Drugs and patents in ATC class D

Last updated: July 27, 2025

Introduction

The dermatologicals sector, classified under ATC Class D, encompasses pharmaceuticals designed to treat a broad spectrum of skin conditions. This segment has experienced dynamic growth driven by increasing awareness of dermatological diseases, innovations in drug delivery systems, and rising prevalence of skin disorders globally. Understanding the evolving market landscape and patent environment is crucial for pharmaceutical entities, investors, and stakeholders aiming to capitalize on emerging opportunities and mitigate risks associated with intellectual property (IP) strategies.

Market Overview and Trends

Global Market Size and Growth Trajectory

The dermatologicals market was valued at approximately USD 24 billion in 2022 and is projected to grow at a CAGR of around 4.8% from 2023 to 2030([1]). Growth is propelled by factors including demographic shifts towards aging populations, increased incidence of skin conditions such as psoriasis and atopic dermatitis, and heightened consumer demand for cosmetic dermatology products.

Drivers of Market Expansion

Rising Prevalence of Skin Disorders: The World Health Organization reports a surge in dermatological conditions, notably psoriasis, eczema, and acne. Urbanization and pollution exacerbate these conditions, fueling demand for effective treatments ([2]).
Advances in Biologics and Targeted Therapies: The advent of monoclonal antibodies and targeted small molecules has revolutionized management strategies, especially for severe psoriasis and atopic dermatitis. Biologics like ustekinumab and dupilumab demonstrate superior efficacy, fostering sustained market growth([3]).
Increase in Consumer Awareness and Cosmetic Dermatology: Growing interest in aesthetic dermatology, driven by social media influences, propels sales of topical agents, sunscreens, and anti-aging products, which often fall within ATC D classes.
Regulatory Approvals and Patent Expirations: New molecule approvals expand market offerings, while patent expirations open opportunities for generics and biosimilars, impacting competitive dynamics.

Regional Market Dynamics

North America: Dominant due to high disease prevalence, advanced healthcare infrastructure, and robust R&D investments. The U.S. leads in biologics adoption.
Europe: Second-largest market with strong growth in both prescription and OTC dermatological products.
Asia-Pacific: Fastest growth, driven by rising disposable incomes, urbanization, and increased awareness regarding skin health.

Patent Landscape in Dermatologicals

Overview of Patent Trends

The patent environment in the dermatologicals space reflects a shift towards biologics and novel formulations. Between 2010 and 2022, there has been a consistent increase in patent filings and grants, particularly for biologic therapies targeting psoriasis and eczema([4]).

Key Patent Attributes

Innovations in Biological Agents: Patents cover monoclonal antibodies (e.g., dupilumab), fusion proteins, and biosimilars that deliver higher specificity and reduced side effects.
Formulation and Delivery Systems: Patents protecting nano-formulations, transdermal patches, and microemulsions aim to enhance skin penetration and drug stability.
Combination Therapies: Patents increasingly encompass combination drugs that target multiple pathways, offering comprehensive management of complex skin diseases.

Patent Lifecycle and Challenges

Patent Expiry and Generic Entry: Biologic patents typically span 12-15 years, but biosimilar competition begins earlier through pathway-specific patent challenges. Patent cliff risks incentivize innovation but also challenge exclusivity.
Patent Thickets: Companies develop overlapping patent families to extend market exclusivity, complicating generic entry pathways.
Regulatory Hurdles: Biologics require rigorous biosimilarity assessments, impacting patent disputes and licensing strategies.

Major Patent Holders and Innovators

Johnson & Johnson (Janssen): Proprietary biologic agents for psoriasis and eczema.
AbbVie: Key patents for Humira and Skyrizi, focusing on cytokine blockade.
Regeneron and Sanofi: Innovations in biologics and topical formulations.
Emerging Startups: Focus on novel delivery mechanisms, such as microneedles and nanoparticle carriers.

Competitive Landscape

The dermatologicals market exhibits intense competition, with major pharmaceutical companies expanding their portfolios through patent filings and licensing. Patent strategies include:

Filing in Multiple Jurisdictions: To maximize market coverage.
Strategic Litigation and Patent Disputes: To defend exclusivity or challenge competitors’ patents.
Innovation Clusters: Concentration around biologics, localized delivery systems, and combination therapies.

The ongoing patent expirations are fostering an influx of biosimilars and generics, compelling originators to innovate continuously. Companies also explore digital health integration, such as apps for diagnosis and adherence, which, although not patent-rich, complement existing IP strategies.

Impact of Patent Landscape on Market Dynamics

Innovation Incentives: Strong patent protection drives R&D investments, leading to novel therapies.
Market Competition: Patent expirations and biosimilar entrants increase price competition and product accessibility.
Regulatory and IP Challenges: Navigating patent cliffs and potential patent litigations influences strategic decisions and fosters collaborations.
Global Jurisdictional Variance: Differing patent laws and enforcement impact rollout timelines and litigation risks across regions.

Regulatory Environment and IP Policy

Regulatory bodies such as the FDA and EMA influence patent strategies through approval pathways and patent linkage rules. Biologics are subject to complex biosimilar regulations, while small-molecule dermatologicals benefit from straightforward generic approvals.

The Patent Cooperation Treaty (PCT) streamlines international patent applications, but regional differences necessitate localized IP strategies for global market access. Recent reforms aim to balance innovation incentives with public health considerations, influencing future patentability criteria.

Future Outlook

The dermatologicals patent landscape will continue to shift, emphasizing biologic innovation, personalized medicine, and advanced delivery systems. Companies that harness IP effectively and anticipate regulatory changes will sustain competitive advantages. Integration with digital health solutions and sustainability initiatives will further shape market trajectories.

Key Takeaways

The dermatologicals market is expanding driven by demographic trends, technological innovations, and increasing disease burdens.
Patent filings are predominantly centered on biologics, formulations, and combination therapies, with intense competition and strategic patenting shaping the landscape.
Patent expirations introduce biosimilar opportunities, fostering market competition but also prompting continued innovation.
Regulatory frameworks and regional IP laws significantly influence market entry, patent enforcement, and licensing strategies.
Stakeholders should monitor evolving patent environments, optimize IP portfolios, and anticipate regulatory developments to sustain competitiveness.

FAQs

How do patent expirations affect the dermatologicals market?
Patent expirations open the door for biosimilars and generics, increasing competition, reducing prices, and expanding access. However, they also compel original innovators to develop next-generation therapies to maintain market share.
What are the key patent types in dermatologicals?
Core patent types include biologic drug patents, formulation patents, delivery system patents, and method-of-use patents, each protecting different aspects of dermatological products.
Which companies are leading patent filers in dermatological biologics?
Johnson & Johnson, AbbVie, Regeneron, and Sanofi are among the top patent filers focusing on biologic treatments for skin diseases.
What role do biosimilars play in the dermatologicals patent landscape?
Biosimilars challenge patent exclusivity by offering cost-effective alternatives, driving market competition. They are especially prominent in blockbuster biologics like adalimumab (Humira).
How can emerging firms leverage patent strategies in dermatologicals?
Innovative formulation development, strategic patent filings across jurisdictions, and collaborations with patent holders can provide competitive advantages and facilitate market entry.

References

[1] MarketResearchFuture, "Global Dermatologicals Market Analysis," 2022.

[2] WHO, "Global Report on Skin Diseases," 2018.

[3] Novartis, "Advances in Biologic Therapies for Skin Conditions," 2021.

[4] Intellectual Property Office, "Patent Trends in Dermatologic Treatments," 2022.

Drugs in ATC Class D

Subclasses in ATC: D - Dermatologicals

Market Dynamics and Patent Landscape for ATC Class: D - Dermatologicals