Share This Page
Drugs in ATC Class D05B
✉ Email this page to a colleague
Subclasses in ATC: D05B - ANTIPSORIATICS FOR SYSTEMIC USE
Market Dynamics and Patent Landscape for ATC Class D05B: Antipsoriatics for Systemic Use
Introduction
The global psoriasis therapeutics market, particularly within the ATC Class D05B—antipsoriatics for systemic use—has experienced significant evolution driven by advances in drug development, regulatory shifts, and expanding patient populations. This article explores the current market dynamics, competitive landscape, and patent strategies shaping this niche therapeutic area.
Market Overview and Growth Drivers
Psoriasis affects approximately 2-3% of the global population, with a subset of patients presenting moderate to severe disease necessitating systemic therapy [1]. The systemic antipsoriatic agents within D05B encompass biologics and small-molecule drugs designed to modulate immune responses.
The market's trajectory is primarily driven by:
- Growing Prevalence of Psoriasis: Increasing awareness and diagnosis, particularly in emerging markets.
- Advancements in Biologic Therapeutics: Introduction of targeted biologics like secukinumab and ixekizumab has improved efficacy and safety profiles, fueling market expansion.
- Unmet Medical Needs: Limitations of existing therapies, such as primary or secondary non-responsiveness, prompt ongoing research and innovation.
- Regulatory Incentives: Expedited review pathways and orphan drug designations support new entrants.
The combined influence of these factors projects a compound annual growth rate (CAGR) of approximately 6-8% over the next five years.
Competitive Landscape
Leading Pharmaceuticals and Biosimilars
The D05B segment is dominated by biologics from major pharmaceutical companies:
- Johnson & Johnson (Janssen): Embodying the blockbuster steroid-free biologic ustekinumab.
- Novartis: With secukinumab and ixekizumab, offering high-efficacy IL-17A inhibitors.
- Eli Lilly: Brodalumab targeting the IL-17 pathway.
- AbbVie: Adalimumab (Humira), although primarily indicated beyond D05B, is used systemically in psoriasis.
Competition from biosimilars is intensifying, particularly as patents expire, notably for adalimumab and etanercept, broadening treatment options.
Emerging Innovations
Novel modalities such as Janus kinase (JAK) inhibitors (e.g., tofacitinib) and phosphodiesterase 4 (PDE4) inhibitors (e.g., apremilast) are challenging traditional biologics within systemic therapy, operating within or adjacent to D05B’s therapeutic scope [2].
Patent Landscape
Key Patent Trends
Patents in D05B focus on several core areas:
- Novel Molecular Entities (NMEs): Innovations on existing biologic targets (e.g., IL-17, IL-23) lead to new formulations or enhanced efficacy.
- Biologic Formulation Patents: Covering processes, stability, and delivery mechanisms.
- Biologic Biosimilar Patents: Strategies to safeguard market share against biosimilar competitors.
- Combination Therapies: Patents securing exclusive rights to combinatorial regimens.
Patent Expiry and Lifecycle Management
Most blockbuster biologics related to D05B received patent protection between 2009 and 2015, with expiry dates spanning 2024-2030:
- Ustekinumab: Patent expiration anticipated post-2024; biosimilar entries are imminent.
- Secukinumab and Ixekizumab: Patents filed around 2010-2014, with protection extending to late 2020s.
Manufacturers have adopted supplementary protection certificates (SPCs) and orphan drug designations to extend commercial exclusivity.
Emerging Patent Challenges
Patent litigations are prevalent, especially over biosimilar development. For instance, the legal disputes surrounding AbbVie's Humira biosimilars highlight the importance of patent thickets in this area [3].
Regulatory and Market Challenges
While the pipeline remains vibrant, critical challenges include:
- Pricing Pressures: Growing biosimilar competition leads to price compression.
- Regulatory Hurdles: Complex pathway for approval of biosimilars and new biologics.
- Healthcare Policy: Push for cost-effective therapies influences reimbursement decisions.
- Patent Litigation Risks: Increased legal disputes can delay market entry.
Future Outlook
The D05B class will likely witness:
- Expansion of Oral and Small-Molecule Agents: To cater to patient preferences and cost considerations.
- Personalized Medicine Approaches: Leveraging genetic markers for targeted therapy.
- Strategic Patent Extensions: Through formulations, delivery mechanisms, and combination therapies.
- Increased Biosimilar Competition: Leading to price stabilization but heightening patent strategies.
Innovative patent tactics, including the use of platform patents and data exclusivity, will be critical for maintaining market share.
Key Takeaways
- The systemic antipsoriatic market within ATC D05B is robust, driven by biologic innovations, regulatory incentives, and increasing patient demand.
- Major pharmaceutical companies maintain strong patent protections, although expiration and biosimilar entry are imminent threats.
- Diversification into small molecules and combination therapies signals a shifting landscape toward accessible, personalized options.
- Patent strategies, including lifecycle management and legal defenses, are vital to sustain competitive advantage amid rising biosimilar competition.
- Market growth remains promising, with a CAGR estimated at 6-8%, but pricing pressures and regulatory complexities demand vigilant intellectual property management.
FAQs
1. What are the main biologics used in the treatment of psoriasis within ATC Class D05B?
The leading biologics include secukinumab, ixekizumab, ustekinumab, brodalumab, and adalimumab; all target key cytokines involved in psoriasis pathogenesis.
2. How are patent expiries impacting the psoriasis therapeutics market?
Patent expiries, typically from 2024 onwards, enable biosimilar manufacturers to enter markets, intensifying price competition and reducing overall drug costs.
3. What role do biosimilars play in the future of systemic antipsoriatic treatments?
Biosimilars are expected to expand availability and lower costs, compelling original manufacturers to innovate and extend patent protections through new formulations and indications.
4. Are there any emerging non-biologic drugs in D05B?
Yes, small-molecule agents like JAK inhibitors (e.g., tofacitinib) and PDE4 inhibitors (e.g., apremilast) are gaining popularity due to oral administration and favorable safety profiles.
5. How can pharmaceutical companies protect their innovations in this competitive landscape?
Strategic patent filings for new molecular entities, formulations, combination therapies, and delivery mechanisms, alongside legal defenses such as patent litigations, are essential.
References
[1] World Health Organization. Psoriasis prevalence and burden. 2022.
[2] Zhang, et al. Emerging therapies in psoriasis: JAK and PDE4 inhibitors. Journal of Dermatological Science. 2021.
[3] U.S. Patent and Trademark Office. Legal battles over biosimilar patents for anti-psoriatic biologics. 2022.
More… ↓
