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Last Updated: April 19, 2025

Mechanism of Action: Nucleic Acid Synthesis Inhibitors


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Drugs with Mechanism of Action: Nucleic Acid Synthesis Inhibitors

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Meitheal AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 212128-001 Nov 2, 2020 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Natco Pharma Ltd AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 207234-001 Jun 23, 2017 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz ARRANON nelarabine INJECTABLE;INTRAVENOUS 021877-001 Oct 28, 2005 AP 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

Nucleic Acid Synthesis Inhibitors Market Analysis and Financial Projection

The market for nucleic acid synthesis inhibitors is experiencing dynamic growth driven by therapeutic innovation and expanding applications in oncology and genetic disorders. This sector encompasses both traditional antimetabolites and advanced nucleic acid-based therapies, supported by intense patent activity and strategic investments.


Market Dynamics

Growth Projections and Segments

  • The global nucleic acid therapeutics market is projected to reach $12.2 billion by 2031, growing at a CAGR of 11.6%, while the broader nucleic acid-based therapeutics market may expand to $12.46 billion by 2030 (CAGR: 14.29%)[1][5].
  • Anti-sense oligonucleotides (ASOs) dominate the market (71% share), validated by treatments for spinal muscular atrophy and Duchenne muscular dystrophy[5].
  • RNA interference (RNAi/siRNAs) is the fastest-growing segment (16% CAGR), driven by FDA approvals like Givosiran and enhanced delivery systems[1][5].

Key Drivers

  • Rising chronic diseases: Increasing prevalence of cancer, cardiovascular disorders, and genetic conditions fuels demand[1][4].
  • Pipeline expansion: Over 200 clinical trials for RNAi therapeutics and ASOs are underway, targeting oncology, infectious diseases, and rare disorders[5][8].
  • Technological advancements: Innovations in delivery mechanisms (e.g., lipid nanoparticles) and CRISPR-based gene editing improve therapeutic precision[6][8].

Regional Trends

  • North America leads with advanced healthcare infrastructure and significant R&D investments (600+ patents in circulating DNA/RNA technologies)[8][9].
  • Asia-Pacific shows rapid growth (13% CAGR) due to improving healthcare access and rising cancer rates[5][14].

Challenges

  • High development costs and regulatory hurdles delay drug approvals[9].
  • Off-target effects and delivery inefficiencies remain key technical barriers[1][12].

Patent Landscape

Major Patent Holders and Innovations

  • AbbVie holds foundational patents for HCV NS5A inhibitors like pibrentasvir, with 10+ patents covering formulations, combination therapies, and crystalline forms[3].
  • Novartis, Alnylam, and Genentech lead in RNAi and ASO patents, focusing on oncology and rare diseases[5][8].
  • NUCLERA NUCLEICS patented a modified terminal transferase enzyme for nucleic acid synthesis, enhancing sequencing and drug development[6].

Competitive Activity

  • Non-sponsor patents: Companies like Glaxo and Medivir are developing long-acting formulations and combination therapies targeting HCV and oncology[3].
  • Litigation trends: Over 1,200 patents filed since 2020 for circulating DNA/RNA technologies, emphasizing non-invasive diagnostics and personalized medicine[8].

Strategic Focus Areas

  • Oncology: 45% of patents relate to cancer biomarkers (e.g., circulating tumor DNA) and DNA-damaging agents[4][8].
  • Delivery systems: 30% of recent patents address oligonucleotide stability and targeted delivery[5][7].

Key Therapeutic Classes

Class Examples Applications Market Impact
ASOs Nusinersen, Eteplirsen Spinal muscular atrophy, Duchenne MD 71% market share, driven by chronic disease
RNAi/siRNAs Givosiran, Patisiran Acute hepatic porphyria, amyloidosis Fastest-growing segment (16% CAGR)[5]
Antimetabolites Methotrexate, 5-FU Cancer, autoimmune diseases $6.9 billion by 2031 (1.9% CAGR)[9][14]

Opportunities and Outlook

  • Combination therapies: ASO/RNAi paired with immunotherapy or chemotherapy to enhance efficacy[3][5].
  • Personalized medicine: Circulating DNA/RNA patents enable non-invasive diagnostics and tailored treatments[8].
  • Emerging markets: Asia-Pacific and Latin America offer growth potential due to unmet medical needs and healthcare investments[9][14].

"The suppression of DNA/RNA synthesis through nucleic acid inhibitors is revolutionizing oncology and genetic disorder treatments"[1][4].


This sector’s trajectory hinges on overcoming delivery challenges and leveraging patent innovations to meet global health demands. Stakeholders prioritizing R&D collaborations and geographic expansion are poised to dominate this rapidly evolving market.

References

  1. https://www.alliedmarketresearch.com/nucleic-acid-therapeutics-market-A17089
  2. https://patents.google.com/patent/CA2362526A1/en
  3. https://unitaid.org/uploads/Pibrentasvir_patent-landscape_March2017.pdf
  4. https://link.epo.org/web/publications/studies/en-patents-and-innovation-against-cancer-study.pdf
  5. https://www.mordorintelligence.com/industry-reports/nucleic-acid-based-therapeutics-market
  6. https://pubchem.ncbi.nlm.nih.gov/patent/WO-2018215803-A1
  7. https://patents.google.com/patent/US5693502A/en
  8. https://www.globenewswire.com/news-release/2025/03/14/3043096/28124/en/Circulating-DNA-RNA-Patent-Landscape-Report-and-Forecast-2024-2032-Nantomics-Genentech-and-Novartis-are-Pivotal-in-the-Development-of-the-16-4-Billion-Market.html
  9. https://www.reanin.com/reports/global-antimetabolite-drug-market
  10. https://www.grandviewresearch.com/industry-analysis/antibiotic-market
  11. https://www.pristinemarketinsights.com/antimetabolite-drugs-market-report
  12. https://taylorandfrancis.com/knowledge/Medicine_and_healthcare/Oncology/Antimetabolites/
  13. https://www.databridgemarketresearch.com/reports/global-anti-metabolite-drugs-market
  14. https://www.openpr.com/news/3491348/antimetabolite-drugs-market-demonstrates-a-spectacular-growth

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