Drugs in ATC Class H02

Up to Top Level ATC Classes

Up to H - Systemic hormonal preparations, excluding sex hormones and insulins

Subclasses in ATC: H02 - CORTICOSTEROIDS FOR SYSTEMIC USE

H02A - CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN

H02C - ANTIADRENAL PREPARATIONS

H02 Market Analysis and Financial Projection

The corticosteroids market for systemic use (ATC Class H02) is experiencing significant growth driven by rising chronic disease prevalence, pharmaceutical innovation, and expanding therapeutic applications. Below is an analysis of market dynamics and patent trends shaping this sector:

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Market Overview

The global corticosteroids market reached $5.2 billion in 2023, with projections to grow at a 7.5% CAGR through 2032[1][6]. Systemic corticosteroids under ATC Class H02—including glucocorticoids (e.g., prednisone, dexamethasone) and mineralocorticoids (e.g., fludrocortisone)—account for a substantial share, particularly in hospital and emergency care settings.

Growth Drivers

1. Chronic Disease Burden: Over 95% of adults aged 60+ have at least one chronic condition, necessitating corticosteroids for managing arthritis, autoimmune disorders, and COPD[18].
2. Cancer Prevalence: With 1.6 million new U.S. cancer cases reported in 2020, corticosteroids are critical for managing chemotherapy-related inflammation[1].
3. COVID-19 Impact: Systemic corticosteroids gained traction as adjunctive therapy for severe COVID-19, contributing to a 2% market surge in 2020[6].

Market Segmentation

Category	Dominant Segment	2023 Revenue	Key Insight
Product	Glucocorticoids	$3.4 billion (65.3%)	Widely used for anti-inflammatory effects in rheumatoid arthritis and lupus[18].
Application	Rheumatology Indications	Leading Share	Driven by osteoarthritis and autoimmune disorder treatments[3][15].
Distribution	Hospital Pharmacies	$2.5 billion (52.4%)	Preferred for acute care and severe condition management[1][18].

North America led the market with 32.6% revenue share in 2023 due to high healthcare expenditure and advanced drug approval pathways[1][18].

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Patent Landscape

Recent patents highlight innovations in safety, efficacy, and delivery systems for systemic corticosteroids:

Key Patent Trends

1. Formulation Advancements:

   • US10478502B2: Topical formulations with reduced corticosteroid concentrations (0.01% vs. 0.05% in prior art) while maintaining efficacy for conditions like psoriasis[2][11].
   • US8828440B2: Microparticle-based injectable corticosteroids for sustained joint pain relief in osteoarthritis[3].

2. Pediatric and Geriatric Focus: Patents like US12076403B2 emphasize age-specific formulations to minimize systemic absorption risks[10].

3. Oral Delivery Innovations:

   • US8771729B2/10632069B2: Orally disintegrating tablets improve bioavailability for autoimmune and respiratory conditions[15][16].

Patent Expirations (2025)

Drug	Company	Impact
Stelara	Johnson & Johnson	Biosimilars to target Crohn’s and psoriasis markets[17].
Jardiance	Boehringer Ingelheim	Generic competition in SGLT2 inhibitor space[17].

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Competitive and Regulatory Dynamics

• Major Players: Pfizer, Novartis, Johnson & Johnson, and AstraZeneca dominate, focusing on biosimilars and targeted therapies[6][18].
• Sustainability Trends: Companies prioritize biodegradable formulations and reduced environmental impact[1][18].
• Off-Label Use Risks: 11.8% of U.S. ARTI patients received unnecessary systemic steroids in 2016, raising safety concerns[8].

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Future Outlook

1. Biosimilars: Patent expirations will drive a $7.24 billion market by 2029, with biosimilars capturing 15-20% cost savings[4][17].
2. Delivery Systems: Inhalers and transdermal patches aim to reduce systemic side effects while enhancing compliance[1][2].
3. R&D Priorities: Focus on immunomodulatory therapies and pediatric formulations to address unmet needs in autoimmune and rare diseases[4][10].

Highlight: "Systemic steroids’ role in COVID-19 underscored their versatility, but judicious use remains critical to avoid adverse effects." [6][8]

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Challenges

• Regulatory Scrutiny: Increased oversight of off-label prescriptions for respiratory infections[8].
• Generic Competition: Price erosion expected post-2025 as key patents lapse[17].

This evolving landscape positions systemic corticosteroids as both a therapeutic cornerstone and a focal point for innovation in drug safety and delivery.

References

1. https://www.gminsights.com/industry-analysis/corticosteroids-market
2. https://patents.google.com/patent/US10478502B2/en
3. https://patents.google.com/patent/US8828440B2/en
4. https://www.openpr.com/news/3878024/corticosteroids-market-outlook-2025-2034-key-trends-growth
5. https://www.atccode.com/H02
6. 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
7. https://www.drugpatentwatch.com/p/generic/hydrocortisone+valerate
8. https://journals.plos.org/plosmedicine/article?id=10.1371%2Fjournal.pmed.1003058
9. https://en.wikipedia.org/wiki/ATC_code_H02
10. https://patents.google.com/patent/US12076403B2/en
11. https://patents.google.com/patent/US11957753B2/en
12. https://go.drugbank.com/drugs/DB00959
13. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2020/may-belgian-reg-med-best.pdf
14. https://www.ic.gc.ca/opic-cipo/cpd/eng/patent/3242384/summary.html?query=Michael+Comerford&type=basic_search
15. https://patents.google.com/patent/US8771729B2/en
16. https://patents.google.com/patent/US10632069B2/en
17. https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html
18. https://market.us/report/corticosteroids-market/