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Last Updated: June 17, 2025

Sphingosine 1-phosphate Receptor Modulator Drug Class List


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Drugs in Drug Class: Sphingosine 1-phosphate Receptor Modulator

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207985-001 Jun 18, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Biocon Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207979-001 Dec 4, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apotex FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207993-001 Dec 18, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mylan FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208005-001 Jan 19, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Prinston Inc FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208003-001 Sep 7, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208014-001 Dec 4, 2019 DISCN 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
>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 Modulator Market Analysis and Financial Projection

The Sphingosine 1-phosphate Receptor (S1PR) modulator drug class has emerged as a transformative therapeutic category, driven by its efficacy in treating autoimmune and inflammatory disorders. Below is an analysis of the market dynamics and patent landscape shaping this sector.


Market Dynamics

Growth Drivers

The global S1PR modulator drugs market is projected to grow from $2.44 billion in 2024 to $3.28 billion by 2029, at a 6.0% CAGR[1][4]. Key drivers include:

  • Rising autoimmune disease prevalence: Over 5–10% of the global population suffers from autoimmune conditions, fueling demand for targeted therapies like S1PR modulators[7].
  • Shift toward oral therapies: Patients increasingly prefer oral formulations (e.g., ozanimod) over injectables, reducing treatment barriers[1][4].
  • Aging populations: Geriatric demographics, prone to conditions like multiple sclerosis (MS), are expanding globally[1][7].

Key Trends

  • Receptor selectivity advancements: Next-generation modulators aim for enhanced safety by targeting specific S1P receptor subtypes (e.g., siponimod’s selectivity for S1PR1 and S1PR5)[12][15].
  • Expanding indications: While MS remains the primary application, clinical trials are exploring uses in inflammatory bowel disease, lupus, and transplant rejection[1][7][13].
  • Real-world evidence integration: Post-marketing data is increasingly used to validate long-term efficacy and safety[1][7].

Regional Insights

  • Asia-Pacific: Expected to dominate with 41% market share by 2037, driven by rising R&D investments (e.g., India’s $17.2 billion R&D expenditure in 2022–23) and clinical trial activity[7][15].
  • North America: Accounts for significant MS prevalence (~1 million cases in the U.S.) and benefits from fast-track regulatory pathways[7][14].

Patent Landscape

Innovation Focus Areas

Patents reveal strategic priorities in S1PR modulator development:

  1. Novel compounds: Patents like EP2291080B1 and WO2011060392A1 cover oxadiazole/oxazole derivatives and chirally synthesized agonists targeting S1PR1[8][9].
  2. Therapeutic applications: US9187405B2 and EP2959894A1 focus on treating relapsing-remitting MS and reducing neo-angiogenesis in demyelinating diseases[5][10].
  3. Drug delivery: US20190002450A1 includes compositions for S1PR1 imaging and transdermal formulations[11][13].

Competitive Strategies

  • Pipeline diversification: Over 14 companies have S1PR modulators in development, spanning oral capsules (ozanimod), transdermal patches (fingolimod), and intravenous formulations[13][15].
  • Collaborations and acquisitions: Partnerships between firms like Novartis and Celgene aim to expand portfolios and geographic reach[14][15].

Challenges and Opportunities

  • Safety concerns: First-generation drugs like fingolimod are associated with cardiovascular risks (e.g., bradycardia), prompting R&D into safer alternatives[12].
  • Patent expiries: Generic competition for older drugs (e.g., fingolimod) is accelerating, pushing innovation toward next-gen modulators[1][15].
  • Regulatory complexity: Stringent approvals for novel indications require robust clinical evidence, prolonging time-to-market[7][13].

“The S1PR modulator market is driven by scientific innovation, strategic collaborations, and an expanding therapeutic horizon.” — DelveInsight Market Research[2][3]

Key Takeaways

  1. The S1PR modulator market is growing at 6.0% CAGR, driven by autoimmune disease prevalence and oral therapy adoption.
  2. Patent activity highlights innovation in receptor selectivity, drug delivery, and novel applications.
  3. Asia-Pacific and North America lead regional growth, fueled by clinical trials and high MS prevalence.

FAQs

Q1. What are S1PR modulators used for?
Primarily for multiple sclerosis, with expanding use in IBD and lupus.

Q2. Which companies dominate the S1PR market?
Novartis, Bristol-Myers Squibb, and Pfizer lead through drugs like ozanimod and siponimod[14][15].

Q3. How do patents influence market competition?
Patents protect novel compounds and delivery methods, delaying generics and incentivizing R&D.

Q4. What risks are associated with S1PR modulators?
Cardiovascular side effects (e.g., bradycardia) and immunosuppression[12].

Q5. Which regions show the highest growth potential?
Asia-Pacific, due to rising healthcare investment and clinical trial activity[7][15].

References

  1. https://www.thebusinessresearchcompany.com/report/sphingosine-1-phosphate-receptor-s1pr-modulator-drugs-global-market-report
  2. 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
  3. https://www.gii.co.jp/report/del1431753-sphingosine-phosphate-receptor-s1pr-modulators.html
  4. https://www.einpresswire.com/article/797985787/sphingosine-1-phosphate-receptor-s1pr-modulator-drugs-market-analysis-key-trends-share-growth-drivers
  5. https://patents.google.com/patent/US9187405B2/en
  6. 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
  7. https://www.researchnester.com/reports/s1p-receptor-modulator-drugs-market/5529
  8. https://patents.google.com/patent/EP2291080B1/en
  9. https://patents.google.com/patent/WO2011060392A1/en
  10. https://patents.google.com/patent/EP2959894A1/ja
  11. https://patents.google.com/patent/US20190002450A1/en
  12. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1376494/full
  13. https://www.businesswire.com/news/home/20210511005678/en/Global-Sphingosine-1-Phosphate-Receptor-Modulators-Pipeline-Insights-Market-Report-2021---ResearchAndMarkets.com
  14. https://www.thebusinessresearchcompany.com/market-insights/sphingosine-1-phosphate-receptor-s1pr-modulator-drugs-market-overview-2025
  15. https://www.cognitivemarketresearch.com/sphingosine-1-phosphate-receptor-s1pr-modulator-market-report
Last updated: 2025-03-31

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