Drugs in ATC Class C05AA

Up to Top Level ATC Classes

Up to C - Cardiovascular system

Up to C05 - VASOPROTECTIVES

Up to C05A - AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE

Drugs in ATC Class: C05AA - Corticosteroids

Tradename	Generic Name
ACETASOL HC	acetic acid, glacial; hydrocortisone
ACETIC ACID W/ HYDROCORTISONE	acetic acid, glacial; hydrocortisone
HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone
ORLEX HC	acetic acid, glacial; hydrocortisone
VOSOL HC	acetic acid, glacial; hydrocortisone

C05AA Market Analysis and Financial Projection

The corticosteroids market, particularly for ATC Class C05AA (topical corticosteroids for hemorrhoids and anal fissures), is shaped by evolving therapeutic demand, patent expirations, and innovations in drug delivery. Here's a detailed analysis:

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Market Dynamics

Growth Drivers

1. Rising Chronic Disease Burden: Chronic conditions like cancer, asthma, and autoimmune disorders are key drivers. For example, the U.S. reported 1.6 million new cancer cases in 2020[1], while over 25 million Americans suffer from asthma, necessitating corticosteroid therapies[7].
2. Hemorrhoid Prevalence: The global hemorrhoid treatment market, a subset of C05AA, is projected to reach $1.74 billion by 2032 (CAGR 6.1%)[9]. Lifestyle factors, aging populations, and increasing obesity rates contribute to this growth[13].
3. Expanding OTC Access: Drugstores and retail pharmacies dominate distribution, as patients prefer self-treatment for hemorrhoids. Over-the-counter creams and ointments (e.g., hydrocortisone, dexamethasone) accounted for a $1.03 billion market in 2023[9].

Regional Landscape

• North America dominates the global corticosteroids market (32.6% share in 2023)[15], driven by high healthcare spending and advanced infrastructure.
• Asia-Pacific exhibits the fastest growth (CAGR 6.2% for corticosteroids[5]), fueled by rising healthcare awareness and aging demographics[13].

Key Players

• Corticosteroids Market: Pfizer, Novartis, GSK, Merck, AstraZeneca, and Horizon Therapeutics (patent holder for Procysbi)[5][7].
• Hemorrhoid Treatments: Haleon Group, Bayer AG, and Church & Dwight lead with products like Anusol and Preparation H[9].

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Patent Landscape

Key Innovations

1. Drug Delivery Systems:

   • Iontophoretic Delivery: EyeGate Pharmaceuticals patented iontophoretic delivery of dexamethasone phosphate for ocular inflammation, showcasing cross-therapeutic applications[8].
   • Combination Therapies: Patents like US20090136430A1 combine antihistamines with corticosteroids for enhanced efficacy in dermatologic conditions[14].

2. Formulation Patents:

   • US3158628A covers 21-carbethoxylates of prednisone/prednisolone, improving solubility and bioavailability[2].
   • Procysbi (cysteamine bitartrate) for cystinosis faces patent expiration in 2027, opening generic competition[4].

Patent Analytics Trends

• The patent analytics market, critical for tracking corticosteroid IP, is projected to grow at 14% CAGR to $3.4 billion by 2032[3]. Tools leveraging AI/ML now identify patent trends and potential infringements faster[3].

Regulatory Developments

• The FDA’s 2023 guidance emphasizes in vivo bioequivalence studies for topical corticosteroids, ensuring generic drug safety and efficacy[10].

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Competitive Pressures

• Generic Entry: Over 59 drug patents expire by 2027[4], including therapies for prostate cancer and diabetes, which may shift focus to hemorrhoid treatment generics.
• Technological Advancements: Minimally invasive treatments (e.g., rubber band ligation) and biodegradable formulations are gaining traction[13].

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Strategic Outlook

Factor	Impact
Chronic Disease Rise	Sustained demand for anti-inflammatory corticosteroids[1][15].
OTC Expansion	Retail pharmacies dominate distribution, but online channels grow rapidly[9].
Patent Cliffs	Opportunities for generics post-2027[4].
R&D Focus	Novel delivery systems (e.g., nanoemulsions) and combination therapies[8][14].

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Blockquote Highlight

"The use of artificial intelligence (AI) and machine learning (ML) is revolutionizing patent analytics. AI tools can analyze vast patent databases faster, providing insights into trends and potential infringements."
— Patent Analytics Market Report[3].

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This market balances growth from chronic disease management with challenges from patent expirations and regulatory scrutiny. Companies investing in advanced formulations and strategic IP management are likely to lead future innovation.

References

1. https://www.gminsights.com/industry-analysis/corticosteroids-market
2. https://patents.google.com/patent/US3158628A/en
3. https://www.alliedmarketresearch.com/patent-analytics-market-A14628
4. https://www.greyb.com/blog/drug-patents-expiring-2027/
5. https://www.thebusinessresearchcompany.com/report/corticosteroid-global-market-report
6. https://atcddd.fhi.no/atc_ddd_index/?code=C05AA&showdescription=yes
7. https://www.mordorintelligence.com/industry-reports/corticosteroids
8. https://kiorapharma.com/eyegate-awarded-new-u-s-patent-for-iontophoretic-delivery-of-corticosteroids-to-the-eye/
9. https://www.fortunebusinessinsights.com/hemorrhoid-treatment-market-110985
10. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/topical-dermatologic-corticosteroids-in-vivo-bioequivalence-0
11. https://www.globenewswire.com/news-release/2021/05/13/2228869/28124/en/Global-Corticosteroids-Market-Report-2021-Featuring-ajor-Players-Sumitomo-Pfizer-Novartis-Merck-Sanofi-Johnson-and-Johnson-GSK-AstraZeneca-Cipla-and-LEO-Pharma.html
12. https://patents.google.com/patent/US20040167159A1/en
13. https://straitsresearch.com/report/hemorrhoids-treatment-market
14. https://patents.google.com/patent/US20090136430A1/en
15. https://market.us/report/corticosteroids-market/
16. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0295587
17. https://arxiv.org/abs/2102.04552