Drugs in ATC Class C09

Up to Top Level ATC Classes

Up to C - Cardiovascular system

Subclasses in ATC: C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

C09A - ACE INHIBITORS, PLAIN

C09C - ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

C09 Market Analysis and Financial Projection

The market for ATC Class C09 agents—targeting the renin-angiotensin system (RAS) for conditions like hypertension, heart failure, and chronic kidney disease—is shaped by evolving patent dynamics, generics penetration, and therapeutic innovation. Below is a detailed analysis:

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Market Dynamics

Growth Drivers

• Expanding demand: Driven by the global rise in hypertension (affecting ~1.13 billion people)[3][11] and cardiovascular diseases (CVDs), which account for 697,000 annual U.S. deaths[3].
• Aging population: Increased need for long-term RAS-acting agents, including ACE inhibitors and angiotensin receptor blockers (ARBs), as ~47% of U.S. adults have hypertension[3].
• Innovation in drug classes: Development of novel RAS modulators (e.g., direct renin inhibitors, angiotensin 1–7 analogs)[4][8] and combination therapies (e.g., RAS inhibitors with statins)[12] to enhance efficacy and compliance[11].

Market Size and Projections

• Valuation: The market was valued at $38.2B in 2022, with projections reaching $59.4B by 2030 (CAGR: 6.5%)[3][8]. Alternate estimates suggest $13.4B by 2031 (CAGR: 4.2%)[11], reflecting variations in regional and therapeutic segmentation.
• Generics dominance: Post-patent expirations, generics now comprise ~68% of molecules in classes like C09 (RAS agents)[5]. This shift reduces prices, improving accessibility but lowering revenue for originators[18].

Challenges

• Safety concerns: Side effects like hyperkalemia and cough limit adherence[3].
• Regulatory hurdles: Lengthy approval processes delay novel agents (e.g., counter-regulatory RAS components like angiotensin 1–7)[4].

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Patent Landscape

Key Therapeutic Patents

• Traditional RAS inhibitors: Most ACE inhibitors (e.g., lisinopril, ramipril) and ARBs (e.g., losartan, valsartan) are off-patent, fueling generics competition[13][14].
• Emerging targets: Over 184 patents focus on counter-regulatory RAS components (e.g., angiotensin 1–7, Mas receptor agonists) for cardiovascular and renal protection[4].

Notable Patent Disputes

• Stroke treatment: A European patent (EP 1 498 124) for RAS inhibitors in stroke prevention faced challenges due to insufficient clinical evidence[10].
• Renin inhibitors: Early patents (e.g., US5260278) covered renin-inhibitory peptides, but recent filings emphasize combination therapies and diagnostic applications[13][15].

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Geographical Insights

• North America: Leads the market (37.3% sales share)[17], driven by high CVD prevalence and advanced healthcare infrastructure[11].
• Europe: Regulatory reassessments (e.g., Denmark’s 2010 reimbursement cuts for ARBs) reflect cost-control measures post-generic entry[9].
• Emerging markets: Growth in Asia-Pacific and Latin America, spurred by rising hypertension rates and generic adoption[3][17].

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Future Outlook

• Pipeline innovation: Focus on multi-target RAS modulators (e.g., ACE2 activators) and non-cardiovascular applications (e.g., diabetic nephropathy, neurological disorders)[4][11].
• Strategic shifts: Originator companies increasingly invest in precision medicine and partnerships to offset revenue loss from generics[8][18].

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Highlight: "The surge in generics has democratized access to RAS-acting agents, but innovation in counter-regulatory targets offers a lifeline for market differentiation." [4][18]

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This landscape underscores a balance between generics-driven affordability and high-stakes R&D to address unmet medical needs. For businesses, success hinges on navigating IP complexities and leveraging emerging science in RAS biology.

References

1. https://stockanalysis.com/quote/sgx/C09/statistics/
2. https://www.wipo.int/en/web/global-health/w/news/2024/crispr-cas-navigating-the-patent-landscape-to-explore-boundless-applications
3. https://www.verifiedmarketreports.com/product/renin-angiotensin-system-ras-acting-agent-market/
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC7097090/
5. https://openaccess.city.ac.uk/25481/10/Serra-Sastre2020_Article_DoesNICEInfluenceTheAdoptionAn.pdf
6. https://www.morningstar.com/stocks/xses/c09/quote
7. https://www.dlapiper.com/en/insights/publications/intellectual-property-news/2022/the-crispr-patent-wars
8. https://www.marketresearchintellect.com/product/renin-angiotensin-system-ras-acting-agent-market/
9. https://laegemiddelstyrelsen.dk/en/news/reassessment-of-reimbursement-of-medicines-news-archives/changes-in-reimbursement-for-cardiovascular-medicines/decision-by-the-danish-medicines-agency-letters-sent-to-companies/~/media/0C3C957E46014C68BB5B3677A82C08DB.ashx
10. https://www.epo.org/en/boards-of-appeal/decisions/t101685eu1
11. https://www.transparencymarketresearch.com/ras-acting-agents-market.html
12. https://atcddd.fhi.no/atc_ddd_index/?code=C09
13. https://patents.justia.com/patents-by-us-classification/530/860
14. https://en.wikipedia.org/wiki/ATC_code_C09
15. https://patents.google.com/patent/US20040087645A1/zh
16. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2019/belgian-reg-med-best-peformers-for-june-2019.pdf?la=en&hash=53ED99C879C5141F1E4DC3ECC69CFEE4
17. https://www.scielo.br/j/csc/a/tMyTK7sW7tBzVVqKh4xLCKn/
18. https://www.qualifyze.com/resources/blog/understanding-the-financial-implications-of-patent-expirations