Last updated: February 19, 2026
What is the current status of secukinumab in clinical trials?
Secukinumab, marketed as Cosentyx by Novartis, is an IL-17A inhibitor approved for psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. It has completed multiple Phase 3 trials demonstrating efficacy and safety. No ongoing Phase 3 trials are listed for additional indications. Novartis registered progress in Phase 4 post-approval safety and real-world effectiveness studies. Recent developments include trials for hidradenitis suppurativa and potential new indications.
Recent Clinical Trial Highlights
| Study Name |
Phase |
Purpose |
Completion Date |
Results Summary |
| SUNSHINE |
Phase 3 |
Hidradenitis suppurativa |
Ongoing |
Pending data |
| NAVIGATE |
Phase 3 |
Psoriatic arthritis with active psoriatic skin disease |
Completed |
Demonstrated significant ACR20 response over placebo |
| FUTURE |
Phase 3 |
Generalized pustular psoriasis |
Ongoing |
Data anticipated in 2023 |
Key Updates
- Hidradenitis suppurativa (HS). Novartis is investigating secukinumab's effectiveness for HS, with Phase 3 trials underway. Initial data is expected late 2023.
- COVID-19 considerations. Safety profiles remain consistent, with no significant increase in adverse events in recent post-market studies.
- Biosimilar development. No biosimilars have reached late-stage development, focusing instead on expanding indications.
How does secukinumab perform in clinical efficacy compared to alternatives?
Secukinumab shows competitive efficacy against other IL-17 inhibitors such as ixekizumab and brodalumab, and TNF inhibitors like adalimumab.
Efficacy in Psoriasis
| Endpoint |
Secukinumab (150 mg) |
Ustekinumab |
Adalimumab |
| PASI 75 |
77-83% at Week 12 |
66-75% |
58-66% |
| PASI 90 |
66-75% |
50-66% |
36-50% |
(PASI = Psoriasis Area and Severity Index)
Efficacy in Psoriatic Arthritis
| Endpoint |
Secukinumab (150 mg) |
Etanercept |
Adalimumab |
| ACR20 at Week 24 |
61-62% |
54-60% |
58-60% |
| Dactylitis/enthesitis |
Significant reduction |
Similar |
Similar |
What is the current and projected market size for secukinumab?
The global secukinumab market was valued at approximately USD 4.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 9.1% from 2023 to 2030, driven by expanding indications, increased treatment rates, and geographies.
Market Factors
- Key markets: North America (~USD 2 billion in 2022), Europe (~USD 1 billion). Asia-Pacific shows rapid growth.
- Drivers: Rising prevalence of psoriasis (125 million globally), increased adoption of biologics.
- Challenges: High drug costs, biosimilar entry predicted post-2025, patent expirations in 2027.
Competitive Landscape
| Competitor |
Product |
Market share (2022) |
Key indications |
| Novartis |
Cosentyx |
~23% |
Psoriasis, psoriatic arthritis, ankylosing spondylitis |
| Eli Lilly |
Taltz |
~20% |
Psoriasis, psoriatic arthritis |
| UCB |
Cimzia |
~10% |
Crohn’s, rheumatoid arthritis |
How will market dynamics evolve through 2030?
Projection models forecast:
- Market expansion to USD 8 billion by 2030, with growth driven predominantly by clinical adoption for hidradenitis suppurativa and ankylosing spondylitis.
- Indication diversification. Secukinumab may secure approvals for ulcerative colitis and Crohn’s disease, adding USD 1.2 billion potential revenue.
- Pricing pressures and biosimilar competition will challenge pricing strategies starting 2027.
Regional Growth Breakdown
| Region |
CAGR (2023-2030) |
Key Factors |
Risks |
| North America |
8.5% |
High adoption |
Patent cliffs |
| Europe |
9.3% |
Reimbursement policies |
Biosimilar competition |
| Asia-Pacific |
12.1% |
Growing disease prevalence |
Regulatory delays |
What are key future opportunities and challenges?
Opportunities
- Secukinumab's potential in hidradenitis suppurativa, with Phase 3 trials generating data in 2023.
- Expansion into inflammatory bowel disease, with early-phase trials initiated.
- Increasing use in juvenile populations upon regulatory approval.
Challenges
- Biosimilar competition from late 2020s may erode market share.
- Patent expiry scenario could reduce sales by up to 40% in affected regions.
- Pricing negotiations and healthcare reforms in major markets could impact margins.
Key Takeaways
- Secukinumab remains a top-performing IL-17A inhibitor with robust efficacy and safety demonstrated across multiple indications.
- Clinical trials for hidradenitis suppurativa and other inflammatory diseases are ongoing, with key data expected by late 2023.
- The market is projected to nearly double by 2030, driven by indication expansion and unmet needs.
- Competition from biosimilars and pricing pressures will influence sales trajectory post-2027.
- Regional growth is strongest in Asia-Pacific, aligned with higher disease prevalence and cheaper reimbursements over time.
FAQs
Q1: When will secukinumab be available for hidradenitis suppurativa?
A1: Phase 3 trials are ongoing, with results anticipated in late 2023, potentially leading to regulatory submissions in 2024.
Q2: Are biosimilars a threat to secukinumab?
A2: Yes. Biosimilars are in late-stage development and may enter markets around 2027, exerting downward pressure on prices.
Q3: How does secukinumab compare to other IL-17 inhibitors?
A3: It shows similar efficacy and safety profiles to ixekizumab and brodalumab, with some efficacy advantages in certain patient subsets.
Q4: What regions will drive the most growth?
A4: North America and Europe will continue to lead, with Asia-Pacific emerging rapidly due to higher disease prevalence.
Q5: Will secukinumab get new indications?
A5: Yes. Trials are underway for ulcerative colitis, Crohn’s disease, and hidradenitis suppurativa, which could expand its clinical use.
References:
[1] Novartis. (2022). Cosentyx (secukinumab) Clinicaltrials.gov Database. Retrieved from https://clinicaltrials.gov/
[2] IQVIA. (2022). Global biologics market analysis.
[3] World Health Organization. (2023). Global psoriasis prevalence.
[4] Market Research Future. (2023). Biologics market forecast.
[5] European Medicines Agency. (2023). Approved indications for secukinumab.
