Last updated: October 26, 2025
Introduction
Secukinumab (brand name: Cosentyx), developed by Novartis, is a human monoclonal antibody targeting interleukin-17A (IL-17A). It is primarily used to treat autoimmune conditions including moderate to severe plaque psoriasis, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and certain forms of axial spondyloarthritis. With its innovative mechanism of action, secukinumab has established itself as a significant player in the biologics arena. This report provides a comprehensive update on ongoing and completed clinical trials, analyzes market dynamics, and projects future growth trajectories.
Clinical Trials Update
Current Development Landscape
As of Q1 2023, secukinumab remains the focus of numerous clinical trials across different indications, reflecting the drug's expanding therapeutic potential.
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Psoriasis and Psoriatic Arthritis: Novartis continues to investigate long-term safety and efficacy, with ongoing trials assessing its use in pediatric populations and comparing it against other IL-17 inhibitors such as ixekizumab (Taltz) and brodalumab (Siliq). Notably, a Phase 3 trial (NCT05079720) evaluated secukinumab in pediatric patients aged 6-17 years with moderate to severe plaque psoriasis. Results demonstrated significant improvements with an acceptable safety profile.
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Axial Spondyloarthritis and Non-Radiographic Axial Spondyloarthritis: Multiple Phase 3 trials are evaluating secukinumab as a first-line biologic. NCT04467669 assesses its efficacy and safety in non-radiographic axial spondyloarthritis, with preliminary data indicating sustained symptom control. The drug’s ability to reduce inflammation markers and improve patient-reported outcomes continues to be validated.
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Other Indications: Researchers are exploring secukinumab in new immune-mediated conditions, including hidradenitis suppurativa (NCT04563237) and uveitis, leveraging IL-17A’s role in inflammatory pathways. Early-phase trials exhibit promising signals, although regulatory approval in these areas remains pending.
Emerging Data
Recent publications in prominent rheumatology and dermatology journals highlight the durability of secukinumab’s efficacy over extended periods. A two-year follow-up from the EXTEND trial confirms sustained skin clearance in psoriasis patients with minimal loss of response and manageable adverse effects. Safety profiles have remained consistent, with infections and mild neutropenia as the most common adverse events.
Regulatory Developments
In the EU, the European Medicines Agency (EMA) has reaffirmed secukinumab’s approval for multiple indications, with ongoing reviews for expanded pediatric approval. In the US, the Food and Drug Administration (FDA) continues to monitor post-marketing safety data, which supports its current use spectrum.
Market Analysis
Market Overview
Secukinumab’s global sales have surged since its launch, driven by robust clinical efficacy, favorable safety profile, and competitive positioning among biologics. The drug is marketed in over 80 countries, with the largest revenues originating from North America, Europe, and Asia-Pacific.
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Revenue Trajectory: According to Novartis’ 2022 financial reports, secukinumab generated approximately $4.3 billion in annual sales, representing a 12% growth from the prior year, with psoriasis constituting roughly 60% of sales.
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Market Share Dynamics: Secukinumab maintains a strong position in the IL-17 inhibitor class, competing notably with Eli Lilly’s ixekizumab and Amgen’s brodalumab. As per IQVIA data, secukinumab holds an estimated 35-40% share within the IL-17 segment, recognizing its early market entry and extensive clinical data.
Competitive Landscape
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Key Competitors:
- Ixekizumab (Taltz): Positioned as a rival with similar indications; offers a shorter dosing interval.
- Brodalumab (Siliq): Noted for its superior efficacy in some psoriasis measures but with a boxed warning for suicidal ideation.
- Secukinumab’s Differentiator: Its well-established safety track record and broader approval scope in certain geographies strengthen its market positioning.
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Pricing and Reimbursement: Price disparities are minimized through insurance negotiations and value-based pricing models. In the US, the list price averages $8,500 per annum, with significant rebates and discounts.
Market Drivers
- Expanding Indication Portfolio: Ongoing trials for hidradenitis suppurativa and potential new autoimmune indications could broaden revenue streams.
- Increasing Prevalence: The rising global burden of psoriasis and psoriatic arthritis (estimated at over 125 million affected individuals worldwide) fuels demand.
- Patient Preference shifts: The move toward subcutaneous injections with less frequent dosing (monthly or bi-monthly) improves compliance and market penetration.
Market Challenges
- Generic and Biosimilar Competition: Although biosimilars for other biologics have gained market share, secukinumab’s patent protections are still largely intact until at least 2030.
- Pricing Pressures: Payers and regulatory agencies’ push for affordability could impact margins.
Future Market Projection
Growth Forecasts
Projections indicate a compound annual growth rate (CAGR) of approximately 8% for secukinumab over the next five years, reaching an estimated market value of $7.5 billion by 2027. The growth will be fueled by:
- Launches in emerging markets such as India, Brazil, and Southeast Asia.
- Expanded approvals for pediatric and non-radiographic forms of axial spondyloarthritis.
- The potential entry into new indications, contingent on successful clinical trial outcomes.
Strategic Opportunities
- Combination Therapies: Integrating secukinumab with other immunomodulators could enhance efficacy, especially in resistant cases.
- Biologic Switching: Positioning for patients transitioning from TNF inhibitors or other biologics offers growth avenues.
- Digital Health Integration: Utilization of remote monitoring applications could improve adherence and real-world effectiveness, making secukinumab more attractive to clinicians and payers.
Risks to Growth
- Regulatory delays or adverse safety signals could curtail expansion.
- Emerging biosimilars with competitive pricing could erode market share.
- Policy shifts favoring oral or small-molecule drugs for autoimmune diseases might impair long-term growth prospects.
Key Takeaways
- Clinical Evidence Reinforces Long-Term Effectiveness: Secukinumab demonstrates sustained efficacy with a manageable safety profile across multiple autoimmune indications, backed by extensive phase 3 trial data.
- Strong Market Position with Growth Potential: The drug’s established presence, combined with ongoing clinical trials and expanded indications, poise it for continued revenue expansion.
- Emerging Indications and Global Expansion Critical: New therapeutic applications and increased access in emerging markets could significantly boost sales.
- Competitive Landscape and Pricing Dynamics Remain Central: Maintaining differentiation and negotiating favorable reimbursement will be key to sustaining market share.
- Innovation and Accessibility Are Pivotal: Digital health initiatives, biosimilar developments, and strategic partnerships could shape secukinumab’s future trajectory.
FAQs
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What current indications does secukinumab have worldwide approval for?
Secukinumab is approved for psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis in multiple regions, including the US, EU, and Japan.
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Are there ongoing clinical trials exploring secukinumab's use in new conditions?
Yes, trials are investigating its efficacy in hidradenitis suppurativa, uveitis, and potential autoimmune diseases, which could expand its therapeutic scope.
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How does secukinumab compare to its competitors?
It has a proven efficacy, robust safety profile, and broad approval spectrum, offering distinct advantages over some rivals, such as ixekizumab and brodalumab, primarily in safety and long-term data.
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What are the main challenges facing secukinumab’s market growth?
Biosimilar competition, pricing pressures, regulatory hurdles in certain markets, and potential safety concerns in new indications could impact growth.
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What is the outlook for secukinumab’s market share in the coming years?
With ongoing clinical development, geographic expansion, and potential indication growth, secukinumab is expected to solidify or even increase its market share through 2027, though competitive and policy factors may influence this trajectory.
References
- Novartis. Cosentyx Product Information. 2022.
- IQVIA. Biologics Market Data. 2022.
- European Medicines Agency (EMA). Cosentyx approval details. 2022.
- ClinicalTrials.gov. Secukinumab Trials. 2023.
- Published literature in The Journal of Rheumatology, The Journal of Dermatology, and related peer-reviewed journals.
Note: The above analysis reflects the most current data as of Q1 2023, subject to change with ongoing research, regulatory decisions, and market developments.
