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Last Updated: June 14, 2025

Mechanism of Action: Sphingosine 1-Phosphate Receptor Modulators


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Drugs with Mechanism of Action: Sphingosine 1-Phosphate Receptor Modulators

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hec Pharm Co Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207939-001 Nov 10, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Pharms Usa FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208008-001 Jul 2, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dr Reddys FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208000-001 Mar 5, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Sphingosine 1-Phosphate Receptor Modulators Market Analysis and Financial Projection

The S1P (sphingosine-1-phosphate) receptor modulator drugs market has emerged as a critical therapeutic arena, driven by advances in autoimmune disease treatment and a robust patent landscape. Below is a detailed analysis of market dynamics, competitive developments, and intellectual property trends.


Market Dynamics

Growth Drivers:

  • Autoimmune Disease Prevalence: Over 2.3 million people globally have multiple sclerosis (MS), a key indication for S1P modulators[1][4]. Autoimmune diseases affect 5–10% of the global population, with MS, ulcerative colitis, and lupus driving demand for targeted therapies[4][12].
  • R&D Investments: Pharmaceutical companies invested $243 billion globally in R&D in 2022, accelerating the development of next-generation modulators like ozanimod and etrasimod[4][15].
  • Emerging Markets: Asia-Pacific’s pharmaceutical sector is growing at 9–12% annually, fueled by improved healthcare infrastructure and clinical trial expansion[1][4].

Challenges:

  • Regulatory Complexity: Evolving safety guidelines require costly clinical trials, delaying drug launches[1][4].
  • Competitive Pressures: Dominance by established players like Novartis and Bristol-Myers Squibb limits new entrants[1][8].

Projections:

  • The market is projected to reach $6.8–$8.01 billion by 2030–2037, growing at a CAGR of 7.9–12.5%[1][4][7].

Regional Insights

Region Key Trends Market Share (2037)
North America High MS prevalence (~1 million cases in the U.S.), fast-track approvals, and $17.2B R&D spend[4][12]. 35–40%
Asia-Pacific Clinical trial surge (e.g., India’s $17.2B R&D investment) and autoimmune disease prevalence 41%
Europe Patent expiries (e.g., fingolimod) and pipeline innovations (e.g., ponesimod)[17]. 20–25%

Patent Landscape

Key Patents:

  1. US9187405B2: Covers FTY720 (fingolimod) for treating multiple sclerosis subtypes, including relapsing-remitting MS[2][5].
  2. US9975863B2: Focuses on S1P1-selective agonists to reduce cardiac risks[3].
  3. EP2959894B1: Highlights combination therapies using S1P modulators with other immunosuppressants[5].

Innovation Trends:

  • Selectivity: Newer drugs like siponimod (S1P1/S1P5) and ponesimod (S1P1-only) minimize side effects by avoiding S1P3 receptor activity[12][14].
  • Pipeline Candidates:
    • Etrasimod: Phase III for ulcerative colitis and atopic dermatitis[15].
    • Cenerimod: Phase II for systemic lupus erythematosus[15].

Competitive Landscape

Major Players:

  • Novartis: Leads with fingolimod (Gilenya®) and siponimod (Mayzent®)[12][17].
  • Bristol-Myers Squibb: Developing ozanimod (Zeposia®) for MS and inflammatory bowel disease[9][17].
  • Janssen: Markets ponesimod (Ponvory®), approved in 2021[17].

Emerging Companies:

  • Akaal Pharma: Advancing AKP-11 for psoriasis and atopic dermatitis[8].
  • Arena Pharmaceuticals: Pioneering etrasimod with a Phase III-ready profile[15].

Therapeutic Applications

Disease Mechanism of Action Key Drug Examples
Multiple Sclerosis Lymphocyte sequestration via S1P1 receptor modulation Fingolimod, siponimod
Ulcerative Colitis Immune response regulation in the gut Ozanimod, etrasimod
Psoriasis S1P1-mediated anti-inflammatory effects AKP-11 (Phase II)[8]

Future Outlook

The S1P receptor modulator market will hinge on selectivity improvements (e.g., avoiding S1P3-linked arrhythmias) and expedited regulatory pathways. With 14+ candidates in clinical trials, including novel monoclonal antibodies like sonepcizumab, the sector is poised for transformative growth[15][16]. However, pricing pressures and biomarker-driven personalized therapies will shape competitive strategies[4][12].

“S1P receptor modulators represent a paradigm shift in autoimmune treatment, combining immunomodulation with CNS repair potential.” – Neurologylive (2023)[12]

References

  1. https://www.verifiedmarketreports.com/product/s1p-receptor-modulator-drugs-market/
  2. https://patents.google.com/patent/US9187405B2/en
  3. https://pubchem.ncbi.nlm.nih.gov/patent/US-9975863-B2
  4. https://www.researchnester.com/reports/s1p-receptor-modulator-drugs-market/5529
  5. https://data.epo.org/publication-server/rest/v1.0/publication-dates/20221012/patents/EP2959894NWB1/document.pdf
  6. https://www.globenewswire.com/news-release/2024/03/01/2838895/28124/en/Sphingosine-1-Phosphate-Receptor-Modulators-Market-Size-Target-Population-Competitive-Landscape-Forecasts-2020-2023-and-2024-2034-Focus-on-US-Germany-France-Italy-Spain-UK-and-Japa.html
  7. https://sites.google.com/view/leapdataanalytics/home/s1p-receptor-modulator-drugs-market-by-deployment-by-applications-by-type
  8. https://www.biospace.com/u-s-patents-issued-to-b-akaal-pharma-b-on-s1p1-receptor-modulators-useful-for-the-treatment-of-autoimmune-and-inflammatory-diseases
  9. https://www.cognitivemarketresearch.com/sphingosine-1-phosphate-receptor-s1pr-modulator-market-report
  10. https://github.com/maaniwilka9y/Market-Research-Report-List-1/blob/main/s1p-receptor-modulator-drugs-market.md
  11. https://www.globenewswire.com/news-release/2024/06/27/2905440/0/en/S1PR-Modulators-Market-to-Register-Immense-Growth-During-the-Study-Period-2020-2034-DelveInsight.html
  12. https://www.neurologylive.com/view/s1p-receptor-modulators-in-multiple-sclerosis
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC4554772/
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC7932974/
  15. https://www.businesswire.com/news/home/20210511005678/en/Global-Sphingosine-1-Phosphate-Receptor-Modulators-Pipeline-Insights-Market-Report-2021---ResearchAndMarkets.com
  16. https://pmc.ncbi.nlm.nih.gov/articles/PMC5773104/
  17. https://www.msif.org/wp-content/uploads/2022/03/DMTs-patent-overview-March-22.pdf
Last updated: 2025-03-24

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.