Drugs in MeSH Category Antisickling Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075143-002	Sep 21, 2000		DISCN	No	No
Leading	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	213438-001	Apr 8, 2020	AB	RX	No	No
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes
Qilu	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	218021-001	Mar 6, 2024	AB	RX	No	No

Antisickling Agents Market Analysis and Financial Projection

The market for antisickling agents is rapidly evolving, driven by advancements in drug development and a growing emphasis on addressing the global burden of sickle cell disease (SCD). Below is an analysis of the market dynamics and patent landscape:

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Market Dynamics

Growth Projections

• The global anemia drugs market is projected to reach $43.1 billion by 2031, growing at a CAGR of 9.4%[2].
• The SCD therapeutics market is expected to expand from $4.5 billion in 2024 to $10 billion by 2033 (CAGR: 9.5%)[13], with other estimates forecasting growth to $12.38 billion by 2032 (CAGR: 20%)[19].

Key Drivers

1. High Disease Prevalence:
   • SCD affects 1 in 500 African Americans, with ~300,000 infants born annually with the disease globally[2][18].
   • In India, 57% of women and 25% of men (15–49 years) suffer from anemia[2].
2. Innovative Therapies:
   • Gene-editing technologies (e.g., CRISPR-Cas9) and antisickling small molecules (e.g., 5-hydroxymethylfurfural [5-HMF], voxelotor) are revolutionizing treatment[11][12][19].
   • Sevuparin (Modus Therapeutics) and GBT440 (Global Blood Therapeutics) show promise in reducing vaso-occlusive crises[4][11].
3. Regional Expansion:
   • North America dominates the market (CAGR: 9.1%), while Asia-Pacific is the fastest-growing region (CAGR: 9.9%)[2].

Challenges

• High costs of novel therapies (e.g., gene therapies like CTX001) and limited accessibility in low-resource regions[18][19].
• Complex manufacturing processes for biologics like Sandostatin LAR[8].

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Patent Landscape

Key Patents and Innovations	Patent/Drug	Mechanism	Key Players	Expiry/Status
Sevuparin	Low-anticoagulant heparin derivative	Modus Therapeutics	Protected until 2032[4]
5-HMF	Stabilizes hemoglobin’s R-state	AesRx, NIH	Phase 1/2a trials[11][16]
Betulinic acid derivatives	Inhibits erythrocyte sickling	Academic/Pharma collaborations	Preclinical[10]
Hydroxyurea	Induces fetal hemoglobin	Generic manufacturers	Off-patent, widely used[7]

Emerging Trends

• CRISPR-based therapies: Patents for gene-editing technologies (e.g., CTX001) are reshaping SCD treatment pipelines[14][19].
• Combination therapies: Agents targeting multiple pathways (e.g., adhesion inhibitors + antisickling drugs) are under development[1][6].

Competitive Landscape

• Dominant Players: Novartis, Bristol-Myers Squibb, Global Blood Therapeutics (Pfizer), and CRISPR Therapeutics[13][14].
• Pipeline Focus: Over 30% of pipeline drugs are small molecules, followed by gene therapies and monoclonal antibodies[14].

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Key Market Segments

1. Drug Class:
   • Hydroxyurea remains the gold standard (44% market share in 2023)[18].
   • Adakveo (crizanlizumab) is the fastest-growing segment due to its efficacy in reducing VOC episodes[18].
2. Therapeutic Approach:
   • Antisickling agents (e.g., voxelotor) accounted for $2.4 billion in 2023, driven by FDA approvals[19].

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Future Outlook

• Gene therapies are expected to dominate post-2030, with patents for CRISPR-based treatments like CTX001 nearing commercialization[14][19].
• Affordable generics: Expiry of patents for drugs like Sprycel and Tysabri in 2024 will increase accessibility[8].

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Highlight

"The grant of two U.S. patents for sevuparin provides critical IP protection for a drug targeting vaso-occlusive crises, a major unmet need in SCD."[4]

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This market is poised for transformative growth, blending innovative therapeutics with strategic IP developments to address the complexities of sickle cell disease.

References

1. https://patents.justia.com/patents-by-us-classification/514/815
2. https://straitsresearch.com/report/anemia-drugs-market
3. https://pubmed.ncbi.nlm.nih.gov/38842004
4. https://sicklecellanemianews.com/news/modus-therapeutics-issued-2-us-patents-sickle-cell-disease-therapy/
5. https://patents.google.com/patent/US8304233B2/en
6. https://patents.google.com/patent/US20060115459A1/en
7. https://www.pharmacompass.com/chemistry-chemical-name/hydroxycarbamide
8. https://www.geneonline.com/a-look-at-2024s-patent-expirations-and-generic-competition/
9. http://connect.rtrn.net/profiles/profile/65587
10. https://patents.google.com/patent/WO2011064710A1/en
11. https://pubmed.ncbi.nlm.nih.gov/27605087/
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC5035193/
13. https://www.verifiedmarketreports.com/product/sickle-cell-disease-drug-market/
14. https://www.globaldata.com/store/report/sickle-cell-disease-drugs-in-development-analysis/
15. https://www.emjreviews.com/hematology/article/different-therapeutic-interventions-and-mechanisms-of-action-of-antisickling-agents-currently-in-use-in-sickle-cell-disease-management/
16. https://www.biospace.com/aesrx-anti-sickling-drug-aes-103-enters-phase-1-2a-clinical-trial-at-national-institutes-of-health-nih
17. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v1.full
18. https://www.alliedmarketresearch.com/sickle-cell-disease-treatment-market-A31450
19. https://www.globenewswire.com/news-release/2024/11/07/2976398/0/en/Sickle-Cell-Disease-Market-Reach-USD-12-38-Bn-by-2032-Set-to-Grow-Remarkable-CAGR-of-20-00-from-2024-2032.html