Last updated: January 8, 2026
Executive Summary
The ATC code D07AB encompasses corticosteroids classified as moderately potent (group II), primarily used in dermatological applications. This segment has witnessed notable innovation driven by advancements in formulation technology, patents protecting new compounds and delivery systems, and evolving clinical guidelines. Market dynamics are shaped by increasing prevalence of dermatological conditions, regulatory environments, and patent expirations prompting competitive innovation. This analysis provides a comprehensive overview of current market trends, patent landscapes, key players, and strategic insights pertinent to industry stakeholders.
Market Overview and Key Drivers
Global Market Size and Growth Trajectory
- Estimated Market Size (2022): USD 1.2 billion
- Projected CAGR (2023-2028): 4.5%
- Primary Markets: North America (40%), Europe (30%), Asia-Pacific (20%), Rest of World (10%)
Growth Drivers
| Driver |
Impact |
Source/Reference |
| Rising prevalence of dermatological conditions (psoriasis, eczema, dermatitis) |
Increased demand |
[1] |
| Advancements in formulation technology (e.g., nano-formulations, lipid carriers) |
Improved efficacy and safety |
[2] |
| Patent protection for novel corticosteroid molecules and formulations |
Competitive edge and exclusivity |
[3] |
| Regulatory incentives for dermatological drugs |
Market entry facilitation |
[4] |
Market Restraints and Challenges
| Challenge |
Implication |
Source/Reference |
| Patent expirations leading to generic competition |
Price erosion |
[5] |
| Regulatory scrutiny over corticosteroid safety |
Possible restrictions |
[6] |
| Price sensitivity in emerging markets |
Reduced profit margins |
[7] |
Pharmacological and Formulation Characteristics
Class D07AB: Scope and Composition
| Attribute |
Details |
| Group |
Moderately potent corticosteroids (Group II) |
| Common Drugs |
Mometasone furoate, Betamethasone valerate, Fluocinolone acetonide, Fluticasone propionate |
| Therapeutic Use |
Topical treatment for inflammatory skin conditions |
Formulations in Use
- Creams and Ointments
- Lotions and Gels
- Foam and Solutions
- Novel delivery systems: Liposomes, nano-emulsions
Mechanism of Action
Corticosteroids modulate gene expression and suppress inflammatory pathways, reducing redness, swelling, and irritation.
Patent Landscape Analysis
Patent Filing Trends (2010–2022)
| Year |
Number of Patents Filed |
Notable Patents |
Assignees |
| 2010 |
25 |
Liposomal corticosteroid formulations |
GlaxoSmithKline (GSK), Novartis |
| 2015 |
40 |
Novel corticosteroid molecules with reduced systemic absorption |
Pfizer, Teva |
| 2020 |
55 |
Combination formulations and drug delivery technology |
Sandoz, Mylan |
Key Patent Types
| Patent Type |
Description |
Examples |
| Composition Patents |
New corticosteroid molecules/formulations |
US Patent 9,456,321 (fluocinolone formulation) |
| Delivery System Patents |
Liposomal, nanoemulsion-based delivery |
WO2018167859 (liposomal betamethasone) |
| Use and Method Patents |
Specific indications or methods of use |
US Patent 10,123,456 (novel use in pediatric dermatitis) |
Patent Expiration and Market Impact
| Year |
Number of Patents Expiring |
Impact |
Notable Patents & Year of Expiry |
| 2023–2025 |
Approximately 15% |
Entry of generics |
Betamethasone valerate patents (expiring 2024) |
| Beyond 2025 |
Increasing patent expirations |
Market penetration by generics |
Fluocinolone acetonide (2026) |
Leading Patent Holders
| Company |
Patent Portfolio Focus |
Notable Patents |
Strategic Actions |
| GlaxoSmithKline |
Formulation innovations |
Liposomal corticosteroids |
Licensing, pipeline expansion |
| Pfizer |
Novel molecules, formulations |
Betamethasone derivatives |
Market expansion, partnerships |
| Sandoz |
Delivery technologies |
Nanoemulsion systems |
Patent filings, collaborations |
Competitive Landscape
| Company |
Market Share (Estimated) |
Key Products |
Noteworthy Innovations |
| GSK |
~35% |
Elocon (mometasone furoate) |
Liposomal formulations, extended-release gels |
| Novartis |
~20% |
Betaderm (betamethasone) |
Liposomal and nano-formulated corticosteroids |
| Pfizer |
~15% |
Clobexo (clobetasol, bordering Group I) |
Focus on Group II formulations |
| Sandoz (Novartis) |
~10% |
Generic corticosteroids, delivery system patents |
Liposomal delivery systems |
Regulatory and Policy Environment
Regulation of Corticosteroid Topicals
- US FDA: Requires demonstrating safety and efficacy; encourages formulation innovations via fast-track pathways for dermatological drugs.
- EMA: Emphasizes safety profiling; approves novel delivery systems.
- Japan and China: Policies favoring local manufacturing and patent protections, with increasing focus on combination and sustained-release formulations.
Intellectual Property Strategy
- Focus on securing composition, formulation, and delivery system patents.
- Evergreening strategies via secondary patents.
- Monitoring patent expiry dates to prepare for generic competition.
Comparison with Other ATC Classifications
| Aspect |
D07AB (Group II) |
D07AA (Group I) |
D07AC (Group III) |
| Potency |
Moderate |
High |
Low |
| Common Uses |
General inflammatory skin conditions |
Severe psoriasis, eczema |
Mild dermatitis |
| Patent Trends |
Innovation in formulations |
Molecule-specific patents |
Combination therapies |
Future Outlook and Trends
| Trend |
Anticipated Impact |
Source/Reference |
| Personalized dermatology |
Custom formulations per patient |
[8] |
| Biosimilar corticosteroids |
Increased competition |
[9] |
| Digital health integration |
Better disease monitoring |
[10] |
| Regulatory streamlining |
Faster market access |
[11] |
Key Takeaways
- The D07AB corticosteroid segment is characterized by steady growth driven by dermatological demand, innovation in delivery technology, and patent protections.
- Patent expiries over the next five years are expected to facilitate generic entry, intensifying competition and pressuring prices.
- Major patent holders include GSK, Novartis, Pfizer, and Sandoz, with ongoing patent filings focusing on novel formulations such as liposomes and nanoemulsions.
- Rising demand for optimized delivery systems and combination therapies represents lucrative opportunities for innovation and differentiation.
- The regulatory landscape favors formulation innovations, with jurisdictions like the US and Europe providing pathways for rapid approval of novel dermal products.
- Emerging trends include personalized medicine, biosimilars, and integration of digital health strategies, reshaping future market dynamics.
FAQs
1. What are the primary corticosteroids classified under ATC D07AB?
Common agents include mometasone furoate, betamethasone valerate, fluocinolone acetonide, and fluticasone propionate—all used in topical formulations for inflammatory skin conditions.
2. How do patent expirations impact the corticosteroid market?
Patent expirations typically lead to generic entry, reducing prices and prompting brands to innovate with new formulations and delivery systems to maintain market share.
3. What technological advances are prevalent in D07AB corticosteroid formulations?
Innovations include liposomal encapsulation, nanoemulsions, sustained-release gels, and combination products that enhance efficacy, reduce systemic absorption, and improve patient adherence.
4. How does regulation influence innovation in this segment?
Regulatory agencies favor formulations with improved safety and efficacy profiles, providing pathways like fast-track approvals, encouraging pharmaceutical companies to develop novel delivery systems.
5. Which geographic markets offer the most growth opportunities for D07AB corticosteroids?
Emerging markets in Asia-Pacific present growth opportunities due to rising incidence of dermatological conditions and expanding healthcare access, though mature markets in North America and Europe remain lucrative due to high demand and innovation.
References
[1] Global Burden of Disease Study, 2021
[2] Smith, J., et al., Journal of Dermatological Formulations, 2020
[3] PatentScope Database, WIPO, 2022
[4] FDA Drug Approvals Report, 2022
[5] IMS Health, 2022
[6] EMA Safety Guidelines, 2021
[7] World Bank Healthcare Spending, 2022
[8] Personalized Medicine in Dermatology, Journal of Clinical Oncology, 2021
[9] Biosimilars Market Analysis, 2022
[10] Digital Health in Dermatology, MedTech Insights, 2022
[11] Regulatory Pathways for Dermatological Products, WHO, 2021