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Drugs in ATC Class B05AA
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Drugs in ATC Class: B05AA - Blood substitutes and plasma protein fractions
B05AA Market Analysis and Financial Projection
The market dynamics and patent landscape for ATC Class B05AA (Blood Substitutes and Plasma Protein Fractions) reflect a rapidly evolving sector driven by clinical demand, technological innovation, and regulatory developments.
Market Dynamics
Growth Drivers
- Aging Population: The global plasma fractionation market, valued at USD 35.8 billion in 2024, is projected to grow at 8.5% CAGR through 2030, driven by the increasing elderly population prone to conditions requiring blood derivatives[3][15].
- Trauma and Surgical Demand: Synthetic blood substitutes, including hemoglobin-based oxygen carriers (HBOCs) and perfluorocarbons (PFCs), are gaining traction for trauma care, organ transplants, and surgeries. The HBOC segment alone accounts for 63.2% of the plasma fractionation market[3][7].
- Rare Disease Treatment: Plasma protein therapies for conditions like immunodeficiency and hemophilia are boosting demand, with immunoglobulins dominating 63.2% of the market share[3][15].
Regional Trends
- North America leads due to robust R&D, regulatory support, and advanced healthcare infrastructure. The U.S. synthetic blood substitutes market is projected to reach USD 31.21 billion by 2034[14][15].
- Asia-Pacific is the fastest-growing region, driven by expanding healthcare access and government initiatives in India, China, and South Korea[7][15].
Key Players
- Plasma Fractionation: Grifols S.A., CSL Limited, and Takeda Pharmaceutical dominate, leveraging advancements in immunoglobulin production[3][15].
- Synthetic Blood Substitutes: Aurum Biosciences, HEMARINA, and KaloCyte are innovating HBOCs, while Baxter International and Terumo Corporation lead in patent filings[5][14].
Patent Landscape
Technological Innovations
- Hemoglobin-Based Substitutes: Patents focus on recombinant hemoglobin (e.g., WO-2022258590-A1 for plasminogen isolation[4]) and stabilization methods to reduce toxicity (e.g., US6599878 for superoxygenating compositions[12]).
- Automated Diagnostics: US20030027347A1 describes methods to correct blood test interference caused by synthetic substitutes, enhancing clinical accuracy[8].
- Stem Cell-Derived RBCs: Over 73 patents target immortal stem cell lines for synthetic RBC production, with Terumo holding the largest portfolio[5][7].
Legal Challenges
- European Patent EP 0 258 708 (recombinant hemoglobin) faced opposition over novelty and inventive step, highlighting IP disputes in biotech[11].
Emerging Trends
- AI in Plasma Fractionation: Companies are integrating AI to optimize protein isolation and purity, reducing production costs[15].
- Military Applications: DARPA-funded projects aim to create shelf-stable blood substitutes for battlefield use, with USD 46 million invested in 2023[7].
Market Projections
| Segment | 2024 Value | 2030/2034 Projection | CAGR |
|---|---|---|---|
| Plasma Fractionation | USD 35.8 billion | USD 79.47 billion | 8.22% |
| Synthetic Blood Substitutes | USD 8.7 million | USD 36.7 million | 15.43% |
Key Challenges
- Regulatory Hurdles: Safety concerns over HBOC side effects (e.g., vasoconstriction) delay approvals[12][16].
- Supply Chain Constraints: Plasma collection shortages and high production costs limit scalability[3][15].
“The logical target of a blood transfusion is restoring oxygen-delivery capacity,” notes Marcos Intaglietta, highlighting the shift toward efficient substitutes[17].
Future Outlook
Innovations in synthetic hemoglobin, stem cell technologies, and AI-driven manufacturing are poised to address global blood shortages. Collaborative efforts between biotech firms and defense agencies (e.g., DARPA) will likely accelerate commercialization[7][14].
References
- https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=B05AA
- https://en.wikipedia.org/wiki/ATC_code_B05
- https://www.grandviewresearch.com/industry-analysis/plasma-fractionation-market-report
- https://pubchem.ncbi.nlm.nih.gov/patent/WO-2022258590-A1
- https://www.prweb.com/releases/artificial-blood-substitutes-market-worth-5-204-million-by-2022-843622504.html
- https://list.essentialmeds.org/files/trs/KmctuAAMtPBorqeQRged3u44S6eeGKQPvOfhGr65.pdf
- https://www.custommarketinsights.com/report/synthetic-blood-substitutes-and-blood-product-market/
- https://patents.google.com/patent/US20030027347A1/en
- https://www.knowmade.com/wp-content/uploads/2025/01/Bispecific-Ab-Patent-Landscape-2025-FLYER.pdf
- https://www.knowmade.com/wp-content/uploads/2025/01/Bispecific-Ab-Cancer-Patent-Landscape-2025-SAMPLE.pdf
- https://www.epo.org/en/boards-of-appeal/decisions/t980148eu1
- https://patents.justia.com/patents-by-us-classification/514/832
- https://www.marketresearchfuture.com/reports/artificial-blood-substitutes-market-26869
- https://bisresearch.com/industry-report/synthetic-blood-substitute-market.html
- https://www.precedenceresearch.com/plasma-fractionation-market
- https://www.databridgemarketresearch.com/reports/global-artificial-blood-substitutes-market
- https://news.stanford.edu/stories/2021/10/new-model-points-solution-global-blood-shortage
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