Drugs in MeSH Category Glycine Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Icu Medical Inc	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018315-001	Approved Prior to Jan 1, 1982	AT	RX	No	No
Baxter Hlthcare	AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	017865-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Baxter Hlthcare	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018522-001	Feb 19, 1982		DISCN	No	No
Hospira	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	017633-001	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	016784-001	Approved Prior to Jan 1, 1982	AT	RX	No	No

Glycine Agents Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs classified under Glycine Agents (NLM MeSH Class D018684) reflect a rapidly evolving sector driven by diverse applications and innovative research. Glycine, a non-essential amino acid, is integral to pharmaceutical formulations, nutritional supplements, and agrochemicals, with its market projected to grow significantly alongside advancements in therapeutic targeting and production methods.

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Market Dynamics

Growth Drivers and Projections

• The global glycine market was valued at USD 5,010.05 million in 2023, with projections reaching USD 8,204.9 million by 2032 (CAGR: 5.2%)[1]. Alternate estimates forecast growth to USD 2.5 billion by 2035 (CAGR: 6.8%), driven by demand in pharmaceuticals, food additives, and animal feed[9][15].
• Pharmaceutical applications dominate, accounting for ~45% of market share, fueled by glycine’s role in intravenous solutions, neurological treatments, and anticancer agents[3][9]. For example, glycine metabolism alterations in cancer cells (e.g., A549 lung cancer) are being explored for therapeutic targeting[3].
• Regional trends highlight Asia-Pacific as the largest market due to robust manufacturing in China and India, while North America and Europe focus on high-value drug formulations[9][15].

Challenges

• Price volatility persists due to oversupply and competition; prices declined in late 2024 despite steady demand from food and pharmaceutical sectors[6].
• Regulatory hurdles and stringent quality standards complicate production, particularly for synthetic glycine used in drug formulations[15].

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Patent Landscape

Synthesis and Production Innovations

• Monochloroacetic acid (MCA)-based synthesis remains central, with patents like US3510515A and US5155264A refining yields (up to 90%) by optimizing hexamethylenetetramine (HMT) recycling and reaction conditions[2][7].
• Green chemistry advancements focus on reducing halogenated byproducts, as seen in US6663764B2, which emphasizes halogen-free glycine derivatives for cosmetics[17].

Therapeutic Applications

• Glycine Transporter-1 (GlyT-1) Inhibitors: Patents like WO2018132876A1 and US20100298341A1 target neuropathic pain and schizophrenia by enhancing synaptic glycine levels to modulate NMDA receptors[11][12][16]. Despite clinical setbacks in schizophrenia, GlyT-1 inhibitors are explored for ADHD and cognitive disorders[12].
• Receptor Modulation: Antibodies targeting glycine receptors (e.g., α3-subunit-selective biologics) show promise in pain management with improved safety profiles[14]. Molecular dynamics studies reveal allosteric binding sites for endocannabinoids, guiding drug design[13].

Competitive Strategies

• Major players like Ajinomoto, Evonik, and GEO Specialty Chemicals prioritize biotechnological production and strategic partnerships to expand capacity[9].
• Drug delivery innovations address peptide instability, with controlled-release systems enhancing glycine-based therapeutic efficacy[5].

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Future Directions

• Biologics Development: Antibodies and recombinant proteins targeting glycine receptors (e.g., GlyR α3) aim to improve specificity in treating neurological disorders[14].
• Sustainable Production: Investment in enzymatic and microbial synthesis methods aims to reduce reliance on chemical processes[9][15].
• C1 Metabolism Engineering: Research into glycine cleavage systems (GCS) explores applications in synthetic biology for CO₂ utilization[10].

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Key Takeaways

• The glycine market is expanding due to its versatility in pharmaceuticals, food, and agriculture, though price volatility and regulatory challenges persist.
• Patent activity emphasizes synthetic efficiency, neurological therapeutics, and biologics, with GlyT-1 inhibitors and receptor modulators leading innovation.
• Asia-Pacific dominates production, while R&D in North America and Europe focuses on high-margin drug formulations and targeted therapies.

References

1. https://www.einpresswire.com/article/793048896/glycine-market-size-projected-to-reach-usd-8-204-9-million-by-2032-at-a-cagr-of-5-2
2. https://patents.google.com/patent/US3510515A/en
3. https://pubmed.ncbi.nlm.nih.gov/32430875/
4. https://www.drugpatentwatch.com/p/generic-api/GLYCINE
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC10526705/
6. https://www.procurementresource.com/resource-center/glycine-price-trends
7. https://patents.google.com/patent/US5155264A/en
8. https://meshb.nlm.nih.gov/record/ui?ui=D018684
9. https://www.globenewswire.com/news-release/2025/01/28/3016512/0/en/Global-Glycine-Market-to-Hit-USD-2-5-Billion-by-2035-Growing-at-a-Robust-CAGR-of-6-8-Future-Market-Insights-Inc.html
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC7733448/
11. https://patents.google.com/patent/WO2018132876A1/en
12. https://pubmed.ncbi.nlm.nih.gov/29338548/
13. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0023886
14. https://pubmed.ncbi.nlm.nih.gov/35926871/
15. https://www.theinsightpartners.com/reports/glycine-market
16. https://uspto.report/patent/app/20100298341
17. https://patents.justia.com/patent/6663764

Last updated: 2025-03-29