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Last Updated: April 8, 2025

Methylating Agent Drug Class List


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Drugs in Drug Class: Methylating Agent

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Eton BETAINE betaine FOR SOLUTION;ORAL 210508-001 Jan 28, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma BETAINE betaine FOR SOLUTION;ORAL 214864-001 Nov 23, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Recordati Rare CYSTADANE betaine FOR SOLUTION;ORAL 020576-001 Oct 25, 1996 AB RX Yes Yes ⤷  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
Showing 1 to 3 of 3 entries

Methylating Agent Market Analysis and Financial Projection

The methylating agents market is a critical segment in pharmaceuticals, agrochemicals, and industrial chemistry, driven by innovation in drug development, agricultural solutions, and advanced chemical processes. Below is an analysis of the market dynamics and patent landscape shaping this sector.


Market Overview and Growth Drivers

  • The global methylating agents market was valued at USD 1.2 billion in 2024 and is projected to reach USD 2.5 billion by 2033, growing at a CAGR of 8.9% [1][7].
  • Pharmaceutical applications dominate demand, particularly in oncology. For example, Temozolomide—a methylating agent used to treat glioblastoma—is projected to grow at a CAGR of 8.5%, reaching USD 2.8 billion by 2030 [13].
  • Agrochemical usage is another key driver, with methylating agents integral to pesticide and herbicide formulations. The need for sustainable agriculture and higher crop yields supports this segment [1][7].
  • DNA methylation, a related niche, is expanding rapidly (CAGR of 14.1–16.3%), fueled by cancer research and epigenetic diagnostics [5][10].

Key Market Restraints

  • Regulatory challenges: Stringent safety assessments by agencies like the EPA and ECHA increase costs and delay approvals for new methylating agents [1][7].
  • Environmental and safety concerns: Agents like dimethyl sulfate (DMS), while effective, require specialized handling due to toxicity. DMS’s market growth faces hurdles despite its importance in industrial methylation [12].
  • Generic competition: Patent expirations for drugs like Temozolomide allow generics to enter the market, pressuring profit margins [13].

Patent Landscape and Innovations

Notable Patents and Technologies

  1. DMTT Reagent: A deuterated methylating agent enabling selective -methylation in drug candidates like Austedo, improving metabolic stability [2].
  2. Methylation Assays: Patent US-11685956-B2 outlines methods for detecting methylated DNA loci, critical for cancer diagnostics [4].
  3. Drug Formulations:
    • Temozolomide patents focus on stabilizing formulations and combination therapies [14][15].
    • Innovations in solid dispersions and polymorphs (e.g., Velpatasvir) enhance drug delivery [9].
  4. Synthesis Techniques: Patents covering intermediates and reaction conditions for Ritonavir and other protease inhibitors highlight advancements in scalable production [8].

Patent Trends

  • Geographic focus: 85% of patents are held by pharmaceutical companies in North America and Europe, with growing activity in Asia-Pacific [11].
  • Collaborations: Partnerships between firms like Biogen and Eisai for combination therapies (e.g., ADUHELM) reflect strategic IP development [6].

Regional Insights

  • North America leads due to robust R&D infrastructure and high cancer prevalence. The U.S. accounts for 71.8% of the DNA methylation market [10].
  • Asia-Pacific is the fastest-growing region (CAGR: 15%), driven by expanding pharmaceutical manufacturing and government healthcare investments [3][10].

Competitive Landscape

  • Major players: Merck, Sun Pharma, and Cipla dominate the Temozolomide market [13].
  • Innovation focus: Companies prioritize sustainable methylating agents and combination therapies to differentiate offerings [2][7].

Emerging Opportunities

  • Personalized medicine: DNA methylation biomarkers for cancer and chronic diseases are a frontier [10].
  • Green chemistry: Developing eco-friendly methylating agents to meet regulatory and environmental standards [12].

Key Takeaways

  1. The methylating agents market is driven by oncology and agrochemical demand but constrained by regulatory and safety challenges.
  2. Patent activity centers on synthesis optimization, deuterated agents, and diagnostic assays.
  3. Asia-Pacific offers high growth potential due to pharmaceutical expansion and rising healthcare investments.

FAQs
Q1: What is the growth rate of the methylating agents market?
A: The market is projected to grow at 6.5–8.9% CAGR, reaching USD 2.0–2.5 billion by 2033 [1][7].

Q2: Which industries use methylating agents most?
A: Pharmaceuticals (drug synthesis), agriculture (pesticides), and industrial chemicals (dimethyl sulfate) [1][12].

Q3: How do patents influence the market?
A: Patents protect synthesis methods, formulations, and diagnostic tools, but generics pose challenges post-expiry [6][13].

Q4: What role does DNA methylation play?
A: It’s vital for epigenetic research, cancer diagnostics, and personalized medicine, with a market CAGR of 14.1% [10].

Q5: Which regions lead in methylating agent innovation?
A: North America dominates, but Asia-Pacific is the fastest-growing due to manufacturing expansion [3][10].

References

  1. https://www.verifiedmarketreports.com/product/methylating-agents-market/
  2. https://www.science.org/doi/10.1126/sciadv.aba0946
  3. https://www.researchdive.com/113/hypomethylating-agents-market
  4. https://pubchem.ncbi.nlm.nih.gov/patent/US-11685956-B2
  5. https://www.futuremarketinsights.com/reports/dna-methylation-market
  6. https://www.alliedmarketresearch.com/patented-drugs-market-A110993
  7. https://www.verifiedmarketreports.com/product/methylating-agent-market/
  8. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
  9. https://unitaid.org/uploads/Velpatasvir_patent-landscape_update_March2017.pdf
  10. https://www.grandviewresearch.com/industry-analysis/dna-methylation-market-report
  11. https://academic.oup.com/bioinformatics/article/39/1/btac716/6794201
  12. https://www.researchandmarkets.com/report/dimethyl-sulfate
  13. https://www.verifiedmarketreports.com/product/temozolomide-market/
  14. https://patents.google.com/patent/US20160199302A1/en
  15. https://patents.google.com/patent/WO2022183044A1

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