Drugs in ATC Class H04AA

Up to Top Level ATC Classes

Up to H - Systemic hormonal preparations, excluding sex hormones and insulins

Up to H04 - PANCREATIC HORMONES

Up to H04A - GLYCOGENOLYTIC HORMONES

Drugs in ATC Class: H04AA - Glycogenolytic hormones

Tradename	Generic Name
BAQSIMI	glucagon
GLUCAGON	glucagon
GVOKE HYPOPEN	glucagon
GVOKE KIT	glucagon
GVOKE PFS	glucagon
ZEGALOGUE	dasiglucagon hydrochloride
ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride

H04AA Market Analysis and Financial Projection

The market for ATC Class H04AA (Glycogenolytic hormones) revolves primarily around glucagon, the sole therapeutic agent in this category, with significant growth driven by diabetes management needs and evolving patent strategies. Below is an analysis of the market dynamics and patent landscape:

---

Market Dynamics

Growth Drivers

• Rising Diabetes Prevalence:
  Over 529 million people globally had type 2 diabetes in 2021[18], increasing demand for glucagon to treat severe hypoglycemia in insulin-dependent patients.
• Product Innovations:
  • Autoinjectors and nasal sprays (e.g., Dasiglucagon) improve emergency hypoglycemia treatment accessibility[9][16].
  • Stable formulations reduce reliance on reconstitution, enhancing usability[9].
• Expanded Applications:
  Glucagon is used diagnostically in gastrointestinal imaging and off-label for cardiogenic shock[1][7].

Market Projections

• Valuation:
  The global market was valued at $278.5 million (2022) and is projected to grow at 6.8% CAGR through 2030, reaching $470.8 million[10]. Alternate estimates suggest $0.3 billion (2023) growing to $0.6 billion by 2033[16].
• Regional Dominance:
  North America holds 85.89% market share (2022)[10], driven by high diabetes prevalence and advanced healthcare infrastructure.

Segment Analysis

• By Application:
  • Hypoglycemia: Dominates revenue (33% of insulin-treated patients experience episodes)[10].
  • Diagnostic Aid: Smaller market share due to limited approved products[10].
• Distribution Channels:
  Retail pharmacies lead sales, with ~1.2 million glucagon units sold annually in Europe[10].

Challenges

• High Costs and Storage Requirements: Temperature-sensitive formulations limit accessibility in developing regions[16].
• Awareness Gaps: Underutilization in low-income countries due to limited hypoglycemia management protocols[16].

---

Patent Landscape

Strategic Patenting Trends

• Device Patents Over Active Ingredients:
  • 57% of patents for GLP-1 receptor agonists (related to glucagon) cover delivery devices rather than active ingredients, creating "patent thickets"[13][17].
  • Examples include autoinjectors and nasal delivery systems[19].
• Extended Exclusivity:
  Median exclusivity for GLP-1 drugs spans 18.3 years through post-approval patents and regulatory exclusivities[17].

Key Innovations

• Nasal Glucagon:
  Amphastar Pharmaceuticals’ patent (US12226456) protects a nasal powder formulation for rapid hypoglycemia treatment[19].
• Fusion Proteins:
  Ultra-stable insulin-glucagon analogs aim to reduce hypoglycemia risk in diabetes therapy[9].

Barriers to Generic Entry

• Patent Thickets:
  Median patent counts per drug exceed 20, with device patents complicating litigation for generics[13].
• Regulatory Hurdles:
  No generic GLP-1 receptor agonists have entered the U.S. market due to protracted patent disputes[17].

---

Competitive Landscape

Key Players

• Novo Nordisk, Eli Lilly, and Xeris Pharmaceuticals dominate with branded glucagon kits (e.g., Glucagen®, Gvoke®)[10][16].
• Zealand Pharma and Amphastar focus on next-gen formulations (e.g., pre-mixed glucagon)[9][16].

Future Outlook

• Biosimilar Opportunities: Patent expirations post-2030 may enable generic entries, reducing costs[16].
• Regulatory Reforms: Advocacy grows to limit non-innovative device patents, shortening exclusivity periods[13].

---

"Removing device patents would reduce patent thickets by 70%, accelerating generic competition." – JAMA Network Analysis[13].

---

The H04AA market is poised for steady growth but faces challenges from complex patent strategies. While innovation improves patient outcomes, systemic reforms are needed to balance affordability and accessibility.

References

1. https://go.drugbank.com/drugs/DB00040
2. https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=H04AA
3. https://www.kegg.jp/dbget-bin/www_bget?dr%3AD02118
4. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/09vLW9zMlcw.pdf
5. https://greenbook.nafdac.gov.ng/atc-classification
6. https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/nvNsI8S7K9U.pdf
7. https://pubchem.ncbi.nlm.nih.gov/compound/Glucagon
8. https://www.mordorintelligence.com/industry-reports/global-servo-motor-market
9. https://www.biorxiv.org/content/10.1101/2024.05.20.594997v1.full.pdf
10. https://www.fortunebusinessinsights.com/glucagon-market-108948
11. https://www.mordorintelligence.com/industry-reports/servo-drives-market
12. https://patents.google.com/patent/US5120712A/en
13. https://www.csrxp.org/dose-of-reality-big-pharma-building-patent-thickets-disconnected-from-actual-innovation-to-create-new-monopolies-on-glp-1-weight-loss-drugs/
14. https://www.zva.gov.lv/sites/default/files/2017-12/Baltic%20Statistics%20on%20Medicines%202013%20-%202015.pdf
15. https://www.uspto.gov/web/patents/classification/cpc/html/cpc-H04L.html
16. https://www.alliedmarketresearch.com/glucagon-market-A324426
17. https://pubmed.ncbi.nlm.nih.gov/37505513/
18. https://www.gminsights.com/industry-analysis/glucagon-market
19. https://patents.justia.com/patents-by-us-classification/514/11.7