Drugs in ATC Class B

Subclasses in ATC: B - Blood and blood forming organs

B01 - ANTITHROMBOTIC AGENTS

B02 - ANTIHEMORRHAGICS

B03 - ANTIANEMIC PREPARATIONS

B05 - BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

B06 - OTHER HEMATOLOGICAL AGENTS

B Market Analysis and Financial Projection

The market for ATC Class B: Blood and Blood Forming Organs is shaped by rising demand for hematological therapies, evolving patent strategies, and technological advancements. Here’s an analysis of key dynamics:

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Market Dynamics

1. Market Growth and Drivers

   • The Blood and Blood Components Market reached $12.1 billion in 2021 and is projected to grow at a 3.4% CAGR through 2028, driven by increasing surgical procedures, cancer treatments, and blood disorders [5].
   • Blood Collection Devices are expected to expand at 6.8% CAGR (2027: $8.42 billion) due to demand for apheresis and plasma therapies [8].
   • Growth in emerging markets (e.g., India, China) is fueled by government initiatives and expanding healthcare infrastructure [11].

2. Key Segments

   • Antithrombotics (B01) and Antianemics (B03) dominate sales, with B01 accounting for 8.1% of Belgium’s retail market value in 2020 [1].
   • Apheresis technology is a critical growth area, enabling efficient separation of blood components like platelets and plasma [8].

3. Challenges

   • High costs of automated blood collection devices and complex storage requirements [8].
   • Regulatory hurdles for biosimilars, particularly for biologics (e.g., monoclonal antibodies) that dominate Class B [6].

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Patent Landscape

1. Expiring Patents and Generic Competition

   • Key drugs like Dasatinib (Sprycel®) and Revefenacin face patent expirations in 2025, opening opportunities for generics and biosimilars [4].
   • Example: Sprycel®, used for chronic myeloid leukemia, generated $477 million in 2019 [4].

2. Innovation Trends

   • Formulation Improvements: Patents covering extended stability, novel delivery mechanisms (e.g., inhaled anticoagulants), and synthetic blood substitutes [16][17].
   • Digital Solutions: Systems like virtual blood supply platforms (e.g., patent CA2846331A1) aim to optimize distribution and reduce waste [3].
   • Biologic Patents: Focus on monoclonal antibodies and gene therapies for blood cancers, with secondary patents often extending exclusivity [12][16].

3. Strategic Patenting

   • Companies file secondary patents (e.g., dosing regimens, combination therapies) to delay generic entry [12].
   • Biosimilars: Regulatory pathways remain complex, but biologics like Eteplirsen (Exondys 51®) face upcoming competition as patents expire in 2025 [4][6].

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Competitive Landscape

• Leading Players:
  • Becton Dickinson and Terumo BCT lead in blood collection devices [8].
  • Sarepta Therapeutics and Pfizer hold significant biologics patents in hematology [4].
• Emerging Technologies: Startups focus on synthetic blood substitutes and AI-driven blood management systems [16].

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Regulatory and Technological Impact

• Biosimilar Pathways: The 12-year exclusivity period for biologics under U.S. law incentivizes innovation but delays market entry for competitors [6][12].
• Digital Platforms: Patent CA2846331A1 highlights trends in integrating blockchain and IoT for real-time blood supply tracking [3].

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Future Outlook

• Opportunities:
  • Expanding apheresis applications in aesthetic medicine and regenerative therapies [5].
  • Growth in gene-editing therapies for blood disorders (e.g., CRISPR-based treatments) [16].
• Risks:
  • Price pressures from generics post-2025 [4].
  • Regulatory scrutiny on biologic safety and efficacy [6].

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Highlight: "The interplay of expiring patents, biosimilar adoption, and digital innovation will redefine competition in the blood therapeutics market." [4][6][16]

This sector’s evolution hinges on balancing innovation with accessibility, ensuring lifesaving therapies reach patients while sustaining R&D investment.

References

1. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2020/may-belgian-reg-med-best.pdf
2. https://www.frontiersin.org/articles/10.3389/frma.2023.978249/full
3. https://patents.google.com/patent/CA2846331A1/en
4. https://www.greyb.com/blog/drug-patents-expiring-2025/
5. https://www.gminsights.com/industry-analysis/blood-and-blood-components-market
6. https://www.nber.org/system/files/working_papers/w16014/w16014.pdf
7. https://www.skyquestt.com/report/automatic-dependent-surveillance-broadcast-ads-b-market
8. https://www.marketsandmarkets.com/Market-Reports/blood-collection-market-39733117.html
9. https://www.aeaweb.org/doi/10.1257/aeri.20210063.appx
10. https://www.iqvia.com/-/media/iqvia/pdfs/files/iqvia-quarterly-pharmaceutical-market-outlook---november-2023.pdf
11. https://www.databridgemarketresearch.com/reports/global-blood-and-organ-bank-market
12. https://events.bse.eu/live/files/3828-manuscript02242022anonymizedpdf
13. https://www.frontiersin.org/journals/research-metrics-and-analytics/articles/10.3389/frma.2023.978249/full
14. https://en.wikipedia.org/wiki/ATC_code_B
15. https://www.cognitivemarketresearch.com/blood-filters-market-report
16. https://patentpc.com/blog/exploring-patentable-aspects-of-blood-and-hematology-drugs
17. https://patents.justia.com/patents-by-us-classification/424/529