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Last Updated: April 16, 2025

Drugs in ATC Class C10


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Subclasses in ATC: C10 - LIPID MODIFYING AGENTS

C10 Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class C10 (lipid-modifying agents) reflect a sector undergoing significant transformation, driven by innovation, patent expirations, and shifting global demand. Here's a detailed analysis:


Market Dynamics

Current Market Valuation

  • The global lipid-lowering agent market was valued at $33.12 billion in 2023, projected to reach $46.58 billion by 2030 at a 3.47% CAGR [16][18].
  • Key growth drivers include rising cardiovascular disease prevalence, aging populations, and advancements in drug delivery systems (e.g., liposomes, RNAi therapies) [15][16].

Regional Growth Patterns

  • Asia Pacific: Accounts for 35% of global CVD-related deaths, driving demand for statins and newer agents. Utilization in Iran grew 7-fold (2005–2016) but remains below OECD averages [3][11].
  • United States: Market value stagnated at $8.3 billion in 2022, projected to dip slightly to $8.02 billion by 2030 due to generics [18].

Key Players and Therapies

  • Major companies: Sanofi, Pfizer, Novartis, Amgen, and Merck dominate, with Leqvio (inclisiran) and Repatha (evolocumab) leading growth. These therapies are projected to contribute 27% of total sales ($23 billion) by 2030 [10][16].
  • Statins (C10AA) remain dominant, representing 80–93% of utilization in Iran and key markets, though combination therapies (e.g., ezetimibe + statins) are rising [1][11].

Challenges

  • Generic competition: Post-2011 patent cliffs (e.g., Lipitor’s $11B revenue drop) caused a 79% market decline [10][16].
  • Affordability gaps: Despite low costs in some regions (e.g., Iran), underdiagnosis and access barriers limit utilization [11].

Patent Landscape

Expiring and Active Patents

  • Juxtapid (lomitapide): Patents for MTP inhibitors held by the University of Pennsylvania expire in 2025–2027 [4].
  • Leqvio: RNAi therapy targeting PCSK9 with patents extending into the 2030s [10].
  • Drug repurposing: Over 190 PCT applications (2010–2023) target rare diseases (e.g., gemfibrozil for Krabbe disease; ambroxol for mucopolysaccharidosis) [2].

Innovation Trends

  • Biologics and RNA-based therapies: PCSK9 inhibitors (e.g., Repatha) and inclisiran dominate recent filings, with a focus on improving bioavailability and reducing dosing frequency [5][10].
  • Structured lipids: Enzymatic production methods (e.g., using lipases) are a niche area, with 44 patents filed since 1989 for nutritional and therapeutic applications [12].

Geographical Patent Activity

  • US and EU: Lead in repurposing patents (one-third of global filings), while Asian countries underpatent despite strong academic output [2][6].
  • Regulatory strategies: Linkage regulations in Canada and the U.S. tie drug approval to patent enforcement, delaying generics and extending exclusivity [6][17].

Future Outlook

  • Growth drivers: Novel therapies (e.g., bempedoic acid, evinacumab) and personalized medicine approaches (e.g., genetic targeting of PCSK9) are expected to reduce reliance on statins [5][13].
  • Market risks: Pipeline concentration (e.g., Leqvio/Repatha dependency) and regulatory hurdles for biologics may slow innovation [17].

Key Takeaway: The C10 market is rebounding through biologics and repurposed therapies, though regional disparities in access and persistent generic competition loom. Strategic patenting and R&D diversification will shape long-term success.

References

  1. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2020/may-belgian-reg-med-best.pdf
  2. https://drugrepocentral.scienceopen.com/hosted-document?doi=10.58647%2FDRUGREPO.24.1.0012
  3. https://www.transparencymarketresearch.com/lipid-lowering-drugs-market.html
  4. https://www.drugs.com/availability/generic-juxtapid.html
  5. https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.118.313171
  6. https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1102&context=njtip
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC7881963/
  8. https://www.drugpatentwatch.com/p/atc-class/C10A
  9. https://en.wikipedia.org/wiki/ATC_code_C10
  10. https://www.pharmalive.com/leqvio-and-repatha-to-spearhead-lipid-modifying-agents-market-resurgence/
  11. https://brieflands.com/articles/ijpr-126246
  12. https://www.eurekaselect.com/article/90888
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC8330577/
  14. https://patents.google.com/patent/WO2021202984A1/en
  15. https://www.futuremarketinsights.com/reports/pharmaceutical-lipids-market
  16. https://www.verifiedmarketreports.com/product/lipid-lowering-agent-market/
  17. https://umbrex.com/resources/industry-analyses/how-to-analyze-a-pharmaceutical-company/drug-pipeline-analysis/
  18. https://www.insights10.com/report/us-cholesterol-lipid-lowering-drugs-market-analysis/

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