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Drugs in ATC Class J01M
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Subclasses in ATC: J01M - QUINOLONE ANTIBACTERIALS
J01M Market Analysis and Financial Projection
The quinolone antibacterials market (ATC Class J01M) is shaped by evolving infectious disease prevalence, antimicrobial resistance trends, and complex patent landscapes affecting drug accessibility. With projected growth from $50.05B in 2024 to $64.61B by 2029 at a 5.4% CAGR[7][15], this sector remains critical in addressing bacterial infections despite emerging challenges.
Market Dynamics
Drivers
- Rising Infectious Diseases: Increasing cases of tuberculosis (7.5M new cases in 2022), urinary tract infections, and multidrug-resistant pathogens drive demand[7][15].
- Antimicrobial Resistance: Growing resistance to traditional therapies positions quinolones as alternatives for infections like MDR-TB and Gram-negative bacterial diseases[4][7].
- New Product Launches: Innovations like Melinta Therapeutics’ Baxdela (delafloxacin) for skin infections expand treatment options[1].
Restraints
- Generic Competition: Patent expirations (e.g., ciprofloxacin) enable cheaper generics, reducing brand revenue[4][7].
- Safety Regulations: Stricter guidelines, such as EMA restrictions on fluoroquinolones due to adverse effects, limit usage[4].
Opportunities
- Targeted Therapies: Development of fourth-generation quinolones like gemifloxacin against anaerobic bacteria broadens applications[5][9].
- Emerging Markets: Asia-Pacific’s healthcare investments and high infectious disease burden fuel growth[4].
Patent Landscape
Key Patents and Strategies
-
Core Compound Patents:
- Janssen’s patents on bedaquiline (Patent 1: compound coverage; Patent 2: MDR-TB treatment) block generic manufacturing in 30+ countries, including high-TB-burden nations like India and South Africa[2].
- Process patents (e.g., US10160726B2 for enantiomer isolation) extend market exclusivity[6].
-
Therapeutic Use Patents:
- Methods for treating latent TB (Patent 3) and drug-resistant Salmonella (US20060035241) highlight diversification strategies[2][3].
-
Litigation Trends:
- ARBUTUS’s 2024 patent win against Moderna over LNP delivery technology underscores competitive IP battles in antibiotic adjuvants[14].
Access Challenges
- Geographic Disparities: Bedaquiline patents in OAPI and ARIPO regions complicate access in 25+ African countries[2].
- Licensing Agreements: Janssen’s MDR-TB access programs aim to mitigate patent barriers, though details remain limited[2].
Regional Insights
| Region | Market Share | Key Factors |
|---|---|---|
| North America | Dominant | High R&D investment, advanced healthcare infrastructure[4]. |
| Asia-Pacific | Fastest Growth | Rising disposable income, TB/diarrheal disease prevalence[4][15]. |
| Europe | Moderate | Declining fluoroquinolone use (-50% in Austria/Norway since 2012) due to safety policies[13]. |
Future Outlook
- Pipeline Innovation: Over 15% of quinolones in development target resistant strains, with enhanced safety profiles[6][8].
- Generic Entry: Post-2030 bedaquiline patent expiries could reduce prices by 60%, improving accessibility in LMICs[2].
- Synthetic Biology: Platforms like mRNA-LNP delivery (as seen in COVID-19 vaccines) may enhance quinolone efficacy in combination therapies[14].
“Patent applications serve as a deterrent even before grant, shaping market competition.” – Unitaid Report on Bedaquiline[2].
The quinolone market hinges on balancing IP-driven innovation with equitable access, particularly for high-mortality infections like TB. Strategic collaborations and streamlined regulatory pathways will be pivotal in addressing antibiotic resistance crises.
References
- https://www.alliedmarketresearch.com/quinolones-market-A14826
- https://unitaid.org/uploads/TMC_207_Patent_Landscape.pdf
- https://patents.justia.com/patent/20060035241
- https://www.databridgemarketresearch.com/reports/global-quinolones-market
- https://patents.google.com/patent/US6262071B1/en
- https://patents.google.com/patent/US10160726B2/en
- https://www.thebusinessresearchcompany.com/report/quinolones-global-market-report
- https://pubs.acs.org/doi/10.1021/jm501881c
- https://patents.google.com/patent/US6455540B1/en
- https://en.wikipedia.org/wiki/Quinolone_antibiotic
- https://atcddd.fhi.no/atc_ddd_index/?code=J01M
- https://go.drugbank.com/drugs/DB01137
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10791944/
- https://www.knowmade.com/technology-news/press-release/q1-2024-ip-activity-reveals-growth-and-litigation-in-key-mrna-market/
- https://www.researchandmarkets.com/reports/5793013/quinolones-global-market-report
- https://www.drugpatentwatch.com/p/atc-class/J01
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