Last updated: October 26, 2025
Introduction
Enstilar (calcipotriene and betamethasone dipropionate) is a topical medication used primarily in the treatment of psoriasis. Approved by the U.S. Food and Drug Administration (FDA) in 2015, it combines a vitamin D analog with a potent corticosteroid, offering a dual mechanism of action to reduce inflammation and normalize skin cell growth. As the psoriasis market continues to evolve with innovative therapies and increased awareness, understanding Enstilar’s clinical developments, market share, and future potential becomes vital for stakeholders.
Clinical Trials Update
Ongoing and Recent Clinical Investigations
Since its approval, Enstilar has been evaluated across multiple clinical studies to establish efficacy, safety, and long-term tolerability:
-
Long-term Safety Study (NCT03412473): Conducted over 52 weeks, this observational study assessed the safety profile of Enstilar in patients with chronic plaque psoriasis. Results reaffirmed its favorable safety, with minimal adverse events (AEs), primarily mild local skin reactions.
-
Head-to-Head Comparative Trials: Comparative studies, such as against other topical corticosteroids and vitamin D analogs, confirm that Enstilar offers superior efficacy in achieving clear or almost clear skin with fewer relapses. Notably, a Phase III trial demonstrated that Enstilar significantly improved Psoriasis Area Severity Index (PASI) scores compared to placebo over a 4-week treatment period (p<0.001).
-
Real-World Effectiveness Studies: Post-marketing surveillance and real-world data analyses have been ongoing, documenting outcomes in diverse populations, including pediatric and elderly patients. These studies emphasize its broad applicability and manageable safety profile across age groups.
-
New Formulation Development: Pharmaceutical companies and research bodies are exploring gel and foam formulations of Enstilar, aiming to improve patient compliance, especially among those with difficult-to-treat scalp and thick plaques.
Regulatory and Future Trials
While no major new clinical trials are currently registered globally, ongoing pharmacovigilance efforts continue to monitor adverse effects and rare reactions. Future research directions include:
- Combination Regimens: Trials examining Enstilar in combination with systemic therapies (e.g., biologics) to optimize treatment for moderate-to-severe psoriasis.
- Expanded Indications: Investigating efficacy in other inflammatory dermatological conditions such as eczema or atopic dermatitis.
- Pediatric Studies: Additional pediatric trials are planned to evaluate safety and efficacy in children under 12.
Market Analysis of Enstilar
Current Market Position
Enstilar holds a significant share in the topical psoriasis treatment segment. Its unique combination therapy addresses unmet needs for rapid onset of action and minimal systemic absorption, making it a preferred choice among dermatologists:
-
Market Penetration: As of 2023, Enstilar is available in over 50 countries, including the United States, European Union, and parts of Asia. Its sales are driven principally by North America and Europe, reflecting high adoption rates due to extensive clinical data and positive reimbursement policies.
-
Competitors: Main competitors include other combination products like Taclonex (calcipotriol and betamethasone), as well as standalone therapies such as topical corticosteroids, vitamin D analogs, and emerging biologics. Enstilar differentiates itself through proven faster efficacy and fewer application restrictions.
-### Market Share & Revenue
According to industry reports, Enstilar generated approximately $500 million globally in 2022, with North America accounting for roughly 60% of sales. The drug’s revenues are projected to grow at a Compound Annual Growth Rate (CAGR) of 8-10% over the next five years, driven by:
- Increasing psoriasis prevalence.
- Expanding insurance coverage.
- Growing penetration in emerging markets.
Market Drivers & Barriers
Drivers:
- Rising awareness and early diagnosis.
- Product positioning as a first-line topical therapy for mild-to-moderate psoriasis.
- Favorable safety profile facilitating long-term use.
Barriers:
- High generic competition, especially with the availability of cheaper corticosteroid formulations.
- Prescription hesitations due to potential side effects like skin atrophy and corticosteroid resistance with prolonged use.
- Limited applicability in severe psoriasis requiring systemic therapy.
Market Projection
Future Market Trends
The outlook for Enstilar is optimistic, with several factors likely to influence growth:
-
Expansion into Adjacent Markets: With ongoing research suggesting utility in atopic dermatitis and other inflammatory dermatoses, Enstilar may diversify its indications.
-
Formulation Innovation: New topical formats, such as foam or gel versions, are anticipated to increase adherence, especially among children and those with scalp involvement.
-
Digital and Remote Healthcare Integration: Teledermatology and digital prescription platforms can enhance access, particularly in underserved regions.
Forecasted Sales Trajectory
Projections indicate that global sales could reach $750 million to $1 billion by 2028, driven by:
-
Increased prevalence of psoriasis, currently affecting approximately 2-3% of the global population [1].
-
Greater acceptance of combination topical therapies for controlled disease management.
-
Broader insurance reimbursement policies in emerging markets.
Regional Market Insights
-
North America: Remains the dominant market, accounting for over 60% of global sales, supported by high dermatologist density and robust healthcare infrastructure.
-
Europe: Rapid adoption in EU countries, especially with expanding psoriasis awareness initiatives.
-
Asia-Pacific: Substantial growth potential, fueled by increasing urbanization, rising psoriasis prevalence, and favorable regulatory environments.
Conclusion: Key Takeaways
-
Enstilar continues to demonstrate efficacy and safety in managing plaque psoriasis, supported by ongoing clinical evaluation and real-world data.
-
Market penetration is strong, particularly in North America and Europe, with a favorable growth outlook driven by increasing disease prevalence and formulation innovations.
-
Competitive pressures from generics and alternative therapies remain relevant, but Enstilar's combination approach maintains its clinical appeal.
-
Strategic expansion into new indications and formulations will be critical to sustain growth through 2028.
FAQs
1. What are the primary advantages of Enstilar over other topical psoriasis treatments?
Enstilar offers rapid symptom relief, a favorable safety profile, and lower application frequency compared to traditional corticosteroids, which reduces side effects like skin thinning.
2. Are there any significant safety concerns associated with long-term use of Enstilar?
Long-term studies indicate minimal risks, but potential side effects include skin atrophy, steroid resistance, and hypercalcemia. Monitoring and adherence to recommended durations mitigate these risks.
3. How does Enstilar compare to biologic therapies for psoriasis?
While biologics target systemic inflammatory pathways and are suitable for severe cases, Enstilar provides an effective topical option for mild to moderate psoriasis, with convenience and safety for sustained use.
4. What is the outlook for Enstilar's market growth?
With expanding indications, innovative formulations, and rising psoriasis prevalence worldwide, Enstilar's market is projected to grow steadily, aiming for global revenues approaching $1 billion by 2028.
5. Are there ongoing efforts to expand Enstilar's indications beyond psoriasis?
Yes. Research is underway to evaluate its efficacy in other inflammatory dermatoses, potentially broadening its use and market reach.
References
[1] World Health Organization. Psoriasis Fact Sheet. 2022.
