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Drugs in ATC Class A10BJ
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Drugs in ATC Class: A10BJ - Glucagon-like peptide-1 (GLP-1) analogues
| Tradename | Generic Name |
|---|---|
| BYDUREON | exenatide synthetic |
| BYDUREON PEN | exenatide synthetic |
| BYETTA | exenatide synthetic |
| >Tradename | >Generic Name |
A10BJ Market Analysis and Financial Projection
The global market for glucagon-like peptide-1 (GLP-1) analogues has transformed into one of pharma’s most dynamic sectors, driven by groundbreaking therapeutic applications and aggressive intellectual property strategies. With projected growth from $47.4 billion in 2024 to $471.1 billion by 2032 (33.2% CAGR), this market exemplifies how patent systems and therapeutic innovation intersect[1][3].
Market Dynamics of GLP-1 Analogues
Explosive Growth Drivers
- Obesity and Diabetes Epidemic: Over 41% of U.S. adults have obesity, while 11.3% have diabetes—conditions where GLP-1 drugs like Ozempic and Wegovy show dual efficacy[7][10].
- Therapeutic Expansion: Beyond diabetes, these drugs are now studied for Alzheimer’s (neuroprotective effects), NASH (reducing liver fat), and cardiovascular risk reduction[3][6].
- R&D Investment: Pharma giants invested $83 billion in U.S. R&D in 2023, with diabetes/obesity treatments as a priority[7]. Novo Nordisk and Eli Lilly dominate 90% of marketed products through proprietary formulations[3].
Delivery Devices Fuel Adoption
Single-dose autoinjectors (e.g., Ozempic’s pen) account for 57% of patents, simplifying administration and improving adherence[3][16]. This focus on user-friendly devices has made weekly injections a standard, contributing to Ozempic’s 2023 market leadership[3].
Patent Landscape: Barriers to Competition
Brand-name manufacturers employ multilayered strategies to block generics:
| Strategy | Impact | Example |
|---|---|---|
| Preapproval Patents | Median 17 patents filed before FDA OK | Novo’s Semaglutide (20+ patents) |
| Device Patents | 54% of all GLP-1 patents target devices | Eli Lilly’s Trulicity pen[2][8] |
| Regulatory Exclusivity | Adds 2–6 years post-approval | Byetta’s 4.8-year extension[8] |
Combined, these tactics yield 18.3 years of market exclusivity per product—nearly double the typical 10-year window[2][12]. No generic GLP-1 agonist has reached the U.S. market despite 70+ patent lawsuits[16].
Regional and Segment Breakdown
Geographic Hotspots
- North America (77% market share): High insurance coverage and obesity rates drive demand[10].
- Asia-Pacific (fastest growth): China’s inclusion of GLP-1s in national insurance and Japan’s aging population fuel expansion[10][14].
Product Segmentation
- Ozempic leads with 33% revenue share due to brand recognition[3].
- CagriSema (Novo Nordisk): Upcoming obesity/diabetes combo projected to capture 15% of Novo’s 2030 sales[3].
Future Trends and Challenges
Opportunities
- Oral Formulations: Novo’s Rybelsus (first oral GLP-1) and Innovent’s mazdutide aim to expand patient preference[3][10].
- Cardiometabolic Pipelines: 45+ candidates target heart failure, NASH, and OSA[1][6].
Barriers
- Duopoly Control: Novo and Lilly’s 2032 revenue share could hit 78%, stifling new entrants[3][10].
- Cost Pressures: At $800–$1,200/month, these drugs burden payers—GLP-1s now account for 9% of U.S. employer prescription spending[5].
“Patent reform is critical to ensure timely generic entry.”
— JAMA Study on GLP-1 Exclusivity[2][12]
Key Takeaways
- Market Growth: 33% CAGR through 2032, fueled by obesity/diabetes demand[1][3].
- Patent Barriers: 19.5 patents per product, primarily on devices, delay generics until the 2040s[2][8].
- Innovation vs. Access: While R&D expands indications, high costs ($9.1 trillion obesity-related healthcare spend by 2035) necessitate policy changes[5][12].
FAQs
1. Why are GLP-1 analogues so expensive?
Manufacturers use 18+ years of patent protection to maintain exclusivity, preventing cheaper alternatives[2][8].
2. When will generics enter the market?
Earliest expirations (e.g., exenatide) occur post-2030, but device patents may extend timelines[16].
3. Which companies lead the market?
Novo Nordisk (Ozempic/Wegovy) and Eli Lilly (Mounjaro/Zepbound) control 90% of sales[3][10].
4. How do delivery devices affect competition?
Device patents (54% of total) force generics to redesign injection systems, delaying FDA approval[16].
5. What’s next for GLP-1 therapies?
Oral formulations and combinations (e.g., CagriSema) aim to improve adherence and broaden applications[3][10].
Sources
- MarketsandMarkets GLP-1 Report, 2024
- JAMA Network, 2023
- MarketsandMarkets Analysis, 2023
- Gallagher Re, 2025
- PMC, 2024
- Grand View Research, 2030
- PubMed, 2023
- PMC, 2024
References
- https://www.prnewswire.com/news-releases/glp-1-analogues-market-forecast-usd-471-1-billion-by-2032-with-a-33-2-cagr--marketsandmarkets-302194539.html
- https://jamanetwork.com/journals/jama/fullarticle/2808050
- https://www.marketsandmarkets.com/Market-Reports/glp-1-analogues-market-218746186.html
- https://pubmed.ncbi.nlm.nih.gov/38315473/
- https://www.ajg.com/gallagherre/-/media/files/gallagher/gallagherre/news-and-insights/2025/march/gallagherre-glp-1-impact-on-medical-trend-and-reinsurance.pdf
- https://www.alliedmarketresearch.com/glucagon-like-peptide-1-agonists-market-A324075
- https://www.verifiedmarketresearch.com/product/glp-1-analogues-market/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11457043/
- https://atcddd.fhi.no/atc_ddd_index/?code=A10BJ
- https://www.grandviewresearch.com/industry-analysis/glp-1-receptor-agonist-market
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11490655/
- https://pubmed.ncbi.nlm.nih.gov/37505513/
- https://www.atccode.com/A10BJ
- https://www.towardshealthcare.com/insights/glp-1-receptor-agonist-market-sizing
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8590792/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10845039/
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