Insulin degludec and insulin aspart - Biologic Drug Details

Summary for insulin degludec and insulin aspart

Tradenames:	1
High Confidence Patents:	9
Applicants:	1
BLAs:	1

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 insulin aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec and insulin aspart 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2034-08-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-12-14	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-11-01	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-12-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2039-08-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2017-06-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin degludec and insulin aspart 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2039-06-21	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2033-10-09	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2032-10-25	Patent claims search

International Patents for insulin degludec and insulin aspart

Country	Patent Number	Estimated Expiration
Denmark	1819382
Australia	2013229432
Canada	2721927
Denmark	2107069
Japan	7138639
Russian Federation	2352581

Supplementary Protection Certificates for insulin degludec and insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300596	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
C02107069/02	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
C02107069/01	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC; SWISSMEDIC-ZULASSUNG, 62562 12.03.2013
132013902172094	Italy		PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART(RYZODEG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/806/001-004-005-007-008, 20130121
C 2013 022	Romania		PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121
13C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121

Market Dynamics and Financial Trajectory for Insulin Degludec and Insulin Aspart

Last updated: July 28, 2025

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Introduction

The global insulin market is undergoing transformative shifts driven by technological advancements, evolving patient demographics, and competitive innovation. Among prominent biologic formulations, insulin degludec and insulin aspart have garnered significant attention due to their enhanced pharmacokinetic profiles and clinical efficacy. This report analyzes current market dynamics and forecasts the financial trajectories of these two drugs, emphasizing key factors shaping their growth prospects.

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Market Overview

The global insulin market, valued at approximately USD 57 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of around 8% through 2030 (1). While traditional insulins dominated historically, the market increasingly favors ultra-long-acting and rapid-acting analogs—categories to which insulin degludec and insulin aspart belong.

Insulin Degludec is an ultra-long-acting basal insulin developed by Novo Nordisk that offers a near 42-hour duration, providing more stable glucose control with a lower risk of hypoglycemia (2). Insulin Aspart, a rapid-acting insulin marketed as NovoLog/NovoRapid, delivers swift glucose reduction around meals, improving postprandial control.

The growth of these agents is intertwined with the rising prevalence of diabetes mellitus globally, notably type 2 diabetes. The International Diabetes Federation estimates that about 537 million adults lived with diabetes in 2021, with projections exceeding 700 million by 2045 (3). Such epidemiological trends underpin a sustained increase in insulin demand.

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Market Dynamics Influencing Revenue and Adoption

1. Competitive Landscape

The dominance of Novo Nordisk and Eli Lilly is noteworthy. Novo Nordisk’s insulin degludec holds a prominent position in basal insulin therapy, while NovoRapid continues to be a preferred rapid-acting agent (4). Eli Lilly’s Trulicity and Humalog also compete vigorously, influencing pricing strategies and market access.

Generic and biosimilar entry remains limited but is gaining momentum, especially for older basal insulins, pressuring branded products to innovate further. This competition affects revenue streams but also the pace of growth for newer biologics.

2. Clinical Advantages and Patient Preference

Insulin degludec's ultra-long duration reduces injection frequency and variability, leading to better adherence and fewer hypoglycemic episodes. This confers a considerable advantage over traditional basal insulins. Its improved safety profile fosters clinician and patient preference, particularly in resource-limited settings with adherence challenges (2).

Insulin aspart offers rapid onset and offset, critical for post-meal glycemic control. Its predictable pharmacokinetics bolster confidence among clinicians, influencing prescribing patterns.

3. Regulatory Approvals and Geographic Penetration

Approval timelines in emerging markets and regulatory incentives influence sales. For instance, China’s increasing acceptance of biosimilar insulins aims to reduce prices and expand access, thus augmenting sales for both insulin degludec and insulin aspart (5).

Market access barriers, including reimbursement policies, significantly impact revenue streams. In high-income countries, insurance coverages generally favor newer insulins, enhancing their financial outlook.

4. Pricing Strategies and Reimbursement

Higher list prices for branded insulin degludec and insulin aspart are offset in many markets by insurance reimbursements. However, in some regions, especially with aggressive biosimilar competition, prices tend to decline, compressing profit margins but expanding volume.

Additionally, patient assistance programs and tiered copayment models influence utilization rates. Manufacturers are investing in digital health solutions to promote adherence and expand market share.

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Financial Trajectory and Revenue Forecasts

Historical Performance

From 2018 to 2022, insulin degludec reported steady revenue growth, driven by increased adoption in North America and Europe—regions accounting for approximately 75% of total sales (4). Novo Nordisk's diabetes segment, which includes both insulin degludec and insulin aspart, experienced a CAGR of about 9% during this period.

Insulin aspart sales benefited from incremental dosing advances and formulations that improved absorption. In 2021, global sales of insulin aspart reached approximately USD 4 billion, with notable expansion in Asian markets (6).

Projected Growth Factors

• Epidemiological Increase: Rising global diabetes prevalence is expected to sustain demand.
• Innovation and Line Extensions: Transition to biosimilars or next-generation formulations could dilute individual drug revenues but may also stimulate market expansion.
• Digital and Personalized Medicine: Integration of continuous glucose monitoring (CGM) and insulin delivery devices can improve outcomes, boosting sales.
• Market Penetration in Emerging Economies: Growth opportunities are substantial, particularly with a focus on price-sensitive markets.

Forecasted Revenue Trajectory (2023–2030)

• Insulin Degludec: Estimated to maintain a CAGR of approximately 8–10%, reaching USD 6.5–7 billion globally by 2030. Adoption will be enhanced by regional approvals and formulary placements.
• Insulin Aspart: Projected to grow at a CAGR of around 6–8%, with anticipated revenues exceeding USD 5 billion by 2030, driven by its critical role in intensive insulin regimens.

These projections are predicated on continued innovation, expanded access, and competitive pricing strategies. Patent cliffs, such as Novo Nordisk's expiry of certain formulations, may introduce biosimilar competition that forces price reductions, slightly tempering growth.

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Market Risks and Opportunities

Risks

• Patent Expiries and Biosimilar Competition: Will pressure prices, reduce margins, and influence market share.
• Regulatory Hurdles: Delays or adverse rulings could impede market expansion.
• Pricing Pressures: Global push for lower-cost insulins may limit revenue growth.

Opportunities

• Emerging Markets Expansion: Untapped markets present substantial growth potential.
• Technological Integration: Development of smart insulin delivery systems could redefine treatment paradigms.
• Personalized Medicine: Tailoring insulin regimens promises improved adherence and outcomes, positively impacting sales.

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Conclusion

The financial trajectory of insulin degludec and insulin aspart remains robust, grounded in their clinical advantages and a burgeoning global diabetes population. While competitive forces and regulatory developments pose risks, strategic innovation and market expansion provide avenues for sustained growth. Sector stakeholders must leverage technological advancements and geographic diversification to optimize revenue streams in an evolving landscape.

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Key Takeaways

• The global insulin market is projected to grow at a CAGR of approximately 8% through 2030, with insulin degludec and insulin aspart key contributors.
• Their unique pharmacokinetics offer clinical advantages, dictating superior market penetration and patient adherence.
• Novo Nordisk maintains a dominant position, with projected revenues for insulin degludec surpassing USD 7 billion by 2030.
• Biosimilar competition and patent expiries will influence pricing strategies but also open new markets.
• Emerging economies represent significant growth opportunities, especially with the increased acceptance of biosimilars and affordability programs.

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FAQs

1. How do insulin degludec and insulin aspart differ from traditional insulins?
Insulin degludec offers ultra-long basal action, reducing injection frequency and hypoglycemia risk, while insulin aspart provides rapid glucose lowering around meals, improving postprandial glucose control.

2. What are the main market drivers for these biologics?
Growing diabetes prevalence, improved clinical profiles, patient adherence benefits, and technological integration drive demand for insulin degludec and insulin aspart.

3. How will biosimilar entry impact the revenues of these insulins?
Biosimilar competition generally exerts downward pressure on prices, which might reduce revenue margins but can increase volume and market access, especially in price-sensitive markets.

4. What role does innovation play in the future of these insulins?
Innovations such as biosimilar formulations, smart insulin delivery devices, and personalized dosing algorithms will influence market share and revenue growth.

5. Which regions are expected to see the highest growth for these drugs?
Emerging markets within Asia, Latin America, and Africa offer considerable expansion opportunities owing to increasing diabetes prevalence and evolving healthcare infrastructure.

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References

1. IQVIA, "Global Insulin Market Report," 2022.
2. Novo Nordisk, "Insulin Degludec Clinical Data," 2021.
3. International Diabetes Federation, "Diabetes Atlas," 2021.
4. Novo Nordisk Annual Report, 2022.
5. Chinese National Medical Products Administration, "Biosimilar Insulin Approvals," 2022.
6. GlobalData, "Insulin Market Insights," 2021.