launch, preserving market dominance post-loss of exclusivity.
• Brand recognition and clinician comfort: Familiarity builds confidence across specialties.
• Comorbidity alignment: Patients often suffer from multiple autoimmune conditions; a single therapy with cross-indication approval simplifies treatment.
• Portfolio streamlining: Fewer assets can serve broader patient populations, improve R&D efficiency, and reduce operational complexity across functions. In particular, these assets enable larger manufacturing volumes under a unified process, reducing cost per dose through economies of scale.

While attractive, this strategy is not without challenges:

1. R&D investment is steep: Pursuing multiple parallel trials demands significant capital and organizational bandwidth. While this strategy accelerates time-to-revenue, it also amplifies downside risk. Safety signals that are introduced in one indication can have ripple effects across the whole franchise, similarly to any regulatory action, especially if the therapy is new to market and not much is known about its use in clinic.
2. Crowded mechanism of action (MoA) classes: JAK inhibitors, for instance, now face a potentially saturated market across multiple autoimmune indications. Differentiation demands more than efficacy; JAK1-selective agents (e.g., upadacitinib) are positioned as safer, more targeted alternatives to pan-JAKs (e.g., tofacitinib). Thus, differentiation hinges on novel endpoints — real world evidence (RWE) that supports moving away from current therapy and alternative formulations or dosing regimens that enhance patient adherence.
3. Regulatory nuance: Efficacy in one condition doesn’t guarantee success in another; trial design must still address condition-specific guidelines and treatment landscape.
4. Commercial cannibalization: Overlap between indications may dilute market share, as a single asset treating multiple conditions can limit revenue compared to having separate products, each tailored to a specific condition.

Additionally, payer scrutiny increases when a therapy spans multiple high-cost indications. Demonstrating consistent value, especially in less severe conditions, is crucial for reimbursement.

Lifecycle Transitions And Strategic Continuity

The pipeline-in-a-product model offers clear advantages for managing and extending product life cycles. Companies like AbbVie and Janssen are using newer assets (Rinvoq, Tremfya) to replace aging blockbusters (Humira, Stelara), often within the same mechanism class or adjacent pathway.

This allows for continuity in branding and positioning, prescriber loyalty, and smooth transition of patients within the same franchise. It also enables built-in defense against biosimilar erosion, ensuring that commercial impact is softened even as older molecules lose exclusivity.

Importantly, this model is not purely commercial. It offers meaningful clinical benefits for patients with chronic diseases, such as simplified treatment plans for patients with multiple autoimmune diseases, streamlined prescribing pathways for physicians and more coherent patient management across specialties

By aligning treatment paradigms across diseases, this model enhances real-world treatment adherence.

Conclusion: Strategic Breadth as a Success Factor in Immunology

The multi-indication expansion model is here to stay. As the immunology pipeline grows more complex, breadth of application — across diseases, specialties, and geographies — will increasingly define commercial success. To succeed in immunology, pharma companies should find opportunities to balance innovation at the MoA level with systematic, indication-spanning execution.

About The Authors:

Mahmoud Choueib (MPharm), Gaja Gasiorek (MPhil), and Pooja Goyal (MSPharm) are with Lifescience Dynamics.