The global corticosteroids market, valued at $4.3–$5.2 billion in 2023, is projected to reach $6.9–$8.2 billion by 2033, growing at a 4.9–7.5% CAGR[1][6][18]. This growth is driven by rising chronic inflammatory diseases, an aging population, and advancements in drug delivery technologies. Below, we analyze the market dynamics and patent landscape shaping this critical pharmaceutical segment.
Market Dynamics
Growth Drivers
-
Chronic Disease Burden:
- Over 25 million Americans suffer from asthma[1], while autoimmune conditions like rheumatoid arthritis and dermatitis drive demand for corticosteroids as first-line anti-inflammatory therapies.
- COVID-19 increased usage for managing cytokine storms, reinforcing corticosteroids’ role in critical care[3][18].
-
Aging Population:
- The global population aged 65+ (727 million in 2020) is expected to double by 2050, heightening susceptibility to chronic diseases[1][6].
-
Innovation in Delivery Systems:
- Technologies like iontophoresis (e.g., EyeGate’s dexamethasone phosphate delivery)[13] and sustained-release formulations (e.g., Sorrento’s intra-articular injections)[14] improve efficacy while reducing systemic side effects.
- Combination therapies with biologics or antihistamines enhance treatment outcomes[16].
-
Regional Expansion:
- North America dominates (32.6% market share)[1], driven by high healthcare spending and respiratory disease prevalence.
- Asia-Pacific is the fastest-growing region due to rising healthcare investments and government initiatives[1][12].
Market Segmentation
| Category |
Leading Segments |
Key Statistics |
| Product Type |
Glucocorticoids (85% share) vs. Mineralocorticoids |
Glucocorticoids projected to hit $8.9B by 2032[6]. |
| Route of Admin. |
Topical (49% share)[3], inhalers, oral |
Topical demand driven by skin allergies (projected $3B by 2032)[6]. |
| Application |
Rheumatology (35%), dermatology (fastest-growing at 5.1% CAGR)[3][12] |
Dermatology growth fueled by eczema, psoriasis, and acne[6]. |
| Distribution |
Hospital pharmacies ($2.5B in 2023)[6] |
Retail and online pharmacies gaining traction post-pandemic. |
Patent Landscape
Key Challenges & Strategies
-
Patent Cliffs:
- Olux (clobetasol) lost exclusivity in 2016, enabling 35 generic entrants[7].
- Entresto (Novartis) faces generics in 2025, risking $7.8B in annual sales[20].
- Zytiga’s method-of-use patent (co-administration with prednisone) extended protection to 2027, delaying generics[4].
-
Life-Cycle Management:
- Formulation Patents: Sorrento’s sustained-release dexamethasone (US12016867B2) and Willow Biosciences’ cost-reduction BioOxi process[14][19].
- Delivery Mechanisms: EyeGate’s iontophoretic patent (US12016867B2)[13] and mucoadhesive patches for targeted release[6].
-
Litigation & Delays:
- Branded drugmakers use 30-month stays and method-of-use patents to block generics. For example, Zytiga’s litigation delayed generics until 2020[4][8].
- Biosimilars face slower adoption due to complex trials and patent thickets[8].
Emerging Trends
-
Precision Medicine:
- Ligand class analysis enables engineering of muscle-sparing corticosteroids (e.g., SR11466, SR16024) to reduce bone loss[5].
- AI and machine learning optimize drug design for reduced side effects[5].
-
Biosimilar Competition:
- Post-2025, biologics like Xolair and Cosentyx will face biosimilar pressure, though slower than small molecules due to regulatory hurdles[8][20].
-
Cost Pressures:
- Willow’s BioOxi process aims to cut production costs by 30–50%, addressing supply-chain vulnerabilities[19].
Future Outlook
The corticosteroids market will prioritize targeted delivery, combination therapies, and patent resilience to offset generic erosion. Innovations in biologics and digital health integration (e.g., connected inhalers) will further differentiate products. However, pricing pressures and regulatory demands for safer formulations remain critical challenges[3][6][14].
“The greatest unmet need is improving glucocorticoids to selectively target inflammation without systemic side effects.”
— Kendall Nettles, Scripps Research[5]
As chronic diseases rise globally, the sector’s ability to balance innovation with accessibility will determine its long-term sustainability.
References
- https://market.us/report/corticosteroids-market/
- https://pubmed.ncbi.nlm.nih.gov/19075977/
- https://www.globenewswire.com/news-release/2024/04/18/2865596/0/en/Corticosteroids-Market-Size-Expected-to-Reach-USD-6-91-Bn-by-2033.html
- https://www.ajmc.com/view/a636-article
- https://wertheim.scripps.ufl.edu/2021/02/02/toward-safer-steroids/
- https://www.gminsights.com/industry-analysis/corticosteroids-market
- https://pharsight.greyb.com/drug/olux-patent-expiration
- https://www.ajmc.com/view/patent-litigation-impacts-on-us-biosimilar-market-entry
- https://pubmed.ncbi.nlm.nih.gov/39219095/
- https://www.uspharmacist.com/article/drug-patent-expirations-and-the-patent-cliff
- https://www.openpr.com/news/3878024/corticosteroids-market-outlook-2025-2034-key-trends-growth
- https://www.giiresearch.com/report/tsci1657618-corticosteroids-market-global-industry-size-share.html
- https://ir.kiorapharma.com/news-events/news-releases/detail/89/eyegate-awarded-new-u-s-patent-for-iontophoretic-delivery-of-corticosteroids-to-the-eye
- https://www.pharmaceutical-technology.com/data-insights/sorrento-therapeutics-gets-grant-for-sustained-release-corticosteroid-compositions-for-pain-treatment/
- https://patents.google.com/patent/US7794738B2/en
- https://patents.justia.com/patent/20240024307
- https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
- https://markets.businessinsider.com/news/stocks/global-corticosteroids-markets-report-2021-2030-glucocorticoids-mineralocorticoids-market-is-expected-to-reach-5-33-billion-in-2025-1030436297
- https://www.biospace.com/willow-announces-filing-of-patent-application-for-process-to-produce-corticosteroids-at-signficantly-reduced-cost
- https://www.biospace.com/business/5-pharma-powerhouses-facing-massive-patent-cliffs-and-what-theyre-doing-about-it
