Insulin aspart - Biologic Drug Details

Summary for insulin aspart

Tradenames:	2
High Confidence Patents:	18
Applicants:	1
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for insulin aspart
Drug Prices:	Drug price information for insulin aspart

Recent Clinical Trials for insulin aspart

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Yanbing Li	PHASE4
Novo Nordisk A/S	PHASE3
Gan & Lee Pharmaceuticals.	PHASE3

See all insulin aspart clinical trials

Pharmacology for insulin aspart

Established Pharmacologic Class	Insulin Analog
Chemical Structure	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 aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for 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.	NOVOLOG	insulin aspart	Injection	020986		2039-06-25	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2006-08-29	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-03-24	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-09-26	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2017-06-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for 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.	NOVOLOG	insulin aspart	Injection	020986		2033-06-12	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2036-12-20	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2035-11-30	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2035-07-16	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2036-09-08	Patent claims search

International Patents for insulin aspart

Country	Patent Number	Estimated Expiration
Taiwan	I459962
Japan	5431241
Australia	2795192
Russian Federation	2016132340
Poland	374182

Supplementary Protection Certificates for insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2017 00026	Denmark		PRODUCT NAME: CERTIFIKAT; REG. NO/DATE:
122017000040	Germany		PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
300880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
32/2000	Austria		PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623

Market Dynamics and Financial Trajectory for Insulin Aspart

Last updated: December 23, 2025

Summary

Insulin aspart, a rapid-acting insulin analog, plays a crucial role in managing diabetes mellitus type 1 and 2. As its global demand increases driven by rising diabetes prevalence, technological innovations, and evolving payer structures, understanding its market dynamics and financial trajectory is essential for stakeholders. This article presents a comprehensive analysis of the current landscape, projected growth, competitive positioning, pricing strategies, and regulatory influences shaping the insulin aspart market.

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Introduction to Insulin Aspart

Insulin aspart is a recombinant DNA-derived fast-acting insulin analog developed to mimic endogenous insulin responses more closely. Key features include:

Attribute	Specification
Molecular Structure	Aspart amino acid substitution at B28 position of human insulin
Onset of Action	Approximately 10-20 minutes post-injection
Peak Activity	1-3 hours
Duration	3-5 hours
Brand	Novolog (Novo Nordisk), Fiasp (Novo Nordisk, with niacinamide)

The drug's rapid pharmacokinetics favor tighter postprandial glucose control, establishing it as a preferred option in insulin therapy regimes.

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Market Size and Growth Drivers

Global Market Overview

Metric	2022 Estimate	2027 Forecast	CAGR (2022-2027)
Market Value	$4.2 billion	$7.1 billion	10.9%
Units Sold (million pens/vials)	170	290	--

(Sources: IQVIA, Global Data)

Key Growth Drivers

• Rising Diabetes Prevalence

  Diabetes affects approximately 537 million adults globally, projected to reach 643 million by 2030. Rising incidence fuels the demand for advanced insulin therapies like insulin aspart [[1]].

• Shift Toward Rapid-Acting Insulins

  Clinical guidelines increasingly favor rapid-acting insulins for better postprandial control, expanding market share [[2]].

• Innovative Formulations

  Introduction of faster-acting formulations like Fiasp enhances therapeutic options and widens market applications.

• Technological Integration

  Usage with insulin pumps and continuous glucose monitoring (CGM) systems boosts demand.

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Competitive Landscape

Major Players

Company	Product(s)	Market Share (2022)	Notes
Novo Nordisk	NovoLog, Fiasp	~55%	Leader in rapid-acting insulins
Eli Lilly	Humalog (Lispro), Lyumjev (Lispro U-300)	~25%	Focus on fast-acting insulins
Sanofi	Apidra	~10%	Smaller player in rapid-acting segment
Others	Biosimilar and emerging brands	~10%	Increasing entry barriers

Market share approximations based on IQVIA data (2022).

Biosimilars and Market Entry

As patents expired or are nearing expiry (e.g., NovoLog’s patent expiry in 2023), biosimilar entrants are poised to challenge incumbents, potentially reducing prices and expanding access [[3]].

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Pricing Strategies and Reimbursement Policies

Pricing Dynamics

Brand	Wholesale Acquisition Cost (WAC) per Unit	Estimated Annual Cost (per patient)	Notes
NovoLog (Fiasp)	~$0.30 per IU	$2,400–3,600	Higher due to innovation premium
Humalog	~$0.27 per IU	$2,200–3,300	Competitor with similar profile

Reimbursement Landscape

• United States

  Medicare and private insurers increasingly favor biosimilars, but high list prices persist. Prior authorization remains common.

• European Union

  Cost-containment policies promote biosimilar uptake, leading to price reductions (~15-30%).

• Emerging Markets

  Price sensitivity limits penetration; local manufacturing and generic biosimilars are pivotal.

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Regulatory Environment & Approvals

• FDA & EMA

  Timely approvals of biosimilars and novel formulations influence market share.

• Pricing & Reimbursement Policies

  Policies aiming to control healthcare expenditures, such as reference pricing and formulary restrictions, directly impact revenues.

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Financial Trajectory Projections

Revenue Trends (2022-2027)

Year	Estimated Market Revenue	Growth Drivers	Challenges
2022	$4.2 billion	Rising prevalence, innovations	Competitive pricing, biosimilars
2023	$4.8 billion	Biosimilar entry, new formulations	Patent expiries, reimbursement shifts
2024	$5.4 billion	Widened access, pump integration	Pricing erosion, regulatory hurdles
2025	$6.1 billion	Increased adoption in emerging markets	Pricing pressures
2027	$7.1 billion	Technological integration, personalized medicine	Market saturation

Assumptions: CAGR of approximately 10.9%; based on market reports and technological adoption trends.

Profitability Outlook

Factor	Impact
Research & Development	Continued innovation necessary to sustain premium pricing
Manufacturing Costs	Stable, but biosimilar production may lower costs over time
Pricing Pressures	Expected to intensify due to biosimilar competition
Reimbursement Policies	Shifting towards value-based models may constrain margins

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Comparative Analysis: Insulin Aspart vs. Other Rapid-Acting Insulins

Attribute	Insulin Aspart	Lispro (Humalog)	Glulisine (Apidra)
Onset	10-20 min	15 min	20 min
Peak	1-3 hours	1 hour	1 hour
Duration	3-5 hours	3-6 hours	3-5 hours
Formulations	Multiple, including Fiasp	Multiple	Single main formulation
Market Share (2022)	~55%	~25%	~10%

By leveraging formulation enhancements and delivery systems, insulin aspart maintains a competitive edge.

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Future Outlook and Strategic Considerations

Technological Innovations

• Development of ultra-rapid formulations (e.g., faster Fiasp variants)
• Integration with insulin pumps and smart device platforms
• Closed-loop insulin delivery system compatibility

Market Expansion Opportunities

• Emerging Markets: Infrastructure investments and affordability programs are key.
• Personalized Medicine: Biosensors and pharmacogenomics could refine dosing and improve outcomes.

Potential Risks

• Patent Expirations: Biosimilar threats may reduce profit margins.
• Regulatory Delays: Slower approvals impact revenue streams.
• Pricing Regulations: Globally increasing price controls pressurize revenues.

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Conclusion

The insulin aspart market stands on the cusp of significant growth driven by rising diabetes prevalence, technological advances, and newer formulations. While incumbent companies like Novo Nordisk dominate, biosimilar competition and reimbursement policies present both challenges and opportunities. Strategic innovation, market expansion, and adaptive pricing models will determine financial trajectories.

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Key Takeaways

• The insulin aspart market is projected to grow at a CAGR of nearly 11%, reaching over $7 billion globally by 2027.
• Innovation in formulation and delivery systems sustains competitive advantage amid biosimilar entries.
• Pricing and reimbursement policies are pivotal; biosimilars prompt downward pressure on prices.
• Embracing adaptative strategies to regulatory changes and market shifts is critical for sustained profitability.
• Emerging markets offer significant growth potential, contingent upon affordability strategies.

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FAQs

Q1: How does insulin aspart differ from other rapid-acting insulins?
Insulin aspart has a faster onset (10-20 min) than some counterparts like lispro and glulisine, with formulations like Fiasp including niacinamide to accelerate absorption. Its pharmacokinetic profile offers improved postprandial glucose control.

Q2: What impact will biosimilars have on the insulin aspart market?
Biosimilars are poised to reduce prices and expand access, increasing overall market volume but potentially lowering profit margins for original manufacturers. Patent expiries in 2023 for key brands will accelerate biosimilar entry.

Q3: Which regions show the highest growth potential for insulin aspart?
Emerging markets in Asia-Pacific, Latin America, and Africa are key growth areas due to increasing diabetes burden and improving healthcare infrastructure, although affordability remains a challenge.

Q4: How are regulatory policies influencing market forecasts?
Regulatory agencies’ pathways for biosimilar approval and pricing controls influence market entry and pricing strategies. Accelerated approvals and policy shifts favoring biosimilars will shape future revenues.

Q5: What technological innovations can secure market dominance?
Integration with insulin pump systems, development of ultra-rapid formulations, and digital health integration (e.g., smart injectors) will be critical for maintaining competitive advantage.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[3] WHO. Biosimilar Medicines: Strategies for Access, 2021.