Drugs and patents in ATC class D

Last updated: December 26, 2025

Summary

The dermatologicals segment, classified under ATC Class D, has experienced rapid evolution driven by rising prevalence of skin-related conditions, technological advances in drug delivery, and expanding market access. This analysis provides a comprehensive review of market trends, competitive landscape, innovative pipeline developments, and patent filings, with an emphasis on how these factors influence industry competitiveness and R&D directions.

Market Overview and Key Drivers

Market Size and Growth Trends

Parameter	2021 Data	Projection (2026)	CAGR (2021-2026)	Notes
Global dermatologicals market value	~$23.5 billion	~$32.8 billion	7.0%	Driven by aging populations and rising skin conditions
Key regions	North America (35%), Europe (25%), Asia-Pacific (25%), Rest of World (15%)	–	–	APAC's CAGR exceeds 8%, reflecting emerging markets

Driving Factors

Increasing Incidence of Skin Disorders: Conditions like psoriasis, acne, dermatitis, and skin infections surging globally.
Aging Population: Elderly demographics facing chronic dermatological conditions; projected to grow by 1.5% annually.
Technological Innovations: Biologics and targeted topical therapies expanding treatment options.
Consumer Preference: Growth in OTC products, reflecting greater demand for skincare and allergy remedies.
Regulatory Environment: Streamlining approval processes in major markets accelerates drug launches.

Market Challenges

Pricing and Reimbursement Pressures: Especially in mature markets leading to reduced margins.
Patent Expirations: Loss of market exclusivity for key brands necessitating continual innovation.
Stringent Regulatory Standards: Particularly related to biologics and topical formulations.
Competition from Biosimilars and Generics

ATC Class D - Dermatologicals: Pharmacological Spectrum

Key Subgroups and Market Shares

Subgroup	Therapeutic Focus	Market Share (2021)	Leading Drugs	Comments
D01 - Antifungals for topical use	Fungal infections	35%	Clotrimazole, terbinafine	Dominates OTC sales
D03 - Eczematous dermatitis and other skin VD	Eczema, psoriasis	25%	Hydrocortisone, tacrolimus	High prescription volume
D02 - Demulcents and protectives	Skin barrier repair	10%	Petrolatum, zinc oxide	Niche but growing segment
D04 - Anti-acne preparations	Acne vulgaris	15%	Adapalene, benzoyl peroxide	Expanding with combination therapies
Others	Various	15%	Including corticosteroid combinations	Fragmented but essential niche

Competitive Landscape

Major Players and Market Shares (2021-2022)

Company	Estimated Market Share	Key Products	Strategy Highlights
Johnson & Johnson	15%	Benadryl, Duac	Strong R&D pipeline; biologics & OTC dominance
Novartis	12%	Topicals, biologics	Focused on psoriasis biologics (e.g., Cosentyx)
AbbVie	10%	Humira, Skyrizi	Leadership in biologic therapies
GSK	8%	Hydrocortisone-based products	Expanding steroid-free non-prescription segment
Others	Remaining	Varied	Growing presence of regional firms

Emerging Competitors and Innovators

Biotech firms developing targeted biologics for psoriasis and atopic dermatitis.
OTC brands leveraging digital marketing and consumer engagement.
Generic manufacturers expanding into biosimilar dermatologics.

Patent Landscape Analysis

Patent Filing Trends (2010–2022)

Year	Number of Patent Applications (D Class)	Focus Areas	Notable Patent Holders
2010-2014	2,500	Formulations, delivery systems	Novartis, Johnson & Johnson
2015-2018	3,200	Biologics, combination therapies	AbbVie, GSK, Pfizer
2019-2022	4,100	Targeted biologics, anti-inflammatory agents	Multiple biotech startups, big pharma
Trend	Increasing patent filings indicating high innovation activity

Major Patent Filings: Innovation Focus

Topical Delivery Technologies: Nanotechnology-enhanced formulations to improve skin penetration.
Biologic Agents: Monoclonal antibodies targeting cytokines (e.g., IL-17, IL-23 inhibitors) for psoriasis.
Combination Therapeutics: Synergistic formulations for acne and dermatitis.
Formulation Stability: Waterless or microemulsion-based systems to extend shelf life.

Patent Expiry Risks & Opportunities

Patent Expiry Year	Major Patents Expiring	Implications	Opportunity Areas
2024-2027	Topical corticosteroids, biologics	Increased generic/biosimilar entry	Market share erosion, need for innovation
2028+	Demulcent formulations, OTC brands	Market saturation	Development of next-gen formulations

Comparison of Key Innovation Trends

Aspect	Traditional Approaches	Current Innovations	Future Outlook
Delivery Systems	Standard creams, ointments	Nanocarriers, liposomes	Enhanced penetration & sustained release
Biologics	Limited	Monoclonal antibodies, fusion proteins	Personalized medicine, biosimilars
Formulations	Steroid-based, antifungals	Non-steroid anti-inflammatory agents	Reduced side effects, improved compliance
Patient Engagement	Prescription & OTC	Digital apps, teledermatology	Increased self-management

Regulatory and Policy Environment

Global Approaches

FDA (U.S.): Encourages biosimilars & innovative biologic approvals; recent focus on biologic reformulations.
EMA (EU): Streamlined procedures for biosimilars; rigorous safety monitoring.
China NMPA: Growing approval of innovative dermatological biologics, fostering domestic R&D.
Japan PMDA: Emphasizes biodegradable and waterless formulations.

Impact on Patent Strategies

Patents increasingly include method-of-use claims, formulation specifics, delivery systems, and biologic targets.
Patent thickets employed to extend exclusivity, prompting innovation in formulations.
Open licensing and patent pools are emerging to improve access.

FAQs

1. Which subgroups within ATC D class are experiencing the fastest growth?
Eczematous dermatitis (D03) and anti-acne preparations (D04) are among the fastest-growing segments, driven by rising skin conditions and expanding OTC markets.

2. What are the current key patent challenges facing dermatological innovators?
Patent expirations, patent thickets, and evolving biologic patent landscapes challenge innovators to develop novel formulations, delivery methods, and biologic targets.

3. How is biologic innovation impacting the dermatologicals market?
Biologics targeting cytokines such as IL-17 and IL-23 have revolutionized psoriasis treatment. Patent protections around these biologics sustain high prices, but biosimilars threaten future market share.

4. What role do generic and biosimilar products play in market dynamics?
They increase affordability and market competition, leading innovator firms to focus on orphan indications, personalized therapies, and combination treatments.

5. How are regulatory policies shaping patent strategies in dermatologicals?
Regulations favoring expedited approvals, biosimilar differentiation, and patent term extensions incentivize firms to file broad longitudinal and method-specific patents.

Key Takeaways

Market expansion is driven by demographic shifts, lifestyle factors, and technological innovations, with Asia-Pacific leading significant growth.
Patent filings are increasingly focused on biologics, delivery systems, and combination therapies, reflecting R&D intensity.
Patent expiries from 2024 onwards will intensify competition, necessitating continuous innovation.
Emerging trends include nanotechnology, biologics, and personalized medicine, shaping future treatment paradigms.
Regulatory landscapes are adapting to foster innovation while balancing access, influencing patent and market strategies.

References

[1] IQVIA Institute. (2022). The Global Dermatology Market.
[2] Global Data, MarketShare, 2022.
[3] European Medicines Agency. (2022). Biologicals and Biosimilars reports.
[4] U.S. FDA. (2022). Biologic Product Approvals and Trends.
[5] PatentScope. (2022). Patent Landscape Reports — Dermatologicals.

End of Document

Drugs in ATC Class D

Subclasses in ATC: D - Dermatologicals

Market Dynamics and Patent Landscape for ATC Class D - Dermatologicals