Drugs in ATC Class B02B

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Up to B - Blood and blood forming organs

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Subclasses in ATC: B02B - VITAMIN K AND OTHER HEMOSTATICS

B02BA - Vitamin K

B02BC - Local hemostatics

B02BX - Other systemic hemostatics

B02B Market Analysis and Financial Projection

The ATC class B02B (Vitamin K and other hemostatics) encompasses therapies critical for managing bleeding disorders, coagulation deficiencies, and surgical hemostasis. This analysis synthesizes market trends, patent activity, and innovation drivers shaping this sector.

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Market Dynamics

Growth Drivers

• Vitamin K Demand:
  The global vitamin K market is projected to grow from $918.94 million in 2023 to $2.13 billion by 2033 (CAGR 8.75%)[10][14]. Growth is fueled by:

  • Rising awareness of its role in bone health (osteoporosis treatment) and blood clotting[3][10].
  • Increasing incidence of neonatal bleeding (VKDB) and anticoagulant overdose management[10][17].
  • Regulatory mandates for fortified foods and injectables[3][8].

• Hemostats Expansion:
  The hemostats market, valued at $4.75 billion in 2023, is expected to reach $9.33 billion by 2032 (CAGR 7.9%)[12]. Key segments include:

  • Local hemostatics (B02BC): Absorbable gelatin, collagen, and thrombin products dominate surgical applications[5][12].
  • Systemic coagulants (e.g., fibrinogen, vitamin K): Held 43.7% market share in 2023, driven by trauma and chronic bleeding disorders[8].

Regional Trends

• North America leads due to advanced healthcare infrastructure, high surgical volumes, and FDA mandates (e.g., ADS-B systems in aviation linked to trauma care)[6][12].
• Asia-Pacific exhibits the fastest growth, attributed to rising health expenditures and vitamin K deficiency awareness[10][14].

Challenges

• Limited awareness in developing regions about vitamin K’s benefits[10][17].
• Regulatory complexities in drug approval and quality control[10][17].

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Patent Landscape

Key Innovations

1. Hemostatic Devices:

   • Tricol Biomedical’s Chito+™ chitosan dressing (patent #11,564,673) for gastrointestinal bleeding[11].
   • Expandable hemostatic particles (US8828050B2) for rapid hemorrhage control[15].

2. Nanoformulations:

   • Nanoemulsion-based vitamin K delivery systems (US9370486B2) enhancing bioavailability[18].

3. Gene and Cell Therapies:

   • Allogeneic CAR-T cell patents focus on scalable manufacturing and immune rejection mitigation, indirectly influencing coagulation therapies[2][16].

Jurisdictional Activity

• U.S.: Leads in CAR-T constructs and gene editing (CRISPR/TALEN)[2].
• Europe: Emphasis on manufacturing processes (e.g., fibrinogen production)[2][7].
• Asia-Pacific: Rising patent filings for cost-effective hemostatic solutions[2][9].

Competitive Strategies

• Baxter, Ethicon, and BD dominate with broad portfolios in passive hemostats[12].
• Startups like Artiva Biotherapeutics and Poseida drive innovation in coagulation factor engineering[2][16].

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Future Outlook

• Technological Integration: CRISPR-enhanced coagulation factor production and 3D-printed hemostatic gauze[2][11].
• Unmet Needs: Development of non-invasive hemostatic monitors and targeted therapies for immune-mediated bleeding disorders[2][7].
• Market Opportunities: Expanding into prenatal vitamin K prophylaxis and combo products (e.g., fibrinogen-thrombin matrices)[5][12].

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Highlight: "The collective effort of biotech firms and academic institutions is crucial for advancing allogenic CAR-T cell therapies, which may revolutionize clotting factor delivery."[2][7]

This sector’s growth hinges on bridging awareness gaps, leveraging gene-editing advancements, and addressing regulatory challenges to meet global demand for bleeding disorder therapies.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=B02B
2. https://www.globenewswire.com/news-release/2025/03/13/3042364/0/en/Allogeneic-CAR-T-Cell-Patent-Landscape-and-Forecast-Report-2024-2032-Profiles-of-Artiva-Biotherapeutics-Poseida-Therapeutics-Nanjing-Beiheng-Biological-Technology-NantCell-GC-Cell-.html
3. https://www.databridgemarketresearch.com/reports/global-vitamin-k-market
4. https://patents.google.com/patent/WO2017160754A1/en
5. https://atcddd.fhi.no/atc_ddd_index/?code=B02BC&showdescription=yes
6. https://www.fortunebusinessinsights.com/automatic-dependent-surveillance-broadcast-ads-b-market-103355
7. https://gevers.eu/blog/patent-landscaping-a-full-picture-of-patents/
8. https://www.grandviewresearch.com/industry-analysis/coagulants-market-report
9. https://www.frontiersin.org/journals/energy-research/articles/10.3389/fenrg.2022.1005720/full
10. https://www.precedenceresearch.com/vitamin-k-market
11. https://www.globenewswire.com/news-release/2023/02/21/2612371/0/en/Tricol-Biomedical-Expands-IP-Protection-with-First-New-Patent-for-Gastrointestinal-Hemostasis.html
12. https://www.fortunebusinessinsights.com/industry-reports/hemostats-market-100084
13. https://publications.jrc.ec.europa.eu/repository/bitstream/JRC113915/jrc113915-dual-use-technologies_online.pdf
14. https://www.gminsights.com/industry-analysis/vitamin-k-market
15. https://patents.google.com/patent/US8828050B2/en
16. https://www.knowmade.com/wp-content/uploads/2025/01/Bispecific-Ab-Patent-Landscape-2025-FLYER.pdf
17. https://www.researchnester.com/reports/vitamin-k-market/6374
18. https://patents.google.com/patent/US9370486B2/en
19. https://www.atccode.com/B02B