GLP-1 Receptor Agonist Drug Class List

Drugs in Drug Class: GLP-1 Receptor Agonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,906,851*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,501,698*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	7,612,176*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	6,515,117*PED				Y

GLP-1 Receptor Agonist Market Analysis and Financial Projection

The GLP-1 receptor agonist market is experiencing explosive growth fueled by rising global diabetes and obesity rates, while complex patent strategies and regulatory exclusivities create barriers to competition. Below is a comprehensive analysis of market dynamics and intellectual property trends:

Market Growth Projections

• Global sales are projected to reach $157.5 billion by 2035 (CAGR 11.1% from 2024)[1][14], with diabetes accounting for over 75% of current demand and obesity treatments driving 41% growth since 2024[1][4].
• Short-term forecasts predict a 5.7% CAGR (2025-2029) to $17.72 billion for diabetes-focused applications[12], while obesity-related GLP-1 sales could hit $58 billion by 2030[1].

Key Growth Drivers

1. Disease Burden:

   • 537 million adults with diabetes (2021), projected to reach 783 million by 2045[3]
   • 4 billion people expected to be overweight/obese by 2035[11]

2. Therapeutic Advantages:

   • Dual HbA1c reduction and weight loss effects[11]
   • Cardiovascular risk reduction (14-26% lower MACE risk)[3]

3. Formulation Innovation:

   • Once-weekly injectables increased adherence by 35% vs daily options[11]
   • Oral semaglutide achieving 1.5% greater HbA1c reduction than injectables[6]

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Regional Market Dynamics

Region	Market Share (2024)	Growth Drivers
North America	77.7%	High obesity rates (42.4% adults), premium pricing ($1,300/month)[3][17]
Asia-Pacific	19% CAGR	228M diabetic patients in China, $12B diabetes care market expansion[7][16]
Europe	22% of global	Universal healthcare adoption, 60% reimbursement coverage for GLP-1 RAs[3][12]

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Patent Landscape & Competitive Strategies

Core Challenges for Generics:

• Patent Thickets: Median 19.5 patents per drug (54% device patents)[2][5]
• Extended Exclusivity: 18.3 years average protection post-FDA approval[5]
• Litigation Barriers: 40 patent infringement lawsuits filed on 5 major products[8]

Brand-Name Tactics:

1. Device Patent Proliferation: 57% of Ozempic patents cover injector pens[8]
2. Secondary Patents: Novo Nordisk filed 22 post-approval patents for liraglutide[2]
3. Regulatory Exclusivity Stacking: Median 3 non-patent exclusivities per product[5]

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Market Constraints

1. Cost Barriers:

   • Development costs exceed $2.6B per new drug[3]
   • Current pricing: $900-$1,500/month (US), 45% higher than insulin analogs[11][13]

2. Manufacturing Complexity:

   • Biologic production requires $24B facility investments[13]
   • Stability challenges limit biosimilar development[9]

3. Access Limitations:

   • Only 8% diabetes/2% obesity patients currently treated[1]
   • 68% of US insurers impose prior authorizations[4]

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Emerging Opportunities

1. New Indications:

   • Neuroprotection (28% lower Parkinson's risk in trials)[6]
   • Cardiovascular (23% HF risk reduction in SELECT trial)[11]

2. Pipeline Innovations:

   • 150+ candidates in development, including triple agonists[14]
   • 73% of Phase III trials targeting obesity-comorbidities[14]

3. Market Expansion:

   • Oral formulations projected to capture 35% market share by 2030[16]
   • Combination therapies with amylin analogs showing additive effects[11]

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"Removing device patents could reduce patent thickets by 67% and shorten exclusivity by 2.6 years" [8][10] — Highlighting potential reform impacts.

The GLP-1 market stands at a crossroads, with therapeutic promise balanced against access barriers. While pipeline innovation and expanding indications suggest sustained growth, patent reforms and manufacturing breakthroughs will determine whether these therapies achieve population-scale impact.

References

1. https://www.tdsecurities.com/ca/en/glp1-market-the-pipeline-expands
2. https://pubmed.ncbi.nlm.nih.gov/37505513/
3. https://www.coherentmarketinsights.com/market-insight/glp-1-receptor-agonist-market-4632
4. https://www.iqvia.com/blogs/2024/03/decoding-the-buzz-around-weight-loss-medications
5. https://jamanetwork.com/journals/jama/fullarticle/2808050
6. https://www.towardshealthcare.com/insights/glp-1-receptor-agonist-market-sizing
7. https://www.insightaceanalytic.com/report/glp-1-market/2592
8. https://jamanetwork.com/journals/jama/fullarticle/2814942
9. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3038-Initial-Transfer-Order-7-22.pdf
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC10845039/
11. https://www.gminsights.com/industry-analysis/glp-1-receptor-agonist-market
12. https://www.researchandmarkets.com/reports/5806922/glp-1-receptor-agonist-market-report
13. https://journals.library.columbia.edu/index.php/stlr/blog/view/653
14. https://www.globenewswire.com/news-release/2025/03/18/3044263/0/en/GLP-1-Market-Industry-Trends-and-Global-Forecasts-2024-2035-Over-150-GLP-1-Drug-Candidates-in-Development-for-Multiple-Indications-Type-2-Diabetes-and-Obesity-Drive-GLP-1-Drug-Deve.html
15. https://ipwatchdog.com/2025/01/28/growing-market-weight-loss-treatments-innovation-patents-future-glp-1-agonists/id=185416/
16. https://www.persistencemarketresearch.com/market-research/glp-1-receptor-agonist-market.asp
17. https://www.grandviewresearch.com/industry-analysis/glp-1-receptor-agonist-market