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Last Updated: December 22, 2024

HUMULIN N Drug Profile


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Recent Clinical Trials for HUMULIN N

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina FasoPhase 4
Juvenile Diabetes Research FoundationPhase 4
Université NAZI BONIPhase 4

See all HUMULIN N clinical trials

Recent Litigation for HUMULIN N

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Sanofi-Aventis U.S. LLC v. Eli Lilly and Company2014-01-30

See all HUMULIN N litigation

Pharmacology for HUMULIN N
Established Pharmacologic ClassInsulin
Chemical StructureInsulin
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 HUMULIN N Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HUMULIN N Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HUMULIN N Derived from Patent Text Search

These patents were obtained by searching patent claims

HUMULIN N Market Analysis and Financial Projection Experimental

Human Recombinant Insulin Market: Focus on Humulin N

Market Overview of Human Recombinant Insulin

The human recombinant insulin market is a significant segment within the pharmaceutical industry, driven by the increasing prevalence of diabetes and the need for effective insulin therapies. As of 2024, the market size is estimated to be USD 28.47 billion and is projected to grow at a CAGR of greater than 2.9% to reach USD 32.20 billion by 2029[1].

Humulin N: A Key Player in the Market

What is Humulin N?

Humulin N is a type of human recombinant insulin produced through recombinant DNA technology in a non-disease-producing laboratory strain of E. coli bacteria. It is formulated to have a slower onset of action than regular insulin and a longer duration of activity, slightly less than 24 hours[1].

Historical Performance

In the past, Humulin has shown robust performance. For instance, in 2016, worldwide Humulin revenue increased by 4% to $1.366 billion, with U.S. revenue reaching $861.8 million, a 13% increase from the previous year[2].

Market Dynamics

Growth Drivers

The growth of the human recombinant insulin market, including Humulin N, is driven by several factors:

  • Increasing Prevalence of Diabetes: The rising number of diabetes cases globally is a significant driver. The COVID-19 pandemic has further exacerbated this trend, as patients with diabetes are at higher risk for severe COVID-19 infections[1].
  • Healthcare Expenditure: Increased healthcare expenditure on insulin therapies, including Humulin, contributes to market growth. For example, the average out-of-pocket spending by Medicare Part D enrollees for Humulin R U-500 was USD 116 in 2022[1].
  • Technological Advancements: Continuous improvements in recombinant DNA technology enhance the production and efficacy of insulin products like Humulin N.

Regional Analysis

  • North America: This region holds the largest market share for human recombinant insulin, including Humulin N, due to high healthcare spending and a large diabetic population[1].
  • Asia Pacific: This is the fastest-growing region, driven by increasing healthcare infrastructure and a rising diabetic population[1].

Financial Trajectory

Revenue Projections

The Humulin segment, including Humulin N, is expected to witness healthy growth. In 2021, the market value of Humulin was USD 1283.7 million and is anticipated to reach USD 1564.1 million by 2030, growing at a CAGR of 2.22%[4].

Pricing and Discounts

The pricing of insulin products, including Humulin N, is complex due to the role of rebates and middlemen. Despite high list prices, commercial discounts have increased significantly. For instance, the mean commercial discounts for short-acting insulin products increased from 37.9% in 2012 to 66.1% in 2019[5].

Competitive Landscape

Humulin N competes with other short-acting and long-acting insulin products such as Novolog and Humalog. While Novolog dominates the market, Humulin N is the fastest-growing segment among these. Key players in the market include Eli Lilly and Company, Novo Nordisk A/S, Sanofi S.A., and Biocon[1][4].

Challenges and Opportunities

Pricing Pressures

The high cost of insulin, including Humulin N, remains a significant challenge. The list prices of insulin products have increased substantially over the years, but the net prices faced by payers have seen fluctuations due to increased discounts. For example, the mean list price of short-acting insulin products increased at an annual rate of 12.7% from 2012 to 2017, but the net price growth was lower due to increased discounts[5].

Regulatory and Market Entry Barriers

New insulin products, including biosimilars, face barriers to entry into formularies and becoming preferred alternatives. This is due to the complex rebate system and the dominance of a few large pharmacy benefit managers (PBMs) and wholesalers[3].

Future Outlook

The future outlook for Humulin N is positive, driven by increasing demand and investments in production capacity. For instance, Eli Lilly & Company announced a USD 400 million investment in 2020 to expand their production capacity, which will support the growth of Humulin N and other insulin products[4].

Key Takeaways

  • Market Growth: The human recombinant insulin market, including Humulin N, is expected to grow at a CAGR of greater than 2.9% from 2024 to 2029.
  • Regional Dominance: North America holds the largest market share, while Asia Pacific is the fastest-growing region.
  • Financial Performance: Humulin N is projected to reach a market value of USD 1564.1 million by 2030, growing at a CAGR of 2.22%.
  • Pricing Dynamics: The market is characterized by high list prices and increasing commercial discounts.
  • Competitive Landscape: Humulin N competes with other major insulin products, and key players include Eli Lilly and Company, Novo Nordisk A/S, and Sanofi S.A.

FAQs

What is the current market size of the human recombinant insulin market?

The human recombinant insulin market size is expected to reach USD 28.47 billion in 2024[1].

Who are the major players in the human recombinant insulin market?

Major players include Novo Nordisk A/S, Eli Lilly and Company, Sanofi S.A., Biocon, and Zhuhai United Laboratories Co., Ltd.[1].

What is the fastest-growing region in the human recombinant insulin market?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period (2024-2029)[1].

How does the pricing of Humulin N compare to other insulin products?

Humulin N, like other insulin products, has high list prices but benefits from increasing commercial discounts, which reduce the net price faced by payers[5].

What are the key drivers for the growth of Humulin N?

Key drivers include the increasing prevalence of diabetes, higher healthcare expenditure, and technological advancements in recombinant DNA technology[1].

Sources

  1. Mordor Intelligence: Human Recombinant Insulin Market - Trends & Industry Analysis.
  2. Eli Lilly Investor Relations: Lilly Reports Fourth-Quarter and Full-Year 2016 Results.
  3. Mayo Clinic Proceedings: The High Cost of Insulin in the United States: An Urgent Call to Action.
  4. Spherical Insights: Short-Acting Insulin Market Size, Share | Statistics 2030.
  5. JAMA Health Forum: Estimated Changes in Insulin Prices and Discounts After Entry of New Products.

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