Insulin degludec and liraglutide - Biologic Drug Details

Summary for insulin degludec and liraglutide

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for insulin degludec and liraglutide

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists
Established Pharmacologic Class	GLP-1 Receptor Agonist Insulin Analog
Chemical Structure	Glucagon-Like Peptide 1 Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin degludec and liraglutide Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec and liraglutide Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2036-02-19	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2026-07-25	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2038-11-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2036-03-14	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2038-07-06	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin degludec and liraglutide Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	XULTOPHY 100/3.6	insulin degludec and liraglutide	Injection	208583		2032-10-25	Patent claims search

International Patents for insulin degludec and liraglutide

Country	Patent Number	Estimated Expiration
China	101969990
China	107439588
Mexico	2017012433
Lithuania	3191139
Spain	2922632

Market Dynamics and Financial Trajectory for the Biologic Drugs: Insulin Degludec and Liraglutide

Last updated: August 7, 2025

Introduction

The global biologic drug market has witnessed exponential growth, driven by innovations targeting chronic diseases such as diabetes mellitus. Among these, insulin degludec and liraglutide stand out as transformative therapies, significantly impacting treatment paradigms. Their unique molecular profiles, mechanisms of action, and clinical benefits position them as pivotal in the landscape of diabetes management. This analysis explores the current market dynamics, competitive positioning, and financial trajectories of these two biologics, providing insights valuable for stakeholders and investors.

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Market Overview

The global diabetes therapeutics market was valued at approximately USD 80 billion in 2022, with biologic agents accounting for a significant share due to their superior efficacy and safety profile over conventional treatments [1]. The rising prevalence of diabetes, particularly type 2 diabetes mellitus (T2DM), and the adoption of innovative therapies, propel market expansion. Insulin degludec, a ultra-long-acting basal insulin, and liraglutide, a GLP-1 receptor agonist, exemplify these biologics' critical roles.

Insulin Degludec: Market Position and Dynamics

Insulin degludec, marketed by Novo Nordisk under the name Tresiba, is renowned for its ultra-long duration of action, providing stable glycemic control with a reduced risk of hypoglycemia. Since its approval in 2015, it has garnered a steady uptake, supported by clinical advantages over traditional insulins such as glargine [2]. Novo Nordisk, dominating the insulin market, benefits from robust brand recognition and a global distribution network, facilitating broader access.

Market penetration of insulin degludec is projected to grow at a CAGR of approximately 8% through 2027, driven by increasing diabetic populations and patient preferences for more convenient and safer insulin regimens [3]. The emergence of biosimilar insulins, however, introduces competitive pressures, potentially impacting pricing and market share.

Liraglutide: Market Dynamics and Growth Triggers

Liraglutide, introduced as Victoza by Novo Nordisk and later expanded as Saxenda for weight management, is positioned at the intersection of diabetes and obesity therapeutics. Its dual indication boosts its market potential. Liraglutide's mechanism, mimicking endogenous GLP-1, improves glycemic control, induces weight loss, and offers cardiovascular benefits, aligning with the holistic management of T2DM [4].

The GLP-1 receptor agonist class has experienced rapid growth, with liraglutide maintaining a leading position, especially in developed markets. Its sales trajectory reflects an estimated CAGR of 12% from 2022 to 2027, driven by expanding indications and increased adoption among clinicians [5].

Market Drivers and Challenges

• Prevalence and Demographics: The global diabetes burden is projected to reach 700 million by 2045, fueling sustained demand for advanced therapeutics (IDF, 2021).

• Clinical Advantages: Both drugs demonstrate superior efficacy and safety profiles, particularly in reducing hypoglycemia and cardiovascular risks. Such benefits underpin their prescription growth.

• Patient Preference: The convenience of once-daily administration, coupled with fewer hypoglycemic episodes, enhances adherence, further elevating market adoption.

• Regulatory Environment: Stringent approval pathways and the emergence of biosimilars introduce complexities. Regulatory approvals in emerging markets remain critical for volume expansion.

• Pricing and Reimbursement: Biologic therapies’ high costs pose barriers, though payers increasingly recognize their long-term cost-effectiveness, especially with better health outcomes.

Competitive Landscape

Novo Nordisk dominates the market with a comprehensive portfolio comprising insulins and GLP-1 receptor agonists. Eli Lilly and Sanofi are significant competitors, offering alternatives such as Trulicity and Lantus, respectively. Biosimilars for insulins threaten price stability, while new entrants, including oral GLP-1 analogs, are poised to disrupt traditional injection-based therapies.

Financial Trajectory and Revenue Outlook

Key financial aspects include:

• Revenue Growth: Novo Nordisk’s sales of Tresiba reached approximately USD 1.2 billion in 2022, with projections indicating sustained growth influenced by expanding indications and geographic penetration [6].

• Profitability: High-margin biologics contribute positively to the company’s operating income. However, R&D investments for emerging therapies and biosimilar development may impact short-term margins.

• Pricing Trends: Marginal pricing pressure exists in mature markets due to biosimilars and competitive offerings, but premium positioning of degludec and liraglutide helps maintain revenue streams.

• Pipeline and Innovation: Continual pipeline expansion, including next-generation insulin analogs and combination therapies, is expected to bolster long-term revenue growth.

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Emerging Trends and Future Outlook

The integration of biosimilars and fixed-dose combination products could significantly reshape the market landscape. The advent of oral GLP-1 formulations, improvements in insulin delivery devices, and digital health integrations are poised to enhance patient engagement and adherence, fostering incremental market expansion.

Regulatory support for novel delivery systems and personalized medicine approaches will further influence market dynamics. Additionally, expanding markets in Asia-Pacific and Africa present lucrative opportunities, although access and affordability issues remain critical.

Projected Market Trajectory

By 2030, the combined global revenues for insulin degludec and liraglutide are anticipated to surpass USD 20 billion, driven by increased prevalence, improved treatment guidelines, and expanding indications. Continued competitive innovations and strategic pricing will play determining roles in maintaining market dominance and profitability.

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Key Takeaways

• Robust Growth Dynamics: Insulin degludec and liraglutide are at the forefront of biologic diabetes therapies, with expected compound annual growth rates of approximately 8% and 12%, respectively, through 2027.

• Market Drivers: Rising global diabetes prevalence, clinical advantages, patient preferences, and expanded indications sustain demand.

• Competitive Pressures: Biosimilars and emerging delivery systems threaten pricing and market share; innovation remains critical.

• Financial Outlook: Leading manufacturers like Novo Nordisk foresee sustained revenue streams, subject to competitive and regulatory influences.

• Future Opportunities: Digital health integration, combination therapies, and emerging markets offer growth avenues, shaping the long-term financial trajectory.

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FAQs

Q1: How does insulin degludec differ from traditional basal insulins?

A1: Insulin degludec offers an ultra-long duration of action (>42 hours) with more stable basal insulin levels, reducing the risk of hypoglycemia, and providing flexible dosing without compromising efficacy, unlike traditional insulins with shorter durations.

Q2: What are the primary clinical benefits of liraglutide in managing T2DM?

A2: Liraglutide improves glycemic control, promotes weight loss, reduces cardiovascular risk, and has a convenient once-daily dosing schedule, making it a comprehensive therapy for T2DM management.

Q3: How will biosimilars impact the market for insulin degludec?

A3: Biosimilars are expected to introduce price competition, potentially reducing insulin degludec’s market share and prompting innovator companies to enhance formulations and delivery methods.

Q4: What is the role of digital health in the future market for these biologics?

A4: Digital health tools, such as continuous glucose monitoring and dose titration apps, will enhance management efficiency, patient adherence, and clinical outcomes, potentially increasing demand for biologic therapies.

Q5: Which emerging markets are likely to drive significant growth for insulin degludec and liraglutide?

A5: Asia-Pacific, Latin America, and Africa are anticipated to experience substantial growth due to expanding healthcare infrastructure, rising diabetes prevalence, and increasing adoption of novel therapies.

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References

[1] Grand View Research, "Diabetes Care Devices Market Size & Share Analysis," 2022.
[2] European Medicines Agency, "Tresiba Summary of Product Characteristics," 2015.
[3] MarketsandMarkets, "Insulin Market by Type, Distribution Channel, and Region," 2022.
[4] American Diabetes Association, "Standards of Medical Care in Diabetes—2022," Diabetes Care.
[5] IQVIA, "Pharmaceutical Market Analytics," 2022.
[6] Novo Nordisk Annual Report 2022.